| ObjectivesIn the study, we chosed the patients with Reflux Esophagitis and cold heat complicated syndromes in TCM as research subjects, taking the plusminus square of Pinelliae Decoction for Purging Stomach-Fire Combined with Rabeprazole Sodium Enteric-coated Tablets as theexperimental group, At the same time, taking the pure Chinese medicine treatment, western medicine treatment as control studys, to observe the score changes of the clinical symptoms, endoscopic classification and anxiety, depression, sleep quality of the patients treated for 4 weeks and 8 weeks, through analyzed between groups and within the group, To observe the clinical effects of Cold and warming method for reflux esophagitis and improving patients’psychological status and sleep quality, With the representative decoction of the plusminus square of Pinelliae Decoction for Purging Stomach-Fire. From the perspective Holism of TCM, To explore the clinical efficacy of Chinese medicine in the treatment of reflux esophagitis.MethodsThis study in guangdong hospital between October 2013 and February 2016 during outpatient and inpatient,72 cases eligible subjects were included in, using Rabeprazole Sodium Enteric-coated Tablets and Pinelliae Decoction for Purging Stomach-Fire Decoction for treatment, According to the order of the patients, the patients were randomly divided into 3 groups, respectively, 24 cases of combined therapy group;24 cases of Chinese medicine group; 24 cases of Western medicine group, all treatment for 8 weeks. Recorded scores of the main clinical symptoms, minor clinical symptom of reflux esophagitis of the three groups before treatment, treatment for 4 weeks, treatment for 8 week respectively s, to evaluate the clinical efficacy depended on the comprehensive curative effect integral as the Curative effect judgment index.The three groups’endoscopic grading were evaluated before and after treatment, the SAS, SDS, PSQI scores were recorded before treatment, treatment for 4 weeks, treatment for 8 weeks, Statistics the scores of symptoms and SAS, SDS, PSQI of three groups, and the variety before and after treatment. Recorded data are input into SPSS statistics 17.0 software package for statistical analysis, measurement data was expressed by(x±s), if the data is normal distribution and homogeneity of variance, Statistical analysis of the results was made by the t test; if not, it will be made by none parameter rank and summing test;Count data were expressed by proportion and rate, Statistical analysis was made by x2 test(precise probability);in to research the evaluation of clinical efficacy of three groups through application of statistical methodology.Result1〠The primary outcome indicators:â‘ The main symptoms of reflux esophagitis:Through the comparative analysis within the group, Three groups can effectively reduce the scores of the main symptoms (P<0.05), The efficacy of 8 weeks was better than 4 weeks (P<0.05);Through the comparison between groups,there was no significant difference in the therapeutic effect for 4 weeks between the traditional Chinese medicine group and the Western medicine group (P>0.05), but there was statistically different for 8 weeks (P<0.05), the combination group and the traditional Chinese medicine group, as well as the combination group and Western medicine group compared to 4 weeks,8 weeks efficacy differences were statistically significant (P<0.05). â‘¡Secondary symptoms:Through the comparative analysis within the group, three groups can effectively reduce the scores of the secondary symptoms (P<0.05), the efficacy of 8 weeks was better than 4 weeks (P<0.05);through the comparison between groups, there was statistically different in the therapeutic effect for 4 weeks between the traditional Chinese medicine group and the Western medicine group (P>0.05), but there was no statistically different for 8 weeks (P<0.05), the combination group and the traditional Chinese medicine group, as well as the combination group and Western medicine group compared to 4 weeks,8 weeks efficacy differences were statistically significant (P<0.05). â‘¢the gastroscopic observation:The results were compared before and after treatment prompting that the three groups can effectively promote the healing of esophageal mucosa (P<0.05),the combination group of esophageal mucosa healing rate was 95.8%, the Chinese medicine group was 87.5%, the western medicine group was 75%, groups comparison results indicated that the combined group and Chinese medicine group, as well as the combined group and Western medicine group compared to significant difference in efficacy (P<0.05), there was no statistically significant difference between Chinese medicine group and Western medicine group in efficacy (P>0.05). â‘£valuation of the clinical symptoms of the comprehensive curative effect:the total efficiency was 100% of the combined group after 4 weeks treatment, the Chinese medicine group was 95.8%, the western medicine group was 58.4%;the total efficiency was 100% of the combined group after 8 weeks treatment, the Chinese medicine group was 95.8%, the western medicine group was75%; for 4 weeks,8 weeks, the total efficiency of 4 weeks treatment and 8 weeks treatment between Western medicine group and the Chinese medicine group was no statistically significant (P>0.05), the total effective rate of 4 weeks treatment and 8 weeks treatment between the combination group and Western medicine group, the combination group and Chinese medicine group was statistically significant (P<0.05).2ã€secondary outcome measures:â‘ SAS score and SDS score:Through the comparative analysis within the group, three groups can effectively reduce the scores of patients SASã€SDS(P<0.05), the efficacy of 8 weeks treatment was better than the efficacy of 4 weeks in the each group(P<0.05); through the comparison between groups, there was no statistically significant difference about the therapeutic effect of 4 weeks treatment in the three groups(P>0.05); the therapeutic effect of 8 weeks treatment between the combination group and the traditional Chinese medicine group was no statistically significant difference(P>0.05), but the two groups were better than the western medicine group (P<0.05). â‘¡SQI scores:Before treatment,7 factors in PSQI scale were statistical analysis, we found that the mainly factors that affect the sleep quality of reflux esophagitis patients were poor sleep time and sleep disorders; post-treatment, Through the comparative analysis within the group, three groups can effectively reduce the scores of the PSQI scores (P<0.05),the efficacy of 8 weeks was better than 4 weeks of each group(P<0.05);through the comparison between groups, there was no significant difference in the therapeutic effect for 4 weeks treatment between the three groups(P>0.05), the therapeutic effect of 8 weeks treatment between the combination group and the traditional Chinese medicine group was no statistically significant difference(P>0.05), but the two groups were better than the western medicine group(P<0.05).Conclusionthe plusminus square of Pinelliae Decoction for Purging Stomach-Fire and Rabeprazole Sodium Enteric-coated Tablets all can efficiently improve reflux symptoms, promote the healing of esophageal mucosa, improve patients anxiety, depression state and sleep quality, the curative effect for 8 weeks treatment is better than that for 4 weeks, in improving reflux symptoms and promotting the healing of esophageal mucosa, the combination treatment is better than pure Chinese medicine or pure western medicine treatment; in improving patients’anxiety, depression state and sleep quality, the combination treatment and pure Chinese medicine treatment is better than pure western medicine treatment. |