舒血宁注射液联合羟苯磺酸钙治疗糖尿病周围神经病变的临床研究

目的评价舒血宁注射液联合羟苯磺酸钙治疗糖尿病周围神经病变的有效性与安全性。方法选取2016年9月—2017年9月首都医科大学石景山教学医院收治的糖尿病周围神经病变患者125例,随机分成对照组(62例)和治疗组(63例)。对照组口服羟苯磺酸钙胶囊,2粒/次,3次/d;治疗组在对照组的基础上静脉滴注舒血宁注射液治疗,20 mL加入250m L生理盐水,1次/d。两组患者均连续治疗2周。观察两组患者临床疗效,同时比较治疗前后两组患者腓总神经运动神经传导速度(MNCV)和感觉神经传导速度(SNCV)及密西根糖尿病神经病评分(MDNS)评分、多伦多临床评分(TCSS)评分、NO和内皮素-1(ET-1)水平。结果治疗后,对照组的总有效率为83.87%,显著低于治疗组的96.83%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者腓总神经MNCV和SNCV均显著加快(P0.05),且治疗组MNCV和SNCV明显快于对照组(P0.05)。治疗后,两组患者MDNS和TCSS评分均显著降低(P0.05),且治疗后治疗组患者MDNS和TCSS评分明显低于对照组(P0.05)。治疗后,两组患者NO水平明显升高(P0.05),ET-1水平明显降低(P0.05),且治疗后治疗组患者NO和ET-1水平明显优于对照组(P0.05)。治疗期间,治疗组临床药物不良反应发生率为3.17%,显著低于对照组的14.52%,两组比较差异具有统计学意义(P0.05)。结论舒血宁注射液联合羟苯磺酸钙治疗糖尿病周围神经病变疗效确切,安全性高,具有一定的临床推广应用价值。

Clinical study on Shuxuening Injection combined with calcium dobesilate in treatment of diabetic peripheral neuropathy

Objective To evaluate the efficacy and safety of Shuxuening Injection combined with calcium dobesilate in treatment of diabetic peripheral neuropathy. Methods Patients (125 cases) with diabetic peripheral neuropathy in Beijing Shijingshan Hospital from September 2016 to September 2017 were randomly divided into control (62 cases) and treatment (63 cases) groups. Patients in the control group were po administered with Calcium Dobesilate Capsules, 2 grains/time, three times daily. Patients in the treatment group were iv administered with Shuxuening Injection on the basis of the control group, 20 mL added into normal saline 250 mL, once daily. Patients in two groups were treated for 2 weeks. After treatment, the clinical efficacy was evaluated, and the MNCV and SNCV of peroneal nerve, MDNS scores, TCSS scores, NO and ET-1 levels in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 83.87%, which was significantly lower than 96.83% in the treatment group, and there were differences between two groups (P<0.05). After treatment, MNCV and SNCV of peroneal nerve in two groups was significantly increased (P<0.05), and the MNCV and SNCV in the treatment group after treatment was significantly faster than that in the control group (P<0.05). After treatment, MDNS and TCSS scores in two groups were significantly decreased (P<0.05), and the MDNS and TCSS scores in the treatment group after treatment were significantly lower than those in the control group (P<0.05). After treatment, NO levels in two groups were significantly increased (P<0.05), and ET-1 levels were significantly decreased (P<0.05), and the NO and ET-1 levels in the treatment group after treatment were significantly better than those in the control group (P<0.05). During the treatment, the adverse reactions rate in the treatment group was 3.17%, which was significantly lower than 14.52% in the control group, with significant difference between two groups (P<0.05). Conclusion Shuxuening Injection combined with calcium dobesilate in treatment of diabetic peripheral neuropathy has significant curative effect and high safety, which has a certain clinical application value.