64例复方甘草片的不良反应文献分析与启示

Literature analysis of 64 cases of adverse drug reactions caused by compound liquorice tablets and the enlightenment

目的 :了解复方甘草片药品不良反应(adverse drug reaction,ADR)发生的类型和特点,为修订说明书提供依据,为临床用药提供参考。方法:检索万方及中国期刊全文数据库中本品ADR文献,进行统计与分析。结果:64例ADR包括外源性皮质激素增多症31例、过敏反应7例、阿片类毒性20例及其他6例。成瘾者多为长期服药的中老年患者;15例阿片中毒者均为小于1岁的婴幼儿。结论:复方甘草片是处方药,可能发生多种ADR,建议修订说明书,并在"注意事项"中增加婴儿及儿童用药信息"不用于婴儿期,必须使用时,参照老幼剂量折算表计算用药剂量",并补充中老年患者不宜长期服用。

Objective： To understand the types and characteristics of the adverse drug reactions caused by compound liquorice tablets and provide the basis for revising the drug instruction and reference for clinical medication. Methods： The Wanfang database and Chinese journal full-text database were retrieved. The literatures of adverse drug reactions（ADRs） caused by compound liquorice tablets were statistically analyzed. Results： There were 64 cases of ADRs related with compound liquorice tablets, including 31 cases of exogenous corticosteroid syndrome, 7 cases of allergic reactions, 20 cases of opioid toxicity and 6 cases of other ADRs. Addicted patients were mainly elderly patients with long-term medication history. Opioid poisoned patients were all younger than 1 year old babies. Conclusion：Compound liquorice tablets is classified as one prescription drug. It is recommended to revise the drug instruction due to a variety of ADRs, and to add the infants and children＇s medication information in the section of ＇Precautions＇. it should be contraindicated in infants. Children and adult dose conversion table should be referred to for calculating the dose for infants when the drug has to be used. The information that elderly patients should not take the drug for a long time need to be added in the drug instruction.