莲必治注射液的临床安全性与风险管理探讨  

Discussion on Clinical Safety and Risk Management of Lianbizhi Injection

作　　者：江锋[1] 王兴文[2] 杨卫彬[2] 曹俊岭[1] 荆志伟[2] 

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]中国中医科学院,北京100700

出　　处：《中国药房》2012年第36期3386-3388,共3页China Pharmacy

基　　金：国家自然科学基金资助项目(81001596);国家科技重大专项资助项目(2012ZX10005009)

摘　　要：目的:了解莲必治注射液的临床安全性,并为其实施风险管理提供参考。方法:通过文献分析,总结莲必治注射液上市后的临床应用概况和过敏反应及肾毒性反应的特征,分析导致不良反应的因素,藉此提出该药的风险管理措施。结果:莲必治注射液临床主要用于感染性疾病(如小儿肺炎、放射性肺炎、急性扁桃体炎、病毒性肠炎等)和恶性肿瘤(如晚期肺癌等);上市应用后发生的不良反应以过敏反应(包括皮肤及其附件损害、胃肠系统损害、中枢及外周神经系统损害等;多数轻型过敏反应发生在给药30min内;其与年龄和给药方式有关)和肾毒性反应(主要表现为急性肾功能衰竭;多数发生于首次用药后0.5～12h;其与年龄有关)为主;导致不良反应的因素包括药物因素、用药不当、个体差异等。该药风险管理应注重改进药品质量,加强处方管理,加强临床宣教,开展集中监测等。结论:莲必治注射液临床效果已受到广泛认可,但对其临床安全性应加以重视,加强风险管理。OBJECTIVE： To investigate the clinical safety of Lianbizhi injection and to provide reference for risk management of it. METHODS： By literature analysis, the clinical application of Lianbizhi injection listed and the characteristics of renal toxicity and allergic reactions were summarized, and the reasons for adverse drug reactions were analyzed to put forward measures of risk management. RESULTS： Lianbizhi injection was used for infectious diseases （such as infantile pneumonia, radiation pneumonia, acute tonsillitis and viral enteritis） and malignant tumors （such as advanced pulmonary cancer）. After listed, adverse drug reactions mostly were allergic reactions （including lesion of skin and appendants, gastrointestinal injury and central and peripheral nervous system damage; most of slight allergic reactions occurred in 30 min after medication; it was related to age and route of adminis- trstion） and renal toxicity （mainly manifested as acute renal failure; most occurred in 0.5~12 h after first medication; it was relat- ed to age） ; the reasons for adverse drug reactions were drug factor, irrational use of drugs, individual difference, etc. Risk manage- ment should focus on improving the quality of drugs, enhancing prescription management and clinical education, carrying out cen- tralized monitoring, etc. CONCLUSION： Clinical efficacy of Lianbizhi injection has been widely approved. Great importance should be attached to clinical safety of it, and risk management should be enhanced.

关 键 词：莲必治注射液 临床应用 不良反应 风险管理 

分 类 号：R95[医药卫生—药学]