ObjectivesDraw up ziyinxiaobi formula using therapy of invigorating liver and kidney to treat liver-kidney deficiency type Diabetic Peripheral Neuropathy(DPN)patients.Observe the improvement of patients' symptoms and objective index to provide clinical evidence for the popularization and application of this formula.MethodsSixty-six patients who were accorded with the inclusive criteria were divided into two groups.On the basis of the effective anti-hyperglycemia,anti-hypertension and anti-hyperlipdiemia,ziyinxiaobi formula was used in the observation group of 33 cases,while only mecobalamine was prescribed in the control group of 33 cases.DPN screening form score,Traditional Ch inese Medicine(TCM)symptom score and Hcy were compared and analysed befo re and after 2 months treatment to comprehensive evaluate the treatment e ffect.Results?Overall efficacy evaluation:For the TCM clinical efficacy,the total effective rate of the observation and control groups were up to 87.9%an d 51.5%.For the neurological function,the total effective rate of the obs ervation and control groups were up to 81.8%and 57.6%.There were signifi cant differences between the two groups in the total effective rate whet her TCM or neurological function curative effect(P<0.05).?TCM symptom s core:The total score of both groups were effectively decreased after the treatment(P<0.01),and the score of observation group was decreased more significantly than the control group(P<0.05).For each TCM symptom,every symptom was significantly improved compared with before in observation gr oup(P<0.05).The control group in improving numbness,weakness,paresthes ia,sting or burning pain,dry mouth and throat,soreness and weakness of wa ist and knees,dizziness and tinnitus was significantly better compared wi th before(P<0.05),while was unconspicuous with it in blurred vision,dry and pale nail,tongue and pulse signs(P>0.05).The sting or burning pain,dry mouth and throat,soreness and weakness of waist and knees,dizziness a nd tinnitus of the observation group decreased significantly compared wit h the control group(P<0.05),while was unconspicuous with it in numbness,weakness,paresthesia(P>0.05).?DPN screening form score:For the symptom questionnaire and the foot inspection section,both groups were significa ntly decreased after the treatment(P<0.01),and the score of observation group was decreased more significantly than the control group(P<0.05).Fo r each physical examination in the foot inspection section,ankle reflex,1 Og nylon pressure,vibration threshold measurement,acupuncture pain and te mperature sensation test were significantly improved compared with before in two groups(P<0.05).Improvement of foot appearance was not obvious(P>0.05).The acupuncture pain,temperature sensation test score of the obse rvation group decreased significantly compared with the control group(P<0.05),while was similar with ankle reflex,10g nylon pressure and vibratio n threshold measurement(P>0.05).?Plasma Hcy level:Both groups can effe ctively reduce Hcy(P<0.01),and the effect was similar(P>0.05).?Blood glucose control:Both groups can be maintained within the recommended cont rol targets,and the change of blood glucose level was unconspicuous(P>0.05).?Safety indicators:Both groups had no adverse events occurred during the treatment,and the safety indicators were in the normal range.ConclusionThe study confirmed clinical efficacy of ziyinxiaobi formula was better than only Mecobalamin.The formula can significantly relieve the subjective discomfort,partial objective signs and accompanying symptoms,while the effect was similar to reduce Hcy as Mecobalamin.So a certain delay can act on the progression of the disease.And the drug has little effect on blood glucose and good safety.Therefore the clinical effect of the formula is more ideal. |