苯磺酸左氨氯地平治疗原发性高血压安全性及疗效评价

Safety of Efficacy of Levamlodipine Besylate for Essential Hypertension

目的:评价苯磺酸左氨氯地平治疗原发性高血压的安全性及疗效。方法:采用多中心、随机、开放、平行对照临床试验,选择120例原发性高血压患者,随机分为实验组(60例)和对照组(60例),实验组给予苯磺酸左氨氯地平2.5mg,qd;对照组给予氯沙坦50mg,qd,共治疗9周。观察两组治疗前后血压、肾功能(血肌酐、β2微球蛋白、尿素氮)、肝功能(AST、ALT)、心功能(心率、每搏输出量)及不良反应情况。结果:两组患者服药9周后收缩压及舒张压均下降,差异有高度统计学意义(P<0.01),实验组血压下降更明显,两组SBP比较,差异有统计学意义(P<0.05);实验组治疗后血肌酐及β2微球蛋白较治疗前降低(P<0.05),对照组β2微球蛋白较治疗前降低(P<0.05),治疗后实验组β2微球蛋白较对照组降低(P<0.05);两组心率治疗前后差异无统计学意义(P>0.05)。实验组不良反应发生率为21.2%,主要为头晕、头痛、心悸、乏力及下肢水肿;对照组为26.6%,主要为头晕、头痛、面部潮红、咳嗽及腹痛。两组比较,差异有统计学意义(P<0.05)。结论:苯磺酸左氨氯地平治疗原发性高血压疗效显著,其降压效果较氯沙坦好,且不良反应少。

OBJECTIVE： To evaluate the safety and efficacy of levamlodipine besylate for essential hypertension. METHODS： By a multi-centered,randomized open and parallel controlled clinical trial,a total of 120 patients with essential hypertension were randomized to either trial group （ n = 60） receiving levamlodipine besylate 2. 5 mg qd or control group （n = 60） treated with Losartan 50 mg qd for 9 weeks. The indexes such as blood pressure,renal function （serum creatinine and β-2-microglobulin and urea nitrogen）,liver function （AST and ALT） and heart function （heart rate and stroke volume） and side effects were recorded before and after treatment. RESULTS： As compared with baseline,both systolic pressure and diastolic pressure in both groups decreased after 9-week treatment,much as in the trial group,and the differences were significantly significant （ P 0. 01） and the differences in SBP were also significant between two groups （ P 0. 05 ）; compared with before treatment,serum creatinine and β-2-microglobulin levels in trial group decreased （P 0. 05）,β-2-microglobulin level in control group decreased （P 0. 05）,and β-2-microglobulin level were more decreased in trial group than in control group after treatment （P 0. 05）. There were no significant differences between two groups in heart rates after treatment （ P 0. 05 ）. The incidence of side effects in the trial group was 21. 2% ,which manifested as dizziness,headache,palpitation, weakness and edema of lower extremities,wherease the incidence of side effects in the control group was 26. 6% which manifestated as dizziness,headache,fushing,cough and abdominal pain,and the differenes between the two groups were significantly significant （ P 0. 05 ）. CONCLUSION： Levamlodipine besylate showed remarkable efficacy for essential hypertension,and its efficacy is better than losartan yet with mild side effects.