Hsiao Po-Jen, Lin Kao-Shin, Chiu Chih-Chien, Chen Hsueh-Wen, Huang Jing-Shu, Kao Sen-Yeong, Lin Yuh-Feng, Chen Jin-Shuen
Division of Nephrology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Division of Nephrology, Department of Internal Medicine, Taoyuan Armed Forces General Hospital, Taiwan.
Department of Chinese Medicine, Tri-Service General Hospital, Taipei, Taiwan.
Complement Ther Med. 2015 Jun;23(3):363-71. doi: 10.1016/j.ctim.2015.03.002. Epub 2015 Mar 14.
Complementary and alternative medicine such as traditional Chinese medicine (TCM) is now frequently used combined with Western medicine for treatment in chronic kidney disease (CKD).
We designed an open-label trial to investigate the safety and potential therapeutic effects of Ren Shen Yang Rong Tang (R-S-Y-R-T) in hemodialysis (HD) patients.
The experimental group was treated with additional R-S-Y-R-T combined with routine western medicine, while the control group was treated only with routine western medicine. The duration of study was 6 months. Primary outcomes were to evaluate the changes in serum hematocrit and albumin levels. Secondary outcomes including blood inflammatory markers (c-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]) were checked. Finally we also followed up the change of quality of life (QOL) in our subjects.
Sixty nine respondents were enrolled in this trial. Finally a total of 59 patients (27 R-S-Y-R-T group, 32 control group) completed the 6-month follow-up. Primary outcomes showed no significant statistical change of hematocrit in either 2 group (P>0.05). But the R-S-Y-R-T group had a statistical increase in serum albumin (P<0.05). Secondary outcomes were that both TNF-α (P=0.003) and IL-6 (P=0.001) showed evident decrease in the R-S-Y-R-T group. CRP was identified without statistical difference in both groups (P=0.226). The R-S-Y-R-T group also had a significant improvement in QOL (P<0.05).
Our study suggests that R-S-Y-R-T could decrease chronic inflammation and increase the life quality in HD patients. Further larger clinical trial of long-term treatment with R-S-Y-R-T is necessary for evaluating treatment use.
补充和替代医学，如传统中医（TCM），现在经常与西医联合用于慢性肾脏病（CKD）的治疗。
我们设计了一项开放标签试验，以研究人参养荣汤（R-S-Y-R-T）在血液透析（HD）患者中的安全性和潜在治疗效果。
实验组在常规西药治疗基础上加用R-S-Y-R-T，对照组仅接受常规西药治疗。研究持续时间为6个月。主要结局是评估血清血细胞比容和白蛋白水平的变化。检查次要结局，包括血液炎症标志物（C反应蛋白[CRP]、白细胞介素-6[IL-6]和肿瘤坏死因子-α[TNF-α]）。最后，我们还随访了受试者生活质量（QOL）的变化。
69名受试者参与了该试验。最终共有59名患者（R-S-Y-R-T组27名，对照组32名）完成了6个月的随访。主要结局显示，两组的血细胞比容均无显著统计学变化（P>0.05）。但R-S-Y-R-T组的血清白蛋白有统计学意义的升高（P<0.05）。次要结局是，R-S-Y-R-T组的TNF-α（P=0.003）和IL-6（P=0.001）均明显下降。两组的CRP均无统计学差异（P=0.226）。R-S-Y-R-T组的生活质量也有显著改善（P<0.05）。
我们的研究表明，R-S-Y-R-T可以减轻慢性炎症，提高HD患者的生活质量。有必要进一步开展更大规模的R-S-Y-R-T长期治疗临床试验，以评估其治疗用途。
