| Objective: (1)To investigate the clinical effect and safety of using a combination treatment of'qi zhi Dan Huang'(QZDH)capsule in combination with conventional western medicine for the patients that have hypercholesterolemia. (2) To explore a new drug treatment and an effective approach to applying the Chinese traditional and Western medicines combination treatment on disease of hypercholesterolemia.Methods: seventy-eight cases with diagnosed hypercholesterolemia, TCM for deficiency of vital energy and blood stasis were randomly divided into QZDH-capsules treatment group (n=39) and conventional western medicine control group (n=39). Subjects in the control group are treated with conventional Western medicine to lower tipod, and received routine use of stations, such as taking atorvastatin 10mg per day orally without any Chinese medicine. Subjects in the treatment group take QZDH-capsules in addition to a basis of conventional western medicine treatment. The usage is four tablets per time, and 3 times per day.(QZDH-capsules are produced by the Guiyang Medical College Affiliated preparation room of production, and its specification is 0.25g each tablet.)The follow-up observation period for each subject is three months. They all must receive the relevant physical and chemical examinations such as the three routine of blood, urine, and stool; blood biochemistry (liver, kidney function, blood sugar, blood lipids, and electrolytes) ;other related checks, or filling out the informed consent. The examinations must be done respectively in the first three days of the observation period and in the following week after it. During the observation period, we were watching if there are any relevant Chinese medicine symptoms or adverse drug reaction.Statistical method: chi-square test for categorical data, and t test for quantitive data. Statistical computation is implemented by software Excel 2007 and SPSS 11.5.ResultsFirstly the effect of decreasing TC, TG and LDL-C is significant (P<0.01) in both groups. But the effect of increasing HDL-C is not significant (P>0.05)in both groups. The difference comparison (P<0.05) before and after treatments for two groups indicates that the treatment group is significantly better than control group in decreasing cholesterol and low-density lipoprotein. However, the difference comparison of TG and HDL-C for two groups is not statistically significant (P>0.05) and thus shows that treatment group has no significant effect in decreasing TG and increasing HDL-C.Secondly in the treatment group for hypercholesterolemia with deficiency of vital energy and Blood Stasis, there are 20 markedly effective cases〔51.28%〕,17 effective cases (43.59%) and 2 ineffective cases (5.13%), and the total efficiency is 94.87%. In the control group, there are markedly 7 effective cases (17.95%), 23 effective cases (58.97%), and 9 ineffective cases (23.08%),and the total efficiency is 76.92%. We conclude that the treatment group is significantly better than the control group (P <0.01).Finally, the analysis of treatment's safety: In the process of therapy, no aggravated conditions or new clinical symptoms on the subjects were found for both groups. The safety examinations of functionalities of liver, kidney didn't show anything abnormal. In all,'qi zhi Dan Huang'capsule has no apparent toxic side-effects, but reliable safety.Conclusion'qi zhi Dan Huang'capsule has significant function when combining with conventionally western medicine in the treatment of disease of hypercholesterolemia with deficiency of vital energy. In particular, it has significant effect in improving Chinese medicine clinical symptoms and enhancing the quality of life in patients. In conclusion,'qi zhi Dan Huang'capsule has no obvious side toxicity effects and has better safety guaranty. |
PDF Full Text Request