Comparison of combination therapy with methotrexate and sinomenine or leflunomide for active rheumatoid arthritis: A randomized controlled clinical trial
| Autor: | Run-Yue Huang, Ying-Yan Zhou, Xiu-Min Chen, Liang Liu, Zhi-xin Xie, Hudan Pan, Ping Qiu, Jiaqi Wu, Zhan-guo Li, Qingchun Huang, Yao Xiao, Hua Zhou |
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| Rok vydání: | 2018 |
| Předmět: |
musculoskeletal diseases
Adult Male medicine.medical_specialty Combination therapy Gastrointestinal Diseases Pharmaceutical Science law.invention Arthritis Rheumatoid 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Drug Discovery medicine Humans skin and connective tissue diseases 030304 developmental biology Leflunomide Pharmacology 0303 health sciences business.industry Middle Aged medicine.disease Rheumatology Clinical trial Methotrexate Treatment Outcome Complementary and alternative medicine Morphinans 030220 oncology & carcinogenesis Rheumatoid arthritis Antirheumatic Agents Molecular Medicine Drug Therapy Combination Female Chemical and Drug Induced Liver Injury business Rheumatism medicine.drug |
| Zdroj: | Phytomedicine : international journal of phytotherapy and phytopharmacology. 57 |
| ISSN: | 1618-095X |
| Popis: | Background A combination of conventional disease-modifying anti-rheumatic drugs improves the treatment of rheumatoid arthritis but with high side-effects. Methotrexate (MTX) combination therapy that with high therapeutic efficacy and low toxicity is in demand in many countries to replace the use of expensive biological agents. Study design This study was an open-label, 24-week, parallel randomized controlled trial conducted between November 2015 and December 2017. Methods Patients were randomly assigned at a 3:2 ratio to receive MTX combined with sinomenine (SIN) at a dose of 120 mg twice daily, or leflunomide (LEF) at a dose of 20 mg once daily. Efficacy and safety were assessed at weeks 4, 12 and 24. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology (ACR)50 response and a European League Against Rheumatism (EULAR) good response at week 24. Results A total of 101/120 (84.2%) patients completed 24 weeks of observation. In the intention-to-treat (ITT) analysis, 65.3% of patients treated with MTX + SIN showed improved disease activity as determined by the ACR50 response at week 24 compared to 69.6% of patients treated with MTX + LEF. A similar insignificant pattern was found for the ACR20 and ACR70 responses, as well as the clinical disease activity index, EULAR response, and remission and low disease activity rates between these two treatment groups. The per-protocol analysis showed results consistent with those of the ITT analysis. Notably, significant reductions in gastrointestinal adverse reactions and liver toxicity were found in patients treated with MTX + SIN compared to patients treated with MTX + LEF (p Conclusion Considering the balance of efficacy and toxicity, the current study provides evidence that MTX + SIN combination therapy is probably one of the choices for treating patients with active rheumatoid arthritis in addition to MTX + LEF combination therapy. |
| Databáze: | OpenAIRE |
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