盐酸羟考酮缓释片联合中医活血化瘀法治疗中重度癌痛的临床研究

Oxycodone Hydrochloride Combined with the Method of Promoting Blood Circulation and Removing Stasis in Treatment of Moderate or Severe Cancer Pain

目的观察中医活血祛瘀法联合盐酸羟考酮缓释片(OXY)控制中重度癌痛的临床疗效及安全性。方法将46例合格纳入对象分为治疗组24例和对照组22例。所有病例均进行羟考酮缓释片剂量滴定。治疗组同时采用化瘀方汤药内服、双柏散外敷和疏血通注射液静脉滴注。比较治疗组与对照组在疼痛控制及不良反应上的差异。结果羟考酮(OXY)滴定过程显示,治疗组及对照组在初始剂量、OXY起效时间、观察期内OXY最大剂量上无明显差异(P>0.05),而在OXY维持剂量、滴定达维持剂量时间的差异均有统计学意义(P<0.05)。组间比较发现,治疗组NRS、PID评分下降较对照组明显,但差异无统计学意义(P>0.05)。结论中医活血化瘀法可能减少阿片类药物的维持剂量、缩短滴定达维持剂量时间,但不降低阿片类药物初始剂量、观察期内最大剂量和缩短起效时间。

Objective To evaluate the efficacy and safety of oxycodone hydrochloride controlled-release tables（OXY） combined with the method of invigorating the circulation of blood and removing stasis in treatment of moderate or severe cancer pain.Methods A total of 46 patients who have cancer pain that need to take opoids were included.They were randomized into treatment group（24 cases） and control group（22 cases）.All cases had oxycodone hydrochloride controlled-release tables.Patients in treatment group were added with traditional Chinese medicine therapy.They had oral administration of dispersing blood-stasis decoction,external application of Shuangbosan and intravenous infusion of Shuxuetong.Compare the difference of pain control and adverse reactions between the two groups.Results Through the observation in titration process,there were no significant differences between the treatment group and the control group in the initial dose,onset time and OXY maximum dose during observation period（P〉0.05）.However,the maintenance dose and the time reaching to maintenance dose were significantly different between the two groups（P〉0.05）.Moreover,the NRS and PID score declined more in the treatment group than in the control group,but the difference has no statistical significance（P〉0.05）.Conclusion The traditional Chinese method of invigorating the circulation of blood and removing stasis would reduce the maintenance dose of opioids and shorten the time to approach maintenance dose but does not affect the initial dose of opioid drugs,the onset time or maximum dose within the observation period.