Rheumatoid arthritis(RA),a globally increasing autoimmune disorder,is associated with increased disability rates due to the disruption of iron metabolism.Tripterygium glycoside tablets(TGTs),a Tripterygium wilfordii H...Rheumatoid arthritis(RA),a globally increasing autoimmune disorder,is associated with increased disability rates due to the disruption of iron metabolism.Tripterygium glycoside tablets(TGTs),a Tripterygium wilfordii Hook.f.(TwHF)-based therapy,exhibit satisfactory clinical efficacy for RA treatment.However,drug-induced liver injury(DILI)remains a critical issue that hinders the clinical application of TGTs,and the molecular mechanisms underlying the efficacy and toxicity of TGTs in RA have not been fully elucidated.To address this problem,we integrated clinical multi-omics data associated with the anti-RA efficacy and DILI of TGTs with the chemical and target profiling of TGTs to perform a systematic network analysis.Subsequently,we identified effective and toxic targets following experimental validation in a collagen-induced arthritis(CIA)mouse model.Significantly different transcriptome–protein–metabolite profiles distinguishing patients with favorable TGTs responses from those with poor outcomes were identified.Intriguingly,the clinical efficacy and DILI of TGTs against RA were associated with metabolic homeostasis between iron and bone and between iron and lipids,respectively.Particularly,the signal transducer and activator of transcription 3(STAT3)–hepcidin(HAMP)/lipocalin 2(LCN2)–tartrate-resis tant acid phosphatase type 5(ACP5)and STAT3–HAMP–acyl-CoA synthetase long-chain family member 4(ACSL4)–lysophosphatidylcholine acyltransferase 3(LPCAT3)axes were identified as key drivers of the efficacy and toxicity of TGTs.TGTs play dual roles in ameliorating CIA-induced pathology and in inducing hepatic dysfunction,disruption of lipid metabolism,and hepatic lipid peroxidation.Notably,TGTs effectively reversed“iron–bone”disruptions in the inflamed joint tissues of CIA mice by inhibiting the STAT3–HAMP/LCN2–ACP5 axis,subsequently leading to“iron–lipid”disturbances in the liver tissues via modulation of the STAT3–HAMP–ACSL4–LPCAT3 axis.Additional bidirectional validation experiments were conducted using MH7A and AML12 cells to confirm the bidirectional regulatory effects of TGTs on key targets.Collectively,our data highlight the association between iron-mediated metabolic homeostasis and the clinical efficacy and toxicity of TGT in RA therapy,offering guidance for the rational clinical use of TwHF-based therapy with dual therapeutic and toxic potential.展开更多
Objective:To study the clinical efficacy of tocilizumab combined with leflunomide in the treatment of rheumatoid arthritis.Methods:114 patients with rheumatoid arthritis admitted from May 2015 to April 2018 were rando...Objective:To study the clinical efficacy of tocilizumab combined with leflunomide in the treatment of rheumatoid arthritis.Methods:114 patients with rheumatoid arthritis admitted from May 2015 to April 2018 were randomly divided into control group(n=57)and observation group(n=57).The control group was treated with leflunomide.On the basis of this,the observation group was treated with tocilizumab for 12 weeks.Functional indicators,erythrocyte sedimentation rate(ESR),rheumatoid factor and inflammatory factors were evaluated and adverse reactions were recorded.Results:The total treatment efficiency of the observation group(89.47%)was significantly higher than that of the control group(75.44%)(P<0.05).Morning stiffness time,joint pain score,joint swelling score,ESR,serum C-reactive protein(CRP),rheumatoid factor(RF),tumor necrosis factor(TNF-α),and interleukin-1 were observed in the observation group and the control group.The levels of IL-1),IL-6,IL-8 and other indicators were lower than those before treatment.The indexes of the observation group were significantly lower than those before treatment(P<0.05),and after treatment The morning stiffness time,joint pain score,joint swelling score,ESR,CRP,RF,TNF-α,IL-1,IL-6,IL-8 and other indicators in the observation group were significantly lower than those in the control group(P<0.05).The incidence of adverse reactions in the observation group was 14%,and the incidence of adverse reactions in the control group was 17.54%.Toltuzumab combined with leflunomide in the treatment of rheumatoid arthritis did not increase the probability of adverse reactions.Conclusion:The use of tocilizumab combined with leflunomide in the treatment of rheumatoid joints has good efficacy and safety.This may be related to a significant reduction in inflammatory factors TNF-α,IL-1,IL-6,IL-8 and the like.展开更多
