Sui Zheng Shi Liang Strategy Research Based On Gegenqinlian Decoction Treating Type2Diabetes

BackgroundChronic non-communicable diseases in the world and China have become a major public health problem. Previous studies showed that Chinese medicine for these diseases have a good effect. So treatment of chronic diseases is one of the priorities in TCM research. In the course of the chronic diseases treatment, therapeutic drug dose or type adjustments are needed. Previous studies in TCM were mainly on the initial drug use, the course during treatment has been less discussed. So it’s difficult to quantify and to guide clinical practice. We called the drug adjustment method of the TCM doctor used according to the patient’s condition during the treatment,"Sui-Zheng-Shi-Liang" strategy. The research of this strategy will complement the TCM research in the chronic disease treatment. Previous study, we identified "Sui-Zheng-Shi-Liang" strategy has three elements:"indications","timing/inflection point" and "the changing dosage," how to quantify the expression of these and put them into clinical applications, is the focus of this study.MethodsTaking Gegenqinlian Decoction treating type2diabetes as an example for the strategy, the research is divided into two partsThe first study takes the results of previous clinical study completed for a data mining, and obtain quantitative key elements of Sui-Zheng-Shi-Liang strategy.The logistic regression using and correlation analysis was used in the study. Correlation analyzing the clinical indicators and treatment effectiveness is used. Located the most outcome-related indicators, which is the "indications" element.Setting boundary values for the indications, using Chi-square analysis and Logistic regression to find out the most related bounds values associated with the outcome. The bound is the "turning point" element.The corresponding time is the "timing" element. According to previous studies dose-related information, get the "the changing dosage" factor. From the above results, the design comprising clinical programs Sui-Zheng-Shi-Liang strategy.Then designing a clinical trial protocol with Sui-Zheng-Shi-Liang strategy with the elements above.The second study is a clinical trial according to the protocol obtained above. The study was a randomized, parallel-group clinical trial. The subjects were type2diabetes patients treated by Gegenqinlian decoction. The subjects were randomly divided into Sui-Zheng-Shi-Liang groups and Non-Sui-Zheng-Shi-Liang group,46cases in each group. Observation time was12weeks. Then we evaluated the efficacy indicators to compare the therapeutic effect of the two groups. And we monitored the safety index to compare the safety of the two groups.ResultIn the first study, in the Sui-Zheng-Shi-Liang strategy of Gegenqinlian de coction treating type2diabetes, the indication can be used as "indications" elements are:SEX、AGE、HEG、WEG0、YW0、GLU04、GLU06、GLU08、 GLUO10CGLU04、CGLU08、YW08、The bounds as the "The timing/infle ction point" elements are:GLU04reached0.5mmol/L. GLU08reached mmol/L,1mmol/L,1.5mmol/L. GLU010reached0.5mmol/L,1mmol/L,1.5mmol/L. CGLUO4reached1mmol/L. CGLU08reachedl mmol/L,2mmol/L,3mmol/L. The do sage as the "the changing dosage" element is:the initial dose of Gegen60g Huangqin22.5g Huanglian22.5g Shenggancaol5g Ganjiang3.5g, dose changi ng each time is half of the dosage above. In the final protocol, we chose "in dications" as fasting blood glucose in the fourth week. The timing/inflection point as the fasting blood glucose of fourth week changes to0.5mmol/L. The dose is set according to the dosage above.In the second study, after the12weeks observation, the key outcome measures glycated hemoglobin, in the two groups were significantly decreased. The treatment is effective. Sui-Zheng-Shi-Liang group had reduced after treatment by0.71±1.00, significantly better than the Non-Sui-Zheng-Shi-Liang group decreased by0.31+0.63.For the fasting glucose, in second week (0.74±0.944), sixth week (0.79± 1.33), eighth week (0.44±1.26), tenth week (1.35±1.49), twelfth week (0.96±1.28) in the Sui-Zheng-Shi-Liang group, tenth week (1.24±2.28) in the Non-Sui-Zheng-Shi-Liang group had decreased significantly; For the2-hour postprandial glucose, in Sui-Zheng-Shi-Liang group in twelfth week (1.99±3.30), Non-Sui-Zheng-Shi-Liang group in eighth week (1.78±3.53) had improved significantly; For cholesterol, body weight, BMI, waist circumference and hip circumference, insulin-related index and blood pressure, treatment was partially effective,no significant difference between two groups. For the safety observation, Sui-Zheng-Shi-Liang group was better than Non-Sui-Zheng-Shi-Liang group. Serious adverse events did not appear in the study.ConclusionsThe study used a data mining method to quantify the expression of elements of the "Sui-Zheng-Shi-Liang" strategy. Designed a dosing regimen according to the elements obtained above. Using the clinical trial to confirm the clinical treatment using the Sui-Zheng-Shi-Liang strategy, is partly effective than the treatment do not adopt this strategy. In terms of security,"Sui-Zheng-Shi-Liang" group was better than the group not applied with the strategy.With the results of previous studies combined, we can build the framework of "Sui-Zheng-Shi-Liang" strategy study ultimately, and establish "Sui-Zheng-Shi-Liang" theory and research system the initially. The research can enrich the TCM medication dosage strategies, improve the dose-effect relationship study in TCM, scientifically improve the clinical efficacy of traditional Chinese medicine and provide theoretical and methodological support.