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Supplementary Material for: Bronchoscopic Lung Volume Reduction Coil Treatment for Severe Emphysema: A Systematic Review and Meta-Analysis of Individual Participant Data

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DataCite Commons2022-04-11 更新2024-07-29 收录
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https://karger.figshare.com/articles/dataset/Supplementary_Material_for_Bronchoscopic_Lung_Volume_Reduction_Coil_Treatment_for_Severe_Emphysema_A_Systematic_Review_and_Meta-Analysis_of_Individual_Participant_Data/19572499
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<b><i>Background:</i></b> Lung volume reduction coil (LVR-coil) treatment provides a minimally invasive treatment option for severe emphysema patients which has been studied in multiple clinical trials. <b><i>Objectives:</i></b> The aim of the study was to assess the effect of LVR-coil treatment on pulmonary function, quality of life, and exercise capacity using individual participant data. <b><i>Method:</i></b> PubMed, Web of Science, and EMBASE were searched until May 17, 2021. Prospective single-arm and randomized controlled trials that evaluated the effect of LVR-coil treatment on forced expiratory volume in 1 s (FEV<sub>1</sub>), residual volume (RV), St. George Respiratory Questionnaire (SGRQ) total score, and/or 6-min walk distance (6MWD) and were registered in an official clinical trial database were eligible for inclusion. Individual patient data were requested, and a linear mixed effects model was used to calculate overall treatment effects. <b><i>Results:</i></b> Eight trials were included in the final analysis, representing 680 individual patients. LVR-coil treatment resulted in a significant improvement in FEV1 at 3- (0.09 L [95% confidence interval (95% CI): 0.06–0.12]) and 6-month follow-up (0.07 L [95% CI: 0.03–0.10]), a significant reduction in RV at 3- (−0.45L [95% CI: −0.62 to −0.28]), 6- (−0.33L [95% CI: −0.52 to −0.14]), and 12-month follow-up (−0.36L [95% CI: −0.64 to −0.08]), a significant reduction in SGRQ total score at 3- (−12.3 points [95% CI: −15.8 to −8.8]), 6- (−10.1 points [95% CI: −12.8 to −7.3]), and 12-month follow-up (−9.8 points [95% CI: −15.0 to −4.7]) and a significant increase in 6MWD at 3-month follow-up (38 m [95% CI: 18–58]). <b><i>Conclusions:</i></b> LVR-coil treatment in emphysema patients results in sustained improvements in pulmonary function and quality of life and shorter lived improvements in exercise capacity. Since the owner of this LVR-coil has decided to stop the production and newer generations LVR-coils are currently being developed, these results can act as a reference for future studies and clinical guidance.

**背景:** 肺减容线圈(Lung Volume Reduction Coil, LVR-coil)治疗为重度肺气肿患者提供了一种微创治疗选择,该疗法已在多项临床试验中得到研究。 **目的:** 本研究旨在利用个体受试者数据,评估LVR-coil治疗对肺功能、生活质量及运动能力的影响。 **方法:** 检索截至2021年5月17日收录于PubMed、Web of Science及EMBASE的文献。纳入标准为:评估LVR-coil治疗对1秒用力呼气容积(forced expiratory volume in 1 s, FEV₁)、残气量(residual volume, RV)、圣乔治呼吸问卷(St. George Respiratory Questionnaire, SGRQ)总分及/或6分钟步行距离(6-min walk distance, 6MWD)影响的前瞻性单臂试验及随机对照试验,且此类试验已在官方临床试验数据库完成注册。研究团队申请获取个体患者数据,并采用线性混合效应模型计算总体治疗效应。 **结果:** 最终共纳入8项试验,涉及680例个体患者。LVR-coil治疗可使患者在随访3个月(0.09 L,95%置信区间[95%CI]:0.06~0.12)及6个月时的FEV₁显著改善(0.07 L,95%CI:0.03~0.10);在随访3个月(−0.45 L,95%CI:−0.62~−0.28)、6个月(−0.33 L,95%CI:−0.52~−0.14)及12个月时的RV显著降低;在随访3个月(−12.3分,95%CI:−15.8~−8.8)、6个月(−10.1分,95%CI:−12.8~−7.3)及12个月时的SGRQ总分显著降低;且在随访3个月时的6MWD显著提升(38 m,95%CI:18~58)。 **结论:** 肺气肿患者接受LVR-coil治疗后,肺功能与生活质量可获得持续改善,而运动能力的改善则持续时间较短。鉴于该款LVR-coil的生产商已决定停产,且新一代LVR-coil目前正处于研发阶段,本研究结果可为未来相关研究及临床实践提供参考依据。
提供机构:
Karger Publishers
创建时间:
2022-04-11
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