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目的评价替米沙坦氢氯噻嗪胶囊治疗轻中度原发性高血压的有效性和安全性。方法符合入排标准的轻中度原发性高血压患者300例(8家医院),先后经2周清洗期和4周替米沙坦片单药治疗期后,血压未达标者(90mmHg≤舒张压(diastolic blood pressure,DBP)<110mmHg并且收缩压(systolic blood pressure,SBP<180mmHg)按随机双盲对照原则分为两组,分别给予替米沙坦氢氯噻嗪胶囊(A组)与替米沙坦片(B组)。主要观察指标是双盲治疗8周后较开始双盲治疗时DBP绝对值的变化。其他观察指标还包括血生化指标、心电图、24小时动态血压(ABPM)参数等。结果 (1)共213例(A组即替米沙坦氢氯噻嗪胶囊组108例,B组即替米沙坦片组105例)完成该研究,33例失访,1例发生严重不良事件——心肌梗塞(研究者判断与本研究药物无关)。(2)双盲治疗8周后DBP绝对值的变化两组间有显著性差异(A组(12.66±10.76)mmHg,B组(7.89±12.15)mmHg,P=0.0203)。(3)A组总有效率、平均血压下降值、达目的的血压率均显著高于B组(P均<0.05)。两组谷峰比值均>50%。(4)两组不良事件发生率(A组21.8%;B组22.1%,P=0.9461)及与研究药物有关不良事件发生率(A组8.1%;B组9.8%,P=0.6264)均无显著性差异。结论替米沙坦氢氯噻嗪胶囊与替米沙坦片(80mg)对轻、中度原发性高血压患者有平稳长效的降压疗效和相同的安全性,且替米沙坦氢氯噻嗪胶囊的疗效优于单方的替米沙坦片。
Objective To evaluate the efficacy and safety of telmisartan hydrochlorothiazide capsule in the treatment of mild to moderate essential hypertension. Methods 300 patients (8 hospitals) with mild-to-moderate primary hypertension who met the entry criteria were treated with telmisartan monotherapy for 2 weeks and 4 weeks, and those who did not meet the standard of 90 mmHg≤ Diastolic blood pressure (DBP) <110 mmHg and systolic blood pressure (SBP <180 mmHg) were divided into two groups according to a randomized, double-blind control principle: telmisartan hydrochlorothiazide capsules (group A) (B group), the main observation index was the change of DBP absolute value when double-blind treatment was started after double-blind treatment for 8 weeks.Other observation indexes included blood biochemistry index, electrocardiogram, ABPM parameters and so on. Results (1) A total of 213 patients (group A, 108 telmisartan hydrochlorothiazide capsules and group B 105 telmisartan tablets) completed the study, 33 were lost to follow-up, and 1 had serious adverse events- Myocardial infarction (the researcher judged that the study drug has nothing to do). (2) After 8 weeks of double-blind treatment, the change of DBP absolute value was significantly different between the two groups (12.66 ± 10.76 mmHg in group A, 7.89 ± 12.15 in group B ) mmHg, P = 0.0203). (3) The total effective rate, the mean blood pressure drop, the blood pressure reaching the goal in group A were significantly higher than those in group B (P (P <0.05) .The incidence of adverse events in two groups were all higher than 50%. (4) The incidence of adverse events in both groups (21.8% in group A, 22.1% in group B, and 0.9461 in group B) , 8.1% in group B, 9.8% in group B, P = 0.6264) .Conclusion Telmisartan hydrochlorothiazide capsules and telmisartan tablets (80mg) have stable and long-term effects on patients with mild to moderate essential hypertension Of antihypertensive efficacy and the same safety, and telmisartan hydrochlorothiazide capsules better than unilateral telmisartan tablets.