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①目的研制人巨细胞病毒特异性转移因子(HCMV-STF),并试用于HCMV-IgM和(或)IgA阳性孕妇,观察其临床防治效果。②方法将HCMV-AD169株病毒感染人二倍体细胞,制备抗原,免疫成猪,待猪的免疫指标明显提高并稳定后,取脾及淋巴结,制备HCMV-STF,并用于治疗HCMV-IgM和(或)IgA阳性孕妇,采用间接ELISA法测血清HCMV-IgM和IgA,同时对羊水、脐血和婴儿尿做PCR检测。③结果制备的HCMV-STF符合肌肉注射用药制剂标准,同时具有明显的促进LACA小鼠脾细胞分化增殖效应。临床疗效验证表明,治疗组和对照组其血清IgM及IgA转阴率分别为74.00%和6.67%,两组比较差异有显著性(χ2=191.12,P<0.01);治疗组和对照组先天性感染率分别为8.04%和22.22%,两组比较差异有显著性(χ2=9.95,P<0.01)。④结论HCMV-STF对孕妇活动性巨细胞病毒感染及胎儿先天性感染有明显的防治作用。
Objective To develop human cytomegalovirus-specific transfer factor (HCMV-STF) and test HCMV-IgM and / or IgA-positive pregnant women to observe its clinical efficacy. Methods HCMV-AD169 virus was used to infect human diploid cells to prepare antigens, which were then immunized into pigs. After the immunological indexes of pigs were significantly improved and stabilized, the spleen and lymph nodes were taken and HCMV-STF was prepared and used to treat HCMV-IgM and (Or) IgA positive pregnant women, using indirect ELISA method to measure serum HCMV-IgM and IgA, at the same time to do amniotic fluid, cord blood and infant urine PCR test. Results The prepared HCMV-STF conformed to the standard of preparation for intramuscular injection, and obviously promoted the proliferation and differentiation of spleen cells in LACA mice. The clinical efficacy showed that the serum IgM and IgA negative rates in the treatment group and the control group were 74.00% and 6.67%, respectively, with significant difference between the two groups (χ2 = 191.12, P <0.01) The rates of congenital infection in treatment group and control group were 8.04% and 22.22%, respectively. There was significant difference between the two groups (χ2 = 9.95, P <0.01). Conclusion HCMV-STF has significant preventive and therapeutic effects on pregnant women with active cytomegalovirus infection and congenital infection of the fetus.