Meaghan Roach, Natalie Land, Jennifer Hernandez, Reina Rau, Jacquelyn W. Chou, Stacey S. Hickson, Danielle F. Rollmann, J. Ross Maclean
Background. Over the last 25 years, clinical practice guidelines have emerged as a means to standardize and improve care. As pharmaceutical innovations develop, guidelines are updated to incorporate new interventions. However, the extent to which pharmacotherapies are represented as treatment options in guideline recommendations has not been well elucidated. This study aimed to quantify the role pharmacotherapy has played in clinical practice guidelines across a range of chronic diseases over the past 20 years. Methods. Clinical practice guidelines published from 2000 to 2021 were identified for five chronic diseases: ischemic heart disease (IHD), non-small cell lung cancer (NSCLC), chronic obstructive pulmonary disease (COPD), Alzheimer’s disease (AD), and type 2 diabetes (T2D). Guidelines were reviewed and data on treatment recommendations were collected, including the type of intervention, line of therapy, and, for pharmacotherapies, year of regulatory approval and year of inclusion in guidelines. Results. In total, 92 clinical practice guidelines were reviewed. Among the 184 discrete recommended interventions across the five disease areas, 146 (79.3%) were pharmacotherapies, 21 (11.4%) were behavioral modifications, 6 (3.3%) were surgical interventions, and 11 (6%) were other interventions. Across guidelines, when a line of therapy was specified, behavioral modifications and pharmacotherapies were most frequently recommended as first-line interventions, whereas surgical interventions were more often recommended for subsequent lines of treatment. The time from regulatory approval of novel pharmacotherapies to inclusion in guideline recommendations varied considerably by disease area and geography. Conclusions. Across the reviewed disease areas, behavioral interventions and pharmacotherapies are shown to be critical components of clinical practice. Over the last 20 years, novel pharmaceutical innovations have been incorporated into clinical practice guideline recommendations; however, with varying speeds of adoption. Given the increasing pace of pharmacologic innovation, timely updates of clinical practice guidelines are critical to evolving the standard of care and practicing evidence-based medicine.
{"title":"The Role of Pharmaceutical Innovation in Clinical Practice Guidelines for Chronic Diseases","authors":"Meaghan Roach, Natalie Land, Jennifer Hernandez, Reina Rau, Jacquelyn W. Chou, Stacey S. Hickson, Danielle F. Rollmann, J. Ross Maclean","doi":"10.1155/2024/5877687","DOIUrl":"10.1155/2024/5877687","url":null,"abstract":"<p><i>Background</i>. Over the last 25 years, clinical practice guidelines have emerged as a means to standardize and improve care. As pharmaceutical innovations develop, guidelines are updated to incorporate new interventions. However, the extent to which pharmacotherapies are represented as treatment options in guideline recommendations has not been well elucidated. This study aimed to quantify the role pharmacotherapy has played in clinical practice guidelines across a range of chronic diseases over the past 20 years. <i>Methods</i>. Clinical practice guidelines published from 2000 to 2021 were identified for five chronic diseases: ischemic heart disease (IHD), non-small cell lung cancer (NSCLC), chronic obstructive pulmonary disease (COPD), Alzheimer’s disease (AD), and type 2 diabetes (T2D). Guidelines were reviewed and data on treatment recommendations were collected, including the type of intervention, line of therapy, and, for pharmacotherapies, year of regulatory approval and year of inclusion in guidelines. <i>Results</i>. In total, 92 clinical practice guidelines were reviewed. Among the 184 discrete recommended interventions across the five disease areas, 146 (79.3%) were pharmacotherapies, 21 (11.4%) were behavioral modifications, 6 (3.3%) were surgical interventions, and 11 (6%) were other interventions. Across guidelines, when a line of therapy was specified, behavioral modifications and pharmacotherapies were most frequently recommended as first-line interventions, whereas surgical interventions were more often recommended for subsequent lines of treatment. The time from regulatory approval of novel pharmacotherapies to inclusion in guideline recommendations varied considerably by disease area and geography. <i>Conclusions</i>. Across the reviewed disease areas, behavioral interventions and pharmacotherapies are shown to be critical components of clinical practice. Over the last 20 years, novel pharmaceutical innovations have been incorporated into clinical practice guideline recommendations; however, with varying speeds of adoption. Given the increasing pace of pharmacologic innovation, timely updates of clinical practice guidelines are critical to evolving the standard of care and practicing evidence-based medicine.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140108072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The emergence of antibiotic-resistant strains, the decreased effectiveness of conventional therapies, and the side effects have led researchers to seek a safer, more cost-effective, patient-friendly, and effective method that does not develop antibiotic resistance. With progress in synthetic biology and genetic engineering, genetically engineered microorganisms effective in treatment, prophylaxis, drug delivery, and diagnosis have been developed. The present study reviews the types of genetically engineered bacteria and phages, their impacts on diseases, cancer, and metabolic and inflammatory disorders, the biosynthesis of these modified strains, the route of administration, and their effects on the environment. We conclude that genetically engineered microorganisms can be considered promising candidates for adjunctive treatment of diseases and cancers.
