世界中医药

目的：观察四合汤加减治疗非酒精性脂肪肝的临床疗效及对相关生化指标的影响，探讨其疗效作用机制，为临床非酒精性脂肪肝患者治疗方案的选择提供参考。方法：选取2015年1月至2017年1月中国中医科学院望京医院收治的非酒精性脂肪肝患者50例作为研究对象，按照就诊顺序编号，单号设为对照组，双号设为观察组，每组25例。2组患者均予以日常生活指导及当飞利肝宁片治疗，观察组患者在对照组治疗基础上，再予以四合汤加减辨治，2组患者均连续治疗12周为1个疗程。比较2组患者治疗前后生化指标：血清谷丙转氨酶(ALT)、血清谷草转氨酶（AST)、血清转化生长因-β1（TGF-β1)、超氧化物歧化酶(SOD)；血清炎性反应递质：白细胞介素-6(IL-6)、白细胞介素-8（IL-8）、肿瘤坏死因子-α（TNF-α）、肝脏彩色超声评分的变化；评价2组患者临床疗效及治疗过程中的药物不良反应并比较。结果：治疗后，2组患者血清ALT,AST、TGF-β1均较治疗前明显降低，且观察组患者TGF-β1明显低于对照组（P<0.05)，ALT,AST组间比较，差异无统计学意义（P>0.05），治疗后，2组血清SOD均较治疗前明显升高，且观察组高于对照组（P<0.05）；治疗后，2组患者血清炎性反应递质IL-6、IL-8、TNF-α均较治疗前明显降低，且观察组明显低于对照组（P<0.05）；2组患者治疗后肝脏彩色超声评分均较治疗前，且观察组低于对照组（P<0.05）；治疗后观察组临床总有效率明显高于对照组（P<0.05）；2组患者药物不良反应率比较，差异无统计学意义（P>0.05）。结论:四合汤加减对非酒精性脂肪肝患者具有明显的保肝降酶作用，还可以改善非酒精性脂肪肝的肝脏组织学病变程度。

English Summary:

To observe the clinical efficacy of Sihe Decoction in the treatment of patients with non-alcoholic fatty liver disease(NAFLD)and its influences on relevant biochemical indexes，as well as to explore its therapeutic mechanism，providing references for the selection of treatment options for clinical patients with NAFLD. Methods:A total of 50 patients with NAFLD were selected from January 2015 to January 2017 in Wangjing Hospital of Chinese Academy of Chinese Medical Sciences. They were numbered according to the order of consultation. The single number was set as the control group，and the double number was set as the observation group，with 25 cases in each group. Two groups of patients were given daily life guidance and Feili Ganning Tablet. Moreover，the observation group patients，on the basis of the control treatment，were given modified Sihe Decoction. Patients in the 2 groups were treated for 12 weeks as a course of treatment. The changes of serum alanine aminotransferase(ALT)，serum glutamate aminotransferase(AST)，serum transforming growth factor-beta 1(TGF-β1)，superoxide dismutase(SOD)，serum inflammatory factors such as interleukin-6(IL-6)，interleukin-8(IL-8)，tumor necrosis factor-alpha(TNF-alpha)and liver color Doppler ultrasound scores before and after treatment were compared between the 2 groups. Therapeutic effects and adverse drug reactions/side effects in the course of treatment were compared. Results:1)After treatment，the levels of serum ALT，AST and TGF-β 1 in the 2 groups were significantly lower than those before treatment. The levels of TGF-β1 in the observation group were significantly lower than those of the control group(P<0.05). There was no significant difference between ALT and AST groups(P>0.05). After treatment，the levels of serum SOD in the 2 groups were significantly higher than those of the control group(P<0.05); 2)After treatment，the serum inflammatory factors IL-6，IL-8 and TNF-α in the 2 groups were significantly lower than those before treatment. Those in the observation group was significantly lower than that of the control group(P<0.05); 3)After treatment，the liver color B-ultrasound scores of the 2 groups were lower than those before treatment. Those in the treatment group was lower than that of the control group(P<0.05); 4)After treatment，the total clinical effective rate of the observation group was significantly higher than that of the control group(P<0.05); 5)There was no significant difference in the rate of adverse reactions between the 2 groups(P>0.05). Conclusion:Modified Sihe Decoction has obvious hepatoprotective on non-alcoholic fatty liver. It can reduce enzymes as well as improve the degree of liver histopathological changes of non-alcoholic fatty liver.

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