Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Chin J Integr Med. 2010 Oct;16(5):399-405. doi: 10.1007/s11655-010-9999-9. Epub 2010 Jun 10.
Compared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI).
A randomized, double-blinded, double-dummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment.
Eighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week's treatment, BSS scores slightly decreased in each group, but no significant differences were found among three groups (P>0.05). After four weeks' treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P <0.05) and the placebo (P <0.01) groups. After the treatment, the efficacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P <0.05,P <0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group P <0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort.
Compared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better efficacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term efficacy and safety still needs further investigation.
比较生脉胶囊（SM），评价血府逐瘀胶囊（XFZY）对经皮冠状动脉介入治疗（PCI）后血瘀证不稳定型心绞痛（UA）患者症状体征及健康相关生活质量（HR-QOL）的疗效和安全性。
采用随机、双盲、双模拟、安慰剂对照试验。入选 90 例 PCI 成功后诊断为 UA 合并血瘀证患者，按就诊顺序编号，采用随机数字表法分为血府逐瘀胶囊组、生脉胶囊组和安慰剂组，每组 30 例。三组患者分别给予相应药物治疗 4 周，观察治疗前后临床症状体征（CSS）、心电图（ECG）、血瘀证积分变化，采用健康调查简表（SF-36）和西雅图心绞痛量表（SAQ）评价患者 HR-QOL，检测治疗前后血常规、肝肾功能等安全性指标。
86 例患者完成研究。治疗后，血府逐瘀胶囊组 CSS 总有效率为 76.7%，ECG 总有效率为 60.0%，均明显高于生脉胶囊组[CSS：53.3%，ECG：36.7%]和安慰剂组[CSS：43.3%，ECG：30.0%]（P<0.05）。治疗 1 周后，三组血瘀证积分均较治疗前降低，但组间比较差异无统计学意义（P>0.05）；治疗 4 周后，血府逐瘀胶囊组血瘀证积分较生脉胶囊组和安慰剂组降低更明显（P<0.05）。治疗后，血府逐瘀胶囊组改善躯体疼痛（BP）、一般健康状况（GH）、活力（VT）、社会功能（SF）、情感职能（RE）、心绞痛稳定状态（AS）、心绞痛发作频率（AF）、治疗满意度（TS）的疗效优于安慰剂组（P<0.05，P<0.01），且 BP、GH、SF、AS、AF、TS 维度改善均优于生脉胶囊组（P<0.05）。治疗期间及治疗后未见明显不良反应，仅血府逐瘀胶囊组 1 例出现胃部不适。
与生脉胶囊比较，短期应用血府逐瘀胶囊治疗 PCI 后血瘀证 UA 患者，在改善 CSS 和血瘀证积分及 HR-QOL 方面疗效更优，但其长期疗效和安全性仍需进一步观察。