{"title":"Genetically Engineered Microorganisms and Their Impact on Human Health","authors":"Marzie Mahdizade Ari, Leila Dadgar, Zahra Elahi, Roya Ghanavati, Behrouz Taheri","doi":"10.1155/2024/6638269","DOIUrl":"10.1155/2024/6638269","url":null,"abstract":"<p>The emergence of antibiotic-resistant strains, the decreased effectiveness of conventional therapies, and the side effects have led researchers to seek a safer, more cost-effective, patient-friendly, and effective method that does not develop antibiotic resistance. With progress in synthetic biology and genetic engineering, genetically engineered microorganisms effective in treatment, prophylaxis, drug delivery, and diagnosis have been developed. The present study reviews the types of genetically engineered bacteria and phages, their impacts on diseases, cancer, and metabolic and inflammatory disorders, the biosynthesis of these modified strains, the route of administration, and their effects on the environment. We conclude that genetically engineered microorganisms can be considered promising candidates for adjunctive treatment of diseases and cancers.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140073205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zuzana Horakova, Ivo Starek, Jana Zapletalova, Richard Salzman
The excellent survival rate of cutaneous squamous cell carcinoma (cSCC) exceeding 90% is reduced by the presence of nodal metastases by over 50%. We analysed various risk parameters of cSCC to predict the incidence of nodal metastases. A total of 118 patients with the head cSCC were included in a single-institution retrospective study covering the period from 2008 to 2020. Tumour recurrence, temple location, and tumour infiltration depth were found to be independent predictors of nodal metastases (increasing the probability of metastases by 8.0, 8.1, and 4.3 times, respectively). Furthermore, univariate analysis shows that the tumour size and T stage are significant factors increasing the risk of metastases. Several independent risk factors for the development of metastases in the head cSCC have been confirmed. These findings might help identify at-risk patients who require additional attention for adequate radical treatment and close follow-up. In contrast, elective treatment of lymph nodes is not recommended due to the low incidence of regional metastases.
皮肤鳞状细胞癌(cSCC)的存活率超过 90%,但由于出现结节转移,存活率降低了 50%以上。我们分析了 cSCC 的各种风险参数,以预测结节转移的发生率。一项单一机构的回顾性研究共纳入了118例头部cSCC患者,研究时间跨度为2008年至2020年。研究发现,肿瘤复发、太阳穴位置和肿瘤浸润深度是结节转移的独立预测因素(转移概率分别增加8.0倍、8.1倍和4.3倍)。此外,单变量分析表明,肿瘤大小和 T 分期是增加转移风险的重要因素。头部 cSCC 发生转移的几个独立风险因素已被证实。这些发现可能有助于确定需要额外关注的高危患者,以进行适当的根治性治疗和密切随访。相比之下,由于区域转移的发生率较低,因此不建议选择淋巴结治疗。
{"title":"Tumour Recurrence, Depth of Invasion, and Temple Location as Independent Prognostic Parameters of Lymph Node Metastases of Head and Neck Cutaneous Squamous Cell Carcinomas","authors":"Zuzana Horakova, Ivo Starek, Jana Zapletalova, Richard Salzman","doi":"10.1155/2024/9960948","DOIUrl":"10.1155/2024/9960948","url":null,"abstract":"<p>The excellent survival rate of cutaneous squamous cell carcinoma (cSCC) exceeding 90% is reduced by the presence of nodal metastases by over 50%. We analysed various risk parameters of cSCC to predict the incidence of nodal metastases. A total of 118 patients with the head cSCC were included in a single-institution retrospective study covering the period from 2008 to 2020. Tumour recurrence, temple location, and tumour infiltration depth were found to be independent predictors of nodal metastases (increasing the probability of metastases by 8.0, 8.1, and 4.3 times, respectively). Furthermore, univariate analysis shows that the tumour size and T stage are significant factors increasing the risk of metastases. Several independent risk factors for the development of metastases in the head cSCC have been confirmed. These findings might help identify at-risk patients who require additional attention for adequate radical treatment and close follow-up. In contrast, elective treatment of lymph nodes is not recommended due to the low incidence of regional metastases.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140072820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gang Yuan, Yili Chen, Li Li, Xin Wang, Gang Wei, Jiawei Zeng, Ai-Min Hui, Yueyun Jiang, Han Zhao, Lei Diao, Yongchun Zhou, Yinglian Xiao, Minhu Chen
Background. Tenapanor is a locally acting selective sodium-hydrogen exchanger 3 inhibitor with the potential to treat sodium/phosphorus and fluid overload in various cardiac-renal diseases, which has been approved for constipation-predominant irritable bowel syndrome in the US. The pharmacokinetics (PK) of tenapanor and its metabolite tenapanor-M1 (AZ13792925), as well as the safety and tolerability of tenapanor, were investigated in healthy Chinese and Caucasian subjects. Methods. This randomized, open-label, single-center, placebo-controlled phase 1 study (https://www.chinadrugtrials.org.cn; CTR20201783) enrolled Chinese and Caucasian healthy volunteers into 4 parallel cohorts (3 cohorts for Chinese subjects, 1 cohort for Caucasian subjects). In each cohort, 15 subjects were expected to be included and received oral tenapanor (10 or 30 mg as single dose, or 50 mg as a single dose followed by a twice-daily repeated dose from Day 5 to 11, with a single dose in the morning on Day 11) or placebo in a 4 : 1 ratio. Results. 59 healthy volunteers received tenapanor 10 mg (n = 12 Chinese), 30 mg (n = 12 Chinese), or 50 mg (n = 12 (Chinese), n = 11 (Caucasian)) or placebo (n = 12, 3 per cohort). After single and twice-daily repeated doses, tenapanor plasma concentrations were all below the limit of quantitation; tenapanor-M1 appeared slowly in plasma. In single-ascending dose evaluation (10 to 50 mg) of Chinese subjects, the mean Cmax, AUC0-t, and AUC0-∞ of tenapanor-M1 increased with increasing dose level, and AUC0-t increased approximately dose proportionally. The Cmax accumulation ratio was 1.55 to 6.92 after 50 mg repeated dose in Chinese and Caucasian subjects. Exposure to tenapanor-M1 was generally similar between the Chinese and Caucasian subjects. Tenapanor was generally well-tolerated and the safety profile was similar between the Chinese and Caucasian participants receiving tenapanor 50 mg, as measured by vital signs, physical and laboratory examination, 12-lead ECG, and adverse events. No serious adverse event or adverse event leading to withdrawal occurred. Conclusion. Tenapanor was well-tolerated, with similar PK and safety profiles between Chinese and Caucasian subjects. This trial is registered with CTR20201783.
