Pipitone V, Loizzi P, Casula P L, Bignamini A A
Curr Med Res Opin. 1979;6(4):287-98. doi: 10.1185/03007997909109440.
A double-blind clinical trial was carried out in 69 rheumatic in-patients to compare the efficacy and tolerance of a new, non-steroidal anti-inflammatory agent, protacine, with that of indomethacin. Patients received either 150 mg protacine or 50 mg indomethacin 3-times daily for 21 days. The time course of symptoms was recorded by semiquantitative scoring, as were side-effects. Uropepsinogen excretion, occult blood in faeces and standard physiological parameters were also monitored. Protacine globally decreased symptom scores by 58.5% and indomethacin by 24.3% (p less than 0.001). The computed time to reduce symptom scores by 50% was 17.2 days with protacine as compared to 39.2 days with indomethacin (p less than 0.001). Physiological parameters did not change, except white blood cells which decreased after protacine (each subject however, remaining well within the physiological range) and erythrocyte sedimentation rate, which decreased in both groups. Uropepsinogen excretion increased by 70% after protacine, and threefold after indomethacin (p less than 0.001). Occult blood search was positive in 1 patient receiving protacine, while 2 who were already positive before receiving protacine became negative during the treatment. Four patients taking indomethacin were found to be positive, 1 showing melaena. The one who was already positive before treatment showed increasing severity of occult bleeding during indomethacin administration. Frequency and severity of side-effects were significantly less with protacine (p = 0.004). In conclusion, protacine showed analgesic and anti-inflammatory actions significantly more potent and rapid than those of indomethacin, with significantly fewer and less severe side-effects.
对69名风湿性疾病住院患者进行了一项双盲临床试验，以比较一种新型非甾体抗炎药普罗他辛与吲哚美辛的疗效和耐受性。患者每天3次，分别服用150毫克普罗他辛或50毫克吲哚美辛，持续21天。通过半定量评分记录症状的时间进程以及副作用。还监测了尿胃蛋白酶原排泄、粪便潜血和标准生理参数。普罗他辛使症状评分总体下降了58.5%，吲哚美辛下降了24.3%（p<0.001）。普罗他辛将症状评分降低50%的计算时间为17.2天，而吲哚美辛为39.2天（p<0.001）。生理参数没有变化，只是普罗他辛治疗后白细胞减少（然而，每个受试者仍处于生理范围内），两组的红细胞沉降率均下降。普罗他辛治疗后尿胃蛋白酶原排泄增加了70%，吲哚美辛治疗后增加了三倍（p<0.001）。1名接受普罗他辛治疗的患者粪便潜血检查呈阳性，而2名在接受普罗他辛治疗前已呈阳性的患者在治疗期间转为阴性。发现4名服用吲哚美辛的患者呈阳性，1名出现黑便。治疗前已呈阳性的患者在服用吲哚美辛期间潜血出血的严重程度增加。普罗他辛的副作用频率和严重程度明显较低（p = 0.004）。总之，普罗他辛显示出比吲哚美辛更强效、更迅速的镇痛和抗炎作用，且副作用明显更少、更轻。
