Clinical observation of Jiangzhi Granule combined with lifestyle intervention in treating NAFLD patients with damp⁃heat accumulation syndrome

SHU Xiangbing; ZHAO Yanting; YANG Zhixin

doi:10.16305/j.1007-1334.2023.2208086

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Clinical observation of Jiangzhi Granule combined with lifestyle intervention in treating NAFLD patients with damp⁃heat accumulation syndrome

更新时间：2023-02-24

- Clinical observation of Jiangzhi Granule combined with lifestyle intervention in treating NAFLD patients with damp⁃heat accumulation syndrome
- Shanghai Journal of Traditional Chinese Medicine Vol. 57, Issue 2, Pages: 35-40(2023)
- 作者机构：
  
  1.上海市宝山区中西医结合医院（上海 201999）
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2023.2208086
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舒祥兵,赵燕婷,杨志新.降脂颗粒联合生活方式干预治疗湿热蕴结型非酒精性脂肪性肝病的临床观察[J].上海中医药杂志,2023,57(2):35-40.

SHU Xiangbing,ZHAO Yanting,YANG Zhixin.Clinical observation of Jiangzhi Granule combined with lifestyle intervention in treating NAFLD patients with damp⁃heat accumulation syndrome[J].Shanghai Journal of Traditional Chinese Medicine,2023,57(2):35-40.
舒祥兵,赵燕婷,杨志新.降脂颗粒联合生活方式干预治疗湿热蕴结型非酒精性脂肪性肝病的临床观察[J].上海中医药杂志,2023,57(2):35-40. DOI： 10.16305/j.1007-1334.2023.2208086.

SHU Xiangbing,ZHAO Yanting,YANG Zhixin.Clinical observation of Jiangzhi Granule combined with lifestyle intervention in treating NAFLD patients with damp⁃heat accumulation syndrome[J].Shanghai Journal of Traditional Chinese Medicine,2023,57(2):35-40. DOI： 10.16305/j.1007-1334.2023.2208086.

摘要

目的,2,观察降脂颗粒联合生活方式干预治疗湿热蕴结型非酒精性脂肪性肝病（NAFLD）的临床疗效及对胆汁酸代谢的影响。,方法,2,将90例湿热蕴结型NAFLD患者随机分为治疗组和对照组，每组45例。对照组采用单纯生活方式干预，治疗组在对照组治疗措施的基础上加用降脂颗粒治疗，两组疗程均为16周。观察肝脏超声疗效，比较两组体质量、体质量指数（BMI）、中医证候积分、血脂［（总胆固醇（TC）、三酰甘油（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）］水平，以及血清、尿液胆汁酸代谢相关指标［总胆汁酸（TBA）、胆酸（CA）、甘氨胆酸（GCA）、猪胆酸（HCA）、熊去氧胆酸（UDCA）、甘氨熊去氧胆酸（GUDCA）、甘氨鹅去氧胆酸（GCDCA）、鹅去氧胆酸（CDCA）、α-鼠胆酸（α-MCA）、甘氨猪胆酸（GHCA）、牛磺胆酸（TCA）、脱氧胆酸（DCA）、石胆酸（LCA）、甘氨脱氧胆酸（GDCA）、甘氨石胆酸（GLCA）、牛磺-β-鼠胆酸（T-β-MCA）］水平的变化情况，同时进行安全性评价。,结果,2,①最终完成试验者84例，其中治疗组43例、对照组41例。②治疗组、对照组肝脏超声总有效率分别为62.8%、36.6%，治疗组疗效优于对照组（,P,<,0.05）。③治疗前后组内比较，治疗组中医证候积分减少，体质量、BMI及血清TC、TG水平降低（,P,<,0.05），对照组中医证候积分减少（,P,<,0.05），血清TG水平降低（,P,<,0.05）；组间治疗后比较，治疗组中医证候积分少于对照组，BMI低于对照组（,P,<,0.05）。④治疗前后组内比较，治疗组血清TBA、初级胆汁酸部分指标（CA、GCA、HCA、UDCA、GUDCA、GCDCA、CDCA）和次级胆汁酸部分指标（DCA、GDCA）水平降低（,P,<,0.05），尿液TBA、初级胆汁酸部分指标（CA、α-MCA、T-β-MCA、CDCA、UDCA）和次级胆汁酸部分指标（DCA、GDCA）水平升高（,P,<,0.05）；对照组血清TBA、初级胆汁酸部分指标（CA、GCA、UDCA、GCDCA、CDCA）和次级胆汁酸部分指标（DCA、GDCA）水平降低（,P,<,0.05），尿液初级胆汁酸部分指标（CA、α-MCA、T-β-MCA、CDCA）和次级胆汁酸部分指标（DCA、GDCA）水平升高（,P,<,0.05）。组间治疗后比较，治疗组血清TBA、初级胆汁酸部分指标（CA、HCA、UDCA、GUDCA、GCDCA）和次级胆汁酸部分指标（DCA、GDCA）水平低于对照组（,P,<,0.05），尿液TBA、初级胆汁酸部分指标（CA、T-β-MCA、CDCA、UDCA）和次级胆汁酸部分指标（DCA、GDCA）水平高于对照组（,P,<,0.05）。⑤两组不良反应发生率比较，差异无统计学意义（,P,>,0.05）。,结论,2,降脂颗粒联合生活方式干预治疗湿热蕴结型NAFLD疗效满意，可有效改善患者的临床症状，调节血脂水平，其机制可能与降低血清胆汁酸水平，促进胆汁酸从尿液排泄，进而维持胆汁酸代谢稳态有关。

