中智中药破壁饮片约10000例安全性集中监测的临床研究

Clinical study on safety centralized monitoring of 10000 cases of ultrafine granular powder of Chinese materia medica

目的研究中智中药破壁饮片的不良反应发生率、性质和临床表现,评价中智中药破壁饮片临床应用的安全性。方法拟收集全国各地共10000例服用中智中药破壁饮片的患者进行观察,真实记录并分析入组病例的患者人口学信息、用药情况以及不良事件/反应发生情况。结果共收集10003例患者,其中剔除4例未服用中智中药破壁饮片的患者,纳入统计分析9999例服用中智中药破壁饮片的患者。9999例患者中发生不良事件14例,均为一般不良事件,无严重不良事件。判定为不良反应的有13例,不良反应发生率为0.13%;不良反应的主要症状为胃肠道症状(腹胀、反胃、呕吐等)及头晕等,在停药或对症处理后不良反应好转或痊愈。Logistic回归分析结果表明,中智中药破壁饮片AE/ADR的发生主要与既往存在AE/ADR以及有合并用药相关。结论根据国家《药品不良反应报告和监测工作手册》中的不良反应分级标准,中智中药破壁饮片不良反应发生率属于罕见范畴,且未见严重不良反应;不良反应的主要症状为胃肠道症状及头晕;不良事件发生主要与既往存在不良事件/反应以及有合并用药相关;中智中药破壁饮片临床应用具有较高的安全性。

Objective Study the incidence,properties and clinical features of adverse drug reaction,to evaluate the safety of clinical application of Ultrafine Granular Powder of Chinese materia medica.Methods A total of 10000 cases of using Ultrafine Granular Powder of Chinese materia medica were collected from all over the country for observation.Demographic information,records of medication consumption and AE/ADR of the cases were recorded and analyzed.Results A total of 10003 patients were collected,of which 4 patients who did not using Ultrafine Granular Powder of Chinese materia medica were excluded.Adverse events occurred in 14 of the 9999 patients.Theorder of severity of these adverse events wereevaluated as general,and 13 ofthem were judged as ADR.Therefore,the incidence of ADR was 0.13%.The main symptoms of ADR were gastrointestinal symptoms(including abdominal distention,nausea,vomiting)and dizziness.These ADR improved or recovered after discontinuation of decoction pieces or corresponding treatment.The results of Logistic regression analysis showed that the occurrence of AE/ADR was mainly related to the previous AE/ADR and the combined medication.Conclusion According to the ADR grading standard,the incidence of ADR of Ultrafine Granular Powderof Chinese materia medica belongs to the rare category,and no serious ADR have been observed.The main symptoms of ADR were gastrointestinal symptoms and dizziness.The results of statistical analysis showed that the occurrence of AE was mainly related to the previous AE/ADR and the combined medication.It indicated the high safety of clinical application of Ultrafine Granular Powder of Chinese materia medica.