坎地沙坦酯氢氯噻嗪对原发性高血压的降压疗效和肾功能影响的对照研究

Antihypertensive Effect and Renal Function Impact of Candesartan Cilexetil/Hydrochlorothiazide in Essential Hypertension Control Study

目的:以坎地沙坦西酯片为阳性对照药,评价国产坎地沙坦酯氢氯噻嗪胶囊治疗轻、中度原发性高血压的疗效和对肾功能的影响。方法:纳入我院2010年12月至2012年2月期间收治的原发高血压病患者296例,将其随机平均分为2组,停用其他降压药2周(清洗期)后,对照组给予坎地沙坦西酯(必洛斯)片(8 mg/片,口服,每次2片,每日1次)治疗,试验组给予坎地沙坦酯氢氯噻嗪胶囊(16 mg/12.5 mg/粒,口服,每次1粒,每日1次)治疗,分别在治疗前,治疗4周、8周后进行血压测量及尿常规、血钾、血钠、血氯、血肌酐(Cr)、肌酐清除率(Ccr)及尿素氮(BUN)等指标检测。结果:治疗8周后,试验组降压显效率为52.0%,总有效率为82.4%(n=148);对照组显效率为28.4%,总有效率为68.2%(n=148);显效率、总有效率两组比较差异有统计学意义(P<0.05)。两组治疗前后尿常规、血钾、血钠、血氯、Cr、Ccr及BUN与经治疗后两组各指标比较差异无统计学意义(P>0.05)。结论:坎地沙坦酯氢氯噻嗪胶囊对于轻、中度高血压患者的降压疗效优于对照组坎地沙坦西酯片,对肾功能的影响与其相当。

Objective： To evaluate the domestic Candesartan Cilexetil/Hydrochlorothiazide Capsules, with Candesartan Cilexetil Tablets as the positive control drug, for the curative effects on moderate primary hypertension and the influence on renal function. Methods： In our hospital, from December 2010 to February2012, 296 patients of primary hypertension were admitted, randomly divided into 2 groups and stopped other blood pressure medication for 2 weeks（cleaning period）. In the control group, patients were given Candesartan Cilexetil Tablets（8 mg/tablet, p.o, 2 tablets once a day）; in the experimental group, patients were given Candesartan Cilexetil/Hydrochlorothiazide Capsules（16 mg/12.5 mg/capsule, p.o, 1 capsule once a day）. Before treatment and 4 and 8 weeks after treatment, patients were measured for blood pressure index,urinalysis, blood serum sodium, potassium, chloride, creatinine（Cr）, creatinine clearance（Ccr） and urea nitrogen（BUN）, etc. Results： After 8 weeks of treatment, the experimental group showed antihypertensive efficiency as 52.0% and total effective rate as 82.4%（n=148）; The control group showed efficiency as 28.4%total effective rate as 28.4%（n =148）; differences of efficiency and total effective rate between the two groups were statistically significant（P〈0.05）. The results of urine and blood tests, between the treatment before and after, or between the two groups after treatment, showed no statistically significant differences（P〈0.05）. Conclusion： Candesartan Cilexetil/Hydrochlorothiazide Capsules in patients with mild-to-moderate hypertension antihypertensive have effects superior to Candesartan Cilexetil Tablets with equivalent influence on renal functions.