摘要
目的观察10mg硫酸吗啡栓治疗中重度慢性癌痛患者的镇痛效果及不良反应。方法采用随机双盲双模拟自身交叉对照研究的方法,入选2005年3月至2006年3月共7个中心中、重度癌痛患者64例。分为2组:A组第1次给予硫酸吗啡栓10mg同时口服硫酸吗啡模拟片;第2次口服硫酸吗啡片同时给予硫酸吗啡栓模拟药。B组给药顺序与A组相反。分别纳入病例33例和31例。评价2组患者的镇痛效果及不良反应。结果2组患者均衡性良好,2组用药前的疼痛(VAS)评分分别为(6.12±0.89)和(6.16±0.90),疼痛评分等级分别为(2.27±0.45)和(2.35±0.49),2组差异无统计学意义(P>0.05)。2组患者第1阶段疼痛起效时间分别为(42.93±27.30)min和(40.21±24.42)min,第2阶段疼痛起效时间分别为(40.80±23.63)min和(51.04±46.44)min,2组疼痛起效时间差异无统计学意义(P>0.05)。2组第1阶段疼痛最佳缓解时间分别是(110.07±72.92)min和(104.89±73.40)min,第2阶段疼痛最佳缓解时间分别是(112.33±82.08)min和(129.86±102.67)min,2组疼痛最佳缓解时间差异无统计学意义(P>0.05)。2组患者的疼痛缓解度及有效率差异亦无统计学意义(P>0.05)。64例患者中共5例发生8次不良事件,主要不良反应为头晕、恶心、呕吐、嗜睡等。结论10mg硫酸吗啡栓经直肠给药对于中重度晚期癌痛患者的镇痛效果确切,同时具有良好的安全性。
Objective To investigate the analgesic effect of 10-mg morphine sulphate suppository in the treatment of patients with severe chronic cancer pain and its adverse reactions.Methods A randomized,double-blind,double-dummy,crossover,multicenter study was performed on 64 patients with moderate to severe cancer pain from 7 hospitals during March 2005 to March 2006.Those pathologically identified cancer patients were 18 to 75 years old,with the Karnofsky performance status scale （KPS） ≥60 and their life expectancy ≥2 months.They all were informed with the aim of this study and an informed content was signed.They were divided into group A （n=33） and group B （n=31）.The patients in A group were first administered 10 mg morphine sulfate suppository by rectum and placebo by mouth,and for the second time,they were administered morphine sulfate tablet by mouth and simulation or placebo by rectum.The patients of group B used the opposite order of administration as those of group A.The analgesic efficacy and adverse reactions of 2 groups of patients were assessed.Results Two groups of patients had a good balance.Baseline pain score in groups A and B was 6.12±0.89 and 6.16±0.90,respectively,and the pain rating scale was 2.27±0.45 and 2.35±0.49,respectively.The difference was not statistically significant （P0.05）.Onset time of pain of 2 groups in first phase was （42.93±27.30） and （40.21±24.42） min respectively.In second phase,the onset time of pain was （40.80±23.63） and （51.04±46.44） min.The difference of onset time of pain in 2 groups was not statistically significant （P0.05）.Best time to ease the pain of 2 groups in first phase was （110.07±72.92） and （104.89±73.40） min respectively.In second phase,the time was （112.33±82.08） and （129.86±102.67） min respectively.The difference of best time to ease the pain in 2 groups was not statistically significant （P0.05）.The difference in relief and efficiency between the 2 groups were also not statistically significant（P0.05）.A total of 5 patients with adverse events occurred eight times.The main adverse reactions were dizziness,nausea,vomiting,sleepiness,etc.Conclusion Rectal administration of 10 mg morphine sulfate suppository for patients with severe cancer pain has good analgesic effect,and sound security.
出处
《第三军医大学学报》
CAS
CSCD
北大核心
2010年第9期963-966,共4页
Journal of Third Military Medical University
关键词
硫酸吗啡栓
癌症镇痛
双模拟
临床试验
不良反应
morphine sulfate suppositories
cancer pain
double dummy
clinical trials
adverse reaction
