白芍总苷治疗幼年特发性关节炎疗效观察

研究白芍总苷(TGP)治疗幼年特发性关节炎(JIA)的疗效及不良反应。采用分组对照研究,治疗组42例应用白芍总苷早期联合应用激素、非甾体抗炎药(NSAIDs),后期以白芍总苷为主,对照组26例采用甲氨蝶呤(MTX),治疗6个月,观察关节晨僵时间、疼痛指数、血沉(ESR)、C反应蛋白(CRP)等指标,分析两组疗效;并总结两者的不良反应。结果:治疗组在关节晨僵、疼痛指数、ESR、CRP和总有效率等与对照组比较差异无显著性(P>0.05);但治疗组激素平均用量比对照组少,激素疗程明显缩短(P<0.05);肝功能损害等严重不良反应少。提示白芍总苷对JIA有效,疗效…     

白芍总苷治疗骨关节炎临床研究

验证白芍总苷(TGP)对骨关节炎(OA)的临床疗效。采用分组临床对照试验,观察口服TGP(治疗组250例)和扶他林(对照组50例)治疗OA后的临床改善指数及不良反应,并进行组间统计学对比。结果:治疗组总有效率88%,显效率33%,疗效明显优于对照组(P<0.01),安全性好。提示TGP对早中期OA有明显疗效,如配合非甾体抗炎药、软骨保护剂等中西医结合治疗可进一步提高疗效,缩短疗程。白芍总苷治疗骨关节炎临床研究@钱祖稀!213003$南京中医药大学附属常州市中医医院风湿病     

白芍总苷治疗类风湿关节炎的临床疗效及对几种可溶性细胞因子(受体)的影响

观察白芍总苷(TGP)对类风湿关节炎(RA)患者症状、体征的改善情况和不良反应,以及对血可溶性白细胞介素C2受体(sIL-2R)、可溶性白细胞介素6受体(sIL-6R)、可溶性肿瘤坏死因子受体I(sTNFR-I)及可溶性CD23(sCD23)的影响。将65例RA患者随机分为治疗组和对照组,治疗组患者服用TGP胶囊,300mg/粒,每次2粒,每日3次,连续服用3个月;对照组患者服用雷公藤多甙,20mg/次,每日3次,连续服用3个月。结果治疗组明显进步9例,进步15例,总有效率达94%,优于对照组的83%(P<0.05)。TGP可显著缓解关节肿胀及关节压痛;明显缩短晨僵时间,且优于对照组(P<0…     

白芍总苷甲氨蝶呤柳氮磺吡啶联合治疗难治性类风湿关节炎的近期疗效观察

探讨白芍总苷(TGP)、甲氨蝶呤(MTX)、柳氮磺吡啶(SASP)联合治疗难治性类风湿关节炎(RA)的疗效和安全性。对2002年5月至12月门诊和病房收治的28例RRA患者,同时应用TGP、MTX及SASP,疗程至少3个月。治疗前及治疗后观察临床及实验室指标,包括晨僵持续时间、关节肿胀指数、关节压痛指数、类风湿因子(RF)、血沉(ESR)、C反应蛋白(CRP)等指标及双手X线检查,并询问不良反应,记录病人自我评价,判定疗效。结果:28例中显效13例,有效12例,无效3例,总有效率89%。治疗前后的关节肿胀指数、关节压痛指数、双手握力、晨僵持续时间均有明显改善(…     

