低剂量氨酚羟考酮片与可待因治疗中度骨转移癌痛的随机对照研究

目的观察低剂量氨酚羟考酮片在中度骨转移癌痛治疗中的疗效及安全性以及是否优于弱阿片药物可待因。方法 78例患者按2:1随机接受氨酚羟考酮片或可待因治疗。氨酚羟考酮片起始剂量为1片,口服,每12小时1次。根据疼痛爆发情况可每8小时1次,氨酚羟考酮片每日总量不超过3片。如出现或疑似消化道出血、肝肾功能异常者停用氨酚羟考酮片。可待因30 mg每12小时1次。根据疼痛爆发情况可每8小时1次。主要观察患者近期(72 h)和远期(2周)的疼痛控制情况及不良反应。疼痛程度用数字化评估量表法(NRS)评估。结果 72 h内单用氨酚羟考酮片NRS降至3分以下:中度疼痛组46/52(88.46%),明显高于可待因组16/26(61.54%)(P=0.006)。远期疗效氨酚羟考酮片有效率为63.46%(33/52),高于可待因组61.54%(16/26),但差异无统计学意义(P=0.868)。不良反应包括恶心、呕吐、嗜睡、便秘等发生率均较低,两组差异均无统计学意义。结论强阿片类药物羟考酮可以用于中度疼痛的治疗,低剂量氨酚羟考酮片比弱阿片药物可待因更有效,即使长期应用,安全性也可以接受。

A Comparison Study Between Low-dose Oxycodone/Acetaminophen Tablet and Codeineon Moderate Bone Metastasis Cancer Pain

Objective To evaluate the efficacy and safety of low-dose Oxycodone and Acetaminophen Tablets in the treatment of moderate bone metastasis cancer pain and whether it is superior to the weak opioid drug codeine. Methods Seventy-eight patients were randomly treated with Oxycodone and Acetaminophen Tablets(n=52) or codeine(n=26). The initial dose of Oxycodone and Acetaminophen Tablets was 1 tablet, Q12h. According to the outbreak of pain, 1 tablet Q8h was permitted, but not more than 3 tablets per day. If there was gastrointestinal bleeding, suspected abnormal liver or kidney function, Oxycodone and Acetaminophen Tablets should be discontinued. The initial dose of Codeine was 30mg Q12h. According to the outbreak of pain, Q8h could be used. The pain control and adverse reactions were observed in the short term (72 hours) and the long term (2 weeks). Pain severity was assessed by numerical rating scale (NRS). Results Within 72 hours, the patients whose NRS score was reduced to 3 points in Oxycodone and Acetaminophen Tablets group were significantly more than those in Codeine group (88.46% vs. 45.45%, P=0.006). The long-term effect in Oxycodone and Acetaminophen group were similar to Codeine group (63.46% vs. 61.54%, P=0.868). The incidence of adverse reactions including nausea, vomiting, lethargy, constipation, etc. were low, without significant difference between two groups. Conclusion Strong opioid drugs such as oxycodone could be used for moderate bone metastasis cancer pain. It is the first time to find that low-dose Oxycodone and Acetaminophen Tablets are more effective than weak opioid drugs codeine, with acceptable safety in long-term use.