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目的研究葛根素注射液的不良反应情况及作用机制。方法参考反映Ⅱ型变态反应的免疫毒理学研究模型,以家兔耳缘静脉注射绵羊红细胞为阳性对照组,连续注射葛根素注射液(28.6 mg.kg-1)6 d,停药1 d,持续6周,停药当天观察家兔免疫系统大体症状如呼吸困难、喷嚏等,并监测体温;检测血液、尿液中溶血相关指标和肝肾功能指标;用Coombs实验法检测家兔血清体外使红细胞溶血情况;给药结束后处死家兔测定脏器指数,并进行组织学观察。结果家兔注射葛根素注射液3周开始出现尿潜血,第5、6周血浆游离血红蛋白显著增加,提示家兔可能出现血管内溶血。中性粒细胞数目从1周开始减少,其中第4周与对照组相比有显著性差异(P<0.05),提示对粒细胞有损伤;淋巴细胞数目在第2周显著增加(P<0.05);血小板数目于第6周显著增加;脏器指数显示胸腺增生,提示免疫系统参与此过程。血清丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)及肝脏病理学结果提示肝脏损伤。而免疫系统大体反应均未见显著变化。Coombs试验结果表明,3周后有67%的家兔血清在体外使与葛根素抗原共孵育的红细胞溶血,提示其含有葛根素抗体。结论静脉注射葛根素注射液会引起家兔溶血、粒细胞减少、淋巴细胞增加及肝损伤等不良反应,其机制可能与Ⅱ型变态反应相关。
Objective To study the adverse reactions and mechanism of puerarin injection. Methods Reference immunosuppressant study of type Ⅱ allergic reaction model to rabbit ear vein red blood cells as a positive control group, continuous injection of puerarin injection (28.6 mg.kg-1) 6 d, withdrawal 1 d, Lasted for 6 weeks, observed rabbits immune system on the day of the general symptoms such as dyspnea, sneezing, etc., and monitoring body temperature; detection of blood and urine hemolysis related indicators and liver and kidney function indicators; Coombs test rabbit serum in vitro Erythrocyte hemolysis; after the administration, rabbits were sacrificed to measure the organ index, and histological observation. Urine occult blood began to appear in rabbits after 3 weeks of puerarin injection, and plasma free hemoglobin was significantly increased in weeks 5 and 6, suggesting that intravascular hemolysis may occur in rabbits. The number of neutrophils decreased from 1 week. There was a significant difference between the 4th week and the control group (P <0.05), which indicated that the number of neutrophils was damaged. The number of lymphocytes increased significantly at the 2nd week (P <0.05) ); The number of platelets increased significantly at the 6th week; the organ index showed thymus hyperplasia, suggesting that the immune system is involved in this process. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and liver pathology prompted liver damage. The immune system showed no significant changes in the general response. Coombs test results showed that 67% of rabbit serum after 3 weeks had hemolysis of erythrocytes co-incubated with the puerarin antigen in vitro, suggesting that they contain puerarin antibodies. Conclusion Intravenous injection of puerarin can cause haemolysis, neutropenia, lymphocytosis and liver damage in rabbits. The mechanism may be related to type Ⅱ allergic reaction.