Pub Date : 2024-02-08eCollection Date: 2024-01-01DOI: 10.2147/TCRM.S434556
Benfa Gong, Li-Jen Cheng, Christopher H Young, Prabhuram Krishnan, Ying Wang, Hui Wei, Chunlin Zhou, Shuning Wei, Yan Li, Qiuyun Fang, Jia Zhong, Eric Q Wu, Yingchang Mi, Jianxiang Wang
Introduction: For acute myeloid leukemia (AML), prognosis is particularly poor in patients harboring FMS-like tyrosine kinase 3 (FLT3) gene mutations, though routine screening for these mutations at diagnosis has been shown to be insufficient. The understanding of the impact of FLT3 mutations on treatment decisions is limited.
Methods: In this retrospective, observational study, we investigated the key epidemiological characteristics, treatment patterns and responses among adult patients with newly diagnosed (ND) AML in China, who initiated treatment from January 1, 2015, to December 31, 2019, or progressed to relapsed/refractory (R/R) AML by December 31, 2020.
Results: Of the 853 ND AML patients included, 63.4% were screened for FLT3 status, and 20.1% tested positive (FLT3MUT) at initial diagnosis. Of 289 patients who progressed to R/R AML during the study period, 24.9% were screened at the diagnosis of R/R AML, and 19.4% tested positive; 20.5% of screened patients changed FLT3 status at first diagnosis of R/R AML. Initial treatment regimens or treatment responses did not seem to differ in patients with ND AML by FLT3 mutation status. In patients with R/R AML, there was an apparent difference in second-line treatment choices by FLT3 mutation status; however, the number of FLT3-mutated patients were limited to demonstrate any meaningful distinction. FLT3-mutated R/R AML was associated with shorter relapse time.
Conclusion: Study findings showed that there was a lack of routine testing for FLT3 mutations at first diagnosis of R/R AML, and initial treatment decisions did not differ by FLT3 mutation status. Given the clinical burden of FLT3MUT, likelihood of FLT3 status changes, and emerging FLT3 inhibitors, further routine FLT3 screening is needed to optimize treatment of R/R AML.
{"title":"Treatment Patterns and <i>FLT3</i> Mutation Testing Among Patients with Acute Myeloid Leukemia in China: A Retrospective Observational Study.","authors":"Benfa Gong, Li-Jen Cheng, Christopher H Young, Prabhuram Krishnan, Ying Wang, Hui Wei, Chunlin Zhou, Shuning Wei, Yan Li, Qiuyun Fang, Jia Zhong, Eric Q Wu, Yingchang Mi, Jianxiang Wang","doi":"10.2147/TCRM.S434556","DOIUrl":"10.2147/TCRM.S434556","url":null,"abstract":"<p><strong>Introduction: </strong>For acute myeloid leukemia (AML), prognosis is particularly poor in patients harboring FMS-like tyrosine kinase 3 (<i>FLT3</i>) gene mutations, though routine screening for these mutations at diagnosis has been shown to be insufficient. The understanding of the impact of <i>FLT3</i> mutations on treatment decisions is limited.</p><p><strong>Methods: </strong>In this retrospective, observational study, we investigated the key epidemiological characteristics, treatment patterns and responses among adult patients with newly diagnosed (ND) AML in China, who initiated treatment from January 1, 2015, to December 31, 2019, or progressed to relapsed/refractory (R/R) AML by December 31, 2020.</p><p><strong>Results: </strong>Of the 853 ND AML patients included, 63.4% were screened for <i>FLT3</i> status, and 20.1% tested positive (<i>FLT3</i><sup>MUT</sup>) at initial diagnosis. Of 289 patients who progressed to R/R AML during the study period, 24.9% were screened at the diagnosis of R/R AML, and 19.4% tested positive; 20.5% of screened patients changed <i>FLT3</i> status at first diagnosis of R/R AML. Initial treatment regimens or treatment responses did not seem to differ in patients with ND AML by <i>FLT3</i> mutation status. In patients with R/R AML, there was an apparent difference in second-line treatment choices by <i>FLT3</i> mutation status; however, the number of <i>FLT3</i>-mutated patients were limited to demonstrate any meaningful distinction. <i>FLT3</i>-mutated R/R AML was associated with shorter relapse time.</p><p><strong>Conclusion: </strong>Study findings showed that there was a lack of routine testing for <i>FLT3</i> mutations at first diagnosis of R/R AML, and initial treatment decisions did not differ by <i>FLT3</i> mutation status. Given the clinical burden of <i>FLT3</i><sup>MUT</sup>, likelihood of <i>FLT3</i> status changes, and emerging FLT3 inhibitors, further routine <i>FLT3</i> screening is needed to optimize treatment of R/R AML.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10861151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139724037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: The objective of this study was to utilize LASSO regression (Least Absolute Shrinkage and Selection Operator Regression) to identify key variables in septic patients and develop a predictive model for intensive care unit (ICU) mortality.
