西北药学杂志2025，Vol.40Issue(3) ：214-220.DOI:10.3969/j.issn.1004-2407.2025.03.030

强肝胶囊联合双环醇片治疗非酒精性脂肪性肝炎的疗效

Efficacy of Qianggan Capsules combined with Dicycloalcohol Tablets in the treatment of nonalcoholic steatohepatitis

李小珍 冯丹丹 赵华山
西北药学杂志2025，Vol.40Issue(3) ：214-220.DOI:10.3969/j.issn.1004-2407.2025.03.030
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强肝胶囊联合双环醇片治疗非酒精性脂肪性肝炎的疗效

Efficacy of Qianggan Capsules combined with Dicycloalcohol Tablets in the treatment of nonalcoholic steatohepatitis

李小珍 1冯丹丹 2赵华山3
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作者信息

  • 1. 河南科技大学第一附属医院消化内科,洛阳 471000
  • 2. 河南科技大学第一附属医院中心实验室,洛阳 471000
  • 3. 河南科技大学第一附属医院全科医学科,洛阳 471000
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摘要

目的 探讨强肝胶囊联合双环醇片治疗非酒精性脂肪性肝炎(non-alcoholic steatohepatitis,NASH)的临床疗效,以及对患者肝纤维化和血清氧化应激、白细胞介素-18(interleukin-18,IL-18)、细胞角蛋白18片段M30(cytokeratin 18 fragment M30,CK-18 M30)水平的影响.方法 选取2022年6月—2023年6月收治的84例NASH患者作为研究对象,用随机数字表法分为2组,每组42例.对照组给予双环醇片治疗,观察组在对照组治疗的基础上联合强肝胶囊治疗.2组均治疗12周.评价2组的临床疗效,统计2组患者不良反应的发生情况.比较治疗前后2组的肝功能指标[丙氨酸氨基转移酶(alanine aminotransferase,ALT)、天冬氨酸氨基转移酶(aspartate aminotransferase,AST)]、血脂指标[总胆固醇(total cholesterol,TC)、三酰甘油(triglycerides,TG)]、肝/脾CT值比值、肝纤维化指标[肝脏硬度测量(liver stiffness measurement,LSM)值、基于 4 因子的肝纤维化指数(fibrosis index based on the four factors,FIB-4)、AST与血小板(platelets,PLT)比值指数(AST/platelet ratio index,APRI)],以及血清谷胱甘肽过氧化物酶(glutathione peroxidase,GPx)、8-异前列腺素F2α(8-iso-prostaglandin F2α,8-iso-PGF2α)、IL-18、CK-18 M30水平.结果 观察组的ALT、肝/脾CT值的总有效率分别为90.48%、73.81%,均显著高于对照组(76.19%、52.38%),P<0.05.治疗后,2组的ALT、AST、TC、TG水平均显著降低(P<0.05),肝/脾CT值比值均显著升高(P<0.05),且观察组以上各指标的变化均更明显(P<0.05).治疗后,2组的LSM值、FIB-4、APRI均显著降低(P<0.05),且观察组以上各指标的变化均更明显(P<0.05).治疗后,2组的血清GPx水平均上升(P<0.05),血清8-iso-PGF2α、IL-18、CK-18 M30水平均下降(P<0.05),且观察组的血清GPx水平高于对照组(P<0.05),血清8-iso-PGF2α、IL-18、CK-18 M30水平均显著低于对照组(P<0.05).观察组的1级不良反应率[7.14%(3/42)]与对照组[4.76%(2/42)]比较,差异无统计学意义(P>0.05).结论 强肝胶囊联合双环醇片治疗NASH的总体疗效确切,能安全、有效地改善患者的肝功能和血脂水平,抑制肝纤维化,其作用可能与其进一步调节血清氧化应激和IL-18、CK-18 M30水平有关.

Abstract

Objective To investigate the clinical efficacy of Qianggan Capsules combined with Dicycloalcohol Tablets in the treatment of non-alcoholic steatohepatitis(NASH)and its effects on liver fibrosis,serum oxidative stress,interleukin-18(IL-18),and cytokeratin 18 fragment M30(CK-18 M30)levels.Methods A total of 84 patients with NASH admitted to our hospital from June 2022 to June 2023 were randomly divided into 2 groups by using a random number table method.The control group received Dicycloalcohol Tablets,while the observation group received Qianggan Capsules in addition to Dicycloalcohol Tablets for 12 weeks.The clinical efficacy of both groups was evaluated,and adverse drug reactions were recorded.Liver function indices[alanine aminotransferase(ALT)and aspartate aminotransferase(AST)],blood lipid indices[total cholesterol(TC),and triglycerides(TG)],and liver/spleen CT value ratios were compared between the 2 groups before and after treatment.Liver fibrosis indicators[liver stiffness measurement(LSM)value,fibrosis index based on the four factors(FIB-4),and AST/platelets(PLT)ratio index(APRI)],and the serum levels of glutathione peroxidase(GPx),8-iso-prostaglandin F2α(8-iso-PGF2α),IL-18,and CK-18 M30 were also assessed.Results The total effective rates for ALT and liver/spleen CT in the observation group were 90.48%and 73.81%,respectively,significantly higher than those in the control group(76.19%and 52.38%,P<0.05).Post-treatment,the ALT,AST,TC and TG levels significantly decreased in both groups(P<0.05),with the liver/spleen CT value ratio significantly increasing(P<0.05),particularly in the observation group(P<0.05).LSM value,FIB-4,and APRI significantly decreased in both groups post-treatment(P<0.05),with more pronounced reductions in the observation group(P<0.05).Serum GPx levels significantly increased(P<0.05),while serum 8-iso-PGF2α,IL-18,and CK-18 M30 levels significantly decreased(P<0.05).The observation group exhibited significantly higher serum GPx levels and significantly lower serum 8-iso-PGF2α,IL-18,and CK-18 M30 levels compared with the control group(P<0.05).The incidence of grade 1 adverse reactions was 7.14%(3/42)in the observation group and 4.76%(2/42)in the control group,with no significant difference between the groups(P>0.05).Conclusion The combination of Qianggan Capsules and Dicycloalcohol Tablets demonstrates definite overall efficacy in treating NASH.It safely and effectively improves liver function and lipid levels,inhibits liver fibrosis,and may be related to the regulation of serum oxidative stress and IL-18,CK-18 M30 levels.

关键词

非酒精性脂肪性肝炎/强肝胶囊/双环醇片/肝纤维化/氧化应激/白细胞介素-18/细胞角蛋白18片段M30

Key words

non-alcoholic steatohepatitis/Qianggan Capsules/Dicycloalcohol Tablets/liver fibrosis/oxidative stress/interleukin-18/cytokeratin 18 fragment M30

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出版年

2025
西北药学杂志
西安交通大学,陕西省药学会

西北药学杂志

影响因子：0.912
ISSN：1004-2407
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