Objective To evaluate the efficacy and safety of leflunomide in comparison with methotrexate (MTX) on patients with rheumatoid arthritis (RA) in China.Methods Five hundred and sixty-six patients with active rheumato...Objective To evaluate the efficacy and safety of leflunomide in comparison with methotrexate (MTX) on patients with rheumatoid arthritis (RA) in China.Methods Five hundred and sixty-six patients with active rheumatoid arthritis were randomly assigned to receive leflunomide at 20 mg once daily or MTX at 15 mg once weekly in a controlled trial. Five hundred and four patients completed the 12-week treatment and some patients continued the treatment for 24 weeks. Results Both leflunomide and MTX could improve the symptoms,signs,and joint function,but there were no changes in X-ray observations of patients with rheumatoid arthritis. In the leflunomide group,the overall rates of effectiveness at 12 weeks and 24 weeks were 86.94% and 92.31% respectively; the rates of remarkable improvement were 64.95% and 79.81% respectively. In the MTX group,the overall rates of effectiveness at 12 weeks and 24 weeks were 84.04% and 83.15% respectively; the rates of remarkable improvement were 56.81% and 75.28% respectively. According to intent-to-treat analysis,the ACR 20% response rates at 12 weeks and 24 weeks in the leflunomide group were 62.54% and 67.18% respectively,compared with 60.08% and 61.32% respectively in MTX group. No statistical differences were shown in the efficacy between the two groups ( P >0.05). The adverse events in the leflunomide group were gastrointestinal symptoms,skin rash,alopecia,nervous system symptoms,decreased leukocyte count,and elevation of alanine aminotransferase (ALT). Most of these side effects were mild and transient. The incidence of adverse events in the leflunomide group was 16.84%,significantly lower than that in MTX group (28.17%,P =0.002).Conclusions Leflunomide is effective in the treatment of RA with less adverse events than MTX. Its efficacy is similar to MTX,but the incidence of adverse events and the rate of withdrawal due to adverse events were lower in the leflunomide group than in MTX group.展开更多
Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis(RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and l...Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis(RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and long?term extension(LTE) studies.Methods: ORAL Sync was a 1?year, randomized, placebo?controlled, Phase 3 trial. Patients received tofacitinib 5 or 10 mg twice daily(BID) or placebo advanced to tofacitinib 5 or 10 mg BID at 3 or 6 months. All patients remained on ≥1 background conventional synthetic disease?modifying antirheumatic drug. ORAL Sequel is an open?label LTE study(data?cut: March 2015; data collection and analyses were ongoing, and study database was not locked at the time of analysis; study was closed in 2017). Efficacy outcomes: American College of Rheumatology(ACR) 20/50/70 response rates and Disease Activity Score in 28 joints using erythrocyte sedimentation rate(DAS28?4 [ESR]). Patient? and physician?reported outcomes: Health Assessment Questionnaire?Disability Index(HAQ?DI), Patient and Physician Global Assessment of Arthritis, and pain(visual analog scale). Safety was assessed throughout.Results: ORAL Sync included 218 patients; 192 were subsequently enrolled into ORAL Sequel. In ORAL Sync, more patients achieved ACR20(tofacitinib 5 mg BID, 67.4%; 10 mg BID, 70.6%; placebo, 34.1%) and DAS28?4(ESR) <2.6(tofacitinib 5 mg BID, 7.1%;10 mg BID, 