CAJ | 학술논문

目的：探讨清肾颗粒治疗慢性肾衰竭（CRF）湿热证患者的抗肾纤维化作用机制。方法将68例在安徽中医药大学第一附属医院治疗的CRF湿热证患者按随机数字表法分为对照组和观察组，每组34例，最终实际完成61例（对照组31例，观察组30例）；并选取30例同期健康体检者作为健康组。观察组与对照组均给予西医基础治疗及中药保留灌肠，观察组加服清肾颗粒，每次1袋（10 g），每日3次，两组疗程均为8周。观察两组临床疗效及治疗前后血肌酐（SCr）、肾小球滤过率（eGFR）估算值、血清白细胞介素-17（IL-17）、Ⅲ型胶原（Col-Ⅲ）和外周血单核细胞（PBMC）核转录因子-κB p65（NF-κB p65）水平，并与健康组比较。结果观察组临床总有效率和中医证候总有效率均明显高于对照组（86.67%比58.06%和83.33%比45.16%，均P＜0.01）。观察组治疗后SCr水平较治疗前显著下降，eGFR水平显著升高，且较对照组治疗后改善更为明显〔SCr（μmol/L）为250.62±164.97比393.72±183.64，eGFR（mL·min-1·1.73 m-2）为33.42±17.24比39.72±23.85，均P＜0.05〕。两组患者治疗后血清IL-17、Col-Ⅲ及PBMC中NF-κB p65水平较治疗前有所下降，且观察组的下降程度较对照组更显著〔IL-17（ng/L）为17.47±8.87比25.51±16.69，Col-Ⅲ（μg/L）为17.06±8.76比23.77±10.44，NF-κB p65（μg/L）为0.58±0.34比0.83±0.30，均P＜0.05〕。结论清肾颗粒可减轻CRF湿热证患者临床症状，改善肾功能，降低血清IL-17、Col-Ⅲ及PBMC中的NF-κB p65水平，干预肾纤维化，最终延缓CRF进展。
목적：탐토청신과립치료만성신쇠갈（CRF）습열증환자적항신섬유화작용궤제。방법장68례재안휘중의약대학제일부속의원치료적CRF습열증환자안수궤수자표법분위대조조화관찰조，매조34례，최종실제완성61례（대조조31례，관찰조30례）；병선취30례동기건강체검자작위건강조。관찰조여대조조균급여서의기출치료급중약보류관장，관찰조가복청신과립，매차1대（10 g），매일3차，량조료정균위8주。관찰량조림상료효급치료전후혈기항（SCr）、신소구려과솔（eGFR）고산치、혈청백세포개소-17（IL-17）、Ⅲ형효원（Col-Ⅲ）화외주혈단핵세포（PBMC）핵전록인자-κB p65（NF-κB p65）수평，병여건강조비교。결과관찰조림상총유효솔화중의증후총유효솔균명현고우대조조（86.67%비58.06%화83.33%비45.16%，균P＜0.01）。관찰조치료후SCr수평교치료전현저하강，eGFR수평현저승고，차교대조조치료후개선경위명현〔SCr（μmol/L）위250.62±164.97비393.72±183.64，eGFR（mL·min-1·1.73 m-2）위33.42±17.24비39.72±23.85，균P＜0.05〕。량조환자치료후혈청IL-17、Col-Ⅲ급PBMC중NF-κB p65수평교치료전유소하강，차관찰조적하강정도교대조조경현저〔IL-17（ng/L）위17.47±8.87비25.51±16.69，Col-Ⅲ（μg/L）위17.06±8.76비23.77±10.44，NF-κB p65（μg/L）위0.58±0.34비0.83±0.30，균P＜0.05〕。결론청신과립가감경CRF습열증환자림상증상，개선신공능，강저혈청IL-17、Col-Ⅲ급PBMC중적NF-κB p65수평，간예신섬유화，최종연완CRF진전。
Objective To observe the anti-fibrosis therapeutic effect and mechanism of Qingshen granule for treatment of patients with chronic renal failure (CRF) accompanied by damp-heat syndrome.Methods Sixty-eight patients with CRF accompanied by damp-heat syndrome were randomly divided into a control group and a observation group, and the study was completed only in 61 patients, 31 in the control group and 30 in the observation group. Thirty subjects having taken physical health examination were assigned in a healthy control group. All the patients in both treatment groups were treated with conventional western medical therapy and traditional Chinese medicine (TCM) retention enema, and for patients in observation group, Qingshen granule was given additionally, 1 bag (10 g) thrice a day taken orally. The therapeutic course was 8 weeks. The clinical therapeutic effect, the levels of serum creatinine (SCr), the glomerular filtration rate (eGFR), serum interleukin-17 (IL-17), collagen type Ⅲ (Col-Ⅲ) and nuclear factor-κB p65 (NF-κB p65) in peripheral blood mononuclear cells (PBMC) were measured before and after treatment in the two treatment groups, and the above results were compared with those in healthy control group.Results Clinically, the total effective rates of the disease and of the TCM syndrome in observation group were significantly higher than those in the control group (86.67% vs. 58.06%, 83.33% vs. 45.16%, bothP < 0.01). In the observation group, the level of SCr was obviously lower, and the level of eGFR was markedly higher after treatment, and compared with the control group, the changes in above data after treatment in observation group were more significant [SCr (μmol/L): 250.62±164.97 vs. 393.72±183.64, eGFR (mL·min-1·1.73 m-2): 33.42±17.24 vs. 39.72±23.85, bothP < 0.05]. After treatment, the levels of serum IL-17, Col-Ⅲ and NF-κB p65 in PBMC were obviously lowered in both treatment groups compared with those before treatment, the therapeutic effect in observation group being superior to that in the control group [IL-17 (ng/L): 17.47±8.87 vs. 25.51±16.69, Col-Ⅲ (μg/L): 17.06±8.76 vs. 23.77±10.44, NF-κB p65 (μg/L): 0.58±0.34 vs. 0.83±0.30, allP < 0.05].Conclusion The Qingshen granule can ameliorate the clinical symptoms, improve renal function, decrease the levels of serum IL-17, Col-Ⅲ and NF-κB p65 in PBMC, intervene renal fibrosis in patients with CRF and damp-heat syndrome, ultimately delaying the progress of CRF.