白芍总苷治疗类风湿关节炎的多中心临床研究

目的进一步评价白芍总苷（TGP）作为治疗类风湿关节炎（RA）病情改变药物的作用。方法370例RA患者随机开放进入甲氨蝶呤（MTX）组、TGP＋MTX组、MTX＋柳氮磺吡啶（SSZ）组、TGP＋SSZ组以及TGP组．共5组．疗程24～48周。观察指标有关节疼痛数、关节压痛数目和压痛指数、关节肿胀数目和肿胀指数、晨僵时间、握力、关节功能、血沉（ESR）、C反应蛋白（CRP）及类风湿因子（RF）。结果治疗24周时，各组临床指标改善的疗效相当。但TGP＋MTX组对关节肿胀指数的改善不如其他组，MTX组对晨僵的改善更优于其他组：治疗36周时．各组疗效继续相当，但MTX组有4项、TGP＋SSZ组有3项、MTX＋SSZ组和TGP组分别有2项比其他组的疗效更好，而TGP＋MTX组有3项的疗效低于其他组；治疗48周时，MTX组有5项、TGP组有3项、MTX＋SSZ组和TGP＋SSZ组均有2项更优于其他组，而TGP＋MTX组有3项、TGP＋SSZ组与TGP组分别有1项指标疗效低于其他各组。治疗24周及48周时，各组ESR均明显下降，除MTX＋TGP组外，其余各组CRP水平也明显下降。治疗24周时，除TGP组外，其余各组RF滴度亦降低；48周时MTX组和TGP＋MTX组RF降低的水平优于TGP＋SSZ组和MTX＋SSZ组。TGP对关节功能的改善较好．但总的起效时间较MTX晚。TGP的主要不良反应为稀便，腹泻，其与其他药物联合后仍以稀便为主，随着治疗时间延长，副作用未见增加。各组均无严重不良反应。结论单独TGP或TGP与MTX及与SSZ的联合对RA的疗效与已知的MTX和MTX＋SSZ疗效相当。除稀便，腹泻外TGP无严重不良反应，提示该品为一有效、安全并具有改变RA病情的植物药。     

白芍总苷联合柳氮磺吡啶治疗强直性脊柱炎的临床疗效观察

观察白芍总苷(TGP)联合柳氮磺吡啶(SASP)治疗强直性脊柱炎(AS)的临床疗效和安全性。AS患者分为治疗组与对照组两组,治疗组用TGP0.6mg,每日3次,治疗组同时口服SASP1.0g,每日2次,连用3个月;对照组单用SASP,同时对比观察脊柱晨僵时间、疼痛程度、血沉的变化。结果:治疗前后两组在脊柱晨僵时间、疼痛程度、血沉三项指标差异有显著性;治疗组对疼痛控制好,不良反应轻,与对照组差异有显著性。提示TGP联合SASP治疗AS是一种可供选择的方案。白芍总苷联合柳氮磺吡啶治疗强直性脊柱炎的临床疗效观察@胡宏$四川省绵阳市中心医院内科!621000…     

口服醋酸泼尼松片联合给药治疗SLE肝损害的临床疗效

目的探讨白芍总苷片与糖皮质激素联合治疗系统性红斑狼疮肝损害的临床疗效,为提高该病治疗效果提供参考.方法收集医院2013-06/2015-06 92例系统性红斑狼疮肝损害患者作为研究对象,依据随机对照组表法分为联合组与对照组,各46例.对照组给予常规糖皮质激素治疗,联合组给予白芍总苷片与糖皮质激素联合治疗,观察两组患者治疗总有效率、肝功能改善状况以及不良反应.结果联合组总有效率高于对照组(93.5%v s73.9%),差异有统计学意义(P0.05).治疗后联合组ALT、γ-GT、AST均明显的低于对照组,(31.7±7.4 vs 62.4±10.5)、(21.7±4.8 vs35.7±5.8)、(88.4±9.1 vs 121.6±10.7),组间差异有统计学意义(P0.05).联合组治疗不良反应发生率明显的低于对照组(8.7%vs23.9%),差异有统计学意义(P0.05).结论系统性红斑狼疮肝损害患者在常规糖皮质激素治疗上加用白芍总苷片治疗效果明显,显著改善患者肝功能,且不良反应少,安全性高,值得应用推广.     

白芍总苷治疗强直性脊柱炎临床观察

观察白芍总苷胶囊治疗强直性脊性炎(AS)的疗效及安全性。54例AS患者随机分为白芍总苷组(治疗组)和柳氮磺吡啶组(对照组)。治疗组口服白芍总苷胶囊,每日3次,每次0.6g;对照组口服柳氮磺吡啶,每日2次,每次1.0g,12周为1疗程,共观察2个疗程。结果:治疗组12周和24周的总有效率分别为82%、93%,而对照组为73%、84%,两组差异无显著性(P>0.05);两组患者治疗过程中均出现不同程度的不良反应,但病人对白芍总苷胶囊的耐受性明显好于柳氮磺吡啶。提示白芍总苷胶囊是一种有效的治疗AS的新药。白芍总苷治疗强直性脊柱炎临床观察@冯福海!450000郑州$河南中…     

