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1.
药物非临床安全性评价毒性试验有害作用的判断非常重要,因其可为保护临床试验暴露于新化学实体或药物的受试者提供重要信息。毒性试验组织病理学检查可提供受试物毒性作用的形态学数据,帮助分析和确定有害作用和非有害作用及其剂量水平。参照美国毒性病理学会(STP)和欧洲毒性病理学会(ESTP)的推荐最佳实践或建议及其他相关文献,对有害作用的定义、区分有害作用与非有害作用的要素、有害作用数据沟通和使用来评估人类潜在风险等建议等进行简要概述分析,以期为我国非临床药物安全性评价毒性试验中有害作用判定提供参考。 相似文献
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Preliminary study on blood coagulation and hemostatic effect and acute toxicity of Oxalis corniculata L. ethanol extract 下载免费PDF全文
In the present study, we aimed to observe the effects of ethanol extract of Oxalis corniculata L. on bleeding time (BT) and coagulation time (CT) and determine its acute toxicity in mice. Firstly, the ethanol extract of O. corniculata was administered to 40 mice, which were randomly divided into the normal control group, Yunnan Baiyao control group, low-dose group, and high-dose group. The low-dose (0.6 g/kg) and high-dose (1.2 g/kg) groups received ethanol extract of O. corniculata by gavage, and the BT and CT of the mice were measured by the slide method and tail clipping method, respectively. Secondly, the median lethal dose method was used with 50 mice to observe the physiological state, poisoning reaction, and death of the mice after intragastric administration. Finally, on the 14th day of the experiment, a necropsy was performed to observe any abnormality of the organs. In conclusion, in the coagulation and hemostasis tests, there were no statistical differences between the groups (P > 0.05), while there was a significant dose-response relationship, and the BT and CT were significantly shorter than those of the negative control group, which were comparable to the Yunnan Baiyao control group. Moreover, in the acute toxicity test, the median lethal dose of ethanol extract of O. corniculata was 6.0291 g/kg, with a 95% confidence interval of 5.3065–6.7829 mg/kg. 相似文献
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《Clinical genitourinary cancer》2022,20(5):442-451
IntroductionSelective internal radiation therapy (SIRT) is a potential treatment of primary renal cell carcinoma (RCC) deemed unsuitable for conventional therapy. RESIRT is the first-in-human study to evaluate safety and feasibility of SIRT for primary RCC.Patients and MethodsPatients with RCC, unsuitable for, or who declined conventional therapy, were eligible. A single transfemoral micro-catheter administration of yttrium-90 (Y-90) resin microspheres (SIR-Spheres) was delivered super selectively via the renal artery to the tumour at intended radiation doses of 75, 100, 150, 200, 300 Gy and a final cohort with a procedural endpoint of “imminent stasis,” in a dose-escalation design. Post-SIRT follow-up was 12 months. Study endpoints included safety and toxicity 30-days and 12-months post-SIRT and tumour response (RECIST v1.1).ResultsIn total, 21 patients were enrolled, mean (SD) age was 75 (9.3) years, WHO performance status was 0 in 81%, 12 (57%) had stage 3 chronic kidney disease, and 7 (33%) had prior contralateral nephrectomy. Overall, 71% of patients completed 12 months of follow-up. Intended doses were delivered without any dose-limiting toxicity. Seventeen out of 21 (81%) patients experienced an adverse event (AE) from any cause within 30 days post-SIRT; all SIRT-related AEs were grade 1 to 2. Best overall tumour responses were partial response 1/21 (4.8%), stable disease 19/21 (90.5%) and progressive disease 1/21 (4.8%).ConclusionThis study demonstrated good tolerability of SIRT at all dose levels including “imminent stasis” in treating primary tumours in RCC patients otherwise unsuitable for conventional therapy. SIRT with Y-90 resin microspheres may be a feasible treatment option for RCC. 相似文献
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炎症被视为肿瘤的第七大生物学特征,而肿瘤被称作“永不愈合的伤口”。炎性微环境作为肿瘤微环境的重要组成部分,不仅诱导正常细胞向肿瘤细胞转化,导致肿瘤的发生,还通过分泌炎性细胞因子、趋化因子参与上皮-间质转化、血管新生、代谢重编程等过程,促进肿瘤侵袭、转移及恶液质的发生。中医学认为,癌毒与痰浊、瘀血、热毒相互滋助、互为因果,胶结留着于至虚之处而发为肿瘤。癌毒窃夺精血、损耗正气,使机体出现“虚劳”之候,体现了肿瘤恶液质 “癌毒致虚” 的病机特点。本文总结分析了炎性微环境在肿瘤恶液质发生发展中的关键作用,并探析其与中医学“癌毒致虚”病机理论的相关性,为“癌毒致虚”治疗肿瘤恶液质提供科学依据。 相似文献
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Karen Kayser Ariel Washington Lesley M. Harris Barbara Head 《Journal of psychosocial oncology》2021,39(1):17-34
Abstract