Su Ming-Hua, Lu Ai-Lian, Li Shi-Hua, Zhong Shao-Hua, Wang Bao-Jian, Wu Xiao-Li, Mo Yan-Yan, Liang Peng, Liu Zhi-Hong, Xie Rong, He Li-Xia, Fu Wu-Dao, Jiang Jian-Ning
Ming-Hua Su, Ai-Lian Lu, Shi-Hua Li, Shao-Hua Zhong, Bao-Jian Wang, Xiao-Li Wu, Yan-Yan Mo, Peng Liang, Zhi-Hong Liu, Rong Xie, Li-Xia He, Wu-Dao Fu, Jian-Ning Jiang, Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, Guangxi Zhuang Autonomous Region, China.
World J Gastroenterol. 2015 Dec 14;21(46):13087-94. doi: 10.3748/wjg.v21.i46.13087.
To investigate clinical outcomes of chronic hepatitis B (CHB) and liver cirrhosis (LC) patients under whole-course management with lamivudine (LAM).
This was a retrospective-prospective cohort study based on two nonrandom cohorts of Chinese patients (LAM group and history control group). Two hundred thirty-eight patients with LAM treatment for at least 12 mo under whole-course management were included in the LAM group. The management measures included regular follow-up and timely adjustment of the therapeutic regimen according to drug-resistance and relapse. Two hundred thirty-eight patients with CHB or LC without any antiviral treatment and with follow-up over 12 mo were included in the history control group. The LAM and control group patients were 1:1 matched by propensity score method to ensure both patients were similar in general datum, sex, age, E antigen, and diagnosis. The incidence rates of endpoint events [LC, hepatocellular carcinoma (HCC), and death] were compared between the LAM and control groups.
Hepatitis B virus-DNA < 1000 copies per mL rate and rate of alanine transaminase < 1.3 of the upper normal limit in LAM and control groups were 89.1% vs 18.5% (P < 0.05) and 89.8% vs 31.1% (P < 0.05), respectively. Viral breakthrough occurred in 77 patients (32.4%); the one-, three-, and five-year cumulative rates were 6.8%, 33.1%, and 41.3%, respectively. In total, 44.5% (106/238) of patients had once stopped LAM, and 63 (59.4%) of them developed virologic relapse; the relapse rate of patients with and without reaching Asian Pacific Association for the Study of the Liver endpoint criteria were 52.4% and 69.8%, respectively. Six CHB patients in the LAM group developed LC compared to 47 patients in the control group; the three-, and five-year cumulative rates of CHB at baseline of LAM were lower than those of the control group: 0.7% vs 12.0% and 1.8% vs 23.8% (P < 0.01), respectively. The incidence of HCC in CHB at baseline of LAM was lower than that of the control group; the three-, and five-year cumulative rates were 0% vs 3.2% and 1.1% vs 3.2% (P = 0.05), respectively. The incidence of HCC in LC at baseline of LAM was lower than that of the control group: 9.8% (5/51) vs 25.0% (12/48), and the three-, and five-year cumulative rates were 4.5% vs 20.7% and 8.1% vs 37.5% (P < 0.01), respectively. The mortality rate in the LAM group was lower than the control group.
Standardized long-term LAM treatment in combination with comprehensive management can reduce the incidence rates of LC and HCC as well as hepatitis B virus-related deaths.
探讨拉米夫定（LAM）全程管理下慢性乙型肝炎（CHB）和肝硬化（LC）患者的临床结局。
这是一项基于两个非随机中国患者队列（LAM组和历史对照组）的回顾性-前瞻性队列研究。LAM组纳入238例接受LAM治疗至少12个月且处于全程管理下的患者。管理措施包括定期随访，并根据耐药和复发情况及时调整治疗方案。历史对照组纳入238例未接受任何抗病毒治疗且随访超过12个月的CHB或LC患者。通过倾向评分法将LAM组和对照组患者1:1匹配，以确保两组患者在一般资料、性别、年龄、E抗原和诊断方面相似。比较LAM组和对照组终点事件（LC、肝细胞癌（HCC）和死亡）的发生率。
LAM组和对照组的乙肝病毒DNA<1000拷贝/mL率分别为89.1%和18.5%（P<0.05），丙氨酸转氨酶<正常上限1.3倍率分别为89.8%和31.1%（P<0.05）。77例患者（32.4%）发生病毒突破；1年、3年和5年累积发生率分别为6.8%、33.1%和41.3%。总共有44.5%（106/238）的患者曾停用LAM，其中63例（59.4%）发生病毒学复发；达到和未达到亚太肝脏研究协会终点标准的患者复发率分别为52.4%和69.8%。LAM组6例CHB患者发展为LC，而对照组有47例；LAM组基线CHB的3年和5年累积发生率低于对照组：分别为0.7%对12.0%和1.8%对23.8%（P<0.01）。LAM组基线CHB的HCC发生率低于对照组；3年和5年累积发生率分别为0%对3.2%和1.1%对3.2%（P=0.05）。LAM组基线LC的HCC发生率低于低于对照组：9.8%（5/51）对25.0%（12/48），3年和5年累积发生率分别为4.5%对20.7%和8.1%对37.5%（P<0.01）。LAM组的死亡率低于对照组。
标准化长期LAM治疗联合综合管理可降低LC和HCC的发生率以及乙肝病毒相关死亡率。
