多中心非干预前瞻性开放的3000例苦碟子注射液应用情况及不良反应集中监测

Application analysis and adverse reactions centralized monitoring of 3000 cases Kudiezi injection by non-intervention prospective multicenter open study

目的：吉林地区7家医院对苦碟子注射液上市后的安全性进行再评价，为临床合理用药提供参考。方法：采用多中心非干预前瞻性集中监测的方法，观察2012年6月–2014年3月3000例应用苦碟子注射液的患者，对药物的临床应用及不良反应情况进行分析。结果：使用苦碟子注射液的患者年龄主要分布在40~80岁，与苦碟子注射液的药理作用相关；有26.83%的患者为超剂量用药，虽未引起不良反应，仍应予以重视；功能主治符合药品说明书；停药原因比较明确，有1例死亡病例与患者年龄及疾病进程有关；在3000例患者中发生3例不良反应，不良反应发生率为0.1%。结论：应加强苦碟子注射液的临床合理应用及不良反应监测，避免超剂量用药；初步建立一套中药注射剂安全性再评价模式，供今后的实践工作予以借鉴。

Objective：To re-evaluate the post-marketing safety ofKudiezi injection in seven hospitals of Jilin area, and provide references for the clinical use of drugs.Methods： Using the prospective centralized monitoring method of non-intervention in multicenter, 3000 cases usedKudiezi injection were observed from June 2012 to March 2014, the clinical application of the drug and the adverse reactions were analyzed.Results：The patients were mainly in the 40–80 years old, which was associated with the pharmacological effects ofKudiezi injection. About 26.83% of the patients were overdose use of drugs, although no adverse reaction was found in those patients, overdose use of drugs should be paid attention to. Indications of the drug comply with the package insert and the compare the reasons for withdrawal of drug were clear. One death case was associated with disease progression and advanced age; three cases of adverse reactions occurred in 3000 cases of patients, adverse reaction rate was 0.1%.Conclusion：Reasonable clinical application ofKudiezi injection should be strengthened, such as avoiding overdose use of drug, strengthening the monitoring of adverse reactions and reducing the incidence of adverse reactions. The safety re-evaluation model of traditional Chinese medicine injection was initially established, which can provide experience for future practice.