Shiokawa Y, Horiuchi Y, Honma M, Kageyama T, Okada T, Azuma T
Arthritis Rheum. 1977 Nov-Dec;20(8):1464-72. doi: 10.1002/art.1780200804.
In order to evaluate clinical efficacy of D-penicillamine (DP) a double-blind study was conducted by the Metalcaptase Research Group consisting of forty-one rheumatological centers in Japan. A total of 179 patients with rheumatoid arthritis (RA) was divided into two groups; one treated with 5 mg (control group) and the other with 100 mg (drug group) of DP in capsule form. The trial lasted 24 weeks. Global judgment by physicians revealed that improvement was found in 27% in the controls and 65% in the drug group. Adverse reactions occurred in 34% of the controls and 49% of the drug group. Skin rashes, taste disturbances, gastrointestinal upset and proteinuria were frequent in the drug group, but severe or fatal reactions could not be seen in this trial.
为评估D-青霉胺(DP)的临床疗效,日本由41个风湿病中心组成的金属巯基酶研究小组进行了一项双盲研究。总共179例类风湿性关节炎(RA)患者被分为两组;一组服用5毫克胶囊形式的DP(对照组),另一组服用100毫克胶囊形式的DP(药物组)。试验持续了24周。医生的总体判断显示,对照组有27%的患者病情改善,药物组有65%的患者病情改善。对照组有34%的患者出现不良反应,药物组有49%的患者出现不良反应。药物组皮疹、味觉障碍、胃肠道不适和蛋白尿较为常见,但在该试验中未观察到严重或致命反应。