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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2024, Vol. 29 ›› Issue (10): 1161-1167.doi: 10.12092/j.issn.1009-2501.2024.10.009

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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

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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