Objective To analyze the application and safety on Gugua Extract Injection in 98th Hospital of People's Liberation Army (“our hospital”for short), as references for proper clinical application and policy decisions from Drug Administration. Methods Cases on Gugua Extract Injection between October 2010 and December 2012 in our hospital were reviewed retrospectively and analyzed statistically on self-built database. Results In 3124 cases, 64.98% patients who took Gugua Extract Injection were aged 30-<60. Gugua Extract Injection was used under clinical indications by intravenous drip. In some cases, dosage, solvent, drug concentration and course of treatment were beyond specification. The incidence of ADRs was 1.92%; anaphylaxis was the main manifestations, severe cases could cause anaphylactic shock, diversity of clinical situation; ADRs involving multiple systems, included damage of skin and its appendages, respiratory system, systemic, hepatobiliary system, nervous system, digestive system. Conclusion The ADRs occurrence rate of Gugua Extract Injection is low, which has high security. Irrational clinical application can increase risk. The su-pervision of clinical application of biochemical drug injection should be strengthened.%目的：分析解放军第九八医院(以下简称“我院”)骨瓜提取物应用情况及安全性，为临床应用和药品监管部门决策提供参考。方法采用病历回顾性研究方法，对我院2010年10月~2012年12月期间使用骨瓜提取物的完整住院病历进行调查，自建数据库，进行统计分析。结果共收集到3124份应用骨瓜提取物的住院患者病历，30~<60岁人群使用骨瓜提取物最多，占64.98%；适应证比较规范，用法均为静脉滴注，用量、溶媒选择、用药浓度及用药疗程上存在超说明书现象；不良反应发生率为1.92%，属常见范畴；主要表现为各种过敏反应，严重者可致过敏性休克，临床表现多样；累及全身多个系统，按发生率高低依次为皮肤及附件系统、呼吸系统、全身性、肝胆系统、神经系统、消化系统损害。结论骨瓜提取物临床应用不良反应发生率较低，安全性较高；不合理应用给临床用药安全性增加了风险，应加强生化药注射剂临床合理使用监管。
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