ABSTRACT
OBJECTIVE:To observe clinical efficacy and safety of Compound xiongshao capsules in the treatment of diabetic peripheral neuropathy (DPN).METHODS:A total of 97 DPN patients selected from our hospital during Jun.2015-Apr.2016 were divided into group A (compound xiongshao treatment group,46 cases) and control group (51 cases) according to random number table.The latter was divided into group B (epalrestat+beraprost sodium group,12 cases),group C (fursultiamine+mecobalamin group,12 cases) and group D (epalrestat group,27 cases) according to clinical symptoms and economic situation of patients.Four groups were given antidiabetic drugs for blood glucose control.Based on it,group A was additionally given Compound xiongshao capsules 0.9 g,tid;group B was additionally given Epalrestat tablets 50 mg,tid+Beraprost sodium tablets 40 μg,tid;group C was additionally given Fursultiamine tablets 50 mg,tid+Mecobalamin tablets 0.5 mg,rid;group D was additionally given Epalrestat tablets 50 mg,tid.All groups were treated for 6 months.Clinical efficacies were observed.TCSS scores,motor nerve conduction velocity (MCV),sensory nerve conduction velocity (SCV),incubation period and amplitude of median nerve and common peroneal nerve,the levels of hemorheology indexes,blood glucose,glycosylated hemoglobin,blood lipid,serum creatinine were compared before and after treatment.The occurrence of ADR was recorded.RESULTS:Total response rates of group A and B (82.61％,83.33％)were significantly higher than those of group C and D (33.33％,66.67％),total response rate of group D was significantly higher than that of group C,with statistical significance (P＜0.05).Before treatment,there was no statistical significance in TCSS scores,MCV,SCV,incubation period and amplitude of median nerve,MCV and amplitude of common peroneal never,SCV,incubation period and amplitude of common peroneal never or whole blood high-shear viscosity among 4 groups (P＞0.05).After treatment,TCSS scores of group A,B and D were decreased significantly compared to before treatment,and those of group A and B were lower than those of group C and D,with statistical significance (P＜0.05).MCV,incubation period and amplitude of median nerve in group A and B,amplitude of median nerve in group C,MCV and amplitude of median nerve in group D were significantly better than before treatment;MCV,incubation period and amplitude of median nerve in group A and B were significantly better than group C and D,with statistical significance (P＜0.05).MCV,incubation period and amplitude of common peroneal never in group A,B,C were significantly better than before treatment,MCV and amplitude of common peroneal never in group A,B were significantly better than group C,D;the improvement of incubation period of common peroneal never in group A,B,D were significantly better than group C,with statistical significance (P＜0.05).SCV,incubation period and amplitude of median nerve,SCV and amplitude of common peroneal nerve in group A,B and D were significantly better than before treatment;SCV,incubation period and amplitude of median nerve,SCV and amplitude of common peroneal nerve in group A,SCV,incubation period and amplitude of median nerve and amplitude of common peroneal nerve in group B were significantly better than group C and D;SCV of median nerve in group D was significantly better than group C,with statistical significance (P＜0.05).Whole blood high-shear viscosity of group A was decreased significantly compared to before treatment,and significantly lower than those of group B,C and D,with statistical significance (P＜0.05).There was no statistical significance in total response rate and TCSS score between group A and B,and in the levels of blood glucose,glycosylated hemoglobin,blood lipid or serum creatinine among 4 groups (P＞0.05).No obvious ADR was found in 4 groups.CONCLUSIONS:Compound xiongshao capsules shows significant therapeutic efficacy for DPN,and improves nerve conduction velocity,incubation period and amplitude of median nerve and common peroneal nerve,whole blood high-shear viscosity.Its effect is similar to that of epalrestat combined with beraprost sodium,and better than those of fursultiamine combined with mecobalamin,epalrestat alone.It does not affect the blood glucose,blood lipid and serum creatinine levels with good safety.
ABSTRACT
The introduction of intravenous nutritional therapy for cosmetic and health purposes in Korea has been controversial. Because it brings ethical problems of off-label prescribing on the basis of low level of medical evidences for claims of fatigue reduction, detoxification, anti-inflammation effect, skin whitening, antioxidant and anti-aging effects. Despite the lack of clinical studies, the verification of the efficacy and safety of intravenous nutritional therapy and the need to provide objective information to patients are prerequisite for the correct intravenous use. In addition, efforts should be made to prevent the abuse for commercial purposes.