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目的分析西京医院2014年1月~2015年12月中成药不良反应(ADR)报告的特点与规律,为加强中成药的ADR监测提供参考。方法按照患者的性别与年龄、给药途径、剂型、引发ADR的主要药品、累及器官或系统、ADR的类型等项目,对192例中成药ADR报告进行统计分析。结果 192例中成药ADR报告中,女性占54.68%;涉及30种中成药,其中报告3例次及以上的有25种,占总例次的95.3%;口服用药引起的ADR最多,占70.9%,其次是静脉给药,占28.1%;ADR的临床表现以消化系统最多,占40.6%,其次是感觉器损害占27.1%。结论中成药的ADR与多种因素有关,应做好监测以促进其用药安全。
Objective To analyze the characteristics and rules of ADR reported by Xijing Hospital from January 2014 to December 2015 and provide references for strengthening the monitoring of ADR of proprietary Chinese medicines. Methods According to the patient’s gender and age, route of administration, dosage form, main drug causing ADR, organs involved or system, type of ADR and other items, 192 cases of proprietary Chinese medicine ADR were analyzed statistically. Results Among 192 Chinese patent medicines, 54.68% were women, involving 30 kinds of proprietary Chinese medicines, of which 25 were reported in 3 cases and above, accounting for 95.3% of the total cases; oral administration of ADR caused the most, accounting for 70.9% , Followed by intravenous administration, accounting for 28.1%; ADR clinical manifestations to the digestive system up to 40.6%, followed by sensory damage accounted for 27.1%. Conclusion The ADR of traditional Chinese medicine is related to many factors and monitoring should be done to promote its drug safety.