口服氨酚待因2号片镇痛效果的临床评价

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<0.01)。PC-2组在服药后2 h的疼痛强度差及服药1 h后的镇痛总有效率均比PC-1组高(P<0.05),对癌症的镇痛效果优于PC-1组;(2)PC-2对术后痛、癌痛和神经痛的总有效率分别为82.5%、76.7%和60.0%,它对鼻咽癌和其它癌症的镇痛效果无明显差别;(3)PC-2 po后吸收迅速,1 h后出现镇痛效应,2 h达峰值,镇痛效应可持续3h;(4)PC-2的不良反应较轻,在进行不良反应观察的50例中,11例出现思睡(占22%),5例胃部不适(占10%),3例头晕(占6%),恶心1例(占2%),上述不良反应大多在1 d内消失,1例在服药第7 d出现便秘,本品对呼吸、心率、血压无影响,对肝、肾、血液系统无损害。

CLINICAL EVALUATION OF ANALGESIC EFFECT OF No. 2 ACETAMINOPHEN-CODEINE COMPOUND TABLET

No. 2 acetaminophen-codeine compound tablet (PC-2) is a newly de- veloped domestic analgesic consisting of 15 mg codeine phosphate and 300 mg ac- etaminophen per tablet. A clinical evaluation of the analgesic effect of PC-2 against mod- erate intensity of pain was carried out in several hospitals according to a randomized and double-blind controlled clinical design. No. 1 acetaminophen-codeine compound tablet (PC-1, consisting of 8.4 mg codeine phosphate and 500 mg acetaminophen per tablet) was used as positive control and placebo (PB) was used as negative control. Total number of the patients were 338 cases (206 cases for PC-2, 32 cases for PC-1, 100 cases for PB). Clinical results showed that:(1) a satisfied analgesic effect against moderate intensity of post-operative pain, cancer pain and neuralgia was obtained by using PC-2. Pain in- tensity difference(PID), pain relief (PAR) and rate of PAR over grade 2 of PC -2 group were higher than those of PB group (P<0.01); PID after two hours medication and total analgesic effective rate after one hour medication of PC-2 group were higher than those of PC-1 group(P<0.05), and the analgesic effect against cancer pain of PC-2 group was better than that of PC -1 group; (2) the total effective rates against post-operative pain, cancer pain and neuralgia of PC-2 were 82.5%, 76.7% and 60.0%, respectively, but there was no significant difference between its analgesic effect against pain due to na- sopharyngeal carcinoma and other cancer pain; (3) PC-2 was absorbed quickly after oral medication, its analgesic effect started after 1 hour and reached the peak effect after 2 hours, the analgesia lasted 3 hours; (4)the adverse drug reactions (ADRs) of PC-2 were weak, among the 50 cases under ADR observation, 11 cases(22%) showed drowsiness, 5 cases(10%) showed gastric discomfort, 3 cases(6%) showed dizziness, nausea appeared in 1 case(2%), the above ADRs disappeared within one day, constipation appeared in one case 7 days after drug administration. PC -2 showed neither influene on respiration, heart rate and blood pressure, nor damage on liver, kidney and blood system.