{"title":"Pharmacokinetics, Safety, and Tolerability of Tenapanor in Healthy Chinese and Caucasian Volunteers: A Randomized, Open-Label, Single-Center, Placebo-Controlled Phase 1 Study","authors":"Gang Yuan, Yili Chen, Li Li, Xin Wang, Gang Wei, Jiawei Zeng, Ai-Min Hui, Yueyun Jiang, Han Zhao, Lei Diao, Yongchun Zhou, Yinglian Xiao, Minhu Chen","doi":"10.1155/2024/1386980","DOIUrl":"10.1155/2024/1386980","url":null,"abstract":"<p><i>Background</i>. Tenapanor is a locally acting selective sodium-hydrogen exchanger 3 inhibitor with the potential to treat sodium/phosphorus and fluid overload in various cardiac-renal diseases, which has been approved for constipation-predominant irritable bowel syndrome in the US. The pharmacokinetics (PK) of tenapanor and its metabolite tenapanor-M1 (AZ13792925), as well as the safety and tolerability of tenapanor, were investigated in healthy Chinese and Caucasian subjects. <i>Methods</i>. This randomized, open-label, single-center, placebo-controlled phase 1 study (https://www.chinadrugtrials.org.cn; CTR20201783) enrolled Chinese and Caucasian healthy volunteers into 4 parallel cohorts (3 cohorts for Chinese subjects, 1 cohort for Caucasian subjects). In each cohort, 15 subjects were expected to be included and received oral tenapanor (10 or 30 mg as single dose, or 50 mg as a single dose followed by a twice-daily repeated dose from Day 5 to 11, with a single dose in the morning on Day 11) or placebo in a 4 : 1 ratio. <i>Results</i>. 59 healthy volunteers received tenapanor 10 mg (<i>n</i> = 12 Chinese), 30 mg (<i>n</i> = 12 Chinese), or 50 mg (<i>n</i> = 12 (Chinese), <i>n</i> = 11 (Caucasian)) or placebo (<i>n</i> = 12, 3 per cohort). After single and twice-daily repeated doses, tenapanor plasma concentrations were all below the limit of quantitation; tenapanor-M1 appeared slowly in plasma. In single-ascending dose evaluation (10 to 50 mg) of Chinese subjects, the mean <i>C</i><sub>max</sub>, AUC<sub>0-<i>t</i></sub>, and AUC<sub>0-∞</sub> of tenapanor-M1 increased with increasing dose level, and AUC<sub>0-<i>t</i></sub> increased approximately dose proportionally. The <i>C</i><sub>max</sub> accumulation ratio was 1.55 to 6.92 after 50 mg repeated dose in Chinese and Caucasian subjects. Exposure to tenapanor-M1 was generally similar between the Chinese and Caucasian subjects. Tenapanor was generally well-tolerated and the safety profile was similar between the Chinese and Caucasian participants receiving tenapanor 50 mg, as measured by vital signs, physical and laboratory examination, 12-lead ECG, and adverse events. No serious adverse event or adverse event leading to withdrawal occurred. <i>Conclusion</i>. Tenapanor was well-tolerated, with similar PK and safety profiles between Chinese and Caucasian subjects. This trial is registered with CTR20201783.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140045486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aim. This study was conducted to determine the effect of combining vibration and external cold on pain caused by vaccine injection among six-month-old infants. Design. Randomized controlled trial. Methods. In this clinical trial, 80 eligible infants were selected from the infants referred to a health center as per the inclusion criteria. The infants were assigned to either a control group or an intervention group by block randomization. In the intervention group, a vibrating and cold device was placed above the injection site from one minute before to 15 seconds after the pentavalent vaccine injection. In the control group, no intervention was performed, and they were vaccinated according to the routine procedure. The pain status in the two groups was measured using the Modified Behavioral Pain Scale (MBPS) 15 seconds after the injection, and the crying duration was assessed from the injection of the vaccine till the end of it. Data were analyzed in SPSS 23 software using Mann–Whitney, t, Spearman, and chi-square tests. The level of significance was set to p < 0.05. Results. Most participants in the control (55%) and intervention (55%) groups were girls. Statistical data analysis of 80 infants showed that the mean pain intensity (p = 0.032) and duration of crying (p = 0.0001) in the intervention group (6.1 ± 1.8, 32.47 ± 16.78) were lower than those of the control group (7.2 ± 0.1, 51.02 ± 25.9), respectively. Conclusion. Because the intensity of pain, especially the duration of crying, was lower in the intervention group than in the control group, we may suggest that nurses use simple pain relief solutions in vaccination centers, such as a combination of vibration and cold. This trial is registered with IRCT201207157130N2.
