注射用血栓通(冻干)联合单唾液酸四已糖神经节苷脂治疗糖尿病周围神经病变的临床研究

Clinical study on Xueshuantong for injection(freeze-dried) combined with monosialotetrahexosylganglioside in treatment of diabetic peripheral neuropathy

目的观察注射用血栓通(冻干)联合单唾液酸神经节苷脂治疗糖尿病周围神经病变的临床疗效。方法选取2016年2月—2017年9月在湖北省中医院就诊的糖尿病周围神经病变患者64例,随机分成对照组(31例)和治疗组(33例)。对照组静脉滴注单唾液酸四己糖神经节苷脂钠注射液,40 mg溶于250 mL生理盐水,1次/d,连用2周,然后改为20 mg肌肉注射,维持2周。治疗组在对照组基础上静脉滴注注射用血栓通(冻干),0.45 g溶于250 mL生理盐水,1次/d,连用4周。观察两组患者临床疗效,比较治疗前后两组患者神经传导速度及血清NF-κB水平和多伦多临床神经病变评分(TCSS)。结果治疗后,对照组临床总有效率为61.29%,显著低于治疗组的84.84%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组胫前神经和腓总神经的感觉神经传导速度(SNCV)传导速度均显著增加,治疗组胫前神经和腓总神经的运动神经传导速度(MNCV)显著增加,同组比较差异具有统计学意义(P<0.05);且治疗组上述神经传导速度明显快于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组血清NF-κB水平和TCSS均显著降低,同组比较差异具有统计学意义(P<0.05);且治疗组比对照组降低更明显,两组比较差异具有统计学意义(P<0.05)。结论注射用血栓通(冻干)联合神经节苷脂治疗糖尿病周围神经病变具有较好的疗效,可降低NF-κB水平,减轻患者神经炎症,具有一定的临床推广应用价值。

Objective To observe the clinical effect of Xueshuantong for injection（freeze-dried） combined with monosialotetrahexosylganglioside in treatment of diabetic peripheral neuropathy. Methods Patients（64 cases） with diabetic peripheral neuropathy in Hubei Provincial Hospital of TCM from February 2016 to September 2017 were randomly divided into control（31 cases） and treatment（33 cases）. Patients in the control group were iv administered with Monosialotetrahexosylganglioside Sodium Injection, 40 mg added into normal saline 250 mL, once daily for 2 weeks, then they were intramuscular injection with 20 mg for 2 weeks. Patients in the treatment group were iv administered with Xueshuantong for injection（freeze-dried） on the basis of the control group, 0.45 g added into normal saline 250 mL, once daily for 4 weeks. After treatment, the clinical efficacy was evaluated, and the nerve conduction velocity, the serum NF-κB level and TCSS in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 61.29%, which was significantly lower than 84.84% in the treatment group, and there were differences between two groups（P＜0.05）. After treatment, the conduction velocity of SNCV of anterior tibial and common peroneal in two groups was significantly increased,and the conduction velocity of MNCV of anterior tibial and common peroneal in the treatment group was significantly increased, the difference was statistically significant in the same group（P＜0.05）. And the nerve conduction velocity in the treatment group was significantly faster than that in the control group, with significant difference between two groups（P＜0.05）. After treatment, the NF-κB level and TCSS in two groups were significantly decreased, and there were differences in the same group（P＜0.05）. And the indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P＜0.05）. Conclusion Xueshuantong for injection（freeze-dried） combined with monosialotetrahexosylganglioside has good clinical effect in treatment of diabetic peripheral neuropathy, can reduce the NF-κB level and alleviate neuro inflammation, which has a certain clinical application value.