Abstract：
This study aimed to compare the efficacy and safety of single inhaler triple therapy and separate triple therapy in the treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD).
PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov databases were searched, and the search date was set from database inception until February 15, 2022. Randomized controlled trials of single inhaler triple therapy versus separate triple therapy, from which the results related to efficacy and safety profiles were extracted, and the methodologic quality and risk of bias were evaluated.
Five published articles (6 clinical trials) were screened from 3437 articles with a total of 4075 patients receiving single inhaler triple therapy and 3533 patients receiving separate triple therapy. Compared with separate triple therapy, single inhaler triple therapy significantly increased the change in forced expiratory volume in 1 second from baseline (mean difference = 0.02 L; 95% CI, 0.00-0.05L; P < 0.01), and there was a statistical difference between the 2 groups. No significant difference was found between the single inhaler triple therapy and separate triple therapy groups in terms of moderate to severe exacerbation rate (relative risk [RR] = 0.97; 95% CI, 0.85-1.10; P = 0.63), the change in St. George\'s Respiratory Questionnaire from baseline (mean difference = 0.34; 95% CI, -0.88 to 1.57; P = 0.58), proportion of St. George\'s Respiratory Questionnaire responders (RR = 0.99; 95% CI, 0.92-1.06; P = 0.77), adverse events (RR= 1.07; 95% CI, 0.90-1.27; P = 0.42), serious adverse events (RR = 1.02; 95% CI, 0.88-1.18; P = 0.81), mortality (RR = 1.10; 95% CI, 0.65-1.86; P = 0.72), risk of pneumonia (RR = 0.86; 95% CI, 0.62-1.18; P = 0.34), and risk of cardiovascular events (RR = 1.22; 95% CI, 0.91-1.65; P = 0.18).
Compared with separate triple therapy, single inhaler triple therapy appears to improve lung function in patients with moderate to severe COPD, especially in terms of forced expiratory volume in 1 second advantages. Single inhaler triple therapy may be a feasible and simplified option for patients with moderate to severe COPD; however, this conclusion needs to be further confirmed by future randomized controlled trials. (Clin Ther. 2022;XX:XXX-XXX) © 2022 Elsevier HS Journals, Inc.
PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov databases were searched, and the search date was set from database inception until February 15, 2022. Randomized controlled trials of single inhaler triple therapy versus separate triple therapy, from which the results related to efficacy and safety profiles were extracted, and the methodologic quality and risk of bias were evaluated.
Five published articles (6 clinical trials) were screened from 3437 articles with a total of 4075 patients receiving single inhaler triple therapy and 3533 patients receiving separate triple therapy. Compared with separate triple therapy, single inhaler triple therapy significantly increased the change in forced expiratory volume in 1 second from baseline (mean difference = 0.02 L; 95% CI, 0.00-0.05L; P < 0.01), and there was a statistical difference between the 2 groups. No significant difference was found between the single inhaler triple therapy and separate triple therapy groups in terms of moderate to severe exacerbation rate (relative risk [RR] = 0.97; 95% CI, 0.85-1.10; P = 0.63), the change in St. George\'s Respiratory Questionnaire from baseline (mean difference = 0.34; 95% CI, -0.88 to 1.57; P = 0.58), proportion of St. George\'s Respiratory Questionnaire responders (RR = 0.99; 95% CI, 0.92-1.06; P = 0.77), adverse events (RR= 1.07; 95% CI, 0.90-1.27; P = 0.42), serious adverse events (RR = 1.02; 95% CI, 0.88-1.18; P = 0.81), mortality (RR = 1.10; 95% CI, 0.65-1.86; P = 0.72), risk of pneumonia (RR = 0.86; 95% CI, 0.62-1.18; P = 0.34), and risk of cardiovascular events (RR = 1.22; 95% CI, 0.91-1.65; P = 0.18).
Compared with separate triple therapy, single inhaler triple therapy appears to improve lung function in patients with moderate to severe COPD, especially in terms of forced expiratory volume in 1 second advantages. Single inhaler triple therapy may be a feasible and simplified option for patients with moderate to severe COPD; however, this conclusion needs to be further confirmed by future randomized controlled trials. (Clin Ther. 2022;XX:XXX-XXX) © 2022 Elsevier HS Journals, Inc.