Methods: We conducted a cohort consisting of septic patients admitted to the ICU between December 2016 and July 2019. The disease severity and laboratory index were analyzed using LASSO regression. The selected variables were then used to develop a model for predicting ICU mortality. AUCs of ROCs were applied to assess the prediction model, and the accuracy, sensitivity and specificity were calculated. Calibration were also used to assess the actual and predicted values of the predictive model.
Results: A total of 1733 septic patients were included, among of whom 382 (22%) died during ICU stay. Ten variables, namely mechanical ventilation (MV) requirement, hemofiltration (HF) requirement, norepinephrine (NE) requirement, septicemia, multiple drug-resistance infection (MDR), thrombocytopenia, hematocrit, red-cell deviation width coefficient of variation (RDW-CV), C-reactive protein (CRP), and antithrombin (AT) III, showed the strongest association with sepsis-related mortality according to LASSO regression. When these variables were combined into a predictive model, the area under the curve (AUC) was found to be 0.801. The AUC of the validation group was 0.791. The specificity of the model was as high as 0.953. Within the probability range of 0.25 to 0.90, the predictive performance of the model surpassed that of individual predictors within the cohort.
Conclusion: Our findings suggest that a predictive model incorporating the variables of MV requirement, HF requirement, NE requirement, septicemia, MDR, thrombocytopenia, HCT, RDW-CV, CRP, and AT III exhibiting an 80% likelihood of predicting ICU mortality in sepsis and demonstrates high accuracy.
{"title":"LASSO-Based Identification of Risk Factors and Development of a Prediction Model for Sepsis Patients.","authors":"Chengying Hong, Yihan Xiong, Jinquan Xia, Wei Huang, Andi Xia, Shunyao Xu, Yuting Chen, Zhikun Xu, Huaisheng Chen, Zhongwei Zhang","doi":"10.2147/TCRM.S434397","DOIUrl":"https://doi.org/10.2147/TCRM.S434397","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to utilize LASSO regression (Least Absolute Shrinkage and Selection Operator Regression) to identify key variables in septic patients and develop a predictive model for intensive care unit (ICU) mortality.</p><p><strong>Methods: </strong>We conducted a cohort consisting of septic patients admitted to the ICU between December 2016 and July 2019. The disease severity and laboratory index were analyzed using LASSO regression. The selected variables were then used to develop a model for predicting ICU mortality. AUCs of ROCs were applied to assess the prediction model, and the accuracy, sensitivity and specificity were calculated. Calibration were also used to assess the actual and predicted values of the predictive model.</p><p><strong>Results: </strong>A total of 1733 septic patients were included, among of whom 382 (22%) died during ICU stay. Ten variables, namely mechanical ventilation (MV) requirement, hemofiltration (HF) requirement, norepinephrine (NE) requirement, septicemia, multiple drug-resistance infection (MDR), thrombocytopenia, hematocrit, red-cell deviation width coefficient of variation (RDW-CV), C-reactive protein (CRP), and antithrombin (AT) III, showed the strongest association with sepsis-related mortality according to LASSO regression. When these variables were combined into a predictive model, the area under the curve (AUC) was found to be 0.801. The AUC of the validation group was 0.791. The specificity of the model was as high as 0.953. Within the probability range of 0.25 to 0.90, the predictive performance of the model surpassed that of individual predictors within the cohort.</p><p><strong>Conclusion: </strong>Our findings suggest that a predictive model incorporating the variables of MV requirement, HF requirement, NE requirement, septicemia, MDR, thrombocytopenia, HCT, RDW-CV, CRP, and AT III exhibiting an 80% likelihood of predicting ICU mortality in sepsis and demonstrates high accuracy.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10859107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139724036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Sharp esophageal foreign body (SEFB) impaction can cause varying degrees of damage to the esophagus. There are few studies analyzing the postoperative fasting time in SEFB patients. Methods: We retrospectively collected 835 SEFB patients. According to the fasting time after the endoscopic removal (ER) of SEFBs, the patients were divided into two groups: short fasting time (SFT, fasted ≤ 24 h) and long fasting time (LFT, fasted > 24 h). Results: There were 216 and 619 patients in the SFT and LFT group, respectively. The average age of the SFT group (52.97 years) was younger than that of the LFT group (55.96 years) (p = 0.025). The LFT group had lower proportion of duration of impaction (DOI) within 12 hours (14.2% vs 22.2%, p = 0.006) and erosion rates (89.0% vs 94.0%, p = 0.034) as well as higher proportion of esophageal perforation (19.5 vs 6.5%, p = 0.010) and patients who got intravenous anesthesia (63.78% vs 31.9%, p = 0.000) than the SFT group. The longest diameter of the foreign body (Lmax) in the LFT group (2.60 ± 1.01 cm) was greater than that in the SFT group (2.41 ± 0.83 cm; p = 0.01). Multivariate regression analysis found that age (OR = 1.726[1.208– 2.465], p = 0.003), DOI (OR = 1.793[1.175– 2.737], p = 0.007), Lmax (OR = 1.477[1.033– 2.111], p = 0.032), perforation (OR = 3.698[2.038– 6.710]; p < 0.01) and intravenous anesthesia (OR = 3.734[2.642– 5.278]; p < 0.01) were the independent factors that prolonged fasting time in patients with SEFBs, while esophageal mucosal erosion (OR = 0.433[0.229– 0.820]; p = 0.01) was the influencing factor leading to shortened fasting time. Conclusion: For the first time, we analyzed factors influencing the fasting time after ER in SEFB patients. Age, DOI, Lmax, perforation and intravenous anesthesia were risk factors for a prolonged postoperative fasting time.
