宁心方2号治疗缓慢性心律失常的临床研究

A Clinical Study of Ningxin Recipe II in the Treatment of Brady Arrhythmia

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.