45例独一味制剂不良反应病例分析

Analysis of 45 Cases ofAdverse Drug Reactions Induced by Lamiophhmis Rotata(Benth.) Kudo Preparations

目的分析45例独一味相关制剂不良反应病例报告,为临床合理用药及其剂型开发提供参考。方法采用描述性研究方法回顾性分析甘肃省2007—2016年45例独一味制剂的不良反应病例报告。结果与独一味不良反应相关的剂型有4种,分别为独一味胶囊、独一味软胶囊、独一味分散片和独一味颗粒。45例独一味制剂发生的不良反应中独一味胶囊发生28例,占62.22%;独一味软胶囊发生13例,占28.89%;独一味分散片和独一味颗粒各发生2例,各占4.44%。独一味胶囊和独一味软胶囊的主要不良反应表现为胃肠道反应、恶心及腹痛。4种剂型的独一味制剂共有的不良反应表现为胃肠道反应和瘙痒。4种剂型的不良反应出现例次排序为:独一味胶囊>独一味软胶囊>独一味颗粒>独一味分散片。结论加强不良反应监测与报告,及时有效掌握独一味制剂可能存在的不良反应,发现风险、最大化预防风险扩张,提高临床用药安全,为独一味制剂的合理开发提供新思路;针对独一味胶囊及独一味软胶囊的不良反应临床上可适当联合保护肠胃药物用药,降低独一味制剂对胃肠道的刺激。

Objective To provide reference for the rational use of drugs in clinic and the development of their dosage forms through analyzing 45 cases of adverse drug reactions（ADRs） induced by Lamiophlomis rotata Kudo. Methods A descriptive study was used to retrospectively analyze 45 cases of adverse drug reactions reported from 2007 to2016 in Gansu province. Results There were four kinds of dosage forms related to the side effects, which were Lamiophlomis rotata capsule, soft capsule, dispersible tablet and granule.45 cases of adverse reactions occurred in the preparations of Lamiophlomis rotata Kudo, of which Lamiophlomis rotata capsule had 28 cases, accounting for 62.22%;13 cases of Lamiophlomis rotata soft capsules, accounting for 28.89%; 2 cases of Lamiophlomis rotata dispersible tablet and granule respectively, accounting for 4.44%. Lamiophlomis rotata capsule ＇s and Lamiophlomis rotata soft capsule ＇s main adverse reactions were gastrointestinal tract reaction, nausea and abdominal pain. The common adverse reactions of the four formulations were gastrointestinal reaction and pruritus. The sequence of adverse reactions in the four formulations is as follows： Lamiophlomis rotata capsule Lamiophlomis rotata soft capsule Lamiophlomis rotata granule Lamiophlomis rotata dispersible tablet. Conclusion The paper is aimed at strengthening the monitoring and reporting of adverse reactions, grasping the possible adverse reactions timely and effectively. Through the study,it is significant to find out the risk so that maximization of the prevention of risk expansion can be reached, improve the safety of clinical drug use, and provide a new idea for the rational development of the drug. According to the adverse reactions of Lamiophlomis rotata capsule and soft capsule, it can be used with gastrointestinal protection drugs to reduce the stimulation of gastrointestinal tract caused by Lamiophlomis rotata capsule.