曲美他嗪片治疗冠心病心力衰竭的临床研究

Clinical trial of trimetazidine tablets in the treatment of chronic heart failure

目的观察曲美他嗪片治疗冠心病心力衰竭的临床疗效及安全性。方法将123例冠心病心力衰竭患者随机分为对照组61例和试验组62例。对照组予以阿司匹林100 mg,qd,口服+阿托伐他汀钙20 mg,qn,口服+培哚普利4 mg,qd,口服+琥珀酸美托洛尔缓释片47.5 mg,qd,口服;试验组在对照组治疗的基础上,予以曲美他嗪每次20 mg,tid,口服。2组患者均治疗6个月。比较2组患者的临床疗效、左心室射血分数(LVEF)、6 min步行试验和脑钠肽(BNP),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分为80.65%(50/62例)和72.13%(44/61例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的LVEF分别为(38.85±4.72)%和(36.53±3.10)%,6 min步行距离分别为(375.23±43.84)和(344.64±38.92)m,血浆BNP分别为(335.48±211.36)和(420.52±237.47)pg·m L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有恶心、呕吐、皮肤瘙痒,对照组的药物不良反应主要有恶心、胃部不适。试验组和对照组的药物不良反应发生率分别为6.45%和3.27%,差异无统计学意义(P>0.05)。结论曲美他嗪片虽不能明显提高冠心病心力衰竭患者的临床疗效,但其能显著地改善患者的心功能和运动耐量,降低BNP水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of trimetazidine tablets in the treatment of chronic heart failure. Methods A total of 123 patients with chronic heart failure were randomized into control group（ n = 61 cases） and treatment group（ n = 61 cases）. Control group was givenaspirin 100 mg,qd,oral ＋ atorvastatin calcium 20 mg,qn,oral ＋ perindopril 4 mg,qd,oral ＋ metoprolol succinate sustained-release tablets 47. 5 mg,qd,oral. Treatment group was given trimetazidine 20 mg,tid,oral,on the basis of control group. Two groups were treated for6 months. The clinical efficacy,left ventricular ejection fraction（ LVEF）,6-minute walking test,brain natriuretic peptide（ BNP） and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates in treatment and control groups were 80. 65%（ 50/62 cases） and 72. 13%（ 44/61 cases） without significant difference（ P〉0. 05）. After treatment,the main indexes in treatment and control groups were compared： the LVEF were（ 38. 85 ± 4. 72） %,（ 36. 53 ±3. 10） %; walking distances during 6 min were（ 375. 23 ±43. 84）,（ 344. 64 ± 38. 92） m; BNP were（ 335. 48 ± 211. 36）,（ 420. 52 ± 237. 47）pg·m L^-1,the differences were statistically significant（ all P〈0. 05）. Theadverse drug reactions in treatment group were based on nausea,vomiting and skin itching,which in treatment group were nausea and stomach discomfort. The incidences of adverse drug reactions in treatment and control groups were 6. 45% and3. 27% without significant difference（ P〈0. 05）. Conclusion Trimetazidine tablets can not significantly improve the clinical efficacy in the treatment of chronic heart failure,but it can significantly improve the patient＇s cardiac function and exercise tolerance,reduce the level of BNP,without increasing the incidence of adverse drug reactions.