Matsuzawa T, Nomura M, Unno T
Safety Research Laboratories, Yamanouchi Pharmaceutical Co., Ltd., Tokyo, Japan.
J Vet Med Sci. 1993 Jun;55(3):351-62. doi: 10.1292/jvms.55.351.
We analyzed historical control data of clinical pathology testings provided by sixty-seven member companies of the Japan Pharmaceutical Manufacturers Association covering study populations of approximately 7,000 rats/sex, 5,000 dogs/sex, and 700 monkeys/sex. This paper assesses the relationship between conditions of sample collection, methods of measurement, etc. and potential factors contributing to variations in reference data, based on weighted means and standard deviations thereof derived from data for rats, dogs and monkeys for those parameters measured using methods most common to the participating facilities. Parameters included erythrocyte count (RBC), hematocrit (Ht), hemoglobin concentration(Hb), reticulocyte count (Rt), platelet count, total leukocyte count (WBC), differential leukocyte count (%WBC), coagulation time (activated partial thromboplastin time: APTT, prothrombin time: PT), and serum/plasma levels of GOT, GPT, ALP, LDH, glucose, cholesterol, triglycerides (TG), total protein, albumin, urea nitrogen (UN), creatinine, sodium (Na), potassium (K), calcium (Ca), chloride (Cl), inorganic phosphorus (Ip), and CPK. Analyses of the data revealed species differences in RBC, Ht, Rt, platelet count, WBC, %WBC, ALP, LDH, glucose, cholesterol, TG, total protein, UN, creatinine, Ca, Ip, and CPK. There were strain differences in rats in platelet count, WBC, GOT, ALP, UN, creatinine, and CPK. Sex differences were noted for Hb, Ht, WBC, ALP, glucose, cholesterol, TG, total protein, A/G ratio, UN, and Ip. Age differences were observed with RBC, Hb, Ht, Rt, %WBC, GOT, GPT, ALP, LDH, cholesterol, TG total protein, Ip, and CPK. APTT, PT, ALP, glucose, TG and UN were found to be subject to the influence of fasting/feeding. In rats, Ht, WBC, CPK and K showed differences by the site of bleeding. Observed values for LDH and CPK varied with specimen type, plasma or serum; serum assay values showed greater variation than plasma values.
我们分析了日本制药商协会67个成员公司提供的临床病理检测历史对照数据，这些数据涵盖了约7000只/性别大鼠、5000只/性别犬和700只/性别猴的研究群体。本文基于参与机构最常用方法测量的大鼠、犬和猴的数据得出的加权均值及其标准差，评估样本采集条件、测量方法等与参考数据变化潜在因素之间的关系。参数包括红细胞计数（RBC）、血细胞比容（Ht）、血红蛋白浓度（Hb）、网织红细胞计数（Rt）、血小板计数、白细胞总数（WBC）、白细胞分类计数（%WBC）、凝血时间（活化部分凝血活酶时间：APTT、凝血酶原时间：PT）以及血清/血浆中的谷草转氨酶（GOT）、谷丙转氨酶（GPT）、碱性磷酸酶（ALP）、乳酸脱氢酶（LDH）、葡萄糖、胆固醇、甘油三酯（TG）、总蛋白、白蛋白、尿素氮（UN）、肌酐、钠（Na）、钾（K）、钙（Ca）、氯（Cl）、无机磷（Ip）和肌酸磷酸激酶（CPK）。数据分析显示，RBC、Ht、Rt、血小板计数、WBC、%WBC、ALP、LDH、葡萄糖、胆固醇、TG、总蛋白、UN、肌酐、Ca、Ip和CPK存在物种差异。大鼠的血小板计数、WBC、GOT、ALP、UN、肌酐和CPK存在品系差异。观察到Hb、Ht、WBC、ALP、葡萄糖、胆固醇、TG、总蛋白、A/G比值、UN和Ip存在性别差异。观察到RBC、Hb、Ht、Rt_%WBC、GOT、GPT、ALP、LDH、胆固醇、TG、总蛋白、Ip和CPK存在年龄差异。发现APTT、PT、ALP、葡萄糖、TG和UN受禁食/进食影响。在大鼠中，Ht、WBC、CPK和K因出血部位不同而存在差异。LDH和CPK的观察值因样本类型（血浆或血清）而异；血清检测值的变化大于血浆值。
