Clinical Research On Shuangle Tiaozhi Capsule In Treating Hyperlipidemia(Sputum Stasis Syndrome)

ObjectivesResearch on the efficacy and safety of Shuangle Tiaozhi capsule in treating hyperlipidemia(Sputum Stasis Syndrome) to explore the mechanism and efficiency for the foundation of clinical application.Methods1. Methods of randomization, double-blindness, parallel control were applied to the eligible 48 patients who were divided to Treatment Group (n=24, given 1g Shuangle Tiaozhi capsule, three times a day) and Contrast Group (n=24, given 1g placebo, three times a day), and received 8 weeks clinical observation simultaneously. The two groups were comparable because of the insignificance level on gender, age, course and underlying diseases (P>0. 05).2. Symptoms and signs before and after treatment were observed, calculated symptom scores, the total effective rate, and analyzed statistically for comparison for the therapeutic effects.3. Changes of blood lipid were observed before and after treatment. 4. Determination of poisonous or side effects of Shuangle Tiaozhi capsule was conducted by observing indexes of routine examinations of blood, urine, stool, the liver and kidney function, CK, blood glucose and ECG.5. The Stat. method: The data was analyzed after observation. The count material, the measuring material and the grade material were examined with Chi-square test, T-test and Ridit respectively. All data was analyzed by SPSS.Results1. Compared with two groups before and after treatment of TCM Syndrome score (see table 3): The two groups after treatment of TCM Syndrome score were significantly lower than that before treatment, there were significance level (P <0. 05); The two groups between their respective groups of comparison, before treatment there was insignificance level ( P> 0.05), after treatment there was significance level (P <0. 05). The result showed two groups' symptom score after treatment decreased significantly, and the treatment group reduced more significantly.2. Compared with two groups of TCM Syndrome improvement (see table 4): The total recovery rate and the total efficiency rate of treatment group were 65. 22% and 81. 30%, it was significantly higher than contrast group, and there was significance level (P <0. 05). The result showed the total recovery rate and the total efficiency rate of treatment group were significantly higher than that of contrast group.3. Compared with two groups before and after treatment of blood lipids improvement (see Table 5): Treatment group could reduce TC, TG, LDL-C, increase HDL-C, and there was significance level (P <0. 05) before and after treatment, compared with contrast group after treatment there was significance level (P <0. 05) except HDL-C (P> 0.05); There was insignificant level (P> 0.05) before and after treatment of contrast group. The result showed contrast group should not significantly reduce TC, TG, LDL-C or increase HDL-C, while treatment group could significantly improve these targets, in particular, significantly reduce TC, TG and LDL-C.4. Blood, Urine, Stool, Liver and Renal function , CK, blood glucose, ECG of two groups of patients after treatment were normal, it was suggested that the drug had insignificant side effects and adverse reactions.ConclusionsShuangle Tiaozhi capsule can obviously alleviate the TCM symptoms, improve and regulate lipid metabolism disorders, significantly reduce TC, TG, LDL-C, and slightly increase HDL-C, and there are insignificant side effects and adverse reactions, so the clinical trials show that Shuangle Tiaozhi capsule in the treatment of hyperlipidemia(Sputum Stasis Syndrome) is safe and effective, there is the prospect of clinical application.