{"title":"Factors Influencing the Fasting Time in Adult Patients After the Endoscopic Management of Sharp Esophageal Foreign Bodies","authors":"Da-Quan Wu, Shu-Yang Chen, Ke-Guang Chen, Tan Wang, Guang-Yao Li, Xin-Sheng Huang","doi":"10.2147/tcrm.s451517","DOIUrl":"https://doi.org/10.2147/tcrm.s451517","url":null,"abstract":"<strong>Background:</strong> Sharp esophageal foreign body (SEFB) impaction can cause varying degrees of damage to the esophagus. There are few studies analyzing the postoperative fasting time in SEFB patients.<br/><strong>Methods:</strong> We retrospectively collected 835 SEFB patients. According to the fasting time after the endoscopic removal (ER) of SEFBs, the patients were divided into two groups: short fasting time (SFT, fasted ≤ 24 h) and long fasting time (LFT, fasted > 24 h).<br/><strong>Results:</strong> There were 216 and 619 patients in the SFT and LFT group, respectively. The average age of the SFT group (52.97 years) was younger than that of the LFT group (55.96 years) (p = 0.025). The LFT group had lower proportion of duration of impaction (DOI) within 12 hours (14.2% vs 22.2%, p = 0.006) and erosion rates (89.0% vs 94.0%, p = 0.034) as well as higher proportion of esophageal perforation (19.5 vs 6.5%, p = 0.010) and patients who got intravenous anesthesia (63.78% vs 31.9%, p = 0.000) than the SFT group. The longest diameter of the foreign body (Lmax) in the LFT group (2.60 ± 1.01 cm) was greater than that in the SFT group (2.41 ± 0.83 cm; p = 0.01). Multivariate regression analysis found that age (OR = 1.726[1.208– 2.465], p = 0.003), DOI (OR = 1.793[1.175– 2.737], p = 0.007), Lmax (OR = 1.477[1.033– 2.111], p = 0.032), perforation (OR = 3.698[2.038– 6.710]; p < 0.01) and intravenous anesthesia (OR = 3.734[2.642– 5.278]; p < 0.01) were the independent factors that prolonged fasting time in patients with SEFBs, while esophageal mucosal erosion (OR = 0.433[0.229– 0.820]; p = 0.01) was the influencing factor leading to shortened fasting time.<br/><strong>Conclusion:</strong> For the first time, we analyzed factors influencing the fasting time after ER in SEFB patients. Age, DOI, Lmax, perforation and intravenous anesthesia were risk factors for a prolonged postoperative fasting time.<br/><br/>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139690008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hesti Platini, Keyzha Amartya Adammayanti, Sidik Maulana, Putu Moradha Kharisma Putri, Welly Grivin Layuk, Juan Alessandro Jeremis Maruli Nura Lele, Hartiah Haroen, Sri Hartati Pratiwi, Faizal Musthofa, Arpit Mago
Introduction: Poorly controlled diabetes mellitus can lead to the development of diabetic foot ulcers (DFU), which is a frequent complication in patients. However, several diabetes management guidelines for older adults do not mention the occurrence of DFUs. Nowadays, Autologous Platelet-Rich Gel (APG) is being used for treating diabetic ulcers. APG is an innovative platelet-derived product with many advantages, such as being low-cost, easy to produce, and readily available materials. Additionally, it does not lead to any rejection reaction. Objective: This study aims to assess the safety and efficacy of APG as a novel treatment of DFU compared with standard treatment in older adult patients. Methods: Randomized Controlled Trials (RCTs) were searched using PubMed, Cochrane, Google Scholar, Wiley, and PlosOne. The keywords have been arranged using the Boolean operator, including autologous platelet-rich gel, DFU, and elderly. The data was screened by inclusion and exclusion criteria. The final inclusion study was analyzed and synthesized by tabulation, clusterization, contextual and thematic approach, and assessed for risk of bias using ROB 2.0. Meta-analysis was conducted by using Review Manager 5.4 and the Mantel Haenszel method. Results: Eight RCTs with 598 patients were eligible for the present analysis. Compared with standard care/conventional treatment, APG could significantly improve the healing wound in patients with diabetic foot ulcers (Relative risk (RR) 1.32, 95% confidence interval (CI) 1.22– 1.57, p < 0.0001), shortened the healing time (Mean difference [MD] − 16.97 days (95% CI: − 32.64 to − 1.29; p < 0.00001), shortened the length of hospital stay (MD= − 20.11, 95% CI: − 38.02, − 2.20; p = 0.03), and amputation rate (MD= 0.36, 95% CI: 0.16, 0.84; p = 0.02). Conclusion: APG treatment can better treat DFU in terms of duration of healing, wound healing, length of hospital stay, and amputation prevention than the standard treatment.
