运脾强肾凝胶改善透析患者的生活质量。

Yunpiqiangshen gel improves quality of life in dialysis patients.

作者信息

Manshu Y U, Chunchun Jiang, Min Yao, Jianwu Hua, Yan Jiang, Min Huang, Jianjing Liu, Yan Zhou, Yuan Wang, Meixiao Sheng

机构信息

Renal Division, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.

Renal Division, Zhangjiagang Hospital of Chinese Medicine, Suzhou 215638, China.

出版信息

J Tradit Chin Med. 2025 Feb;45(1):123-131. doi: 10.19852/j.cnki.jtcm.2025.01.011.

DOI:10.19852/j.cnki.jtcm.2025.01.011

PMID:39957166

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11764941/

Abstract

OBJECTIVE

To evaluate the efficacy and safety of Yunpiqiangshen gel which composed of eleven herbs on quality of life (QOL) improvement.

METHODS

We enrolled 180 patients lasted from January 2020 to December 2021. Seventy-eight patients received standards of care (control group) and 76 patients received Yunpiqiangshen gel [Traditional Chinese Medicine, (TCM) group] for 6 months in statistical analysis. The primary outcome assessed using Kidney Disease Quality of Life Short Form Questionnaire version 1.3 (KDQOL-SF 1.3), including Short Form Health Survey (SF-36) and Kidney Disease Targeted Areas (KDTA) scores. The second outcomes included the TCM syndrome score, Fatigue Assessment Instrument (FAI) score, Modified Quantitative Subjective Global Assessment (MQSGA) score, anthropometric indicators, and blood chemical testing. Adverse events, including decompensated gastrointestinal symptoms, were evaluated.

RESULTS

The results showed that the mean change of SF-36 (75 13 64 16, 6.070, 0.015) and KDTA (76 7 70 9, 4.118, 0.044) scores in the TCM group had an improvement (increase) from baseline, as compared with the control group. Yunpiqiangshen gel also resulted in a significant improvement in almost dimensions of QOL. At the end of follow-up, the imputed percentage of patients in the response rate of TCM syndrome was greater in the TCM group than in the control group (76.32% 20.51%, = 48.02, 0.000). The fatigue, soreness of waist, anorexia, abdominal distension, loose stool, and constipation were alleviated after Yunpiqiangshen gel therapy. The FAI (98.58 25.08 131.21 31.85, 8.745, 0.004) and MQSGA (10.13 2.84 12.83 3.85, 11.396, 0.001) scores in the TCM group had an improvement (reduce) from baseline compared with the control group. A higher level of albumin of patients in the TCM group compared with the control group. Diarrhea, vomit, and loose stool were more common in the TCM group, but generally mild in severity.

CONCLUSION

Compared with the standards of care, added Yunpiqiangshen gel was a safe and effective therapy for improving QOL in dialysis patients.

摘要

目的

评估由11味中药组成的运脾强肾凝胶改善生活质量（QOL）的有效性和安全性。

方法

我们纳入了2020年1月至2021年12月期间的180例患者。在统计分析中，78例患者接受标准治疗（对照组），76例患者接受运脾强肾凝胶治疗（中药组），为期6个月。使用肾脏病生活质量简表问卷第1.3版（KDQOL-SF 1.3）评估主要结局，包括健康调查简表（SF-36）和肾脏病特定领域（KDTA）评分。次要结局包括中医证候评分、疲劳评估量表（FAI）评分、改良定量主观全面评定（MQSGA）评分、人体测量指标和血液化学检测。评估不良事件，包括失代偿性胃肠道症状。

结果

结果显示，与对照组相比，中药组的SF-36（75±13 vs 64±16，t = 6.070，P = 0.015）和KDTA（76±7 vs 70±9，t = 4.118，P = 0.044）评分从基线开始有改善（升高）。运脾强肾凝胶还使生活质量的几乎所有维度都有显著改善。随访结束时，中药组患者中医证候有效率的估算百分比高于对照组（76.32%±20.51%，Z = 48.02，P = 0.000）。运脾强肾凝胶治疗后，疲劳、腰酸、食欲不振、腹胀、便溏和便秘症状得到缓解。与对照组相比，中药组的FAI（98.58±25.08 vs 131.21±31.85，t = 8.745，P = 0.004）和MQSGA（10.13±2.84 vs 12.83±3.85，t = 11.396，P = 0.001）评分从基线开始有改善（降低）。中药组患者的白蛋白水平高于对照组。腹泻、呕吐和便溏在中药组更常见，但一般严重程度较轻。