目的 通过调查我院口服中成药的品种和使用现状,分析中成药说明书中存在的问题,并提出建议,为临床合理用药提供参考。方法 分析我院101种口服中成药的作用类别、剂型、基本药物、医保、非处方药品(OTC)等情况,收集说明书,对其中的用法用量、不良反应、禁忌证、注意事项等项目进行统计分析。结果 101种口服中成药中,44.6%为儿童专用药。按作用类别和剂型统计,以调理脾胃剂数量居多,剂型以颗粒剂数量居多。统计基本药物占19.8%、医保占70.4%、OTC占26.7%。调查说明书中儿童用法用量、不良反应、禁忌证和注意事项等信息发现,药品详细标有年龄段服用剂量的占51.5%,药品未标注明确的不良反应和禁忌证的占59.4%,药品标示的最小服用剂量小于最小包装剂量的占14.9%。结论 中成药在儿科应用较为广泛,但仍存在药品说明书儿童用药信息不全等情况,医生在开具处方中的问题主要体现为遴选药品不适宜以及联合用药不适宜,建议有关部门开展儿科用药的临床再评价工作,并完善儿科用中成药说明书。

OBJECTIVE To investigate the varieties and use of oral proprietary Chinese medicines in our hospital, analyze the problems existing in their labelings, and put forward suggestions to provide reference for clinical rational drug use. METHODS The properties of the 101 kinds of oral proprietary Chinese medicines in regard to the category, dosage form, essential drug, health care, OTC, and so on were summarized. Their labelings were collected to analyze the specification, usage and dosage, adverse reactions, contraindications and precautions, etc. RESULTS Among the 101 traditional Chinese medicines, 44.6% were developed specially for children. When counted by categories and dosage forms, the medicines for regulating spleen and stomach and granules accounted for the majority, respectively. Essential drugs, drugs belonging to the directory of insured drugs, and OTC drugs accounted for 19.8%, 70.4%, and 26.7%, respectively. It was found that 51.5% of the labelings included dosage information for different ages in detail, 59.4% did not state adverse reactions and contraindications clearly, and the smallest dosage suggested by 14.9% of the labelings were less than the smallest packaging dose. CONCLUSION Chinese patent medicines are widely used in pediatrics, but the information for children is still incomplete. The problems in the prescribing mainly include inappropriate selection of drugs and combination of medications. It was recommended that the relevant authorities carry out pediatric drug reevaluation and improve the labelings of pediatric drugs.