国产与进口硫酸吗啡控释片用于癌症止痛自身交叉双盲对照试验  

A self-Crossover Double-Blind Controlled clinical study of Domestic and ImportedMorphine Sulphate Modified Release Tablet for Analgesia in Terminal Cancer

作　　者：邓艳萍[1] 孙莉[1] 段砺瑕[1] 徐国柱[1] 许德凤[2] 鲍继桂[3] 李树业 

机构地区：[1]北京大学中国药物依赖性研究所,北京100083 [2]同济大学铁路医院,上海200072 [3]上海市东医院,上海200090 [4]陕西省肿瘤医院,西安710061

出　　处：《中国临床药理学杂志》2002年第2期90-93,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:评价国产硫酸吗啡控释片对晚期癌症伴重度疼痛患者的镇痛效果和药物不良反应。方法:30例国产控释片与进口控释片自身交叉对照试验,47例开放试验。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评价指标。结果:国产控释片与进口控释片对照试验的临床镇痛显效率和有效率均分别为 96.7%和 3.3%,部分有效和无效均为0,无显著性差异。开放试验显效率和有效率分别为97.6%和 2.1%。药物不良反应主要有头晕、头痛、恶心、呕吐、胃不适、便秘等,如采用滴定法给药,可降低药物不良反应发生率。结论:国产控释片与进口控释片的临床镇痛效果良好,差异无显著性。OBJECTIVE:TO evaluate clinical analgesic effect and adverse drugreactions of domestic and imported morphine sulphate modified release tablet forcancer patients with severe pain. METHOD:30 cases were enrolled in a randomized,double-blind-self crossover, multi-center clinical trial and 47 cases were enrolledin an open trial.The parameters for analgesic assessment were pain intensitydifference, sum of pain intensity difference, pain relief, and pain relief grade 2-4.RESULTS: In the controlled trial of the domestic and imported tablet groups, rate ofmarked relief and effective rate were 96.7% and 3.3%, Partial effective and failurewere 0.In the open trial, rate of marked relief and effective rate were 97.6% and 2.l%. The adverse drug reactions included dizziness, headache, nausea, vomiting,stomach upset and constipation etc, and the incidence decreased with dosagetitration according to the individual patient's need. CONCLUSIONS:There was nosignificant difference among the domestic and imported drugs, which were goodanalgesic effective.

关 键 词：硫酸吗啡控释片 镇痛药物 评价 癌性疼痛 

分 类 号：R730.53[医药卫生—肿瘤] R441.1[医药卫生—临床医学]