抗乙肝胎盘转移因子治疗慢性乙型肝炎的临床研究

Study on the treatment of chronic hepatitis B in patients with anti-hepatitis B placents trandfer factor

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 evaluate the therapeutic efficacy and side effecs of antihepatitis B placenta transfer factor(PSTF). Methods 346 cases of chronic hepatitis B patients were divided at random into three groups, PSTF group, placenta transfer factor group and zhulinduotang plus hepatitis B vaccine group, by double blind multicentres study. Results The improvement of subjective symptoms and recovery of liver function tests of the first group were much better than the second and the third group. And the sero-conversion of HBsAg, HBeAg and HBVDNA of the first group were 4.3%,53.0% and 53.3%m respectively, and those in the second and third group. No side-effect was observed during the treatment and during follow-up. Hence, PSTF can be considered as an effective immuno-regulator for chronic hepatitis B.