【摘要】 目的 调查北京积水潭医院骨科用中成药品种分布、药品说明书、临床应用现状，分析潜在用药风险，为骨科合理用药提供参考依据。方法 归纳北京积水潭医院骨科用中成药品种、类别和含毒性药材的骨科中成药分布情况；统计其药品说明书中成分、用法用量等基本信息，以及不良反应、禁忌证、注意事项和药物相互作用等安全信息的标注情况；对2022年12月至2024年12月与骨科中成药相关的不合理处方进行点评和分析。结果 北京积水潭医院骨科用中成药共计77种，分布占比前3位的是活血剂、祛湿剂、补益剂。含毒性成分的品种共计42种，占总品种的54.54%，出现频率前2位的毒性药材是制草乌和生川乌。药品说明书内容调查显示，详尽注明用法用量、疗程等信息的共计38种（49.35%）。明确不良反应、禁忌证、注意事项和不宜同用品种分别占48.05%、67.53%、77.92%和12.99%，儿童安全用药信息甚少。不合理处方集中在诊断与用药不符、药物联用不合理、处方开药超限量、疑似重复用药和超禁忌证用药。结论 含有毒性药材的骨科中成药应给予较高的关注度，完善药品说明书中剂量不明确、部分安全项“尚不明确”和儿童安全用药信息缺失等内容。加强不合理处方监控，降低“医-药-患”联合体各个环节存在的潜在用药风险，构建合理用药模式，保障临床用药安全。更多还原

【Abstract】 Objective To investigate variety distribution, drug directions, and clinical application status of traditional Chinese patent medicines and simple preparations in orthopedics at Beijing Jishuitan Hospital, analyze potential medication risks, and provide reference for rational use of drugs in orthopedics. Methods The varieties, category of traditional Chinese patent medicines and simple preparations in orthopedics at Beijing Jishuitan Hospital, and distribution of traditional Chinese patent medicines and simple preparations in orthopedics containing toxic medicinal materials; the labeling of basic information such as ingredients, usage, and dosage in drug instructions, as well as safety information such as adverse reactions, contraindications, precautions, and drug interactions were statistically analyzed; unreasonable prescriptions related to traditional Chinese patent medicines and simple preparations in orthopedics from December 2022 to December2024 were reviewed and analyzed. Results There were 77 kinds of traditional Chinese patent medicines and simple preparations in orthopedics at Beijing Jishuitan Hospital, and the top three were blood activating agents, dehumidifying agents, and tonics agents. There was 42 varieties containing toxic ingredients, accounting for 54.54% of the total varieties,the top two toxic medicinal herbs with the highest frequency of occurrence were Aconiti Kusnezoffii Radix Cocta and Aconiti Radix. According to a survey of drug instructions, a total of 38 types(49.35%) provided detailed information on usage,dosage, treatment course, etc. Adverse reactions, contraindications, precautions, and incompatible varieties accounted for48.05%, 67.53%, 77.92%, and 12.99%, respectively, there was little information on safe medication for children.Unreasonable prescriptions were concentrated in cases where the diagnosis did not match the medication, the combination of drugs was unreasonable, the prescription exceeds the limit,suspicion of repeated use, and beyond the contraindications.Conclusion High attention should be paid to traditional Chinese patent medicines and simple preparations in orthopedics containing toxic medicinal materials, the contents such as unclear dosage,“unclear”safety items in some safety items, and lack of information on safe drug use for children in the drug manual should be improved. Strengthen the monitoring of unreasonable prescriptions, reduce potential medication risks in various links of “medical-drug-patient”consortium, establish a rational medication model, and ensure clinical medication safety.更多还原