宁心方2号治疗缓慢性心律失常的临床研究

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英文篇名：A Clinical Study of Ningxin Recipe II in the Treatment of Brady Arrhythmia 作者：徐煜凌 ; 周凤华 ; 刘晓瑜 ; 顾民华 ; 何培坤 ; 贾钰华 英文作者：XU Yuling;ZHOU Fenghua;LIU Xiaoyu;GU Minhua;HE Peikun;JIA Yuhua;School of Traditional Chinese Medicine,Southern Medical University; 关键词：缓慢性心律失常 ; 宁心方2号 ; 中医药疗法 ; 心宝丸 英文关键词：Brady arrhythmia;;Ningxin Recipe Ⅱ;;therapy of traditional Chinese medicine;;Xinbao pills 中文刊名：ZYXY 英文刊名：Traditional Chinese Drug Research & Clinical Pharmacology 机构：南方医科大学中医药学院; 出版日期：2019-02-25 出版单位：中药新药与临床药理 年：2019 期：v.30;No.155 基金：国家自然科学基金(81373574);; 广东省科技计划项目(2016A020226002);; 广州市科技计划产学研协同创新重大专项项目(201704020042);; 广东省名优中成药二次开发项目(20174010) 语种：中文; 页：ZYXY201902019 页数：6 CN：02 ISSN：44-1308/R 分类号：105-110

摘要

目的通过随机对照临床研究,明确缓慢性心律失常的中医证候要素,客观评价宁心方2号治疗缓慢性心律失常的疗效和安全性。方法将246例缓慢性心律失常患者随机分为3组。宁心方2号组81例,服用宁心方2号;心宝丸组81例,服用心宝丸;对照组80例,服用三七总甙片、复方丹参滴丸与肌苷片。8周为一疗程。治疗期间定期检测心电图,一疗程后比较疗效。结果缓慢性心律失常的中医主症证候要素为心悸心慌、晕厥、气短、疲乏、胸闷胸痛、脉象,次症证候要素为自汗、盗汗、畏寒肢冷、纳差、面色、舌象。总有效率:宁心方2号组(85.19%)>心宝丸组(65.43%)>对照组(41.25%)(P<0.01)。宁心方2号组、心宝丸组治疗前后24 h心室率比较,最慢、最快心率及平均心室率有显著性差异(P<0.01)。以中医证候积分评价证候疗效:宁心方2号组>心宝丸组>对照组(P<0.01)。结论宁心方2号可提高缓慢性心律失常患者心率,改善中医临床证候,其疗效明显高于心宝丸。
        Objective To define the traditional Chinese medicine(TCM)syndrome elements of brady arrhythmia and to clarify the exact curative effect of Ningxin Recipe Ⅱ(NXR Ⅱ)in the treatment of brady arrhythmia,a randomized controlled clinical study has been conducted.Methods 246 patients with brady arrhythmia were randomly divided into 3 groups,81,81 and 80 cases in NXR Ⅱ group,Xinbao pills(XBP)group and control group,respectively.NXR Ⅱ group was given NXR Ⅱ.XBP group was treated with XBP.Patients in control group were given Panax notoginosides tablets,compound Danshen dripping pills and inosine tablets.Electrocardiogram was periodically measured during treatment and the effect was evaluated after one course of 8 weeks.Results The main TCM syndrome elements of brady arrhythmia are palpitation,fainting,shortness of breath,fatigue,chest distress,chest pain and typical pulse,and the secondary are spontaneous perspiration,night sweat,aversion to cold,cold limbs,inappetence,abnormal complexion and typical tongue picture.The total efficiency of NXR Ⅱ group,XBP group and control group were 85.19%,65.43%and 41.25%,respectively.There were significant differences in the slowest,the fastest and the mean heart rate 24 hours before and after treatment in NXR Ⅱ group and XBP group(P<0.01).The scores of TCM syndrome have shown that the curative effect of NXR Ⅱ was better than XBP,and these both were better than control group(P<0.01).Conclusions NXR Ⅱ can increase the heart rate of patients with brady arrhythmia and improve the TCM clinical symptoms,which is obviously better than that of XBP.

引文

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