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西咪替丁与胃癌:上市后监测研究的初步报告

Cimetidine and gastric cancer: preliminary report from post-marketing surveillance study.

作者信息

Colin-Jones D G, Langman M J, Lawson D H, Vessey M P

出版信息

Br Med J (Clin Res Ed). 1982 Nov 6;285(6351):1311-3. doi: 10.1136/bmj.285.6351.1311.

DOI:10.1136/bmj.285.6351.1311
PMID:6812688
Abstract

Widespread publicity has been given to te possibility that cimetidine treatment might cause gastric cancer. Preliminary data are given from a post-marketing surveillance study in four centres. A total of 9940 patients taking the drug entered study and 9504 were observed for at least a year. Seventy-four cases of gastric cancer were identified in those taking cimetidine, but 23 of these were diagnosed before the use of the drug and 29 others with advanced malignancy had received cimetidine within the previous six months only. Ten of the remaining 22 had gastric cancer diagnosed within a year of starting treatment, and 12 after more than a year; only four of the total group had histologically "early" cancer. The occurrence of gastric cancer a long time after starting cimetidine treatment cannot be explained in every case, but it is noteworthy that in control group (which is not directly comparable) gastric cancer was observed in eight patients. The hypothesis that cimetidine treatment predisposes to gastric cancer cannot be excluded by our findings: in our view, however, they do not support such an association.

摘要

西咪替丁治疗可能导致胃癌这一可能性已得到广泛宣传。文中给出了来自四个中心的上市后监测研究的初步数据。共有9940名服用该药物的患者进入研究,其中9504人被观察了至少一年。在服用西咪替丁的患者中确诊了74例胃癌,但其中23例在使用该药物之前就已被诊断,另外29例患有晚期恶性肿瘤的患者仅在之前六个月内服用过西咪替丁。其余22例中,有10例在开始治疗后一年内被诊断为胃癌,12例在一年多之后被诊断;在整个组中只有4例组织学上为“早期”癌症。开始使用西咪替丁治疗很长时间后发生胃癌的情况并非在每种情况下都能解释,但值得注意的是,在对照组(并非直接可比)中有8名患者被观察到患有胃癌。我们的研究结果不能排除西咪替丁治疗易引发胃癌这一假说:然而,在我们看来,这些结果并不支持这种关联。

相似文献

1
Cimetidine and gastric cancer: preliminary report from post-marketing surveillance study.西咪替丁与胃癌:上市后监测研究的初步报告
Br Med J (Clin Res Ed). 1982 Nov 6;285(6351):1311-3. doi: 10.1136/bmj.285.6351.1311.
2
Gastric cancer and cimetidine.胃癌与西咪替丁
J R Coll Surg Edinb. 1981 Jan;26(1):34-5.
3
Post-cimetidine surveillance for up to ten years: incidence of carcinoma of the stomach and oesophagus.西咪替丁使用后长达十年的监测:胃癌和食管癌的发病率
Q J Med. 1991 Jan;78(285):13-9.
4
Does cimetidine cause gastric cancer?西咪替丁会引发胃癌吗?
Br Med J (Clin Res Ed). 1981 May 9;282(6275):1545. doi: 10.1136/bmj.282.6275.1545-a.
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Does cimetidine cause gastric cancer?西咪替丁会引发胃癌吗?
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Cimetidine and gastric cancer.西咪替丁与胃癌
Lancet. 1979 May 12;1(8124):1005-6. doi: 10.1016/s0140-6736(79)92757-0.
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Cimetidine and gastric cancer.西咪替丁与胃癌
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Cimetidine and gastric cancer.西咪替丁与胃癌
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Gastric cancer in patients who have taken cimetidine.服用西咪替丁患者的胃癌
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引用本文的文献

1
European postmarketing surveillance of ramipril in hypertension. 1. Feasibility and study cohort.
Eur J Clin Pharmacol. 1995;49(1-2):73-9. doi: 10.1007/BF00192362.
2
Habit, prejudice, power and politics: issues in the conversion of H2-receptor antagonists to over-the-counter use.习惯、偏见、权力与政治:H2受体拮抗剂转为非处方药使用中的问题。
CMAJ. 1996 Jan 1;154(1):49-53.
3
Peptic ulcer, cimetidine, and motor neurone disease--a record linkage study.消化性溃疡、西咪替丁与运动神经元病——一项记录链接研究。

本文引用的文献

1
Early carcinoma of the stomach. A ten-year survey.早期胃癌。一项十年调查。
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Early gastric cancer.早期胃癌
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Effect of cimetidine on gastric juice N-nitrosamine concentration.西咪替丁对胃液中N-亚硝胺浓度的影响。
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Safety of acid-suppressing drugs.抑酸药物的安全性。
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Assessing the safety of drugs for the long-term treatment of peptic ulcers.评估用于消化性溃疡长期治疗的药物安全性。
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Postmarketing surveillance of the safety of cimetidine: mortality during second, third, and fourth years of follow up.西咪替丁安全性的上市后监测:随访第二、三、四年期间的死亡率
Br Med J (Clin Res Ed). 1985 Oct 19;291(6502):1084-8. doi: 10.1136/bmj.291.6502.1084.
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Gastric microflora.胃微生物群
Br Med J (Clin Res Ed). 1985 Aug 10;291(6492):367-8. doi: 10.1136/bmj.291.6492.367.
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The refractory ulcer.难治性溃疡。
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Post-marketing surveillance in the UK (1984).英国的上市后监测(1984年)。
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Cimetidine is unlikely to increase formation of intragastric N-nitroso-compounds in patients taking a normal diet.西咪替丁不太可能在正常饮食的患者中增加胃内N-亚硝基化合物的形成。
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Gastric carcinoma and previous peptic ulceration.胃癌与既往消化性溃疡
Br J Surg. 1979 Feb;66(2):117-9. doi: 10.1002/bjs.1800660211.
6
Cimetidine and gastric cancer.西咪替丁与胃癌
Lancet. 1979 May 12;1(8124):1005-6. doi: 10.1016/s0140-6736(79)92757-0.