The clinical efficacy of hydrogen combined with tetrandrine in the treatment of silicosis fibrosis: A randomized controlled intervention study.

2026-08
Respiratory medicine 260
- Kang Xiao
- Yanping Sang
- Mao Cao
- Yong Yang
- Mengjie Cheng
- Jiazi Ma
- Siqi Wang
- Xinyue Li
- Xuansheng Ding
- Zhongjun Du

PubMed: 42250702
DOI: 10.1016/j.rmed.2026.108939

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 116
Population: 116 patients with stage II silicosis
Methods: prospective, randomized, double-blind, controlled study, Tet alone or Tet combined with H2 inhalation
Blinding: Double-blind
Funding: Unclear

Large Human Trial

Objective

This study aimed to evaluate the efficacy of tetrandrine (Tet) alone and in combination with hydrogen (H₂) inhalation in patients with stage II silicosis.

Methods

In this prospective, randomized, double-blind, controlled study, 116 patients with stage II silicosis treated at Lai Zhou City Chronic Disease Prevention and Treatment Hospital were enrolled. The assessed outcomes included pulmonary function, exercise tolerance, clinical symptoms, and serum interleukin-6 (IL-6) levels following treatment with Tet alone or Tet combined with H₂ inhalation.

Results

From October 2023 to February 2024, 116 patients were enrolled, and 108 were included in the final analysis, with 54 patients in the Tet monotherapy group and 54 patients in the H₂ plus Tet combination therapy group. Combination therapy with hydrogen significantly improved diffusing capacity for carbon monoxide (diffusing capacity of the lung for carbon monoxide) compared with Tet alone (7.370 L vs. 8.589 L, P < 0.05). Additionally, it significantly reduced serum IL-6 levels (4.74 mg/L vs. 2.32 mg/L, P < 0.05) and alleviated clinical symptoms, including dyspnea.

Conclusions

H₂ combined with Tet was more effective than Tet alone in the treatment of stage II silicosis.

Research Insights

Stephania→Improved Diffusing Capacity for Carbon Monoxide
Combination therapy with hydrogen significantly improved diffusing capacity for carbon monoxide ... compared with Tet alone (7.370 L vs. 8.589 L, P < 0.05).
Effect
Beneficial
Effect size
Moderate
Stephania→Reduced Dyspnea
alleviated clinical symptoms, including dyspnea
Effect
Beneficial
Effect size
Small
Stephania→Reduced Interleukin-6 Levels
Additionally, it significantly reduced serum IL-6 levels (4.74 mg/L vs. 2.32 mg/L, P < 0.05)
Effect
Beneficial
Effect size
Large