13.1%; placebo, 2.3%) with tofacitinib versus placebo at Month 6. Mean changes from baseline in HAQ?DI were greater with tofacitinib versus placebo at Month 6. In ORAL Sequel, efficacy was consistent to Month 48. Incidence rates for adverse events of special interest in tofacitinib?treated patients were similar to the global population.Conclusions: Tofacitinib significantly reduced signs/symptoms and improved physical function and quality of life in Chinese patients with moderate?to?severely active RA up to Month 48. The safety profile was consistent with the global population.Clinical Trial Identifier: NCT00856544 and NCT00413699.展开更多
Background:Clinical observational studies revealed that ^(99)Tc-methylene diphosphonate(^(99)Tc-MDP)could reduce joint pain and swollenness in rheumatoid arthritis(RA)patients.This multicenter,randomized,double-blind,...Background:Clinical observational studies revealed that ^(99)Tc-methylene diphosphonate(^(99)Tc-MDP)could reduce joint pain and swollenness in rheumatoid arthritis(RA)patients.This multicenter,randomized,double-blind,double-dummy study aimed to evaluate the effects of ^(99)Tc-MDP plus methotrexate(MTX)vs.MTX alone or ^(99)Tc-MDP alone on disease activity and structural damage in MTX-naïve Chinese patients with moderate to severe RA.Methods:Eligible patients with moderate to severely active RA were randomized to receive ^(99)Tc-MDP plus MTX(n=59)vs.MTX(n=59)alone or ^(99)Tc-MDP(n=59)alone for 48 weeks from six study sites across four provinces in China.The primary outcomes were the American College of Rheumatology 20%improvement(ACR20)response rates at week 24 and changes in modified total Sharp score at week 48.Results:At week 24,the proportion of participants achieving ACR20 was significantly higher in the MTX+^(99)Tc-MDP combination group(69.5%)than that in the MTX group(50.8%)or ^(99)Tc-MDP group(47.5%)(P=0.03 for MTX+^(99)Tc-MDP vs.MTX,and MTX+^(99)Tc-MDP vs.^(99)Tc-MDP,respectively).The participants in the MTX+^(99)Tc-MDP group and the ^(99)Tc-MDP group had significantly less important radiographic progression than the participants in the MTX group over the 48 weeks(MTX+^(99)Tc-MDP vs.MTX:P=0.03,^(99)Tc-MDP vs.MTX:P=0.03,respectively).There was no significant difference in terms of adverse events(AEs)among the groups.No serious AEs were observed.Conclusions:This study demonstrated that the combination of ^(99)Tc-MDP with MTX inhibited structural damage and improved disease activity in RA patients compared with MTX and ^(99)Tc-MDP monotherapies,without increasing the rate of AEs.Additional clinical studies of ^(99)Tc-MDP therapy in patients with RA are warranted.Trial Registration:Chictr.org,ChiCTR-IPR-14005684;http://www.chictr.org.cn/showproj.aspx?proj=10088.展开更多
目的:探索汉防己甲素治疗类风湿关节炎的有效性和安全性。方法:在中国知网、维普网、万方数据、SinoMed、PubMed、Springer、Web of Science、Cochrane Central Register of Controlled Trails数据库中检索汉防己甲素治疗类风湿关节炎...目的:探索汉防己甲素治疗类风湿关节炎的有效性和安全性。方法:在中国知网、维普网、万方数据、SinoMed、PubMed、Springer、Web of Science、Cochrane Central Register of Controlled Trails数据库中检索汉防己甲素治疗类风湿关节炎的随机对照临床试验。采用R 3.5.3软件对有效率、红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子、视觉模拟评分(VAS)、疾病活动度评分(DAS)、压痛关节计数(TJC)、肿胀关节计数(SJC)和晨僵持续时间等临床指标,以及不良事件发生率进行meta分析。结果:最终纳入10篇研究。meta分析结果显示,汉防己甲素对治疗的有效率(OR=3.27,95%CI:2.01~5.37,P<0.01)、ESR(SMD=1.12,95%CI:0.06~2.19,P<0.05)、CRP(SMD=0.75,95%CI:0.28~1.22,P<0.01)、VAS(SMD=0.64,95%CI:0.29~1.00,P<0.01)、TJC(SMD=1.16,95%CI:0.58~1.74,P<0.01)、SJC(SMD=0.85,95%CI:0.40~1.31,P<0.01)、晨僵持续时间(SMD=1.09,95%CI:0.68~1.50,P<0.01)有一定的改善作用,对类风湿因子(SMD=1.70,95%CI:-1.10~4.51,P>0.05)和DAS(SMD=0.26,95%CI:-0.59~1.11,P>0.05)的改善与对照组差异无统计学意义。汉防己甲素治疗类风湿关节炎的不良事件总发生率为20%(95%CI:12%~27%,I^(2)=60%,P<0.05),不良事件的程度较轻,患者转归良好。结论:汉防己甲素能提高药物治疗类风湿关节炎的临床效果,且不良事件程度较轻。展开更多
基金supported by the Scientific and Technological Innovation Project of the China Academy of Chinese Medical Sciences(CI2021A03807 and CI2021A01501)the National Natural Science Foundation of China(82330124)+2 种基金the Beijing Municipal Natural Science Foundation(7212186)the Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(ZYYCXTD-C-202002)the Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences.
