起搏胶囊治疗窦性心动过缓心气阳虚证的临床观察

Clinic observation on effect of Qibo capsule in treating sinus bradycadia (the syndrome of heart-energy and yang insufficient)

关键词:  起搏胶囊  窦性心动过缓  临床观察

Key words:  QiBo capsule  Xinbao pill  sinus bradycardia

摘要:

[目的]对起搏胶囊治疗窦性心动过缓心气阳虚的临床疗效及安全性进行初步评价。[方法]采用随机、双盲、双模拟阳性药物对照方法,将符合西医窦性心动过缓诊断标准和中医心气阳虚证的患者随机分为治疗组和对照组,每组24例。治疗组予以起搏胶囊,3次/d,3粒/次;对照组予以心宝丸,3次/d,3粒/次,疗程4周。观察中医症状、24h动态心电图等变化,以及其对于肝肾功能、血尿常规等安全性指标的影响。[结果]临床研究共纳入病例48例,脱落4例,剔除0例,有效病例44例。治疗4周后治疗组和对照组在中医症状、24h最低心率、最高心率、平均心率、总心率等方面治疗前后比较均有明显统计学差异(P<0.05);两组组间在治疗后中医症状总积分减少值、减少率以及24h最低心率、最高心率、平均心率、总心率方面增加值和增加率比较均没有出现显著差异(P>0.05);治疗前后两组均没有出现不良反应,血尿常规、肝肾功能等安全性指标没有出现异常情况。[结论]起搏胶囊对于窦性心动过缓(心气阳虚证)患者具有良好的治疗作用,临床效果显著,安全可靠。

Abstract:

[Objective] To observe the clinical effect and security of Qibo (entrain) capsule in treating the syndrome of insufficiency of heart-energy and yang in sinus bradycadia preliminarily. [Methods] Using random, double-blind and double positive medicine control the diagnosed patients with sinus bradycadia (the syndrome of heart-energy and yang insufficiency) were randomly divided into two groups with 24 cases in each, treatment and control group. In the first group three grains of Qibo capsule was taken three times a day. For the patients in control three grains of Xinbao pill was given three times a day. For the treatment course of 4 weeks the changes of symptoms in TCM, the dynamic electrocardiogram for twenty-four etc., the effect on the function of liver, kidney and urine routine test were observed. [Results] In the clinical study forty-eight cases were enrolled, 4 cases missed and 0 cases deleted. Significant difference was obtained in symptoms of TCM, the lowest heart rate, the highest one, the mean one and the total heart rate for 24 hours etc. before and after treatment(P<0.05). No statistical difference(P>0.05) was seen in the decreasing value of total integral score of symptoms in TCM, the decreasing rate and the lowest heart rate, the highest one, the average one and the total heart rate between both groups. In both groups adverse reaction was not observed before and after treatment. abnormal change in hepatic function, renal function, blood and urine routine test ect. were also not seen. [Conclusions] The Qibo capsule has good therapeutic effect in treating sinus bradycadia (the syndrome of heart-energy and yang insufficiency), and apparent clinical effect and safety.