丁丙诺啡片用于镇痛随机双盲双模拟对照多中心的临床试验

采用双盲双模拟对照多中心实验，临床评价了丁丙诺啡（Ｂｕｐ）舌下含片（每片０．２ｍｇ）的镇痛效果，对照药为硫酸吗啡普通片。结果表明：（１）Ｂｕｐ用于缓解手术后急性中度疼痛０．２ｍｇ－０．４ｍｇ丁丙诺啡的临床镇痛效果与１０ｍｇ吗啡相当；（２）丁丙诺啡片用于缓解中度疼痛，其一次剂量０．２ｍｇ与０．４ｍｇ的临床镇痛效果几乎无差别，提示每次应用１片即可；（３）Ｂｕｐ片用于缓解晚期癌症慢性中度疼痛，每次剂量０．２－０．８ｍｇ，一日三次，可使８０％的疼痛患者得到中度以上缓解，临床镇痛总有效率９１．６７％，显效率８６．１１％。本试验，日剂量加大到１．２－２．４ｍｇ时，完全缓解率达到６０％，中度以上缓解率达到９５％，给药间隔时间可延长到６－８ｈ，显示本药具有中长镇痛时效。可以认为，通过剂量调整能使中度癌痛患者达到无疼痛；（４）Ｂｕｐ的不良反应主要为头晕、恶心、呕吐，服药当天较重，分别可达３０％、３０％和２０％左右。１ｗｋ内明显下降。少数人可有头痛、皮肤瘙痒、皮疹、排尿困难等。开放试验思睡发生率２ｗｋ内一直在２０％－３０％左右，明显高于对照试验丁丙诺啡组；（５）未发现丁丙诺啡对呼吸、血压、心率造成明显影响。经２ｗｋ用药观察，血?

CLINICAL EVALUATION OF ANALGESIC EFFECTS OF BUPRENORPHINE SUBLINGUAL TABLET BY DOUBLE BLIND, DOUBLE DUMY, MULTIPLE CENTER METHOD

A singal day and 7 day clinical evaluation of analgesic effect of buprenorphine sublingual tablet was carried out in several hospitals according to a randomized and double-blind,double-dumy design.The clinical results showed that: (1) The analgesic effect of buprenorphine sublingual tablet (dose 0.2-0.4 mg, tid) was equal to that of morphine sulfate tablet (dose 10 mg);(2) Taking one sublingual tablet of buprenorphine could well relieve the middle pain intensity of patients;(3) There was no significant differences between 0.2 mg and 0.4 mg singal oral dose of buprenorphine sublingual tablet in pain control;(4) The adverse effects of buprenorphine tablet were dizzy, vomitting and nausing,but the rate of occurence of these three reactions decreased after taking Bup for a week;(5)Buprenorphine sublingual tablet showed no influence on respiration,heart rate and blood pressure, no damage of liver,kidney and blood system was found. No tolerance and dependence were formed.