Clinical Observation of Shenxie Zhitong Capsule in Treating Diabetic Peripheral Neuropathy of Stagnant Blockade of Collaterals / 中国实验方剂学杂志

ABSTRACT

Objective:To observe the clinical efficacy of Shenxie Zhitong capsule in the treatment of diabetic peripheral neuropathy（DPN） of stagnant blockade of collaterals， and evaluate its effectiveness and safety. Method:The 104 patients were randomly divided into the Shenxie Zhitong capsule treatment group （the treatment group， 53 patients） and the alpha lipoic acid group （control group， 51 patients）， and two groups were compared by random and contrast test. The changes of the Toronto clinical scoring system （TCSS）， utah early neuropathy scores （UENS）， traditional Chinese medicine（TCM）syndrome scores， visual analysis scale （VAS）， ankle brachial index （ABI）， vibrating perception threshold （VPT） before and after treatment were compared between two groups， and the endpoint events， such as foot ulcers， percutaneous coronary intervention （PCI）， death and composite endpoint events， related indicators of glucose and lipid metabolism and safety indicators were recorded among patients. Result:Compared with the data before treatment， the scores of TCSS， UENS， and TCM syndromes in two groups were significantly reduced （<italic>P</italic><0.01） after treatment， and VAS and glycosylated haemoglobin A1c （HbA1c） were significantly reduced （<italic>P</italic><0.05）， during follow-up visit， the levels of right ABI，total cholesterol （TC）， and low-density lipoprotein （LDL） in two groups were significantly reduced （<italic>P</italic><0.05）， and high-density lipoprotein （HDL） level was significantly increased （<italic>P</italic><0.05）. control group in control group， the 2-hour postprandial plasma glucose （2 h PG） and HbA1c levels were significantly increased （<italic>P</italic><0.05）. Compared with control group， the VAS of the treatment group after treatment was significantly reduced （<italic>P</italic><0.05）. After treatment and during follow-up visit， compared with control group， the 2 h PG levels of the right toe in the treatment group were significantly reduced （<italic>P</italic><0.05）. There was no statistically significant difference in endpoint events and safety indicators between two groups， but the incidence trend of composite endpoint events in the treatment group was lower than that in control group. Conclusion:Shenxie Zhitong capsule has definite clinical curative effect in treating diabetic peripheral neuropathy， which is more safe and effective than alpha lipoic acid in improving pain symptoms.