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盐酸丁丙诺啡Ⅰ期临床药物耐受性试验 被引量:2

PHASE I CLINICAL TRIAL OF BUPRENORPHINE HYDROCHLORIDE
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摘要 健康成年人自愿受试者17例,随机分为5组,分别肌注盐酸丁丙诺啡0.03、0.05、0.1、0.2和0.3mg,住院观察。结果表明,该药可使心率减慢,0.3mg组峰作用时可减少12.8%(P<0.05);使收缩血压最大下降幅度在7~10%之间(p<0.05),但舒张压却呈轻度上升趋势;能产生类似于吗啡的呼吸抑制作用;对正常人体温影响不大。上述各项生理参数无重要临床意义。该药可提高辐射热所致基础痛阈和痛耐受(p<0.05),且持续时问在6h以上。正常人用药后可产生典型吗啡样副作用和轻度改变心境作用,包括头晕、嗜睡、恶心、呕吐、松驰、舒适和飘然欲仙等。肝肾功能和血尿常规检查未见异常。本研究认为将盐酸丁丙诺啡控制在0.1至0.3mg成年人使用,便具有明显镇痛作用,而且不会产生严重不良反应。 17 Healthy volunteers were selected and randomized into5 dose groups. Each of them received a single dose of buprenorphine0.03, 0.05, 0. 1, 0 .2 and 0 .3mg by im injection respectively. Results showedthat heart rate was clianged with a maximal decrease of 12.810 (p<0.05)in 0 .3mg group. Systolic blood pressure was dropped with a range of 7-10% (p<0 .05), but diastolic blood pressure appeared with a trend ofminor increace. There was a statistically significant fall in respirationrate, but no significant change was measured in body temperature. In nocase was there any cause for clinic concern and no treatment was requiredfor these respiratory or cardioyascular changes. Studies using thermal stimulation showed that buprenorphine elevatedthe experimental pain threshold and tolerance and the analgesic effect canpersisted more than six hours, The most common side-effects were diz-ziness, drowsiness, nausea and vomiting, and some slight morpine-likemood-altering effects were observed during this trail. Laboratory analysesrevealed no abnormalities. By coming to a conclusion, buprenorphine is apotent analgesic and no severe side-effects may be produced with a doseranges of 0. 1 to 0 .3mg.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 1990年第1期37-43,共7页 The Chinese Journal of Clinical Pharmacology
关键词 盐酸丁丙诺啡 药物耐受试验 buprenorphine phase I clinical trial
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  • 1郑继旺,张开镐.丁丙诺啡治疗阿片依赖性的研究进展[J].中国药物依赖性通报,1992,1(2):78-82. 被引量:29
  • 2蔡志基.我国对药物滥用的管制及药物依赖性的研究[J].中国临床药理学杂志,1989,5(1):39-47. 被引量:9
  • 3Lewis JW. Buprenorphine[ J]. Drug Alcohol Depend, 1985,14(3 - 4): 363- 372.
  • 4Bullinghan RES,McQuay BJ,Dwyer D,et al.Sublingual buprenorphine used postoperativly:clinical observations and preliminary pharmacokinetic analysis[J].Br J Clin Pharmac,1981,12(2):117-122.
  • 5Robinson SE: Buprehorphine: an analgesic with an expanding role in the treatment of opioid addiction[J]. CNS Drug Rev,2002,8(4) :377 - 390.
  • 6Weno NK, Mendelson JH. Behavioral pharmacology of buprenorphine[ J]. Drug Alcohol Depend, 1985,14(3 -4) :283 - 303 .
  • 7Edge WG.Cooper GM,Morgan M.Analgesic effects of sublingual buprenorphine[J].Anaesthesia,1979,34(5):463-467.
  • 8曹贵华,蔡志基.国产丁丙诺啡的药物依赖性特性[J]中国临床药理学杂志,1987(03).
  • 9龚苕,郑继旺.药物依赖的医学治疗研究[J].中国药物依赖性杂志,1990,5(1):1-4. 被引量:10
  • 10刘丽京,徐国柱,王凯.丁丙诺啡舌下含片的不良反应分析[J].中国新药杂志,2000,9(10):709-710. 被引量:4

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