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富马酸替诺福韦二吡呋酯与替诺福韦艾拉酚胺治疗慢性乙型肝炎患者骨质疏松性骨折风险的比较:韩国全国性索赔研究。

Tenofovir disoproxil fumarate versus tenofovir alafenamide on risk of osteoporotic fracture in patients with chronic hepatitis B: A nationwide claims study in South Korea.

机构信息

Department of Gastroenterology, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea.

Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

出版信息

Aliment Pharmacol Ther. 2023 Dec;58(11-12):1185-1193. doi: 10.1111/apt.17716. Epub 2023 Sep 11.

Abstract

BACKGROUND

As tenofovir disoproxil fumarate (TDF) requires long-term use, a reduction in bone density should be considered a possibility when treating patients with chronic hepatitis B (CHB) with aging and systemic diseases. Patients treated with tenofovir alafenamide (TAF) have improved bone mineral density loss compared to patients treated with TDF. Although improvements in bone density caused by TAF have been reported, studies on the actual reduction of fractures are insufficient.

AIM

To evaluate the impact of TAF on the risk of osteoporotic fractures in comparison with that of TDF.

METHODS

Using the national claims data of the Health Insurance Review and Assessment Service, we conducted a retrospective cohort study of 32,582 patients with CHB who had been initially treated with TDF or TAF between November 2017 and December 2020. The numbers of patients treated with TDF and TAF were 20,877 and 11,705, respectively. The annual fracture rate per 100 patients in each group was calculated, and the Cox proportional hazard ratio (HR) was analysed after applying inverse probability treatment weights (IPTW) for both groups.

RESULTS

Among 32,582 patients, the average age was 47.8 ± 11.2 years, 64.5% were men, and the follow-up period was 24.4 ± 11.6 months. The incidence of osteoporotic fractures was 0.78 and 0.49 per 100 person-years in the TDF and TAF groups, respectively. After application of IPTW, the HR was 0.68 (95% confidence interval 0.55-0.85, p = 0.001).

CONCLUSION

TAF-treated patients with CHB had a significantly lower risk of osteoporotic fracture than TDF-treated patients.

摘要

背景

由于替诺福韦二吡呋酯富马酸(TDF)需要长期使用,因此在治疗慢性乙型肝炎(CHB)患者时,随着年龄的增长和全身疾病的出现,应考虑降低骨密度的可能性。与接受替诺福韦艾拉酚胺(TAF)治疗的患者相比,接受 TDF 治疗的患者的骨矿物质密度损失得到了改善。虽然已经报道了 TAF 引起的骨密度改善,但关于骨折实际减少的研究还不够充分。

目的

评估 TAF 对骨质疏松性骨折风险的影响,并与 TDF 进行比较。

方法

利用健康保险审查与评估服务的全国索赔数据,我们对 2017 年 11 月至 2020 年 12 月间初次接受 TDF 或 TAF 治疗的 32582 例 CHB 患者进行了回顾性队列研究。TDF 和 TAF 组患者的数量分别为 20877 例和 11705 例。计算了每组每 100 例患者的年骨折发生率,并对两组患者进行了逆概率治疗权重(IPTW)分析后计算了 Cox 比例风险比(HR)。

结果

在 32582 例患者中,平均年龄为 47.8±11.2 岁,64.5%为男性,随访时间为 24.4±11.6 个月。TDF 和 TAF 组的骨质疏松性骨折发生率分别为 0.78 和 0.49/100 人年。经过 IPTW 校正后,HR 为 0.68(95%置信区间 0.55-0.85,p=0.001)。

结论

与 TDF 治疗的 CHB 患者相比,TAF 治疗的患者发生骨质疏松性骨折的风险显著降低。

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