我院骨瓜提取物临床应用安全性评价报告  

Safety evaluation on the clinical application of Gugua extract injection in our hospital

作　　者：孔飞飞 沈洁 吴洁 叶光明 郭良君 谭兴起 傅明强 

机构地区：[1]解放军第九八医院药械科,浙江湖州313000 [2]解放军第九八医院骨六科,浙江湖州313000 [3]解放军第九八医院呼吸科,浙江湖州313000 [4]解放军第九八医院医务处,浙江湖州313000 [5]解放军118医院,浙江温州325000

出　　处：《中南药学》2015年第12期1322-1327,共6页Central South Pharmacy

基　　金：2012年浙江省药学会医院药学专项科研基金项目(编号:2012ZYY24)

摘　　要：目的对骨瓜提取物临床应用的安全性进行前瞻性临床研究和综合评价。方法选取2013年1月-2014年4月在本院使用骨瓜提取物的住院患者为研究对象,从用药开始至用药结束后15 d内,观察记录患者的药品应用情况及不良反应发生情况,并进行数据统计分析。结果共收集使用过骨瓜提取物的住院患者1030例,涉及12个科室,男女比例为2.03：1,年龄以40-49、50-59、30-39岁年龄段居多,但随着年龄的增长,女性患者的比例也在逐步增加。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1.74%,属常见范畴;临床表现多样,涉及系统按发生率高低依次为：皮肤及附件系统损害、呼吸系统损害、肝胆系统损害、消化系统损害、全身性损害。结论本院临床使用骨瓜提取物基本按照说明书规定使用,有利于提高药物临床使用的安全性;不良反应发生率较低,安全性较高;但也有不合理现象,应进一步规范骨瓜提取物在临床中的使用,保证药物治疗的安全有效。Objective To prospective study and comprehensive evaluate the clinical application safety of Gugua extract injection. Methods Collecting the cases of Gugua extract injection in our hospital from January 2013 to April 2014. Recording the clinical application and adverse reaction（ADR） from beginning to the end during 15 days, and analyzed the results. Results Totally 1030 cases from 12 departments were collected. The ratio of male to female was 2.03 ：1. Most of the inpatients were 40- 49 year-old, 50- 59 year-old and 30- 39 year-old, but the female patients increased with ages. In most cases, indications were consistent with the drug instruction. Usage was intravenous infusion. But, dosage, solvent, drug concentration and treatments existed off-label indications. The incidence of ADR was 1.74%, belonging to a common category. ADR could affect multiple organs and systems, followed by skin and accessories damage, respiratory system, hepatobiliary system, digestive system, and systemic damage. Conclusion In our hospital, clinical application for Gugua extract injection fit in with drug instruction on the whole, and it is good for improving drug application safety. The occurrence rate of ADRs is low and safety used in orthopedics is high. However, the clinical application exists unreasonable. We should further regulate the usage of Gugua extract injection to ensure safe and effective medication.

关 键 词：骨瓜提取物 安全性评价 前瞻性 临床应用 不良反应 

分 类 号：R286[医药卫生—中药学]