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Abstract：
UNASSIGNED: The risk of serious clinical outcomes following cessation of nucleos(t)ide analogues (NUCs) in individuals with chronic hepatitis B remains poorly characterized. This systematic review and meta-analysis aimed to evaluate current literature on this issue.
UNASSIGNED: We searched PubMed, Embase, and Web of Science for NUC stop studies that noted clinical outcomes published between January 1, 2006 and August 18, 2022. We performed meta-research analyses to examine the relationships of reported outcomes with study designs and characteristics and also pooled studies with non-overlapping populations to provide risk estimates for the proportions of (1) severe hepatitis flares or hepatic decompensation or (2) hepatitis flare-related death or liver transplantation.
UNASSIGNED: The meta-research analysis included 50 studies of highly heterogeneous designs and characteristics. We found that reporting of safety outcomes varied widely according to outcome definition, follow-up duration, and sample size. Only ten studies prespecified safety events as the study outcome, and only four had an outcome definition to include hepatic insufficiency, a follow-up duration >12 months, and a sample size >100 patients. We further pooled 15 studies with 4,525 individuals and estimated that severe hepatitis flares or decompensation would occur in 1.21% (95% CI 0.70-2.08%), with significant heterogeneity (I 2 = 54%, p <0.01), while hepatitis flare-related death or liver transplantation would occur in 0.37% (95% CI 0.20-0.67%), without significant heterogeneity (I 2 = 0.00%, p = 1.00).
UNASSIGNED: Current literature on the risk of serious clinical outcomes following NUC cessation is very limited and highly heterogeneous. Pooled analyses of available data found approximately 1% of patients who stopped NUCs developed severe flares or hepatic decompensation.
UNASSIGNED: Current literature regarding the safety concerns surrounding NUC cessation for individuals with chronic hepatitis B is limited and heterogeneous in designs and characteristics, and thus should be interpreted with great caution. Based on currently available data, the proportion of patients that develop severe hepatitis flares or hepatic decompensation was estimated at 1.21% and that of flare-related death or liver transplantation at 0.37%. Our findings are important for individuals receiving nucleos(t)ide analogues for hepatitis B virus infection because we not only pooled currently available data to estimate the risk of serious clinical adverse events following treatment cessation but also uncovered critical limitations of existing literature regarding the safety of finite therapy.
UNASSIGNED: We searched PubMed, Embase, and Web of Science for NUC stop studies that noted clinical outcomes published between January 1, 2006 and August 18, 2022. We performed meta-research analyses to examine the relationships of reported outcomes with study designs and characteristics and also pooled studies with non-overlapping populations to provide risk estimates for the proportions of (1) severe hepatitis flares or hepatic decompensation or (2) hepatitis flare-related death or liver transplantation.
UNASSIGNED: The meta-research analysis included 50 studies of highly heterogeneous designs and characteristics. We found that reporting of safety outcomes varied widely according to outcome definition, follow-up duration, and sample size. Only ten studies prespecified safety events as the study outcome, and only four had an outcome definition to include hepatic insufficiency, a follow-up duration >12 months, and a sample size >100 patients. We further pooled 15 studies with 4,525 individuals and estimated that severe hepatitis flares or decompensation would occur in 1.21% (95% CI 0.70-2.08%), with significant heterogeneity (I 2 = 54%, p <0.01), while hepatitis flare-related death or liver transplantation would occur in 0.37% (95% CI 0.20-0.67%), without significant heterogeneity (I 2 = 0.00%, p = 1.00).
UNASSIGNED: Current literature on the risk of serious clinical outcomes following NUC cessation is very limited and highly heterogeneous. Pooled analyses of available data found approximately 1% of patients who stopped NUCs developed severe flares or hepatic decompensation.
UNASSIGNED: Current literature regarding the safety concerns surrounding NUC cessation for individuals with chronic hepatitis B is limited and heterogeneous in designs and characteristics, and thus should be interpreted with great caution. Based on currently available data, the proportion of patients that develop severe hepatitis flares or hepatic decompensation was estimated at 1.21% and that of flare-related death or liver transplantation at 0.37%. Our findings are important for individuals receiving nucleos(t)ide analogues for hepatitis B virus infection because we not only pooled currently available data to estimate the risk of serious clinical adverse events following treatment cessation but also uncovered critical limitations of existing literature regarding the safety of finite therapy.
