开发一种评分系统，以预测亚洲慢性乙型肝炎抗病毒治疗患者的肝细胞癌。
Development of a scoring system to predict hepatocellular carcinoma in Asians on antivirals for chronic hepatitis B.
机构信息
Big Data Research Center, School of Medicine, Fu-Jen Catholic University, New Taipei, Taiwan; Division of Gastroenterology, Fu-Jen Catholic University Hospital, New Taipei, Taiwan; Division of Gastroenterology and Hepatology, E-Da Hospital, Kaohsiung, Taiwan; Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.
Institute of Digestive Disease, Chinese University of Hong Kong, Hong Kong; Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong; State Key Laboratory of Digestive Disease, Chinese University of Hong Kong, Hong Kong.
出版信息
J Hepatol. 2018 Aug;69(2):278-285. doi: 10.1016/j.jhep.2018.02.032. Epub 2018 Mar 16.
BACKGROUND & AIMS: The risk of hepatocellular carcinoma (HCC) during antiviral therapy in patients with chronic hepatitis B (CHB) is inadequately predicted by the scores built from untreated patients. We aimed at developing and validating a risk score to predict HCC in patients with CHB on entecavir or tenofovir treatment.
METHODS
This study analysed population-wide data from the healthcare databases in Taiwan and Hong Kong to identify patients with CHB continuously receiving entecavir or tenofovir. The development cohort included 23,851 patients from Taiwan; 596 (2.50%) of them developed HCC with a three-year cumulative incidence of 3.56% (95% CI 3.26-3.86%). The multivariable Cox proportional hazards model found that cirrhosis, age (cirrhosis and age interacted with each other), male sex, and diabetes mellitus were the risk determinants. These variables were weighted to develop the cirrhosis, age, male sex, and diabetes mellitus (CAMD) score ranging from 0 to 19 points. The score was externally validated in 19,321 patients from Hong Kong.
RESULTS
The c indices for HCC in the development cohort were 0.83 (95% CI 0.81-0.84), 0.82 (95% CI 0.81-0.84), and 0.82 (95% CI 0.80-0.83) at the first, second, and third years of therapy, respectively. In the validation cohort, the c indices were 0.74 (95% CI 0.71-0.77), 0.75 (95% CI 0.73-0.78), and 0.75 (95% CI 0.72-0.77) during the first three years, and 0.76 (95% CI 0.74-0.78) and 0.76 (95% CI 0.74-0.77) in the extrapolated fourth and fifth years, respectively. The predicted and observed probabilities of HCC were calibrated in both cohorts. A score <8 and >13 points identified patients at distinctly low and high risks.
CONCLUSIONS
The easily calculable CAMD score can predict HCC and may inform surveillance policy in patients with CHB during oral antiviral therapy.
LAY SUMMARY
This study analyses population-wide data from the healthcare systems in Taiwan and Hong Kong to develop and validate a risk score that predicts hepatocellular carcinoma during oral antiviral therapy in patients with chronic hepatitis B. The easily calculable CAMD score requires only simple information (i.e. cirrhosis, age, male sex, and diabetes mellitus) at the baseline of treatment initiation. With a scoring range from 0 to 19 points, the CAMD score discriminates the risk of hepatocellular carcinoma with a concordance rate of around 75-80% during the first three years on therapy. The risk prediction can be extrapolated to five years on treatment with similar accuracy. Patients with a score <8 and >13 points were exposed to distinctly lower and higher risks, respectively.
背景与目的
乙型肝炎病毒（HBV）相关慢性乙型肝炎（CHB）患者接受抗病毒治疗时，发生肝细胞癌（HCC）的风险不能仅通过未治疗患者的评分来准确预测。本研究旨在开发和验证一种风险评分，用于预测恩替卡韦或替诺福韦治疗的 CHB 患者的 HCC 风险。
方法
本研究分析了来自中国台湾和中国香港医疗保健数据库的人群数据，以确定连续接受恩替卡韦或替诺福韦治疗的 CHB 患者。在开发队列中，有 23851 例患者；其中 596 例（2.50%）发生 HCC，三年累积发病率为 3.56%（95%CI 3.26-3.86%）。多变量 Cox 比例风险模型发现肝硬化、年龄（肝硬化与年龄相互作用）、男性和糖尿病是风险决定因素。这些变量的权重被用来开发肝硬化、年龄、性别和糖尿病（CAMD）评分，范围为 0 到 19 分。该评分在中国香港的 19321 例患者中进行了外部验证。
结果
在开发队列中，该评分在治疗第一年、第二年和第三年预测 HCC 的 C 指数分别为 0.83（95%CI 0.81-0.84）、0.82（95%CI 0.81-0.84）和 0.82（95%CI 0.80-0.83）。在验证队列中，第一年、第二年和第三年的 C 指数分别为 0.74（95%CI 0.71-0.77）、0.75（95%CI 0.73-0.78）和 0.75（95%CI 0.72-0.77），第四年和第五年外推的 C 指数分别为 0.76（95%CI 0.74-0.78）和 0.76（95%CI 0.74-0.77）。在两个队列中，预测概率和观察概率都得到了校准。评分<8 分和>13 分分别识别出风险低和高的患者。
结论
易于计算的 CAMD 评分可预测 HCC，并可能为接受口服抗病毒治疗的 CHB 患者的监测策略提供信息。
背景与目的
乙型肝炎病毒（HBV）相关慢性乙型肝炎（CHB）患者接受抗病毒治疗时，发生肝细胞癌（HCC）的风险不能仅通过未治疗患者的评分来准确预测。本研究旨在开发和验证一种风险评分，用于预测恩替卡韦或替诺福韦治疗的 CHB 患者的 HCC 风险。
方法
本研究分析了来自中国台湾和中国香港医疗保健数据库的人群数据，以确定连续接受恩替卡韦或替诺福韦治疗的 CHB 患者。在开发队列中，有 23851 例患者；其中 596 例（2.50%）发生 HCC，三年累积发病率为 3.56%（95%CI 3.26-3.86%）。多变量 Cox 比例风险模型发现肝硬化、年龄（肝硬化与年龄相互作用）、男性和糖尿病是风险决定因素。这些变量的权重被用来开发肝硬化、年龄、性别和糖尿病（CAMD）评分，范围为 0 到 19 分。该评分在中国香港的 19321 例患者中进行了外部验证。
结果
在开发队列中，该评分在治疗第一年、第二年和第三年预测 HCC 的 C 指数分别为 0.83（95%CI 0.81-0.84）、0.82（95%CI 0.81-0.84）和 0.82（95%CI 0.80-0.83）。在验证队列中，第一年、第二年和第三年的 C 指数分别为 0.74（95%CI 0.71-0.77）、0.75（95%CI 0.73-0.78）和 0.75（95%CI 0.72-0.77），第四年和第五年外推的 C 指数分别为 0.76（95%CI 0.74-0.78）和 0.76（95%CI 0.74-0.77）。在两个队列中，预测概率和观察概率都得到了校准。评分<8 分和>13 分分别识别出风险低和高的患者。
结论
易于计算的 CAMD 评分可预测 HCC，并可能为接受口服抗病毒治疗的 CHB 患者的监测策略提供信息。
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