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目的:比较低剂量培哚普利／吲哒帕胺复合制剂与吲哒帕胺缓释剂治疗高血压患者血压的变化和治疗反应率及其安全性。方法:共入选原发性高血压病患者231例。经2周安慰剂洗脱期后,分为试验组(n=116)和对照组(n=115)。完成试验患者210例,符合方案分析集(PPS)203例,其中试验组107例,对照组96例。2组随机双盲接受培哚普利2 mg／吲哒帕胺0．625 mg或吲哒帕胺缓释剂(纳催离SR)1．5 mg,qd;治疗6周后,如果舒张压(DBP)<90 mmHg。继续上述治疗;如果DBP≥90 mmHg,试验组改为qid口服培哚普利4 mg／吲哒帕胺1．25 mg;对照组在纳催离SR的基础上加用美托洛尔50 mg,qd,继续治疗6周。部分患者在治疗前及治疗12周时行动态血压检测(ABPM)。结果:用药后第6周时,试验组药物剂量加倍比率为48．6％(52／107),对照组有54．2％(52／96)的病例需加用美托洛尔,两组加药率比较无差异(P=0．43)。与给药前比较,治疗12周后两组DBP均明显下降(P<0．01),下降幅度试验组和对照组平均为12．4和13．6 mmHg(P=0．191),两组收缩压(SBP)在用药后备时点亦均明显下降(P<0．01),下降幅度为15．4和15．7 mmHg。两组ABPM各指标均明显下降,试验组和对照组的DBP谷峰比(T／P)为80％和47％。两组不良事件发生率无差异,主要的不良事件为咳嗽、鼻炎、低钾血症。结论:2种治疗方法12周后均可显著降低DBP和SBP。试验组可以维持24 h平稳降压。两组不良反应发生率相似。
OBJECTIVE: To compare the changes of blood pressure, response rate and safety of low-dose perindopril / indapamide and indapamide in the treatment of patients with hypertension. Methods: A total of 231 patients with essential hypertension were enrolled. After 2 weeks of placebo elution, they were divided into experimental group (n = 116) and control group (n = 115). 210 patients completed the trial, in line with 203 cases of program analysis set (PPS), of which 107 cases in the test group, 96 cases in the control group. Two groups were randomized and double-blind received perindopril 2 mg / indapamide 0.625 mg or indapamide sustained-release agent (natrium SR) 1.5 mg, qd; after 6 weeks of treatment, if diastolic blood pressure (DBP) <90 mmHg. Continue the above treatment; if DBP ≥ 90 mmHg, the experimental group was changed to oral qd oral perindopril 4 mg / indapamide 1.25 mg; control group on the basis of natrium SR plus metoprolol 50 mg , qd, continue treatment for 6 weeks. Some patients underwent ambulatory blood pressure testing (ABPM) before treatment and at 12 weeks of treatment. Results: At the 6th week after treatment, the dose doubling ratio of the experimental group was 48.6% (52/107), while that of the control group was Metoprolol 54.2% (52/96) Dosing rate was no difference (P = 0.43). Compared with those before treatment, the DBP in both groups decreased significantly after 12 weeks of treatment (P <0.01), and the decreasing range was 12.4 and 13.6 mmHg in the experimental and control groups (P = 0.191) Systolic blood pressure (SBP) also decreased significantly (P <0.01) at 15 and 15.7 mmHg. The indexes of ABPM in both groups were obviously decreased, and the DBP peak-to-peak ratio (T / P) of test group and control group was 80% and 47% respectively. There was no difference in the incidence of adverse events between the two groups. The main adverse events were cough, rhinitis and hypokalemia. Conclusion: DBP and SBP can be significantly reduced by both treatments after 12 weeks. Test group can maintain stable blood pressure 24 h. The incidence of adverse reactions in both groups was similar.