文章摘要
聚乙二醇干扰素α-2b或联合阿德福韦酯治疗慢性乙型肝炎患者的外周血象变化
Clinical study of changes in peripheral blood cells of chronic hepatitis B patients treated with pegylated interferon alpha-2b or combined with adefovirdipivoxil
投稿时间:2017-02-17  
DOI:10.3969/j.issn.1000-0399.2017.09.007
中文关键词: 干扰素-α  阿德福韦酯  药物不良反应  慢性乙型肝炎
英文关键词: Interferon-alpha  Adefovirdipivoxil  Adverse drug reactions  Chronic hepatitis B
基金项目:安徽省卫生厅医学科研重点项目(项目编号:2010A010)
作者单位E-mail
苏倩 230022 合肥 安徽医科大学第一附属医院感染病科  
刘艳艳 230022 合肥 安徽医科大学第一附属医院感染病科  
李家斌 230022 合肥 安徽医科大学第一附属医院感染病科 lijiabin948@163.com 
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中文摘要:
      目的 观察聚乙二醇干扰素α-2b或联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎(CHB)患者的外周血象变化。方法 收集2012年6月至2013年9月安徽医科大学第一附属医院、安徽医科大学附属巢湖医院、安徽中医药大学第一附属医院、阜阳市第二人民医院、皖南医学院附属弋矶山医院等10家医院就诊的HBeAg阳性的CHB患者102例,签署知情同意书,随机分为单药组(51例)和联合组(51例),治疗48周,停药后再随访24周。通过检测受试者基线(0周)、4周、8周、12周、24周、36周、48周、60周、72周的外周血象变化,观察2种治疗方案对外周血象的影响。结果 治疗48周时,联合组患者的HBV DNA转阴率(76.60%)、ALT复常率(70.21%)高于单药组,差异有统计学意义(P<0.05)。不同时间点间白细胞(WBC)、中性粒细胞(N)、淋巴细胞(L)、红细胞(RBC)、血红蛋白(Hb)、血小板(PLT)变化不同,差异有统计学意义(P<0.05);Hb、PLT与组别之间有交互作用,差异有统计学意义(P<0.05)。单药组对N的影响较联合组更大,差异有统计学意义(P<0.05)。两组患者治疗期间WBC、N、L、PLT均有不同程度的下降,在第0~4周下降最明显,治疗期间趋于稳定,停药后很快恢复正常。结论 联合治疗有一定优势,患者治疗期间外周血WBC、N、L、RBC都具有类似的下降趋势,但联合治疗对Hb、PLT有影响,呈可逆性,停药后很快恢复,治疗期间应严密监测。
英文摘要:
      Objective To explore the changes of peripheral blood cells in HBeAg positive chronic hepatitis B (CHB) patients treated with pegylated interferon alpha-2b or combined with adefovirdipivoxil (ADV) via a randomized, open-label and multicenter clinical study. Methods Between June 2012 and September 2013, 102 HBeAg positive CHB cases from 10 hospitals of Anhui province, such as the First Affiliated Hospital of Anhui Medical University, Affiliated Chaohu Hospital of Anhui Medical University, the First Affiliated Hospital of Anhui University of Chinese Medicine, the Second People's Hospital of Fuyang City, Affiliated Yijishan Hospital of Wangnan Medical College and so on, were recruited and randomly divided into pegylated interferon alpha-2b monotherapy group and pegylated interferon alpha-2b combined with ADV therapy group. All patients provided written informed consent before enrolling in the study. The study consisted of 48 weeks of treatment and a 24-week follow-up period after end-of-treatment. The changes in peripheral bloodcells at baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks and 72 weeks of each group were inspected to compare the effects of two treatment regimens. Results At the 48 weeks of treatment, the negative conversion rate of HBV DNA (76.60%) and the ALT recurrence rate (70.21%) in the combination group were significantly higher than those in the monotherapy group, and the difference was statistically significant (P<0.05). White blood cells (WBC), neutrophils (N), lymphocyte (L), red blood cells (RBC), hemoglobin (Hb) and platelet (PLT) levels were different at different time points, and the difference was statistically significant (P<0.05). There were interactions between Hb levels, PLT levels and groups, and the difference was statistically significant (P<0.05). The influence of the monotherapy group on neutrophils was greater than that of the combination group, and the difference was statistically significant (P<0.05). WBC, N, L and PLT levels of each group were reduced in varying degrees, especially at the first 0~4 weeks, then turned to be stable during the treatment and returned to normal after end-of-treatment. Conclusion Combination therapy has some advantages. There are similar down regulations of peripheral blood cells, including WBC, N, L and RBC, in patients between two groups during the therapy. However, combination therapy has reversible impacts on Hb and PLT levels which recover quickly after end-of-treatment, indicating the necessity of close monitoring during therapy.
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