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重组甲状旁腺激素对恶性肿瘤和死亡率的影响:基于丹麦全国登记系统的7年经验

The impact of recombinant parathyroid hormone on malignancies and mortality: 7 years of experience based on nationwide Danish registers.

作者信息

Bang U C, Hyldstrup L, Jensen J E B

机构信息

Department of Endocrinology, University Hospital of Hvidovre, Kettegård Allé 30, 2650, Hvidovre, Denmark,

出版信息

Osteoporos Int. 2014 Feb;25(2):639-44. doi: 10.1007/s00198-013-2470-y. Epub 2013 Aug 14.

DOI:10.1007/s00198-013-2470-y
PMID:23943162
Abstract

UNLABELLED

We used Danish registers to identify patients with osteoporosis, who had been treated with parathyroid hormone and evaluated the probability of developing cancer. We did not find an increased risk of cancer among the patients treated with parathyroid hormone.

INTRODUCTION

We evaluated the incidences of malignancies and mortality in osteoporotic patients treated with rPTH.

METHODS

Using Danish nationwide registers, we identified patients diagnosed with osteoporosis in the period 1995 through 2010. Each patient treated with rPTH ("case") was compared with 10 gender- and age-matched patients who did also have osteoporosis but did not receive rPTH ("control").

RESULTS

A total of 4,104 cases (80.3 % females) were identified. The mean age at the beginning of rPTH treatment was 70.9 (SD 9.7) years. During a follow-up time of 10,118 person-years for the cases and 88,005 person-years for the controls, a total of 255 cases (6.2 %) compared with 2,103 controls (5.1 %) experienced a cancer (Chi square, p = 0.003). We found an adjusted cancer related HR of 1.1 (95 %CI 0.9-1.4) among the cases. Lung cancer was the only cancer type with a significantly increased rate among patients receiving rPTH (HR 1.7; 95 % CI 1.3-2.3). No cases developed osteosarcomas and nine controls developed osteosarcoma. During follow-up, 627 (15.3 %) cases died and 4,175 (10.2 %) controls died, which yielded an excess mortality risk of 26 % (95 % CI 16-37 %). This could be due to differences in the prevalence of vertebral fractures between the rPTH-treated and non-treated patients.

CONCLUSION

This study did not support the hypothesis describing a possible link between rPTH treatment and the development of cancer. We also conclude that osteosarcoma has not been diagnosed in any Danish patient receiving rPTH since the year 2003 when it was introduced on the market.

摘要

未标注

我们利用丹麦的登记资料来识别接受甲状旁腺激素治疗的骨质疏松症患者,并评估其患癌概率。我们未发现接受甲状旁腺激素治疗的患者患癌风险增加。

引言

我们评估了接受重组甲状旁腺激素(rPTH)治疗的骨质疏松症患者的恶性肿瘤发病率和死亡率。

方法

利用丹麦全国性登记资料,我们识别出1995年至2010年期间被诊断为骨质疏松症的患者。每例接受rPTH治疗的患者(“病例”)与10例性别和年龄匹配、同样患有骨质疏松症但未接受rPTH治疗的患者(“对照”)进行比较。

结果

共识别出4104例病例(80.3%为女性)。rPTH治疗开始时的平均年龄为70.9(标准差9.7)岁。病例组随访时间为10118人年,对照组为88005人年,共有255例病例(6.2%)与2103例对照(5.1%)患癌(卡方检验,p = 0.003)。我们发现病例组经调整后的癌症相关风险比(HR)为1.1(95%置信区间0.9 - 1.4)。肺癌是接受rPTH治疗的患者中唯一发病率显著增加的癌症类型(HR 1.7;95%置信区间1.3 - 2.3)。没有病例发生骨肉瘤,9例对照发生骨肉瘤。随访期间,627例(15.3%)病例死亡,4175例(10.2%)对照死亡,这导致额外死亡风险为26%(95%置信区间16 - 37%)。这可能是由于接受rPTH治疗和未治疗患者之间椎体骨折患病率的差异。

结论

本研究不支持描述rPTH治疗与癌症发生之间可能存在联系的假设。我们还得出结论,自2003年rPTH上市以来,丹麦没有任何接受rPTH治疗的患者被诊断出骨肉瘤。

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