RESUMO
Objective: Pulmonary hypertension (PH) in context with interstitial lung disease (ILD) portends serious clinical consequences and a high rate of mortality. Recently published randomized controlled trials (RCTs) which assessed the pulmonary arterial hypertension (PAH)-specific drugs for pulmonary hypertension and interstitial lung disease (PH-ILD) revealed inconsistent clinical outcomes with previous studies. We conducted a systemic review and meta-analysis to further investigate the effect of PAH-specific therapies for PH-ILD. Methods: Clinical trials were searched from the EMBASE, PUBMED, and CENTRAL databases. The duration from the establishment of the database to June 2022 for RCTs evaluates the effect of PAH-specific therapy in patients with PH-ILD. RevMan 5.4 was used for the meta-analysis. Results: A total of six articles (with a total of 791 patients) were included, including 412 patients in the treated group and 379 patients in the control group. As compared to placebo, the change of 6MWD was a significant improvement with PAH-specific therapy in the six RCTs (23.09; 95% CI, 12.07-34.12 P < 0.0001); but when the study with inhaled treprostinil was excluded, the significant improvement in the change of 6MWD from baseline was not present anymore (MD 11.01, 95%CI-6.43-28.46 P = 0.22). There was no significant improvement in the change in lung function, hemodynamic parameters, clinical worsening, all-cause death, and serious adverse effects in the treated group compared to placebo. Conclusion: PAH-specific therapy significantly improved exercise capacity in the patients with PH-ILD, but this is due to the greater contribution of the study with inhaled treprostinil. Therefore, our findings still did not support the routine use of the whole PAH-specific drugs for PH-ILD.
RESUMO
Introduction: The Shenqisuxin granule (SQSX), a novel Chinese herbal formula, has the effect of preventing in-stent restenosis and improving angiogenesis. We intend to evaluate the efficacy and safety of SQSX to provide a possible therapeutic strategy for complex coronary artery disease (CCAD) after percutaneous coronary intervention (PCI). Methods/design: The study is a multi-center, randomized, double-blinded, parallel, placebo-controlled trial. A total of 120 participants will be randomized 1:1 into the intervention group and the control group. Based on standardized treatment, the intervention group and control group will receive SQSX and placebo for 2 months, respectively. The primary outcomes, metabolic equivalents (METS) and peak oxygen uptake (Peak VO2), and the secondary outcomes, including other indicators of cardiorespiratory fitness (CRF), the European Quality of Life Questionnaire (EQ-5D-5L), the Seattle Angina Scale (SAQ), etc., will be assessed at baseline and 2 months ± 3 days. In addition, the survey scales will also be tested at 1 month ± 3 days. Trimethylamine N-oxide (TMAO), high-sensitivity C-reactive protein (hs-CRP), and gut microbiota features will be assessed at baseline and 2 months ± 3 days to probe possible mechanism. The major adverse cardiac and cerebrovascular events (MACCE) and bleeding events will be monitored until the 12-month follow-up. Discussion: This study is launched to assess the efficacy and safety of SQSX in CCAD after PCI and probe the possible mechanism. Clinical trial registration: China Clinical Trial Registry, ChiCTR2200060979, Registered on June 14, 2022.
RESUMO
Background: Cardiac rehabilitation is an important part of the therapeutic regimen for chronic heart failure. Acute decompensated heart failure (ADHF) in hospitalized patients were usually excluded from cardiac rehabilitation programs. The initiation of cardiac rehabilitation with ADHF usually occurs after hospital discharge. This study included recent clinical trials in patients beginning early exercise-based rehabilitation during their hospitalization and compared the efficacy and safety of early cardiac rehabilitation to ADHF patients who didn't receive cardiac rehabilitation. Methods: Clinical trials were searched from the EMBASE, PubMed, CENTRAL, and WAN FANG. We included randomized controlled trials (RCTs) in which early exercise-based rehabilitation started during the index hospitalization, from the establishment of the database to July 2022. RevMan 5.4 was used for the statistical analysis. Results: Six studies, with a total of 668 patients were included; 336 patients in the early rehabilitation group and 332 patients in the control group. Exercise capacity was significantly improved in the 6-minute walk distance [mean difference (MD): 32.97, 95% CI: 31.03 to 34.90, p < 0.00001], and the Short Physical Performance Battery (MD: 1.40, 95% CI: 1.35 to 1.44, p < 0.00001). The rate of all-cause rehospitalization was significantly decreased in the early rehabilitation group (OR: 0.67, 95% CI: 0.45 to 0.99, p = 0.04). Conclusions: Early exercise-based rehabilitation for eligible ADHF in-patients starting during, or early after, hospitalization could significantly improve exercise capacity. A transitional, individualized, progressive, exercise-based rehabilitation program during hospitalization combined with post-discharge clinic rehabilitation is an integrated rehabilitation strategy for acute decompensated heart failure.