Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing, People's Republic of China.
Int J Chron Obstruct Pulmon Dis. 2022 May 5;17:1051-1067. doi: 10.2147/COPD.S347588. eCollection 2022.
Several large randomized clinical trials (RCTs) have assessed the efficacy and safety of inhaled corticosteroid (ICS) combination regimens versus non-ICS therapy in patients with chronic obstructive pulmonary disease (COPD) at increased risk of exacerbation risk with mixed results.
We performed a systematic literature review and meta-analysis of RCTs comparing the effect of ICS-containing combination therapy and non-ICS regimen in patients with COPD.
A total of 54 RCTs (N = 57,333) reported treatment effects on various outcomes and were eligible for inclusion. Overall, the number of patients experiencing moderate/severe exacerbations was significantly lower for ICS-containing combination therapy versus non-ICS therapy (RR: 0.86 [95% CI: 0.80-0.93]). The annual rate of exacerbations was also significantly reduced by 22% (0.78 [0.72-0.86]) with ICS-containing versus non-ICS therapy. The annual rate of exacerbations requiring hospitalisation was reduced by 31% versus non-ICS therapy (0.69 [0.54-0.88]); similar reduction was observed for exacerbations requiring oral steroids (0.69 [0.66-0.73]). Overall, the effect on trough FEV1 was comparable between ICS-containing and non-ICS therapies (follow-up: 6-52 weeks); however, a significant improvement in lung function (trough FEV1) was observed for ICS/LABA versus LABA (MD: +0.04 L [0.03-0.05]) and ICS/LABA/LAMA versus LAMA (MD: +0.09 L [0.05-0.13]) regimens. In addition, a significant improvement in QoL was observed with ICS-containing versus non-ICS therapy (MD in SGRQ score: -0.90 [-1.50, -0.31]).
This meta-analysis demonstrated that a wide range of patients with COPD could benefit from dual and triple ICS-containing therapy.
几项大型随机临床试验（RCT）评估了在有加重风险的慢性阻塞性肺疾病（COPD）患者中，吸入皮质类固醇（ICS）联合治疗与非 ICS 治疗的疗效和安全性，结果喜忧参半。
我们对比较 COPD 患者中 ICS 联合治疗与非 ICS 方案的 RCT 进行了系统文献回顾和荟萃分析。
共有 54 项 RCT（N=57333）报告了各种结局的治疗效果，符合纳入标准。总的来说，ICS 联合治疗组患者中发生中重度加重的人数明显少于非 ICS 治疗组（RR：0.86[95%CI：0.80-0.93]）。ICS 联合治疗组的年加重率也显著降低了 22%（0.78[0.72-0.86]）。与非 ICS 治疗相比，需要住院治疗的年加重率降低了 31%（0.69[0.54-0.88]）；需要口服类固醇治疗的加重率也观察到类似的降低（0.69[0.66-0.73]）。总的来说，ICS 联合治疗和非 ICS 治疗对谷值 FEV1 的影响相当（随访时间：6-52 周）；然而，与 LABA 相比，ICS/LABA （MD：+0.04 L [0.03-0.05]）和 ICS/LABA/LAMA （MD：+0.09 L [0.05-0.13]）方案对肺功能（谷值 FEV1）有显著改善。此外，与非 ICS 治疗相比，ICS 联合治疗可显著改善 QoL（SGRQ 评分 MD：-0.90[-1.50，-0.31]）。
这项荟萃分析表明，广泛的 COPD 患者可能受益于双和三联 ICS 联合治疗。
