运用循证医学方法建立胸腺法新合理用药评价标准

Establishment of evidence-based criteria to evaluate the new rational use of thymalfasin

目的:通过循证医学的方法建立胸腺法新合理用药评价标准,为处方点评中超说明书用药的评价提供方法学参考。方法:随机提取2016年1月份某院使用胸腺法新的200例出院病历,对胸腺法新的使用进行分析,提炼问题并制定检索策略,检索PubMed数据库、ELSEVIER数据库、The Cochrane Library、中国期刊全文数据库、万方数据库,采用Revman5.3软件对随机对照临床试验研究进行系统评价,采用GRADE profiler 3.6软件进行证据质量评价,制定合理用药评价标准。结果:胸腺法新在某院主要用于肾病综合征、紫癜、慢性乙型肝炎、肿瘤及感染等,文献检索后共纳入6篇系统评价研究,4篇随机对照临床试验研究。其中用于紫癜和肾病综合征为极低级别证据,用于肿瘤和感染为中级级别证据。用于慢性乙型肝炎为胸腺法新的适应证用药,用于紫癜和肾病患者为无充足循证医学依据的超说明书用药,用于肿瘤仅限于非小细胞肺癌患者和黑色素瘤患者为有循证学依据,用于感染仅限于老年人以及急重症者为有循证学依据。结论:通过循证医学方法建立药物合理使用的评价标准切实可行。

OBJECTIVE To establish the evidence-based criteria to evaluate the new rational use of thymalfasin,and provide a reference for evaluating the off-label drug use.METHODS According to the results of thymalfasin prescription analysis in our hospital,literatures searched from the PubMed,ELSEVIER,The Cochrane Library,CNKI and WanFang Data were screened.The criteria to evaluate the new rational use of thymalfasin were established based on the results of literatures analyzing by Revman5.3 and GRADE profiler 3.6.RESULTS In our hospital,thymalfasin was mainly used to patients with primary nephrotic syndrome,purpura,chronic hepatitis B,cancer or respiratory infection.Six meta-analysis and the four controlled trials showed that,evidence level was very low for thymalfasin used against primary nephrotic syndrome and purpura,and moderate for thymalfasin used against tumors and infection.It was a new indication to chronic hepatitis B,off-label use in patients with purpura and nephrotic syndrome,evidence based for patients with non small cell lung cancer and melanoma.The drug could only be used to senile people and patients with severe and/or acute diseases with available evidences.CONCLUSION It is feasible to apply evidence-based medicine method to establish evaluation standards for rational drug use.