目的 評價甲型乙型肝炎聯(lián)合疫苗是否具有肌肉刺激性、急性毒性和過敏性反應(yīng)。方法 家兔后肢股四頭肌im 0.5 mL甲型乙型肝炎聯(lián)合疫苗，每天給藥1次，連續(xù)給藥2 d，停藥2和21 d后對注射部位進行肉眼和病理組織學檢查；小鼠后肢im 0.2 mL甲型乙型肝炎聯(lián)合疫苗，給藥1次后觀察小鼠的不良反應(yīng)情況；豚鼠后肢隔日im 0.5 mL甲型乙型肝炎聯(lián)合疫苗，連續(xù)注射3次，分別于末次致敏后第14和21 d iv給予1.0 mL甲型乙型肝炎聯(lián)合疫苗進行激發(fā)，觀察豚鼠30 min內(nèi)是否出現(xiàn)過敏反應(yīng)。結(jié)果 甲型乙型肝炎聯(lián)合疫苗可導致注射部位肌肉局灶性炎細胞浸潤，停藥21 d后肌肉組織無異常；在本實驗條件中，未見對小鼠有明顯的毒性反應(yīng)；豚鼠全身主動過敏反應(yīng)陰性。結(jié)論 甲型乙型肝炎聯(lián)合疫苗無全身主動過敏性反應(yīng)且毒性較低，對肌肉有輕度的刺激反應(yīng)，但其刺激作用可恢復。

Objective To evaluate whether hepatitis A and hepatitis B combined vaccine (HABV) has muscular stimulation, acute toxicity, and anaphylaxis. Methods Rabbits were im administrated with HABV (0.5 mL, once daily continuously for 2 d), and macrography and pathological examination of injection site were conducted on the days 2 and 21 d after the last administration. Mice were im administrated once with HABV (0.2 mL) and observed continuously for 14 d for acute toxical symptoms. Guinea pigs were im administrated with HABV (0.5 mL) every other day for three times successively, and on the Days 14 and 21 after the last sensitization, HABV (1.0 mL) was iv administrated to observe whether the allergic reaction appeared within 30 min. Results It showed that HABV could induce the focal inflammatory cell infiltration and histopathologic changes disappear at day 21 after stopping administration. No evidence of acute toxicity in mice and allergic reaction on guinea pig in vivo was observed. Conclusion There is gentle stimulation on quadriceps femoris in rabbits, no sensitization on guinea pig in vivo, the low toxicity treated with HABV. There is muscular stimulation, which is reversible.