Pub Date : 2018-01-01DOI: 10.4172/Clinical-Investigation.1000130
N. Ukibe, Sn Ukibe, E. Onwubuya, C. C. Onyenekwe, Ifeoma Nwamaka Monago, O. Emelumadu, I. Ikegwuonu, I. Okonkwo, J. Ahaneku
Objective: The second leading cause of human mortality from infectious diseases worldwide is Mycobacterium tuberculosis (Mtb). This chronic infection is accompanied by prolonged cytokine production, which might affect the immuno-reproductive communication and favour the establishment of an adverse state. This was a prospective study designed to evaluate possible impact of some cytokine variations on menstrual cycle in TB infected females. Methods: A total of 90 premenopausal females aged (18-45) years were randomly recruited and grouped into 30 Symptomatic TB, 30 Symptomatic TB females on ATT and 30 Control females. Blood samples were collected at follicular (Fp) and luteal phases (Lp) of menstrual cycle for determination of IL-8, IL-6, TNFα, IL-4, CD4+ T-cells, and Absolute Lymphocytes counts using enzyme-linked immunosorbent assay (ELISA), Cyflow SL Green Cytometer and Sysmex K21N Hematology Analyzer respectively. Results: There was significantly higher IL-6, IL-8, IL-4 and TNFα with lower CD4 T-cells and Abs Lym counts in TB and TB on ATT compared to Control females at both phases of menstrual cycle (P<0.05). All the cytokines were significantly lowered with higher CD4 T-cells in TB on ATT compared to TB females at both phases (P<0.05). Hypogonadism correlated positively with pro and anti-inflammatory cytokines Conclusion: The study revealed significant cytokine alterations which suggest active inflammatory process while CD4 T-cells and Abs Lym dropped showing some degree of derangement in cellular immunity at both phases of menstrual cycle; which tends to normalize on treatment. This may affect the reproductive potentials in these women.
{"title":"Possible impact of variations in some Cytokine levels during menstrual cycle in women of reproductive age infected with Pulmonary Tuberculosis at Nnewi, Nigeria'","authors":"N. Ukibe, Sn Ukibe, E. Onwubuya, C. C. Onyenekwe, Ifeoma Nwamaka Monago, O. Emelumadu, I. Ikegwuonu, I. Okonkwo, J. Ahaneku","doi":"10.4172/Clinical-Investigation.1000130","DOIUrl":"https://doi.org/10.4172/Clinical-Investigation.1000130","url":null,"abstract":"Objective: The second leading cause of human mortality from infectious diseases worldwide is Mycobacterium tuberculosis (Mtb). This chronic infection is accompanied by prolonged cytokine production, which might affect the immuno-reproductive communication and favour the establishment of an adverse state. This was a prospective study designed to evaluate possible impact of some cytokine variations on menstrual cycle in TB infected females. Methods: A total of 90 premenopausal females aged (18-45) years were randomly recruited and grouped into 30 Symptomatic TB, 30 Symptomatic TB females on ATT and 30 Control females. Blood samples were collected at follicular (Fp) and luteal phases (Lp) of menstrual cycle for determination of IL-8, IL-6, TNFα, IL-4, CD4+ T-cells, and Absolute Lymphocytes counts using enzyme-linked immunosorbent assay (ELISA), Cyflow SL Green Cytometer and Sysmex K21N Hematology Analyzer respectively. Results: There was significantly higher IL-6, IL-8, IL-4 and TNFα with lower CD4 T-cells and Abs Lym counts in TB and TB on ATT compared to Control females at both phases of menstrual cycle (P<0.05). All the cytokines were significantly lowered with higher CD4 T-cells in TB on ATT compared to TB females at both phases (P<0.05). Hypogonadism correlated positively with pro and anti-inflammatory cytokines Conclusion: The study revealed significant cytokine alterations which suggest active inflammatory process while CD4 T-cells and Abs Lym dropped showing some degree of derangement in cellular immunity at both phases of menstrual cycle; which tends to normalize on treatment. This may affect the reproductive potentials in these women.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"32 1","pages":"63-73"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75984254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/CLINICAL-INVESTIGATION.1000135
U. Koehler, O. Hildebrandt, A. Weissflog, A. Zacharasiewicz, K. Sohrabi, N. Koehler, V. Gross
Children with asthma often have a decreased performance during the day because of night-time asthma symptoms. Asthma is still poorly controlled in more than 50% of patients despite the availability of very effective drugs. GINA defined criteria for asthma control include asking about daytime symptoms, limitation of activity, night-time symptoms/awakenings and need for reliever treatment. Standardized and validated questionnaires such as asthma control test (ACT) help to assess the level of asthma control. Approximately 30 to 40% of asthmatic children are affected by sleep disturbances. Asthma symptoms during night-time must be seen as a special feature of asthma. Computerized cough, wheeze and respiratory rate monitoring provides additional and objective information on current night-time symptoms. To reduce risk for children with asthma, control of night-time symptoms is important to improve respiratory function and quality of sleep.
