口服氨酚待因2号片镇痛效果的临床评价

<正> 氨酚待因2号片(PC-2)每片含磷酸可待因15 mg和扑热息痛300 mg,是国内新开发的复方镇痛药,本文采用多中心、随机双盲双模拟平行对照的试验设计,对中度疼痛患者进行临床验证,以氨酚待因1号片(PC-1,每片含磷酸可待因8.4 mg和扑热息痛500 mg)作为阳性对照药,阴性对照药用安慰剂(PB)。患者总数338例(206例用PC-2,32例用PC-1,100例用PB)。临床验证结果表明:(1)PC-2组对中等程度的手术后疼痛、中晚期癌痛和某些神经痛均有满意的镇痛效果,其疼痛强度差、疼痛缓解度以及2度以上疼痛缓解率等各项检查指标均明显优于PB组(P     

口服氨酚待因2号片镇痛效果的临床评价

氟酚待因2号片(PC-2)每片磷酸可待因15mg和扑热息痛300mg．是国内新开发的复方镇痛药．本文采用多中心、随机双盲双模拟平等对照的试验设计．对中度疼痛患者进行临床验证，以氨酚待因1号片(PC-1，每片含磷酸可待因8．4mg和扑热息痛500mg)作为阳性对照药，     

氯芬待因片镇痛效果临床评价

氯芬待因片（每片含双氯芬酸２５ｍｇ和磷酸可待因１５ｍｇ）与氨酚待因２号片（每片含扑热息痛３００ｍｇ和磷酸可待因１５ｍｇ）安慰剂进行双盲对照试验，旨在考察其对手术后疼痛，癌痛，神经痛等中度疼痛患者的临床镇痛效果和不良反应，氯芬待因组３０３例，氨酚待因２号片组３１例，安慰剂组６９例，采用疼痛强度差，总疼痛强度差，疼痛缓解度中度以上疼痛缓解率等镇痛效果评价指标。结果表明：（１）氯芬待因镇痛效果明显优于对     

氯芬待因片镇痛效果临床评价

氯芬待因片（每片含双氯芬酸２５ｍｇ和磷酸可待因１５ｍｇ）与氨酚待因２号片（每片含扑热息痛３００ｍｇ和磷酸可待因１５ｍｇ）、安慰剂进行双盲对照试验，旨在考察其对手术后疼痛、癌痛、神经痛等中度疼痛患者的临床镇痛效果和不良反应。氯芬待因组３０３例，氨酚待因２号片组３１例，安慰剂组６９例。采用疼痛强度差、总疼痛强度差、疼痛缓解度、中度以上疼痛缓解率等镇痛效果评价指标。结果表明：（１）氯芬待因镇痛效果明显优于安慰剂（Ｐ＜０．００１），某些指标方面亦优于氨酚待因２号片（Ｐ＜０．０５）；（２）氯芬待因不良反应轻微，胃不适、恶心、呕吐在１０％以下，头晕、思睡在５％左右。多在１ｄ内消失。     

氨酚待因片Ⅱ号的镇痛药效和药物依赖性

<正> 镇痛强度大,依赖性小,滥用潜力低的镇痛剂盐酸丁丙诺啡开始在我国临床推广使用,为我国镇痛药增添了新品种。但可待因复方制剂系列产品的开发应用与国际上许多国家比较,有不少差距。在临床上广泛应用的可待因复方制剂只有氨酚待因片(以下称氨酚待因片Ⅰ号,简称PC-1,每片含磷酸可待因8.4 mg和扑热息痛500 mg),开发新的可待因制剂品种是十分必要的。汕头(鱼它)滨制药厂和北京益民制药厂经卫生部审定批准,在PC-1组方的基础上,联合研     

