新语丝4118COM云顶集团资深医学翻译译员整理翻译的有关药物临床实验文件,以下就是具体的案例。
给药后1日
day after drug administration
给药后24h,体格检查,测量血压、脉搏、呼吸、体温,同时查血常规及凝血功能、尿常规、大便常规及隐血试验、血生化、心电图、脑电图。试验期间密切观察有无不良反应,记录其表现、发生时间、程度、处理经过、持续时间及转归。
Carry out physique examination and detect blood pressure, pulse, breath, body temperature and at the same time carry out routine analysis of blood and blood coagulation, routine analysis of urine and stool, and occult blood test, blood biochemical test, electrocardiogram and encephalogram 24 hours after drug administration. Closely observe whether there is adverse event and record its behavior, accident time, degree, disposal course, lasting time and lapse during trial period.
随访
Following visit
如果给药后1日发现有意义的临床表现或实验室检查异常,给药后7天,对这些受试者进行随访,再做相关检查,并判断与药物的相关性和追踪其恢复情况。
If clinical behavior with meaning or abnormal lab examination result is found 1 day after drug administration, carry out following visit on these testees on the seventh day after drug administration and carry out corresponding examination again, and judge correlation with drug and tract their recovery situations.
附:
Attachment:
血常规(9项):红细胞(RBC)、白细胞(WBC)、白细胞分类、血红蛋白(Hb)、平均红细胞容积(MCV)、红细胞压积(HCT)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白(NCHC)、血小板计数(PLT);
Routine analysis of blood (9 items): red blood cell (RBC), white blood cell (WBC), classification of WBC, haemoglobin (Hb), mean corpuscular volume (MCV), hematocrit (HCT), mean corpuscular hemoglobin (MCH), average red cell haemoglobin (NCHC) and platelet count (PLT).
凝血功能(2项):凝血酶原时间(PT)、纤维蛋白原(Fibrinogen);
Blood coagulation (2 items): prothrombin time (PT) and fibrinogen.
血生化(18项):钙(Ca2+)、钾(K+)、钠(Na+)、氯(Cl-)、肌酐(Cr)、γ-谷氨酰胺转肽酶(γ-GT或GGT)、尿素(Urea)、尿酸(Ua)、血糖(Glu)、乳酸脱氢酶(LDH)、总胆红素(TB)、谷草转氨酶(GOT)、谷丙转氨酶 (GPT)、碱性磷酸酶(ALP)、甘油三酯(TG)、总胆固醇(CH)、总蛋白(TP)、白蛋白(Alb);
Biochemical test of blood (18 items): Ca2+,K+,Na+,Cl-,Cr, γ-glutamine transpeptidase (γ-GT or GGT), Urea, Ua, Glu, LDH, TB, GOT, GPT, ALP, TG, CH, TP and Alb.
尿常规(12项):pH值、尿蛋白(PRO)、尿糖(GLU)、酮体(KET)、尿胆元(UBG)、尿胆素(BIL)、白细胞/高倍视野(LEU/HP)、红细胞/高倍视野(ERY/HP)、管型/高倍视野(Casts/HP)、细菌(Bacterias)、上皮/高倍视野(Epithelias cells/HP)、结晶/高倍视野(crystals/HP)。
Routine analysis of urine (12 items): pH value, PRO, GLU, KET, UBG, BIL, LEU/HP, ERY/HP, Casts/HP, bacteria, Epithelias cells/HP, crystals/HP.
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