摘要
目的观察小剂量激素泼尼松（PDN）联合甲氨蝶呤（MTX）治疗早期类风湿性关节炎（RA）的疗效及安全性。方法未接受过治疗的早期RA患者60例,随机分为观察组30例,予PDN联合MTX治疗（PDN 10～15mg/d,MTX7.5～20mg/w）,对照组30例,予MTX（7.5～20mg/w）加安慰剂治疗,疗程均12周。治疗0、4、8、12周评估两组疗效及安全性。以美国风湿病学会（ACR）疗效评价指标ACR20、DAS28-ESR指标、疼痛目视模拟测试表（VAS）评分、患者对病情活动的总体VAS评分、医生对病情活动的总体VAS评分、压痛关节数、肿胀关节数、健康评估问卷（HAQ-DI）评分、晨僵持续时间、CRP和ESR作为疗效指标。结果治疗第4周和第8周,观察组达到ACR20改善者分别为43.3%、66.7%,对照组分别为16.7%、30.0%,两组比较差异均有统计学意义（P均〈0.05）。治疗第12周,观察组83.3%（25例）达到ACR20的改善,对照组为43.3%（13例）（P=0.001）。第4周起,观察组DAS28-ESR评分均持续低于对照组（P均〈0.05,P〈0.01）。治疗12周,除关节压痛数、晨僵时间和CRP,观察组其它各项临床和实验室炎症指标改善均优于对照组（P〈0.05,P〈0.01）。观察组RA病程与12周DAS28-ESR评分存在显著正相关（r=0.643,P=0.000）。结论小剂量GC联合MTX治疗能显著改善ERA症状、体征和实验室炎性指标,疗效优于单用MTX。两者联合治疗安全耐受性良好。
Objective To investigate the clinical efficacy and safety of low-dose prednisone（PDN） combined with methotrexate（MTX） for previously untreated patients with early rheumatoid arthritis（ERA）.Methods In a randomized,single-blinded,controlled study,60 patients with ERA were randomly assigned to receive low-dose PDN（15 mg/d） plus MTX（7.5-20mg/w） or placebo plus MTX（7.5-20mg/w） for 12 weeks.Clinical variables were assessed at baseline and every 4 weeks.Adverse effects were documented every 4 weeks.The primary outcomes were the pro portion of patients meeting the American College of Rheumatology 20% improvement criteria（achieving an ACR20 response） and Disease Activity Score in 28 joints using the erythrocyte sedimentation rate（DAS28-ESR） at week 4,8 and 12.The change from baseline in duration of pain,patient＇s global assessment,physician＇s global assessment,tender joint count,swollen joint count,health assessment questionnaire（HAQ）,ESR and CRP were also evaluated.Results At week 4,8,and 12,the ACR20 was achieved in 43.3%,66.7%,and 83.3% of patients receiving lowdose PDN plus MTX,compared with 16.7%,30.3%,and 43.3% of patients receicing placebo plus MTX（P〈0.05,P 0.05,P=0.001）.Significant differences in DAS28-ESR were noted between two groups at week 4,8 and 12（Ps〈 0.05）.At week 12,other clinical variables improved better in low-dose PDN plus MTX group than in placebo plus MTX group（Ps〈0.05） and the duration of RA before therapy was correlated with DAS28-ESR（r=0.643,P=0.000）.Conclusion Low-dose PDN plus MTX can effectively reduce the signs and symptom of RA and is generally well tolerated by patients without significant increase in the rate of adverse events compared with MTX monotherapy.
出处
《浙江中西医结合杂志》
2014年第5期383-386,390,共5页
Zhejiang Journal of Integrated Traditional Chinese and Western Medicine
