麝香保心丸早期辅助治疗肺心病合并急性冠脉综合征临床研究

摘要

Objectuve To observe the clinical effect and safety if traditionary Chinese medicine Shexiang Baoxinwan in chronic cor pulmonale with ACS as an ancillary treatment. Methods 153 cases of chronic cor pulmonale and ACS were assigned two groups randomly. In addition to standard treatment of chronic cor pulmonale with ACS, the treatment group, (n = 77) was added SXBXW 2 pills three times per day; the control group was given placebo as control, All cases were followed up for 1 year, and the effecacy, the changing in cardiac function and the occurrence of cardiocerebral eveents were observed. Results The severtiy and reoccurrence of angina pectoris were decreased significantly in the treatment group (total effective rate 88.3％, P＜0.05). In the treatment group, the ischemic electrocardiograph was also significantly improved (total effective rate57.4％, P＜0.05). The events such as recurred angina pectoris, nonfatal acute myocardial infarction, heart failure, the need for percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafty (CABG) and the rale or re- hospitalizing were significantly lower in the treatment group ( P ＜ 0.05 ). Left ventricular ejeetive frachion (LVEF), fractional shortening (FS), the ratio If peak flow velocily between early diastole and atrial contraction (E/A) were 3 months later in the treatment group than the control. (all P＜0.05). CRP, FIB and D-dimer were significantly decreased in the treatment group too. And the adverse reactions were similar and mild in the two groups. Conclusion SXBXW is safe and more effective assistant treatment in chronic cor pulmonale with acute coronary ayndrome.%目的 探讨慢性肺源性心脏病合并急性冠脉综合征早期辅助应用中药麝香保心丸治疗的有效性、安全性、预防心脑血管事件及改善肺功能的作用.方法 将153例肺心病合并ACS患者随机分为两组:治疗组77例,麝香保心丸每次2丸(每丸22.5 mg),3次/d;对照组76例,安慰剂每次2粒,3次/d.观察两组抗心绞痛疗效、心功能改变、心脑血管事件发生情况、肺功能改变及不良反应发生情况.结果 治疗组显著改善心绞痛(AP)症状(总有效率88.3%);改善AP的缺血心电图(总有效率57.4% ),肺功能改善(总有效率56.7%),2者均优于对照组(P<0.05);治疗组随防1年中复发性 AP、非致死性心肌梗死(MI)、心力衰竭(HF),需做经皮腔内冠脉成形术/冠脉旁路移植术,需再住院治疗的病例均较对照组明显降低(P<0.05);SXBXW治疗3个月明显改善左心室射血分数(LVEF)、左心室短轴缩短率(FS)、二尖瓣快速充盈期和心房收缩期血流速度比(E /A),且明显优于对照组(P<0.05).治疗组降低C-反应蛋白(CRP)、纤维蛋白原(FIB )和D-二聚体作用均明显优于对照组(P<0.05),治疗组FEV1、IC优于对照组(P<0.05 ),且SXBXW辅助治疗ACS不良反应轻微.结论 肺心病合并ACS早期辅助 应用SXBXW有效安全,可预防心脑血管事件发生,有效改善肺功能,作为辅助药物之一值得临床推广应用.