Michael Bindhu, Yano Barry, Sellers Rani S, Perry Rick, Morton Daniel, Roome Nigel, Johnson Julie K, Schafer Ken, Pitsch Sue
Merck Research Laboratories, West Point, Pennsylvania 19586, USA.
Toxicol Pathol. 2007 Aug;35(5):742-50. doi: 10.1080/01926230701595292.
The Society of Toxicologic Pathology convened a working group to evaluate current practices regarding organ weights in toxicology studies. A survey was distributed to pharmaceutical, veterinary, chemical, food/nutritional and consumer product companies in Europe, North America, and Japan. Responses were compiled to identify organs routinely weighed for various study types in rodent and non-rodent species, compare methods of organ weighing, provide perspectives on the value of organ weights and identify the scientist(s) responsible for organ weight data interpretation. Data were evaluated as a whole as well as by industry type and geographic location. Regulatory guidance documents describing organ weighing practices are generally available, however, they differ somewhat dependent on industry type and regulatory agency. While questionnaire respondents unanimously stated that organ weights were a good screening tool to identify treatment-related effects, opinions varied as to which organ weights are most valuable. The liver, kidneys, and testes were commonly weighed and most often considered useful by most respondents. Other organs that break were commonly weighed included brain, adrenal glands, ovaries, thyroid glands, uterus, heart, and spleen. Lungs, lymph nodes, and other sex organs were weighed infrequently in routine studies, but were often weighed in specialized studies such as inhalation, immunotoxicity, and reproduction studies. Organ-to-body weight ratios were commonly calculated and were considered more useful when body weights were affected. Organ to brain weight ratios were calculated by most North American companies, but rarely according to respondents representing veterinary product or European companies. Statistical analyses were generally performed by most respondents. Pathologists performed interpretation of organ weight data for the majority of the industries.
毒理病理学会召集了一个工作组，以评估毒理学研究中有关器官重量的当前做法。向欧洲、北美和日本的制药、兽医、化工、食品/营养和消费品公司分发了一份调查问卷。对回复进行了汇总，以确定在啮齿动物和非啮齿动物物种的各种研究类型中常规称重的器官，比较器官称重方法，提供关于器官重量价值的观点，并确定负责器官重量数据解释的科学家。对数据进行了整体评估，也按行业类型和地理位置进行了评估。描述器官称重做法的监管指导文件一般都有，但它们因行业类型和监管机构的不同而有所差异。虽然调查问卷的受访者一致表示器官重量是识别与治疗相关效应的良好筛选工具，但对于哪些器官重量最有价值，意见不一。肝脏、肾脏和睾丸通常被称重，大多数受访者最常认为它们是有用的。其他经常被称重的器官包括大脑、肾上腺、卵巢、甲状腺、子宫、心脏和脾脏。在常规研究中，肺、淋巴结和其他性器官很少被称重，但在吸入、免疫毒性和生殖研究等专门研究中经常被称重。器官与体重的比值通常会被计算出来，当体重受到影响时，这些比值被认为更有用。大多数北美公司会计算器官与大脑的重量比值，但代表兽医产品公司或欧洲公司的受访者很少这样做。大多数受访者通常会进行统计分析。大多数行业的器官重量数据解释工作由病理学家完成。