白芍总苷治疗系统性红斑狼疮的初步探讨

初步探讨白芍总苷(TGP)在系统性红斑狼疮(SLE)治疗中的应用价值。用随机双盲安慰剂对照的研究方法,将70例活动期SLE患者随机分为两组各35例,分别接受TGP(1.8g/d)和安慰剂治疗,疗程3个月,比较两组受试者的狼疮疾病活动指数(SLEDAI)、有效率、糖皮质激素用量及不良反应。结果TGP组SLEDAI较对照组明显降低,且TGP组的糖皮质激素用量较治疗前明显减少。TGP组的缓解率、部分缓解率和无效率分别为21%、52%和28%;安慰剂组分别为7%、29%和65%,TGP组显著高于安慰剂组(P<0.004)。TGP组的不良反应发生率与对照组相比差异无显著性(P>0.0…     

白藜芦醇对胶原诱导大鼠关节炎的抗炎作用研究

目的 观察白藜芦醇对胶原诱导大鼠关节炎(CIA)的抗炎作用.方法 选择牛Ⅱ型胶原(CⅡ)为免疫原,建立CIA模型.选取42只造模成功的大鼠随机分为7组:模型组;来氟米特(LEF)对照组;白芍总苷(TGP)对照组;甲氨蝶呤(MTX)对照组;白藜芦醇(Res)小剂量组;白藜芦醇中剂量组;白藜芦醇高剂量组.采用关节炎指数评分(AI)法对大鼠关节炎症程度进行评分;采用酶联免疫吸附试验(ELISA)方法测定各组大鼠血清中抗CⅡ抗体水平.结果 AI评分:低剂量白藜芦醇组与模型组比较差异无统计学意义(12.3±0.5与12.8±0.4);高剂量白藜芦醇组低于中、低剂量组(6.0±0.6与8.2±1.0,12.3±0.5,P＜0.01).高剂量白藜芦醇组低于白芍总苷组(6.0±0.6与8.8±0.8,P＜0.01);LEF组低于TGP组、MTX组、3组白藜芦醇组(4.7±0.5与8.9±0.8,6.4+0.5,P＜0.01);血清抗CⅡ抗体水平:模型组明显高于LEF组、MTX组、TGP组及高、中剂量白藜芦醇组(0.928±0.021与0.391±0.016,0.503±0.010,0.525±0.015,0.507±0.01,0.570±0.021,P＜0.01),而与低剂量白藜芦醇组之间差异无统计学意义(0.928±0.021与0.908±0.026);高剂量白藜芦醇组低于白芍总苷组及低剂量白藜芦醇组(0.507±0.01与0.525±0.015,0.908±0.026,P＜0.01);LEF组低于高、中剂量白藜芦醇组(0.391±0.026与0.507±0.010,0.570±0.021,P＜0.01).结论 ①高、中剂量白藜芦醇能够缓解CIA的炎症症状,而低剂量白藜芦醇则无此作用.②中等剂量白藜芦醇对CIA大鼠的短期疗效与TGP相当,高剂量白藜芦醇的疗效强于TGP,但弱于LEF.③白藜芦醇能够抑制血清抗CⅡ抗体的生成.     

Randomized, placebo-controlled, crossover trial of low-dose oral methotrexate in children with extended oligoarticular or systemic arthritis

OBJECTIVE: Juvenile idiopathic arthritis (JIA) can persist through adolescence and adulthood, resulting in significant disability. The use of low-dose oral methotrexate (MTX) for persistent polyarthritis has been shown to be effective by the USA/USSR collaborative study group. However, 2 of the most disabling subgroups of JIA, systemic and extended oligoarthritis, were underrepresented in that study. The present study was therefore conducted to investigate the efficacy of MTX in these 2 subgroups. METHODS: Patients under the age of 16 years who fulfilled the International League of Associations for Rheumatology criteria for systemic or extended oligoarticular arthritis were eligible for this multicenter, double-blind, placebo-controlled crossover trial. Forty-five patients with systemic and 43 with extended oligoarticular arthritis were enrolled. The dosage of MTX or placebo was 15 mg/m2, which could be increased to 20 mg/m2 after 2 months. Core outcome variables were considered as primary measures, giving a final score of "improved" or "not improved." Secondary measures included scores of systemic features and biochemical laboratory measures. Assessment of function was not included since there were no validated functional measures at the start of this trial in 1991. RESULTS: In the extended oligoarticular arthritis group, MTX treatment produced significant improvement in 3 of 5 core variables (erythrocyte sedimentation rate, physician's global assessment of disease activity, and parent's global assessment of disease activity). By the primary improvement criteria, there was significant overall improvement during MTX treatment. In the systemic arthritis group, only 2 of 5 core variables were significantly improved (physician's and parent's global assessment of disease activity). Systemic features were not part of the core variables, but the systemic feature score was not significantly different between MTX and placebo treatment. There was no significant overall improvement in this group during MTX treatment. However, no significant interaction between disease subgroup and treatment effect was demonstrated. When the data from both disease subgroups were combined, there was significant clinical improvement during MTX treatment (P = 0.006). CONCLUSION: MTX 15-20 mg/m2 given orally once a week was found to be an effective treatment for both extended oligoarticular and systemic JIA in this shortterm trial. Long-term efficacy needs to be addressed in future studies.     

