黛力新联合恩再适治疗老年痛性糖尿病周围神经病变的临床研究

Effects of combination therapy of deanxit and analgecine on elderly painful diabetic peripheral neuropathy

目的 观察黛力新和恩再适联合治疗老年痛性糖尿病周围神经病变的临床效果.方法 选择连云港市第二人民医院老年医学科自2010年1月至2012年5月收治的痛性糖尿病周围神经病患者180例,按照随机数字表法分为对照组（A组）、恩再适组（B组）及黛力新＋恩再适组（C组）,每组60例.在控制血糖治疗基础上,A组患者给予甲钴胺注射液0.5 mg肌注,1次/d,3次/周,共12周;B组患者给予恩再适3mL肌注,1次/d,治疗2周、休息2周为1个疗程,共3个疗程;C组患者口服黛力新,晨起一片,恩再适给药方法同B组.治疗过程中及治疗12周后对所有患者进行神经病变量表、定量感觉检查、疼痛视觉模拟评分等有效性评估和安全性评价. 结果 （1）C组治疗12周后焦虑和抑郁量表得分较A组、B组及治疗前明显下降,差异均有统计学意义（P＜0.05）.（2）治疗12周后,B组和C组患者冷感觉较A组患者明显升高,热感觉、冷痛觉较A组患者明显降低,差异均有统计学意义（P＜0.05）.（3）治疗1周、2周、4周、8周及12周末C组的疼痛视觉模拟评分均较A组及B组明显降低,差异有统计学意义（P＜0.05）.（4）3组治疗前后神经传导速度差异均没有统计学意义（P＞0.05）.（5）C组有1例治疗2周后出现粒细胞减少,停药1周后粒细胞升至正常.观察期内未发现肝功能异常等情况出现. 结论 黛力新联合恩再适治疗痛性糖尿病周围神经病变在止痛、改善精神状态等方面优于单用恩再适,在缓解感觉障碍方面与恩再适疗效相当;整个治疗过程安全性较高.

Objective To observe the efficacy and safety of combination therapy of deanxit and analgecine on elderly painful diabetic peripheral neuropathy （PDPN）.Methods One hundred and eighty PDPN patients,admitted to our hospital from January 2010 to May 2012,were chosen in this study; they were randomly divided into Group A （control group,n=60）,Group B （analgecine treatment group,n=60） and Group C （deanxit and analgecine combined treatment group,n=60）.On the basis of controlling the plasma glucose of all subjects,Group A was treated with methycobal 0.5 mg intramuscular injection once a day,three times a week for 12 weeks; Group B was treated with analgecine 3 mL intramuscular injection once a day for 2 weeks and then rested for 2 weeks,which repeated for three courses; Group C was treated with deanxit orally 1 capsule every morning and analgecine in the same way with Group B.The evaluation and analysis of the efficacy （mental state,quantitative sensory,scores of visual analog scale of pain intensity [VASPI],and nerve conduction velocity） and safety （nausea,dry mouth,diarrhea,dizziness,headache,drowsiness,fatigue,tremors,blurred vision,neutropenia,and liver dysfunction） of all patients were carried out after 12 weeks.Results （1） The anxiety and depression scale scores of Group C 12 weeks after treatment were significantly lower than those of Group A and Group B （P〈0.05）.（2） After 12 weeks of treatment,cold sensation in Group B and Group C was significantly higher than that in Group A,while thermal sensation and cold pain sensation in Group B and Group C were significantly lower than those in Group A （P〈0.05）.（3） VASPI scores in group C were significantly lower than those in Group A and Group B at the 1st,2nd,4th,8th and 12th weeks （P〈0.05）.（4） No significant difference was observed in nerve electrophysiological examination before and 12 weeks after treatment in all 3 groups （P〉0.05）.（5） One patient in Group C appeared neutropenia two weeks after treatment,but the granulocyte rose to normal after stopping the deanxit for one week; no other abnormal condition was found in the observation period.Conclusion Combination therapy of deanxit and analgecine on elderly PDPN achieves good clinical effect and it is safe using in the elderly.