摘要
应用硫酸吗啡控释片路泰(简称路泰)与硫酸吗啡普通片(简称吗啡普通片)随机双盲对照试验,对晚期癌症伴有中、重度疼痛患者进行镇痛效果观察。结果表明,路泰每12h口服一次可以有效地控制晚期癌症慢性中度以上疼痛。与硫酸吗啡普通片相比较,镇痛效果在日剂量相同的情况下,组间无显著性差异。路泰不良反应主要表现有头晕、思睡、胃不适、恶心、呕吐、便秘等,与吗啡普通片相比较,组间无显著性差异。采用滴定法给药,可明显降低不良反应发生率。
A randomized and double-blind clinical trial of the analgesic effect of sustained-release morphine sulphate (SRM-Rhotard tablets, SRMS) was carried out on cancer patients in terminal state with moderate and severe pain.Immediate-release morphine sulphate (IRMS) tablets was used as positive control. Results indicated that SRMS was effective in the control of moderate to severe cancer-related pain while administered every 12 hours,there was no significant difference between SRMS and IRMS. The adverse drug reactions of SRMS and IRMS showed the same profile, they were drowsiness, dizziness, discomport in stomach,nausea, vomiting, itching. The incidence of ADRs had a declining tendency by using dose titration studies.
关键词
路泰
癌
疼痛
镇痛
sustained-release morphine sulphate tablet
immediate-releasemorphine sulphate tablet
clinical evalution
analgesic of cancer-related pain
