启东肝癌防治研究所

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队列建立 Cohort foundation

Qidong City, namely Qidong County before 1988, located in the north shore beside the estuary of Yangtze River, has a population of approximate 1.1 million. In 1970s, A population-based retrospective survey on cancer mortality revealed that mortality rate ascribed to hepatocellular carcinoma (HCC) in Qidong were 48.37/100,000, not only getting a leading position in the rank list of all cancer mortality, but exceeding all other adjacent areas along the Yangtze river such as Haimen and Shanghai. Subsequently, further whole-population incidence survey found that the HCC incidence rate in Qidong was 85.1/100,000 in male, and 23.3/100,000 in female respectively during 1983-1987, both of which were ranked leading position across mainland China.

Thus, habitually named “Qidong high incidence scene of liver cancer” had been accepted and known to outside since then. Several etiological factors had been suggested to explain the high endemicity of HCC in Qidong, which were chronic hepatitis B virus (HBV) infection, dietary aflatoxin contamination, selenium deficiency, familial transmissibility, and drinking water polluted by blue green algal toxins. Because the associations between HCC and its risk factors were almost all obtained from the cross-sectional studies, obviously, there was an urgent need of more convinced data with superior validity to explain such breathtaking HCC occurrence, and which consequently inspired an active motivation for establishing cohort studies in Qidong. Based on this reason, the “Qidong Hepatitis B Virus Infection Prospective Study, QHBVIPS” was initiated in 1991 by Qidong liver cancer institute, Shanghai cancer institute, and Johns Hopkins University.

We planned to allocate the participants whose serum Hepatitis B virus antigen(HBsAg) were positive into HBV infected sub-cohort and those who were HBsAg negative into HBV uninfected sub-cohort. In 20 MAY 1992, the enrollment phase of this cohort was completed and follow-up procedure launched as scheduled. The study protocol and the informed consent used for this study were approved by the ethical review committees of Qidong liver cancer institute(QDLCI), Shanghai cancer institute(SCI), and Johns Hopkins University(JHU).

启东市(1989年撤县建市)位于长江入海口的北岸,常住居民约110万。上世纪70年代,一项基于全人群的癌症死亡率回顾性调查显示,启东的肝癌死亡率为48.37/10万人,不仅在本地所有肿瘤死因中排名第一,肝癌死亡率也高于长江沿岸其他地区如海门、上海。随后进行的全人群肝癌发病率研究发现,1983至1987年间,启东的男性肝癌发病率为85.1/10万人,女性肝癌发病率为23.3/10万人,在中国大陆地区位居肝癌高发排行最前列。从此,“启东肝癌高发现场”从上世纪70年代便为国内外学术界所公认。

启东肝癌呈现地区高发的危险因素(病因)包括以下几个:乙肝病毒感染、食物黄曲霉毒素污染、硒缺乏、家族遗传、饮水中蓝绿藻毒素,但启东现场最初的关于肝癌发病危险因素的结论均来自横断面研究。毫无疑问,建立前瞻性队列研究以更好的阐明肝癌病因成为了当务之急。在这样的背景下,1991年,启东肝癌防治研究所、上海市肿瘤研究所、美国霍普金斯大学三方启动“启东乙肝病毒感染者前瞻队列”的研究工作。乙肝病毒表面抗原携带者进入感染者亚队列,乙肝病毒表面抗原阴性者进入非感染者亚队列。1992年5月,该队列完成了研究对象纳入工作,队列随访随之展开。

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