Liu Hua, Xu Meng, Xie Yiqun, Gao Jie, Ni Songshi
1 Department of Respiratory Medicine, Affiliated Hospital of Nantong University, Nantong 226001, China ; 2 Department of Pulmonary Disease, Rugao Traditional Chinese Medicine Hospital, Rugao 226500, China.
J Thorac Dis. 2015 Mar;7(3):320-8. doi: 10.3978/j.issn.2072-1439.2014.11.04.
A meta-analysis was undertaken to evaluate the efficacy and safety of bronchoscopic lung volume reduction with endobronchial valves (EBV) for advanced emphysema.
A systematic search was performed from PubMed, EMBASE, CNKI, Cochrane Library database. Randomized control clinical trials on treatment of emphysema for 3-12 months with the EBV compared with standard medications and sham EBV were reviewed. Inclusion criteria were applied to select patients with advanced emphysema treated with EBV. The primary outcome was the percentage of the forced expiratory volume in the first second (FEV1%). Secondary outcomes included St George's Respiratory Questionnaire (SGRQ) score, the distance of the 6-minute walk (6MWD) test, the Modified Medical Research Council (MMRC) dyspnoea score, cycle ergometry workload, and the rate of the six major complications at 3 or 12 months. Fixed- or random-effects models were used and weighted mean differences (WMD), relative risks (RR) and 95% confidence intervals (CI) were calculated.
Three trials (565 patients) were considered in the meta-analysis. EBV patients yielded greater increases in FEV1% than standard medications (WMD =6.71; 95% CI, 3.31 to 10.10; P=0.0001), EBV patients also demonstrated a significant change for SGRQ score (WMD =-3.64; 95% CI, -5.93 to -1.34; P=0.002), MMRC dyspnoea score (WMD =-0.26; 95% CI, -0.44 to -0.08; P=0.004), and cycle ergometry workload (WMD =4.18; 95% CI, 2.14 to 6.22; P<0.0001). A similar level was evident for 6MWD (WMD =11.66; 95% CI, -3.31 to 26.64; P=0.13). EBV may increase the rate of hemoptysis (RR =5.15; 95% CI, 1.16 to 22.86; P=0.03), but didn't increase the adverse events including mortality, respiratory failure, empyema, pneumonia, pneumothrax. The overall rates for complications compared EBV with standard medications and sham EBV was not significant (RR =2.03; 95% CI, 0.98 to 4.21; P=0.06).
EBV lung volume reduction for advanced emphysema showed superior efficacy and a good safety and tolerability compared with standard medications and sham EBV, further more randomized controlled trial (RCT) studies are needed to pay more attention to the long-term efficacy and safety of bronchoscopic lung volume reduction with EBV in advanced emphysema.
进行一项荟萃分析，以评估支气管镜下使用支气管内瓣膜（EBV）进行肺减容术治疗晚期肺气肿的疗效和安全性。
从PubMed、EMBASE、中国知网、考克兰图书馆数据库进行系统检索。纳入了比较使用EBV治疗肺气肿3至12个月与标准药物及假EBV的随机对照临床试验。应用纳入标准选择接受EBV治疗的晚期肺气肿患者。主要结局指标为第1秒用力呼气容积百分比（FEV1%）。次要结局指标包括圣乔治呼吸问卷（SGRQ）评分、6分钟步行试验（6MWD）距离、改良医学研究委员会（MMRC）呼吸困难评分、蹬车运动负荷以及3个月或12个月时六大主要并发症的发生率。采用固定效应或随机效应模型，并计算加权均数差（WMD）、相对危险度（RR）和95%置信区间（CI）。
荟萃分析纳入了3项试验（565例患者）。EBV治疗组患者的FEV1%升高幅度大于标准药物治疗组（WMD = 6.71；95% CI，3.31至10.10；P = 0.0001），EBV治疗组患者的SGRQ评分（WMD = -3.64；95% CI，-5.93至-1.34；P = 0.002）、MMRC呼吸困难评分（WMD = -0.26；95% CI，-0.44至-0.08；P = 0.004）和蹬车运动负荷（WMD = 4.18；95% CI，2.14至6.22；P < 0.0001）也有显著变化。6MWD的变化情况类似（WMD = 11.66；95% CI，-3.31至26.64；P = 0.13）。EBV可能会增加咯血发生率（RR = 5.15；95% CI，1.16至22.86；P = 0.03），但不会增加包括死亡、呼吸衰竭、脓胸、肺炎、气胸在内的不良事件。与标准药物及假EBV相比，EBV并发症的总体发生率无显著差异（RR = 2.03；95% CI，0.98至4.21；P = 0.06）。
与标准药物及假EBV相比，EBV肺减容术治疗晚期肺气肿显示出更好的疗效以及良好的安全性和耐受性，此外，还需要进一步的随机对照试验（RCT）研究来更多地关注EBV支气管镜肺减容术治疗晚期肺气肿的长期疗效和安全性。
