【摘要】 目的阿片类药物是治疗癌痛的基石,但对于药物剂量调整时机临床上有待进一步探讨。本研究旨在评估盐酸羟考酮缓释片12h调整剂量治疗中重度癌痛的疗效和安全性。方法选择2016-10-01-2017-04-30收治的中重度阿片类药物未耐受癌痛患者154例(NRS评分4~10分)作为研究对象。按盐酸羟考酮缓释片剂量调整的时间不同分为A和B两组。两组患者均起始采用盐酸羟考酮缓释片给药,中度癌痛患者(NRS评分4~6分)给予10mg,重度癌痛患者(NRS评分7~10分)给予20mg。A组:首次给药12h时调整盐酸羟考酮缓释片剂量(将前12h阿片类药物总剂量转换为盐酸羟考酮缓释片),后续调整剂量方案同前,同时采用即释吗啡处理爆发痛。B组:首次给药24h时调整盐酸羟考酮缓释片剂量,同时采用即释吗啡处理爆发痛。比较两组患者在给药24、48和72h的疼痛缓解率、睡眠情况和不良反应。结果 A组给药24和48h的疼痛缓解率分别为78.95%和92.11%,显著高于B组的55.13%和75.64%(P<0.05),72h观察期内两组疼痛缓解率差异无统计学意义,P>0.05。24和48h时两组患者睡眠情况比较,A组均明显优于B组,差异有统计学意义,P<0.05。两组患者的主要不良反应发生率差异无统计学意义,P>0.05。结论在中重度癌痛患者中采用盐酸羟考酮缓释片背景给药、12h调整剂量能明显提高患者24和48h疼痛缓解率,并且明显改善患者睡眠质量,安全性良好。更多还原

【Abstract】 OBJECTIVE Opioids are the mainstay of analgesic therapy in treating cancer-related pain,but the timing for dose titration remains to be clinically further investigated.The purpose of this study was to evaluate the efficacy and safety of dose titration at 12 hof hydrochloride oxycodone controlled-release tablets for moderate or severe cancer pain.METHODS A total of 154 cases of patients with moderate or severe cancer pain(NRS score 4-10) from October 2016 to April 2017 were divided into two groups according to the dose titration time of hydrochloride oxycodone controlled-release tablet.Both groups used hydrochloride oxycodone controlled-release tablets 10 mg or 20 mg,respectively,as the initial dose for moderate or severe cancer pain.Group A adjusted the dose at 12 h(total opioid dose in the 12 hours switch to hydrochloride oxycodone controlled-release tablets),and used immediate-release morphine to treat breakthrough pain.The following adjustment scheme was the same as before.Group B adjusted the dose at 24 hour,and also used immediate-release morphine to treat breakthrough pain.The pain relief rates,sleep quality and adverse reactions at 24 h,48 h and 72 h of administration were compared between the two groups.RESULTS The pain relief rate at 24 h and 48 hof administration were 78.95% and 92.11%in group A,significantly higher than 55.13% and 75.64% in group B(P<0.05).No statistical difference was found between two groups in pain relief rate at 72 h of administration(P>0.05).A group had statistically significant better sleep quality at 24 h and 48 h(P<0.05).The incidences of adverse reactions during therapy of two groups had no statistically significant difference(P>0.05).CONCLUSION Dose titration at 12 h of hydrochloride oxycodone controlled-release tablets can improved the pain relief rate and quality of sleep at 24 h and 48 h,with good safety.更多还原