Department of Epidemiology and Biostatistics, Peking University Health Science Center, Beijing, China.
Clin Drug Investig. 2011 Nov 1;31(11):769-77. doi: 10.1007/BF03256917.
A fixed-dose combination (FDC) of four compounds, hydrochlorothiazide 12.5 mg, triamterene 12.5 mg, dihydralazine 12.5 mg and reserpine 0.1 mg (HTDR), is widely used as an antihypertensive treatment in China. Although HTDR has been used in China for more than 30 years, there have been few comprehensive evaluations of this treatment.
The aim of this study was to investigate the long-term efficacy and tolerability of HTDR in Chinese patients with essential hypertension.
This was a 36-month, community-based, open-label surveillance study, conducted in the Huangpu District (Shanghai, China). The study was based in local primary healthcare settings. Subjects were recruited if they had essential hypertension, were aged ≥35 years at the time of enrolment, were expected to remain in the area for 3 years, and were able to provide informed consent. Patients who had secondary hypertension, myocardial infarction or stroke within 6 months of screening, impaired renal or hepatic function, history of cardiomyopathy or chronic heart failure, or were pregnant or lactating were excluded. HTDR was administered as one or two tablets per day in the morning. If necessary, additional hydrochlorothiazide was added. Blood pressure (BP) was measured at baseline and throughout the 36-month surveillance period every 3 months. Biochemical indicators (e.g. fasting blood glucose, plasma lipid parameters, plasma sodium and potassium, plasma uric acid and serum creatinine) were also measured, and adverse events were noted. BP reductions and the rate at which patients achieved BP targets (systolic BP [SBP] <140 mmHg and diastolic BP [DBP] <90 mmHg) throughout the period were determined. Subgroup analyses by sex and age were also conducted.
A total of 1529 patients (550 male, 979 female; mean age 65.7 years) entered the study. After the 36-month treatment period, 93.1% of patients had achieved the SBP target, 97.9% had achieved the DBP target, and 92.1% had achieved both. The mean decreases in SBP and DBP were 15.3 mmHg and 9.9 mmHg, respectively. Overall, 127 adverse events in 119 patients (7.8%) occurred during the follow-up period, most of which were mild to moderate. Plasma lipid profiles were improved after 24 months of treatment. In addition, a significant increase in plasma potassium and a significant reduction in plasma uric acid were seen.
HTDR was found to have good long-term efficacy and tolerability in Chinese patients with essential hypertension.
四种化合物的固定剂量组合（FDC），氢氯噻嗪 12.5 毫克，阿米洛利 12.5 毫克，二氢氯噻嗪 12.5 毫克和利血平 0.1 毫克（HTDR），在中国被广泛用作抗高血压治疗药物。尽管 HTDR 在中国已经使用了 30 多年，但对这种治疗方法的综合评估很少。
本研究旨在探讨 HTDR 对中国原发性高血压患者的长期疗效和耐受性。
这是一项为期 36 个月的、基于社区的、开放性监测研究，在上海市黄浦区进行。研究基于当地的初级医疗保健环境。如果患者患有原发性高血压，在登记时年龄≥35 岁，预计在该地区停留 3 年，并且能够提供知情同意，则可以参加研究。患有继发性高血压、筛选后 6 个月内发生心肌梗死或中风、肾功能或肝功能受损、心肌病或慢性心力衰竭病史、怀孕或哺乳期的患者被排除在外。HTDR 每天早上服用一片或两片。如果需要，可额外添加氢氯噻嗪。在 36 个月的监测期间，每 3 个月测量一次血压（BP），并在基线时进行测量。还测量了生化指标（如空腹血糖、血浆脂质参数、血浆钠和钾、血浆尿酸和血清肌酐），并记录了不良事件。确定了整个期间的血压降低情况以及达到血压目标的患者比例（收缩压[SBP]＜140mmHg 和舒张压[DBP]＜90mmHg）。还进行了按性别和年龄划分的亚组分析。
共有 1529 名患者（550 名男性，979 名女性；平均年龄 65.7 岁）进入研究。经过 36 个月的治疗后，93.1%的患者达到了 SBP 目标，97.9%的患者达到了 DBP 目标，92.1%的患者同时达到了两个目标。SBP 和 DBP 的平均降幅分别为 15.3mmHg 和 9.9mmHg。总体而言，在随访期间，119 名患者（7.8%）共发生了 127 起不良事件，大多数为轻至中度。治疗 24 个月后，血浆脂质谱得到改善。此外，还观察到血钾显著升高和血尿酸显著降低。
HTDR 对中国原发性高血压患者具有良好的长期疗效和耐受性。
