依折麦布片联合氟伐他汀片治疗高危冠心病的临床研究

Clinical trial of ezetimibe tablets combined with fluvastatin tablets in the treatment of high-risk coronary heart disease

目的观察依折麦布片联合氟伐他汀片治疗高危冠心病的临床疗效及安全性。方法将78例高危冠心病患者随机分为对照组和试验组,每组39例。对照组予以氟伐他汀每次40 mg,qd,口服;试验组在对照组治疗的基础上,予以依折麦布每次10 mg,qd,口服。2组患者均治疗4周。比较2组患者的临床疗效、左心室功能,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别为87. 18%(34例/39例)和64. 10%(25例/39例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的左心室舒张末期内径分别为(58. 32±7. 42)和(62. 36±8. 27) mm,左心室收缩末期内径分别为(40. 83±5. 21)和(43. 68±5. 72) mm,左心室射血分数分别为(59. 83±8. 37)%和(54. 76±7. 21)%,差异均有统计学意义(均P <0. 05)。2组患者发生药物不良反应均以胃肠道症状、肌痛/肌酶升高和疲乏无力为主。试验组和对照组的总药物不良反应发生率分别为17. 95%和15. 38%,差异无统计学意义(P> 0. 05)。结论依折麦布片联合氟伐他汀片治疗高危冠心病的临床疗效确切,其能有效地改善患者的左心室功能,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of ezetimibe tablets combined with fluvastatin tablets in the treatment of high-risk coronary heart disease.Methods A total of 78 patients with high-risk coronary heart disease were randomly divided into control and treatment groups with 39 cases per group.Control group was treated with fluvastatin 40 mg per time,qd,orally.Treatment group received with ezetimibe 10 mg per group,qd,orally,on the basis of control group.Two groups were treated for 4 weeks.The clinical efficacy,left ventricular function and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 87.18%(34 cases/39 cases)and 64.10%(25 cases/39 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:left ventricular end-diastolic diameter were(58.32±7.42)and(62.36±8.27)mm,left ventricular end-systolic diameter were(40.83±5.21)and(43.68±5.72)mm,left ventricular ejection fraction were(59.83±8.37)%and(54.76±7.21)%,the differences werestatistically significant(all P<0.05).The adverse drug reactions of two groups were gastrointestinal symptoms,myalgia/muscle enzyme elevation and fatigue and weakness.The total incidences of adverse drug reactions in the treatment and control groups were 17.95%and 15.38%without significant difference(P>0.05).Conclusion Ezetimibe tablets combined with fluvastatin tablets have a definitive clinical efficacy in the treatment of high-risk coronary heart disease,which can effectively improve the left ventricular function,without increasing the incidence of adverse drug reactions.