丹参多酚酸盐治疗心绞痛的非随机、同期对照临床研究

Salvianolate therapy for angina pectoris

目的:评价注射用丹参多酚酸盐治疗冠心病心绞痛的疗效与安全性,并与丹参酮2a磺酸钠注射液进行疗效比较。方法:采用非随机、同期对照临床研究方法;研究对象为稳定性心绞痛患者;对治疗组(注射用丹参多酚酸盐)、对照组(丹参酮2a磺酸钠注射液)的心绞痛疗效、硝酸甘油减退率与心电图疗效进行比较,并进行安全性评价;疗程14d。结果:治疗组50例,8例中途退出;对照组38例,5例中途退出。两组患者基线资料比较除年龄外经检验差异均无统计学意义。治疗组心绞痛有效率90.5%、硝酸甘油减停率92.3%,对照组心绞痛有效率72.8%、硝酸甘油减停率72.4%,治疗组有效率高于对照组(P<0.05)。治疗组心电图有效率42.9%,对照组36.3%,经检验差异无统计学意义(P>0.05)。结论:注射用丹参多酚酸盐治疗稳定性心绞痛患者安全、有效,心绞痛有效率、硝酸甘油减停率高于丹参酮2a磺酸钠。

Objective To explore the efficacy and safety of salvianolate therapy for angina pectoris, and to compare the efficacy of salvianolate with that of sulfotanshinone sodium injection. Methods We conducted a nonrandomized, concurrent controlled trial to study salvianolate therapy for stable angina. We assigned the patients to receive salvianolate （study group） or sulfotanshinone sodium （control group）for 14 days, and then compared the efficacy and safety of the therapies, rate of nitroglycerin reduction or discontinuation, and ECG findings. Results 8 of 50 patients were withdrawn in the study group and 5 of 38 in the control group during the trial. The baseline data exeept age did not differ significantly between the two groups. The efficacy and the rate of nitroglycerin reduction or discontinuation were greater in the study group than in the control group （90.5% vs. 72.8% and 92.3% vs. 72.4%, P 〈 0.05）. However, there was no significant difference in the rate of ECG improvement （42.9% vs. 36.3% ,P 〉 0.05）. Conclusions Salvianolate is safe and effective in the treatment of stable angina, and has a greater efficacy and a higher rate of nitroglyeerin reduction or discontinuation than sulfotanshinone sodium.