我院2008-2015年妇科中成药不良反应报告分析

Retrospective Analysis of ADR Induced by Gynecological Chinese Patent Medicine in Our Hospital during 2008-2015

目的：探讨妇科中成药应用中不良反应（ADR）发生的特点及一般规律,为妇科临床合理使用中成药提供参考依据。方法：收集我院ADR报告信息系统2008-2015年上报的妇科ADR报告,从中提取所有中成药ADR报告病例,对其进行统计、分析。结果：41例中成药ADR中无严重的ADR;新的一般的ADR 24例,占58.54%;一般的ADR 17例,占41.46%;用药后1~3 d ADR发生率高,占97.6%;以口服给药（19例,占46.3%）和阴道给药（15例,占36.6%）引发的ADR为主;ADR主要累及消化系统反应（29.79%）、全身性反应（19.15%）和生殖系统（17.02%）等。结论：妇科使用中成药相对安全,但对于某些特殊的病例仍需谨慎,注意区别用药。

OBJECTIVE：To explore the characteristics and regularity of ADR induced by gynecological Chinese patent medicine,and to provide reference for rational use of gynecological Chinese patent medicine. METHODS：ADR reports were collected from gynecological ADR reporting information system of our hospital during 2008-2105;all ADR cases of Chinese patent medicine were collected and analyzed. RESULTS：No severe ADR was found among 41 cases of Chinese patent medicine-induced ADR,24 cases of new and common ADR（58.54%）,17 cases of common ADR（41.46%）;the incidence of ADR was in high level 1-3 d after medicating,being 97.6%. Main routes of administration were oral administration（19 cases,46.3%）and vaginal administration（15 cases,36.6%）in ADR cases. Clinical manifestations were gastrointestinal reaction（29.97%）,systemic reaction（19.15%）and mild injury of reproductive system（17.02%）,etc. CONCLUSIONS：Chinese patent medicine is relatively safety in gynecological department. However,caution should be exercised in special cases and different medication.