Methotrexate in rheumatoid arthritis: a prospective study in Israeli patients with immunogenetic correlations.

In a prospective open study 44 Israeli patients with rheumatoid arthritis were treated with weekly low dose methotrexate (MTX) for up to 36 months. Nine patients withdrew from the study: six because of side effects and three due to inefficacy. One patient died of septicaemia following septic arthritis. Significant improvement, graded by Ritchie articular index, grip strength, physician's global assessment, erythrocyte sedimentation rate (ESR), and platelet counts, was noticed in response to treatment. Seronegative patients had a better clinical response. Transient gastrointestinal symptoms were common and correlated with increases of serum aspartate transaminase (AST). HLA-DR1 and DR7 were significantly associated with increased serum AST concentrations.     

A randomized, double-blind, multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis

OBJECTIVE: To assess the efficacy and safety of chicken type II collagen (CCII) in rheumatoid arthritis (RA) compared with methotrexate (MTX). METHODS: We conducted a prospective, 24-week, followup, multicenter, double-blind, controlled study of CCII (0.1 mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical assessments were performed at screening and at 12, 18, and 24 weeks of treatment. RESULTS: A total of 236 RA patients were included; 211 patients (89.4%) completed the 24-week followup. In both groups there was a decrease in pain, morning stiffness, tender joint count, swollen joint count, Health Assessment Questionnaire score, and investigator and patient assessment of function; all differences were statistically significant. In the MTX group, erythrocyte sedimentation rate and C-reactive protein level decreased. Rheumatoid factor did not change in either group. At 24 weeks, 68.57% of patients in the CCII group and 83.02% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII group were lower than those in the MTX group, and this difference was statistically significant (P < 0.05). Gastrointestinal symptoms were common in both groups. There were fewer and milder side effects in the CCII group than the MTX group. The difference in incidence of adverse events between the 2 groups was statistically significant (P < 0.05). CONCLUSION: CCII is effective in the treatment of RA. CCII is well tolerated, and the incidence of adverse events of CCII is lower than that of MTX.     

甲氨蝶呤联合环磷酰胺治疗类风湿关节炎随机单盲对照临床研究

目的 评价甲氨蝶呤(MTX)联合环磷酰胺(CTX)及单独应用MTX、单独应用CTX治疗类风湿关节炎(RA)的疗效和安全性.方法 本研究为随机、单盲、对照的临床试验.符合纳入及排除标准的RA患者随机分为单用MTX(10～15 mg/周)、单用CTX(400 mg/2～3周)及MTX联合CTX治疗组(MTX10～15 mg/周+CTX 400 mg/2～3周).疗程24周,在基线、6、12、24周进行疗效及安全性评估.以美国风湿病学会(ACR)疗效评价指标ACR20为主要疗效指标,ACR50、ACR70、欧洲抗风湿联盟(EULAR)疗效指标、疼痛目视模拟测试表(VAS)评分、患者对自身健康状况的总体评估(PGA)、医生总体评价、压痛关节数(TJC)、压痛关节指数(TJI)、肿胀关节数(SJC)、肿胀关节指数(SJI)、健康评估问卷(HAQ)为次要疗效指标.结果 在第24周,MTX+CTX组达ACR20改善的患者比例(81%)高于MTX组(56%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组达ACR50改善的患者比例高于CTX组(P＜0.05).与MTX组之间差异无统计学意义(P＞0.05).在第24周,MTX+CTX组达到EULAR有效的患者比例(77%)高于MTX组(48%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组在TJC/TJI、SJC/SJI疼痛VAS评分、ESR的改善程度高于MTX组(P＜0.05).在压痛关节数脂数、肿胀关节数/指数、疼痛VAS评分、PGA、医生总体评价、HAQ、ESR的改善程度高于CTX组(P＜0.05).3组之间不良反应发生率差异无统计学意义.结论 MTX联合CTX治疗能显著改善RA的症状、体征和实验室炎性指标,疗效优于单用MTX及单用CTX.两者联合治疗安全耐受性好,与单用MTX及单用CTX相比,并不增加不良反应的发生率.     