导言：糖尿病控制不佳会导致糖尿病足溃疡（DFU）的发生，这是患者经常出现的并发症。然而，一些针对老年人的糖尿病管理指南并未提及糖尿病足溃疡的发生。如今，自体富血小板凝胶（APG）正被用于治疗糖尿病溃疡。自体富血小板凝胶是一种创新的血小板衍生产品，具有成本低、易于生产、材料易得等诸多优点。此外，它还不会导致任何排异反应：本研究旨在评估 APG 作为一种新型的 DFU 治疗方法与老年患者标准治疗方法相比的安全性和有效性：方法：使用 PubMed、Cochrane、Google Scholar、Wiley 和 PlosOne 搜索随机对照试验 (RCT)。使用布尔运算符排列关键词，包括自体富血小板凝胶、DFU 和老年人。根据纳入和排除标准对数据进行筛选。通过制表、聚类、上下文和主题方法对最终纳入的研究进行分析和综合，并使用 ROB 2.0 评估偏倚风险。使用 Review Manager 5.4 和 Mantel Haenszel 方法进行 Meta 分析：共有 8 项 RCT，598 名患者符合本次分析的条件。与标准护理/常规治疗相比，APG能显著改善糖尿病足溃疡患者的伤口愈合情况（相对风险（RR）1.32，95% 置信区间（CI）1.22- 1.57，p <0.0001），缩短愈合时间（平均差[MD] - 16.97天 (95% CI: - 32.64 to - 1.29; p < 0.00001)，缩短了住院时间（MD= - 20.11, 95% CI: - 38.02, - 2.20; p = 0.03）和截肢率（MD= 0.36, 95% CI: 0.16, 0.84; p = 0.02）：自体富血小板血浆凝胶治疗在愈合时间、伤口愈合、住院时间和预防截肢方面均优于标准治疗。
{"title":"The Potential of Autologous Platelet-Rich Plasma Gel for Diabetic Foot Ulcer Care Among Older Adults: A Systematic Review and Meta-Analysis","authors":"Hesti Platini, Keyzha Amartya Adammayanti, Sidik Maulana, Putu Moradha Kharisma Putri, Welly Grivin Layuk, Juan Alessandro Jeremis Maruli Nura Lele, Hartiah Haroen, Sri Hartati Pratiwi, Faizal Musthofa, Arpit Mago","doi":"10.2147/tcrm.s433033","DOIUrl":"https://doi.org/10.2147/tcrm.s433033","url":null,"abstract":"<strong>Introduction:</strong> Poorly controlled diabetes mellitus can lead to the development of diabetic foot ulcers (DFU), which is a frequent complication in patients. However, several diabetes management guidelines for older adults do not mention the occurrence of DFUs. Nowadays, Autologous Platelet-Rich Gel (APG) is being used for treating diabetic ulcers. APG is an innovative platelet-derived product with many advantages, such as being low-cost, easy to produce, and readily available materials. Additionally, it does not lead to any rejection reaction.<br/><strong>Objective:</strong> This study aims to assess the safety and efficacy of APG as a novel treatment of DFU compared with standard treatment in older adult patients.<br/><strong>Methods:</strong> Randomized Controlled Trials (RCTs) were searched using PubMed, Cochrane, Google Scholar, Wiley, and PlosOne. The keywords have been arranged using the Boolean operator, including autologous platelet-rich gel, DFU, and elderly. The data was screened by inclusion and exclusion criteria. The final inclusion study was analyzed and synthesized by tabulation, clusterization, contextual and thematic approach, and assessed for risk of bias using ROB 2.0. Meta-analysis was conducted by using Review Manager 5.4 and the Mantel Haenszel method.<br/><strong>Results:</strong> Eight RCTs with 598 patients were eligible for the present analysis. Compared with standard care/conventional treatment, APG could significantly improve the healing wound in patients with diabetic foot ulcers (Relative risk (RR) 1.32, 95% confidence interval (CI) 1.22– 1.57, p < 0.0001), shortened the healing time (Mean difference [MD] − 16.97 days (95% CI: − 32.64 to − 1.29; p < 0.00001), shortened the length of hospital stay (MD= − 20.11, 95% CI: − 38.02, − 2.20; <em>p</em> = 0.03), and amputation rate (MD= 0.36, 95% CI: 0.16, 0.84; p = 0.02).<br/><strong>Conclusion:</strong> APG treatment can better treat DFU in terms of duration of healing, wound healing, length of hospital stay, and amputation prevention than the standard treatment.<br/><br/><strong>Keywords:</strong> autologous platelet-rich plasma gel, diabetic foot ulcers, older adult<br/>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139551812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Corrigendum for the article Hard-Candy Consumption Does Not Have an Effect on Volume and pH of Gastric Content in Patients Undergoing Elective Gastrointestinal Endoscopic Procedures: A Randomized Controlled Trial
{"title":"Hard-Candy Consumption Does Not Have an Effect on Volume and pH of Gastric Content in Patients Undergoing Elective Gastrointestinal Endoscopic Procedures: A Randomized Controlled Trial [Corrigendum]","authors":"Pawit Somnuke, Nuanprae Kitisin, Phornprasurt Chumklud, Pishsinee Kunavuttitagool, Penpuk Deepinta, Araya Wadrod, Warayu Prachayakul, Somchai Amornyotin, Nattaya Raykateeraroj","doi":"10.2147/tcrm.s459875","DOIUrl":"https://doi.org/10.2147/tcrm.s459875","url":null,"abstract":"Corrigendum for the article Hard-Candy Consumption Does Not Have an Effect on Volume and pH of Gastric Content in Patients Undergoing Elective Gastrointestinal Endoscopic Procedures: A Randomized Controlled Trial","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139483426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: To evaluate the effectiveness and safety of diazepam in maintaining stable intraoperative blood pressure (BP) in hypertensive patients undergoing vitrectomy under nerve block anesthesia. Methods: A total of 180 hypertensive patients undergoing