替米沙坦治疗轻中度原发性高血压的疗效和安全性的临床研究

The Study of Safely and Efficacy by Telmisartan Therapy in Patientswith Essential Hypertension

目的:探讨替米沙坦治疗轻、中度原发性高血压的临床疗效和安全性。方法:121例轻中度原发性高血压患者随机单盲分为两组,替米沙坦(治疗)组:61例,80mg/d,晨顿服。6周后未达显效者,加双氢氯噻嗪(HCTZ)12.5mg/d,疗程半年。氯沙坦(对照)组:60例,50mg/d,晨顿服,6周后未达显效者,加服HCTZ 12.5mg/d,疗程半年。治疗前后均进行偶测血压、动态血压(ABPM)、肝肾功能、血生化、血浆纤溶酶原激活物抑制剂-1(PAI-1)、纤维蛋白原(FG)、C-反应蛋白(CRP)、血尿酸(BUA)等检查,并观察心脑事件发生情况及药物不良反应。结果:替米沙坦(治疗)组:降压总有效率78.7％(48/61例),降压幅度25.6/14.6mmHg,谷/峰(T/P)比值:收缩压(SBP)0.88,舒张压(DBP)0.89,6周后未达显效者,加服HCTZ 2周后,达显效25％(9/36例);氯沙坦(对照)组:降压总有效率75％(45/60例),降压幅度22.1/12.1mmHg。T/P比值:SBP 0.86、DBP 0.87,6周后未达显效者,加服.HCTZ 2周达显效21.1％(8/38例),两组组间比较,降压幅度有明显差异(P7<0.05),ABPM中的24h SBP和24h DBP治疗后降低值,两组也有显著性差异(P<0.05);两组治疗后PAI-1、FG、CRP均较治疗前明显降低(P<0.01),但3项指标组间比较无显著性差异(P>0.05),两组治疗后BUA均较治疗前有明显降低(P<0.05),且氯沙坦组比替米?

Objective:Toinvestigate the safety and efficacy by telmisartan thetapy in patients with mild or middle type essential hyper- tension. Methods: 121 patients with mild or middle type essential hypertension were divided into two groups randomly: Group one was given with 80mg telmisartan per day in the morning , group two was given with 50mg loaartan. Larsting 6 weeks treatment without remarkable effect,hydrochlorothiazide was added . The renal function, hepatic function, plasma electrolye , plasminogen activator inhibiter-1 (PAI-l), fibrinogen(FG), C-creatin protein(CRP), plasma uric-acid and ambulatory blood pressure were compared before and after treatment in the groups. The cardiovascular events or incidence of stroke and drug adverse reaction were following up for 6 months at least. Results: Results: In the group one the total effective rate of blood control was 78.7% (48/61 case). The degree of blood lowing was25.6/14.6mmHg. The trough-to peak(T/P) ratio was: Systolic blood pressure(SBP) 0.88,Diastolic blood pressure(DBP)0.89. Hydrochorothiazade (HCT) was taken in 9 cases who appeared inefficacy after 6 weeks telmisartan therapy and the remarkable efficacy was 25% after adding HCT.In the group two the total effective rate of blood control was 75.0% (45/60} and the blood lowing was 22.1/ 12. 1mmHg.The T/P ratio was: SBP 0.86,DBP 0.87.Hydrochorothizide was added when it appeared inefficacy in 8 cases after 6 weeks losartan therapy and the remarkable efficacy was 21.1%. Comparing to group two, group one had significantly difference in degree of blood lowing (P<0.05) and had significantly difference on mean SBP and mean DBP by ambulatory monitoring(P<0.05). The PAI-1, FG , CRP were remarkably lowing after treatment in either telmisartan or losartan group (P<0.05) but telmisartan was more remarkable(P<0.05). After 6 months following up the cardiovascular events and stroke were similar in two groups. The drag adverse reaction was mild and similar in two groups. Conclusion: There are safety, efficacy, stability,less adverse reaction, convenience for taking in treatment with patients who suffer from mild or middle essential hypertension. It is recommended that telmisartan as one kind of an- giotensin receptor antagonists would be chosen for first-line of anti-hypertensive therapy.