A systemic review and meta-analysis of the clinical efficacy and safety of total glucosides of peony combined with methotrexate in rheumatoid arthritis

To assess the efficacy and safety of the combination of total glucoside of peony (TGP) and methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). Randomized controlled trial (RCT) data on the traditional Chinese active component TGP combined with MTX vs. MTX alone for the treatment of RA was collected by searching the Pubmed, Embase, Cochrane Library, CNKI, VIP Journals database, and Wanfang database up to February 2017. Study selection, data extraction, data synthesis, and data analyses were performed according to the Cochrane standards. A total of eight RCTs involving 522 participants were included in this meta-analysis. Compared with MTX alone, the use of TGP combined with MTX exhibited better therapeutic effects for the treatment of RA (P = 0.004). In addition, TGP combined with MTX caused a more significant decrease in erythrocyte sedimentation rate (ESR) (P < 0.0001) and swollen joint count (SJC) (P < 0.00001). However, no significant differences were found in C-reactive protein (CRP) (P = 0.19), duration of morning stiffness (DMS) (P = 0.32), or tender joint count (TJC) (P = 0.23) between the two groups. In addition, adverse events were more frequently reported in the MTX monotherapy group than in the TGP and MTX combination group (P = 0.0007). Our study demonstrates that TGP combined with MTX is more effective than MTX alone for the treatment of RA. Nevertheless, the adverse effects of the combination of TGP and MTX need to be further assessed. Due to the poor methodological quality of included trials, well-designed, multi-center, and large-scale RCTs are necessary to draw a more definitive conclusion.     

Influence of methylenetetrahydrofolate reductase polymorphisms on efficacy and toxicity of methotrexate in patients with juvenile idiopathic arthritis

OBJECTIVE: To study the relationship of C677T and A1298C polymorphisms in the methylenetetrahydrofolate reductase (MTHFR) gene to toxicity and efficacy of methotrexate (MTX) in patients with juvenile idiopathic arthritis (JIA). METHODS: Single nucleotide polymorphisms of the MTHFR gene were investigated by polymerase chain reaction and restriction enzyme analysis of DNA extracted from peripheral blood cells. The fasting plasma homocysteine concentration was analyzed by enzyme immunoassay. Clinical data of 58 patients with JIA treated with MTX were analyzed retrospectively. RESULTS: The 1298A/A genotype was present in 31 patients, 1298C/C in 4 patients, and 21 patients were heterozygous. The 677C/C genotype was present in 29 patients, 677 T/T in 3 patients, and 26 patients were heterozygous. In patients who presented the C allele of the A1298C polymorphism, improvement with respect to the number of swollen joints, the number of tender joints, and a decrease in erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels occurred more frequently than in 1298 A/A homozygous patients (p < 0.05 for ESR, p < 0.01 for CRP, chi-square test). There was no relationship between the C677T polymorphism and the efficacy of MTX treatment. Forty-two adverse events were noted in 26 patients; gastrointestinal symptoms were most common (n = 20), followed by elevated serum levels of transaminases (n = 19) and hair loss (n = 3). There was no cytopenia. Patients with the heterozygous genotype 677C/T exhibited adverse events more frequently than patients with the homozygous C/C genotype (65% vs 31%; p < 0.05, chi-square test). The A1298C polymorphism, however, was not associated with occurrence of adverse events. Plasma homocysteine was elevated in 6 patients with up to 16.9 mmol/l. No association was found to a specific genotype or to adverse events. CONCLUSION: These preliminary data suggest an association of the MTHFR 677C/C polymorphism to a higher tolerability of MTX, and of the 1298A/A to lower clinical efficacy of MTX therapy in JIA.     