{"title":"LEOSound - A new device for long-term recording of wheezing and cough in pediatric and adult patients with asthma (during sleep)","authors":"U. Koehler, O. Hildebrandt, A. Weissflog, A. Zacharasiewicz, K. Sohrabi, N. Koehler, V. Gross","doi":"10.4172/CLINICAL-INVESTIGATION.1000135","DOIUrl":"https://doi.org/10.4172/CLINICAL-INVESTIGATION.1000135","url":null,"abstract":"Children with asthma often have a decreased performance during the day because of night-time asthma symptoms. Asthma is still poorly controlled in more than 50% of patients despite the availability of very effective drugs. GINA defined criteria for asthma control include asking about daytime symptoms, limitation of activity, night-time symptoms/awakenings and need for reliever treatment. Standardized and validated questionnaires such as asthma control test (ACT) help to assess the level of asthma control. Approximately 30 to 40% of asthmatic children are affected by sleep disturbances. Asthma symptoms during night-time must be seen as a special feature of asthma. Computerized cough, wheeze and respiratory rate monitoring provides additional and objective information on current night-time symptoms. To reduce risk for children with asthma, control of night-time symptoms is important to improve respiratory function and quality of sleep.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"13 1","pages":"103-107"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79009464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/CLINICAL-INVESTIGATION.1000137
Aida X Medina-Urrutia, C. Posadas-Romero, E. Jorge-Galarza, Á. R. López-Uribe, del Carmen Gonzalez-Salazara, J. G. Juárez-Rojas
Background: High-density lipoprotein cholesterol (HDL-C) concentrations are determined by environmental and metabolic factors, but systemic inflammation markers had been less studied. Aim: To evaluate the independent association of systemic inflammation markers to HDL-C concentration, considering the relative contribution of envioromental, and metabolic factors, in a well-characterized Mexican-Mestizo population. Methods: We used logistic regression and linear regression analysis to assess the effect of inflammatory (high sensitivity C-reactive protein (hs-CRP), adiponectin, tumor necrosis factor alpha, interleukins 6, 10, 15, and 1β), environmental (diet and physical activity) and metabolic factors (triglyceride (TG) levels, insulin resistance, abdominal visceral fat) on HDL-C concentrations, in 907 adults (46.5% female, aged 52 ± 9 years), without diabetes, TG ≤ 600 mg/dL, and hs-CRP ≤ 3 mg/L. Results: We found hypoalphalipoproteinemia (HA: HDL-C ≤ 50 mg/dL in women and ≤ 40 mg/dL in men) in 44.8% of women and 48.8% of men. Carbohydrate intake (standardized coefficient β: -0.109 and -0.142), TG (-0.280 and -0.418), and interleukin-1β (-0.156 and -0.159) were inversely and independently associated to HDL-C levels, whereas adiponectin had a positive effect on the lipoprotein concentrations (0.196 and 0.169) for women and men, respectively (p<0.05 for all). Conjointly, these variables explained 33% of the variance in HDL-C levels. Conclusion: The study confirms the strong association of TG and carbohydrate intake with HDL-C levels. In addition, the results highlight the relevance of inflammatory processes in HA, which is one of the most prevalent cardiovascular risk factors in the Mexican population.
