Clinical Study of Xiongshao Capsule (芎芍胶囊) in Preventing Restenosis after Coronary Interventional Treatment

Objective: To evaluate the effect of Xiongshao Capsule (XS, 芎芍胶囊) in preventing clinical and angiographic restenosis after coronary angioplasty or/and stenting. Methods: The total of 108 coronary heart disease patients with successful coronary angioplasty or/and stenting were randomly divided into the control group (55 cases, routine treatment) and the XS group (53 cases, routine treatment combined with XS). The recurrence of angina, clinical end-point events, changing of blood-stasis syndrome score (BSSS) and coronary angiography within 6 month after coronary angioplasty or/and stenting were observed. Results: Follow-up angiography was performed in 42 patients including 18 cases in the XS group (restenosis was observed in 7 patients) and 24 cases in the control group (restenosis was observed in 17 patients), there was significant difference between the occurrence of restenosis in XS and that in control group (P<0.05). The occurrence of clinical end-point events (death, nonfatal target lesion myocardial infarction, coronary artery bypass graft surgery, or repeat target-vessel angioplasty) in the XS group (18.8%) was significantly lower than that in the control group (40%)(P<0.05). The recurrent angina was observed in 13 cases in the XS group, there was significant difference as compared with 27 cases in the control group (P<0.05). There was also remarkable significance for the difference of base-line and follow-up BSSS between groups (P<0.01). Logistic multivariate stepwise regress analysis and multivariate regress analysis of the related factors with restenosis confirmed by coronary angiography showed that, the base-line BSSS and the difference of base-line and follow-up BSSS were important influencing factors on the occurrence of restenosis after interventional treatment (P<0.05). Conclusion: XS could markedly reduce the occurrence of angiographic restenosis, clinical end-point events and recurrent angina, improve condition of blood-stasis after coronary angioplasty or/and stenting. The severity of blood-stasis syndrome was an important influencing factor on the occurrence of restenosis. It still needs to be further demonstrated by large-scale, double-blinded, randomized and controlled study.

芎芍胶囊预防冠状动脉介入治疗后再狭窄的临床研究

目的：观察芎芍胶囊预防冠状动脉介入治疗后再狭窄的临床疗效。方法：６５例经皮冠状动脉腔内成形术（ＰＴＣＡ）或（及）支架植入术成功的冠心病患者，随机分为西药常规治疗（对照）组３７例和西药常规加芍芍胶囊治疗（加中药）组２８例。对患者术后６个月的心绞痛复发、血瘀证积分值变化、冠脉造影等进行随访观察。结果：加中药组心绞痛复发率显著低于对照组（Ｐ＜０．０５）。两组患者共有２６例复查冠脉造影，其中加中药组１０例中，再狭窄４例；对照组１６例中，再狭窄１３例，两组比较再狭窄发生率有显著性差异（Ｐ＜０．０５）。治疗后血瘀证积分值（分）加中药组（１６．８９±５．４５）与对照组（２１．４１±４．９８）比较有显著性差异（ Ｐ＜ ０． ０１）。Ｌｏｇｉｓｔｉｃ回归分析发现，加用中药及术前血瘀证积分值是再狭窄发生与否的重要影响因素（Ｐ＜０．０５）。血瘀证积分值＞２５较血瘀证积分值≤２５的患者再狭窄发生的比数比为６．５。结论：芎芍胶囊可明显降低冠状动脉介入治疗后的冠脉造影随访再狭窄的发生，减少心绞痛复发并改善患者的血瘀状态；血瘀证的轻重程度是冠状动脉介入治疗后再狭窄发生与否的重要影响因素。

芎芍胶囊治疗PCI术后再狭窄的临床疗效和安全性的Meta分析

目的系统评价芎芍胶囊治疗冠心病经皮冠状动脉介入治疗(PCI)术后再狭窄的有效性和安全性。方法计算机检索PubMed、Web of Science、EMbase、the Cochrane Library、中国知网(CNKI)、维普中文科技期刊全文数据库(VIP)、中国生物医学文献服务系统(SinoMed)、万方数据资源系统(WanFang Data)等数据库,纳入芎芍胶囊联合常规西药对比单独使用常规西药干预冠心病PCI术后的随机对照试验(RCT)。由两位评价者独立筛选文献、提取资料、评价偏倚风险,应用RevMan 5.3软件进行Meta分析。结果共纳入RCT 7项,涉及938例病人,Meta分析结果显示,试验组在心绞痛复发率[RR=0.30,95%CI(0.23,0.40),P<0.00001]、再狭窄发生率[RR=0.56,95%CI(0.45,0.70),P<0.00001]、终点事件发生率[RR=0.47,95%CI(0.33,0.67),P<0.0001]、血瘀证积分[MD=-5.92,95%CI(-7.74,-4.10),P<0.00001]、最小管腔直径[MD=0.47,95%CI(0.35,0.59),P<0.00001]、狭窄程度[MD=-13.71,95%CI(-18.09,-9.33),P<0.00001]方面均优于对照组,而两组不良反应发生率差异无统计学意义(P>0.05)。结论现有证据表明,在西药常规基础上加用芎芍胶囊联合治疗冠心病PCI术后临床效果更好,且安全性较好。