vitrectomy with nerve block anesthesia were randomized into two groups. The intervention group was given oral diazepam 60 min before operation, while the control group was given oral placebo 60 min before operation. The primary outcome is the effective rate of intraoperative BP control, defined as systolic blood pressure (SBP) during the operation maintained < 160 mmHg at all timepoints. The logistic regression model will be performed to analyze the compare risk factors for ineffective BP control. Results: The effective rate of intraoperative SBP control in the diazepam group was significant higher than that in the placebo group from 15 min to 70 min of the surgery (P < 0.05). The proportion of patients with SBP ≥ 180 mmHg at any timepoint from operation to 1 h postoperation was higher in the placebo group (12.22%) than in the diazepam group (2.22%) (P = 0.0096). We observed that the change in SBP from baseline consistently remained higher in the placebo group than in the diazepam group. In the logistic regression analysis, age, years of diagnosed hypertension and SBP 1h before surgery were significant risk factors for ineffective BP control. Conclusion: This study provides robust evidence supporting the effectiveness of oral diazepam as a pre-surgery intervention in maintaining stable blood pressure during vitrectomy in hypertensive patients. Trial Registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2100041772.
{"title":"The Efficacy and Safety of Diazepam for Intraoperative Blood Pressure Stabilization in Hypertensive Patients Undergoing Vitrectomy Under Nerve Block Anesthesia: A Prospective, Single-Center, Double-Blind, Randomized, Controlled Trial","authors":"Tianwei Qian, Qiaoyun Gong, Yiyang Shu, Hangqi Shen, Xia Wu, Weijun Wang, Zhihua Zhang, Hui Cao, Xun Xu","doi":"10.2147/tcrm.s441152","DOIUrl":"https://doi.org/10.2147/tcrm.s441152","url":null,"abstract":"<strong>Purpose:</strong> To evaluate the effectiveness and safety of diazepam in maintaining stable intraoperative blood pressure (BP) in hypertensive patients undergoing vitrectomy under nerve block anesthesia.<br/><strong>Methods:</strong> A total of 180 hypertensive patients undergoing vitrectomy with nerve block anesthesia were randomized into two groups. The intervention group was given oral diazepam 60 min before operation, while the control group was given oral placebo 60 min before operation. The primary outcome is the effective rate of intraoperative BP control, defined as systolic blood pressure (SBP) during the operation maintained < 160 mmHg at all timepoints. The logistic regression model will be performed to analyze the compare risk factors for ineffective BP control.<br/><strong>Results:</strong> The effective rate of intraoperative SBP control in the diazepam group was significant higher than that in the placebo group from 15 min to 70 min of the surgery (<em>P</em> < 0.05). The proportion of patients with SBP ≥ 180 mmHg at any timepoint from operation to 1 h postoperation was higher in the placebo group (12.22%) than in the diazepam group (2.22%) (<em>P</em> = 0.0096). We observed that the change in SBP from baseline consistently remained higher in the placebo group than in the diazepam group. In the logistic regression analysis, age, years of diagnosed hypertension and SBP 1h before surgery were significant risk factors for ineffective BP control.<br/><strong>Conclusion:</strong> This study provides robust evidence supporting the effectiveness of oral diazepam as a pre-surgery intervention in maintaining stable blood pressure during vitrectomy in hypertensive patients.<br/><strong>Trial Registration:</strong> Chinese Clinical Trial Registry (ChiCTR), ChiCTR2100041772.<br/><br/><strong>Keywords:</strong> nerve block anesthesia, vitrectomy, diazepam, blood pressure stabilization<br/>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139464235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract: Chronic hepatitis C (HCV) affects up to 3.25 million children and adolescents. Early treatment of HCV in children and adolescents reduces progression to advanced liver disease and cancer. Treatment for HCV has evolved to highly effective direct acting antiviral therapy in adults and now in children ≥ 3 years of age. This review focuses on the role of sofosbuvir and velpatasvir (SOF/VEL), a newer treatment of children and adolescents with chronic HCV. SOF/VEL is a pangenotypic DAA with primary clearance via the liver and biliary excretion. It has been studied in children and adolescents and is approved in the US for use in children and adolescents ≥ 3 years of age. Although the data are currently limited, SOF/VEL has demonstrated sustained viral response rates similar to comparable DAAs in the range of 95– 98%. To date, side effects have been minimal.