氨酚待因2号片的镇痛作用实验研究

本文用小鼠醋酸扭体法、热板法以及大鼠甩尾法比较了氨酚待因2号片(每片含磷酸可待因15 mg和扑热息痛300 mg)与氨酚待因片(每片含磷酸可待因8.4 mg和扑热息痛500 mg)的镇痛效应,结果表明,氨酚待因2号片的镇痛强度明显高于氨酚待因片,提示氨酚待因2号片可能是一疗效更好的镇痛药。     

镇痛新药安度芬片在申城推广应用

北京益民制药厂生产的安度芬片是在氨芬待因1号的基础上改进的。原氨酚待因1号每片含扑热息痛500mg和磷酸可待因8.4mg,而安度芬(即氨酚待因2号)则每片含扑热息痛300mg和磷酸可待因15mg。这是一种镇痛作用强、毒副作用小的新镇痛药。按卫生部规     

口服氮酚待因2号片对神经痛镇痛的临床评价

氨酚待因２号片系口服复方镇痛药。每片含磷酸可待因１５ｍｇ和扑热息痛３００ｍｇ。为验证其对中度神经痛的镇痛效果，本文自１９９２年１０月至１２月对３０例患有颈肩臂痛腰骶神经痛及三叉神经痛的病人，采用随机双盲对照法进行了临床试验。结果表明氨酸待因２号片对神经的镇痛效果明显。总有效率达６０％。     

氨酚待因片Ⅱ号的镇痛药效和药物依赖性

镇痛强度大，依赖性小，滥用潜力低的镇痛剂盐酸丁丙诺啡开始在我国临床推广使用，为我国镇痛药增添了新品种。但可待因复方制剂系列产品的开发应用与国际上许多国家比较．有不少差距。在临床上广泛应用的可待因复方制剂只有氮酚待因片(以下称氨酚待因片Ⅰ号，简称PC-1．每片古磷酸可待因8.4mg和扑热息痛500mg)，     

舒尔芬镇痛效果临床评价

舒尔芬为可待因和双氯芬酸组成的复方片剂 ,采用多中心开放试验 ,进一步考虑舒尔芬对中度疼痛患者的止痛效果。一次口服2片组 ,43例 ,分别为颌面术后痛、牙痛和月经痛 ;一天3次用药组90例。分别为癌痛、神经痛慢性痛、妇科和骨科手术后痛。两组镇痛效果均十分显著。中度以上疼痛缓解率100 %。与初始报道[1]相比 ,镇痛效果好 ,起效快 ,不良反应发生率相似 ,症状较轻。     

酒石酸双氢可待因片用于镇痛的随机双盲对照临床试验

目的 :评价国产Ⅳ类新药双氢可待因片的临床镇痛效果和药物不良反应。方法 :采用多中心随机双盲平行对照的方法 ,以磷酸可待因片为对照药 ;用单次给药治疗术后疼痛 ;多次给药治疗癌痛。以疼痛强度差、总疼痛强度差、疼痛缓解率、有效率等为镇痛效果判定指标。结果 :用于术后疼痛时 ,试验组各时点的疼痛强度差均高于对照组 ,用药后 1h两组疼痛强度差的差异有显著性 (P <0 0 5 ) ;用药后 6h两组中度以上缓解度的差异有显著性 (P <0 0 5 )。用于癌痛时 ,在试验组患者的平均体重明显大于对照组 (P <0 0 5 ) ,而平均用药剂量无明显差异的情况下 ,两组镇痛效果差异无显著性 ,即表明试验药的镇痛效果略强于对照药。两药最常见的不良反应均为便秘、恶心和胃不适。结论 :双氢可待因片是安全有效的二阶梯镇痛药。     

氨酚待因2号片的药物依赖性实验评价

每片含磷酸可待因15 mg,扑热息痛300 mg的复方制剂-氨酚待因2号片(PC-2)的身体依赖性用多种实验模型作了评价。PC-2在小鼠的用药剂量为相应临床日剂量(CDD)的6-20倍产生了身体依赖性,但大鼠的给药剂量为3CDD就产生了依赖性,然而,PC-2或磷酸可待因的日剂量为4CDD却不引起猴产生身体依赖性。这些结果表明PC-2具有一定程度的身体依赖性,PC-2在动物产生的身体依赖性有种属差异。     

