PDF(Pubmed)
Abstract：
UNASSIGNED: This study aimed to conduct a systematic review and meta-analysis of randomized controlled trials to evaluate the effects of elexacaftor-tezacaftor-ivacaftor (ELX-TEZ-IVA) on patients with cystic fibrosis (CF).
UNASSIGNED: A systematic search was performed in PubMed, Embase, and the Cochrane Library from inception to August 1, 2022. Meta-analysis was conducted using Review Manager 5.3 software.
UNASSIGNED: Six studies comprising seven reports involving a total of 1125 CF patients were included. The meta-analyses indicated that ELX-TEZ-IVA significantly improved the percentage predicted forced expiratory volume in 1 s (ppFEV1) by 10.29% (95% confidence interval (CI) (6.44, 14.14), p < 0.00001) and the CF questionnaire-revised respiratory domain (CFQ-R RD) by 14.59 points (95% CI (9.25, 19.94), p < 0.00001) compared to placebo, ivacaftor (IVA), or tezacaftor-ivacaftor (TEZ-IVA). In addition, the ELX-TEZ-IVA group showed significantly lower sweat chloride concentrations by 40.30 mmol/L (95% CI (-49.85, -30.74), p < 0.00001). However, the incidence of adverse events in the ELX-TEZ-IVA group was slightly higher than that in the placebo, IVA, or TEZ-IVA groups.
UNASSIGNED: ELX-TEZ-IVA demonstrated efficacy in improving ppFEV1, CFQ-R RD, and sweat chloride concentrations in patients with CF. However, caution should be exercised regarding the incidence of AEs, particularly mild and moderate ones.
UNASSIGNED: A systematic search was performed in PubMed, Embase, and the Cochrane Library from inception to August 1, 2022. Meta-analysis was conducted using Review Manager 5.3 software.
UNASSIGNED: Six studies comprising seven reports involving a total of 1125 CF patients were included. The meta-analyses indicated that ELX-TEZ-IVA significantly improved the percentage predicted forced expiratory volume in 1 s (ppFEV1) by 10.29% (95% confidence interval (CI) (6.44, 14.14), p < 0.00001) and the CF questionnaire-revised respiratory domain (CFQ-R RD) by 14.59 points (95% CI (9.25, 19.94), p < 0.00001) compared to placebo, ivacaftor (IVA), or tezacaftor-ivacaftor (TEZ-IVA). In addition, the ELX-TEZ-IVA group showed significantly lower sweat chloride concentrations by 40.30 mmol/L (95% CI (-49.85, -30.74), p < 0.00001). However, the incidence of adverse events in the ELX-TEZ-IVA group was slightly higher than that in the placebo, IVA, or TEZ-IVA groups.
UNASSIGNED: ELX-TEZ-IVA demonstrated efficacy in improving ppFEV1, CFQ-R RD, and sweat chloride concentrations in patients with CF. However, caution should be exercised regarding the incidence of AEs, particularly mild and moderate ones.
摘要：
■本研究旨在对随机对照试验进行系统评价和荟萃分析，以评估elexacaftor-tezacaftor-ivacaftor（ELX-TEZ-IVA）对囊性纤维化（CF）患者的影响。
■在PubMed中进行了系统搜索，Embase,和Cochrane图书馆从成立到2022年8月1日。采用ReviewManager5.3软件进行Meta分析。
■纳入了六项研究，包括七份报告，共涉及1125名CF患者。荟萃分析表明，ELX-TEZ-IVA使预测的1s用力呼气量百分比（ppFEV1）显着提高了10.29％（95％置信区间（CI）（6.44，14.14），p<0.00001）和CF问卷修订的呼吸域（CFQ-RRD）14.59分（95％CI（9.25，19.94），p<0.00001)与安慰剂相比，ivacaftor(IVA)，或tezacaftor-ivacaftor（TEZ-IVA）。此外,ELX-TEZ-IVA组显着降低汗液氯化物浓度40.30mmol/L（95％CI（-49.85，-30.74），p<0.00001)。然而,ELX-TEZ-IVA组的不良事件发生率略高于安慰剂组,IVA,或TEZ-IVA组。
■ELX-TEZ-IVA在改善ppFEV1、CFQ-RRD、和CF患者的汗液氯化物浓度。然而,应谨慎对待AE的发生率，特别是轻度和中度。
■在PubMed中进行了系统搜索，Embase,和Cochrane图书馆从成立到2022年8月1日。采用ReviewManager5.3软件进行Meta分析。
■纳入了六项研究，包括七份报告，共涉及1125名CF患者。荟萃分析表明，ELX-TEZ-IVA使预测的1s用力呼气量百分比（ppFEV1）显着提高了10.29％（95％置信区间（CI）（6.44，14.14），p<0.00001）和CF问卷修订的呼吸域（CFQ-RRD）14.59分（95％CI（9.25，19.94），p<0.00001)与安慰剂相比，ivacaftor(IVA)，或tezacaftor-ivacaftor（TEZ-IVA）。此外,ELX-TEZ-IVA组显着降低汗液氯化物浓度40.30mmol/L（95％CI（-49.85，-30.74），p<0.00001)。然而,ELX-TEZ-IVA组的不良事件发生率略高于安慰剂组,IVA,或TEZ-IVA组。
■ELX-TEZ-IVA在改善ppFEV1、CFQ-RRD、和CF患者的汗液氯化物浓度。然而,应谨慎对待AE的发生率，特别是轻度和中度。
