不孕症临床试验产科结局的追踪策略  

Strategy of obstetric outcome tracking in a large clinical trial about infertility

作　　者：高敬书[1] 沈文娟[1] 王桂媛[1] 刘建平[2] 吴效科[1] 

机构地区：[1]黑龙江中医药大学附属第一医院,哈尔滨150040 [2]北京中医药大学基础医学院,北京100029

出　　处：《中华中医药杂志》2015年第11期3996-3998,共3页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家"十一五"科技支撑计划(No.2007BAI20B015);国家重大科技专项--国家公益性行业专项(No.2008207021)~~

摘　　要：多囊卵巢综合征(PCOS)是生育期妇女最常见的生殖内分泌疾病,临床上以生殖机能障碍为突出表现。由于PCOS患者特殊的病理生理,临床治疗特点是"治证不治病",判定治疗是否有效的最有力证据就是治疗后患者的活产率。文章以国家中医临床研究基地:妇科病基地实施的08行业专项"痰湿型不孕证中医治疗方案的优化研究"大型RCT为背景,针对试验中的关键环节——产科结局追踪,分别从收集难度、收集过程、以及对信息的全面性、等级、真实性几个方面进行分析,强调产科结局的追踪对于解决不孕症临床研究的有效性、可靠性以及反应中药生殖毒性的意义。以期对不孕症临床试验产科结局工作的开展提供参考。Polycystic ovary syndrome（PCOS） is the most common reproductive endocrine disease in reproductiveage women. PCOS is characterized by reproductive dysfunction. Due to the special pathological physiology in PCOS, the key point of treatment is aiming to improve symptoms but not to cure disease. Live birth rate is considered as the most powerful evidence to appraise the efficacy of therapies. Based on a large RCT about ‘study on optimal therapeutic schedule for infertility with syndrome of phlegm-dampness＇ conducted by gynecology base of national trial base of Chinese Medicine, we illustrate the importance of obstetric outcome tracking, including the difficulty of collecting, gathering process as well as the significance of comprehensiveness, grade, reality of obstetric outcome information. We conclude that obstetric outcome tracking play important role in the efficacy, reliability, TCM reproductive toxicity in an infertility clinical trial. We aim at providing reference for the practicing of obstetric outcome tracking in a clinical trial of infertility.

关 键 词：多囊卵巢综合征 临床试验 活产率 产科结局 

分 类 号：R271.14[医药卫生—中医妇科学]