{"title":"The Effect of a Combination of Vibration and External Cold on Pain Caused during Vaccine Injection in Infants: A Randomized Clinical Trial","authors":"Zahra Unesi, Zahra Amouzeshi, Javad Jamavar, Fatemeh Mahmoudzadeh Zarandi","doi":"10.1155/2024/7170927","DOIUrl":"10.1155/2024/7170927","url":null,"abstract":"<p><i>Aim</i>. This study was conducted to determine the effect of combining vibration and external cold on pain caused by vaccine injection among six-month-old infants. <i>Design</i>. Randomized controlled trial. <i>Methods</i>. In this clinical trial, 80 eligible infants were selected from the infants referred to a health center as per the inclusion criteria. The infants were assigned to either a control group or an intervention group by block randomization. In the intervention group, a vibrating and cold device was placed above the injection site from one minute before to 15 seconds after the pentavalent vaccine injection. In the control group, no intervention was performed, and they were vaccinated according to the routine procedure. The pain status in the two groups was measured using the Modified Behavioral Pain Scale (MBPS) 15 seconds after the injection, and the crying duration was assessed from the injection of the vaccine till the end of it. Data were analyzed in SPSS 23 software using Mann–Whitney, <i>t</i>, Spearman, and chi-square tests. The level of significance was set to <i>p</i> < 0.05. <i>Results</i>. Most participants in the control (55%) and intervention (55%) groups were girls. Statistical data analysis of 80 infants showed that the mean pain intensity (<i>p</i> = 0.032) and duration of crying (<i>p</i> = 0.0001) in the intervention group (6.1 ± 1.8, 32.47 ± 16.78) were lower than those of the control group (7.2 ± 0.1, 51.02 ± 25.9), respectively. <i>Conclusion</i>. Because the intensity of pain, especially the duration of crying, was lower in the intervention group than in the control group, we may suggest that nurses use simple pain relief solutions in vaccination centers, such as a combination of vibration and cold. This trial is registered with IRCT201207157130N2.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140025947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bingchao Ling, Weishun Xie, Yi Zhong, Taowen Feng, Yueli Huang, Lianying Ge, Aiqun Liu
Background. Endobronchial ultrasound (EBUS) sonographic features help identify benign/malignant lymph nodes while conducting transbronchial needle aspiration (TBNA). This study aims to identify risk factors for malignancy based on EBUS sonographic features and to estimate the risk of malignancy in lymph nodes by constructing a nomogram. Methods. 1082 lymph nodes from 625 patients were randomly enrolled in training (n = 760) and validation (n = 322) sets. The subgroup of EBUS-TBNA postoperative negative lymph nodes (n = 317) was randomly enrolled in a training (n = 224) set and a validation (n = 93) set. Logistic regression analysis was used to identify the EBUS features of malignant lymph nodes. A nomogram was formulated using the EBUS features in the training set and later validated in the validation set. Results. Multivariate analysis revealed that long-axis, short-axis, echogenicity, fusion, and central hilar structure (CHS) were the independent predictors of malignant lymph nodes. Based on these risk factors, a nomogram was constructed. Both the training and validation sets of 5 EBUS features nomogram showed good discrimination, with area under the curve values of 0.880 (sensitivity = 0.829 and specificity = 0.807) and 0.905 (sensitivity = 0.819 and specificity = 0.857). Subgroup multivariate analysis revealed that long-axis, echogenicity, and CHS were the independent predictors of malignancy outcomes of EBUS-TBNA postoperative negative lymph nodes. Based on these risk factors, a nomogram was constructed. Both the training and validation sets of 3 EBUS features nomogram showed good discrimination, with the area under the curve values of 0.890 (sensitivity = 0.882 and specificity = 0.786) and 0.834 (sensitivity = 0.930 and specificity = 0.636). Conclusions. Our novel scoring system based on two nomograms can be utilized to predict malignant lymph nodes.
