Vourli G, Papatheodoridis G, Raptopoulou M, Dalekos G N, Hounta A, Nikolopoulou G, Zouboulis-Vafeiadis I, Manesis E, Kitis G, Gogos C, Ketikoglou I, Hatzis G, Vasilialdis T, Karatapanis S, Mimidis K, Drakoulis C, Touloumi G
Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece.
Department of Gastroenterology, Athens University Medical School, "Laiko" General Hospital of Athens, Athens, Greece.
Hippokratia. 2016 Jul-Sep;20(3):214-221.
Although effective treatment in terms of inducing virological and biochemical response for chronic hepatitis B (CHB) is available, its effect on the clinical course of the disease has not yet been accurately estimated. Objective of this study was to evaluate the effect of antiviral therapy and its type [interferon +/- nucleos(t)ide analogs (NAs) vs. NAs] on the occurrence of a clinical event (liver decompensation, liver transplant, hepatocellular carcinoma and death from a liver-related cause) in CHB patients.
The study population was derived from the HEPNET-Greece, a nationwide cohort study aimed to evaluate the current epidemiological course of viral hepatitis. To account for time-dependent confounding, Cox marginal structural models were used to analyze data.
Thirty out of 2,125 eligible patients experienced a clinical event during their follow-up. When comparing treated to untreated individuals, the hazard ratio (HR) for a clinical event was 0.39 (95% CI: 0.16-0.98; p =0.044) in the whole sample, whereas there were indications of a more intense effect in the subgroup of patients with cirrhosis at presentation (HR =0.16, 95% CI: 0.02-1.21; p =0.075). The effect of Interferon initiated treatment was not significantly different of that of NAs. There was some evidence, albeit not statistically significant, of a protective treatment effect on hepatocellular carcinoma development (HCC).
Data from observational studies can provide useful inference, provided they are analyzed appropriately. The current study has shown that the available treatment options for CHB offer a significant clinical benefit to CHB infected individuals. Hippokratia 2016, 20(3): 214-221.
尽管目前已有能诱导慢性乙型肝炎（CHB）患者产生病毒学和生化应答的有效治疗方法，但该治疗对疾病临床进程的影响尚未得到准确评估。本研究的目的是评估抗病毒治疗及其类型（干扰素±核苷（酸）类似物（NAs）与仅使用NAs）对CHB患者临床事件（肝失代偿、肝移植、肝细胞癌及肝脏相关原因导致的死亡）发生情况的影响。
研究人群来自希腊全国性队列研究HEPNET - Greece，该研究旨在评估当前病毒性肝炎的流行病学进程。为应对时间依赖性混杂因素，采用Cox边际结构模型分析数据。
在2125例符合条件的患者中，有30例在随访期间发生了临床事件。在整个样本中，将接受治疗的患者与未接受治疗的患者进行比较时，临床事件的风险比（HR）为0.39（95%置信区间：0.16 - 0.98；p = 0.044），而在基线时患有肝硬化的患者亚组中，有迹象表明治疗效果更强（HR = 0.16，95%置信区间：0.02 - 1.21；p = 0.075）。干扰素起始治疗的效果与核苷（酸）类似物的效果无显著差异。有一些证据表明治疗对肝细胞癌（HCC）的发生有保护作用，尽管未达到统计学显著性。
只要分析得当，观察性研究的数据可提供有用的推断。本研究表明，CHB现有的治疗方案可为CHB感染个体带来显著的临床益处。《希波克拉底》2016年，20(3): 214 - 221。
