| Objective:Xinnao Zhibaoping Capsules in treatment of hyperlipidemia clinical study effectiveness and clinical drug safety assessed. Recommend the clinical use.Methods:1.Control drug use placebo, stratified block randomized, double-blind, single-simulation, placebo-controlled clinical trial method,36 eligible patients were divided into treatment group,18 patients (test group of patients for each oral Xinnao Zhibaoping Capsules 4 capsules,3 times/day) and the control group,18 patients (control group patients in each placebo capsules 4 capsules,3 times/day).8 weeks clinical observation. Two groups of patients with sex, age, course of disease and illness, etc., the difference was not statistically significant (P<0.05), comparable.2.Observation of TCM symptoms and signs before and after treatment to calculate symptom points. Under the integral method to determine efficacy of traditional Chinese medicine symptoms. And do statistical analysis to compare its efficacy.3.Observed before and after treatment of blood lipid changes. Observation of laboratory tests of blood, urine, stool routine, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr), blood lipids, CK examination, electrocardiogram and other safety indicators, to detect Xinnao Zhibaoping Capsules whether the toxic side effects.4.Statistical analysis:Statistical analysis software will be used SAS10.0calculated. Measurement information to S that the use of t test analysis; count data using X2 test, grade Ridit analysis of data used.Results:1.The two groups before and after treatment in patients with symptoms of integral medicine comparison (see Table 1):two points after treatment of Chinese medicine symptoms were significantly lower than before treatment, statistically significant differences (P<0.05); the two groups before and after treatment in Chinese medicine symptoms integration of their respective groups were compared before treatment was no significant difference between the two groups (P>0.05), treatment group after treatment was significantly lower than the control group, there is a significant difference (P<0.05). shows that the two groups before and after the traditional Chinese medicine in the treatment of patients with symptoms of points are markedly reduced. But the treatment group was significantly lower than in the control group.2.Two groups before and after treatment in patients with symptoms of traditional Chinese medicine to improve the comparison (see table 2):the treatment group, the total efficiency of 88.90% do statistical analysis to compare its efficacy.3.Observed before and after treatment of blood lipid changes. Observation of laboratory tests of blood, urine, stool routine, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr), blood lipids, CK examination, electrocardiogram and other safety indicators, to detect heart and brain caused by Bao-Ping Capsules whether the toxic side effects.4.Statistical analysis:Statistical analysis software will be used SAS10. Ocalculated. Measurement information to S that the use of t test analysis; count data using X2 test, grade Ridit analysis of data used.Results:1.The two groups before and after treatment in patients with symptoms of integral medicine comparison (see Table 1):two points after treatment of Chinese medicine symptoms were significantly lower than before treatment, statistically significant differences (P<0.05); the two groups before and after treatment in Chinese medicine symptoms integration of their respective groups were compared before treatment was no significant difference between the two groups (P>0.05), treatment group after treatment was significantly lower than the control group, there is a significant difference (P<0.05). shows that the two groups before and after the traditional Chinese medicine in the treatment of patients with symptoms of points are markedly reduced. But the treatment group was significantly lower than in the control group.2.Two groups before and after treatment in patients with symptoms of traditional Chinese medicine to improve the comparison (see table 2):the treatment group, the total efficiency of 88.90% in the control group, the total efficiency of 50%. Significantly higher than that, there is a significant difference (P<0.05).3.Lipids to improve the two groups were compared before and after treatment (Table 3):the treatment group compared to 4 after treatment blood lipid (TC, TG, LDL-C, HDL-C) compared with before treatment there was significant difference (P<0.05), compared with the control group after treatment there was significant difference (P<0.05); control group, comparison group before and after treatment showed no statistical significance. Note After treatment, improvement of blood lipids, in particular, can significantly reduce TC, TG, LDL-C.4. Two groups of patient safety indicators before and after treatment has been no unusual circumstances, the drug shows toxic side effects and adverse reactions.Conclusions:Xinnao Zhibaoping Capsules Chinese medicine can ease the symptoms, improve and regulate lipid metabolism, significantly reduced TC, TG, LDL-C. And a slight increase in the role of HDL-C, no obvious toxic side effects and adverse reactions. Recommend clinical use of Xinnao Zhibaoping Capsules in treatment of hyperlipidemia (phlegm and blood stasis deter card).
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