基于不良反应/事件文献分析的骨科中成药安全用药通则规律的初步研究

骨科中成药组分复杂,多含药性峻烈及毒性饮片,药物安全窗口较窄,临床禁忌较多,不良反应/事件发生频率较高。为探索骨科中成药安全用药的通则规律,提炼用药教育关键点,以保障临床合理用药,以近80种本院常用骨科中成药为研究对象,通过系统的检索策略,收集汇总来自164篇不良反应文献的237例案例,采用多维度的文献分析和个案荟萃防范,尝试确定骨科中成药安全合理用药的风险共性因素,建立不良反应/事件防范通则。包括1不良反应临床表现方面,无论内服或外用,皮肤过敏反应为最常见的不良反应表现;循环、消化等其他系统不良反应与药品所含毒性成分密切相关;部分药品存在隐匿而累积的肝肾损伤。2不良反应发生时间方面,存在3个重要时间节点,用药30 min与患者特异体质相关、用药数月至半年与药源性肝肾损伤相关,最常见的不良反应发生节点为7 d,且呈现与药理作用相关的可预测型不良反应特征。3毒性因素对于骨科中成药不良反应的发生(频度、广度、难易度)具有极端重要性。4特殊用药因素如联合西药、中药汤剂,超剂量超疗程用药、自我药疗等也需重点关注。综上,总结骨科中成药不良反应/事件防范的通则规律,为临床医师安全合理用药提供支持,为临床药师用药教育提供指导。

Preliminary study on general safe medication regularity of Chinese patent orthopedic medicines based on adverse reaction/event literature analysis

To study the general safe medication regularity of Chinese patent orthopedic medicines, define key points in the medication education and ensure rational clinical medication, the authors took 80 types of commonly used Chinese patent orthopedic medicines as the study objects, collect 237 cases from 164 ADR/ADE documents through a system retrieval strategy, make a multidimensional literature analysis to determine the common risk factors for safe and rational medication of Chinese patent orthopedic medicines and establish an ADR/ADE prevention regularity. First, in the aspect of clinical symptoms, skin allergy is the most common ADR/ADE and closely related to the toxic ingredients, particularly accumulated liver or kidney damage caused by some drugs. Second, there are three time nodes in the ADR/ADE occurrence; The ADR/ADE occurred in 30 minutes is closely related to the idiosyncrasy; The ADR/ADE occurred between several months and half a year is related to the drug-induced liver and kidney damages; The most common ADR/ADE was observed within 7 days and predictable according to the pharmacological actions; Third, toxicity is an important factor in the occurrence of ADR/ADE of Chinese patent orthopedic medicines. Fourth, emphasis shall be given to the special medication factors, such as the combination with western medicines and Chinese herbal decoctions, overdose and long-course medication and self-medical therapy. In conclusion, the general ADR/ADE prevention regularity for Chinese patent orthopedic medicines was summarized to provide supports for clinicians in safe and rational medication and give the guidance for pharmacist in medication education.