Paulus H E, Williams H J, Ward J R, Reading J C, Egger M J, Coleman M L, Samuelson C O, Willkens R F, Guttadauria M, Alarcón G S
Arthritis Rheum. 1984 Jul;27(7):721-7. doi: 10.1002/art.1780270701.
Two hundred six patients were entered into a prospective controlled, double-blind, multicenter trial comparing azathioprine (AZA) 1.25-1.5 mg/kg/day with D-penicillamine (DP) 10-12 mg/kg/day. One hundred thirty-four patients completed 24 weeks of therapy. Improvement in nearly all efficacy variables was seen in both groups. Patients taking DP demonstrated a greater rise in hemoglobin concentration and greater fall in erythrocyte sedimentation rate than patients receiving AZA; these were the only efficacy variables with a significant difference between the treatment groups. Fewer withdrawals for adverse reactions occurred among the patients receiving AZA, but the difference was not significant. Patients receiving AZA were withdrawn from the drug mainly for abnormal liver function test results, nausea and gastrointestinal upset, and leukopenia. The main reasons for withdrawal of patients receiving DP were nausea, rash and pruritus, thrombocytopenia, dysgeusia, and proteinuria.
206例患者进入一项前瞻性对照、双盲、多中心试验,比较硫唑嘌呤(AZA)1.25 - 1.5mg/(kg·天)与青霉胺(DP)10 - 12mg/(kg·天)的疗效。134例患者完成了24周的治疗。两组几乎所有疗效指标均有改善。服用DP的患者血红蛋白浓度升高幅度大于接受AZA的患者,红细胞沉降率下降幅度也大于接受AZA的患者;这些是治疗组间仅有的有显著差异的疗效指标。接受AZA的患者因不良反应而停药的较少,但差异不显著。接受AZA的患者主要因肝功能检查结果异常、恶心和胃肠道不适以及白细胞减少而停药。接受DP的患者停药的主要原因是恶心、皮疹和瘙痒、血小板减少、味觉障碍和蛋白尿。