中药固定汤合甲钴胺治疗糖尿病周围神经病变68例临床观察

Clinical efficacy of fixed decoction of traditional Chinese medicine combined with mecobalamin in treatment of diabetic peripheral neuropathy: a report of 68 cases

目的:观察中药固定汤合甲钴胺胶囊治疗糖尿病周围神经病变气阴两虚、瘀血阻滞证的临床疗效,探讨该病的有效中医临床诊疗方案。方法:采用多中心、分层区组随机、平行对照观察的方法,对144例糖尿病周围神经病变证属气阴两虚、瘀血阻滞的患者进行为期8周的临床治疗,其中脱落4例,剔除5例,纳入分析135例(治疗组68例,对照组67例),治疗组予口服甲钴胺胶囊加中药固定汤治疗,对照组仅口服甲钴胺胶囊治疗。结果:综合疗效与中医证候疗效总有效率治疗组分别为76.47%、85.30%,对照组分别为52.24%、61.19%,组间比较,差异均有统计学意义(P<0.01);神经传导速度治疗前后差值组间比较,差异均有统计学意义(P<0.01)。结论:中药固定汤合甲钴胺胶囊治疗糖尿病周围神经病变,可以改善患者的临床症状和感觉、运动神经传导速度,疗效较单用甲钴胺胶囊为优,值得临床推广。

Objective： To investigate the clinical efficacy of fixed decoction of traditional Chinese medicine（ TCM）combined with mecobalamin capsules in the treatment of deficiency of both qi and yin and blood stasis in diabetic peripheral neuropathy（ DPN） and to discuss the effective TCM therapy for this disease. Methods： A total of 144 DPN patients with deficiency of both qi and yin and blood stasis were treated for 8 weeks using a multi- centered,stratified blocked randomization,and parallel controlled method. Four patients were lost to follow- up,five patients were excluded from the study,and 135 patients were included in the study（ 68 in treatment group and 67 in control group）. The treatment group was treated with mecobalamin capsules combined with fixed decoction of TCM,and the control group was treated with mecobalamin capsules alone. Results： The overall response rate and TCM syndrome response rate were76. 47% and 85. 30%,respectively,in the treatment group,and 52. 24% and 61. 19%,respectively,in the control group,with significant differences between the two groups（ P〈0. 01）. Nerve conduction velocity was significantly different between the two groups before and after treatment（ P〈0. 01）. Conclusion： Fixed decoction of TCM combined with mecobalamine capsules can improve patients＇ clinical symptoms and nerve conduction velocity in the treatment of DPN,and is superior to mecobalamin capsules alone. Therefore,it should be promoted in clinical practice.