{"title":"Inflammasome activation markers are independently associated with hypoalphalipoproteinemia in a Mexican-Mestizo population","authors":"Aida X Medina-Urrutia, C. Posadas-Romero, E. Jorge-Galarza, Á. R. López-Uribe, del Carmen Gonzalez-Salazara, J. G. Juárez-Rojas","doi":"10.4172/CLINICAL-INVESTIGATION.1000137","DOIUrl":"https://doi.org/10.4172/CLINICAL-INVESTIGATION.1000137","url":null,"abstract":"Background: High-density lipoprotein cholesterol (HDL-C) concentrations are determined by environmental and metabolic factors, but systemic inflammation markers had been less studied. Aim: To evaluate the independent association of systemic inflammation markers to HDL-C concentration, considering the relative contribution of envioromental, and metabolic factors, in a well-characterized Mexican-Mestizo population. Methods: We used logistic regression and linear regression analysis to assess the effect of inflammatory (high sensitivity C-reactive protein (hs-CRP), adiponectin, tumor necrosis factor alpha, interleukins 6, 10, 15, and 1β), environmental (diet and physical activity) and metabolic factors (triglyceride (TG) levels, insulin resistance, abdominal visceral fat) on HDL-C concentrations, in 907 adults (46.5% female, aged 52 ± 9 years), without diabetes, TG ≤ 600 mg/dL, and hs-CRP ≤ 3 mg/L. Results: We found hypoalphalipoproteinemia (HA: HDL-C ≤ 50 mg/dL in women and ≤ 40 mg/dL in men) in 44.8% of women and 48.8% of men. Carbohydrate intake (standardized coefficient β: -0.109 and -0.142), TG (-0.280 and -0.418), and interleukin-1β (-0.156 and -0.159) were inversely and independently associated to HDL-C levels, whereas adiponectin had a positive effect on the lipoprotein concentrations (0.196 and 0.169) for women and men, respectively (p<0.05 for all). Conjointly, these variables explained 33% of the variance in HDL-C levels. Conclusion: The study confirms the strong association of TG and carbohydrate intake with HDL-C levels. In addition, the results highlight the relevance of inflammatory processes in HA, which is one of the most prevalent cardiovascular risk factors in the Mexican population.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"85 1","pages":"113-121"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90873327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/CLINICAL-INVESTIGATION.1000142
Z. Abedin, Jennifer Dochee, David Gough, M. Abedin, T. Siddiqi, D. Mukherjee, Z. Mulla, Z. Abedin
Background: A diagnosis of an old Inferior Wall Myocardial Infarction (IMI), on a routinely performed Electrocardiogram (ECG) often leads to further consultations and imaging studies. The aim of this study was to assess the predictive value of Q waves in inferior leads, alone or in combination with repolarization abnormalities, for the diagnosis of inferior wall myocardial infarction confirmed by imaging studies. Methods: Fifty-six patients, in whom computerized interpretation of the electrocardiogram resulted in the diagnosis of inferior wall myocardial infarction, and in whom imaging studies were also available, were included in this study. Electrocardiograms were performed using the GE MACHD 5500. Electrocardiograms were interpreted using the MUSE GE system. Echocardiograms and nuclear medicine cardiac imaging were performed and interpreted using standard equipment and techniques. S AS 9.3 software (SAS Institute, Inc., Cary, North Carolina) was used to calculate 95% exact binomial confidence intervals (CI) for the population PPVs. Results: Computerized interpretation of the ECGs leading to the diagnosis of old inferior wall myocardial infarction when compared with inferior wall myocardial infarction confirmed by imaging studies, had a positive predictive value of 52.78%. Adding the criteria of Q waves wider than 0.04 ms, using manual interpretation of ECG, increased the positive predictive value of the test to 80%. However, the presence of ST changes and/or negative or isoelectric T waves, in the presence of diagnostic Q waves in the inferior leads, increased the positive predictive value to 92%. Conclusion: These results suggest that the computerized interpretation of ECG results in a high rate of false positive readings of old inferior myocardial infarction. This may result in overutilization of imaging modalities. Presence of diagnostic Q waves in inferior leads, if accompanied by repolarization abnormalities, improves the accuracy of the electrocardiogram for the diagnosis of inferior wall myocardial infarction..
