Shenge Recipe in the treatment of senile non-alcoholic steatohepatitis with syndrome of phlegm turbidity due to spleen deficiency:A randomized,double-blind and placebo-controlled trial

MAI Jingyin; GAO Yueqiu; CAI Zheng; FANG Manqian

doi:10.16305/j.1007-1334.2018.04.013

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Shenge Recipe in the treatment of senile non-alcoholic steatohepatitis with syndrome of phlegm turbidity due to spleen deficiency:A randomized,double-blind and placebo-controlled trial

更新时间：2022-08-31

- Shenge Recipe in the treatment of senile non-alcoholic steatohepatitis with syndrome of phlegm turbidity due to spleen deficiency:A randomized,double-blind and placebo-controlled trial
- Shanghai Journal of Traditional Chinese Medicine Vol. 52, Issue 4, Pages: 44-48(2018)
- 作者机构：
  
  1. 上海中医药大学附属曙光医院肝病科,上海,201203
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2018.04.013
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MAI Jingyin, GAO Yueqiu, CAI Zheng, et al. Shenge Recipe in the treatment of senile non-alcoholic steatohepatitis with syndrome of phlegm turbidity due to spleen deficiency:A randomized,double-blind and placebo-controlled trial. [J]. Shanghai Journal of Traditional Chinese Medicine 52(4):44-48(2018)
DOI：

MAI Jingyin, GAO Yueqiu, CAI Zheng, et al. Shenge Recipe in the treatment of senile non-alcoholic steatohepatitis with syndrome of phlegm turbidity due to spleen deficiency:A randomized,double-blind and placebo-controlled trial. [J]. Shanghai Journal of Traditional Chinese Medicine 52(4):44-48(2018) DOI： 10.16305/j.1007-1334.2018.04.013.

摘要

目的：观察参葛方治疗脾虚痰浊型老年性非酒精性脂肪性肝炎的临床疗效。方法：将96例非酒精性脂肪性肝炎老年患者,随机分为治疗组与对照组,每组48例。两组均予合理饮食及运动方案,积极控制原发疾病及常规保肝抗炎药治疗,治疗组加服参葛方颗粒,对照组加服安慰剂。两组疗程均为6个月,观察B超疗效,比较肝功能、血脂、血常规、中医证候及无创肝纤维化模型指数FIB-4的情况。结果：①最终完成试验者80例,治疗组39例、对照组41例。②治疗组治愈9例,有效24例,有效率为84.6%；对照组治愈3例,有效19例,有效率为53.7%。组间B超疗效比较,差异有统计学意义,治疗组明显优于对照组(P＜0.05)。③组间治疗后比较,治疗组ALT、AST降低水平更甚于对照组(P＜0.05)。④组间治疗后比较,治疗组TC、TG降低水平更甚于对照组(P＜0.05)。⑤组间治疗后比较,治疗组中医证候积分明显低于对照组(P＜0.05)。⑥组间治疗后比较,治疗组FIB-4指数明显更低于对照组(P＜0.05)。结论：参葛方治疗脾虚痰浊型老年性非酒精性脂肪性肝炎的疗效满意,可明显改善患者临床症状、肝脏脂肪浸润程度及脂质代谢紊乱,保护肝功能,还可明显改善肝脏纤维化程度。

Abstract

Objective:To observe the clinical efficacy of Shenge Recipe in the treatment of senile non-alcoholic steatohepatitis with syndrome of phlegm turbidity due to spleen deficiency. Methods96 elderly patients with non-alcoholic steatohepatitis were randomly divided into the treatment group and control group,48 cases in each group. Patients in both groups were treated with the proper diet and exercise regimen to control the primary disease. Meanwhile,all patients were treated with conventional hepatoprotective and anti-inflammatory drugs. In addition,the treatment group was treated with Shenge Recipe granules and the control group was treated with placebo,with a course of 6 months. The efficacy was observed by B-mode ultrasound. The liver function indexes,blood lipid levels,blood routine examination,TCM syndrome score and non-invasive liver fibrosis model index based on 4 factors(FIB-4) were compared. Results:①Finally 80 cases completed the trial,among 39 cases in the treatment group and 41 cases in the control group. ②In the treatment group,9 cases were cured,24 cases were effective and the effective rate was 84.6%. While in the control group,3 cases were cured,19 cases were effective and the effective rate was 53.7%. There was statistically significant difference on the efficacy of B-mode ultrasound,and the effective rate in the treatment group was obviously higher than that in the control group (P<0.05). ③After treatment,the levels of alanine transaminase (ALT) and aspartate transaminase (AST) in the treatment group were significantly lower than those in the control group (P<0.05). ④After treatment,the levels of total cholesterol (TC) and triglyceride (TG) in the treatment group were significantly lower than those in the control group (P<0.05). ⑤After treatment,the TCM syndrome score in the treatment group was significantly lower than that in the control group (P<0.05). ⑥After treatment,the FIB-4 index in the treatment group was significantly lower than that in the control group (P<0.05). Conclusion:Shenge Recipe shows satisfactory efficacy on senile non-alcoholic steatohepatitis with syndrome of phlegm turbidity due to spleen deficiency,which can obviously improve the clinical symptoms,the degree of hepatic fatty infiltration and the disorder of lipid metabolism in patients,protect the liver function,and also significantly allievate the degree of liver fibrosis.

关键词

非酒精性脂肪性肝炎脾虚痰浊证老年人群参葛方肝功能肝纤维化

Keywords

non-alcoholic steatohepatitissyndrome of phlegm turbidity due to spleen deficiencyelderly populationShenge Recipeliver functionliver fibrosis

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