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Preliminary Clinical Study of Anti-HBV-DC Combine Lamivudine and Thymosin-A1 Treating the Chronic Hepatitis B Virus Carriers
发布时间: 2010-04-02    人气指数:2181

The 20th Conference of the Asian Pacific Association for the Study of the Liver
Poster Presentation(PP237)

2010亚肝会海报PP237  

Hepatology International.2010, 4(1):159

Bang-Fu Wu1,2, Jiang-Ying Yang2, Fang-Qin Li1, Wen-Bao Zhu1, Yun Zhou2, Fu-Xin Lin1, Yan-Ping Fu1, Jun Yang2, Chun-Qiong Hou1, Hui-Hua Zhou1, Wei Zheng1, Wei Chen1, Xue-Song Li1
1Gastroenterology and Hepatology Center, Tongji Medical College Affiliated Dongguan Hospital, Huazhong University of Science and Technology, Liaobu Southwest Road, No. 171-175, Dongguan, China

 2 Guangzhou Pubang Biological Immune Technology Research Center, Room 904, D District, Guangzhou International Business Incubator, Guangzhou Science City, Luogang District, Guangzhou, China

        Background:  To observe the clinical treatment effects of the HBsAg pulsed autologous dendritic cells (anti-HBV-DC) derived from peripheral blood mononuclear cells (PBMC) combine lamivudine and Thymosin-a1 for the chronic HBV carriers.
        Methods:  Thirteen HBeAg positive and two HBeAg negative chronic HBV carriers included in the study. Taking peripheral venous blood 50 ml and obtain PBMC, GM-CSF and IL-4 induced expansion of DC. At the sixth days, a 30 μg HBsAg was give to pulse the DCs. At the seventh days, the anti-HBVDCs were harvested and were injected into body by subcutaneous and intravenous. Every 2 weeks one time, a total of six times. 100 mg Lamivudine every day, and 1.6 mg thymosin-a1 every one week 2 times.
        Results:  The serum HBsAg, HBeAg and HBVDNA were significantly decreased at 4, 12 weeks. One patient’s HBcAb was from negative converted to positive after treatment. One patient’s HBsAb turn positive at 4 weeks. The HBeAg/HBeAb seroconversion occurred in one patient at 4 weeks, the conversion rate was 7.69% (1/13). The HBeAg/HBeAb seroconversion occurred in another patient at 12 weeks. The total HBeAg/HBeAb seroconversion rate was 15.39% (2/13). The serum HBVDNA negative conversion occurred in four patients at 4 weeks, the negative conversion rate was 26.67% (4/15). Theserum HBVDNA negative conversion occurred in other four patients at 12 weeks. The total serum HBVDNA negative conversion rate was 53.33% (8/15). Three patient’s ALT increased to 1–2 times normal value at 4 weeks, but returned to normal in two patients at 12 weeks. Another case’s ALT have a mild increase at 12 weeks.
        Conclusions:  The anti-HBV-DC combine lamivudine and Thymosin-a1 can effectively inhibit HBVDNA replication, decrease rapidly the serum HBsAg, HBeAg and HBVDNA levels, and enhance the HBeAg/HBeAb seroconversion rate, which were a safe and effective treatment method for the chronic HBV carriers.

 

HBV-DC联合拉米夫定和胸腺肽a1治疗慢性HBV携带者的初步临床研究

第20届亚太肝脏研究会年会(北京)

海报展示(PP237) 

Hepatology International.2010, 4(1):159

华中科技大学同济医学院附属东莞医院消化肝病中心  吴邦富 李芳琴 凌佛鑫 朱文宝 付彦平 李雪松 侯春琼 郑硕 陈伟 周慧华

广州普邦生物免疫技术研究院  杨江英 周赟 杨军

    目的 观察HBsAg致敏自体外周血单个核细胞(PBMC)来源的树突状细胞(HBV-DC)联合拉米夫定和胸腺肽a1治疗慢性HBV携带者的临床效果。

    方法 HBeAg阳性慢性HBV携带者13人和HBeAg阴性慢性HBV携带者2人接受临床研究。取肝素抗凝外周静脉血50ml,以密度梯度离心及贴壁法获得PBMCGM-CSFIL-4诱导扩增DC,第6天给予30μgHBsAg致敏DC,第7天收获抗HBV-DC,皮下和静脉各注射1/2。每21次,共6次。口服拉米夫定每次100mg,每天1次。皮下注射1.6mg胸腺肽a1,每周2次。分别于0412周检测HBVM定量(时间分辨荧光免疫分析技术,TRFIA)HBV-DNA定量及肝功能。

    结果 0412周的HBsAg分别为(467.90±364.41)ng/ml(241.94±267.25)ng/ml(t=2.73P=0.016)(183.88±108.66)ng/ml(t=2.90P=0.012)HBeAg(90.76±104.81)PEIU/ml(36.17±74.25) PEIU/ml(t=3.94P=0.002)(44.64±85.84)PEIU/ml(t=2.86P=0.014)HBV-DNA(17.96±27.25)×106copy/ml(0.94±2.67)×106copy/ml(t=2.45P=0.028)(0.27±0.87)×106copy/ml(t=2.50P=0.026)治疗后412HBsAgHBeAgHBV-DNA显著下降。1例治疗前为HBsAgHBeAg阳性,治疗后HBV-DNA显著下降,HBcAb转阳性。14周时HBsAb转阳性,未出现HBsAg/HBsAb的血清转换。14周时出现HBeAg/HBeAb血清转换,转换率7.69%(1/13),另112周时出现HBeAg/HBeAb血清转换,总转换率15.39%(2/13)44周时HBV-DNA转阴,转阴率26.67%(4/15),另412周时HBV-DNA转阴,总HBV-DNA转阴率53.33%(8/15)治疗前ALT均正常,治疗后34周时ALT升高1-2倍,其中212周时恢复正常,另112周时ALT轻度升高。

    结论 HBV-DC联合拉米夫定和胸腺肽a1治疗,可有效地抑制慢性HBV携带者的HBV-DNA复制,快速降低血中HBsAgHBeAgHBV-DNA,促进HBeAb的产生,提高HBeAg/HBeAb的血清学转换率,是一种安全、有效的治疗慢性HBV携带者的方法。