Keywords: pediatric hepatitis C, pediatric hepatitis C treatment
{"title":"Profile of Sofosbuvir and Velpatasvir Combination in the Treatment of Chronic Hepatitis C in Children and Adolescents: Current Evidence","authors":"Dania Brigham, Michael R Narkewicz","doi":"10.2147/tcrm.s326099","DOIUrl":"https://doi.org/10.2147/tcrm.s326099","url":null,"abstract":"<strong>Abstract:</strong> Chronic hepatitis C (HCV) affects up to 3.25 million children and adolescents. Early treatment of HCV in children and adolescents reduces progression to advanced liver disease and cancer. Treatment for HCV has evolved to highly effective direct acting antiviral therapy in adults and now in children ≥ 3 years of age. This review focuses on the role of sofosbuvir and velpatasvir (SOF/VEL), a newer treatment of children and adolescents with chronic HCV. SOF/VEL is a pangenotypic DAA with primary clearance via the liver and biliary excretion. It has been studied in children and adolescents and is approved in the US for use in children and adolescents ≥ 3 years of age. Although the data are currently limited, SOF/VEL has demonstrated sustained viral response rates similar to comparable DAAs in the range of 95– 98%. To date, side effects have been minimal.<br/><br/><strong>Keywords:</strong> pediatric hepatitis C, pediatric hepatitis C treatment<br/>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139421737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: This study aimed to rank the features that are important in terms of safety and effectiveness in choosing the surgical method and providing appropriate care to the patient by using the variables examined before and after the surgery to evaluate the success of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy surgeries. Patients and Methods: The features evaluated before and after surgery were ranked according to their importance in the features considered, using Multivariate Adaptive Regression Splines (MARS), LASSO, Ridge, Elastic_net, and Random Forest algorithms as variable selection techniques. There are 278 samples in the relevant data set. Results: Type of surgery (100%), intercostal access (97.75%), kidney opening procedure (94.25%), postoperative creatinine (59.22%), hydronephrosis (52.23%), the number of entries (41.61%), and pre- and post-operative hemoglobin difference (45.13%) were determined as the most critical variables. The MARS algorithm showed the most successful performance, with the lowest mean absolute error (MAE) value of 0.3622, the lowest root mean square error (RMSE) value of 0.3960, and the highest R2 value of 0.3405. Conclusion: Clinical decision support systems can be helpful in eliminating errors and reducing costs. It can also improve the quality of healthcare and aid in the early diagnosis of diseases. Computer-aided decision-making systems can be developed using the results of such products. These systems can provide doctors with better information about their patient’s treatment options and improve decision-making. It can contribute to patients being better informed about the surgery results and taking an active role. In conclusion, this study provides essential information that should be included in the surgical decision-making process for patients using medications and with a history of percutaneous nephrolithotomy.
