CAJ | 학술논문

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。
목적：분석해방군제구팔의원(이하간칭“아원”)골과제취물응용정황급안전성，위림상응용화약품감관부문결책제공삼고。방법채용병력회고성연구방법，대아원2010년10월~2012년12월기간사용골과제취물적완정주원병력진행조사，자건수거고，진행통계분석。결과공수집도3124빈응용골과제취물적주원환자병력，30~<60세인군사용골과제취물최다，점64.98%；괄응증비교규범，용법균위정맥적주，용량、용매선택、용약농도급용약료정상존재초설명서현상；불량반응발생솔위1.92%，속상견범주；주요표현위각충과민반응，엄중자가치과민성휴극，림상표현다양；루급전신다개계통，안발생솔고저의차위피부급부건계통、호흡계통、전신성、간담계통、신경계통、소화계통손해。결론골과제취물림상응용불량반응발생솔교저，안전성교고；불합리응용급림상용약안전성증가료풍험，응가강생화약주사제림상합리사용감관。
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.