摘要：
UNASSIGNED：在慢性乙型肝炎患者中停止核苷（酸）类似物（NUCs）后严重临床结果的风险仍然不明确。本系统综述和荟萃分析旨在评估有关此问题的现有文献。
未经授权：我们搜索了PubMed，Embase,和WebofScienceforNUC停止研究，注意到2006年1月1日至2022年8月18日发表的临床结果。我们进行了荟萃研究分析，以检查报告的结果与研究设计和特征的关系，并与非重叠人群进行了汇总研究，以提供（1）严重肝炎耀斑或肝功能失代偿或（2）肝炎耀斑相关死亡或肝移植的比例的风险估计。
UNASSIGNED：荟萃研究分析包括50项高度异质性设计和特征的研究。我们发现，根据结果定义，安全性结果的报告差异很大，随访持续时间,和样本量。只有10项研究预先指定的安全事件作为研究结果，只有四个人的结局定义包括肝功能不全，随访时间>12个月，样本量>100名患者。我们进一步汇集了15项研究，包括4,525名个体，估计1.21％（95％CI0.70-2.08％）会发生严重的肝炎耀斑或失代偿。具有显著的异质性(I2=54%，p<0.01),而肝炎相关死亡或肝移植将发生在0.37％（95％CI0.20-0.67％），无明显异质性(I2=0.00%，p=1.00)。
UNASSIGNED：目前关于NUC停止后严重临床结局风险的文献非常有限且高度异质性。对现有数据的汇总分析发现，停止NUCs的患者中约有1％出现严重的耀斑或肝功能失代偿。
UNASSIGNED：目前有关NUC停止治疗慢性乙型肝炎患者的安全性问题的文献在设计和特征上是有限和异质的，因此，应该非常谨慎地解释。根据现有数据，发生严重肝炎耀斑或肝功能失代偿的患者比例估计为1.21%,耀斑相关死亡或肝移植的患者比例估计为0.37%.我们的发现对于接受核苷（t）ide类似物用于乙型肝炎病毒感染的个体非常重要，因为我们不仅汇集了当前可用的数据来估计停止治疗后严重临床不良事件的风险，而且还揭示了现有文献关于有限治疗安全性的关键限制。
未经授权：我们搜索了PubMed，Embase,和WebofScienceforNUC停止研究，注意到2006年1月1日至2022年8月18日发表的临床结果。我们进行了荟萃研究分析，以检查报告的结果与研究设计和特征的关系，并与非重叠人群进行了汇总研究，以提供（1）严重肝炎耀斑或肝功能失代偿或（2）肝炎耀斑相关死亡或肝移植的比例的风险估计。
UNASSIGNED：荟萃研究分析包括50项高度异质性设计和特征的研究。我们发现，根据结果定义，安全性结果的报告差异很大，随访持续时间,和样本量。只有10项研究预先指定的安全事件作为研究结果，只有四个人的结局定义包括肝功能不全，随访时间>12个月，样本量>100名患者。我们进一步汇集了15项研究，包括4,525名个体，估计1.21％（95％CI0.70-2.08％）会发生严重的肝炎耀斑或失代偿。具有显著的异质性(I2=54%，p<0.01),而肝炎相关死亡或肝移植将发生在0.37％（95％CI0.20-0.67％），无明显异质性(I2=0.00%，p=1.00)。
UNASSIGNED：目前关于NUC停止后严重临床结局风险的文献非常有限且高度异质性。对现有数据的汇总分析发现，停止NUCs的患者中约有1％出现严重的耀斑或肝功能失代偿。
UNASSIGNED：目前有关NUC停止治疗慢性乙型肝炎患者的安全性问题的文献在设计和特征上是有限和异质的，因此，应该非常谨慎地解释。根据现有数据，发生严重肝炎耀斑或肝功能失代偿的患者比例估计为1.21%,耀斑相关死亡或肝移植的患者比例估计为0.37%.我们的发现对于接受核苷（t）ide类似物用于乙型肝炎病毒感染的个体非常重要，因为我们不仅汇集了当前可用的数据来估计停止治疗后严重临床不良事件的风险，而且还揭示了现有文献关于有限治疗安全性的关键限制。
