天智颗粒治疗轻中度血管性痴呆的安全性评价  

Safety Evaluation of Tianzhi Granules in Treating Mild-to-moderate Vascular Dementia

作　　者：刘文芳[1] 林阳[1] 刘显峰 白帆 LIU Wenfang;LIN Yang;LIU Xianfeng;BAI Fan(Beijing Anzhen Hospital of Capital Medical University,Beijing 100029,China;Zhongjing Wanxi Pharmaceutical Co.Ltd.,Nanyang 474500,China)

机构地区：[1]首都医科大学附属北京安贞医院,北京100029 [2]仲景宛西制药股份有限公司,河南南阳474500

出　　处：《中国实验方剂学杂志》2024年第2期142-147,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：“重大新药创制”科技重大专项十二五第二批项目(国科发社[2012]734号)。

摘　　要：目的:系统评价天智颗粒用于治疗轻中度血管性痴呆的安全性。方法:通过天智颗粒治疗轻中度血管性痴呆的随机、双盲双模拟、阳性药物/安慰剂平行对照的多中心Ⅳ期临床试验和开放性多中心Ⅳ期临床试验,根据纳入和排除标准,共纳入并分析1 492例患者的安全性数据,主要评价指标为不良事件/不良反应发生率、实验室检查指标、生命体征和心电图检查结果。结果:双盲试验中520例患者共发生6例次与试验药物可能相关的不良事件,均为轻度且已经缓解,天智颗粒、多奈哌齐和安慰剂组发生率差异无统计学意义。开放性试验中972例患者共发生9例次可能与试验药物相关的不良事件,均为轻度且已缓解。对患者治疗前(基线)、治疗第12周、治疗第24周分别进行用药前后实验室检查(血常规、尿便常规、肝功能、肾功能、凝血四项)、生命体征的对比,主要指标治疗前后差异无统计学意义。双盲试验中,不同试验组治疗前后安全性指标变化的差异无统计学意义。试验中发生率最高的不良反应为消化道不适(发生率6.64‰)。结论:偶见患者使用天智颗粒发生不良反应,临床用于轻中度血管性痴呆治疗安全性较好。Objective:To systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia.Method:A randomized,double-blind,double-simulated,positive drug/placebo parallel controlled multi-center phaseⅣclinical trial and an open multi-center phaseⅣclinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted.Safety data of 1492 patients were included and analyzed according to inclusion and exclusion criteria.The main evaluation measures were the incidence rate of adverse events/adverse reactions,laboratory indicators,vital signs,and electrocardiogram(ECG)results.Result:A total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial,and the symptoms were all mild and recovered.The incidence of adverse events was not statistically different among Tianzhi granules,donepezil,and placebo groups.Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial,and the symptoms were mild and recovered.Laboratory tests(blood routine,urine routine,liver function,kidney function,and coagulation)and vital signs were compared before treatment(baseline)and after treatment of 12 and 24 weeks,respectively.There was no statistical significance in the main indicators before and after treatment.In the doubleblinded trial,there was no significant difference in safety indicators between different groups before and after treatment.The most frequent adverse reaction was gastrointestinal discomfort,with an incidence rate of 6.64‰.Conclusion:Adverse reactions occasionally occur in patients using Tianzhi granules,and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.

关 键 词：天智颗粒 血管性痴呆 安全性 不良事件 不良反应 

分 类 号：R2-0[医药卫生—中医学] R22R242R287