中华骨质疏松和骨矿盐疾病杂志2025，Vol.18Issue(5)：526-535,10.DOI:10.3969/j.issn.1674-2591.2025.05.003
骨质疏松症患者双膦酸盐治疗后药物假期的观察性队列研究
An observational cohort study on the drug holiday after bisphosphonate treatment in patients with osteoporosis
刘婉琪 1卜石 2刘雨则 1张莉 3段瑞瑞 4邢小燕 2王娜 5邓瑞芬 2吴丽莉 2于利平2
作者信息
- 1. 100029 北京,北京中医药大学研究生院
- 2. 100029 北京,中日友好医院内分泌科
- 3. 450052 郑州,郑州大学第一附属医院呼吸内科
- 4. 100029 北京,中日友好医院呼吸与危重症医学科
- 5. 100029 北京,中日友好医院体检中心
- 折叠
摘要
Abstract
Objective To explore the safety of entering a drug holiday for osteoporosis patients after more than 3 years of bisphosphonate treatment.Methods A cohort of patients with osteoporosis treated with bisphosphonates(oral alendronate 70 mg weekly or intravenous zoledronate 5 mg annually)for more than 3 years at the Endocrinology or Osteo-porosis Clinics of China-Japan Friendship Hospital from January 2010 to December 2023 were evaluated.Patients who dis-continued bisphosphonates(while maintaining calcium and vitamin D supplementation)entered a drug holiday.Baseline data(gender,age,BMI,fracture history,family history of fractures,past medical history and medication use,etc.),bone mineral density(BMD)and bone turnover markers(β-CTX,P1NP)were collected.Regular follow-up was conduc-ted to record the BMD,bone turnover markers and clinical fracture events during the drug holiday.Results The data of 47 patients with complete information were analyzed.The median duration of bisphosphonate treatment was 4 years.During the treatment,the BMD of all sites increased,and the increase in BMD at lumbar spine was the most pronounced.The in-crease was 14.54%(9.25%,18.02%)after 5 years of treatment.The BMD of the hip reached the maximum increase approximately in the third year of treatment[BMD at femoral neck increased by 6.48%(2.65%,9.00%),BMD at total hip increased by 5.30%(1.04%,8.29%)];β-CTX and P1NP decreased the most in the first year of medication,and then were maintained at low levels.The duration of the drug holiday in this cohort was 2.5(2.0,4.0)years.After drug withdrawal,the bone turnover markers of the patients were significantly higher than those at the time of drug withdrawal[β-CTX increased by 100%(0%,380%)at 1 year after drug withdrawal,and P1NP increased by 33.08%(19.63%,104.37%)],but their absolute values were still lower than the pre-treatment levels.Although the BMD of the patients decreased within 2 years after drug withdrawal compared with those at the time of drug withdrawal,there was no significant statistical difference(lumbar spine:t=-1.302,P=0.204;femoral neck:t=0.082,P=0.935;total hip:t=-0.844,P=0.406).The lumbar spine BMD at 4 years after drug withdrawal(t=2.651,P=0.045)was still higher than the pre-treatment level,while the femoral neck and total hip BMD at 3 years after drug withdrawal(femoral neck:t=0.336,P=0.754;total hip:t=1.177,P=0.304)had decreased to the pre-treatment level.A total of 6 osteoporotic fracture events occurred during the drug holiday period,and only 1 was a major fracture(lumbar vertebral compression fracture),which occurred in the fourth year after drug withdrawal.The incidence of fractures was 0.03 cases per person-year.Conclusion It is relatively safe for osteoporosis patients with a good response after at least 3 years of bisphospho-nate treatment to enter a drug holiday for 2-4 years.关键词
骨质疏松症/双膦酸盐/药物假期Key words
osteoporosis/bisphosphonates/drug holiday分类
医药卫生引用本文复制引用
刘婉琪,卜石,刘雨则,张莉,段瑞瑞,邢小燕,王娜,邓瑞芬,吴丽莉,于利平..骨质疏松症患者双膦酸盐治疗后药物假期的观察性队列研究[J].中华骨质疏松和骨矿盐疾病杂志,2025,18(5):526-535,10.