{"title":"A Nomogram to Predict Benign/Malignant Mediastinal Lymph Nodes Based on EBUS Sonographic Features","authors":"Bingchao Ling, Weishun Xie, Yi Zhong, Taowen Feng, Yueli Huang, Lianying Ge, Aiqun Liu","doi":"10.1155/2024/3711123","DOIUrl":"10.1155/2024/3711123","url":null,"abstract":"<p><i>Background</i>. Endobronchial ultrasound (EBUS) sonographic features help identify benign/malignant lymph nodes while conducting transbronchial needle aspiration (TBNA). This study aims to identify risk factors for malignancy based on EBUS sonographic features and to estimate the risk of malignancy in lymph nodes by constructing a nomogram. <i>Methods</i>. 1082 lymph nodes from 625 patients were randomly enrolled in training (<i>n</i> = 760) and validation (<i>n</i> = 322) sets. The subgroup of EBUS-TBNA postoperative negative lymph nodes (<i>n</i> = 317) was randomly enrolled in a training (<i>n</i> = 224) set and a validation (<i>n</i> = 93) set. Logistic regression analysis was used to identify the EBUS features of malignant lymph nodes. A nomogram was formulated using the EBUS features in the training set and later validated in the validation set. <i>Results</i>. Multivariate analysis revealed that long-axis, short-axis, echogenicity, fusion, and central hilar structure (CHS) were the independent predictors of malignant lymph nodes. Based on these risk factors, a nomogram was constructed. Both the training and validation sets of 5 EBUS features nomogram showed good discrimination, with area under the curve values of 0.880 (sensitivity = 0.829 and specificity = 0.807) and 0.905 (sensitivity = 0.819 and specificity = 0.857). Subgroup multivariate analysis revealed that long-axis, echogenicity, and CHS were the independent predictors of malignancy outcomes of EBUS-TBNA postoperative negative lymph nodes. Based on these risk factors, a nomogram was constructed. Both the training and validation sets of 3 EBUS features nomogram showed good discrimination, with the area under the curve values of 0.890 (sensitivity = 0.882 and specificity = 0.786) and 0.834 (sensitivity = 0.930 and specificity = 0.636). <i>Conclusions</i>. Our novel scoring system based on two nomograms can be utilized to predict malignant lymph nodes.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140007980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background. Local infiltration analgesia (LIA) provides postoperative analgesia for total knee arthroplasty (TKA). The purpose of this study was to evaluate the analgesic effect of a cocktail of ropivacaine, morphine, and Diprospan for TKA. Methods. A total of 100 patients from September 2018 to February 2019 were randomized into 2 groups. Group A (control group, 50 patients) received LIA of ropivacaine alone (80 ml, 0.25% ropivacaine). Group B (LIA group, 50 patients) received an LIA cocktail of ropivacaine, morphine, and Diprospan (80 ml, 0.25% ropivacaine, 0.125 mg/ml morphine, and 62.5 μg/ml compound betamethasone). The primary outcomes were the levels of inflammatory markers C-reactive protein (CRP) and interleukin-6 (IL-6), pain visual analog scale (VAS) scores, opioid consumption, range of motion (ROM), functional tests, and sleeping quality. The secondary outcomes were adverse events, satisfaction rates, HSS scores, and SF-12 scores. The longest follow-up was 2 years. Results. The two groups showed no differences in terms of characteristics (P > 0.05). Group B had lower resting VAS pain scores (1.54 ± 0.60, 95% CI = 1.37 to 1.70 vs. 2.00 ± 0.63, 95% CI = 2.05 to 2.34) and active VAS pain scores (2.64 ± 0.62, 95% CI = 2.46 to 2.81 vs. 3.16 ± 0.75, 95% CI = 2.95 to 3.36) within 48 h postoperatively than Group A (P < 0.001), while none of the pain differences exceeded the minimal clinically important difference (MCID). Group B had significantly lower CRP levels (59.49 ± 13.01, 95% CI = 55.88 to 63.09 vs. 65.95 ± 14.41, 95% CI = 61.95 to 69.94) and IL-6 levels (44.11 ± 13.67, 95% CI = 40.32 to 47.89 vs. 60.72 ± 15.49, 95% CI = 56.42 to 65.01), lower opioid consumption (7.60 ± 11.10, 95% CI = 4.52 to 10.67 vs. 13.80 ± 14.68, 95% CI = 9.73 to 17.86), better ROM (110.20 ± 10.46, 95% CI = 107.30 to 113.09 vs. 105.30 ± 10.02, 95% CI = 102.52 to 108.07), better sleep quality (3.40 ± 1.03, 95% CI = 3.11 to 3.68 vs. 4.20 ± 1.06, 95% CI = 3.90 to 4.49), and higher satisfaction rates than Group A within 48 h postoperatively (P < 0.05). Adverse events, HSS scores, and SF-12 scores were not significantly different within 2 years postoperatively. Conclusions. A cocktail of ropivacaine, morphine, and Diprospan prolongs the analgesic effect up to 48 h postoperatively. Although the small statistical benefit may not result in MCID, the LIA cocktail still reduces opioid consumption, results in better sleeping quality and faster rehabilitation, and does not increase adverse events. Therefore, cocktails of ropivacaine, morphine, and Diprospan have good application value for pain control in TKA. This trial is registered with ChiCTR1800018372.
