| Objective:To evaluate the clinical efficacy of Warming Kidney and to restore normal Collateral Suppository treating diabetic peripheral neuropathy(DPN) and explore its role mechanisms, menawhile, to discuss the correlation between the collateral disease theory and DPN as well as the foundation of treating DPN with warming Yang to restore normal collateral principle.Methods: 60 cases patients who consistent with DPN medical diagnostic standards and Yang Deficiency and collateral obstructed type diagnostic standards of Chinese Traditional medicine(TCM) simultaneity were diveded randomly into the treatment groups (Warming Kidney and to restore normal Collateral Suppository group) and the control group(mecobalamine group), parallel comparison had been empolyed in the test, every group contained 30 patiants, the test cycle was eight weeks. All the patients's clinical symptoms, physical sign, vibration of thumb of foots, Sense Nerve Conduction Velocity(SNCV) and those important factors, such as fasting blood glucose(FBG), pastprandial 2 hour Blood Glucose(P2hBG) were contrasted between the two groups as well as in the own control, all these data were used to evaluate the clinic efficacy of Warming Kidney and to restore normal Collateral Suppository. At the same time, the red blood cell(RBC) Aldose Reductase(AR) activity, the RBC Na~+-K~+-ATP enzymes activity, the serum nitrogen monoxide(NO) and the β — Endorphin( 3 — EP) level were detected in the test, it was used to explor potential role mechanisms and channel in the treating DPN of Warming Kidney and to restore normal Collateral Suppository, the statstical methods, such as T test, chi square test and nonparametric statistics were used to analyse the data.Results:(l)There weren't statistical significant difference between the treatment group and the control group on the FBG and the P2hBG including before and after the test(P>0.05), and there weren't statistical significant difference in their own control(P >0.05);(2)The clinical comprehensive curative effect was 77.7% of the treatment group and 57.7% of the control group, there weren't statistical significant difference between the two groups on the clinical comprehensive curative effect(P>0.05);(3)There were statistical significant difference respectively on the overall scores of symptom of the two groups in their own control(P<0.05), there weren't statistical significant difference between the two groups(P>0.05);the total efficiency was 81.5% in the treatment group and 73.1% in the control group, there weren't tatistical difference between the two groups(P>0.05);(4)There were statistical significant difference on the overall scores of physical sign in the own control of the treatment group, but there weren't it in thecontrol group, there weren't statistical significant difference between the two groups before and after the test(P > 0.05), but there were statistical significant difference between the two groups in the comparison of the overall scores difference from before and after the test(P<0.05). the total efficiency of the treatment group was 37% against 38.5% of the control group, there weren't statistical significance differences between the two groups (P > 0.05);(5)There weren't statistical significance differences in the comparison on the thumb vibration of foot between the two groups before and after the test(P>0.05);(6)There weren't statistical significant difference in the comparison on the SNCV of both sides' sural nerve and right's median nerve between the two groups and in the own control respectively(P>0.05), but there were statistical significant difference between the two groups in the comparison of the difference of the SNCV of both sides' sural nerve(P<0.05);(7)There were statistical significant difference on the RBC AR activity in the own control in the treatment group(P<0.05), there weren't statistical significant difference in the own control in the control group on the contrary(P>0.05), there were statistical significant difference after the test between the two groups(P< 0.05), but there weren't statistical significant difference on the difference from the before and after the test between the two groups(P > 0.05);there were statistical significant difference on the RBC Na+-K+-ATP enzymes activity in the own control in the treatment group(P<0.05), there weren't statistical significant difference in the own control in the control group on the contrary(P>0.05), at the same time, there were statistical significant difference after the test and on the difference from the before and after the test between the two groups(P < 0.05);there were statistical significant difference on the level of NO of the treatment group in the own control(P<0.05), and the same in the control group(P < 0.05), but there weren't statistical significant difference between the two groups(P > 0.05);there weren't statistical significant difference on the 3 -EP level between the two groups and in their own control(P> 0.05);(8)there weren't statistical significant difference on the examinition of safety inspections in the own control respectively in the two groups(P>0.05), there weren't statistical significant difference on the Adverse Event(AE) in the two groups also(P> 0.05).Conclusion:(l)There weren't statistical significant differences on the comprehensive curative effect in the two groups, Warming Kidney and to restore normal Collateral Suppository had the clinical efficacy accord with the mecobalamine;(2)Warming Kidney and to restore normal Collateral Suppository cure effectively the patients on the DPN symptoms, and it had evident effective especially to the symptoms such as numbness, chilly;at the same time, it effect efficiently to the patients' physical signs to a certain extent;(3)Warming Kidney and to restore normal Collateral Suppository didn't treat the patients effectively on the vibration of thumb offoot and the SNCV hadn't been improved through the test, so the two medicine hadn't obvious curative effect to the two aspects;(4)Warming kidney and to restore normal Collateral Suppository inhibit obviously the RBC AR activity, raise the RBC Na+-K+-ATP enzymes activity and enhanc the serum NO levels, the clinical effective of Warming kidney and to restore normal Collateral Suppository treated the patients of DPN may be concerned with inhabiting the channel of polyalcohol, raising the ability of utilizing energy of RBC and leading to improve the blood rheology to a certain extent, improving the inflammation response and immunity reaction and so on, however, Warming kidney and to restore normal Collateral Suppository had little effact to the level of P -EP, all these descript that it didn't effective role the pain threshold of DPN patients, mecobalamine didn't create obvious impact to the above factors except for the level of NO;(5)Warming kidney and to restore normal Collateral Suppository was a safe and effective drugs and it hadn't obvious impact to the all the indicators of the safety factor, the good compliance of the medicie indicate the suppository of Chinese herbs had broad prospects in the application to the DPN patients;(6)The collateral disease theory direct well to the treating the DPN paient with TCM.
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