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中国临床药理学与治疗学 ›› 2024, Vol. 29 ›› Issue (10): 1161-1167.doi: 10.12092/j.issn.1009-2501.2024.10.009

• 药物治疗学 • 上一篇    下一篇

阿法骨化醇联合熊去氧胆酸对原发性胆汁性胆管炎的疗效研究

张梓珊1,张耀武2,董晓明2,高雪2   

  1. 1山西医科大学汾阳学院,汾阳  032200,山西;2山西医科大学附属汾阳医院感染性疾病科,汾阳  032200,山西

  • 收稿日期:2024-01-08 修回日期:2024-02-27 出版日期:2024-10-26 发布日期:2024-09-29
  • 通讯作者: 张耀武,男,硕士,主任医师,硕士生导师,教授,研究方向:肝病。 E-mail: zyw5680@126.com
  • 作者简介:张梓珊,女,在读硕士研究生,研究方向:自身免疫性肝病。 E-mail: zhang244s@163.com
  • 基金资助:
    山西省卫健委科研基金项目(2023XG112)

Study on the efficacy of alfacalcidol combined with ursodeoxycholic acid in primary biliary cholangitis

ZHANG Zishan1, ZHANG Yaowu2, DONG Xiaoming2, GAO Xue2   

  1. 1 Fenyang College, Shanxi Medical University, Fenyang 032200, Shanxi, China; 2 Fenyang Hospital of Shanxi Medical University, Fenyang 032200, Shanxi, China
  • Received:2024-01-08 Revised:2024-02-27 Online:2024-10-26 Published:2024-09-29

摘要:

目的:探究阿法骨化醇联合熊去氧胆酸(UDCA)对原发性胆汁性胆管炎(PBC)的疗效及抗肝纤维化作用。方法:2022年6月至2023年6月山西省汾阳医院收治的符合纳入标准的25羟维生素D即25(OH)D3<50 nmol/L的PBC患者70例,随机分为治疗组35例和对照组35例,治疗组为阿法骨化醇联合UDCA治疗;对照组为UDCA单独治疗。持续治疗6月后检查患者的25(OH)D3、血小板、肝功能、免疫球蛋白、肝硬度(LSM)和药物不良反应,计算FIB-4指数(fibrosis 4 score)、天冬氨酸转氨酶和血小板比率指数(aspartate aminotransferase to platelet ratio index,APRI)评分、GLOBE评分和UK-PBC评分,满足正态分布的计量资料采用均数±标准差([x]±s)表示,两组间比较用独立样本t检验;不满足正态分布的计量资料采用M(P25,P75)表示,两组间比较采用Mann-Whitney U检验;应答率比较用卡方检验。结果:治疗后对照组和治疗组应答率分别为42.85%和71.42%;γ-谷氨酰转肽酶(GGT)分别为160(128,194)、85(72,102)U/L,碱性磷酸酶(ALP)分别为156(123,264)、110(56,141)U/L;免疫球蛋白M(IgM)分别为(3.51±0.84)、(2.71±0.81)g/L;25(OH)D3分别为(40.21±3.25)、(57.06±14.76)nmol/L;肝硬度分别为10.8(8.3,15.1)、8.9(6.7,12.2)Kpa;FIB-4指数分别为2.28(0.99,3.66)、1.46(0.97,2.55);APRI评分分别为0.65(0.33,1.09)、0.30(0.17,0.53);GLOBE评分分别为0.85±0.73、0.13±0.51;UK-PBC评分分别为0.024(0.018,0.060)、0.021(0.012,0.033),差异均有统计学意义(均P<0.05)。结论:阿法骨化醇联合UDCA较单独应用UDCA可显著提高PBC患者治疗应答率,而且阿法骨化醇一定程度上可改善肝纤维化,有助于PBC的病情改善,无不良反应。

关键词: 25(OH)D3, 熊去氧胆酸, 原发性胆汁性胆管炎, 治疗效果, 肝纤维化

Abstract:

AIM: To investigate the efficacy and anti-hepatic fibrosis of alfacalcidol combined with ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC). METHODS: Seventy cases of PBC patients with 25 hydroxyvitamin D (25(OH)D3)<50 nmol/L, admitted to Fenyang Hospital in Shanxi Province from June 2022 to June 2023, who met the inclusion criteria, were randomly divided into 35 cases in the treatment group and 35 cases in the control group. and the treatment group was treated with alfacalcidol combined with UDCA; the control group was treated with UDCA alone; after 6 months of treatment, the patients were examined for 25(OH)D3, platelets, liver function, immunoglobulin, liver stiffness (LSM), and adverse drug reactions, and the FIB-4 index, APRI score, GLOBE score, and UK-PBC score were calculated. Measurements that satisfied the normal distribution were expressed as [x]±s, and comparisons between the two groups were made with the t-test; those that did not satisfy the normal distribution were expressed as M (P25, P75) was used to express the information, and the Mann-Whitney U test was used to compare the two groups. Response rates were compared with the chi-square test. RESULTS: The response rates in the control and experimental groups after treatment were  42.85% and 71.42%; γ-glutamyl transpeptidase (GGT) was 160 (128, 194) and 85 (72, 102) U/L; alkaline phosphatase (ALP) was 156 (123, 264) and 110 (56, 141) U/L; respectively; immunoglobulin M (IgM) were 3.51±0.84 and 2.71±0.81 g/L; 25(OH)D3 was 40.21±3.25 and 57.06±14.76 nmol/L; respectively, liver hardness was 10.8 (8.3, 15.1) and 8.9 (6.7, 12.2) KPa; respectively, and FIB-4 index was 2.28 (0.99, 3.66) and 1.46 (0.97, 2.55); respectively, APRI scores were 0.65 (0.33, 1.09) and 0.30 (0.17, 0.53); respectively, GLOBE scores were 0.85±0.73 and 0.13±0.51, and UK-PBC scores were 0.024 (0.018, 0.060) and 0.021 (0.012, 0.033), and the differences were statistically significant (all P<0.05). CONCLUSION: Alfacalcidol combined with UDCA significantly increased the treatment response rate of PBC patients compared with UDCA alone, and alfacalcidol improved hepatic fibrosis to a certain extent, contributing to the improvement of PBC without adverse effects.

Key words: 25(OH)D3, UDCA, PBC, therapeutic effect, liver fibrosis

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