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中药灌肠方对3至5期慢性肾脏病透析前患者肾功能、肠源性尿毒症毒素及肠道屏障功能的影响:一项随机对照试验。

Effect of Chinese herbal enema prescription on renal function, enterogenous uremic toxins and intestinal barrier function in stage 3 to 5 chronic kidney disease predialysis participants: A randomized controlled trial.

作者信息

Ru Xue, Zhang Yi, Chen Xiaolei, Zhong Jie, Gong Xuefeng, Fan Tao

机构信息

Department of Nephrology, Affiliated Hospital of Panzhihua University, Panzhihua, Sichuan, China.

Department of Chemical Engineering, School of Biological and Chemical Engineering, Panzhihua University, Panzhihua, Sichuan, China.

出版信息

Medicine (Baltimore). 2025 Aug 8;104(32):e43791. doi: 10.1097/MD.0000000000043791.

Abstract

BACKGROUND

This study investigates the efficacy and mechanism of a Chinese herbal enema prescription (CHEP) in improving renal function and delaying progression to dialysis in patients with chronic kidney disease (stage 3-5) before dialysis.

METHODS

A total of 102 patients (mean age: 47.6 ± 12.3 years; male: 46.15%) satisfying the inclusion criteria were randomized into control or experimental groups. Patients in the experimental group received retention enema using CHEP in addition to standard Western medical treatment, whereas patients in the control group only received standard Western medical treatment, 2-week intervention period. Changes in traditional Chinese medicine (TCM) symptom scores (a composite score based on the severity and frequency of TCM-defined symptoms such as fatigue, anorexia, and edema), renal function (serum creatinine [SCr], uric acid, blood urea nitrogen, microinflammatory C-reactive protein [CRP]), enterogenous uremic toxins (trimethylamine oxide [TMAO], indoxyl sulfate), and intestinal barrier function (endotoxin [ET], d-Lactate [DL], and diamine oxidase [DAO]) before and after treatment in both groups were compared.

RESULTS

After treatment, the TCM symptom scores of both groups decreased compared to those before treatment. Moreover, the difference in the scores of the experimental group pre- versus post- treatment was significantly greater than that of the control group (standardized mean difference [SMD] = -1.79, 95% confidence interval [CI] = -2.56 to 1.02) (P < .01).The total effective rate based on TCM symptom improvement was 73.3% in the control group and 91.3% in the experimental group (odds ratio = 2.34, 95% CI = 1.56-4.28) (P < .05). Concentrations of SCr and blood urea nitrogen were significantly lower (P < .05) in CHEP versus control at the end of treatment; however, there were no significant differences in uric acid, estimated glomerular filtration rate (eGFR), and CRP (P > .05). The levels of DL (SMD = 84.11, 95% CI = 10.65-162.21), DAO (SMD = 14.08, 95% CI = 2.33-27.41), and ET (SMD = 37.27, 95% CI = 9.31-65.50) in the experimental group after treatment showed significant differences (P < .05). The indoxyl sulfate (SMD [95%] CI = 16.11 [1.22-33.11]) and TMAO (SMD [95%] CI = 8.13 (1.26-15.86)] in the experimental group after treatment were significantly lower compared to the control group (P < .05).

CONCLUSION

CHEP can enhance the clinical function and delay the decline of kidney function in patients with chronic kidney disease (stage 3-5), mainly by promoting the excretion of enterogenic uremic toxins and improving intestinal barrier function to delay renal function progression.

摘要

背景

本研究旨在探讨中药灌肠方(CHEP)对慢性肾脏病(3 - 5期)透析前患者改善肾功能及延缓透析进程的疗效及作用机制。

方法

将102例符合纳入标准的患者(平均年龄:47.6±12.3岁;男性:46.15%)随机分为对照组和试验组。试验组患者在接受标准西医治疗的基础上,加用CHEP进行保留灌肠,而对照组患者仅接受标准西医治疗,干预期为2周。比较两组治疗前后中医症状评分(基于疲劳、厌食、水肿等中医定义症状的严重程度和频率的综合评分)、肾功能(血清肌酐[SCr]、尿酸、血尿素氮、微炎症C反应蛋白[CRP])、肠源性尿毒症毒素(氧化三甲胺[TMAO]、硫酸吲哚酚)及肠屏障功能(内毒素[ET]、d - 乳酸[DL]、二胺氧化酶[DAO])的变化。

结果

治疗后,两组中医症状评分均较治疗前降低。此外,试验组治疗前后评分差异显著大于对照组(标准化均数差[SMD]= - 1.79,95%置信区间[CI]= - 2.56至1.02)(P <.01)。基于中医症状改善的总有效率,对照组为73.3%,试验组为91.3%(优势比=2.34,95% CI = 1.56 - 4.28)(P <.05)。治疗结束时,CHEP组的SCr和血尿素氮浓度显著低于对照组(P <.05);然而,尿酸、估算肾小球滤过率(eGFR)和CRP无显著差异(P >.05)。试验组治疗后DL(SMD = 84.11,95% CI = 10.65 - 162.21)、DAO(SMD = 14.08,95% CI = 2.33 - 27.41)和ET(SMD = 37.27,95% CI = 9.31 - 65.50)水平显示出显著差异(P <.05)。试验组治疗后的硫酸吲哚酚(SMD [95%] CI = 16.11 [1.22 - 33.11])和TMAO(SMD [95%] CI = 8.13 (1.26 - 15.86)])显著低于对照组(P <.05)。

结论

CHEP可增强慢性肾脏病(3 - 5期)患者的临床功能并延缓肾功能下降,主要通过促进肠源性尿毒症毒素的排泄及改善肠屏障功能来延缓肾功能进展。

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