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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。
Clinical evaluation of buprenorphine sublingual tablets analgesic effect and adverse drug reactions. A total of 235 patients with various types of moderate pain were enrolled in the double-blind, double-dummy, multicenter trial. The reference drug was morphine sulfate. The results showed that: (1) 0.2-0.4 mg of buprenorphine was used to relieve the acute pain caused by surgery and the clinical effect was similar to that of 10 mg morphine; (2) Buprenorphine tablets were used to relieve the chronic moderate- Pain, each dose of 0.2 ~ 0.4mg, three times a day, can make 80% of patients with moderate pain relief, dosing interval can be increased to 6 ~ 8h; (3) buprenorphine adverse drug reactions Mainly dizziness, nausea, vomiting and so on. The incidence of 0.4mg buprenorphine group was slightly higher than 0.2mg buprenorphine group and 10mg morphine group. Open trial 4d before taking the drug adverse reactions were higher, respectively, 20.4%, 22.4% and 14.3%; after a significant decline. Skin itching, skin rashes or dysuria and other occasional occurrence; (4) did not find buprenorphine on breathing, blood pressure, heart rate caused significant effect. After observation, blood, urine, liver, kidney function and ECG no abnormal changes. No drug resistance or physical dependence was found. Clinical observations show buprenorphine buccal tablets can effectively relieve moderate pain, with long and medium analgesic aging.