Clinical Randomized Controlled Trial of Traditional Chinese Medicine Compound Shenlong Decoction Granules in Treatment of Idiopathic Pulmonary Fibrosis
10.13422/j.cnki.syfjx.20251291
- VernacularTitle:中药复方参龙煎剂颗粒剂治疗特发性肺纤维化临床随机对照试验
- Author:
Qi SI
1
;
Ningzi ZANG
2
;
Mei WANG
1
;
Weidong ZHENG
2
;
Chuang LIU
2
;
Yongming LIU
2
;
Haoyang ZHANG
2
;
Zhongxue ZHAO
2
;
Jiyu ZOU
1
;
Jingze LI
1
;
Lijian PANG
2
;
Xiaodong LYU
1
Author Information
1. Liaoning University of Traditional Chinese Medicine（TCM），Shenyang 110847，China
2. Affiliated Hospital of Liaoning University of TCM，Shenyang 110032，China
- Publication Type:Journal Article
- Keywords:
Shenlong decoction;
idiopathic pulmonary fibrosis;
lung deficiency and collateral stasis syndrome;
randomized controlled trial;
clinical efficacy
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(11):237-245
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo assess the therapeutic effectiveness and safety of the traditional Chinese medicine compound Shenlong decoction in addressing the symptoms of pulmonary deficiency and stasis in patients with idiopathic pulmonary fibrosis （IPF）. MethodsSixty eligible patients with lung deficiency and collateral stasis syndrome of IPF were randomly assigned to the observation （30 patients） and control groups （30 patients）. All patients underwent standard Western medical therapy. Additionally，the observation group received Shenlong decoction granules，while the control group received a placebo. Both treatments were packaged in four doses of 10.5 g each，taken twice daily for three months. The indexes of the patients during the treatment cycle were observed，and the main indexes include traditional Chinese medicine （TCM） syndrome scores and 6 min walk test （6MWT）. The secondary indexes include pulmonary function test ［actual value/expected value of total lung volume （TLC%），actual value/expected value of vital capacity（FVC%），actual/predicted diffusing capacity of the lung for carbon monoxide（DLCO%），actual/predicted forced expiratory volume in one second （FEV1%），and FEV1/ forced vital capacity （FVC）］，blood gas analysis ［arterial blood diathesis partial pressure of oxygen （PaO2），partial pressure of carbon dioxide （PaCO2），and arterial oxygen saturation （SaO2）］，serum inflammatory factors ［transforming growth factor-β1 （TGF-β1），interleukin-4 （IL-4），interleukin-13 （IL-13），interleukin-12 （IL-12），and gamma-interferon （IFN-γ）］，and quality of survival evaluation ［St George's Respiratory Questionnaire （SGRQ） score］. The patients' clinical manifestations were determined at the end of the treatment， and the occurrence of adverse events was recorded. ResultsA total of 53 patients completed the study，comprising 27 in the control group and 26 in the observation group. Upon completion of the treatment period，the control group achieved a total effective rate of 33.33% （9/27），whereas the observation group demonstrated a total effective rate of 53.85% （14/26），which was statistically superior to the control group （χ2=4.034，P<0.05）. After the treatment，the TCM syndrome scores，6MWT，DLCO%，FEV1%，PaO2，PaCO2，TGF-β1，IL-4，IL-13，IL-12，and IFN-γ in the two groups were all significantly improved （P<0.01）. Compared with those in the control group after treatment at the same period，the TCM syndrome scores，6MWT，PaO2，and PaCO2 were significantly improved in the observation group after 60 days and 90 days of medication （P<0.01）. Three months after the end of medication，the SGRQ score in the observation group showed significant improvement when compared to that in the control group （P<0.05），and no severe adverse events were reported during the follow-up period. ConclusionCompound Shenlong decoction can alleviate clinical symptoms such as shortness of breath and wheezing in patients with lung deficiency and collateral stasis syndrome of IPF，enhance exercise tolerance，improve the quality of life，and have certain potential advantages in improving pulmonary function.