Abstract

Objective,2,To investigate the clinical efficacy of Jiangzhi Granule combined with lifestyle intervention in treating non-alcoholic fatty liver disease （NAFLD） patients with damp-heat accumulation syndrome and the effect on bile acid metabolism.,Methods,2,Ninety NAFLD patients with damp-heat accumulation syndrome were randomized into a treatment group （,n,=45） and a control group （,n,=45）. The lifestyle intervention was implemented to the control group， while the treatment group received Jiangzhi Granule plus lifestyle intervention. The clinical efficacy was evaluated after 16 weeks of continuous treatment through the liver ultrasound imaging， as well as comparative analysis of body weight， body mass index （BMI）， TCM syndrome scores， blood lipids profiles （TC， TG， HDL-C， and LDL-C）， and bile acids metabolome in serum and urine （TBA， CA， GCA， HCA， UDCA， GUDCA， GCDCA， CDCA， α-MCA， GHCA， TCA， DCA， LCA， GDCA， GLCA and T-β-MCA） before and after intervention. The treatment safety was assessed simultaneously.,Results,2,①There were 84 cases that finally completed the trial， including 43 cases in the treatment group and 41 cases in the control group. ②According to the liver ultrasound imaging， the total effective rate of the treatment group （62.8%） was significantly higher than that of the control group （36.6%） after intervention （,P,<,0.05）. ③After intervention， the TCM syndrome scores， body weight， BMI and serum TC and TG levels decreased in the treatment group （,P,<,0.05）， and the TCM syndrome scores and serum TG levels also decreased in the control group （,P,<,0.05）； The TCM syndrome scores and BMI in the treatment group were lower than those in the control group （,P,<,0.05）. ④In the treatment group， the levels of serum total bile acids （TBA）， primary bile acids （CA， GCA， HCA， UDCA， GUDCA， GCDCA， CDCA） and secondary bile acids （DCA， GDCA） decreased significantly after intervention （,P,<,0.05）， and the levels of urinary TBA， primary bile acids （CA， α-MCA， T-β-MCA， CDCA， UDCA） and secondary bile acids （DCA， GDCA） increased significantly after intervention （,P,<,0.05）； In the control group， the levels of serum TBA， primary bile acids （CA， GCA， UDCA， GCDCA， CDCA） and secondary bile acids （DCA， GDCA） decreased significantly after intervention （,P,<,0.05）， and the levels of urinary primary bile acids （CA， α-MCA， T-β-MCA， CDCA） and secondary bile acids （DCA， GDCA） increased significantly after intervention （,P,<,0.05）. After intervention， the levels of serum TBA， primary bile acids （CA， HCA， UDCA， GUDCA， GCDCA） and secondary bile acids （DCA， GDCA） in the treatment group were lower than those in the control group （,P,<,0.05）， and the levels of urinary TBA， primary bile acids （CA， T-β-MCA， CDCA， UDCA） and secondary bile acids （DCA， GDCA） in the treatment group were higher than those in the control group （,P,<,0.05）. ⑤There was no statistically significant difference in the incidence of adverse reactions between the two groups （,P,>,0.05）.,Conclusions,2,The combination of Jiangzhi Granule and lifestyle intervention was effective in treating NAFLD patients with damp-heat accumulation syndrome， which could significantly improve the clinical symptoms and regulate blood lipid levels of patients. The mechanism may be related to lowering the serum levels of bile acids， promoting the urinary excretion of bile acids， and maintaining the homeostasis of bile acid metabolism.

关键词

非酒精性脂肪性肝病代谢相关脂肪性肝病降脂颗粒胆汁酸代谢湿热蕴结中药研究临床试验

Keywords

non-alcoholic fatty liver diseasemetabolic associated fatty liver diseaseJiangzhi Granulebile acid metabolismdamp-heat accumulationtraditional Chinese herbal medicine researchclinical trial

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