背景。局部浸润镇痛(LIA)为全膝关节置换术(TKA)提供术后镇痛。本研究的目的是评估罗哌卡因、吗啡和 Diprospan 鸡尾酒对 TKA 的镇痛效果。方法。将2018年9月至2019年2月的100名患者随机分为2组。A 组(对照组,50 名患者)接受单独的罗哌卡因 LIA(80 毫升,0.25% 罗哌卡因)。B组(LIA组,50名患者)接受罗哌卡因、吗啡和Diprospan鸡尾酒LIA(80毫升,0.25%罗哌卡因、0.125毫克/毫升吗啡和62.5微克/毫升复方倍他米松)。主要结果是炎症指标C反应蛋白(CRP)和白细胞介素-6(IL-6)水平、疼痛视觉模拟量表(VAS)评分、阿片类药物用量、活动范围(ROM)、功能测试和睡眠质量。次要结果包括不良事件、满意率、HSS 评分和 SF-12 评分。最长随访时间为 2 年。结果显示两组在特征方面没有差异()。与A组相比,B组在术后48小时内的静息VAS疼痛评分(1.54±0.60,95% CI = 1.37至1.70 vs. 2.00±0.63,95% CI = 2.05至2.34)和活动VAS疼痛评分(2.64±0.62,95% CI = 2.46至2.81 vs. 3.16±0.75,95% CI = 2.95至3.36)更低,而疼痛差异均未超过最小临床意义差异(MCID)。B 组的 CRP 水平(59.49 ± 13.01,95% CI = 55.88 至 63.09 vs. 65.95 ± 14.41,95% CI = 61.95 至 69.94)和 IL-6 水平(44.11 ± 13.67,95% CI = 40.32 至 47.89 vs. 60.72 ± 15.49,95% CI = 56.42 至 65.01)明显降低,阿片类药物用量(7.60 ± 11.10,95% CI = 4.52 至 10.67 vs. 13.80 ± 14.68,95% CI = 9.73 至 17.86),更好的 ROM(110.20 ± 10.46,95% CI = 107.30 至 113.09 vs. 105.30 ± 10.02,95% CI = 102.52 至 108.07),更好的睡眠质量(3.40 ± 1.03,95% CI = 3.11 至 3.68 vs. 4.20 ± 1.06,95% CI = 3.90 至 4.49),术后 48 h 内满意率高于 A 组()。不良事件、HSS评分和SF-12评分在术后2年内无显著差异。结论罗哌卡因、吗啡和Diprospan鸡尾酒可将镇痛效果延长至术后48小时。虽然统计上的微小获益可能不会导致MCID,但LIA鸡尾酒仍然减少了阿片类药物的消耗,提高了睡眠质量,加快了康复速度,而且不会增加不良反应。因此,罗哌卡因、吗啡和Diprospan鸡尾酒在TKA疼痛控制中具有良好的应用价值。本试验注册号为ChiCTR1800018372。
{"title":"Cocktail of Ropivacaine, Morphine, and Diprospan Reduces Pain and Prolongs Analgesic Effects after Total Knee Arthroplasty: A Prospective Randomized Controlled Trial","authors":"Zhenyu Luo, Weinan Zeng, Xi Chen, Qiang Xiao, Anjing Chen, Jiali Chen, Haoyang Wang, Zongke Zhou","doi":"10.1155/2024/3697846","DOIUrl":"10.1155/2024/3697846","url":null,"abstract":"<p><i>Background</i>. Local infiltration analgesia (LIA) provides postoperative analgesia for total knee arthroplasty (TKA). The purpose of this study was to evaluate the analgesic effect of a cocktail of ropivacaine, morphine, and Diprospan for TKA. <i>Methods</i>. A total of 100 patients from September 2018 to February 2019 were randomized into 2 groups. Group A (control group, 50 patients) received LIA of ropivacaine alone (80 ml, 0.25% ropivacaine). Group B (LIA group, 50 patients) received an LIA cocktail of ropivacaine, morphine, and Diprospan (80 ml, 0.25% ropivacaine, 0.125 mg/ml morphine, and 62.5 <i>μ</i>g/ml compound betamethasone). The primary outcomes were the levels of inflammatory markers C-reactive protein (CRP) and interleukin-6 (IL-6), pain visual analog scale (VAS) scores, opioid consumption, range of motion (ROM), functional tests, and sleeping quality. The secondary outcomes were adverse events, satisfaction rates, HSS scores, and SF-12 scores. The longest follow-up was 2 years. <i>Results</i>. The two groups showed no differences in terms of characteristics (<i>P</i> > 0.05). Group B had lower resting VAS pain scores (1.54 ± 0.60, 95% CI = 1.37 to 1.70 vs. 2.00 ± 0.63, 95% CI = 2.05 to 2.34) and active VAS pain scores (2.64 ± 0.62, 95% CI = 2.46 to 2.81 vs. 3.16 ± 0.75, 95% CI = 2.95 to 3.36) within 48 h postoperatively than Group A (<i>P</i> < 0.001), while none of the pain differences exceeded the minimal clinically important difference (MCID). Group B had significantly lower CRP levels (59.49 ± 13.01, 95% CI = 55.88 to 63.09 vs. 65.95 ± 14.41, 95% CI = 61.95 to 69.94) and IL-6 levels (44.11 ± 13.67, 95% CI = 40.32 to 47.89 vs. 60.72 ± 15.49, 95% CI = 56.42 to 65.01), lower opioid consumption (7.60 ± 11.10, 95% CI = 4.52 to 10.67 vs. 13.80 ± 14.68, 95% CI = 9.73 to 17.86), better ROM (110.20 ± 10.46, 95% CI = 107.30 to 113.09 vs. 105.30 ± 10.02, 95% CI = 102.52 to 108.07), better sleep quality (3.40 ± 1.03, 95% CI = 3.11 to 3.68 vs. 4.20 ± 1.06, 95% CI = 3.90 to 4.49), and higher satisfaction rates than Group A within 48 h postoperatively (<i>P</i> < 0.05). Adverse events, HSS scores, and SF-12 scores were not significantly different within 2 years postoperatively. <i>Conclusions</i>. A cocktail of ropivacaine, morphine, and Diprospan prolongs the analgesic effect up to 48 h postoperatively. Although the small statistical benefit may not result in MCID, the LIA cocktail still reduces opioid consumption, results in better sleeping quality and faster rehabilitation, and does not increase adverse events. Therefore, cocktails of ropivacaine, morphine, and Diprospan have good application value for pain control in TKA. This trial is registered with ChiCTR1800018372.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140007809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zainab Ali Alkhalaf, Mohammed Ghazi Sghaireen, Kiran Kumar Ganji, Mohammad Khursheed Alam, Rakhi Issrani, Raghad Mohammed Alsaleh, Sultana Zamil Almegren, Mahmoud Gamal Salloum
Aim. To investigate the impact of the curve of Spee (CS) accentuation on bite force, chewing ability, and additionally, other factors that influence chewing ability and bite force such as restorations, caries, gender, habits, and TMJ problems. Materials and Methods. 231 participants (118 male and 113 female, mean age = ±27.96 years) were recruited for this cross-section study. Participants completed a data collection sheet in which age, gender, Angle’s classification of malocclusion, overjet, overbite, TMJ problems, habits, restorations, and caries experience were recorded. Two examiners made a lower impression, chewing ability test and measured the bite force for each participant. Measurement of the CS was obtained digitally from the poured dental cast, and the categorization was as follows: flat (<1 mm), normal (1-2 mm), or deep (>2 mm). Results. The mean maximum bite force (MBF) was 468.722 N for participants with flat CS, 389.822 N for normal CS, 647.08 N for deep CS, and 384.667 N for reverse CS. The average MBF was higher for participants with deep CS (p < 0.05). MBF force was higher in males. However, BMI was not significantly related to MBF values. Participants with normal and flat CS have comparable chewing capacity (p > 0.05). Also, a significant difference in bite force and chewing ability was found between the three categories of CS (p < 0.05). Conclusion. Bite force variations across various CS types were linked to gender and habits. Chewing ability showed no differences concerning gender, habits, TMJ problems, caries, or restorations, emphasizing CS’s significant impact on bite force while showcasing the unchanged nature of chewing ability amidst diverse factors.
