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Partl Clinical StudyObjective:To obsever the adverse reaction of Jin Fu An Decoction (JFAD), to evaluate its safety in treating medium or late stage non-small cell lung cancer.Methods:60 patients with medium or late stage non-small cell lung cancer were divided randomly into two groups. In GroupⅠ,30 patients were treated with JFAD and the best supportive care;In GroupⅡ,30 patients were only treated with the best supportive care. The adverse reaction of the two groups were evaluated after one course of treatment. For example, blood shapes,liver and kidney function,immune function and the quality of life were compared.Results:1 Adverse Reaction:In hematologic system, digestive system, urinary system, cardiac, nervous system, there was no significant difference between the GroupIandⅡ(P>0.05), and pointed out JFAD for the each system without causing obvious side effects. In other skin, hair loss, fever, allergic reaction etc, Comparing with the GroupⅡ, the JFAD had no severe adverse reactions (P>0.05).2 Physical state:The alterations of the Karnosfky scores in GroupⅠandⅡhad statistical difference (P<0.05), and pointed out the JFAD not to cause obvious side effects. On the contrary, the JFAD could improve the physical state.3 Immune Function:In the percentage of LBT, CD4+, CD8+, CD4+/CD8+ in T-lymphocyte subcategory, it is no significant difference in statistics between groupⅠandⅡ(P>0.05). But in the JFAD group, there were significantly increased before treatment (P<0.05) about LBT、CD4+、CD4+/CD8+. In sum, the JFAD Could improve the immune function。Conclusion:Taking JFAD in non-small cell lung cancer treatment was safe, not to lessen the physical state and immune function of the patients, instead of to improve the patient’s physical state and immune function.Partll Acute Toxicity ExperimentObjective:Through to try JFAD by oral acute toxicity experiment in mice, to evaluate the safety of JFAD.Methods:Pre-experiments results showed that it could not be determined of the Half Lethal Dose (LD50) of JFAD. According to A Research of New Herb, it Should carry on the Maximum Tolerable Dose (MTD).40 Mice (20 male and 20 female) were randomly divided into 2 groups:JFAD were perfuse stomach to mice on maximal concentration and maximal capacity two times daily,and observed for 7 days, compared with the same capacity of distilled water group. And then the times equal to human were calculated accordingly.Results:Acute toxicology experiment showed that the MTD administration to mice was 587.0g/kg·d, about 200.11 times equal to the adult clinical daily dose.Conclusion:JFAD for oral use was safe and of little toxicology.
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