背景:在常规心电图(ECG)上诊断为陈旧性下壁心肌梗死(IMI)通常会导致进一步的咨询和影像学研究。本研究的目的是评估单独或联合复极异常的下导联Q波对经影像学证实的下壁心肌梗死的预测价值。方法:本研究纳入56例经心电图计算机解释诊断为下壁心肌梗死并有影像学检查的患者。使用GE MACHD 5500进行心电图检查。使用MUSE GE系统解释心电图。超声心动图和核医学心脏成像使用标准设备和技术进行和解释。使用SAS 9.3软件(SAS Institute, Inc.， Cary, North Carolina)计算总体ppv的95%精确二项置信区间(CI)。结果:与影像学证实的下壁心肌梗死相比，计算机解释的心电图诊断为陈旧性下壁心肌梗死的阳性预测值为52.78%。增加Q波宽度大于0.04 ms的标准，采用人工解读心电图，将试验的阳性预测值提高到80%。然而，ST段改变和/或负T波或等电T波的存在，以及下导联存在诊断性Q波，将阳性预测值提高到92%。结论:这些结果表明，计算机心电图解释导致老年性下壁心肌梗死的假阳性率很高。这可能导致过度使用成像方式。下导联出现诊断性Q波，若伴有复极异常，可提高心电图诊断下壁心肌梗死的准确性。
{"title":"Predictive value of q waves in inferior leads for the diagnosis of old inferior wall myocardial infarction","authors":"Z. Abedin, Jennifer Dochee, David Gough, M. Abedin, T. Siddiqi, D. Mukherjee, Z. Mulla, Z. Abedin","doi":"10.4172/CLINICAL-INVESTIGATION.1000142","DOIUrl":"https://doi.org/10.4172/CLINICAL-INVESTIGATION.1000142","url":null,"abstract":"Background: A diagnosis of an old Inferior Wall Myocardial Infarction (IMI), on a routinely performed Electrocardiogram (ECG) often leads to further consultations and imaging studies. The aim of this study was to assess the predictive value of Q waves in inferior leads, alone or in combination with repolarization abnormalities, for the diagnosis of inferior wall myocardial infarction confirmed by imaging studies. Methods: Fifty-six patients, in whom computerized interpretation of the electrocardiogram resulted in the diagnosis of inferior wall myocardial infarction, and in whom imaging studies were also available, were included in this study. Electrocardiograms were performed using the GE MACHD 5500. Electrocardiograms were interpreted using the MUSE GE system. Echocardiograms and nuclear medicine cardiac imaging were performed and interpreted using standard equipment and techniques. S AS 9.3 software (SAS Institute, Inc., Cary, North Carolina) was used to calculate 95% exact binomial confidence intervals (CI) for the population PPVs. Results: Computerized interpretation of the ECGs leading to the diagnosis of old inferior wall myocardial infarction when compared with inferior wall myocardial infarction confirmed by imaging studies, had a positive predictive value of 52.78%. Adding the criteria of Q waves wider than 0.04 ms, using manual interpretation of ECG, increased the positive predictive value of the test to 80%. However, the presence of ST changes and/or negative or isoelectric T waves, in the presence of diagnostic Q waves in the inferior leads, increased the positive predictive value to 92%. Conclusion: These results suggest that the computerized interpretation of ECG results in a high rate of false positive readings of old inferior myocardial infarction. This may result in overutilization of imaging modalities. Presence of diagnostic Q waves in inferior leads, if accompanied by repolarization abnormalities, improves the accuracy of the electrocardiogram for the diagnosis of inferior wall myocardial infarction..","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"30 1","pages":"155-160"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79035126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/Clinical-Investigation.1000125
Ye Cao, X. Wang, Yu Cao, Fuyu Song, S. Minelli, Jibin Li, Kexin Li, M. Hong
Objective: With the rapid increasing clinical trials in China in recent years, there has been rising concern on the management of investigator initiated trials. Compared with the trials sponsored by pharmaceutical companies, IIT is facing practical challenges in China due to the lack of experience by investigator and immature regulatory circumstances. We conducted an internet-based survey to understand the overall picture of IITs management in China. Methods: An internet-based questionnaire was developed and the staff of clinical trial offices from different types of hospitals was invited to provide response via mobile based App or online website in 2 weeks. We have collected the responses from the following aspects: administrative and governance infrastructure, ethical review, project management, funding resources and research staff management. Results: From December 8 to 20, 2016, a total of 259 responses were collected from the staffs that are mainly responsible for the clinical trial management and scientific research based in the different clinical facilities. Conclusion: In China, three key factors are important to improve the management on IITs: funding support, staffing resourcing and regulatory guidance.