文摘Rheumatoid arthritis(RA),a globally increasing autoimmune disorder,is associated with increased disability rates due to the disruption of iron metabolism.Tripterygium glycoside tablets(TGTs),a Tripterygium wilfordii Hook.f.(TwHF)-based therapy,exhibit satisfactory clinical efficacy for RA treatment.However,drug-induced liver injury(DILI)remains a critical issue that hinders the clinical application of TGTs,and the molecular mechanisms underlying the efficacy and toxicity of TGTs in RA have not been fully elucidated.To address this problem,we integrated clinical multi-omics data associated with the anti-RA efficacy and DILI of TGTs with the chemical and target profiling of TGTs to perform a systematic network analysis.Subsequently,we identified effective and toxic targets following experimental validation in a collagen-induced arthritis(CIA)mouse model.Significantly different transcriptome–protein–metabolite profiles distinguishing patients with favorable TGTs responses from those with poor outcomes were identified.Intriguingly,the clinical efficacy and DILI of TGTs against RA were associated with metabolic homeostasis between iron and bone and between iron and lipids,respectively.Particularly,the signal transducer and activator of transcription 3(STAT3)–hepcidin(HAMP)/lipocalin 2(LCN2)–tartrate-resis tant acid phosphatase type 5(ACP5)and STAT3–HAMP–acyl-CoA synthetase long-chain family member 4(ACSL4)–lysophosphatidylcholine acyltransferase 3(LPCAT3)axes were identified as key drivers of the efficacy and toxicity of TGTs.TGTs play dual roles in ameliorating CIA-induced pathology and in inducing hepatic dysfunction,disruption of lipid metabolism,and hepatic lipid peroxidation.Notably,TGTs effectively reversed“iron–bone”disruptions in the inflamed joint tissues of CIA mice by inhibiting the STAT3–HAMP/LCN2–ACP5 axis,subsequently leading to“iron–lipid”disturbances in the liver tissues via modulation of the STAT3–HAMP–ACSL4–LPCAT3 axis.Additional bidirectional validation experiments were conducted using MH7A and AML12 cells to confirm the bidirectional regulatory effects of TGTs on key targets.Collectively,our data highlight the association between iron-mediated metabolic homeostasis and the clinical efficacy and toxicity of TGT in RA therapy,offering guidance for the rational clinical use of TwHF-based therapy with dual therapeutic and toxic potential.
基金Science and Technology Research and Development Program of Affiliated Hospital of Yan'an University(2018PT-09).
文摘Objective:To study the clinical efficacy of tocilizumab combined with leflunomide in the treatment of rheumatoid arthritis.Methods:114 patients with rheumatoid arthritis admitted from May 2015 to April 2018 were randomly divided into control group(n=57)and observation group(n=57).The control group was treated with leflunomide.On the basis of this,the observation group was treated with tocilizumab for 12 weeks.Functional indicators,erythrocyte sedimentation rate(ESR),rheumatoid factor and inflammatory factors were evaluated and adverse reactions were recorded.Results:The total treatment efficiency of the observation group(89.47%)was significantly higher than that of the control group(75.44%)(P<0.05).Morning stiffness time,joint pain score,joint swelling score,ESR,serum C-reactive protein(CRP),rheumatoid factor(RF),tumor necrosis factor(TNF-α),and interleukin-1 were observed in the observation group and the control group.The levels of IL-1),IL-6,IL-8 and other indicators were lower than those before treatment.The indexes of the observation group were significantly lower than those before treatment(P<0.05),and after treatment The morning stiffness time,joint pain score,joint swelling score,ESR,CRP,RF,TNF-α,IL-1,IL-6,IL-8 and other indicators in the observation group were significantly lower than those in the control group(P<0.05).The incidence of adverse reactions in the observation group was 14%,and the incidence of adverse reactions in the control group was 17.54%.Toltuzumab combined with leflunomide in the treatment of rheumatoid arthritis did not increase the probability of adverse reactions.Conclusion:The use of tocilizumab combined with leflunomide in the treatment of rheumatoid joints has good efficacy and safety.This may be related to a significant reduction in inflammatory factors TNF-α,IL-1,IL-6,IL-8 and the like.
