无烟艾灸联合血液灌流对维持性血液透析患者蛋白质能量消耗的影响

Effect of Smokeless Moxibustion Combined with Hemoperfusion on Protein-Energy Wasting in Maintenance Hemodialysis Patients

摘要: 目的：评价在常规血液透析联合血液灌流基础上加用无烟艾灸，对维持性血液透析(maintenance hemodialysis, MHD)患者蛋白质能量消耗(protein-energy wasting, PEW)的影响。方法：本研究为单中心、前瞻性、随机对照研究，共纳入101例MHD患者。联合治疗组51例，在常规血液透析、每2周1次血液灌流及每月饮食宣教基础上，加用无烟艾灸每周3次、每次30 min，主要取足三里和三阴交；对照组50例接受相同的血液透析、血液灌流及饮食宣教。干预6个月。采用由血清白蛋白、体质量指数(BMI)、透析前血清肌酐/体表面积(SCr/BSA)和标准化蛋白质分解代谢率(nPCR)组成的简化PEW评分(0~4分)评价营养状态，0~2分定义为PEW，3~4分定义为非PEW。共同主要结局为新发PEW和PEW缓解，次要结局为6个月PEW比例和评分提高≥1分。二分类结局报告相对危险度(RR)、率差(RD)及95%置信区间(CI)；两个共同主要结局采用Bonferroni法校正，双侧P < 0.025为差异有统计学意义；连续结局采用基线校正的协方差分析。结果：联合治疗组49例、对照组47例完成6个月PEW评估。基线无PEW患者中，新发PEW率分别为3.4%和28.6% (RR = 0.12, 95% CI: 0.02~0.89; P = 0.009)；基线PEW患者中，PEW缓解率分别为40.0%和8.3% (RR = 4.80, 95% CI: 0.68~33.80; P = 0.103)。次要结局中，6个月PEW比例分别为26.5%和44.7% (RR = 0.59, 95% CI: 0.34~1.04; P = 0.088)，评分提高≥1分的比例分别为18.4%和8.5% (RR = 2.16, 95% CI: 0.71~6.53; P = 0.234)。探索性分析显示，联合治疗组6个月PEW评分较对照组校正后高0.38分(95% CI: 0.12~0.63; P = 0.004)，nPCR校正后高0.12 g/(kg·d) (95% CI: 0.02~0.21; P = 0.017)。联合治疗组5例(9.8%)出现艾灸部位局部皮肤发红，未见烫伤；其他安全事件未系统收集。结论：在规律HD联合每2周1次HP基础上加用无烟艾灸，可能降低6个月内新发PEW风险，但尚不能确认其可促进既有PEW缓解。简化PEW评分和nPCR的改善为探索性发现，仍需采用充分把握度、多中心并系统收集营养摄入和安全性资料的随机对照试验验证。

Abstract: Objective: To evaluate the effect of adding smokeless moxibustion to conventional hemodialysis combined with hemoperfusion on protein-energy wasting (PEW) in patients undergoing maintenance hemodialysis (MHD). Methods: This single-center, prospective, randomized controlled study enrolled 101 patients with MHD. The combined-treatment group (n = 51) received smokeless moxibustion three times weekly for 30 min per session, mainly at Zusanli (ST36) and Sanyinjiao (SP6), in addition to conventional hemodialysis, hemoperfusion once every 2 weeks, and monthly dietary education. The control group (n = 50) received the same hemodialysis, hemoperfusion, and dietary education. The intervention lasted 6 months. Nutritional status was evaluated using a simplified PEW score (0~4) comprising serum albumin, body mass index (BMI), predialysis serum creatinine/ body surface area (SCr/BSA), and normalized protein catabolic rate (nPCR); scores of 0~2 indicated PEW and scores of 3~4 indicated non-PEW. Coprimary outcomes were incident PEW and PEW remission; secondary outcomes were PEW prevalence at 6 months and a score increase of at least 1 point. Binary outcomes were reported as relative risks (RRs), risk differences (RDs), and 95% confidence intervals (CIs). Bonferroni correction was applied to the coprimary outcomes, with two-sided P < 0.025 considered statistically significant. Continuous outcomes were analyzed by analysis of covariance with adjustment for baseline values. Results: At 6 months, 49 patients in the combined-treatment group and 47 in the control group completed PEW assessment. Among patients without PEW at baseline, incident PEW occurred in 3.4% and 28.6%, respectively (RR = 0.12, 95% CI: 0.02~0.89; P = 0.009). Among patients with PEW at baseline, remission rates were 40.0% and 8.3% (RR = 4.80, 95% CI: 0.68~33.80; P = 0.103). For secondary outcomes, PEW prevalence at 6 months was 26.5% and 44.7% (RR = 0.59, 95% CI: 0.34~1.04; P = 0.088), and the proportions with a score increase of at least 1 point were 18.4% and 8.5% (RR = 2.16, 95% CI: 0.71~6.53; P = 0.234). Exploratory analyses showed a baseline-adjusted between-group difference of 0.38 points in PEW score (95% CI: 0.12~0.63; P = 0.004) and 0.12 g/(kg·d) in nPCR (95% CI: 0.02~0.21; P = 0.017), favoring the combined-treatment group. Five patients (9.8%) in the combined-treatment group developed local skin erythema at moxibustion sites; no burns occurred. Other safety events were not systematically collected. Conclusion: Adding smokeless moxibustion to regular hemodialysis plus hemoperfusion once every 2 weeks may reduce the risk of incident PEW over 6 months, but its ability to promote remission of established PEW remains unconfirmed. Improvements in simplified PEW score and nPCR were exploratory and require confirmation in adequately powered, multicenter randomized trials with systematic collection of dietary intake and safety data.