摘要
目的 :评价国产伊贝沙坦 (Irbesartan)治疗轻、中度原发性高血压疗效和安全性。方法 :43例轻、中度原发性高血压患者(坐位舒张压在95～110mmHg及收缩压<180mmHg) ,性别不限 ,采用随机、双盲双模拟、平行对照研究的方法 ,经口服安慰剂2周后 ,平均坐位舒张压95～110mmHg,收缩压<180mmHg进入治疗期 ,给予伊贝沙坦150mg/天或缬沙坦80mg/天口服。两周后降压若未达有效 ,加量至伊贝沙坦300mg/日或缬沙坦160mg/天 ,继续服药2周。4周后开盲 ,服用伊贝沙坦患者继续服用原剂量8周 ,8周结束时测量血压。每次随访均记录不良反应 ,包括程度、与试验药物的关系和处理办法及试验开始前、治疗4周、12周进行体格检查 ,心电图 ,血常规 ,尿常规 ,生化等指标检查。结果:伊贝沙坦组与缬沙坦组治疗前与治疗后2周及4周收缩压 (SBP)与舒张压 (DBP)均有下降 ,差异有统计学显著性意义 (P<0.01)。伊贝沙坦组降压总有效率63.6 % ,缬沙坦组降压总有效率57.1% ,两组比较差异无统计学显著性意义 (P>0.05)。伊贝沙坦组有效者服300mg占50 % ,缬沙坦组有效者服160mg占83.3 % ,两组比较差异有统计学显著性意义 (P<0.01)。用药前后血、尿常规 ,生化指标 (肝、肾功能 ,电解质 ,血糖 ,血脂 ,尿酸 ) ,ECG比较 ,两组间差异无统计学显著性意义 (P>
Objective: To evaluate the therapeutic effect and safety of domestic Irbesartan in treating mild and moderate primary hypertension patients.Methods:43 patients with mild or moderate primary hypertension (DBP:95～110 mmHg and SBP<180 mmHg) were divided into two groups using random, double blind, and parallel comparative methods. After taking placebo for two weeks, only the patients with mean DBP 95～110 mmHg and SBP<180 mmHg were selected for the trial. Each patient took 150 mg Irbesartan or 80 mg Valsartan per day for two weeks. If the therapeutic effect was not obvious,300 mg Irbesartan or 160 mg Valsartan was given per day for another two weeks.After 4 weeks, the same treatment for another 8 weeks was continued in Irbesartan group, then blood pressure was measured.Side-effects, including their degree and management were recorded,as well as the relationships between the side-effects and the drugs.Physical examinations,electrocardiogram,blood routine test,urine routine test and biochemistry were performed before and 4 week and 12 week after the treatment.Results: SBP and DBP in Irbesartan and Valsartan groups at 4-weeks and 12-weeks after treatment were statistically lower than that of before treatment (P<0.01).The effective rate was 63.6% in Irbesartan group and 57.1% in Valsartan group, no significant difference was found(P>0.05).To get the satisfied effects, 50% patients needed to take 300 mg in Irbesartan group, and 83.3% patients in Valsartan group had to use 160 mg, significant difference was found between the two groups(P<0.01).No significant difference was found in blood routine, urine routine, biochemistry (liver and renal function, electrolyte, blood sugar, blood lipoid, uric acid) and ECG between pretherapy-and post treatment in these two groups. And the side-effects was no significant difference (P>0.05). Conclusion: Domestic Irbesartan (150～300 mg each day) is safe and effective for treating mild and moderate primary hypertension patients.
出处
《天津医科大学学报》
2002年第4期424-426,共3页
Journal of Tianjin Medical University
基金
国家药品监督管理局临床药物试验(编号:2000XL0174)
