Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, China.
The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
Trials. 2022 Feb 2;23(1):103. doi: 10.1186/s13063-022-06026-0.
At present, there is short of effective treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF). The treatment of IPF with traditional Chinese medicine (TCM) has some advantages. However, the evidence is unclear whether TCM can be recommended as an effective therapy to treat AE-IPF. The purpose of the study is to explore the efficacy and safety of TCM for patients with AE-IPF.
A randomized, double-blind, placebo-controlled, exploratory clinical trial will be performed. A total of 80 patients diagnosed with AE-IPF will be randomized into the intervention or control group. In addition to conventional treatment, the intervention group will be treated with Kangxianhuanji granule, and the control group will be given a placebo granule. The administration frequency is 10 g each time and two times daily. After 4 weeks of treatment, the patients were followed up for 12 weeks. The primary outcomes are treatment failure rate and all-cause mortality. Secondary outcome measures will include the length of hospitalization, overall survival, acute exacerbation rate, intubation rate, Modified British Medical Research Council (mMRC) score, the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis (SGRQ-I) score, and arterial blood gas analysis.
TCM may be beneficial in IPF. However, it has never been evaluated in patients with AE-IPF, who are incredibly prone to respiratory failure and have a high mortality rate. It is the first clinical trial to explore the efficacy and safety of TCM in the treatment of AE-IPF. This result will provide a basis for further study, which provides a high-quality evidence for the treatment of AE-IPF with TCM.
Chinese Clinical Trial Registry ChiCTR1900026289 . Registered on 29 September 2019.
目前，特发性肺纤维化（IPF）急性加重症（AE-IPF）缺乏有效的治疗方法。中医药（TCM）治疗 IPF 具有一定优势。但 TCM 是否可作为有效的治疗方法推荐用于 AE-IPF 尚缺乏证据。本研究旨在探索 TCM 治疗 AE-IPF 的疗效和安全性。
采用随机、双盲、安慰剂对照、探索性临床试验。将 80 例确诊为 AE-IPF 的患者随机分为干预组和对照组。除常规治疗外，干预组给予抗纤环肌颗粒治疗，对照组给予安慰剂颗粒治疗。给药频率为每次 10g，每日 2 次。治疗 4 周后，对患者进行 12 周的随访。主要结局是治疗失败率和全因死亡率。次要结局指标包括住院时间、总生存率、急性加重率、插管率、改良英国医学研究理事会呼吸困难量表（mMRC）评分、圣乔治呼吸问卷特发性肺纤维化（SGRQ-I）评分和动脉血气分析。
TCM 可能对 IPF 有益。然而，它从未在 AE-IPF 患者中进行过评估，这些患者极易发生呼吸衰竭且死亡率极高。这是首个探索 TCM 治疗 AE-IPF 疗效和安全性的临床试验。该结果将为进一步研究提供依据，为 TCM 治疗 AE-IPF 提供高质量的证据。
中国临床试验注册中心 ChiCTR1900026289 。注册于 2019 年 9 月 29 日。