Keywords: digital decision in healthcare, percutaneous nephrolithotomy, surgery success, machine learning, MARS
{"title":"Mini Percutaneous Nephrolithotomy vs Standard Percutaneous Nephrolithotomy: A Perioperative Decision Support System for Surgical Success Comparison","authors":"Kerem Gencer","doi":"10.2147/tcrm.s444519","DOIUrl":"https://doi.org/10.2147/tcrm.s444519","url":null,"abstract":"<strong>Purpose:</strong> This study aimed to rank the features that are important in terms of safety and effectiveness in choosing the surgical method and providing appropriate care to the patient by using the variables examined before and after the surgery to evaluate the success of mini percutaneous nephrolithotomy and standard percutaneous nephrolithotomy surgeries.<br/><strong>Patients and Methods:</strong> The features evaluated before and after surgery were ranked according to their importance in the features considered, using Multivariate Adaptive Regression Splines (MARS), LASSO, Ridge, Elastic_net, and Random Forest algorithms as variable selection techniques. There are 278 samples in the relevant data set.<br/><strong>Results:</strong> Type of surgery (100%), intercostal access (97.75%), kidney opening procedure (94.25%), postoperative creatinine (59.22%), hydronephrosis (52.23%), the number of entries (41.61%), and pre- and post-operative hemoglobin difference (45.13%) were determined as the most critical variables. The MARS algorithm showed the most successful performance, with the lowest mean absolute error (MAE) value of 0.3622, the lowest root mean square error (RMSE) value of 0.3960, and the highest R<sup>2</sup> value of 0.3405.<br/><strong>Conclusion:</strong> Clinical decision support systems can be helpful in eliminating errors and reducing costs. It can also improve the quality of healthcare and aid in the early diagnosis of diseases. Computer-aided decision-making systems can be developed using the results of such products. These systems can provide doctors with better information about their patient’s treatment options and improve decision-making. It can contribute to patients being better informed about the surgery results and taking an active role. In conclusion, this study provides essential information that should be included in the surgical decision-making process for patients using medications and with a history of percutaneous nephrolithotomy.<br/><br/><strong>Keywords:</strong> digital decision in healthcare, percutaneous nephrolithotomy, surgery success, machine learning, MARS<br/>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2023-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139064742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Systemic AL amyloidosis, a plasma cell dyscrasia, is characterized by the production of misfolded immunoglobulin light chain. These misfolded proteins aggregate into amyloid fibrils and deposit throughout the body, resulting in widespread organ dysfunction and ultimately death. Achieving rapid and maximal elimination of the plasma cell clone is crucial to long-term survival. Daratumumab, an anti-CD38 monoclonal antibody delivered intravenously, has been swiftly incorporated into standard first-line treatment regimens. A novel formulation of daratumumab has been developed that can be injected subcutaneously. Areas Covered: As a retrospective qualitative review of prior publications involving daratumumab, this work briefly summarizes the existing data regarding the safety and efficacy of subcutaneous (SC) daratumumab, compared to intravenous (IV) daratumumab. SC daratumumab appears to deliver the same disease benefit as IV daratumumab to patients with decreased infusion-related reactions (IRRs), decreased time for administration, and similar rates of adverse events (AEs) intrinsically related to daratumumab. Expert Opinion: SC daratumumab is preferred over IV daratumumab, but the clinical situation ultimately should determine route of administration. Further investigation into cost-effectiveness benefit is warranted.
Keywords: plasma cell dyscrasia, daratumumab, AL amyloidosis, adverse events, AE
简介系统性 AL 淀粉样变性是一种浆细胞发育不良症，其特征是产生折叠错误的免疫球蛋白轻链。这些错误折叠的蛋白质聚集成淀粉样纤维并沉积在全身，导致广泛的器官功能障碍，最终导致死亡。快速、最大限度地消除浆细胞克隆对长期生存至关重要。达拉单抗是一种静脉注射的抗CD38单克隆抗体，已被迅速纳入标准一线治疗方案。目前已开发出一种可皮下注射的新型达拉单抗制剂：作为对以前发表的涉及达拉单抗的文章的回顾性定性综述，本研究简要总结了与静脉注射达拉单抗相比，皮下注射达拉单抗的安全性和有效性方面的现有数据。皮下注射达拉单抗似乎能为患者带来与静脉注射达拉单抗相同的疾病获益，同时输液相关反应（IRRs）减少，用药时间缩短，与达拉单抗内在相关的不良事件（AEs）发生率相似：专家意见：与静脉注射达拉单抗相比，首选静脉注射达拉单抗，但最终应由临床情况决定给药途径。有必要进一步研究其成本效益。关键词：浆细胞异常、达拉单抗、AL 淀粉样变性、不良事件、AE
