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金属对金属髋关节置换后 7 年内的癌症风险与其他轴承和普通人群相比:英格兰和威尔士国家联合登记处与医院发病统计数据的链接研究。

Risk of cancer in first seven years after metal-on-metal hip replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics.

机构信息

Musculosketal Research Unit, School of Clinical Sciences, University of Bristol, Avon Orthopaedic Centre, Bristol BS10 5NB, UK.

出版信息

BMJ. 2012 Apr 3;344:e2383. doi: 10.1136/bmj.e2383.

Abstract

OBJECTIVE

To determine whether use of metal-on-metal bearing surfaces is associated with an increased risk of a diagnosis of cancer in the early years after total hip replacement and specifically with an increase in malignant melanoma and haematological, prostate, and renal tract cancers.

DESIGN

Linkage study with multivariable competing risks flexible parametric survival model to examine the incidence of new diagnoses of cancer in patients with metal-on-metal hip replacement compared with those with alternative bearings and to compare the observed incidence of diagnoses in patients undergoing hip replacement with that predicted by national incidence rates in the general population.

SETTING

National Joint Registry of England and Wales (NJR) linked to NHS hospital episode statistics data.

PARTICIPANTS

40,576 patients with hip replacement with metal-on-metal bearing surfaces and 248,995 with alternative bearings.

MAIN OUTCOME MEASURES

Incidence of all cancers and incidence of malignant melanoma and prostate, renal tract, and haematological cancers.

RESULTS

The incidence of new diagnoses of cancer was low after hip replacement (1.25% at one year, 95% confidence interval 1.21% to 1.30%) and lower than that predicted from the age and sex matched normal population (1.65%, 1.60% to 1.70%). Compared with alternative bearings, there was no evidence that metal-on-metal bearing surfaces were associated with an increased risk of any cancer diagnosis in the seven years after surgery (mean follow-up of three years, 23% (n=67,361) of patients observed for five years or more). Similarly, there was no increase in the risk of malignant melanoma or haematological, prostate, and renal tract cancers. The adjusted five year incidence of all cancers for men aged 60 was 4.8% (4.4% to 5.3%) with resurfacing, 6.2% (5.7% to 6.7%) with stemmed metal-on-metal, and 6.7% (6.5% to 7.0%) for other bearing surfaces. Equivalent rates for women aged 60 were lower: 3.1% (2.8% to 3.4%) with resurfacing, 4.0% (3.7% to 4.3%) with stemmed metal-on-metal, and 4.4% (4.2% to 4.5%) with other bearings.

CONCLUSIONS

These data are reassuring, but the findings are observational with short follow-up. The use of hospital episode statistics data might underestimate cancer diagnoses, and there is the possibility of confounding by indication. Furthermore, as some cancers have a long latency period it is important that we study the longer term outcomes and continue to investigate the effects of exposure to orthopaedic metals.

摘要

目的

确定金属对金属关节表面的使用是否会增加全髋关节置换术后早期癌症诊断的风险,特别是增加恶性黑色素瘤以及血液、前列腺和肾脏癌症的风险。

设计

通过多变量竞争风险灵活参数生存模型进行的关联研究,以检查使用金属对金属髋关节置换的患者与使用其他髋关节置换的患者相比,新诊断癌症的发生率,并比较接受髋关节置换的患者的实际诊断发生率与一般人群的全国发病率预测值。

环境

英格兰和威尔士国家联合登记处(NJR)与国民保健制度(NHS)医院发病统计数据链接。

参与者

40576 例使用金属对金属关节表面的髋关节置换患者和 248995 例使用其他髋关节的患者。

主要观察指标

所有癌症的发生率和恶性黑色素瘤以及前列腺、肾脏和血液癌症的发生率。

结果

髋关节置换后新发癌症的发生率较低(一年时为 1.25%,95%置信区间为 1.21%至 1.30%),低于年龄和性别匹配的正常人群的预测值(1.65%,1.60%至 1.70%)。与其他髋关节相比,在手术后 7 年内,金属对金属关节表面与任何癌症诊断风险增加均无证据相关(平均随访 3 年,5 年或更长时间观察到 23%(n=67361)的患者)。同样,恶性黑色素瘤或血液、前列腺和肾脏癌症的风险也没有增加。60 岁男性使用表面关节置换的 5 年累计癌症发生率为 4.8%(4.4%至 5.3%),使用带柄金属对金属关节置换的为 6.2%(5.7%至 6.7%),其他关节表面的为 6.7%(6.5%至 7.0%)。60 岁女性的相应比率较低:表面关节置换为 3.1%(2.8%至 3.4%),带柄金属对金属关节置换为 4.0%(3.7%至 4.3%),其他关节为 4.4%(4.2%至 4.5%)。

结论

这些数据令人安心,但发现是基于短期随访的观察性研究。使用医院发病统计数据可能会低估癌症的诊断,并且存在混杂因素的可能性。此外,由于某些癌症潜伏期较长,因此我们研究长期结果并继续研究骨科金属的影响非常重要。

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