不同剂量银杏达莫注射液治疗糖尿病周围神经病变的安全性评价

Safety Evaluation of Different Doses of Ginkgo Leaf Extract and Dipyridamole Injection on Diabetes Peripheral Neuropathy

目的:评价不同剂量的银杏达莫注射液治疗糖尿病周围神经病变的安全性。方法:将60例糖尿病周围神经病变患者随机分为高、低剂量组各30例,分别给予银杏达莫注射液30 m L和20 m L静脉滴注,10 d为1个疗程;于治疗期间及停药后14 d分别观察不良事件的发生情况,并检测凝血功能、血常规、肝肾功能等指标。结果:两组患者近期不良事件(治疗后10 d)及远期不良事件(停药后14 d)均无明显异常,均未见不良事件发生。结论:不同剂量银杏达莫注射液治疗糖尿病周围神经病变的效应无明显差异,安全性好。

Objective： To evaluate the safety of different doses of ginkgo leaf extract and dipyridamole injection intervention diabetes peripheral nenropathy （DPN）. Methods： The 60 patients with DPN were randomly divided into high and low dose groups, and patients each group were given ginkgo leaf extract and dipyridamole injection 30 mL and 20 mLintravenous drip, once per day, 10 days for a period of treatment; During the period of treatment and 14 days after the drug was stopped, we observed the occurrence of adverse events, and detected blood coagulation function, blood routine, liver and kidney function, etc. Results： It was significantly abnormal in two groups of patients on recent adverse events （10 days after treatment） and long-term adverse events （14 days after the drug was stopped）, and there was no adverse events. Conclusion： Different doses of ginkgo leaf extract and dipyridamole injection in the treatment of DPN showed good security, without significant difference on efficacy.