Fixed-dose combination therapy-based protocol compared with free pill combination protocol: Results of a cluster randomized trial.
Fixed-dose combination therapy-based protocol compared with free pill combination protocol: Results of a cluster randomized trial.
复制标题
DOI：
10.1111/jch.14632
复制
发表时间：
2023-02
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
在尼日利亚，基于个体水平的随机试验，推荐将固定剂量联合(FDC)疗法用于高血压治疗。这项整群随机试验评估了使用两种药物的FDC疗法作为高血压控制的第二步和第三步的治疗方案的有效性和安全性，并与使用免费药物组合的方案进行了比较。从2021年1月到2021年6月，尼日利亚联邦首都地区的60家初级医疗保健中心被随机分为两组，一组使用FDC治疗作为第二步和第三步，另一组使用相同的药物进行免费药物联合治疗。符合条件的患者为患有高血压的成年人(≥为18岁)。主要结果是与免费避孕药组相比，FDC组患者在基线至6个月随访期间的最后一次就诊时得到控制的几率。4427例患者(平均年龄49.0[12.4]岁，女性70.5%)平均(SD)基线收缩/舒张压155(20.6)/96(13.1)mm Hg。两组的基线特征相似。6个月后，两种治疗方案的高血压控制率均有改善，但调整后两组间差异无统计学意义(FDC=0.53.9%，与免费联合用药比较=0.47.9%，整群调整后P=0.29)。两组的不良反应发生率相似(1%)。与基线相比，两种方案都提高了6个月的高血压控制率，尽管两组之间没有观察到差异。需要进一步的工作来确定前期FDC治疗是否更有效和有效地提高高血压控制率。
Fixed‐dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster‐randomized trial evaluates effectiveness and safety of a treatment protocol that used two‐drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6‐month follow‐up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6‐months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster‐adjusted p = .29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6‐months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates.
登录
查看更多内容
影响因子：
39.3
作者：
Iung, B;Baron, G;Vahanian, A
通讯作者：
Vahanian, A
影响因子：
3.7
作者：
Odili, Augustine N.;Chori, Babangida S.;Isiguzo, Godsent C.
通讯作者：
Isiguzo, Godsent C.
影响因子：
2.5
作者：
Cheong, Ai Theng;Said, Salmiah Mohd;Muksan, Norliza
通讯作者：
Muksan, Norliza
高血压患者的血压控制实施策略的比较有效性：系统的综述和荟萃分析。
影响因子：
39.2
作者：
Mills KT;Obst KM;Shen W;Molina S;Zhang HJ;He H;Cooper LA;He J
通讯作者：
He J
影响因子：
5.4
作者：
Mu L;Mukamal KJ
通讯作者：
Mukamal KJ