Sinomenine(SIN)is commonly used as part of rheumatoid arthritis(RA)therapy in China,but there is still no published evidence of the efficacy of SIN monotherapy.This work investigates the efficacy and safety of SIN in treating RA patients and analyzes the correlation between ornithine level and the alleviation of disease activity in RA patients.In this 24 week,randomized,placebo-controlled,double-blind clinical trial,people with mild to moderate RA were randomly assigned(1∶1∶1,stratified by hospital)to receive SIN(120 mg,twice daily),methotrexate(MTX)(10 mg per week),or SIN+MTX therapy.The primary out-come was the proportion of patients who achieved a 50％improvement in the American College of Rheumatology(ACR50)criteria at week 24 and who showed improvement according to the clinical dis-ease activity index(CDAI).In this prospective subgroup analysis,we also assessed whether the 24-week alterations of disease activity in the treatment group were significantly correlated to the levels of blood ornithine.Of the 135 enrolled participants,38,39,and 36 patients were treated with SIN,MTX,and SIN+MTX,respectively.In the SIN-treated group,52.63％of patients achieved ACR50 after 24-weeks of treatment,which was comparable to the results in the MTX-treated and SIN+MTX-treated groups.Hepatic and gastrointestinal disorders were the main adverse events;however,the ratio of patients suf-fering from hepatic disorder in the SIN group(1/38)was much lower than that in the MTX(10/39)and SIN+MTX(8/36)groups.A total of 221 serum samples were collected at the four follow-up time points in the three treatments,and the levels of ornithine,citrulline,and arginine were obtained through ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF/MS).The serum ornithine level decreased after the 24-week treatment along with a decrease in disease activity,and may reflect therapeutic responses with a sensitivity value of 80％.In conclusion,SIN revealed a comparable efficacy to MTX for treating RA patients,but with fewer side effects.In addition,the serum ornithine level was found for the first time to have a close correlation with the alleviation of RA,which shows the value of this measure as an assessment indicator of drugs in treating RA.

Ying Shi;Hu-Dan Pan;Jian-Lin Wu;Qing-Hua Zou;Xin-Yi Xie;Hong-Gang Li;Hua Zhou;Xi-Qing Bian;Wen-Fei Leng;Can-Jian Wang;Ya-Feng Wang;Yong-Fei Fang;Liang Liu

Department of Rheumatology,The Southwest Hospital of Army Military Medical University,Chongqing 400038,China;State Key Laboratory of Dampness Syndrome Chinese Medicine,The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510000,China;State Key Laboratory of Quality Research in Chinese Medicine&Macau Institute for Applied Research in Medicine and Health,Macau University of Science and Technology,Macao 999078,China;People's Hospital of Changshou Chongqing,Chongqing 401220,China;Traditional Chinese Medicine Hospital Dianjiang Chongqing,Chongqing 408300,China;Medical Management Center,World Federation of Chinese Medicine Societies,Beijing 100101,China

工程（英文）

[1]Ying Shi;Hu-Dan Pan;Jian-Lin Wu;Qing-Hua Zou;Xin-Yi Xie;Hong-Gang Li;Hua Zhou;Xi-Qing Bian;Wen-Fei Leng;Can-Jian Wang;Ya-Feng Wang;Yong-Fei Fang;Liang Liu-.The Correlation Between Decreased Ornithine Level and Alleviation of Rheumatoid Arthritis Patients Assessed by a Randomized,Placebo-Controlled,Double-Blind Clinical Trial of Sinomenine)[J].工程（英文）,2022(09):93-99

Ornithine,Assessed,Sinomenine,SIN+MTX

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