骨化三醇补充治疗可加速维生素 D 缺乏的肺结核患者康复：一项随机、单盲、对照临床试验。

Calcitriol supplementation accelerates the recovery of patients with tuberculosis who have vitamin D deficiency: a randomized, single-blind, controlled clinical trial.

机构信息

Department of Respiratory Medicine, Zigong First People's Hospital, Zigong, 643000, Sichuan Province, People's Republic of China.

Department of Internal Medicine, Department of Obstetrics, Shenzhen Baoan Women's and Children's Hospital, Jinan University, No. 56 Yulv Road, Baoan District, Shenzhen, 518102, Guangdong Province, People's Republic of China.

出版信息

BMC Infect Dis. 2022 May 5;22(1):436. doi: 10.1186/s12879-022-07427-x.

DOI:10.1186/s12879-022-07427-x

PMID:35513795

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9074353/

Abstract

BACKGROUND

This study aimed to evaluate whether calcitriol supplementation enhances CD4 T cell count and prognosis in patients with tuberculosis and low 25(OH)D levels.

METHODS

This randomized controlled clinical trial enrolled treatment-naïve patients with tuberculosis admitted to Zigong First People's Hospital (June 2016 to April 2017). The patients were grouped as the serum 25(OH)D ≥ 75 nmol/L (Normal-25(OH)D) and 25(OH)D < 75 nmol/L (Low-25(OH)D) groups. The Low-Vit-D group was randomized to the Low-25(OH)D and Low-25(OH)D-Calcitriol groups. All patients were treated with the 2HRZE/4HR regimen. The patients in the Low-25(OH)D-Calcitriol group received calcitriol 0.25 µg bid. The main endpoints were CD4 T cell count during treatment, time to sputum culture conversion, time to 50% lesion absorption, and a 6-month cure rate.

RESULTS

This study included 30 patients in each group. Baseline 25-(OH) D levels and CD4 T cell counts were higher in the Normal-25(OH)D group than in the Low-25(OH)D and Low-25(OH)D-Calcitriol groups (25(OH)D: 79.3 ± 3.4 vs. 37.8 ± 13.4 vs. 11.9 nmol/L, P < 0.05; 671 ± 287 vs. 200 ± 110 vs. 194 ± 119 cell/µL, P < 0.05). 25-(OH) D levels and CD4 T cell counts increased in the Low-25(OH)D-Calcitriol group during treatment to reach higher levels than in the Low-25(OH)D group at 1, 4, 8, and 24 weeks (all P < 0.05). Compared with the Low-25(OH)D group, the Low-25(OH)D-Calcitriol group showed shorter time to sputum culture conversion (3.2 ± 1.4 vs. 5.9 ± 2.5 days, P < 0.001) and time to 50% lesion absorption (7.4 ± 1.5 vs. 10.9 ± 4.0 days, P = 0.014) and similar to those in the Normal-25(OH)D group (3.1 ± 1.2 and 7.3 ± 1.5 days, respectively. The cure rate was 86.7% in the Low-25(OH)D group and 96.7% in the two other groups.

CONCLUSIONS

Calcitriol supplementation can elevate CD4 T cell levels, shorten the time to sputum culture conversion, and accelerate lesion absorption in patients with tuberculosis and 25(OH)D deficiency. Trial registration The study is registered at the Chinese Clinical Trial Registry (ChiCTR2000039832).

摘要

背景

本研究旨在评估骨化三醇补充是否能提高结核患者的 CD4 T 细胞计数并改善其预后，这些患者的 25(OH)D 水平较低。

方法

这是一项随机对照临床试验，纳入了自贡市第一人民医院（2016 年 6 月至 2017 年 4 月）收治的初治结核患者。患者被分为血清 25(OH)D≥75 nmol/L（正常 25(OH)D）和 25(OH)D<75 nmol/L（低 25(OH)D）组。低 25(OH)D 组再随机分为低 25(OH)D 组和低 25(OH)D-骨化三醇组。所有患者均接受 2HRZE/4HR 方案治疗。低 25(OH)D-骨化三醇组患者接受骨化三醇 0.25µg bid 治疗。主要终点为治疗期间的 CD4 T 细胞计数、痰培养转阴时间、50%病灶吸收时间和 6 个月的治愈率。

结果

每组各纳入 30 例患者。正常 25(OH)D 组的 25-(OH)D 水平和 CD4 T 细胞计数均高于低 25(OH)D 组和低 25(OH)D-骨化三醇组（25(OH)D：79.3±3.4 vs. 37.8±13.4 vs. 11.9 nmol/L，P<0.05；671±287 vs. 200±110 vs. 194±119 cell/µL，P<0.05）。低 25(OH)D-骨化三醇组在治疗期间 25-(OH)D 水平和 CD4 T 细胞计数升高，在第 1、4、8 和 24 周时均高于低 25(OH)D 组（均 P<0.05）。与低 25(OH)D 组相比，低 25(OH)D-骨化三醇组痰培养转阴时间更短（3.2±1.4 vs. 5.9±2.5 天，P<0.001），病灶吸收时间更快（7.4±1.5 vs. 10.9±4.0 天，P=0.014），与正常 25(OH)D 组相似（分别为 3.1±1.2 和 7.3±1.5 天）。低 25(OH)D 组的治愈率为 86.7%，其他两组均为 96.7%。