摘要
目的评价复律保心平口服液治疗冠心病室性早搏(气阴两虚、痰瘀互阻证)的有效性和安全性。方法240例受试者采用分层区组随机、双盲双模拟、阳性药平行对照、多中心临床研究方法。其中治疗组120例,采用复律保心平口服液10 mL(含生药13.33g),同时用步长稳心颗粒模拟剂,9 g/次,每天3次口服;对照组120例,采用步长稳心颗粒,9 g/次,同时用复律保心平口服液模拟剂10 mL,每天3次口服;疗程均为28天。观察两组冠心病室性早搏疗效及中医证候积分改善情况。结果冠心病室性早搏疗效治疗组显效率为55.0%,总有效率为78.4%;对照组显效率为37.2%,总有效率为53.1%,两组显效率、总有效率比较,差异均有统计学意义(P<0.05)。两组24 h动态心电图室性早搏总数治疗组减少(3460.59±6516.56)次/24 h,对照组减少(2148.36±5129.47)次/24 h,两组比较,差异无统计学意义(P>0.05)。两组治疗后中医证候积分均较治疗前降低(P<0.01);治疗前后差值治疗组为(-9.34±4.21)分,对照组为(-8.08±4.33)分,两组比较,差异有统计学意义(P<0.05)。结论复律保心平口服液对冠心病室性早搏(气阴两虚、痰瘀互阻证)患者,疗效确切,未发现明显不良反应。
Objective To evaluate the efficacy and safety of Fulu Baoxinping （FLBXP） oral liquid in the treatment of coronary heart disease patients with premature ventricular beat （PVB） , differentiated as qi-yin deficiency with phlegm-stasis syndrome type. Methods Adopting randomized, double-blinded, double-simulated, positive drug parallel controlled and multi-centered clinical research method, 240 patients enrolled were randomly assigned equally to the treatment group treated with FLBXP 10 mL （containing 13.33 g of crude drug） thrice a day and the control group treated with Wenxin Granule 9 g thrice a day. Meanwhile, simulator of the test or positive control drug was given to them all correspondingly. The therapeutic course for them all was 28 days. Efficacy on PVB and TCM syndrome was observed. Results The markedly effective rate and total effective rate on PVB were 55.0% and 78.4% in the treatment group, and 37.2% and 53. 1% in the control group, significant difference between groups was shown in comparison of both indexes （P 〈 0. 05 ）. Dynamic ECG showed the total number of PVB decreased for 3460. 59 ±6516.56 beats/24 h in the treatment group, and for 2148.36 ±5129. 47 beats/24 h in the control group, difference between them showed no statistical significance （P 〉 0. 05）. The TCM syndrome score in both groups was markedly decreased after treatment when compared with before treatment （P 〈 0. 01 ） ; the differences of the treated and the control groups were -9.34 ±4.21 and -8.08 ±4. 33 respectively, showing sigificant difference （ P 〈 0. 05 ）. Conclusion FLBXP oral liquid has certain effect on PVB in CHD patients of qi-yin deficiency with phlegm-stasis syndrome type, no obvious adverse reaction was found in the clinical trial.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2008年第6期509-512,共4页
Chinese Journal of Integrated Traditional and Western Medicine
关键词
复律保心平口服液
冠心病室性早搏
气阴两虚
痰瘀互阻证
Fulu Baoxinping oral liquid
premature ventricular beat of coronary heart disease
qin-yin deficiency with phlegm-stasis sydrome type
