丁丙诺啡含片的随机双盲双模拟对照多中心及开放的临床试验

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

临床评价丁丙诺啡舌下含片的镇痛效果及药物不良反应。将入选的各类型中度疼痛患者２３５例采用双盲双模拟对照多中心试验，对照药为硫酸吗啡普通片。结果表明：（１）丁丙诺啡０．２～０．４ｍｇ用于缓解手术后引起的急性疼痛的临床效果与１０ｍｇ吗啡相当；（２）丁丙诺啡片用于缓解晚期癌症慢性中度疼痛，每次剂量０．２～０．４ｍｇ，一日三次，可使８０％的疼痛患者得到中度以上缓解，给药间隔可增加到６～８ｈ；（３）丁丙诺啡药物不良反应主要为头晕、恶心、呕吐等。其发生率０．４ｍｇ丁丙诺啡组略高于０．２ｍｇ丁丙诺啡组和１０ｍｇ吗啡组。开放试验在服药前４ｄ上述药物不良反应发生率较高，分别达到２０．４％、２２．４％和１４．３％；尔后明显下降。皮肤瘙痒、皮疹或排尿困难等偶有发生；（４）未发现丁丙诺啡对呼吸、血压、心率造成明显影响。经观察，血常规、尿常规、肝、肾功能及心电图无异常改变。未发现药物耐受或身体依赖现象。临床观察显示丁丙诺啡含片可有效缓解中度以上疼痛，具有中长镇痛时效。

Cases of 235 according to a randomized and double-blind, double-dumy design, a clinical evaluation of analgesic effect of buprenophine sublingual tablet was performed. The results showed that: (1)The analgesic effect of buprenophine sublingual tablet (dose 0.2～0.4mg) was equal to morphine sulfate tablet (dose 10mg);(2)The middle pain intensity of the cancer patients were well relieved by buprenophine sublingual tablet (dose 0.2～0.4mg, tid); (3)The adverse effects of buprenophine sublingual tablet were dizzy, vomitting and nausing. The rate of occurrence of buprenophine sublingual tablet (dose 0.4mg) was higher than buprenophine sublingual tablet (dose 0.2mg) and morphine sulfate tablet (dose 10mg). After taking Bup for a week, these reactions decreased; (4) buprenophine 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.