摘要：
本研究旨在比较单一吸入器三联疗法和单独三联疗法治疗中重度慢性阻塞性肺疾病（COPD）的疗效和安全性。
PubMed,Embase,WebofScience,科克伦图书馆,搜索了ClinicalTrials.gov数据库，搜索日期从数据库开始到2022年2月15日。单吸入器三联疗法与单独三联疗法的随机对照试验，从中提取与疗效和安全性相关的结果，并评估了方法学质量和偏倚风险。
从3437篇文章中筛选了5篇已发表的文章（6项临床试验），共有4075名患者接受单吸入器三联疗法，3533名患者接受单独三联疗法。与单独三联疗法相比，单一吸入器三联疗法显著增加了1秒内从基线开始的用力呼气量的变化(平均差异=0.02L;95%CI,0.00-0.05L;P<0.01),两组间差异有统计学意义。在中重度加重率方面，单一吸入器三联疗法组和单独三联疗法组之间没有发现显着差异（相对风险[RR]=0.97;95％CI，0.85-1.10;P=0.63），圣乔治呼吸问卷相对于基线的变化（平均差异=0.34;95％CI，-0.88至1.57;P=0.58），圣乔治呼吸问卷应答者的比例(RR=0.99；95%CI，0.92-1.06；P=0.77)，不良事件（RR=1.07；95%CI，0.90-1.27；P=0.42），严重不良事件（RR=1.02；95%CI，0.88-1.18；P=0.81），死亡率（RR=1.10；95%CI，0.65-1.86；P=0.72），肺炎风险（RR=0.86；95%CI，0.62-1.18；P=0.34），和心血管事件的风险（RR=1.22;95％CI，0.91-1.65;P=0.18）。
与单独三联疗法相比，单一吸入器三联疗法似乎可以改善中度至重度COPD患者的肺功能，特别是在1秒用力呼气量方面有优势。对于中度至重度COPD患者，单一吸入器三联疗法可能是一种可行且简化的选择；然而，这一结论需要未来的随机对照试验进一步证实.（ClinTher。2022；XX：XXX-XXX）©2022ElsevierHS期刊，Inc.
PubMed,Embase,WebofScience,科克伦图书馆,搜索了ClinicalTrials.gov数据库，搜索日期从数据库开始到2022年2月15日。单吸入器三联疗法与单独三联疗法的随机对照试验，从中提取与疗效和安全性相关的结果，并评估了方法学质量和偏倚风险。
从3437篇文章中筛选了5篇已发表的文章（6项临床试验），共有4075名患者接受单吸入器三联疗法，3533名患者接受单独三联疗法。与单独三联疗法相比，单一吸入器三联疗法显著增加了1秒内从基线开始的用力呼气量的变化(平均差异=0.02L;95%CI,0.00-0.05L;P<0.01),两组间差异有统计学意义。在中重度加重率方面，单一吸入器三联疗法组和单独三联疗法组之间没有发现显着差异（相对风险[RR]=0.97;95％CI，0.85-1.10;P=0.63），圣乔治呼吸问卷相对于基线的变化（平均差异=0.34;95％CI，-0.88至1.57;P=0.58），圣乔治呼吸问卷应答者的比例(RR=0.99；95%CI，0.92-1.06；P=0.77)，不良事件（RR=1.07；95%CI，0.90-1.27；P=0.42），严重不良事件（RR=1.02；95%CI，0.88-1.18；P=0.81），死亡率（RR=1.10；95%CI，0.65-1.86；P=0.72），肺炎风险（RR=0.86；95%CI，0.62-1.18；P=0.34），和心血管事件的风险（RR=1.22;95％CI，0.91-1.65;P=0.18）。
与单独三联疗法相比，单一吸入器三联疗法似乎可以改善中度至重度COPD患者的肺功能，特别是在1秒用力呼气量方面有优势。对于中度至重度COPD患者，单一吸入器三联疗法可能是一种可行且简化的选择；然而，这一结论需要未来的随机对照试验进一步证实.（ClinTher。2022；XX：XXX-XXX）©2022ElsevierHS期刊，Inc.
