Department of Pharmacy, Second Hospital of Hebei Medical University, Shijiazhuang, China.
Department of Pharmacology, Hebei Medical University, Shijiazhuang, China.
Chest. 2016 Aug;150(2):353-66. doi: 10.1016/j.chest.2016.03.031. Epub 2016 Apr 2.
Previous meta-analyses of pulmonary arterial hypertension (PAH)-specific therapy for PAH pooled PAH-specific combination therapy and monotherapy. This flaw may threaten the authenticity of their findings.
PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials that evaluated any PAH-specific medications in the treatment of PAH. We calculated ORs with 95% CIs for dichotomous data and standardized mean differences for continuous data.
In total, 35 randomized controlled trials involving 6,702 patients were included. In monotherapy vs placebo/conventional therapy, significance was obtained in mortality reduction (OR, 0.50 [95% CI, 0.33 to 0.76]; P = .001), 6-min walk test (mean difference, 31.10 m [95% CI, 25.40 to 36.80]; P < .00001), New York Heart Association/World Health Organization functional class (OR, 2.48 [95% CI, 1.51 to 4.07]; P = .0003), and hemodynamic status based on mean pulmonary artery pressure, pulmonary vascular resistance, cardiac index, and incidence of withdrawal due to adverse effects. In combination therapy vs monotherapy, significance was reached for the 6-min walk test (mean difference, 19.96 m [95% CI, 15.35 to 24.57]; P < .00001), functional class (OR, 1.65 [95% CI, 1.20 to 2.28]; P = .002), hemodynamic status, and incidence of withdrawal due to adverse effects (OR, 2.01 [95% CI, 1.54 to 2.61]; P < .00001) but not for mortality reduction (OR, 0.98 [95% CI, 0.57 to 1.68]; P = .94).
Our meta-analysis revealed that PAH-specific monotherapy could improve mortality, exercise capacity, functional class, and hemodynamic status compared with placebo or conventional therapy. However, combination therapy could further improve exercise capacity, functional class, and hemodynamic status compared with monotherapy, but it had no proven effect on mortality. Combination therapy had a much higher incidence of withdrawal due to adverse effects than monotherapy.
先前的肺动脉高压（PAH）特异性治疗的荟萃分析汇总了 PAH 特异性联合治疗和单药治疗。这一缺陷可能会威胁到其研究结果的真实性。
检索了 PubMed、Embase 和 Cochrane 图书馆中评估任何 PAH 特异性药物治疗 PAH 的随机对照试验。我们计算了二分类数据的比值比（OR）和连续数据的标准化均数差（SMD）。
共纳入 35 项随机对照试验，涉及 6702 例患者。与安慰剂/常规治疗相比，单药治疗在降低死亡率（OR，0.50 [95%CI，0.33 至 0.76]；P =.001）、6 分钟步行试验（SMD，31.10 m [95%CI，25.40 至 36.80]；P <.00001）、纽约心脏协会/世界卫生组织功能分级（OR，2.48 [95%CI，1.51 至 4.07]；P =.0003）和平均肺动脉压、肺血管阻力、心指数以及因不良反应停药的血流动力学状态方面具有显著意义。与单药治疗相比，联合治疗在 6 分钟步行试验（SMD，19.96 m [95%CI，15.35 至 24.57]；P <.00001）、功能分级（OR，1.65 [95%CI，1.20 至 2.28]；P =.002）、血流动力学状态和因不良反应停药的发生率（OR，2.01 [95%CI，1.54 至 2.61]；P <.00001）方面具有显著意义，但在死亡率降低方面没有显著意义（OR，0.98 [95%CI，0.57 至 1.68]；P =.94）。
本荟萃分析表明，与安慰剂或常规治疗相比，PAH 特异性单药治疗可改善死亡率、运动能力、功能分级和血流动力学状态。然而，与单药治疗相比，联合治疗可进一步改善运动能力、功能分级和血流动力学状态，但对死亡率没有显著影响。联合治疗的不良反应停药发生率明显高于单药治疗。
