| 郭元彪,应海峰,徐佳悦,朱文华,程时丹.熊去氧胆酸联合非诺贝特对原发性胆汁性胆管炎的临床疗效及安全性[J].,2021,(14):2670-2674 |
| 熊去氧胆酸联合非诺贝特对原发性胆汁性胆管炎的临床疗效及安全性 |
| Clinical Efficacy and Safety of Ursodeoxycholic Acid Combined with Fenofibrate in the Treatment of Primary Biliary Cholangitis without Ursodeoxycholic Acid Biochemical Reaction |
| 投稿时间：2021-02-06 修订日期：2021-02-28 |
| DOI：10.13241/j.cnki.pmb.2021.14.015 |
| 中文关键词: 原发性胆汁性胆管炎 非诺贝特 无熊去氧胆酸生化反应 临床疗效 安全性 |
| 英文关键词: Primary Biliary Cirrhosis Fenofibrate No Ursodeoxycholic Acid Biochemical Reaction Clinical Efficacy Safety |
| 基金项目:国家中医药管理局国家中医临床研究基地科研项目（JDZX2015068） |
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| 中文摘要: |
| 摘要 目的：分析熊去氧胆酸联合非诺贝特对原发性胆汁性胆管炎无熊去氧胆酸生化反应的临床疗效及安全性。方法：151例原发性胆汁性胆管炎无熊去氧胆酸患者按随机数表法分为73例对照组和78例研究组。对照组在常规治疗基础上给予安慰剂联合熊去氧胆酸治疗，研究组在常规基础上给予非诺贝特联合熊去氧胆酸治疗，两组均持续治疗12个月。比较两组临床疗效，肝功能，血脂指标，肝纤维化指标，免疫球蛋白G（IgG）、免疫球蛋白M（IgM），瘙痒及乏力评分，不良反应发生情况。结果：治疗后，研究组总有效率高于对照组，比较差异有统计学意义（P<0.05）。治疗后，两组肝功能指标均降低，研究组低于对照组，比较有统计学意义（P<0.05）。治疗后，两组总胆固醇（TC）、甘油三酯（TG）均降低，研究组低于对照组，比较有统计学意义（P<0.05），两组治疗前后低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）比较无统计学意义（P>0.05）。治疗后，两组肝纤维化指标均降低，研究组低于对照组，比较有统计学意义（P<0.05）。治疗后，两组IgG、IgM均降低，研究组低于对照组，比较有统计学意义（P<0.05）。治疗后，两组瘙痒、乏力评分均降低，研究组低于对照组，比较有统计学意义（P<0.05）。两组不良反应发生率比较差异无统计学意义（P>0.05）。结论：熊去氧胆酸联合非诺贝特对原发性胆汁性胆管炎无熊去氧胆酸生化反应的疗效较好，能够改善肝功能，且未明显增加药物不良反应。 |
| 英文摘要: |
| ABSTRACT Objective: To analyze the clinical efficacy and safety of ursodeoxycholic acid combined with fenofibrate in the treatment of primary biliary cholangitis without ursodeoxycholic acid biochemical reaction. Methods: 151 patients with primary biliary cholangitis without ursodeoxycholic acid who according to random number table method were divided into 73 cases of control group and 78 cases of research group. control group was treated with placebo combined with ursodeoxycholic acid on the basis of conventional treatment, research group was treated with fenofibrate combined with deoxycholic acid based on the basis of conventional treatment. The clinical efficacy, liver function, blood lipid index, liver fibrosis index, immunoglobulin G(IgG), immunoglobulin M(IgM), itching and fatigue scores, and adverse reactions were compared between the two groups. Results: After treatment, the total effective rate of the research group was higher than that of the control group, and the difference was statistically significant (P<0.05). After treatment, the liver function indexes of the two groups decreased, which was lower in the research group than in the control group (P<0.05). After treatment, the total cholesterol (TC) and triglyceride (TG) of the two groups decreased, which was lower in the research group than that of the control group (P<0.05), there was no significant difference in LDL-C and HDL-C between the two groups before and after treatment (P>0.05). After treatment, the index of liver fibrosis in both groups decreased, which was lower in the research group than in the control group (P<0.05). After treatment, IgG and IgM decreased in both groups, which were lower in the research group than in the control group (P<0.05). After treatment, the scores of pruritus and fatigue in both groups decreased, which was lower in the research group than in the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). Conclusion: Fenofibrate has a good effect on primary biliary cholangitis without ursodeoxycholic acid biochemical reaction, and can improve liver function without significantly increasing adverse drug reactions. |
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