替米沙坦氢氯噻嗪胶囊与替米沙坦片治疗轻中度原发性高血压的临床研究

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。

Clinical Observation on efficacy and safety of Telmisartan hydrochlorothiazide and Telmisartan in patients with Mild to Moderate Essential hypertension

Objective To evaluate the efficacy and safety of telmisartan+hydrochlorothiazide(T-H) and telmisartan monotherapy(T-m) in patients with mild to moderate essential hypertension.Methods This was a multicenter,randomized,double-blind,double-dummy,comparative,controlled trial.After a 2-week,single-blind,placebo run-in period,patients with mild to modertate hypertension were eligible to enter the 4-week,single-blind treatment with telmisartan monotherapy.Next,if DBP < 90mmHg,the patients will be excluded;if 90 ≤ DBP < 110 mmHg,the patients will enter the 8-week,double-blind,double-dummy therapy period and according to the randomized principle,they were divided into two groups.Study comparisons were between once-daily telmisartan+hydrochlorothiazide and telmisartan monotherapy.The primary endpoint was the decline of DBP from week 4 to week 12.Blood biochemical examinations,ECG,ABPM,etc were the observational parameters,too.Results(1) In total,300 patients(eight hospitals) were enrolled in and 213 patients had completed the study.One severe adverse event—myocardial infarction—ccurred in a patient,but it was considerd drug independent.(2) When unblinded,it revealed that there was a significant significance in the decline of DBP(A(12.66±10.76)mmHg,B(7.89±12.15)mmHg,P=0.0203).(3) At week 12,both groups had a sharply drop of BP,but T-H provided significantly greater reductions than T-m(SBP:P=0.0016;DBP:P=0.0186).The total efficacy rate was higher in T-H group(T-H:83.1%;T-m:67.2%,P<0.05),and the BP target achievement rate(T-H:71.8%,T-m:54.9%,P=0.0061),as well.The T/P ratio was>50% in both groups.(4) There was no significant difference between the two groups in the rate of total adverse events(T-H:21.8%,T-m:22.1%,P=0.9461) and drug-dependent adverse events(T-H:8.1;T-m:9.8%.P=0.6264).Conclusions T-H and T-m can both significantly and steadily reduce SBP and DBP and are very safe,well tolerated and accepted by patients with mild to moderate essential hypertension.T-H provides significantly greater BP lowering than T-m.