{"title":"Analysis of the Current Clinical Research Management System of Investigator Initiated Trials in China","authors":"Ye Cao, X. Wang, Yu Cao, Fuyu Song, S. Minelli, Jibin Li, Kexin Li, M. Hong","doi":"10.4172/Clinical-Investigation.1000125","DOIUrl":"https://doi.org/10.4172/Clinical-Investigation.1000125","url":null,"abstract":"Objective: With the rapid increasing clinical trials in China in recent years, there has been rising concern on the management of investigator initiated trials. Compared with the trials sponsored by pharmaceutical companies, IIT is facing practical challenges in China due to the lack of experience by investigator and immature regulatory circumstances. We conducted an internet-based survey to understand the overall picture of IITs management in China. Methods: An internet-based questionnaire was developed and the staff of clinical trial offices from different types of hospitals was invited to provide response via mobile based App or online website in 2 weeks. We have collected the responses from the following aspects: administrative and governance infrastructure, ethical review, project management, funding resources and research staff management. Results: From December 8 to 20, 2016, a total of 259 responses were collected from the staffs that are mainly responsible for the clinical trial management and scientific research based in the different clinical facilities. Conclusion: In China, three key factors are important to improve the management on IITs: funding support, staffing resourcing and regulatory guidance.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"9 1","pages":"19-27"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79148271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/CLINICAL-INVESTIGATION.1000132
A. Abuhamda
Klippel-Trenaunay-Weber syndrome (KTWS) is a rare congenital disorder. The incidence of KTWS is 3-5/100000 live birth. It is characterized by port-wine stain, varicose veins, and bony and soft tissue hypertrophy affecting a limb. Most of the cases were diagnosed after the childhood when the clinical picture became clear and complete. Our baby was diagnosed just after birth; the right lower leg was hypertrophied with port-wine stained. Early diagnosis and multidisciplinary approach will improve the outcome and decrease the morbidity.
{"title":"Pooling of lupus can \"catch\" early skin cancerous: \"Rapid Progression in DNA Damage\"","authors":"A. Abuhamda","doi":"10.4172/CLINICAL-INVESTIGATION.1000132","DOIUrl":"https://doi.org/10.4172/CLINICAL-INVESTIGATION.1000132","url":null,"abstract":"Klippel-Trenaunay-Weber syndrome (KTWS) is a rare congenital disorder. The incidence of KTWS is 3-5/100000 live birth. It is characterized by port-wine stain, varicose veins, and bony and soft tissue hypertrophy affecting a limb. Most of the cases were diagnosed after the childhood when the clinical picture became clear and complete. Our baby was diagnosed just after birth; the right lower leg was hypertrophied with port-wine stained. Early diagnosis and multidisciplinary approach will improve the outcome and decrease the morbidity.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"14 1","pages":"87-89"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86710699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/Clinical-Investigation.1000127
Xiufeng Xie, Tianchang Li
Objective: The aim is to demonstrate the clinical outcomes in non-valvular atrial fibrillation with low CHA 2 DS 2 -VASc score after coronary stent implantation with and without hyperhomocysteinemia. Methods: In a retrospective, multicenter, cohort study (2011–2013) in Beijing, China (n=1713), we compared non-valvular AF patients with CHA 2 DS 2 -VASc score =0 or 1 receiving dual antiplatelet therapy at discharge after coronary artery stent implantation and estimated absolute risks and relative risks (RRs) of major adverse cardiac events (MACE) within 1 year . They were divided into two groups according to the plasma HCY levels before catheterization: group normal (1135 patients, <15 μmol/L) and group hHcy (553 patients, ≥15 μmol/L). The primary endpoint, which was occurrence of major adverse cardiac events (MACE). Results: After 1year follow-up, the group hHcy patients had a higher MACE rate (p=0.017). The main differences between two groups were ischemic stroke (p=0.009), cardiac death (p=0.046) and non-fatal MI (p=0.044). Conclusions: Elevated Hcy level was independently associated with increased risk of MACE events in non-valvular atrial fibrillation patients with low CHA 2 DS 2 -VASc score after coronary artery stents implantations.
