中国中药杂志

2018, v.43(02) 234-241

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川草乌治疗类风湿性关节炎的效益-风险评价
Aconitum in treatment of rheumatoid arthritis: benefit-risk assessment

张晓朦;金勇男;张冰;李宁;
ZHANG Xiao-meng;JIN Yong-nan;ZHANG Bing;LI Ning;Beijing University of Chinese Medicine;

摘要(Abstract):

类风湿性关节炎(RA)病势缠绵、较难治愈,常规治疗用药周期长、易诱发不良反应,特别需要考量患者的获益与风险。毒性中药川草乌作为RA治疗重要手段之一,用药存在一定争议。该研究切入临床用药的实际问题,基于多准则决策模型量化评估川草乌中药单独应用以及联用西药的效益与风险。采用Rev Man 5.2软件分别综合21项川草乌单独应用治疗RA的随机对照试验(RCT)、49项川草乌联用西药治疗RA的RCT各指标结果,显示相较于常规西药治疗,无论单独应用还是联用西药,川草乌均可提高疗效、降低不良反应/事件发生率。结合RA治疗的效益-风险评价指标决策体系,应用Hiview 3软件以及Crystal Ball蒙特卡洛模拟计算川草乌单独应用与联用西药的效益值、风险值、效益-风险总值。结果显示川草乌联用西药的效益高于其单独应用(效益差=15,95%CI[9.72,20.25]),但其风险也相对更高(风险差=23,95%CI[15.57,30.55]),当效益与风险对RA患者同等重要时,川草乌单独应用的效益-风险总值为58,联用西药为55,且单独应用优于联用西药的概率为81.07%。由此可见,川草乌是RA临床治疗手段的重要补充,且当患者对于风险的可接受性较低时,则不推荐中西药联用。
Rheumatoid arthritis(RA) has the characteristics of long course of disease and difficulty in treatment. The conventional therapy may easily induce adverse drug reactions or events( ADR/ADE) due to the long-time medication. Thus,it should be given special attentions to treatment benefit and medication risk of RA patients. Aconitum,a kind of toxic traditional Chinese herbs,is an important complement therapy for RA,with some controversy in clinical application. Coming straight to the practical problem of combined use of traditional Chinese medicines( TCM) and Western medicines( WM),this study conducted quantitative assessment on the benefits and risks of Aconitum using combined with WM or not,which was carried out by the method of multi-criteria decision analysis model. Rev Man 5. 2 software was used to separately analyze the results of every index of 21 random clinical trials( RCTs) of Aconitum exclusive use in the treatment of RA,and 49 RCTs of Aconitum combined use with WM. The merged results indicated that as compared with the conventional therapy of WM,no matter the exclusive use or the combined use of Aconitum could improve the efficacy and decrease the incidence of ADR/ADEs. Based on the benefit-risk assessment decision tree of RA treatment,Hiview 3 software and Crystal Ball Monte Carlo simulation were used to calculate the benefit value,risk value and benefit-risk value of Aconitum exclusive use and the combined use of Aconitum with WM. The results showed that the combination therapy had significantly better benefits than Aconitum exclusive using,difference value was 15,( 95 % CI[9. 72,20. 25 ]),but the risk of combined use was higher difference value =23,( 95 % CI[15. 57,30. 55 ]). In comprehensive consideration of the benefit and risk,the total benefit-risk value of using Aconitum alone was 58,while that of the combination therapy was 55,and the probability of the former superior to the latter was 81. 07 %.The study showed that Aconitum was the important therapy to supply RA treatment. In clinical application,the patient' s acceptability of benefit and risk need to be considered; if patients cannot bear the risk, the combination use of Aconitum and WM is not recommended.

关键词(KeyWords): 乌头;效益-风险评价;多准则决策;蒙特卡洛
Aconitum;benefit-risk assessment;multi-criteria decision analysis(MCDA);Monte Carlo

Abstract:

Keywords:

基金项目(Foundation): 药品评价中心项目(2020071420118);; 北京市中医管理局项目(2020071520049);; 北京中医药大学新奥优秀传承团队建设项目(1000062720028/001)

作者(Author): 张晓朦;金勇男;张冰;李宁;
ZHANG Xiao-meng;JIN Yong-nan;ZHANG Bing;LI Ning;Beijing University of Chinese Medicine;

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