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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?
A double-blind, double-dummy, multicenter trial was used to evaluate the analgesic effect of sublingual buprenorphine (0.2 mg per tablet) in buprenorphine (Bup). The reference drug was morphine sulfate. The results showed that: (1) Bup was used to relieve the acute analgesic effect of 0.2mg-0.4mg buprenorphine after surgery, which was equivalent to 10mg morphine; (2) Buprenorphine tablets were used to relieve moderate Pain, a dose of 0.2mg and 0.4mg clinical analgesic effect almost no difference, suggesting that each application can be; (3) Bup tablets for the treatment of chronic cancer of chronic moderate pain, each dose 0. 2-0.8mg, three times a day, can make 80% of patients with moderate to moderate pain relief, the total effective rate of clinical analgesia was 91.67%, markedly effective rate of 86.11%. The test, the daily dose increased to 1.2-2.4mg, the complete remission rate reached 60%, moderate remission rate of 95%, dosing interval can be extended to 6-8h, indicating that the drug has a long Pain and aging. It can be considered that the dose adjustment can make patients with moderate cancer pain achieve no pain; (4) The adverse reactions of Bup are mainly dizziness, nausea and vomiting, and they are heavier on the day of taking medicine, reaching up to 30%, 30% and 20% respectively. 1wk significantly decreased. A few people may have headache, itchy skin, rashes, dysuria and so on. The prevalence of open sleep test was 20% -30% within 2 weeks, which was significantly higher than that of the control group. (5) No significant effect of buprenorphine on respiration, blood pressure and heart rate was found. After 2wk medication observation, blood?