中药注射剂临床使用合理性与安全性再评价方法学探讨

Analysis of rational clinical uses of traditional Chinese medicine injections and factors influencing adverse drug reactions

合理性与安全性是中药注射剂上市后临床再评价的关键问题之一。该研究随机抽取某医院2011年1月—12月份出院患者病历240份,通过12种中药注射剂药品说明书一致性与配伍禁忌评价、药物利用研究(DUR)以及药品不良反应/事件(ADR/ADE)条件Logistic回归分析,综合评价该医院2011年中药注射剂临床使用情况,初步探讨中药注射剂临床使用合理性与安全性再评价方法。研究结果显示该医院2011年中药注射剂临床使用给药剂量、给药浓度、溶媒选择、辨病辨证及四项指标与说明书一致性普遍偏低,其中中药注射剂临床超剂量与超浓度使用情况严重,而给药浓度作为保护因素对于评价和预测中药注射剂ADR/ADE发生具有借鉴意义。因此应进一步加强中药注射剂临床使用合理性与安全性再评价研究,可以综合借鉴药品说明书一致性与配伍禁忌评价、DUR以及ADR/ADE条件Logistic回归分析多种评价方法。

Objective： To rationalize the clinical use and safety are some of the key issues in the surveillance of traditional Chinese medicine injections （TCMIs）. Method： In this 2011 study, 240 medical records of patients who had been discharged follow- ing treatment with TCMIs between 1 and 12 month previously were randomly selected from hospital records. Consistency between clini- cal use and the description of TCMIs was evaluated. Research on drug use and adverse drug reactions/events using logistic regression analysis was carried out. Result： There was poor consistency between clinical use and best practice advised in manuals on TCMIs. Over-dosage and overly concentrated administration of TCMIs occurred, with the outcome of modifying properties of the blood. Logistic regression analysis showed that, drug concentration was a valid predictor for both adverse drug reactions/events and benefits associated with TCMIs. Conclusion： Surveillance of rational clinical use and safety of TCMIs finds that clinical use should be consistent with technical drug manual specifications, and drug use should draw on multi-layered logistic regression analysis research to help avoid ad- verse drug reactions/events.