Luwei Yang1, Qian Wang1, Yong Hou1, Jiuliang Zhao1, Mengtao Li1, Dong Xu2, Xiaofeng Zeng3. 1. Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China. 2. Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China. xudong74@hotmail.com. 3. Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China. xiaofengzeng@cstar.org.cn.
Abstract
OBJECTIVE: To assess the efficacy and safety of the Chinese herb Tripterygium wilfordii Hook F (TwHF) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS:SSc-ILD patients who were regularly treated for more than 1 year and were currently taking a stable dose of TwHF (40-60 mg/day) or CYC (100 mg/day) were selected from the EUSTAR database of Peking Union Medical College Hospital. The efficacy of treatments was assessed by the change in pulmonary function, including the forced vital capacity (FVC) and the percentage of predicted FVC (FVC pred%). RESULTS: Among the 431 patients diagnosed with SSc-ILD, 76 fulfilled the inclusion and exclusion criteria. Twenty eight patients received TwHF monotherapy, while 48 received oral CYC monotherapy. Baseline data prior to treatment did not differ significantly between the two groups. After 1 year of treatment, significant improvements in the FVC and FVC pred% were seen in both groups (P < 0.05) and the magnitude of improvement was comparable (P = 0.93). However, TwHF was only found to be effective in improving FVC and FVC pred% when administered as a maintenance therapy, but not as an induction therapy. No severe adverse events were seen in either group. Leucopenia occurred more often in the CYC group compared to the TwHF group (P = 0.034). CONCLUSION:TwHF may be considered as a potential alternative drug for SSc-ILD patients, especially as a maintenance therapy. A prospective randomized controlled trial is necessary to further confirm these results.Key Points• This is the first clinical study of Tripterygiumwilfordii Hook F (TwHF) in the treatment of SSc-ILD, providing a novel therapeutic option for SSc-ILD.• TwHF shows a comparable therapeutic efficacy to CYC when treating SSc-ILD.• TwHF has unique therapeutic advantages considering the balance of economy and safety and may be a good potential choice for maintenance therapy.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety of the Chinese herb Tripterygium wilfordii Hook F (TwHF) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS:SSc-ILDpatients who were regularly treated for more than 1 year and were currently taking a stable dose of TwHF (40-60 mg/day) or CYC (100 mg/day) were selected from the EUSTAR database of Peking Union Medical College Hospital. The efficacy of treatments was assessed by the change in pulmonary function, including the forced vital capacity (FVC) and the percentage of predicted FVC (FVC pred%). RESULTS: Among the 431 patients diagnosed with SSc-ILD, 76 fulfilled the inclusion and exclusion criteria. Twenty eight patients received TwHF monotherapy, while 48 received oral CYC monotherapy. Baseline data prior to treatment did not differ significantly between the two groups. After 1 year of treatment, significant improvements in the FVC and FVC pred% were seen in both groups (P < 0.05) and the magnitude of improvement was comparable (P = 0.93). However, TwHF was only found to be effective in improving FVC and FVC pred% when administered as a maintenance therapy, but not as an induction therapy. No severe adverse events were seen in either group. Leucopenia occurred more often in the CYC group compared to the TwHF group (P = 0.034). CONCLUSION:TwHF may be considered as a potential alternative drug for SSc-ILDpatients, especially as a maintenance therapy. A prospective randomized controlled trial is necessary to further confirm these results.Key Points• This is the first clinical study of Tripterygium wilfordii Hook F (TwHF) in the treatment of SSc-ILD, providing a novel therapeutic option for SSc-ILD.• TwHF shows a comparable therapeutic efficacy to CYC when treating SSc-ILD.• TwHF has unique therapeutic advantages considering the balance of economy and safety and may be a good potential choice for maintenance therapy.
Authors: Gary W Hoyle; Christine I Hoyle; Jing Chen; Weiyuan Chang; Ronald W Williams; Roy J Rando Journal: Am J Physiol Lung Cell Mol Physiol Date: 2010-03-26 Impact factor: 5.464
Authors: Philip J Clements; Michael D Roth; Robert Elashoff; Donald P Tashkin; Jonathan Goldin; Richard M Silver; Mildred Sterz; James R Seibold; Dean Schraufnagel; Robert W Simms; Marcy Bolster; Robert A Wise; Virginia Steen; M D Mayes; Kari Connelly; Mark Metersky; Daniel E Furst Journal: Ann Rheum Dis Date: 2007-05-07 Impact factor: 19.103
Authors: Donald P Tashkin; Michael D Roth; Philip J Clements; Daniel E Furst; Dinesh Khanna; Eric C Kleerup; Jonathan Goldin; Edgar Arriola; Elizabeth R Volkmann; Suzanne Kafaja; Richard Silver; Virginia Steen; Charlie Strange; Robert Wise; Fredrick Wigley; Maureen Mayes; David J Riley; Sabiha Hussain; Shervin Assassi; Vivien M Hsu; Bela Patel; Kristine Phillips; Fernando Martinez; Jeffrey Golden; M Kari Connolly; John Varga; Jane Dematte; Monique E Hinchcliff; Aryeh Fischer; Jeffrey Swigris; Richard Meehan; Arthur Theodore; Robert Simms; Suncica Volkov; Dean E Schraufnagel; Mary Beth Scholand; Tracy Frech; Jerry A Molitor; Kristin Highland; Charles A Read; Marvin J Fritzler; Grace Hyun J Kim; Chi-Hong Tseng; Robert M Elashoff Journal: Lancet Respir Med Date: 2016-07-25 Impact factor: 30.700