中成药不良反应报告中不合理用药回顾性分析

Retrospective analysis of irrational use of proprietary Chinese medicine in adverse drug reaction reports

目的观察中成药不良反应报告中不合理用药情况及发生原因。方法对2015年1月至2015年12月我院门诊开具的1 280张中药处方进行回顾性分析,观察不良反应类型,涉及器官、严重程度及发生原因。结果 51例出现不良反应的患者中,以过敏样反应及皮肤黏膜损害占比最高,以肾损害占比最低。涉及器官排序依次为皮肤/附件、心血管系统、胃肠道系统、中枢/外周神经系统、呼吸系统。严重程度中,以中度不良反应占比最高,重度不良反应占比最低。药品与不良反应关联性评价中,总关联性达100.00%。发生原因中,以剂量使用不当占比最高,药物自身因素占比最低。结论在使用中药制剂时,需严格按照中医学理论辨证施治,遵循中成药临床应用指导原则,按照中药制剂药品说明书的用法用量、注意事项等合理用药。

Objective To observe the irrational use of proprietary Chinese medicine and the causes in adverse drug reaction reports. Methods A total of 1 280 prescriptions of proprietary Chinese medicine from January 2015 to December 2015 in our hospital were retrospectively analyzed, and the types of adverse reactions, involving organ, severity, and causes were observed. Results In 51 patients with adverse reactions, the anaphylactoid reaction, skin and mucous membrane damage accounted the highest, the lowest was renal damage. The order of organs involved were the skin/appendages, the cardiovascular system, the gastrointestinal system, the central/peripheral nervous system, and the respiratory system. Among the severity, moderate adverse reactions accounted the highest, and the proportion of severe adverse reactions was the lowest. In the evaluation of the association between adverse drug reactions and adverse events, the total correlation reached 100.00%. Among the causes, the proportion of inappropriate use of drugs was the highest, and the proportion of drug self factors was the lowest. Conclusion In the use of proprietary Chinese medicine, it is necessary to strictly refer to the theory of TCM syndrome differentiation, follow the guidelines for clinical application of proprietary Chinese medicine, and take the medicines rationally according to the usage, dosage and precautions of the proprietary Chinese medicine specification.