文摘Objective To evaluate the efficacy and safety of leflunomide in comparison with methotrexate (MTX) on patients with rheumatoid arthritis (RA) in China.Methods Five hundred and sixty-six patients with active rheumatoid arthritis were randomly assigned to receive leflunomide at 20 mg once daily or MTX at 15 mg once weekly in a controlled trial. Five hundred and four patients completed the 12-week treatment and some patients continued the treatment for 24 weeks. Results Both leflunomide and MTX could improve the symptoms,signs,and joint function,but there were no changes in X-ray observations of patients with rheumatoid arthritis. In the leflunomide group,the overall rates of effectiveness at 12 weeks and 24 weeks were 86.94% and 92.31% respectively; the rates of remarkable improvement were 64.95% and 79.81% respectively. In the MTX group,the overall rates of effectiveness at 12 weeks and 24 weeks were 84.04% and 83.15% respectively; the rates of remarkable improvement were 56.81% and 75.28% respectively. According to intent-to-treat analysis,the ACR 20% response rates at 12 weeks and 24 weeks in the leflunomide group were 62.54% and 67.18% respectively,compared with 60.08% and 61.32% respectively in MTX group. No statistical differences were shown in the efficacy between the two groups ( P >0.05). The adverse events in the leflunomide group were gastrointestinal symptoms,skin rash,alopecia,nervous system symptoms,decreased leukocyte count,and elevation of alanine aminotransferase (ALT). Most of these side effects were mild and transient. The incidence of adverse events in the leflunomide group was 16.84%,significantly lower than that in MTX group (28.17%,P =0.002).Conclusions Leflunomide is effective in the treatment of RA with less adverse events than MTX. Its efficacy is similar to MTX,but the incidence of adverse events and the rate of withdrawal due to adverse events were lower in the leflunomide group than in MTX group.
文摘Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis(RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and long?term extension(LTE) studies.Methods: ORAL Sync was a 1?year, randomized, placebo?controlled, Phase 3 trial. Patients received tofacitinib 5 or 10 mg twice daily(BID) or placebo advanced to tofacitinib 5 or 10 mg BID at 3 or 6 months. All patients remained on ≥1 background conventional synthetic disease?modifying antirheumatic drug. ORAL Sequel is an open?label LTE study(data?cut: March 2015; data collection and analyses were ongoing, and study database was not locked at the time of analysis; study was closed in 2017). Efficacy outcomes: American College of Rheumatology(ACR) 20/50/70 response rates and Disease Activity Score in 28 joints using erythrocyte sedimentation rate(DAS28?4 [ESR]). Patient? and physician?reported outcomes: Health Assessment Questionnaire?Disability Index(HAQ?DI), Patient and Physician Global Assessment of Arthritis, and pain(visual analog scale). Safety was assessed throughout.Results: ORAL Sync included 218 patients; 192 were subsequently enrolled into ORAL Sequel. In ORAL Sync, more patients achieved ACR20(tofacitinib 5 mg BID, 67.4%; 10 mg BID, 70.6%; placebo, 34.1%) and DAS28?4(ESR) <2.6(tofacitinib 5 mg BID, 7.1%;10 mg BID, 13.1%; placebo, 2.3%) with tofacitinib versus placebo at Month 6. Mean changes from baseline in HAQ?DI were greater with tofacitinib versus placebo at Month 6. In ORAL Sequel, efficacy was consistent to Month 48. Incidence rates for adverse events of special interest in tofacitinib?treated patients were similar to the global population.Conclusions: Tofacitinib significantly reduced signs/symptoms and improved physical function and quality of life in Chinese patients with moderate?to?severely active RA up to Month 48. The safety profile was consistent with the global population.Clinical Trial Identifier: NCT00856544 and NCT00413699.
