Rheumatoid arthritis(RA) has a high disability rate and is highly harmful. It has a long course of treatment and is prone to adverse reactions or events(ADR/ADE). Selection of drugs in particular shall give consideration to both benefits and risk. Tripterygium Glycosides Tablets(TGT) is one of the important drugs for the treatment of RA. It has a remarkable efficacy, but a strong toxicity, which is controversial in clinical use. The study was oriented to patients, and quantitatively evaluated the efficacy and risk of TGT in treatment of RA, providing an intuitive basis for clinical safety and effective application of TGT. A multi-criteria decision-making analysis(MCDA) model of TGT was built in the treatment of RA, and then benefit and risk indicators were weighted by SWING method. Totally 53 random clinical trials(RCT) in accordance with the evaluation criteria were included by Meta-analysis method. The RCT results were merged by Meta-analysis, indicating that compared with the conventional therapy of chemical immunosuppressant(CISD), TGT could improve the curative effect whether it was used alone or in combination with CISD, but it would increase the incidence of reproductive system damage. The combined administration with CISD would also increase the incidence of liver and kidney damages. Treatment outcomes varied according to the different conditions of the combined administration with CISD. Based on MCDA model and clinical results, the benefit value, risk value and benefit-risk value of different doses, courses and combined administration of TGT in the treatment with RA were compared. The results showed that when the benefit and risk of the drug were equally important to the patient, the benefit-risk value of the single administration of TGT was 59, while that of the combined administration of TGT and CISD was 39. Therefore, the benefit-risk value of the single administration of TGT was 100% better than the combined administration. When the combined administration of TGT and CISD is unavoidable, the benefit-risk value of low-dose TGT(0.10-0.99 mg·kg~(-1)·d~(-1)) was 48, while that of high-dose TGT was 36. Therefore, low-dose TGT combined with CISD was more easily accepted by patients. The 2 to 3-month treatment course had a benefit-risk value of 40, while the long treatment course had a benefit-risk value of 38. Based on existing evidences, the single administration of TGT may be better than the combined administration with CISD. If the patients need to combine with CISD to treat RA, low dosage and 2 to 3-month course may be relatively optimal.
Keywords: Tripterygium Glycosides Tablets (TGT); benefit; multi-criteria decision-making analysis (MCDA); rheumatoid arthritis (RA); risk.