红花注射液对急性冠状动脉综合征患者血小板糖蛋白Ⅱb／Ⅲa受体影响的随机对照研究

背景：血小板表面糖蛋白（glycoprotein,GP）Ⅱb／Ⅲa受体是评价血小板活化的重要指标,具有活血化瘀作用的中成药红花注射液对该指标的影响对于探讨其抗血小板凝集作用机制及疗效有重要意义。目的：观察红花注射液对急性冠状动脉综合征患者血小板表面糖蛋白GPⅡb／Ⅲa受体的影响,探讨红花注射液在抗血小板凝集治疗中的作用及其机制。设计、场所、对象和干预措施：选择2008年9月至2009年5月在上海中医药大学附属岳阳中西医结合医院心血管内科住院的急性冠状动脉综合征患者64例,用随机数字表法分为红花注射液治疗组（32例,常规西药加红花注射液）与对照组（32例,常规西药）,两组疗程均为14d。主要结局指标：采用免疫荧光标记法和流式细胞仪检测治疗前后血小板活化标志物GPⅡb／Ⅲa复合物（CD41）、P选择素（CD62p）和溶酶体膜糖蛋白（CD63）的表达,同时观察红花注射液对急性冠状动脉综合征患者心绞痛症状及近期预后的影响。结果：对照组中有4例患者因提前出院而退出试验。对照组和治疗组的CD41比例、CD41抗体荧光量治疗后比治疗前均有所降低,差异有统计学意义（P〈0．05,P〈0．01）;治疗后治疗组CD41比例、CD41抗体荧光量低于对照组（P〈0．05）;两组CD62p比例和CD63比例治疗后均呈现出一定的下降趋势,但与治疗前比较差异无统计学意义。两组患者在住院14d中均未发生死亡、心肌梗死、脑卒中事件,红花注射液治疗组患者心绞痛症状缓解和心电图表现均明显好于对照组。结论：红花注射液具有抑制血小板膜糖蛋白GPⅡb／Ⅲa受体表达的作用,对急性冠状动脉综合征患者心绞痛具有很好的缓解作用,可增强常规西药抗血小板活化的作用。

Effects of the Chinese patent medicine, Honghua Injection, on platelet glycoprotein IIb/III a receptors in patients with acute coronary syndrome: a randomized controlled trial

BACKGROUND： Glycoprotein （GP） Ⅱb/Ⅲa is an important index for assessing the function of platelets. To investigate the effects of Honghua Injection, a Chinese patent medicine made from extracts of Carthamus tinctorius L, on GP Ⅱb/Ⅲa is a key study in evaluating the inhibition properties of Honghua Injection on platelet aggregation. OBJECTIVE： To observe the effects of Honghua Injection on platelet GP Ⅱb/Ⅲa receptors and explore the mechanisms of Honghua Injection in inhibiting platelet aggregation in patients with acute coronary syndrome. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： A total of 64 patients from Yueyang Hospital of Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine were randomly divided into Honghua Injection group （n = 32, routine Western medicine plus Honghua Injection） and control group （n=32, routine Western medicine） according to the random number table. The patients were treated for 14 d. MAIN OUTCOME MEASURES： The expressions of GPⅡb/Ⅲa （CD41）, P-selection （CD62p）, and lysosome-associated membrane GP （CD63） were measured by flow cytometry before and after treatment. Meanwhile the therapeutic effects of Huonghua Injection on angina and short-term prognosis were observed. RESULTS： The observational period was 14 d and four patients in the control group were omitted due to early discharge. The expression of CD41 in both the Honghua Injection group and the control group was inhibited after treatment （P〈0.05, P〈0.01）. The inhibition of the Honghua Injection group was stronger than that of the control group （P〈0.05）. There was no case of death, myocardial infarction and cerebral apoplexy during 14 d of treatment. The improvement of angina symptoms and electrocardiographic manifestation in the Honghua Injection group was greater than that of the control group （P〈0.05）. CONCLUSION： Honghua Injection can inhibit the expression of GPllb/llla receptors by preventing aggregation of platelets and may be considered as an effective traditional Chinese medicine for acute coronary syndrome.