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A method for determining the maximum tolerated dose of defibrinating drugs in human body
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A drug and dosage technology, which is applied in the field of determining the maximum tolerated dose of defibrinating drugs in the human body, can solve the problems of unreasonable and unconsidered fibrinogen duration, etc., and achieve the effect of reducing the effect of defibrinating drugs and strong repeatability
Active Publication Date: 2018-12-21
北京儒展生化药物研究中心
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[0009] The second problem is that the observation index of hypofibrinogenemia only considers the level and percentage of fibrinogen reduction, and does not consider the duration of fibrinogen reduction, which is obviously unreasonable
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Embodiment 1
[0045] Example 1 The general information of the subjects in each group is tabulated, and the general information of the subjects is analyzed according to the method of statistical analysis. The analysis results are shown in Table 1.
[0046] Table 1 The general situation of the subjects
[0047]
[0048] The test results showed that all subjects were 21-29 (25.2±2.6) years old, 158-173 (164.0±5.2) cm in height, 50.0-64.0 (55.9±5.2) kg in weight, and 20.0-22.0 (20.9±0.95) in body mass index. ). Among them, the average age of the 25,000 unit group was 23.8±2.8 years old, the height was 167.5±3.8cm, the weight was 59.4±3.7kg, and the body mass index was 21.5±0.5. The average age of the 50,000 unit group was 26.5±2.3 years old, the height was 160.5±6.5cm, and the weight was 52.5±5. 6.7kg, body mass index 20.4±1.4. All subjects had no important past medical history and drug allergy history, and all met the inclusion criteria.
Embodiment 2
[0049] Example 2 The pre-medication observation indexes of the subjects in each group were listed, and the pre-medication observation indexes of the subjects were analyzed according to the method of statistical analysis. The analysis results are shown in Table 2.
[0050] Table 2 Laboratory test results during subject screening
[0051]
[0052] The test results showed that no clinically significant abnormalities were found in the pre-medication physical examination, laboratory examination, and electrocardiogram examination.
Embodiment 3
[0053] Example 3 The vital signs of the subjects before and after the administration of each group were tabulated, and the vital signs of the subjects before and after the administration were analyzed according to the method of statistical analysis. The analysis results are shown in Table 3 and Table 4.
[0054] Table 3 Vital signs of subjects before medication
[0055]
[0056] Table 4 Vital signs of subjects after administration (48h)
[0057]
[0058] The test results showed that after a single intravenous infusion of 25,000 units and 50,000 units of lumbrokinase injection, the blood pressure, heart rate, respiration and body temperature of all subjects were within the normal range at each monitoring time point.
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Abstract
The invention provides a method for determining the maximum tolerated dose of a defibringen medicine in a human body. The method is characterized in that the method comprises the following steps: by adopting a defibringen pharmacological effect curve method, injecting a defibringen medicine into the human body, then immediately monitoring dynamic change of fibrinogen, and drawing a defibringen pharmacological effect curve. In a low dose group, quick synthesis of the fibrinogen in the human body is not activated, so the duration time of the defibringen pharmacological effect is as long as 48 hours, and the fibrinogen restores to a baseline level on the tenth days after administration; along with continuous addition of administration dose, if the administration dose is over great, the quick synthesis of the fibrinogen in the human body can be activated, so that the duration time of the defibringen pharmacological effect is shortened to 12 hours. Therefore, the maximum dose under the condition that the quick synthesis of the fibrinogen in the human body is not activated is the maximum tolerated dose of the human body. The significance for determining the dose is to prevent over-great administration dose and activate the quick synthesis of the fibrinogen in the human body, thereby remarkably shortening the duration time of the defibringen pharmacological effect and obviously reducing the defibringen pharmacological effect.
Description
technical field [0001] The invention relates to a method for determining the maximum tolerated dose of defiberizing drugs in the human body, in particular to a method for determining the maximum tolerated dose of defiberizing drugs such as lumbrokinase and thrombin in the human body by using a defiberizing drug efficacy curve method. Background technique [0002] Lumbrokinase Injection is a fiber-lowering drug developed by Beijing Ruzhan Biochemical Drug Research Center. Lumbrokinase is a general term for a group of thrombolytic enzymes with a molecular weight of 10,000-60,000 obtained from Eisenia Foetide Sarigny as a raw material. Lumbrokinase has the effects of reducing fibrin in small doses and dissolving thrombosis in large doses, and can be absorbed into the blood through the intestinal tract to hydrolyze fibrinogen, and become a drug for preventing and treating abnormal blood rheology in ischemic cerebrovascular diseases. However, the dosage of oral lumbrokinase prep...
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