克林霉素注射剂安全性相关国家标准的国内外比较研究  

Comparative analysis of domestic and external information regarding safety of clindamycin injection

作　　者：万征[1] 张慧[2] 

机构地区：[1]国家食品药品监督管理总局高级研修学院,北京100073 [2]中日友好医院儿科

出　　处：《中国医药》2015年第8期1208-1211,共4页China Medicine

摘　　要：目的 比较克林霉素注射剂与安全性相关的国内外上市情况,为提高药品安全性提供参考.方法 检索世界主要国家克林霉素注射剂的上市情况,对国内外产品的剂型、质量标准、药品说明书进行对比,并结合药物不良反应发生情况进行分析.结果 克林霉素磷酸酯注射剂在国外主要发达国家上市并列入多国药典,盐酸克林霉素注射剂仅在我国上市;我国克林霉素磷酸酯及其注射剂的质量标准与国外基本一致;“心脏骤停”的不良反应载入国外药品说明书,且国内已有文献报道;盐酸克林霉素静脉注射给药的急性毒性大于克林霉素磷酸酯,临床引起肾毒性的风险也高于后者.结论 克林霉素磷酸酯注射剂是安全有效的抗微生物药物.应关注“心脏骤停”的不良反应,加强监测和风险提示.建议对盐酸克林霉素注射剂的安全性进行深入的评价和研究.Objective To compared the domestic and external information related to the safety of clindamycin injection.Methods The market information of clindamycin injection was retrieved;the formulation,quality standard and drug instruction were compared between China information and worldwide information.The adverse events were analyzed.Results Clindamycin phosphate injection has been approved in most developed countries,while clindamycin hydrochloride injection has been only approved in China.The quality standard of clindamycin phosphate injection in China was consistent with that of worldwide.The adverse reaction of ＆quot; cardiac arrest＆quot; was listed in the drug instructions worldwide,and it had been reported in domestic literatures.The clindamycin hydrochloride had a higher acute toxicity and a higher risk of renal toxicity compared with clindamycin phosphate injection when being intravenously administrated.Conclusions Clindamycin phosphate injection is a safe and effective anti-microbial agent.The adverse reaction of ＆quot;cardiac arrest＆quot; should be monitored.

关 键 词：克林霉素 安全性 质量标准 药品说明书 

分 类 号：R917[医药卫生—药物分析学]