{"title":"Unveiling the Influence of the Curve of Spee on Bite Force and Chewing Ability: A Comparative Study","authors":"Zainab Ali Alkhalaf, Mohammed Ghazi Sghaireen, Kiran Kumar Ganji, Mohammad Khursheed Alam, Rakhi Issrani, Raghad Mohammed Alsaleh, Sultana Zamil Almegren, Mahmoud Gamal Salloum","doi":"10.1155/2024/6533841","DOIUrl":"10.1155/2024/6533841","url":null,"abstract":"<p><i>Aim</i>. To investigate the impact of the curve of Spee (CS) accentuation on bite force, chewing ability, and additionally, other factors that influence chewing ability and bite force such as restorations, caries, gender, habits, and TMJ problems. <i>Materials and Methods</i>. 231 participants (118 male and 113 female, mean age = ±27.96 years) were recruited for this cross-section study. Participants completed a data collection sheet in which age, gender, Angle’s classification of malocclusion, overjet, overbite, TMJ problems, habits, restorations, and caries experience were recorded. Two examiners made a lower impression, chewing ability test and measured the bite force for each participant. Measurement of the CS was obtained digitally from the poured dental cast, and the categorization was as follows: flat (<1 mm), normal (1-2 mm), or deep (>2 mm). <i>Results</i>. The mean maximum bite force (MBF) was 468.722 N for participants with flat CS, 389.822 N for normal CS, 647.08 N for deep CS, and 384.667 N for reverse CS. The average MBF was higher for participants with deep CS (<i>p</i> < 0.05). MBF force was higher in males. However, BMI was not significantly related to MBF values. Participants with normal and flat CS have comparable chewing capacity (<i>p</i> > 0.05). Also, a significant difference in bite force and chewing ability was found between the three categories of CS (<i>p</i> < 0.05). <i>Conclusion</i>. Bite force variations across various CS types were linked to gender and habits. Chewing ability showed no differences concerning gender, habits, TMJ problems, caries, or restorations, emphasizing CS’s significant impact on bite force while showcasing the unchanged nature of chewing ability amidst diverse factors.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139920955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction. Takotsubo cardiomyopathy (TCM) features transient left ventricular apical dysfunction or ballooning. The underlying mechanism remains elusive; however, evidence suggests the role of different physical and psychological stressors. We systematically reviewed patients presenting with TCM and autoimmunity to explore the link between the two conditions. Methods. We applied the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) to report this review. Using keywords related to autoimmune/immune-mediated diseases and TCM, we searched PubMed, Scopus, and WOS in March 2022. The final results were added to a data extraction sheet. Data were analyzed by SPSS version 26.0. Results. Our search yielded 121 studies, including 155 patients. Females were considerably predominant. Most patients had a history of autoimmune disease, and almost a third had a history of cardiovascular disease. Dyspnea and chest pain were the most common chief complaints. More than 70% of patients had experienced physical stress. Myasthenia gravis, systemic lupus erythematosus, and multiple sclerosis were the most frequently reported autoimmune diseases. Conclusion. There were similarities in age and sex compared to classic TCM. TCM should be considered as a differential diagnosis for ACS, especially in patients with a positive background of autoimmunity. A precise reporting system is required for further studies.
