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Background
Post-TB lung disease (PTLD) causes significant disability in survivors of TB .
结核病后肺部疾病(PTLD)在结核病幸存者中造成了显著的残疾。
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Pulmonary rehabilitation (PR) may offer effective disease management but lacks high-quality evidence in this underrepresented population .
肺康复(PR)可能提供有效的疾病管理,但在这一代表性不足的人群中缺乏高质量的证据。
research_question
Compared with usual care , does a 6-week PR program improve exercise capacity and health-related quality of life (HRQoL) cost-effectively in adults living with post-TB lung disease?
与常规护理相比,6周的肺康复(PR)计划是否能以成本效益的方式改善结核后肺病成人患者的运动能力和健康相关生活质量(HRQoL)?
study_design_and_methods
We conducted a single-center randomized controlled trial with blinded outcome assessments , comparing PR vs usual care (UC) for adults in Kampala , Uganda with PTLD .
我们在乌干达坎帕拉进行了一项单中心随机对照试验,对成年结核后肺病患者进行了盲法结果评估,比较了肺康复(PR)与常规护理(UC)的效果。
Participants were randomized (1:1) to receive either PR or UC , with assessments at 6 weeks postintervention .
参与者被随机分配(1:1)接受PR或UC治疗,并在干预后6周进行评估。
The primary outcome was change in exercise capacity measured by the Incremental Shuttle Walk Test .
主要结果是通过增量穿梭步行测试测量的运动能力的变化。
Secondary outcomes included HRQoL , respiratory symptoms , psychological well-being , and cost-benefit analysis .
次要结果包括健康相关生活质量(HRQoL)、呼吸症状、心理福祉以及成本效益分析。
A generalized linear mixed model was used for the primary efficacy analysis ( intention-to-treat ) and a difference-in-differences analysis for secondary outcomes (modified intention-to-treat ).
主要疗效分析采用广义线性混合模型(意向治疗),次要结果采用差异-差异分析(修改意向治疗)。
Results
Between November 2020 and September 2022, 178 adults with PTLD were assessed for eligibility and 114 were randomized (mean age ± SD , 43.3 ± 15.2 years ; 65 [57%] were male ).
在2020年11月至2022年9月期间,共有178名成人PTLD患者被评估是否符合入选标准,其中114名被随机分配(平均年龄±标准差为43.3±15.2岁;65名[57%]为男性)。
The postintervention improvement in mean Incremental Shuttle Walk Test in the PR group was significantly greater than in the UC group , by 54.36 m (95% CI , 17.22-91.51 m ; P = .004).
PR组在干预后平均增量穿梭步行测试的改善显著大于UC组,提高了54.36米(95%置信区间,17.22-91.51米;P = .004)。
We also observed significant improvements in HRQoL in PR compared with UC : COPD Assessment Test score , -3.6 (95% CI , -6.7 to -0.39; P = .015); and Clinical COPD Questionnaire total , -0.37 (95% CI , -0.68 to -0.06; P = .004).
我们还观察到PR组在健康相关生活质量(HRQoL)方面与UC组相比有显著改善:COPD评估测试得分,-3.6(95%置信区间,-6.7至-0.39;P = .015);临床COPD问卷总分,-0.37(95%置信区间,-0.68至-0.06;P = .004)。
The EuroQol Visual Analog Scale and quality-adjusted life-years (QALYs) marginally improved in the PR group vs the UC group : 3.98 (95% CI , -2.05 to 10.02; P = .191) and 0.02 (95% CI , -0.02 to 0.05; P = .334), respectively .
PR组的欧洲五维健康量表视觉模拟评分和质量调整生命年(QALYs)与UC组相比略有改善:3.98(95%置信区间,-2.05至10.02;P = .191)和0.02(95%置信区间,-0.02至0.05;P = .334),分别。
The average cost of PR was $6,468/QALY gained , equating to $20,000/QALY gained after adjusting for purchasing power (below the National Institute for Health and Care Excellence cost-effectiveness threshold ).
PR的平均成本为每获得一个QALY(质量调整生命年)6,468美元,调整购买力后为每获得一个QALY 20,000美元(低于国家卫生与临床优化研究所的成本效益阈值)。
interpretation
In adults with PTLD , a 6-week PR program elicited clinically and statistically significant improvements in exercise capacity and HRQoL compared with UC , and was cost-effective .
在成人PTLD患者中,与UC相比,一个为期6周的PR计划在运动能力和HRQoL(健康相关生活质量)方面引起了临床上和统计学上显著的改善,并且具有成本效益。
clinical_trial_registration
ISRCTN Clinical Trial Registry ; No .: ISRCTN 18256843; URL : isrctn.com.
ISRCTN 临床试验注册; 编号: ISRCTN18256843; 网址: isrctn.com.
本文献翻译由 AI 辅助生成,仅供文献精读与英语学习参考。临床决策请以 PubMed / PMC 原文为准。
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