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在二级骨折预防计划启动后口服双膦酸盐治疗的依从性和持续性:专科医生与非专科医生管理的随机对照试验

Compliance and persistence to oral bisphosphonate therapy following initiation within a secondary fracture prevention program: a randomised controlled trial of specialist vs. non-specialist management.

作者信息

Ganda K, Schaffer A, Pearson S, Seibel M J

机构信息

Bone Research Program, ANZAC Research Institute, The University of Sydney, Hospital Road, Concord, NSW, 2139, Australia,

出版信息

Osteoporos Int. 2014 Apr;25(4):1345-55. doi: 10.1007/s00198-013-2610-4. Epub 2014 Jan 21.

Abstract

UNLABELLED

Following initiation of oral bisphosphonate therapy through a secondary fracture prevention program, 2-year treatment compliance and persistence remained high and were similar in patients randomised to follow-up by either the program or primary care physician. Thus, community-based and specialist management are equally effective in supporting compliance and persistence with anti-osteoporotic treatments.

INTRODUCTION

The purpose of this study was to determine whether management by a secondary fracture prevention (SFP) program (aka "fracture liaison service") results in better compliance and persistence to oral bisphosphonate therapy than follow-up by the primary care physician, after initiation within an SFP program.

METHODS

This prospective RCT included 102 patients with incident osteoporotic fractures referred to a SFP program in Sydney, Australia. Following oral bisphosphonate therapy initiation, patients were randomised to either 6-monthly follow-up with the SFP program (group A) or referral to their primary care physician with a single SFP program visit at 24 months (group B). Compliance and persistence to treatment were measured using pharmaceutical claims data. Predictors of compliance and persistence and associations between compliance and persistence, and changes in bone mineral density (BMD) or bone resorption marker, urinary deoxypyridinoline over 24 months were analysed.

RESULTS

The median medication possession ratio at 24 months was 0.78 (IQR, 0.50-0.93) in group A and 0.79 (IQR, 0.48-0.96) in group B (p = 0.68). Persistence at 24 months was also similar in both groups (64 vs. 61%, respectively; p = 0.75). After adjusting for confounders, patients in group A were not more likely to be compliant (OR, 1.06; 95% CI, 0.46-2.47) or persistent (HR, 0.83; 95% CI, 0.27-1.67) than those randomised to group B. Time-based changes in BMD or bone turnover were not associated with compliance or persistence.

CONCLUSION

Compliance and persistence to oral bisphosphonate therapy remain high amongst patients initiated within an SFP program, with community-based and SFP program management being equally effective in maintaining therapeutic compliance and persistence over 2 years. These results indicate that one of the main functions of an SFP program may be the initiation of therapy rather than continuous patient monitoring.

摘要

未标注

通过二级骨折预防项目开始口服双膦酸盐治疗后,2年治疗依从性和持续性保持在较高水平,随机分配由该项目或初级保健医生进行随访的患者情况相似。因此,基于社区的管理和专科管理在支持抗骨质疏松治疗的依从性和持续性方面同样有效。

引言

本研究的目的是确定在二级骨折预防(SFP)项目(又称“骨折联络服务”)内开始治疗后,由SFP项目管理(相对于由初级保健医生随访)是否能使口服双膦酸盐治疗的依从性和持续性更好。

方法

这项前瞻性随机对照试验纳入了102例在澳大利亚悉尼被转诊至SFP项目的新发骨质疏松性骨折患者。在开始口服双膦酸盐治疗后,患者被随机分为两组,A组每6个月接受SFP项目随访,B组转诊至其初级保健医生处,并在24个月时接受一次SFP项目门诊。使用药物报销数据来衡量治疗的依从性和持续性。分析了依从性和持续性的预测因素、依从性与持续性之间的关联,以及24个月内骨密度(BMD)或骨吸收标志物尿脱氧吡啶啉的变化。

结果

A组24个月时的药物持有率中位数为0.78(四分位间距,0.50 - 0.93),B组为0.79(四分位间距,0.48 - 0.96)(p = 0.68)。两组24个月时的持续性也相似(分别为64%和61%;p = 0.75)。在对混杂因素进行调整后,A组患者与随机分配至B组的患者相比,依从性(比值比,1.06;95%置信区间,0.46 - 2.47)或持续性(风险比,0.83;95%置信区间,0.27 - 1.67)并无更高可能性。基于时间的骨密度或骨转换变化与依从性或持续性无关。

结论

在SFP项目内开始治疗的患者中,口服双膦酸盐治疗的依从性和持续性仍然很高,基于社区的管理和SFP项目管理在维持2年治疗依从性和持续性方面同样有效。这些结果表明,SFP项目的主要功能之一可能是启动治疗,而非持续对患者进行监测。

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