氨酚羟考酮不同给药模式治疗中、重度癌性疼痛及其爆发痛的临床疗效观察

Efficacy of oxycodone-acetominophen by different administrations in controlling moderate to severe cancer pain and break-out pain

目的:观察氨酚羟考酮在不同给药模式下,对控制中、重度癌性疼痛及其爆发痛的疗效进行临床观察,以期确定氨酚羟考酮作为第二阶梯药物在中、重度癌性疼痛的应用范围和给药方法。方法:选择不同部位肿瘤患者198人,并经过第一阶梯治疗疗效不满意(应用非甾体类服镇痛药后VAS≥5)。随机将患者分为3组:单纯氨酚羟考酮模式组(组I,n=78);氨酚羟考酮背景药量+必要时给药模式组(组II,n=61);羟考酮缓释剂型背景药量+氨酚羟考酮必要时给药模式组(组III,n=59)。观察指标:药物观察时间为12周。①用药前后VAS评分;②爆发痛次数及程度控制VAS评分;③药物副作用;④疼痛控制满意率(生活质量评分);⑤根据药物疗效,各组晋级入组人数比例比较。结果:①2周内:组I,组II,组III内用药前后VAS评分比较均有明显下降,具有统计学意义。第3周:组I用药后VAS评分值上升,与治疗前比较无显著性统计学意义;而组II和组III内用药后与治疗前仍显示良好的控制水平(P<0.05),且后两组组间治疗后VAS评分值比较无统计学差异;此时组I与组II、组III治疗后VAS评分值比较出现显著性统计学差异。②3周内组II和组III爆发痛次数及程度控制VAS评分均明显低于组I(P<0.05),组II和组III两组间比较无统计学意义。此结果持续至治疗后第10周(11～12周由于氨酚羟考酮药物极量问题,故转入组III)。③所有治疗组在治疗观察期间恶心、呕吐、头晕、便秘、尿潴留、皮肤瘙痒各组内治疗前后和治疗后组间比较无统计学意义。④2周内:组I,组II,组III内用药前后比较生活质量均有明显提高,具有统计学意义。第3周组I用药后与治疗前比较无统计学显著差异,但第3周至第10周组II和组III内用药后患者生活质量维持改善状态(P<0.05)。⑤转组比例显示:第3周至第10周组I内67/78(86%)转入组II,转组后各观察指标明显改善,与组II原组病例比较无统计学差异;组II于第11周有21/61(35%)转入组III,调整后应用10mg羟考酮缓释剂型+氨酚羟考酮必要时给药,并达到原治疗后水平。第11周组III内有17/59(28%)调整后应用10mg羟考酮缓释剂型,并达到原治疗后水平。结论:①氨酚羟考酮背景药量+必要时给药方式对中、重度癌性疼痛伴爆发性疼痛具有较好的镇痛控制作用;②氨酚羟考酮必要时给药可以有效控制癌性爆发痛的疼痛程度。③临床应用具有较好的安全性和临床顺应性。

Objective：To observe the efficacy of oxycodone-acetominophen by different administrations in controlling moderate to severe cancer pain and break-out pain. Methods：Patients （n = 198） suffered from cancer with moderate to severe pain and break-out pain were enrolled, who had used nonsteroidal anti-inflammatory drugs （NSAIDs） and the pain intensity was still higher （visual analog score≥5 ）. They were divided randomly into three groups, and treated with fixed doses of oxycodone-acetominophen （group 1 ,n = 78） , background doses of oxycodone-acetominophen plus additional dose when breat - out pain happened （ group 2, n = 61 ） , or controlled released oxycodone plus oxycodone-acetominophen when breat - out pain happened （ group 3, n = 59）. All the patients were treated for 12 weeks. The changes in pain intensity, the rate of break-out pain per day, drug side effects, upward transfer rate between groups before and after treatment were observed and compared. Results：①Within 2 weeks after treatment, visual analog score （VAS） in three groups were significantly lower than before treatment （P 〈 0.05）. Three weeks later, the pain was satisfactorily controlled in groups 2 and 3, but not in group 1 ; the VAS value was lower than that in group 1 （ P 〈 0.05 ）. ② Within 3 weeks, the rate of break-out pain per day was significantly lower in groups 2 and 3 than in group 1 （P 〈 0.05） , but the difference between groups 1 and 2 was not significant. Within 10 weeks, the break-out pain was satisfactorily controlled in groups 2 and 3. ③ In all the groups, no nausea, vomiting, constipation, urinary retention, and itching were found after the treatments. ④ Within 2 weeks, the life qualities were higher after treatment than before （P 〈0.05） ; 3 weeks later, the life qualities were improved and maintained to 10th week in groups 2 and 3, but not in group 1. ⑤ For the upward transfer rate, 67 patients in group 1 （86%） were transferred into group 2 from third week to 10th week, and thereafter their pain situations had been improved markedly. Twenty-one patients in group 2 （35%） were transferred into group 3; their pain also was satisfactorily controlled after transfer. Seventeen patients in the group 3 （28%） , the dose of controlled released oxycodone was adjusted from 5mg to 10mg for better control. Conclusions：The background doses of oxycodone-acetominophen and controlled released oxycodone plus oxycodone-acetominophen when breat-out pain happened may effectively control the cancer pain and breat-out pain.