Introduction:Letrozole showed higher ovulation and live birth rates than clomiphene in infertile women with polycystic ovary syndrome(PCOS).Berberine,a major active component of Chinese herbal medicine rhizomacoptidis...Introduction:Letrozole showed higher ovulation and live birth rates than clomiphene in infertile women with polycystic ovary syndrome(PCOS).Berberine,a major active component of Chinese herbal medicine rhizomacoptidis,has been used to improve insulin resistance to facilitate ovulation induction in women with PCOS,but there is no study reporting the live birth or its potential as a complementary treatment to letrozole.We aim to determine the efficacy of letrozole with or without berberine in achieving live births among 644 infertile women with PCOS in China's Mainland.Methods and analysis:This is a prospective,randomized,multicentre,double-blinded,controlled design.Infertile women with PCOS were randomized into three-arm,letrozole and berberine,letrozole and berberine placebo,letrozole placebo and berberine.Data and blood were collected at baseline,the third month and sixth month after treatment,or immediately were collected if subject was pregnant.Statisticians and clinical investigators were blinded to treatment allocation and treatment related study results until the central database was locked for final data extraction and analysis determined.The statistical analysis plan described basic analysis principles,methods commonly encountered in data analysis issues,and the specific statistical procedures for analyzing the primary,secondary,and safety outcomes.Ethics and dissemination:The study was approved by the ethics committee of the First Affiliated Hospital,Heilongjiang University of Chinese Medicine.The study findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration:Chinese Clinical Trial Registry:Chi CTR-TRC-09000376.Clinical Trials.gov identifier:NCT01116167.展开更多
目的：借助循证医学的方法为1例急性痛风性关节炎患者制定循证治疗方案。方法：在充分评估患者的情况后,提出临床问题,检索Medline（1990年1月-2009年10月）、Cochrane图书馆（2009年第3期）及CBMWeb（1990年1月-2009年10月）。检索主...目的：借助循证医学的方法为1例急性痛风性关节炎患者制定循证治疗方案。方法：在充分评估患者的情况后,提出临床问题,检索Medline（1990年1月-2009年10月）、Cochrane图书馆（2009年第3期）及CBMWeb（1990年1月-2009年10月）。检索主题词：中西医结合疗法（TCM-WMtherapy）;急性（acute）;痛风性关节炎（Gouty arthritis）;治疗（treat ment ORtherapy）;随机对照试验（RCT）;Meta-分析（Meta-analysis）;系统评价（systematic review）;人类（human）。结果：检索发现,关于急性痛风型关节炎132篇RCT,0篇SR,通过分析检索结果、结合临床经验及患者实际情况,为患者制定了循证治疗方案。通过半年随访证实,该方案适合患者。结论：对急性痛风性关节炎患者,采用循证治疗的方法,可有效提高治疗效果,改善患者的预后。展开更多
文摘数据管理是临床研究质量控制的关键环节,数据管理计划(data management plan,DMP)对于每一项临床研究都是不可或缺的,它为数据管理工作提供全面的指导,使各部门工作遵循良好的临床研究数据管理规范,同时DMP也是稽查人员对数据管理部门必须稽查的文件之一。因此,撰写一份符合本机构实际情况的,高质量的DMP十分重要。本文从制定DMP的意义、临床研究数据管理规范对于制定DMP的最低标准和最佳措施、基于电子数据获取(electronic data capture,EDC)的临床研究DMP的制定、制定DMP的关键因素等几个方面进行探讨。最后针对在中医临床研究中使用EDC系统存在的问题进行分析,并提出改进的建议。
基金Funded by the National Public Welfare Projects for Chinese Medicine(200807021)of Chinathe "11th–Five" Supportive Program for Science and Technology of China(2007BAI20B015)+1 种基金the Heilongjiang Province Foundation for Outstanding Youths(JC200804)the Intervention for Polycystic Ovary Syndrome Based on Traditional Chinese Medicine Theory-‘Tian Gui Shi Xu’(2011TD006)
文摘Introduction:Letrozole showed higher ovulation and live birth rates than clomiphene in infertile women with polycystic ovary syndrome(PCOS).Berberine,a major active component of Chinese herbal medicine rhizomacoptidis,has been used to improve insulin resistance to facilitate ovulation induction in women with PCOS,but there is no study reporting the live birth or its potential as a complementary treatment to letrozole.We aim to determine the efficacy of letrozole with or without berberine in achieving live births among 644 infertile women with PCOS in China's Mainland.Methods and analysis:This is a prospective,randomized,multicentre,double-blinded,controlled design.Infertile women with PCOS were randomized into three-arm,letrozole and berberine,letrozole and berberine placebo,letrozole placebo and berberine.Data and blood were collected at baseline,the third month and sixth month after treatment,or immediately were collected if subject was pregnant.Statisticians and clinical investigators were blinded to treatment allocation and treatment related study results until the central database was locked for final data extraction and analysis determined.The statistical analysis plan described basic analysis principles,methods commonly encountered in data analysis issues,and the specific statistical procedures for analyzing the primary,secondary,and safety outcomes.Ethics and dissemination:The study was approved by the ethics committee of the First Affiliated Hospital,Heilongjiang University of Chinese Medicine.The study findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration:Chinese Clinical Trial Registry:Chi CTR-TRC-09000376.Clinical Trials.gov identifier:NCT01116167.
文摘目的：借助循证医学的方法为1例急性痛风性关节炎患者制定循证治疗方案。方法：在充分评估患者的情况后,提出临床问题,检索Medline（1990年1月-2009年10月）、Cochrane图书馆（2009年第3期）及CBMWeb（1990年1月-2009年10月）。检索主题词：中西医结合疗法（TCM-WMtherapy）;急性（acute）;痛风性关节炎（Gouty arthritis）;治疗（treat ment ORtherapy）;随机对照试验（RCT）;Meta-分析（Meta-analysis）;系统评价（systematic review）;人类（human）。结果：检索发现,关于急性痛风型关节炎132篇RCT,0篇SR,通过分析检索结果、结合临床经验及患者实际情况,为患者制定了循证治疗方案。通过半年随访证实,该方案适合患者。结论：对急性痛风性关节炎患者,采用循证治疗的方法,可有效提高治疗效果,改善患者的预后。
