目的 相同剂量卵白蛋白和相同激发时间的条件下，比较豚鼠主动全身过敏反应症状的严重程度与致敏途径和激发途径的关系。方法 取300～400 g豚鼠78只，雌雄各半，随机分为13组，每组6只。以0.4%卵白蛋白溶液为受试物，氯化钠注射液为阴性对照，每组动物均隔日致敏1次，连续致敏3次，致敏剂量为0.5 mL（2 mg/只），末次致敏后第14天各组分别进行激发，激发剂量为1.0 mL（4 mg/只）。研究不同致敏途径和激发途径条件下，豚鼠主动全身过敏的发生情况。结果 在相同致敏剂量、激发剂量和激发时间的条件下，均以ip致敏的条件下，豚鼠主动全身过敏反应的症状严重程度为iv激发 > im激发 > ip激发 > sc激发；均以im致敏的条件下，症状严重程度为iv激发 > ip激发 > im激发 > sc激发；均以sc致敏的条件下，症状严重程度为iv激发 > im激发 > ip激发 > sc激发；均以iv激发的条件下，症状严重程度为ip致敏 > im致敏 > sc致敏。结论 新药主动全身过敏试验临床前安全性评价研究应注意致敏途径和激发途径。
Objective The relationship between the severity of active systemic anaphylaxis and the sensitization and activation pathways in guinea pigs was compared under the same dose of ovalbumin and the same excitation time. Methods A total of 78 Guinea pigs weighted 300 to 400 grams were randomly divided into 13 groups, each group of six guinea pigs. The 0.4% ovalbumin were used as experimental materials, and sodium chloride injection as negative control, sensitizing once every other day for 3 d, with sensitizing dose of 0.5 ml (2 mg/animal). The excitation was carried out at the fourteenth day after the end sensitization, with challenge dose of 1.0 ml (4 mg/animal). Guinea pigs had active systemic allergic reaction in the study of different sensitizing and challenge way. Results In the conditions of the same sensitizing dose, challenge dose and challenge interval, under the condition of ip sensitization, the severity of guinea pigs' active systemic anaphylaxis was iv excitation > im excitation > ip excitation > sc excitation; Under the condition of im sensitization, the severity of symptoms was iv excitation > ip excitation > im excitation > sc excitation; Under the condition of sc sensitization, the severity of symptoms was iv excitation > im excitation > ip excitation> sc excitation. Under iv stimulation, the severity of symptoms was ip sensitization > im sensitization > sc sensitization. Conclusion Preclinical safety evaluation of the new drug active systemic anaphylaxis should pay attention to the route of sensitization and challenge.