利用Cochrane Library对处方点评中常见超说明书用药进行循证评估的探讨

Technological Process with Cochrane Library of Reasonability Assessment of Off-label Uses of Drugs Found in Comments on Prescription

目的超说明书用药目前国内外存在争议,对超说明书用药的合理性进行徇证判断是问题的核心,是处方点评中常见并急需解决的难题,目前还没有成熟的标准做法,笔者对处方点评中常见超说明书用药的循证评估进行探讨。方法以对2014年我院处方点评中发现的常见超说明书用药进行徇证评估为例,使用Cochrane Library针对具体超说明书用药现象,查询循证证据包括系统评价数据库(cochrane database of systematic review,CDSR),疗效评价摘要数据库(database of abstracts of reviews of effectiveness,DARE),随机临床对照实验(random clinical controlled trial,RCT)或临床对照实验(clinical controlled trial,CCT),按设置标准对结果进行粗筛和分析后,判断超说明书用药有无循证依据。结果处方点评结果汇总后有8项超说明书用药现象,其中依达拉奉治疗脑外伤,门冬氨酸鸟氨酸治疗肝转氨酶升高,黄体酮治疗泌尿道结石梗阻,左卡尼汀保护心肌均未发现Cochrane Library相关资料,评估为无循证依据,依达拉奉治疗脑出血,左卡尼汀治疗肿瘤衰弱患者根据CDSR或DARE结论评估为无循证依据,胸腺法新用于肿瘤患者根据CDSR结论评估为有循证依据,前列地尔治疗肺动脉高压在对临床试验偏倚性风险评价后评估为严格限定条件下有循证依据。结论处方点评后按流程使用Cochrane Library对超说明书用药合理性进行循证评估,不仅能促进临床合理用药和循证药学的发展,还能够增加临床药师工作的技术含量,增加药师医师用药知识。

OBJECTIVE Off-label uses of drugs incur much debate, which is often encountered when doing prescription comment. The reasonability assessment of off-label uses is the key problem and requires solution urgently. This paper attempts to set up a normative evaluation process of off-label uses in routine prescription comment. METHODS The off-label uses gathered in 2014 prescription comment were used for example. The off-label uses were searched in the Cochrane Library, and the RESULTS such as CDSR（Cochrane Database of Systematic Review）,DARE（Database of Abstracts of Reviews of Effectiveness）,RCT（Random Clinical Controlled Trial）and CCT（Clinical Controlled Trial）were screened according the criterion and analyzed. RESULTS Eight Off-label uses were found with prescription comment. The edaravone for head injury, L-ornithine-L-aspartate for rise of hepatic transaminase, progesterone for urinary calculi and levocarnitine for myocardium protection were no evidence found in Cochrane Library, and were treated as irrationality. According to RESULTS of CDSR and DARE the edaravone for brain hemorrhage, and levocarnitine for cancer fatigue were not supported, but thymalfasin for cancer were supported. After assessing risk of bias with cochrane tool, only under special circumstances can alprostadil for pulmonary hypertension（PH） or pulmonary arterial hypertension（PAH） be evaluated as conformation with evidence-based medicine. CONCLUSION Assessment of reasonability for Off-label uses according to evaluation process using Cochrane Library can improve medication reasonability and safety, and increase the knowledge and competence of drug administration.