复方磷酸可待因片镇痛效果的多中心临床评价

目的 :观察复方磷酸可待因片的临床镇痛效果和不良反应。方法 :采用多中心随机双盲对照试验和开放试验设计。以氨酚待因为对照药 ,设单次给药、3d给药、1周给药组 ;分别用于治疗牙痛、痛经、神经性头痛、癌痛和骨科慢性疼痛。镇痛效果评定指标为疼痛强度差、总疼痛强度差、疼痛缓解率、有效率。结果 :复方磷酸可待因片与氨酚待因片的效果基本一致 ,其不良反应较低 ,主要为胃不适、头晕和嗜睡等。结论 :复方磷酸可待因片是安全有效的镇痛药     

硫酸吗啡控释片治疗癌症疼痛的临床观察

目的:观察硫酸吗啡控释片对晚期癌症镇痛的效果。方法:采用开放试验方法,对100例中、重度癌痛患者进行治疗。硫酸吗啡控释片单片剂量为30mg,每12h给药一次,在用药过程中根据疼痛缓解程度调整剂量。结果:本组100例患者中显效65例,显效率65·0%,有效32例,有效率32·0%,无效3例,无效率3·0%,总有效率为97·0%(97/100)。结论:硫酸吗啡控释片治疗癌症疼痛疗效确切,有效率高。是中、重度癌痛的首选药品,现已应用于临床。     

The analgesic effect of etoricoxib relative to that of cetaminophen analgesics: a randomized, controlled single-dose study in acute dental impaction pain

BACKGROUND: To compare the analgesic effect of single doses of etoricoxib 120 mg, oxycodone/ acetaminophen 10 mg/650 mg and codeine/ acetaminophen 60 mg/600 mg in acute pain using the dental impaction model. METHODS: In this randomized, double-blind, placebo-controlled, parallel-group study, patients reported pain intensity and pain relief (16 times) and global scores (twice) during a 24-h period. The primary endpoint was the overall analgesic effect, total pain relief over 6 h (TOPAR6). Other endpoints were patient global evaluation, time to onset (2-stopwatch method), duration of analgesic effect (median time to and amount of rescue medication use). Tolerability was evaluated by overall and opioid-related (nausea and vomiting) adverse experiences. RESULTS: 302 patients (mean age 23; 63% women; 63 % White) were randomized to etoricoxib 120 mg, oxycodone/acetaminophen 10 mg/650 mg, codeine/acetaminophen 60 mg/600 mg, and placebo (2:2:1:1). Etoricoxib demonstrated significantly greater overall analgesic efficacy (TOPAR6) (13.2 units) versus oxycodone/acetaminophen (10.2 units); and codeine/acetaminophen (6.0 units); p < 0.001 for all. All active treatments were superior to placebo. Median time to onset was significantly (p < 0.001) shorter for oxycodone/acetaminophen (20 min) and numerically but not significantly shorter (p = 0.259) for codeine/acetaminophen (26 min) compared with etoricoxib (40 min). Etoricoxib (24 h) had a significantly longer lasting analgesic effect than oxycodone/acetaminophen (5.3 h), codeine/acetaminophen (2.7 h), and placebo (1.7 h) (p < 0.001 for all). Etoricoxib patients experienced fewer clinical adverse experiences than patients on oxycodone/acetaminophen and codeine/acetaminophen, specifically, significantly (p < 0.05) fewer episodes of nausea. CONCLUSION: Etoricoxib 120 mg provided superior overall analgesic effect with a smaller percentage of patients experiencing nausea versus both oxycodone/acetaminophen 10 mg/650 mg and codeine/acetaminophen 60 mg/600 mg.     