{"title":"Safety and Efficacy of Subcutaneous Daratumumab in Systemic AL Amyloidosis","authors":"Michael Sang Hughes, Suzanne Lentzsch","doi":"10.2147/tcrm.s325859","DOIUrl":"https://doi.org/10.2147/tcrm.s325859","url":null,"abstract":"<strong>Introduction:</strong> Systemic AL amyloidosis, a plasma cell dyscrasia, is characterized by the production of misfolded immunoglobulin light chain. These misfolded proteins aggregate into amyloid fibrils and deposit throughout the body, resulting in widespread organ dysfunction and ultimately death. Achieving rapid and maximal elimination of the plasma cell clone is crucial to long-term survival. Daratumumab, an anti-CD38 monoclonal antibody delivered intravenously, has been swiftly incorporated into standard first-line treatment regimens. A novel formulation of daratumumab has been developed that can be injected subcutaneously.<br/><strong>Areas Covered:</strong> As a retrospective qualitative review of prior publications involving daratumumab, this work briefly summarizes the existing data regarding the safety and efficacy of subcutaneous (SC) daratumumab, compared to intravenous (IV) daratumumab. SC daratumumab appears to deliver the same disease benefit as IV daratumumab to patients with decreased infusion-related reactions (IRRs), decreased time for administration, and similar rates of adverse events (AEs) intrinsically related to daratumumab.<br/><strong>Expert Opinion:</strong> SC daratumumab is preferred over IV daratumumab, but the clinical situation ultimately should determine route of administration. Further investigation into cost-effectiveness benefit is warranted. <br/><br/><strong>Keywords:</strong> plasma cell dyscrasia, daratumumab, AL amyloidosis, adverse events, AE<br/>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2023-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139051515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chang Tang, Lanting Wang, Zihua Chen, Jin Yang, Haiqing Gao, Chenggong Guan, Qiaozhi Gu, Shan He, Fanping Yang, Shengan Chen, Li Ma, Zhen Zhang, Ying Zhao, Lin Tang, Yu Xu, Yue Hu, Xiaoqun Luo
Purpose: Several in vivo experiments have shown that molecular hydrogen is a promising therapeutic agent for interstitial lung diseases (ILD). In this study, hydrogen therapy was investigated to determine whether it is superior to N-Acetylcysteine (NAC) for the treatment of patients with early-stage ILD. Patients and Methods: A prospective, single-center, randomized, controlled clinical trial was conducted in 87 patients with early-stage ILD. Hydrogen or NAC therapy was randomly assigned (1:1 ratio) to the eligible patients. The primary endpoint was the change in the high-resolution computed tomography (HRCT) and composite physiologic index (CPI) scores from baseline to week 48. Pulmonary function was evaluated as a secondary endpoint, and adverse events were recorded for safety analysis. Results: The rate of HRCT image improvement from the baseline in the HW group (63.6%) was higher than that in the NAC group (39.5%). A significant decrease in CPI and improvement in DLCO-sb were observed in the hydrogen group compared with those in the control group. Changes in other pulmonary function parameters, including FVC, FEV1, FEV1/FVC%, and TLC, were not significantly different between the two groups. Adverse events were reported in 7 (15.9%) patients in the HW group and 10 (23.3%) patients in the NAC group, but the difference was not significant (P=0.706). Conclusion: Hydrogen therapy exhibits superior efficacy and acceptable safety compared with NAC therapy in patients with early-stage ILD.
{"title":"Efficacy and Safety of Hydrogen Therapy in Patients with Early-Stage Interstitial Lung Disease: A Single-Center, Randomized, Parallel-Group Controlled Trial","authors":"Chang Tang, Lanting Wang, Zihua Chen, Jin Yang, Haiqing Gao, Chenggong Guan, Qiaozhi Gu, Shan He, Fanping Yang, Shengan Chen, Li Ma, Zhen Zhang, Ying Zhao, Lin Tang, Yu Xu, Yue Hu, Xiaoqun Luo","doi":"10.2147/tcrm.s438044","DOIUrl":"https://doi.org/10.2147/tcrm.s438044","url":null,"abstract":"<strong>Purpose:</strong> Several in vivo experiments have shown that molecular hydrogen is a promising therapeutic agent for interstitial lung diseases (ILD). In this study, hydrogen therapy was investigated to determine whether it is superior to N-Acetylcysteine (NAC) for the treatment of patients with early-stage ILD.<br/><strong>Patients and Methods:</strong> A prospective, single-center, randomized, controlled clinical trial was conducted in 87 patients with early-stage ILD. Hydrogen or NAC therapy was randomly assigned (1:1 ratio) to the eligible patients. The primary endpoint was the change in the high-resolution computed tomography (HRCT) and composite physiologic index (CPI) scores from baseline to week 48. Pulmonary function was evaluated as a secondary endpoint, and adverse events were recorded for safety analysis.<br/><strong>Results:</strong> The rate of HRCT image improvement from the baseline in the HW group (63.6%) was higher than that in the NAC group (39.5%). A significant decrease in CPI and improvement in D<sub>L</sub>CO-sb were observed in the hydrogen group compared with those in the control group. Changes in other pulmonary function parameters, including FVC, FEV<sub>1</sub>, FEV<sub>1</sub>/FVC%, and TLC, were not significantly different between the two groups. Adverse events were reported in 7 (15.9%) patients in the HW group and 10 (23.3%) patients in the NAC group, but the difference was not significant (<em>P</em>=0.706).<br/><strong>Conclusion:</strong> Hydrogen therapy exhibits superior efficacy and acceptable safety compared with NAC therapy in patients with early-stage ILD.<br/><br/><strong>Keywords:</strong> hydrogen, N-acetylcysteine, interstitial lung disease, therapeutic effects<br/>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138567046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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