基金funded by the Chengdu Yunke Pharmaceutical Co.,Ltd.
文摘Background:Clinical observational studies revealed that ^(99)Tc-methylene diphosphonate(^(99)Tc-MDP)could reduce joint pain and swollenness in rheumatoid arthritis(RA)patients.This multicenter,randomized,double-blind,double-dummy study aimed to evaluate the effects of ^(99)Tc-MDP plus methotrexate(MTX)vs.MTX alone or ^(99)Tc-MDP alone on disease activity and structural damage in MTX-naïve Chinese patients with moderate to severe RA.Methods:Eligible patients with moderate to severely active RA were randomized to receive ^(99)Tc-MDP plus MTX(n=59)vs.MTX(n=59)alone or ^(99)Tc-MDP(n=59)alone for 48 weeks from six study sites across four provinces in China.The primary outcomes were the American College of Rheumatology 20%improvement(ACR20)response rates at week 24 and changes in modified total Sharp score at week 48.Results:At week 24,the proportion of participants achieving ACR20 was significantly higher in the MTX+^(99)Tc-MDP combination group(69.5%)than that in the MTX group(50.8%)or ^(99)Tc-MDP group(47.5%)(P=0.03 for MTX+^(99)Tc-MDP vs.MTX,and MTX+^(99)Tc-MDP vs.^(99)Tc-MDP,respectively).The participants in the MTX+^(99)Tc-MDP group and the ^(99)Tc-MDP group had significantly less important radiographic progression than the participants in the MTX group over the 48 weeks(MTX+^(99)Tc-MDP vs.MTX:P=0.03,^(99)Tc-MDP vs.MTX:P=0.03,respectively).There was no significant difference in terms of adverse events(AEs)among the groups.No serious AEs were observed.Conclusions:This study demonstrated that the combination of ^(99)Tc-MDP with MTX inhibited structural damage and improved disease activity in RA patients compared with MTX and ^(99)Tc-MDP monotherapies,without increasing the rate of AEs.Additional clinical studies of ^(99)Tc-MDP therapy in patients with RA are warranted.Trial Registration:Chictr.org,ChiCTR-IPR-14005684;http://www.chictr.org.cn/showproj.aspx?proj=10088.
文摘目的:探索汉防己甲素治疗类风湿关节炎的有效性和安全性。方法:在中国知网、维普网、万方数据、SinoMed、PubMed、Springer、Web of Science、Cochrane Central Register of Controlled Trails数据库中检索汉防己甲素治疗类风湿关节炎的随机对照临床试验。采用R 3.5.3软件对有效率、红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子、视觉模拟评分(VAS)、疾病活动度评分(DAS)、压痛关节计数(TJC)、肿胀关节计数(SJC)和晨僵持续时间等临床指标,以及不良事件发生率进行meta分析。结果:最终纳入10篇研究。meta分析结果显示,汉防己甲素对治疗的有效率(OR=3.27,95%CI:2.01~5.37,P<0.01)、ESR(SMD=1.12,95%CI:0.06~2.19,P<0.05)、CRP(SMD=0.75,95%CI:0.28~1.22,P<0.01)、VAS(SMD=0.64,95%CI:0.29~1.00,P<0.01)、TJC(SMD=1.16,95%CI:0.58~1.74,P<0.01)、SJC(SMD=0.85,95%CI:0.40~1.31,P<0.01)、晨僵持续时间(SMD=1.09,95%CI:0.68~1.50,P<0.01)有一定的改善作用,对类风湿因子(SMD=1.70,95%CI:-1.10~4.51,P>0.05)和DAS(SMD=0.26,95%CI:-0.59~1.11,P>0.05)的改善与对照组差异无统计学意义。汉防己甲素治疗类风湿关节炎的不良事件总发生率为20%(95%CI:12%~27%,I^(2)=60%,P<0.05),不良事件的程度较轻,患者转归良好。结论:汉防己甲素能提高药物治疗类风湿关节炎的临床效果,且不良事件程度较轻。