摘要
不孕症临床试验妊娠随访的关键意义,是获得有效评估干预措施的有效性及安全性的数据,文章以国家临床研究基地中医妇科所承担的大样本、多中心中医不孕症临床试验为例,分析国内妊娠随访研究现状;从评估临床试验有效性、安全性及对患者的积极影响分析妊娠随访重要性;从专人专职、明确其具体职责介绍妊娠随访人员的配备情况;从妊娠随访记录方式、随访文件准备、电话加微信的随访途径描述妊娠随访方式;详细阐述妊娠随访内容包括孕期宣教内容重点、收集妊娠结局应注意妊娠各阶段概念的区别及其之间的逻辑关系、不良事件阶段、人群和分类的特异性以及妊娠结局证据的等级。旨在为不孕症临床试验的随访工作提供借鉴作用。
The significance of pregnancy follow-up in the infertility clinical trials is to obtain the effective and safe data of intervention measures. Based on the large sample and multi center infertility clinical trials undertaken by Chinese gynecology department at the national clinical research base, this article analyzed the current situation of pregnancy follow-up in China. The importance of pregnancy follow-up was evaluated from the effectiveness, safety and positive impact of clinical trials. The staffing of pregnancy follow-up staff was introduced from full-time and specific responsibilities, and the way of follow-up including follow-up documents preparation, follow-up record form, and communication tools （telephone and wechat）. We illustrated the follow-up details including health education during pregnancy, collecting the pregnancy outcomes in many details, taking care of the adverse events occurred in different phases and population, we also described the evidence grade of pregnancy outcomes. The aim is to provide reference for the follow-up work in a clinical trial of infertility.
作者
高敬书
于佳瑞
吴效科
刘松江
GAO Jing-shu;YU Jia-rui;WU Xiao-ke;LIU Song-jiang(First Affiliated Hospital,Heilongjiang University of Chinese Medicine,Harbin 150040,China;Heilongjiang University of Chinese Medicine,Harbin 150040,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2018年第8期3471-3476,共6页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
黑龙江中医药大学科研基金项目-面上项目(黑龙江省教育厅联合项目
No.201727)
黑龙江省教育厅2017年度黑龙江省普通本科高等学校青年创新人才计划(No.UNPYSCT-2017226)~~
关键词
不孕症
临床试验
妊娠结局
不良事件
随访
策略
Infertility
Clinical trial
Pregnancy outcome
Adverse event
Follow-up
Strategy