萘普待因镇痛效果开放试验临床评价

目的 :评价国产三类新药萘普待因片的镇痛效果及安全性。方法 :采用开放性试验方法。各种中度疼痛病人共 84例 ,口服萘普待因片 1～ 2片 ,tid。分为 2组 :1d组 ( 4 3例 ,年龄 4 0a±s15a ,男性13例 ,女性 30例 ;普通外科术后病人 31例 ,骨科术后与神经痛病人 12例 )仅服 1d ;7d组 ( 4 1例 ,年龄4 6a± 15a ,男性 31例 ,女性 10例 ;癌症病人 19例 ,骨科术后与神经痛病人 2 2例 )连服 7d ,其中d 2～ 7着重观察不良反应。结果 :1d组显效率 86% ,总有效率 98% ,7d组服药d 1内显效率 51% ,总有效率90 %。不良反应轻 ,主要有思睡、头晕及消化道症状 ,病人能耐受。结论 :萘普待因片对中度疼痛具有良好的镇痛效果 ,且较安全     

Evaluation of flurbiprofen, acetaminophen, an acetaminophen-codeine combination, and placebo in postoperative oral surgery pain

Eighty-eight outpatients with postoperative pain after the surgical removal of impacted third molars were randomly assigned, on a double-blind basis, to receive a single, oral dose of flurbiprofen 100 mg, acetaminophen 600 mg, a combination of acetaminophen 600 mg with codeine 60 mg, or placebo. Using a self-rating record, subjects rated their pain and its relief hourly for 12 hours after medicating. Estimates of sum of pain intensity differences, peak pain intensity differences, total relief, peak relief, and hours of 50% relief were derived from these subjective reports. Flurbiprofen and the acetaminophen-codeine combination were significantly superior to placebo for every measure of total and peak analgesia and significantly superior to acetaminophen alone for most measures of efficacy. Based on the 12-hour data, acetaminophen alone did not differ significantly from placebo; however, it was superior to placebo for measures of total effect based on the 4-hour data. Flurbiprofen was significantly superior to the acetaminophen codeine combination with respect to the number of hours until remedication. All medications had manifested an effect by hour 1; analgesia persisted for 12 hours for flurbiprofen, 6 hours for acetaminophen-codeine, and 3 hours for acetaminophen alone. The frequency of adverse effects was similar for the active medications.     

Analgesic efficacy of an ibuprofen-codeine combination in patients with pain after removal of lower third molars

Summary A double-blind, randomised analgesic trial was carried out in 165 patients undergoing surgical removal of one impacted lower wisdom tooth. In a two-dose regimen, the analgesic efficacy of the combination ibuprofen-codeine 200 mg : 30 mg was compared with that of acetylsalicylic acid-codeine 500 mg : 30 mg and codeine 30 mg. Each dose was taken when the patient needed pain relief. The intensity of the pain was measured on a visual analogue scale during the 10-h period after the first dose.The mean pain reduction by Dose 1 in patients on ibuprofen-codeine, acetylsalicylic acid-codeine and codeine was 64%, 45% and 26%, respectively, and the mean duration of effect was 8.3, 6.3 and 5.6 h. According to the pain reduction, duration of effect and pain reduction index after Doses 1 and 1 + 2. there was a significant difference between ibuprofen-codeine and the other two drugs. The maximum pain reduction within 4 hours was 84% with ibuprofen-codeine. This was significantly different from the reduction achieved both with acetylsalicylic acid-codeine (64 %) and codeine (35 %). Seventeen patients reported adverse events: 5 on ibuprofen-codeine, 4 on acetylsalicylic acid-codeine and 8 on codeine. The most common events were tiredness and vertigo.It is concluded that the combination ibuprofen-codeine 200 mg :30 mg had greater analgesic efficacy compared to the combination acetylsalicylic acid-codeine 500 mg : 30 or codeine 30 mg in patients with pain after removal of the lower third molars.     

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?