雙磷酸鹽類藥物使用對骨鬆骨折病人死亡率的影響－健保資料庫分析

Bisphosphonate and Mortality in Patients with Osteoporotic Fracture: An Analysis based on National Health Insurance Research Database

目的：使用骨質疏鬆藥物可降低骨鬆骨折後死亡風險，而台灣相對缺乏本土的巨資料研究，尤其是雙磷酸鹽類藥物的研究更是不足。本研究旨在探討骨鬆骨折後有無使用雙磷酸鹽類藥物對死亡率之影響。

方法：本研究納入2009至2017年全民健康保險資料庫之門診有骨質疏鬆症診斷且有住院骨折住院診斷新發個案，串連死因統計檔，分析有無使用雙磷酸鹽類藥物對於全死因死亡的風險。

結果：本研究總樣本為149,288人，存活者平均追蹤人年為4.96人年，死亡者為3.15人年。相較於無使用雙磷酸鹽類藥物者，使用雙磷酸鹽類藥物的死亡風險比為0.97 (95% CI 0.95-0.99)。而單獨使用口服alendronate/risedronate的死亡風險比為1.01 (95% CI 0.99-1.03)，針劑ibandronate為0.87 (95% CI 0.81-0.93)，針劑zoledronic acid則為0.74 (95% CI 0.70-0.78)。在髖骨骨折或脊椎骨折的次分析皆有相似結果。

結論：本研究發現骨鬆骨折個案使用雙磷酸鹽類藥物者之整體死亡風險顯著降低，尤其是針劑藥物。此研究結果應可供臨床實務及公共政策之參考。

 

Purpose: While pharmacological intervention does help reduce the risk of total mortality induced by osteoporotic fracture, few studies have been conducted to examine the impact of specific drugs, especially bisphosphonates, on osteoporotic fractures in Taiwan. Therefore, the study aimed to analyze the relationship between the use of bisphosphonates for osteoporotic fractures and resulting mortality.

Methods: The National Health Insurance Research Database (NHIRD), together with the Cause of Death Data, provided by Health and Welfare Data Science Center was consulted for analysis on subjects hospitalized for osteoporotic fracture from 2009 to 2017 to study the connection between the use of bisphosphonates and mortality among patients with osteoporotic fracture.

Results: A total of 149,288 valid participants were enrolled, and the mean follow-up personyears of the survivor and death were respectively 4.96 and 3.15. Compared with those who used no bisphosphonates, the mortality hazard ratio was 0.97 (95% confidence interval, CI 0.95-0.99)for patients receiving bisphosphonates, 1.01 (95% CI 0.99-1.03) for oral alendronate/risedronate, 0.87 (95% CI 0.81-0.93) for ibandronate by injection, and 0.74 (95% CI 0.70-0.78) for zoledronic acid in total fractures. Consistent results were found in subgroup-analysis of hip fractures or spine fractures.

Conclusion: Use of bisphosphonates, especially through injection, appears to be significantly associated with reduced mortality in patients with osteoporotic fractures. The result of this study should be considered in clinical practice and public policy.