周期联合甲氨蝶呤环磷酰胺治疗类风湿关节炎的临床疗效及疗效预测因素分析

Efficacy of periodical combination of methotrexate and cyclophosphamide in patients with rheumatoid arthritis and factors for predicting clinical responses

目的探讨周期联合甲氨蝶呤、环磷酰胺治疗类风湿关节炎(RA)的临床疗效和达到临床疗效的预测因素。方法本研究共纳入60例活动期RA患者,给予甲氨蝶呤(10～15mg/周)、环磷酰胺(400mg/2～3周)周期联合治疗。在第24周时对临床疗效进行评估。以治疗24周时达到美国风湿病学会(ACR)20为疗效标准,对基线时的14项参数[年龄、性别、病程、疼痛视觉模拟量表(VAS)评分、患者对疾病总体状况的评估(PGA)、医生对疾病总体状况的评估(PhGA)、压痛关节数、肿胀关节数、健康评估问卷(HAQ)、红细胞沉降率(ESR)、C反应蛋白(CRP)、激素的使用情况、类风湿因子(RF)和抗环瓜氨酸肽(CCP)抗体水平]进行Logistic单因素和多因素疗效预测分析。结果共58例RA患者完成24周疗效观察。在第24周时,79%(46/58)的患者达ACR20改善,55%(32/58)的患者达ACR50改善,21%(12/58)的患者达ACR70改善。24周时达到EULAR临床有效的患者比例为76%(44/58)。Logistic单因素和多因素分析显示:年龄、肿胀关节数是ACR20疗效的预测因素。结论甲氨蝶呤联合环磷酰胺治疗RA疗效显著,两者联合治疗能明显改善RA的症状、体征和实验室炎性指标;年龄和肿胀关节数是ACR20疗效的预测因素。

Objective To assess the efficacy of periodical combination of mcthotrcxate （MTX） and cyclophos- phamide （CTX） in patients with rheumatoid arthritis （RA） and the factors for predicting clinical responses. Methods Sixty patients with active RA were assgined to receive the combination of MTX （10-15 mg/week） and CTX （400 mg/2- 3 week） for assessment of the clinical efficacy at week 24. Univariate and multivariate Logistic regression was em- ployed to investigate the following parameters, including age, sex, disease duration, visual analogue scale （VAS） for pain, patient＇s global assessment, physician＇s global assessment, tender joint count, swollen joint count, health assess- ment questionnaire （HAQ）, erythrocyte sedimentation rate （ESR）, C-reactive protein （CRP）, use of glucocorticoid, rheumatoid factor and anti-CCP antibody, based on the criteria established by American College of Rheumatology （ACR） 20 at week 24. Results Of 58 patients with RA who completed the 24-week treatment, 79% （46/58） achieved improvements that met the ACR20 criteria, 55% （32/58） were the ACR50 responders, 21% （12/58） fulfilled ACR70 improvement and 76% （44/58） satisfied the EULAR clinical responder criteria. Univariate and multivariate Logistic regression analysis showed that age and swollen joint counts at week 0 were predictors of the clinical efficacy in terms of ACR20. Conclusion Methotrexate in combination with cyclophosphamide, which markedly improves the symp- toms, signs and laboratory variables, may achieve significant responses in patients with RA. Age and swollen joint counts at week 0 are predictors of the efficacy as assessed by ACR20.