The role of subcutaneous administration of methotrexate in children with juvenile idiopathic arthritis who have failed oral methotrexate

OBJECTIVE: To describe the outcome of patients with juvenile idiopathic arthritis (JIA) treated with subcutaneous (Sc) methotrexate (MTX) after failing oral MTX (either because of inefficacy or toxicity) in a clinic population. METHODS: The study cohort was identified from our clinical database, and consisted of 61 children with JIA treated with MTX between 1988-2001. All patients fulfilled International League Against Rheumatism (ILAR) criteria for JIA and had disease duration of >/= 6 months and 3 or more active joints before institution of MTX. All patients had a core set of outcome variables assessed at baseline and at 3 months after achieving both maximum oral and SC MTX. Outcome variables included physician global assessment of disease activity, number of active joints, number of joints with limited range of motion, duration of early morning stiffness, and erythrocyte sedimentation rate (ESR). Improvement was defined as at least 30% improvement from baseline in 3 of 5 variables in the core set, with no more than one of the remaining variables worsening by more than 30%. RESULTS: A total of 61 patients, 43 females and 18 males with JIA were studied. The disease subtypes were systemic 8, polyarticular 25 (12 rheumatoid factor positive), oligoarticular 14, enthesitis related arthritis 5, and unclassified 4. Thirty-one patients were switched to SC MTX, 13 of whom had not improved, and 18 who had improved, but had nausea (11) or insufficient clinical improvement (7). After 3 months of SC MTX treatment, 76% of patients were classified as improved and 23% as not improved. Toxicity on SC MTX was less than on oral MTX. CONCLUSION: Our results suggest that for patients failing oral MTX either because of inefficacy or toxicity, the use of SC MTX has a high likelihood of success with more than 70% of patients achieving clinically significant improvement, without clinically significant toxicity.     

Preliminary report of higher dose methotrexate treatment in juvenile rheumatoid arthritis.

Methotrexate (MTX) is widely used to treat juvenile rheumatoid arthritis (JRA). Although most patients respond to lower doses (0.15-0.5 mg/kg/wk), some patients have required higher doses of MTX to control their arthritis. Thirteen children were treated with MTX 0.82-1.1 mg/kg/wk for 2-26 months. Although all children initially responded (> 50% improvement in joint index, erythrocyte sedimentation rate, morning stiffness and global evaluation), 4 patients discontinued treatment because of side effects or lack of prolonged efficacy. Five patients have continued taking higher dose MTX for 4-26 months, while 4 other patients have been able to decrease their MTX dose and maintain improvement. Twenty-four hour MTX levels were done on all patients at initiation of higher dose MTX and all cleared MTX well. Our report suggests that MTX in doses of 0.82-1.1 mg/kg/wk can successfully treat active synovitis in some children with severe JRA with few short term toxicities. Longterm use at these doses has not been studied and thus its safety is not known.     

A randomized,double‐blind,multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis

Objective

To assess the efficacy and safety of chicken type II collagen (CCII) in rheumatoid arthritis (RA) compared with methotrexate (MTX).

Methods

We conducted a prospective, 24‐week, followup, multicenter, double‐blind, controlled study of CCII (0.1 mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical assessments were performed at screening and at 12, 18, and 24 weeks of treatment.

Results

A total of 236 RA patients were included; 211 patients (89.4%) completed the 24‐week followup. In both groups there was a decrease in pain, morning stiffness, tender joint count, swollen joint count, Health Assessment Questionnaire score, and investigator and patient assessment of function; all differences were statistically significant. In the MTX group, erythrocyte sedimentation rate and C‐reactive protein level decreased. Rheumatoid factor did not change in either group. At 24 weeks, 68.57% of patients in the CCII group and 83.02% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII group were lower than those in the MTX group, and this difference was statistically significant (P < 0.05). Gastrointestinal symptoms were common in both groups. There were fewer and milder side effects in the CCII group than the MTX group. The difference in incidence of adverse events between the 2 groups was statistically significant (P < 0.05).

Conclusion

CCII is effective in the treatment of RA. CCII is well tolerated, and the incidence of adverse events of CCII is lower than that of MTX.