基于“哈尔滨共识”报告多囊卵巢综合征大型临床试验的不良事件

Discussion on adverse events in large clinical trials about PCOS based on 'Harbin Consensus'

基于不孕症临床试验国际报告标准-哈尔滨共识,以一项多中心、大样本、双盲的针刺临床随机对照试验为例,通过专人专项的围产医学小组负责制等策略来收集不良事件(AE),共收集AE近2 000件。AE发生的人群包括受试者(1 000余件)、受试者丈夫(3件),胎儿及新生儿(近40件);其分别发生在干预期间(近1 000件),妊娠期间(700余件),产后(近10件),胎儿及新生儿期间(近40件);其中和干预措施及多囊卵巢综合征相关的特异性AE为500余件,非特异性AE为600余件,偶发AE近10件;严重不良事件70余件。但仍存在一定不足之处,今后需改进。

Based on the international report standard about infertility clinical trials: ‘Harbin Consensus', taking a multicenter, large sample, double-blind acupuncture clinical randomized controlled trial for an example, a total of nearly 2 000 cases of adverse events were collected through the specialization of perinatal medical group responsibility system and other strategies. The population of serious adverse events included subjects(more than 1 000), subject's husband(3), fetus and neonate(nearly 40); the stages of their occurrence were the intervention period(nearly 1 000), pregnancy duration(more than 700), postpartum(close to 10) and fetal and neonatal period(nearly 40); the number of specific adverse events which was associated with the intervention and polycystic ovarian syndrome was more than 500, nonspecific adverse events was more than 600, accidental adverse events was nearly 10; serious adverse events was more than 70. But there were still some shortcomings, and the collection about adverse events needs to be improved.