{"title":"Clinical outcomes in non-valvular atrial fibrillation with low CHA 2 DS 2 -VASc score after coronary stent implantation with and without hyperhomocysteinemia","authors":"Xiufeng Xie, Tianchang Li","doi":"10.4172/Clinical-Investigation.1000127","DOIUrl":"https://doi.org/10.4172/Clinical-Investigation.1000127","url":null,"abstract":"Objective: The aim is to demonstrate the clinical outcomes in non-valvular atrial fibrillation with low CHA 2 DS 2 -VASc score after coronary stent implantation with and without hyperhomocysteinemia. Methods: In a retrospective, multicenter, cohort study (2011–2013) in Beijing, China (n=1713), we compared non-valvular AF patients with CHA 2 DS 2 -VASc score =0 or 1 receiving dual antiplatelet therapy at discharge after coronary artery stent implantation and estimated absolute risks and relative risks (RRs) of major adverse cardiac events (MACE) within 1 year . They were divided into two groups according to the plasma HCY levels before catheterization: group normal (1135 patients, <15 μmol/L) and group hHcy (553 patients, ≥15 μmol/L). The primary endpoint, which was occurrence of major adverse cardiac events (MACE). Results: After 1year follow-up, the group hHcy patients had a higher MACE rate (p=0.017). The main differences between two groups were ischemic stroke (p=0.009), cardiac death (p=0.046) and non-fatal MI (p=0.044). Conclusions: Elevated Hcy level was independently associated with increased risk of MACE events in non-valvular atrial fibrillation patients with low CHA 2 DS 2 -VASc score after coronary artery stents implantations.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"2 1","pages":"35-41"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83412207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/CLINICAL-INVESTIGATION.1000141
M. Konstan, J. Wagener, M. Wilschanski, I. Laki, S. Boas, S. Dorota, M. Gangal, R. S. Martin, W. Shanahan, J. Pennington
Objective: Porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (CF). Liprotamase is a biotechnology-derived, non-porcine, enzyme replacement without enteric coating. This study compared the effects of liprotamase and porcinederived pancrelipase on Coefficient of Fat Absorption (CFA) in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF. Methods: We conducted a randomized, open-label, assessor blind, parallel group, multicenter, international trial to evaluate the noninferiority of liprotamase to porcine pancrelipase in 128 CF patients’ age ≥7 years with pancreatic insufficiency (Study NCT02279498). Subjects were randomized to liprotamase or pancrelipase, dose-matched to pre-study lipase doses. The primary endpoint was the between group difference in least square (LS) mean change from baseline in CFA, with a non-inferiority margin of -15% for the lower bound of the 95% confidence interval (CI). Key secondary endpoints compared treatment effects on CFA in the absence or presence of concomitant gastric acid suppression (GAS), and coefficient of nitrogen absorption (CNA). Results: Liprotamase missed the noninferiority criterion for CFA (95% CI -16.0, -7.7%), but met that criterion for CNA (95% CI -1.9, -0.7%). Concomitant GAS was associated with higher CFA with liprotamase but not pancrelipase. Conclusion: In this study, liprotamase was inferior to pancrelipase with regards to CFA, but not CNA. Higher doses and GAS may improve the efficacy of liprotamase.
目的:猪源性酶用于囊性纤维化(CF)患者胰酶替代治疗。利朊酶是一种生物技术衍生的，非猪的，不含肠道包衣的酶替代品。本研究比较了利protamase和猪源性胰酶对CF所致外分泌胰功能不全(EPI)患者脂肪吸收系数(CFA)的影响。方法:我们进行了一项随机、开放标签、评估者盲、平行组、多中心、国际试验，评估128例年龄≥7岁的CF伴胰功能不全患者使用利protamase对猪源性胰酶的非效性(研究NCT02279498)。受试者被随机分配到脂肪酶或胰酶组，剂量与研究前的脂肪酶剂量相匹配。主要终点是CFA中最小二乘(LS)平均变化与基线的组间差异，95%置信区间(CI)下界的非劣效裕度为-15%。关键次要终点比较了在没有或存在胃酸抑制(GAS)和氮吸收系数(CNA)的情况下对CFA的治疗效果。结果:利普塔酶未达到CFA的非劣效性标准(95% CI -16.0， -7.7%)，但达到了CNA的标准(95% CI -1.9， -0.7%)。伴随的GAS与较高的CFA与利朊酶相关，但与胰酶无关。结论:本研究中，对于CFA，利普曲酶不如胰酶，而对于CNA，则不如胰酶。高剂量和GAS可提高利朊酶的疗效。
