加巴喷丁联合低剂量盐酸羟考酮缓释片治疗老年糖尿病周围神经痛的随机对照研究

GABAPENTIN COMBINED WITH LOW DOSE PROLONGED-RELEASE OXYCODONE HYDROCHLORIDE FOR THE TREATMENT OF ELDERLY PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHIC PAIN

目的:观察加巴喷丁联合低剂量盐酸羟考酮缓释片治疗老年糖尿病周围神经痛(diabetic peripheral neuropathic pain,DPNP)的疗效及安全性。方法:70例老年DPNP患者随机均分为两组(n=35),分别接受2周加巴喷丁单药(单药组)或加巴喷丁联合低剂量盐酸羟考酮缓释片治疗(联合组),加巴喷丁100 mg/日起始并逐渐增量,羟考酮剂量固定为10 mg/q 12小时。治疗前、治疗后第8及15日评估患者的疼痛程度及副作用。结果:共62例完成2周研究(单药组30例,联合组32例,基线VAS评分无差异,联合组第8及第15日疼痛缓解率均显著高于单药组(P<0.05),联合组第8日的显效率显著高于单药组(P<0.05)。两组第8日的加巴喷丁日均剂量无显著性差异,但第15日时单药组显著高于联合组(P<0.05);联合组的便秘发生率显著高于单药组(P<0.03)。结论:加巴喷丁单药或联合低剂量盐酸羟考酮缓释片可有效缓解老年患者的DPNP,联合治疗疗效优于单药,但要注意防治便秘。

Objective： To observe and evaluate the analgesic efficacy and safety of gabapentin combined with low dose prolonged-release oxycodone hydrochloride for the treatment of diabetic peripheral neuropathic pain（DPNP）.Method： A total of 70 elderly patients with DPNP were randomized into 2 groups（each contains 35 cases）,one accepted gabapentin monotherapy（G1）,and the other received both gabapentin and low dose prolonged-release oxycodone hydrochloride（G2）.The initial dose of gabapentin was 100 mg/d and gradually titrated.The dose of prolonged-release oxycodone hydrochloride was fixed at 10 mg/q 12 h,and the therapy keeps 2 weeks.VAS was evaluated before and at the 8th and 15th day of the treatment.Side effects were observed and recorded.Results： Totally 62（G1 = 30,G2 = 32） patients completed the 2 weeks treatment.Basic characteristics have no significant difference including mean VAS scores between the 2 groups.After the treatment,the total rate of pain relief at the 8th and 15th day were significantly higher in G1 compared with G2（P 0.05） and the rate of excellent pain relief in G1 was higher than G2 at the 8th day（P 0.05）.The mean daily dose of gabapentin at the 8th day have no significant difference between G1 and G2,but at the 15th day,G2 was significant higher than G1（P 0.05）.The occurrence rate of constipation in G2 was obviously higher compared with G1（P 0.05）.Conclusion：Gabapentin monotherapy or combined with low dose Prolongedrelease oxycodone hydrochloride could effectively release elderly patients’ DPNP,and the efficacy of the combination therapy was better,but should give preventive measures to constipation.