盐酸羟考酮缓释片联合普瑞巴林治疗糖尿病性神经痛的临床观察

目的研究盐酸羟考酮缓释片联合普瑞巴林治疗中重度糖尿病性神经痛的疗效及不良反应。方法将56例糖尿病性神经痛患者随机分成联合用药组(A)与单一用药组(B),每组28例。A组应用盐酸羟考酮缓释片联合普瑞巴林治疗,B组单纯应用盐酸羟考酮缓释片治疗,观察比较两组患者疼痛程度、疼痛缓解程度、疼痛缓解率、盐酸羟考酮缓释片使用剂量及药物不良反应等。结果两组糖尿病性神经痛患者疼痛均明显缓解,经4周治疗后,A组的疼痛程度及疼痛缓解率明显高于B组(VAS评分:A组1.2±0.4,B组2.9±0.4;疼痛缓解率:A组96.4%,B组75%),差异有统计学意义(P<0.05);同时可以减少盐酸羟考酮缓释片的使用量,两组分别为(31.9±4.4)mg、(41.1±5.5)mg,两组比较差异有统计学意义(P<0.05)。两组患者的药物不良反应主要表现为恶心呕吐、便秘、头晕、口干及尿潴留,其中A组头晕及口干症状的发生率高于B组,治疗7、14、21、28 d头晕的发生率:A组为57.1%、46.4%、35.7%、28.6%,B组为21.4%、14.3%、14.3%、3.6%,口干的发生率:A组为28.6%、42.9%、17.9%、10.7%,B组为25.0%、17.9%、10.7%、3.6%,两组比较差异有统计学意义(P<0.05)。结论盐酸羟考酮缓释片联合普瑞巴林治疗中重度糖尿病性神经痛疗效确切,安全可行。

Clinical application of oxycodone hydrochloride controlled-release tablets combined with pregabalin treatment for painful diabetic neuropathy

Objective To investigate the efficacy and safety of oxycodone hydrochloride controlled-release tablets combined with pregabalin on painful diabetic neuropathy.Methods 56 patients with painful diabetic neuropathy were randomly divided into group A and group B.Patients in group A were treated with oxycodone hydrochloride controlled-release tablets combined with pregabalin,while group B with simple oxycodone hydrochloride controlled-release tablets.The differences in visual analogue scale(VAS),scale of pain relief,effective analgesic rate,dose of oxycodone hydrochloride controlled-release tablets and adverse effect of the two groups were observed and compared.Results All patients of the two groups got pain relief obviously.The VAS after treatment in group A was superior to group B(1.2±0.4 vs.2.9±0.4,P<0.05),while the difference between effective analgesic rate was also significant(96.4% vs.75%,P<0.05).The doses of oxycodone hydrochloride controlled-release tablets in group A and group B were(31.9±4.4) mg and(41.1±5.5) mg respectively(P<0.05).The adverse effects were mainly nausea,vomiting,constipation,dizziness,dry mouth and urinary retention.After 7,14,21 and 28 d of treatments,the incidences of dizziness in group A were 57.1%,46.4%,35.7%,28.6% respectively,while the incidences in group B were 21.4%,14.3%,14.3%,3.6% respectively.At the same time,the incidences of dry mouth in group A were 28.6%,42.9%,17.9%,10.7% respectively,while in group B,the incidences were 25.0%,17.9%,10.7%,3.6% respectively.The incidences of dizziness and dry mouth between the two groups were significantly different(P<0.05).Conclusion Oxycodone hydrochloride controlled-release tablets combined with pregabalin is effective and safe for the management of painful diabetic neuropathy.