稳心颗粒治疗心律失常(气阴两虚证)的临床综合评价

Clinical comprehensive evaluation of Wenxin Granules in treatment of arrhythmia with deficiency of Qi and Yin

评价稳心颗粒治疗心律失常(室性早搏和房性早搏)气阴两虚证的安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色("6+1"维度),采用多准则决策分析(MCDA)模型,经过专家对准则层、指标层赋予权重,应用CSC v2.0软件,对"6+1"维度进行临床综合评价,体现稳心颗粒的临床价值,推动其安全、有效、合理用药,为国家医疗卫生决策提供依据。安全性多源证据显示其不良反应以胃肠道损害为主,基于现有研究,风险较可控,评价为B级;有效性系统评价显示与抗心律失常西药相比,改善临床疗效和心电图疗效指标优于对照组,且证据质量较好,评价为A级;经济性研究显示较抗心律失常西药更具有成本-效果优势,证据报告比较充分、结果较明确,评价为B级;适应症和禁忌症明确且细化到不同类型心律失常,定位更精准,临床创新和产业创新较突出,评价为A级;剂型、用法、储存和处方流转等适宜性基本满足医护和患者的临床用药需求,评价为B级;处方限制较小,药材资源有可持续性,可及性评价为A级;组方配伍抓住疾病气阴两虚的病机特点,真实世界研究累计超3000例,中医药特色评价为B级。综合各维度证据评价稳心颗粒为A类,临床价值较高,中医药特色较突出,建议按程序转化为基本临床用药管理的相关政策结果。

This study evaluated the safety,effectiveness,economy,innovation,suitability,accessibility,and characteristics of traditional Chinese medicine of Wenxin Granules in the treatment of arrhythmia(ventricular premature beat and atrial premature beat)with deficiency of Qi and Yin.The multi-criteria decision analysis(MCDA)model was adopted,and the criterion layer and index layer were weighted by experts.CSC v2.0 was used for clinical comprehensive evaluation.This study embodies the clinical value of Wenxin Granules,promotes its safe,effective and rational use,and provides a basis for national medical decision-making.The multi-source evidence shows that the major adverse reaction of Wenxin Granules is gastrointestinal damage.According to the available studies,Wenxin Granules has controllable risk and thus is rated as grade B in terms of safety.The systematic evaluation of effectiveness shows that compared with antiarrhythmic western medicine,Wenxin Granules demonstrates improved clinical efficacy and electrocardiogram efficacy,which is supported by high-quality evidence,and thus the effectiveness of Wenxin Granules is evaluated as grade A.Economic research shows that Wenxin Granules is more economical than antiarrhythmic western medicine,which is supported by sufficient evidence and clear results,and thus the economy of this preparation is rated as grade B.The indications and contraindications of Wenxin Granules are clear and detailed to different types of arrhythmia,which,together with the precise positioning and prominent clinical innovation and industrial innovation,rates it as grade A in terms of innovation.The suitability of drug storage,prescription circulation,dosage form and course of treatment basically meet the clinical medication needs of doctors and patients,and thus the suitability of Wenxin Granules is evaluated as grade B.Because of the few restrictions and the sustainable resources of medicinal materials,the accessibility of Wenxin Granules is evaluated as grade A.The prescription compatibility focuses on the pathogenesis characteristics of deficiency of Qi and Yin,and there are more than 3000 cases studied.Therefore,the characteristics of traditional Chinese medicine of Wenxin Granules are evaluated as grade B.Based on the evidence from all the above dimensions,Wenxin Granules has the clinical comprehensive value of class A and prominent characteristics of traditional Chinese medicine.It is suggested to include Wenxin Granules into the policy results related to basic clinical medication management according to the procedure.