苯扎贝特片联合氨氯地平片治疗高血压合并血脂代谢紊乱患者的临床研究

Clinical trial of bezafibrate tablets combined with amlodipine tablets in the treatment of hypertension complicated with dyslipidemia

目的观察苯扎贝特片联合氨氯地平片治疗高血压合并血脂代谢紊乱的临床疗效及安全性。方法将92例高血压合并血脂代谢紊乱患者随机分为对照组和试验组,每组46例。对照组给予氨氯地平片每次5.0 mg,qd,口服;试验组在对照组治疗的基础上,给予苯扎贝特片每次200 mg,tid,口服。2组患者均治疗8周。比较2组患者的临床疗效,血清一氧化氮(NO)、一氧化氮合酶(NOS)和内皮素-1(ET-1)水平,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93.48%(43例/46例)和78.26%(36例/46例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的NO分别为(28.06±5.20)和(24.69±5.13)μmol·L^-1,NOS分别为(26.18±4.57)和(22.02±4.26)U·m L^-1,ET-1分别为(82.06±7.81)和(87.36±8.24)pg·m L^-1,差异均有统计学意义(均P<0.05)。试验组和对照组的心脑血管事件发生率分别为4.35%和17.39%,差异有统计学意义(P<0.05)。试验组的药物不良反应主要有头痛、水肿和胃肠道不适,对照组的药物不良反应主要有头痛、水肿和心悸。试验组和对照组的总药物不良反应发生率分别为13.04%和8.70%,差异无统计学意义(P>0.05)。结论苯扎贝特片联合氨氯地平对高血压合并血脂代谢紊乱患者的疗效确切,其能显著改善血管内皮细胞功能,降低心脑血管事件的发生率,且不增加药物不良反应的发生率。

Objective zafibrate tablets combined with amlodipine tablets in the treatment of hypertension complicated with dyslipidemia.Methods patients with hypertension complicated with dyslipidemia were randomly divided into control and treatment groups with 46 cases per group.Control group was treated with amlodipine tablets 5.0 mg per time,qd,orally.Treatment group received bezafibrate tablets 200 mg per time,tid,orally,on the basis of control group.Two groups were treated for 8 weeks.The clinical efficacy,serum levels of nitric oxide(NO),nitric oxide synthase(NOS)and endothelin-1(ET-1),and adverse drug reactions were compared between two groups.Results the total effective rates of treatment and control groups were 93.48%(43 cases/46 cases)and 78.26%(36 cases/46 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:the NO were(28.06±5.20)and(24.69±5.13)μmol·L^-1,the NOS were(26.18±4.57)and(22.02±4.26)U·m L^-1,ET-1 were(82.06±7.81)and(87.36±8.24)pg·m L^-1,the differences were statistically significant(all P<0.05).The incidences of cardiovascular and cerebrovascular events in the treatment and control groups were 4.35%and 17.39%with significant difference(P<0.05).The adverse drug reactions of treatment group were headache,edema and gastrointestinal discomfort,while those in the control group were headache,edema and palpitation.The total incidences of adverse drug reactions in the treatment and control groups were 13.04%and 8.70%without significant difference(P>0.05).Conclusion combined with amlodipine tablets have a definitive clinical efficacy in the treatment of hypertension complicated with dyslipidemia,which can significantly improve the function of vascular endothelial cells and reduce the incidence of cardiovascular and cerebrovascular events,without increasing the incidence of adverse drug reactions.