评估细菌裂解物在慢性阻塞性肺疾病中的治疗获益：一项系统评价与荟萃分析。
完整摘要 · 中文译文
背景：慢性阻塞性肺疾病（COPD）的急性加重常由感染诱发。细菌溶解产物已被研究作为减少COPD急性加重的干预措施。 方法：我们开展了一项系统评价和荟萃分析，纳入评估细菌溶解产物（BLs）用于成人慢性阻塞性肺疾病（COPD）的随机对照试验（RCTs）。检索了PubMed、EMBASE、CENTRAL、Web of Science、Google Scholar、ICTRP和ClinicalTrials.gov。纳入对象为比较细菌溶解产物与安慰剂或常规COPD治疗的成人COPD患者。主要结局为BLs对急性加重及其持续时间的影响。次要结局为住院风险、试验随访期间每名受试者急性加重的平均次数、呼吸困难、痰、咳嗽的症状评分以及不良事件。我们采用随机效应荟萃分析，使用Cochrane RoB 2评估偏倚风险，并使用GRADE对证据确定性进行分级。 结果：共纳入15项RCTs。接受BLs治疗的COPD患者与对照组相比，急性加重的合并风险比（RR）为0.83（95% CI 0.74-0.93；P = 0.0009）。急性加重持续时间的平均差（MD）未显示具有统计学意义的缩短，为-9.26天（95% CI -19.56至1.03；P = 0.08）。急性加重平均次数（MD）为-0.19（95% CI -0.30至-0.08；P = 0.0009）。住院RR为0.52（95% CI 0.35-0.78；P = 0.001）。症状结局为呼吸困难标准化均数差（SMD）-0.42（95% CI -0.75至-0.10；P = 0.01）、咳嗽（SMD）-0.37（95% CI -0.63至-0.11；P = 0.006），而咳痰显示n 无显著变化（SMD）-0.20（95% CI -0.65至0.25；P = 0.39），不良事件的RR为0.95（95% CI 0.86-1.04；P = 0.27）。 结论：细菌裂解物可能与较低的COPD急性加重和住院风险相关，在呼吸困难、咳嗽方面有小的数值改善，咳痰显示无显著改善；效应因制剂而异，这些发现需要在针对特定制剂的试验中加以证实。 系统评价注册：https://www.crd.york.ac.uk/PROSPERO/view/CRD42024570783，PROSPERO CRD42024570783。
完整摘要 · 英文原文
BACKGROUND: Chronic obstructive pulmonary disease (COPD) with exacerbations often triggered by infections. Bacterial lysates have been investigated as interventions to reduce the exacerbations of COPD. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating bacterial lysates (BLs) in adults with chronic obstructive pulmonary disease (COPD). PubMed, EMBASE, CENTRAL, Web of Science, Google Scholar, ICTRP, and ClinicalTrials.gov were searched. In adults with COPD that compared bacterial lysates with placebo or conventional COPD therapy. Primary outcomes were the effect of BLs on exacerbations and duration. Secondary outcomes were hospitalisation risk, the mean number of exacerbations per participant during trial follow up, symptom scores for dyspnoea, sputum, cough, and adverse events. We used random-effects meta-analysis, assessed risk of bias with Cochrane RoB 2, graded certainty with GRADE. RESULTS: Fifteen RCTs were included. The pooled risk ratio (RR) for exacerbation in patients with COPD treated with BLs vs. control was 0.83 (95% CI 0.74-0.93; P = 0.0009). The mean difference (MD) for exacerbation duration showed no statistical significant reduction -9.26 Days (95% CI -19.56 to 1.03; P = 0.08). Mean number of exacerbations (MD) -0.19 (95% CI -0.30 to -0.08; P = 0.0009). Hospitalisation RR was 0.52 (95% CI 0.35-0.78; P = 0.001).Symptom outcomes were dyspnoea standardised mean difference (SMD) -0.42 (95% CI -0.75 to -0.10; P = 0.01), cough (SMD) -0.37 (95% CI -0.63 to -0.11; P = 0.006), while sputum production showed no significant change (SMD) -0.20 (95% CI -0.65 to 0.25; P = 0.39), The RR for adverse events was 0.95 (95% CI 0.86-1.04; P = 0.27). CONCLUSION: Bacterial lysates may be associated with lower COPD exacerbation and hospitalisation risk, with small numerical improvements in dyspnoea, cough, sputum production showed no significant improvement; effects varied by formulation, these findings require confirmation in formulation specific trials. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024570783, PROSPERO CRD42024570783.