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目的验证抗乙肝胎盘转移因子（ＰＳＴＦ）的临床疗效和不良反应。方法以胎盘转移因子（ＰＴＦ）及猪苓多糖加乙肝疫苗为对照，进行“多中心”临床研究。采用随机分组，双盲对照治疗慢性乙型肝炎共３４６例，疗程均为 ３个月。结果 ＰＳＴＦ改善症状和体征、恢复肝功能均优于猪苓多糖加乙肝疫苗。 ＰＳＴＦ组 ＨＢｓＡｇ、 ＨＢｅＡｇ及 ＨＢＶ ＤＮＡ的阴转率分别达４．３％、 ５３．０％及 ５３．３％； ＰＴＦ组分别为０、 ２２．５％及 ２６．５％；猪苓多糖组分别为 ０、２７．６％及２７．０％，差异显著。随访结果与治疗结束时相似，未观察到ＰＳＴＦ有任何不良反应。结论ＰＳＴＦ是治疗慢性乙型肝炎、抗乙型肝炎病毒的安全有效药物。
Objective To verify the clinical efficacy and adverse reactions of anti-hepatitis B placental transfer factor (PSTF). Methods The placental transfer factor (PTF) and Polyporus umbellatus polysaccharide plus hepatitis B vaccine as a control, the “multicenter” clinical study. Randomized, double-blind control of chronic hepatitis B were 346 cases, treatment were 3 months. Results PSTF improved symptoms and signs, recovery of liver function were better than Polyporus umbellatus plus hepatitis B vaccine. In the PSTF group, the negative conversion rates of HBsAg, HBeAg and HBV DNA were 4.3%, 53.0% and 53.3%, respectively; the PTF group was 0, 22.5% and 26.5% Was 0, 27.6% and 27.0%, the difference was significant. Follow-up results Similar to the end of treatment, no adverse reactions to PSTF were observed. Conclusion PSTF is a safe and effective drug for the treatment of chronic hepatitis B and anti-hepatitis B virus.