心速宁胶囊治疗痰热扰心证室性早搏多中心随机对照研究

Multi-center Randomized Controlled Trial of Xinsuning Capsule in the Treatment of Ventricular Premature Beat with Phlegm-heat Disturbing Xin Syndrome

目的评价心速宁胶囊治疗室性早搏(痰热扰心证)有效性和安全性。方法本试验已于中国临床试验注册中心注册(No.ChiCTR-TRC-14004180)。采用分层区组随机方法,将861例痰热扰心证室性早搏患者随机分为试验组(343例)、阳性对照组(345例)和安慰剂组(173例)。试验组给予心速宁胶囊加盐酸美西律片模拟剂,阳性对照组盐酸美西律片加心速宁胶囊模拟剂,安慰剂组心速宁胶囊模拟剂加盐酸美西律片模拟剂。3组疗程均为4周。观察治疗14、28天室性早搏24小时动态心电图(holter)疗效、中医证候疗效积分以及不良反应发生情况。结果与安慰剂组[27.27%(45/165)]比较,试验组[65.85%(216/328)]及阳性对照组[63.10%(212/336)]holter总有效率升高(Z=8.1727,7.4809,P<0.01)。与阳性对照组及安慰剂组比较,试验组中医证候积分治疗14、28天与治疗前差值更多(P<0.05)。治疗14天,与安慰剂组比较,试验组口干症状改善更明显(Z=1.1731,P<0.05)。治疗28天,与阳性对照组、安慰剂组比较,试验组口干、口苦症状改善更明显(P<0.05)。与安慰剂组比较,试验组治疗28天多梦症状改善更明显(Z=2.5085,P<0.0167)。3组间不良反应发生情况比较,差异无统计学意义(P=0.4280)。结论心速宁胶囊可有效改善痰热扰心证室性早搏患者holter总有效率、中医证候积分以及口干、口苦、失眠等症状方面,安全性好。

Objective To evaluate the efficacy and safety of Xinsuning Capsule(XSNC)in the treatment of ventricular premature beats(VPB)with syndrome of phlegm heat disturbing the Xin.Methods This study was registered in the Chinese Clinical Trial Registry(No.ChiCTR-TRC-14004180).Totally 861 patients with Phlegm-heat disturbing Xin syndrome were randomly assigned to experimental group(343 cases),positive control group(345 cases)and placebo group(173 cases).The experimental group was given XSNC plus Mexilol hydrochloride tablet simulation agent,the positive control group was given Mexilol hydrochloride tablet plus XSNC simulation agent,the placebo group was given XSNC simulation agent plus Mexilol hydrochloride tablet simulation agent.The treatment course of 3 groups was 4 weeks.The curative effect of 24 hour dynamic electrocardiogram(holter),Chinese Medicine(CM)syndrome curative effect score and the occurrence of adverse reactions after 14 and 28 days of treatment were observed.Results Compared with placebo group[27.27%(45/165)],the holter total effective rate of experimental group[65.85%(216/328)]and positive control group[63.10%(212/336)]was increased(Z=8.1727,7.4809,P<0.01).Compared with positive control group and placebo group,the difference of CM syndrome score between 14 and 28 days of treatment and before treatment was larger in experimental group(P<0.05).After 14 days of treatment,dry mouth symptoms improved more in the experimental group than in the placebo group(Z=1.1731,P<0.05).After 28 days of treatment,compared with positive control group and placebo group,the symptoms of dry and bitter mouth symptoms in experimental group improved more significantly(P<0.05).Compared with placebo group,the improvement of dreamful sleeping symptoms was more significant in the experimental group after 28 days of treatment(Z=2.5085,P<0.0167).There was no significant difference in the incidence of adverse reactions among the 3 groups(P=0.4280).Conclusion XSNC has significant efficacy and good safety in improving holter total effective rate,CM syndrome score,dry mouth,bitter mouth,insomnia and other symptoms in VPB patients with phlegm heat disturbing Xin syndrome.