{"title":"Takotsubo Cardiomyopathy and Autoimmune Disorders: A Systematic Scoping Review of Published Cases","authors":"Mohsen Farjoud Kouhanjani, Seyed Ali Hosseini, Seyedeh Maryam Mousavi, Zahra Noroozi, Paniz Sadeghi, Armita Jokar-Derisi, Mohammad Saleh Jamshidi Mouselou, Meysam Ahmadi, Armin Attar","doi":"10.1155/2024/7259200","DOIUrl":"10.1155/2024/7259200","url":null,"abstract":"<p><i>Introduction</i>. Takotsubo cardiomyopathy (TCM) features transient left ventricular apical dysfunction or ballooning. The underlying mechanism remains elusive; however, evidence suggests the role of different physical and psychological stressors. We systematically reviewed patients presenting with TCM and autoimmunity to explore the link between the two conditions. <i>Methods</i>. We applied the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) to report this review. Using keywords related to autoimmune/immune-mediated diseases and TCM, we searched PubMed, Scopus, and WOS in March 2022. The final results were added to a data extraction sheet. Data were analyzed by SPSS version 26.0. <i>Results</i>. Our search yielded 121 studies, including 155 patients. Females were considerably predominant. Most patients had a history of autoimmune disease, and almost a third had a history of cardiovascular disease. Dyspnea and chest pain were the most common chief complaints. More than 70% of patients had experienced physical stress. Myasthenia gravis, systemic lupus erythematosus, and multiple sclerosis were the most frequently reported autoimmune diseases. <i>Conclusion</i>. There were similarities in age and sex compared to classic TCM. TCM should be considered as a differential diagnosis for ACS, especially in patients with a positive background of autoimmunity. A precise reporting system is required for further studies.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139920932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zuzana Horakova, Ivo Starek, Jana Zapletalova, Richard Salzman
Cutaneous squamous cell carcinomas (cSCC) are malignant tumours with excellent prognosis unless nodal metastases develop. The aim of our study is to determine the prognostic significance of the clinical stage of parotid gland metastases and the incidence of occult cervical lymph node involvement in cSCC of the head. Our retrospective analysis includes 39 patients with cSCC parotid gland metastases, 15 of whom had concurrent cervical node involvement. In 32 patients, the lymph nodes manifested at stage N3b. A total of 26 patients were treated with parotidectomy, 9 patients received radiotherapy alone, and 4 received symptomatic therapy. The surgical treatment included either total conservative (21 cases) or superficial parotidectomy (5 cases) and neck dissection (therapeutic neck dissections in 11 cases and elective in 14 cases). In all cases, surgery was performed with sufficient tumour-free resection margins. Adjuvant radiotherapy was administered postoperatively in 16 patients. Occult metastases were present in 21% of cases after an elective neck dissection, but not in any case in the deep lobe of the parotid gland. The five-year overall survival and recurrence-free interval were 52% and 55%, respectively. Patients with the cN3b stage and G3 histological grade tend to have a worse prognosis, but not at a statistically significant level. The prognosis was not worse in patients with concurrent parotid and cervical metastases compared to those with metastases limited to the parotid gland only. The addition of adjuvant irradiation, in comparison to a single modality surgical treatment, was the only statistically significant prognostic factor that reduced the risk of death from this diagnosis (p = 0.013). The extent of parotidectomy (partial vs. total) had no impact on either the risk of recurrence or patient prognosis. The combination of surgery with irradiation provides the best results and should be applied to all patients who tolerate the treatment. A partial superficial parotidectomy should be sufficient, with a minimum risk of occult metastasis in the deep lobe. Conversely, the relatively high incidence of occult neck metastases indicates that patients could likely benefit from elective neck dissection.
{"title":"Parotid Gland Metastases of Cutaneous Squamous Cell Carcinoma of the Head: Occult Metastases Occurrence and Their Late Manifestation","authors":"Zuzana Horakova, Ivo Starek, Jana Zapletalova, Richard Salzman","doi":"10.1155/2024/5525741","DOIUrl":"10.1155/2024/5525741","url":null,"abstract":"<p>Cutaneous squamous cell carcinomas (cSCC) are malignant tumours with excellent prognosis unless nodal metastases develop. The aim of our study is to determine the prognostic significance of the clinical stage of parotid gland metastases and the incidence of occult cervical lymph node involvement in cSCC of the head. Our retrospective analysis includes 39 patients with cSCC parotid gland metastases, 15 of whom had concurrent cervical node involvement. In 32 patients, the lymph nodes manifested at stage N3b. A total of 26 patients were treated with parotidectomy, 9 patients received radiotherapy alone, and 4 received symptomatic therapy. The surgical treatment included either total conservative (21 cases) or superficial parotidectomy (5 cases) and neck dissection (therapeutic neck dissections in 11 cases and elective in 14 cases). In all cases, surgery was performed with sufficient tumour-free resection margins. Adjuvant radiotherapy was administered postoperatively in 16 patients. Occult metastases were present in 21% of cases after an elective neck dissection, but not in any case in the deep lobe of the parotid gland. The five-year overall survival and recurrence-free interval were 52% and 55%, respectively. Patients with the cN3b stage and G3 histological grade tend to have a worse prognosis, but not at a statistically significant level. The prognosis was not worse in patients with concurrent parotid and cervical metastases compared to those with metastases limited to the parotid gland only. The addition of adjuvant irradiation, in comparison to a single modality surgical treatment, was the only statistically significant prognostic factor that reduced the risk of death from this diagnosis (<i>p</i> = 0.013). The extent of parotidectomy (partial vs. total) had no impact on either the risk of recurrence or patient prognosis. The combination of surgery with irradiation provides the best results and should be applied to all patients who tolerate the treatment. A partial superficial parotidectomy should be sufficient, with a minimum risk of occult metastasis in the deep lobe. Conversely, the relatively high incidence of occult neck metastases indicates that patients could likely benefit from elective neck dissection.</p>","PeriodicalId":13782,"journal":{"name":"International Journal of Clinical Practice","volume":"2024 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139920731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}