The Study Of Dose-effect Relationships Of He Qi San On Treating Metabolic Syndrome With Phlegm-blood Stasis Syndrome

ObjectiveTo observe the curative effect of different doses of He Qi San treating the Metabolic Syndrome with phlegm-blood stasis syndrome during clinical. To study the correlation between the curative effect and drug dosage from the point of TCM syndrome integral、human parameters and metabolic indexs. Provide an objective clinical evidence for treating Metabolic Syndrome with proper dose of He Qi San.MethodsAccording to the standard of study, we collected120cases of the Metabolic Syndrome with phlegm-blood stasis syndrome from outpatient clinic and inpatient department. Continuing the original therapeutic regimens, all of the patients were randomized into control group and treatment groups. The treatment groups were randomly divided into low-dose, middle-dose and high-dose groups, taking He Qi San of different doses, while the control group without any traditional Chinese medicine. We assessed the TCM syndrome integral of all patients before they joined in the research, and15days、30days,45days after researching, We also measured the human parameters and metabolic indexs, recorded adverse reactions of all patients before and45days after researching in order to summarize the curative effects and the dose-effect relationships of He Qi San. We use SPSS16th version statistical software to analyse the clinical datas. Measurement datas will be verified by the statistical methods of means and standard deviations. The statistical methods of t-test will be used to compare datas between groups. When the test level a equal to0.05, the differences are significant.ResultsIncluded in this study, objects are given priority to male patients, and focused on the31-50years of age. Most of the patients are cadres, staffs and the individuals. Improper diet and lack of exercises are the main unhealthy life styles. The majority of patients have the history of family related diseases. The TCM curative effect of this study shows that He Qi San can effectively improve the TCM syndrome indicators, especially in middle-dose group and high-dose group. The curative effect is obviously appeared after30days. Compared with the control group, the treatment groups controls body weight better(P<0.05), obviously in middle-dose group and high-dose group(P<0.05). However, the results of waists decreasing and blood pressure controlling are alike(P>0.05), and the dose-effect relationships are not obvious(P<0.05). In the side of lowering postprandial glucose, treatment group acts better than the control group(P<0.05), particularly in middle-dose group and high-dose group(P<0.05), without differences in reducing fasting glucose(P>0.05). The treatment group reduces postprandial insulin(P <0.05), which the difference is more apparent in high-dose group(P<0.05), and the control group can not change the insulin level(P>0.05). The treatment group reduces TG, TC, LDL obviously(P<0.05), particularly in middle-dose group and high-dose group of lowering TG, TC (P<0.05) and each groups have no significant dose-effect relationships of lowering LDL(P>0.05). Both groups can not improve HDL levels(P>0.05). Treatment group can strikly lower levels of Leptin and Tumor Necrosis Factor and elevate Adiponectin level(P <0.05), especially in low-dose group(P<0.05). The clinical curative effect of most indexs in this study shows that, the middle-dose group and high-dose group are without significant difference.ConclusionThe results shows that He Qi San can reduce TCM syndrome integral, relieving clinical symptoms effectively. It can significantly control body weight, adjusting the metabolic disorder and relieving insulin resistance. It can also reduce the secretion of Leptin and Tumor Necrosis Factor, increasing the level of Adiponectin. The curative effect of middle dose and high dose of He Qi San are more ideal and considerable. In addition, the results show that He Qi San don’t cause hyperinsulinemia. However, there is no obvious advantages in the side of lowering blood pressure and improving HDL levels. This study also suggests, He Qi San with middle dose can achieve satisfactory curative effect in clinical prescription.