A Non-randomized Controlled Clinical Trials: Therapeutic Effect Of Sanyrene On Diabetic Skin Pruritus

Research backgroundDiabetic skin pruritus is a common chronic complications of diabetes that occurs on the lumbar spine, limbs,abdomen, oral, and genital areas. Pruritus often appear eczema-like with pigmentation, and it even may be secondary to dermatitis. Skin itching often make patients restless and cause serious impact on patient’s quality of life.Sanyrene is a liquid excipient containing essential fatty acids (EFA), palmitic acid, stearic acid, plant sterols, vitamin E and other ingredients. The main ingredient peroxide fatty acid esters play a role by molecular replacement. Sanyrene can repair the skin epithelial cells of damaged skin, protect the integrity of the skin, restrict skin moisture loss, prevent dry skin and accelerate skin cell repair and renewal.Sanyrene has been in market for 7 years in China. However, there are no reports about its therapeutic effect on skin pruritus in diabetes. Therefore, this study summarizes the characteristics and efficacy of Sanyrene so that it can be more widely used in future clinical practice and alleviate the suffering of patients.Research purposesThis study aimed to explore the role of Sanyrene in decreasing skin itching and observe its therapeutic effect on skin pruritus in patients with diabetes.Materials and methodsSubjects were recruited from endocrinological inpatients with diabetic skin pruritus in Xintai City People’s Hospital between October 2012 to May 2014.221 patients were selected and assigned to different treatment group according to voluntary principle. These patients were divided three groups:conventional therapy plus calamine smear (n=80), conventional therapy plus Sanyrene (n=80) and the conventional treatment only control group (n=61).The data collected from these subjects include demographic characteristics such as age, occupation, income (monthly), the type of health insurance, education and fasting blood glucose level during the course of hospitalization for treatment.Digital itching assessment was applied to determine the status of skin itching and evaluate therapeutic efficacy.In this study, data were analyzed using generalized estimation equations (GEE) with SAS9.0 software package.Research results1. Univariate rating factors analysis of pruritusIn order to analyze the therapeutic effect using single factor estimating equations, variable (action, age, gender, education level, occupation, family income, health insurance forms, the baseline level of pruritus, baseline of fasting plasma glucose, fasting blood glucose levels during treatment, observation time) was taken as the independent variable. The results indicated that available treatment measures, education level, occupation, family income, health insurance forms, the baseline and fasting blood glucose levels during treatment, observation time were significantly correlated with pruritus rating in observation periods (P<0.05).2. Multi-factor analysis of different groupsIn order to compare therapeutic effect in different treatment groups, pruritus grade was taken as variable during observation period. The other selected variables (age, sex, education, occupation, family income, health insurance forms, baseline pruritus rating, baseline fasting blood glucose level, fasting blood glucose levels during treatment, observation time) from this study was taken as a covariate to establish generalized estimating equations. An independent structure was used for working correlation matrix and the cumulative Logit function was applied for the connection function.Referring to the control group, Model one was established. The coefficients in Sanyrene treatment and Calamine control group were2.20、1.29, respectively. The therapeutic efficacy was significantly increased 9.03(OR=e2.20)times in Sanyrene group and 3.63(OR=e1.29)times in Calamine group compared to blank control; Referring to Calamine group, Model two was established. The coefficients in Sanyrene treatment and blank control group were 0.91、-1.29, respectively. The therapeutic efficacy was significantly increased 2.48 (OR= e0.91) times in Sanyrene group and 0.28 (OR= e-1.29) times in blank group compared to Calamine control. In addition, the baseline level of pruritus and fasting blood glucose level, fasting blood glucose levels during treatment and observation time were also likely to be statistically significant influence factors to pruritus. Coefficient of pruritus grade at baseline levels was -1.48 with statistical significance and the efficacy was 0.23 (OR= e-1.84) times of original value for every aggravating a rating of baseline pruritus. Coefficient of fasting blood glucose levels during treatment was -0.21 with statistical significance, namely fasting blood glucose value per unit increasing during treatment, the efficacy was 0.81 (OR= e-0.21)times of the original value.ConclusionSanrene is effective in improving in diabetic skin pruritus situation. And compared with calamine, the treatment efficacy of Sanrene is better, which suggesting that Sanrene can be used in the clinical treatment of diabetic skin pruritus.