Piazza M, Sagliocca L, Tosone G, Guadagnino V, Stazi M A, Orlando R, Borgia G, Rosa D, Abrignani S, Palumbo F, Manzin A, Clementi M
Istituto di Malattie Infettive, Universitá degli Studi di Napoli Federico II, Naples, Italy.
Arch Intern Med. 1997 Jul 28;157(14):1537-44.
To estimate the risk of sexual transmission of hepatitis C and to assess the value of prophylaxis with periodic intramuscular immune serum globulin administration.
Of 1102 steady heterosexual partners of patients with antibodies to the hepatitis C virus (HCV), 899 were enrolled in a single-blind, randomized, controlled trial. All the partners tested negative for antibodies to HCV and had normal baseline serum aminotransferase concentrations. The partners were assigned to receive 4 mL of 16% polyvalent immune serum globulin prepared from unscreened donors every 2 months (n = 450) or a placebo (n = 449). Tests for HCV infection were performed every 4 months.
Eight hundred eighty-four partners completed the study. Seven partners became infected with HCV: 6 in the control group (incidence density, 12.00 per 1000 person-years; 95% confidence interval, 3.0 21.61) and 1 in the immune serum globulin group (incidence density, 1.98 per 1000 person-years; 95% confidence interval, 0-5.86). The risk of infection was significantly higher for partners in the control group (P = .03): for each year approximately 1% of the partners became infected. Sequence homology studies strongly suggest the sexual transmission of HCV. All immune serum globulin lots used had high enzyme-linked immunosorbent assay titers of neutralizing antibodies to HCV envelope glycoproteins and high neutralization titers in the neutralization of binding assay.
Hepatitis C can be sexually transmitted. Immune serum globulin prepared from unscreened donors significantly reduced the risk. The treatment was safe and well tolerated. Because only immune serum globulin from unscreened donors (and not from those screened for HCV) contain anti-HCV neutralizing antibodies, hyperimmune anti-HCV immune serum globulin should be prepared from blood testing positive for antibodies to HCV, which is currently discarded.
评估丙型肝炎性传播的风险，并评估定期肌内注射免疫血清球蛋白进行预防的价值。
在1102名丙型肝炎病毒（HCV）抗体阳性患者的稳定异性伴侣中，899名参与了一项单盲、随机、对照试验。所有伴侣的HCV抗体检测均为阴性，且基线血清氨基转移酶浓度正常。将伴侣们随机分为两组，一组每2个月接受4毫升由未筛查供血者制备的16%多价免疫血清球蛋白（n = 450），另一组接受安慰剂（n = 449）。每4个月进行一次HCV感染检测。
884名伴侣完成了研究。7名伴侣感染了HCV：对照组6名（发病密度为每1000人年12.00例；95%置信区间为3.0至21.61），免疫血清球蛋白组1名（发病密度为每1000人年1.98例；95%置信区间为0至5.86）。对照组伴侣的感染风险显著更高（P = 0.03）：每年约1%的伴侣会被感染。序列同源性研究强烈提示HCV可通过性传播。所使用的所有免疫血清球蛋白批次对HCV包膜糖蛋白的酶联免疫吸附测定中和抗体滴度高，在结合测定中和试验中的中和滴度也高。
丙型肝炎可通过性传播。由未筛查供血者制备的免疫血清球蛋白可显著降低风险。该治疗安全且耐受性良好。由于只有未筛查供血者（而非筛查HCV的供血者）的免疫血清球蛋白含有抗HCV中和抗体，因此应从HCV抗体检测呈阳性的血液（目前被丢弃）中制备高效价抗HCV免疫血清球蛋白。
