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评估氯沙坦 50 毫克对透析后血容量正常的高血压患者生存的影响:HELD 试验的结果。

Assessment of Losartan 50 mg on Survival of Post-Dialysis Euvolemic Hypertensive Patients: Findings from HELD Trial.

机构信息

School of Pharmacy, Taylor's University, Subang Jaya, Malaysia.

Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences Universiti Sains Malaysia, Gelugor, Malaysia.

出版信息

Blood Purif. 2019;48(3):233-242. doi: 10.1159/000500997. Epub 2019 Aug 6.

Abstract

AIMS AND OBJECTIVE

To estimate the effect of losartan 50 mg on survival of post-dialysis euvolemic hypertensive patients.

METHODOLOGY

A single center, prospective, single-blind randomized trial was conducted to estimate the survival of post-dialysis euvolemic hypertensive patients when treated with lorsartan 50 mg every other day. Post-dialysis euvolemic assessment was done by a body composition monitor. Covariate Adaptive Randomization was used for allocation of participants to the standard or intervention arm, and the follow-up duration was twelve months. The primary end point was achieving targeted blood pressure (BP) of <140/90 mm Hg and maintaining for 4 weeks, whereas secondary end point was all cause of mortality. Pre-, intra-, and post-dialysis session BP measurements were recorded, and survival trends were analyzed using Kaplan-Meier analysis.

RESULTS

Of the total 229 patients, 96 (41.9%) were identified as post-dialysis euvolemic hypertensive. Final samples of 88 (40.1%) patients were randomized into standard (n = 44) and intervention arms (n = 44), and 36 (81.8%) patients in each arm completed a follow-up of 12 months. A total of eight patients passed away during the 12-month follow-up period (6 deaths among standard arm and 2 in intervention arm). However, the probability of survival between both arms was not significant (p = 0.13). Cox regression analysis revealed that chances of survival were higher among the patients in the intervention (OR 3.17) arm than the standard arm (OR 0.31); however, the survival was found not statistically significant.

CONCLUSION

There was no statistical significant difference in 1 year survival of post-dialysis euvolemic hypertensive patients when treated with losartan 50 mg.

摘要

目的和目标

评估氯沙坦 50mg 对透析后血容量正常高血压患者生存的影响。

方法

进行了一项单中心、前瞻性、单盲随机试验,以评估在透析后血容量正常的高血压患者中,氯沙坦 50mg 隔日治疗的生存情况。通过身体成分监测器评估透析后血容量正常。协变量适应性随机化用于将参与者分配到标准或干预组,随访时间为 12 个月。主要终点是达到<140/90mmHg 的目标血压并维持 4 周,次要终点是全因死亡率。记录了透析前、透析中和透析后 session 的血压测量值,并使用 Kaplan-Meier 分析来分析生存趋势。

结果

在总共 229 名患者中,有 96 名(41.9%)被确定为透析后血容量正常的高血压患者。最终有 88 名(40.1%)患者被随机分配到标准(n=44)和干预组(n=44),其中 36 名(81.8%)患者完成了 12 个月的随访。在 12 个月的随访期间,共有 8 名患者死亡(标准组 6 例,干预组 2 例)。然而,两组之间的生存概率没有显著差异(p=0.13)。Cox 回归分析显示,干预组(OR 3.17)患者的生存机会高于标准组(OR 0.31);然而,生存没有统计学意义。

结论

在透析后血容量正常的高血压患者中,用氯沙坦 50mg 治疗 1 年后的生存率没有统计学上的显著差异。

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