丹蒌片治疗痰瘀互结型非血运重建急性冠脉综合征的临床观察

The Clinical Efficacy of Danlou Tablet in Non-revascularization Patients With Acute Coronary Syndrome and Phlegm and Blood Stasis Syndrome Type

目的观察丹蒌片治疗痰瘀互结型非血运重建急性冠脉综合征（ACS）的临床疗效。方法选择因各种原因未能行血运重建治疗的中医辨证为痰瘀互结证的ACS患者70例,随机分配至对照组和治疗组,对照组给予单纯的标准化西医治疗,治疗组在标准化西医治疗基础上加用中成药丹蒌片（每次1.5 g,1日3次）,疗程1个月。观察治疗前后2组患者心绞痛发作情况（程度、频率、持续时间）、硝酸甘油使用情况（用量、使用后心绞痛缓解时间）及心绞痛积分,并对治疗前后中医临床证候（包括：胸闷、胸痛及其发作频率和持续时间、心悸、气短、乏力及证候总评分）进行评分;观察治疗前后2组患者血脂[总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、甘油三酯（TG）]及超敏C反应蛋白（hs-CRP）的变化。比较2组患者心绞痛疗效、中医临床证候评分及血生化改变情况。结果治疗组心绞痛总有效率（85.29%）显著优于对照组（48.48%）,P〈0.01。与本组治疗前相比,2组患者治疗后的心绞痛发作频率、持续时间、服用硝酸甘油后心绞痛缓解时间、硝酸甘油使用量、心绞痛积分、中医临床证候评分及证候总评分均显著降低（P〈0.01）。2组治疗后相比,治疗组显著低于对照组（P〈0.05~0.01）。治疗组中医临床证候改善情况（证候评分总有效率79.41%）显著优于对照组（证候评分总有效率45.45%）,P〈0.01。2组治疗后TC、LDL-C（P〈0.01）及hs-CRP（P〈0.05）水平均显著低于同组治疗前,2组治疗后比较,治疗组hs-CRP显著低于对照组（P〈0.05）。结论丹蒌片对痰瘀互结型非血运重建急性冠脉综合征患者的心绞痛及中医临床证候有显著改善作用,并可能抑制炎症反应,稳定斑块。

OBJECTIVE To investigate the clinical efficacy of Danlou tablet in Non-revascularization Patients with acute coronary syndrome（ ACS） and phlegm and blood stasis syndrome type（ PBSST）. METHODS 70 ACS patients with PBSST for various reasons failed revascularization therapy were randomly assigned to the control group and the treatment group. The control group was given a standardized western medicine treatment and the treatment group was given Danlou tablets（ every time 1. 5g, 3 times a day） based on standardized western medicine treatment for a month. Angina episodes（ intensity, frequency, duration）, nitroglycerin use（ consumption, angina relief time after taking nitroglycerin） and the score of angina, traditional Chinese Medicine（ TCM） clinical syndrome（ including： chest pain or tightness and its frequency and duration, palpitations, shortness of breath, fatigue and total syndrome score）,lipids including total cholesterol（ TC）, low-density lipoprotein cholesterol（ LDL-C）, high density lipoprotein cholesterol（ HDL-C）,triglycerides（ TG） ] and hypersensitive C-reactive protein（ hs-CRP） were observed in the two groups of patients before and after treatment. The clinical efficacy of angina,the score of TCM clinical syndrome and blood biochemical changes were recorded and compared between the two groups. RESULT The total effective rate of angina（ 85. 29%） was significantly better than that of the control group（ 48. 48%）（ P〈0. 01）. Compared with the same group before treatment, the frequency and duration of angina, the angina relief time after taking nitroglycerin, the amount of nitroglycerin, the score of angina and TCM clinical syndromes and the total score of syndrome,all these were significantly lower（ P〈0. 01） in the two groups of patients after treatment. Compared with the control group, the frequency and duration of angina, the angina relief time after taking nitroglycerin, the amount of nitroglycerin, the total score of TCM clinical syndrome（ P〈0. 05） and the score of angina（ P〈0. 01） were significantly lower in the treatment group after treatment. The improvement of TCM clinical syndromes in the treatment group（ the total efficiency of syndrome score was 79. 41%） was significantly better than the control group（ the total efficiency of syndrome score was 45. 45%）（ P〈0. 01）. TC, LDL-C（ P〈0. 01） and hs-CRP（ P〈0. 05）levels after treatment were significantly lower than before. After treatment, hs-CRP in the treatment group was significantly lower compared with the control group（ P〈0. 05）. CONCLUSION Danlou tablet can promote a significant improvement to angina and TCM clinical syndromes in Non-revascularization Patients with ACS and PBSST, inhibit the inflammation, and show plaque stabilizing effects.