参芪扶正注射液的安全性评价

目的分析参芪扶正注射液临床应用的不良反应、发生类型以及相关危险因素,为临床安全用药提供依据。方法对医院2009年2月1日至2011年1月31日使用参芪扶正注射液的住院患者442例进行统计分析。结果参芪扶正注射液不良反应的总发生率为1.35%,发生类型有全身性损害、消化系统损害、呼吸系统损害、循环系统损害等。除药品说明书上常见不良反应以外,另有静脉炎、多汗、眼干等新的不良反应发生。发生时间多集中在用药几天以后,为迟发型不良反应。结论应加强参芪扶正注射液不良反应监测,完善药品说明书内容,规范临床医务人员的合理用药,防止其严重不良反应发生。

Safety Evaluation of Shenqifuzheng Injection

Objective To observe the adverse reactions, occurrence types and related risk factors in the clinical application of Shenqi-fuzheng Injection to provide the basis for clinical rational drug use. Methods Four hundred and forty-two inpatients with using Shen- qifuzheng Injection in this hospital from February 1, 2009 to January 31, 2011 were performed the statistical analysis. Results The total incidence rate of adverse reactions of Shenqifuzheng Injection was 1.35%, and the occurrence types included systemic damage, gastroin-testinal system damage, respiratory system damage, circulatory system damage, etc. In addition to the common adverse reactions introduced in the package insert, there were some new adverse reactions like phlebitis, hidrosis and dry eye syndrome. The occurrence time focused on several days after the drug use, most of those adverse reactions were late onset. Conclusion Monitoring the adverse reactions of Shenqifuzheng Injection should be strengthened, the content of the package insert should be perfected and the rational drug use in clin-ical medical staff should be standardized in order to prevent the occurrence of serious adverse reactions.