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目的 进行Ⅰ期和Ⅱ期临床试验，评价乙肝转移因子对健康志愿者和慢性乙肝患者的有效性和安全性。方法 Ⅰ期试验：１５名志愿者随机分成 ５组，每组 ３人，分别给予 ０．２５、０．５、１、２、４ ｍｇ ５个剂量，每日肌注一次，连续 １４天。对另外 １４名志愿者，每日肌注 ２ ｍｇ，共１４天，于注射前后进行淋巴细胞增殖试验和巨噬细胞移动抑制试验。对１８名慢性乙肝患者进行 ０，５、１、２ ｍｇ三种不同剂量的注射，共 ３个月。Ⅱ期试验：分别对 １０９例馒性乙肝患者给予 ＨＢＶ－ＴＦ１ｍｇ和安慰剂及 ３０９例慢性乙肝患者ＨＢＶ－ＴＦ１ｍｇ和２ ｍｇ随机对照治疗。结果１５位健康志愿者能够很好地耐受，无明显副反应。１４名淋巴细胞增殖试验刺激指数从治疗前０．７７±０．２１增加到治疗后１．５７±０．７９（Ｐ＜０．０１），巨噬细胞移动抑制试验抑制指数从治疗前 ０．９２６± ０．０６减少到治疗后 ０．７８４± ０．０８９ （Ｐ＜０ ０５）。剂量选择试验表明１ｍｇ和 ２ ｍｇ对血清 ＨＢｅＡｇ和ＨＢＶ－ＤＮＡ清除有效。１０９例患者中，治疗组５４例，ＨＢｅＡｇ和 ＨＢＶ－ＤＮＡ清除率分别为 ４４．４％和 ４６．９％。安慰剂组 ５５例，ＨＢｅＡｇ和ＨＢＶ－ＤＮＡ清除率分别为
Objective To carry out phase I and phase II clinical trials to evaluate the efficacy and safety of hepatitis B transfer factor in healthy volunteers and patients with chronic hepatitis B. Methods In the phase I trial, 15 volunteers were randomly divided into 5 groups with 3 patients in each group. Five doses of 0.25, 0.5, 1, 2 and 4 mg were administered intramuscularly once a day for 14 consecutive days. For another 14 volunteers, daily intramuscular injection of 2 mg for a total of 14 days, before and after injection of lymphocyte proliferation test and macrophage migration inhibition test. 18 patients with chronic hepatitis B were 0,5,1,2 mg three different doses of injection, a total of 3 months. Phase II trial: HBV-TF1mg and placebo were given to 109 patients with steatotic hepatitis B and HBV-TF1mg and 2mg patients with 309 patients with chronic hepatitis B were randomized and controlled. Results Fifteen healthy volunteers were well tolerated with no obvious side effects. The stimulation index of 14 lymphocyte proliferation test increased from 0.77 ± 0.21 before treatment to 1.57 ± 0.79 after treatment (P <0.01), and the inhibition index of macrophage migration inhibition test from 0 before treatment. 926 ± 0.06 to 0.784 ± 0.089 after treatment (P <0.05). Dose-selection tests showed that 1 mg and 2 mg were effective in clearing serum HBeAg and HBV-DNA. Of the 109 patients, the treatment group, 54 patients, HBeAg and HBV-DNA clearance rates were 44.4% and 46.9%. 55 cases in placebo group, HBeAg and HBV-DNA clearance rates were