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 curative effect of oxycodone in different modes of administration on the control of moderate and severe cancerous pain and its outbreak of pain, in order to determine the efficacy of oxycodone as second-step drug in moderate and severe cancers Application and administration of sexual pain. Methods: A total of 198 cancer patients of different locations were selected and the first step treatment was not satisfactory (VAS≥5 after applying NSAIDs). The patients were randomized to 3 groups: naïve oxycodone-only model group (Group I, n = 78); background dose of oxycodone â ... ¢ oxycodone + mode of administration if necessary (Group II, n = 61) Background dose of oxycodone sustained-release formulation + oxycodone-treated model group (Group III, n = 59). Observations: Drug observation time of 12 weeks. ① VAS score before and after treatment; ② the number and degree of outbreak pain control VAS score; ③ side effects of drugs; ④ satisfaction rate of pain control (quality of life score); ⑤ According to the drug efficacy, Results: ① Within 2 weeks, the VAS scores of group I, group II and group III before and after treatment were significantly decreased, with statistical significance. The third week: the VAS score of Group I increased after treatment, which was not statistically significant compared with that before treatment; while the levels of control in Group II and III after administration and before treatment still showed good control (P <0.05) There was no significant difference in the VAS score between the two groups after treatment; at this time, the VAS scores of group I and group II, group III after treatment showed statistically significant difference. ② The number of outbreaks and degree of control VAS in group II and group III within 3 weeks were significantly lower than those in group I (P <0.05). There was no significant difference between group II and group III. This result lasted until the 10th week after treatment (11-12 weeks due to extreme problems with the drug oxycodone, which led to Group III). ③ All treatment groups in the treatment of nausea and vomiting during the observation period, dizziness, constipation, urinary retention, pruritus within each group before and after treatment and after treatment was no significant difference between groups. ④2 weeks: group I, group II, group III within the quality of life before and after treatment were significantly improved, with statistical significance. After 3 weeks of treatment, there was no significant difference between before and after treatment in group I, but the quality of life of patients in groups II and III was improved (P <0.05) from the third week to the tenth week after treatment. (5) The proportion of transposition group showed that 67/78 (86%) of group I was changed into group II in the third week to the tenth week, the observation indexes improved significantly after the transfusion group, and there was no significant difference between the two groups At week 11, 21/61 (35%) were transferred to group III, after adjustment, 10 mg of oxycodone sustained-release preparation plus oxycodone was administered as necessary to achieve the original post-treatment level. During Week 11, 17/59 (28%) of Group III was adjusted with 10 mg oxycodone sustained-release formulation and reached the original post-treatment level. CONCLUSION: ① The background dose of oxycodone and the mode of administration when necessary may have a good analgesic effect on moderate and severe cancerous pain with explosive pain. ② Oxycodone can be effectively controlled when necessary The degree of pain of a cancerous burst of pain. ③ clinical application has good safety and clinical compliance.