2475例宫血宁胶囊治疗药物流产后阴道出血的安全性观察

Safety Evaluation of Gongxuening Capsule in the Treatment of Colporrhagia after Medical Abortion

目的通过分析药物流产后患者服用宫血宁胶囊的不良事件观察结果,对宫血宁胶囊减少术后出血的安全性进行评价.方法收集2007年1月至2008年1月我省各地州医院药物流产后口服宫血宁胶囊2 475例,对所有服药者的不良反应事件发生率进行多中心/安全性监测,评价宫血宁胶囊的安全性.结果2 475例药物流产后口服宫血宁胶囊的患者的不良事件发生率为0.97%,其中以胃肠道反应的发生率最高,其他不良事件,如下腹隐痛、头晕以及阴道出血多发生率低,不良事件的持续时间短,程度为中度者占0.20%,轻度者占0.77%,全部好转或消失.结论健康育龄妇女药物流产的同时服用宫血宁后不良反应事件发生率低,持续时间短,程度轻,很快消失或好转,无需特殊处理,显示其安全性很高.

Objective To evaluate the satety of Gongxuening capsule in the treatment of colporrhagia after medical abortion by observing the incidence of adverse events. Methods 2 475 patients who took Gongxuening capsule after medical abortion were collected from hospitals in Yunnan Province from Jan. 2007 to Jan. 2008. The incidence of adverse events was monitored in nuhi-centers to evaluate the satety of Gongxuening capsule. Results The incidence of adverse events in 2 475 patients selected was 0.97%, in which the incidence of gastro-intestinal tract response was the highest, the incidences of other adverse events such as abdominal ache, dizzy and colporrhagia were lower. The duration of adverse events was short. The moderate degree of adverse events accounted for 0.20%, and the the mild degree accounted for 0.77%. All adverse events turned for the better or disappeared eventurally. Conclusions The incidence of adverse events in healthy women who take Gongxuening capsule after medical abortion is low, the duration is short, the degree is mild. Adverse events turns for the better or disappears quickly, and don＇t need special handling. Therefore, the safety of Gongxuening capsule is very high.