Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage.

Whether a single pill that combines three antihypertensive drugs at low doses, in addition to standard antihypertensive treatment, can lower blood pressure more than standard care alone and reduce the risk of recurrent stroke after intracerebral hemorrhage is uncertain.

尚不确定，除了标准降压治疗外，是否有一种单一药物，它结合了三种低剂量的降压药物，能否比单独的标准治疗更能降低血压，并减少脑出血后复发性中风的风险。

Methods

We conducted a multinational, double-blind, randomized, placebo-controlledtrial involving patients with a history of intracerebral hemorrhage.

我们开展了一项多国参与的、双盲的、随机的、安慰剂对照试验，研究对象为有脑内出血病史的患者。

Patients were eligible for the trial if they had a systolic blood pressure of 130 to 160 mm Hg at baseline and were in clinically stable condition.

如果患者基线时的收缩压在130至160毫米汞柱之间，并且临床状况稳定，则有资格参加试验。

After a 2-week active run-in phase during which all the patients received a once-daily pill containing three antihypertensive agents at low doses (telmisartan at 20 mg, amlodipine at 2.5 mg, and indapamide at 1.25 mg; the triple pill), the patients were randomly assigned to continue receiving the triple pill or to receive matching placebo.

在为期2周的积极启动阶段，所有患者每天一次服用含有三种低剂量抗高血压药物的药片（替米沙坦20毫克，氨氯地平2.5毫克，吲达帕胺1.25毫克；三药合剂），之后患者被随机分配继续服用三药合剂或服用匹配的安慰剂。

The primary outcome was the first recurrent stroke.

主要结果是首次复发性中风。

Secondary outcomes included blood-pressure control, major cardiovascular events, death from cardiovascular causes, and safety.

次要结果包括血压控制、主要心血管事件、心血管原因死亡和安全性。

Results

Of 1670 patients who underwent randomization, 833 were assigned to receive the triple pill and 837 to receive placebo.

在进行随机分组的1670名患者中，833名被分配接受三联药物治疗，837名被分配接受安慰剂。

The mean age of the patients was 58 years.

患者的平均年龄为58岁。

At a median follow-up of 2.5 years, recurrent stroke had occurred in 38 patients (4.6%) in the triple-pill group and 62 (7.4%) in the placebo group (hazard ratio, 0.61; 95% confidence interval[CI], 0.41 to 0.92; P = 0.02).

中位随访2.5年时，三联药物组中有38名患者（4.6%）和安慰剂组中有62名患者（7.4%）发生了复发性中风（风险比，0.61；95%置信区间[CI]，0.41至0.92；P = 0.02）。

The mean systolic blood pressure during follow-up was 127 mm Hg and 138 mm Hg, respectively.

随访期间的平均收缩压分别为127毫米汞柱和138毫米汞柱。

The incidenceof major cardiovascular events was lower with the triple pill than with placebo (6.6% vs. 9.8%; P = 0.04).

与安慰剂相比，三联药物治疗的主要心血管事件发生率较低（6.6%对比9.8%；P=0.04）。

Serious adverse events occurred in 23.2% of the patients in the triple-pill group and 26.0% of those in the placebo group.

在三联药物组中，23.2%的患者出现了严重不良事件，在安慰剂组中这一比例为26.0%。

Early discontinuation of the trial regimen due to an adverse eventoccurred in 13.6% and 6.0%, respectively.

由于不良事件导致试验方案早期停药的发生率分别为三联药物组的13.6%和安慰剂组的6.0%。

The most common adverse eventleading to discontinuation was an increase of 20% or more in the serum creatinine level.

导致停药的最常见不良事件是血清肌酐水平增加20%或更多。

Conclusions

Among patients with intracerebral hemorrhage, treatment with a combination of three low-dose antihypertensive agents in a single pill, in addition to standard care, was associated with a lower incidenceof recurrent stroke and major cardiovascular events than placebo.

在脑出血患者中，与标准治疗相结合，使用单片低剂量三种降压药物组合治疗，与安慰剂相比，复发性中风和主要心血管事件的发生率较低。

(Funded by the National Health and Medical Research Council of Australia and the Brazilian Ministry of Health; TRIDENT ClinicalTrials.gov number, NCT02699645; Australian New Zealand Clinical Trials Registry number, ACTRN12616000327482.).

(由澳大利亚国家卫生与医学研究委员会和巴西卫生部资助；TRIDENT ClinicalTrials.gov编号，NCT02699645；澳大利亚新西兰临床试验注册号，ACTRN12616000327482。)