丹参多酚酸盐治疗冠心病心绞痛(心血瘀阻证)的临床研究

Clinical Observation on Salvianolate for the Treatment of Angina Pectoris in Coronary Heart Disease with Heart-Blood Stagnation Syndrome

目的进一步评价注射用丹参多酚酸盐治疗冠心病心绞痛(心血瘀阻证)的有效性和安全性。方法采用随机、仿盲、3组平行、阳性药对照、多中心研究方法进行丹参多酚酸盐的III期临床试验。受试者共480例,试验Ⅰ组240例,试验Ⅱ组120例,对照组为120例,分别应用注射用丹参多酚酸盐200,400mg和丹参注射液20mL静滴,疗程14d,观察其临床疗效和安全性。结果心绞痛疗效比较,试验Ⅰ组总有效率为88.085%,试验Ⅱ组为89.744%,对照组为67.257%,两试验组与对照组相比P<0.01。中医症状疗效,试验Ⅰ组总有效率为80.426%,试验Ⅱ组为80.342%,对照组为58.407%,两试验组与对照组相比P<0.01。心电图疗效,试验Ⅰ组总有效率为44.444%,试验Ⅱ组为53.086%,对照组为32.530%。试验Ⅱ组与对照组心电图总有效率比较差异有统计意义(P<0.05)。治疗14d后,部分受试者出现血常规、肝肾功能轻度异常;不良事件12例,10例为不良反应,其中试验Ⅰ组有3例;试验Ⅱ组有5例;对照组有2例。结论注射用丹参多酚酸盐200mg剂量治疗冠心病心绞痛(心血瘀阻证)患者安全有效。

Objective To further study the clinical efficacy and safety of salvianolate injection for the treatment of angina pectoris in coronary heart disease （CHD）with heartblood stagnation syndrome. Methods A randomized imitativeblind mutli - center clinical trials with positive control and 3 parallel tests was carried out in 480 cases. The patients were divided into three groups： the control group received salviane injection 20 mL （ n = 120）, the treatment group 1 （ n = 240） and treatment group 2 （ n = 120） received salvianolate injection in a dosage of 200 mg and 400mg respectively. After 14 -7 daytreatment, the clinical efficacy and safety of salvianolate were observed. Results The total angina pectoris efficacy rates were 88. 085 % in treatment group 1, 89. 744 % in treatment group 2 and 67. 257 % in control group （ P 〈 0.01） ; the total TCM syndrome efficacy rates were 80. 426 % in treatment group 1, 80. 342 % in treatment group 2 and 58. 407% in control group （ P 〈 0. 01）; and the total ECG efficacy rates were 44.444 % in treatment group 1, 53.086 % in treatment group 2 and 32. 530 % in control group. Compared with the control group , the differences of total ECG efficacy rate and total effect rate were significant in treatmentgroup 2 （ P 〈 0.01 or P 〈 0. 05） . The results of the safety evaluation showed no abnormity in routine physical examination, urine examination and stool examination after treatment. Slight abnormity occurred in liver and kidney function and routine blood examination in three groups after 14 - day treatment. Meanwhile, adverse events occurred inl2 cases, and adverse reaction occurred in 10 cases. Among the 10 cases, t 3 cases （1. 250 % ） were in treatment group 1, 5 cases （4. 167 % ） in treatment group 2 and 2 cases （1. 667 % ） in control group. Conclusion Injective salvianolate in a dosage of 200mg is effective and safe for the treatment of CHD angina pectoris with heart - blood stasis syndrome.