芎芍胶囊干预冠心病介入治疗后再狭窄的研究

Clinical Study on Effect of Xiongshao Capsule on Restenosis after Percutaneous Coronary Intervention

目的在以往临床初步证明芎芍胶囊有预防冠心病介入治疗(PCI)后再狭窄(RS)的基础上,进一步评价其干预PCI后RS的作用。方法采用双盲、随机、安慰对照方法,124例冠心病支架置入患者,随机分为芎芍胶囊试验组和安慰剂对照组,每组62例,随访6个月。依据冠状动脉造影(CAG),以RS率为主要疗效指标,结合心绞痛复发率、临床终点事件发生率和血瘀证计分,观察芎芍胶囊对PCI后患者RS的干预作用。结果118例有效病例中62例进行了6个月CAG随访,随访率为52·5%。试验组RS发生率为24·1%,支架内RS率为14·0%。对照组RS发生率为48·5%,支架内RS率为42·0%。与对照组比较,试验组RS率明显降低(P<0·05)。试验组6个月后CAG复查病变血管管腔直径为(2·21±0·85)mm、血管狭窄程度为(26·58±20·72)%,对照组血管管腔直径为(1·72±0·99)mm、狭窄程度为(41·19±30·92)%;与对照组比较,试验组狭窄程度显著降低、管腔直径丢失显著减少(均P<0·05)。试验组6个月临床终点事件发生率为11·7%,对照组为27·6%,试验组较对照组下降,已明显接近统计学差异水平(P=0·051)。6个月后血瘀证计分试验组显著低于对照组(P<0·01)。结论在西药常规治疗基础上加用芎芍胶囊,对PCI后RS可以起到较好的防治作用。

Objective To further evaluate the effect of Xiongshao Capsule （XSC） on the restenosis （RS） after percutaneous coronary intervention （PCI）, based on previous clinical trials by which the preventive effect of XSC on RS after PCI has been proved. Methods Adopting the randomized, double blind and placebo con trolled method, the 124 patients enrolled, who were patients with coronary artery disease and received intracoronary stenting, were randomly assigned into two groups, the XSC group and the placebo control group, with 62 in each group. Six months of follow-up study was carried out on them to observe the intervention effect of XSC, which was predominantly evaluated by RS rate estimated by coronary angiography （CAG）, combined with the recurrent rate of angina, clinical end-point event, and blood-stasis syndrome scores. Results Sixty two cases of 118 effective patients were followed-up with CAG for 6 months, the follow-up rate was 52.5 %. The incidence of RS in the XSC group and the control group was 24.1% and 48.5 % respectively, and the incidence of RS in stent in them was 14.0% and 42.0 % respectively, indicating that the incidence of RS rate in the XSC group was significantly lower than that in the control group （P 〈 0.05）. After patients had been treated for 6 months the extent of angiostenosis and diameter of the culprit arteries, determined by CAG was 26.58 ± 20.72 % and 2.21 ± 0.85 mm in the XSC group, and 41.19 ± 30.92% and 1.72 ± 0.99 mm in the control group, respectively, suggesting that the extent of angiostenosis and the diameter loss were significantly reduced in the former than those in the latter, respectively （P〈0.05）. The incidence of clinical end-point event was 11.7% and 27.6% in the XSC group and the control group in the 6 months＇ follow-up period respectively, it was significantly lower in the XSC group than that in the control group, with the P value close to statistical significance （P = 0.051）. The blood-stasis syndrome scores in the XSC group was significantly lower in comparing with that in the control group after 6 months＇ treatment （P〈0.01）. Conclusion XSC can effectively prevent RS after PCI in combination with conventional Western medical treatment.