{"title":"A comparison of liprotamase, a non-porcine pancreatic enzyme replacement therapy, to porcine extracted pancrelipase in a noninferiority randomized clinical trial in patients with cystic fibrosis","authors":"M. Konstan, J. Wagener, M. Wilschanski, I. Laki, S. Boas, S. Dorota, M. Gangal, R. S. Martin, W. Shanahan, J. Pennington","doi":"10.4172/CLINICAL-INVESTIGATION.1000141","DOIUrl":"https://doi.org/10.4172/CLINICAL-INVESTIGATION.1000141","url":null,"abstract":"Objective: Porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (CF). Liprotamase is a biotechnology-derived, non-porcine, enzyme replacement without enteric coating. This study compared the effects of liprotamase and porcinederived pancrelipase on Coefficient of Fat Absorption (CFA) in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF. Methods: We conducted a randomized, open-label, assessor blind, parallel group, multicenter, international trial to evaluate the noninferiority of liprotamase to porcine pancrelipase in 128 CF patients’ age ≥7 years with pancreatic insufficiency (Study NCT02279498). Subjects were randomized to liprotamase or pancrelipase, dose-matched to pre-study lipase doses. The primary endpoint was the between group difference in least square (LS) mean change from baseline in CFA, with a non-inferiority margin of -15% for the lower bound of the 95% confidence interval (CI). Key secondary endpoints compared treatment effects on CFA in the absence or presence of concomitant gastric acid suppression (GAS), and coefficient of nitrogen absorption (CNA). Results: Liprotamase missed the noninferiority criterion for CFA (95% CI -16.0, -7.7%), but met that criterion for CNA (95% CI -1.9, -0.7%). Concomitant GAS was associated with higher CFA with liprotamase but not pancrelipase. Conclusion: In this study, liprotamase was inferior to pancrelipase with regards to CFA, but not CNA. Higher doses and GAS may improve the efficacy of liprotamase.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"5 1","pages":"147-154"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81043096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/Clinical-Investigation.1000122
Changkai Deng, Qiang Peng, Xianliang Hu, Yang Lin, Fulin Li, Chao Ma, Feng Liu
Congenital anterior urethrocutaneous fistula (CAUF), is a uncommon anomaly characterised by fistulisation of penile urethra to skin. It’s usually seen as an isolated deformity or may accompany genitourinary or anorectal malformations. The cause is obscure, but probably reflects a focal defect in the urethral plate that prevents fusion of the urethral folds. This case reports states that CAUF is mainly located in subcoronal level and treatment of this entity is personalized according to size and locatiton of fistula. Success rates are high with the principles of hypospadias surgery
{"title":"Congenital Anterior Urethrocutaneous Fistula: A Case Report","authors":"Changkai Deng, Qiang Peng, Xianliang Hu, Yang Lin, Fulin Li, Chao Ma, Feng Liu","doi":"10.4172/Clinical-Investigation.1000122","DOIUrl":"https://doi.org/10.4172/Clinical-Investigation.1000122","url":null,"abstract":"Congenital anterior urethrocutaneous fistula (CAUF), is a uncommon anomaly characterised by fistulisation of penile urethra to skin. It’s usually seen as an isolated deformity or may accompany genitourinary or anorectal malformations. The cause is obscure, but probably reflects a focal defect in the urethral plate that prevents fusion of the urethral folds. This case reports states that CAUF is mainly located in subcoronal level and treatment of this entity is personalized according to size and locatiton of fistula. Success rates are high with the principles of hypospadias surgery","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"79 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79273608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/CLINICAL-INVESTIGATION.1000126
K. Kaarniranta, A. Ropo
Key points When prescribing intraocular pressure (IOP)-lowering medication for glaucoma, physicians’ considerations of a patient’s age, preferences and prior experience using different types of eye drop containers could potentially improve adherence, prevent glaucomatous progression and ultimately improve outcomes.
{"title":"Preferences and ease of use of preservative-free IOP-lowering eye drop containers: A comparison of two multi-dose bottles","authors":"K. Kaarniranta, A. Ropo","doi":"10.4172/CLINICAL-INVESTIGATION.1000126","DOIUrl":"https://doi.org/10.4172/CLINICAL-INVESTIGATION.1000126","url":null,"abstract":"Key points When prescribing intraocular pressure (IOP)-lowering medication for glaucoma, physicians’ considerations of a patient’s age, preferences and prior experience using different types of eye drop containers could potentially improve adherence, prevent glaucomatous progression and ultimately improve outcomes.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"26 1","pages":"29-33"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73895243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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