皮下注射与静脉注射硼替佐米：疗效的实践变量和患者偏好。
Subcutaneous versus intravenous bortezomib: efficiency practice variables and patient preferences.
机构信息
Department of Pharmaceutical Services, Emory Healthcare, Atlanta, GA.
出版信息
Ann Pharmacother. 2013 Sep;47(9):1136-42. doi: 10.1177/1060028013503122.
BACKGROUND
Subcutaneous bortezomib is noninferior in efficacy to intravenous bortezomib and is associated with a lower incidence of neuropathy in the treatment of multiple myeloma. However, there are no data assessing the effect of subcutaneous bortezomib administration on practice variables or patient preferences.
OBJECTIVE
To quantify the difference in efficiency practice variables and patient preferences regarding subcutaneous versus intravenous bortezomib administration in patients with multiple myeloma.
METHODS
This study was divided into 2 parts consisting of mutually exclusive patients: a retrospective efficiency study and a survey study. Patients' medical records were reviewed for efficiency data measures including length of infusion chair time and overall infusion center visit time in patients who received at least 6 doses of bortezomib. Patients who received at least 1 dose each of subcutaneous and intravenous administration were surveyed regarding preference, satisfaction, injection site reactions, and quality of life measures. A database was used to identify eligible patients for each portion of the study.
RESULTS
A review of 92 medical records demonstrated a 38% reduction in chair time (143 vs 89 minutes; p < 0.001) and a 27% reduction in infusion center visit time (169 vs 123 minutes; p < 0.001) with subcutaneous versus intravenous administration of bortezomib. Of 47 eligible patients, 60% (28) completed the survey; 68% (19; p = 0.0002) of these patients preferred and were more satisfied with subcutaneous bortezomib administration. The overall incidence of injection site reactions was 39% (11) in the surveyed population and was not significantly different between the 2 preference groups. Limitations of the study include single-center design, small sample size, and nonvalidated survey.
CONCLUSIONS
Subcutaneous administration of bortezomib is more time efficient for the patient and institution and is preferred by patients compared to intravenous bortezomib.
背景
皮下注射硼替佐米在疗效上不劣于静脉注射硼替佐米，且与周围神经病变的发生率较低相关，可用于治疗多发性骨髓瘤。然而，目前尚无数据评估皮下注射硼替佐米给药对实践变量或患者偏好的影响。
目的
定量评估多发性骨髓瘤患者中，与静脉注射硼替佐米相比，皮下注射硼替佐米在实践变量和患者偏好方面的差异。
方法
本研究分为两部分，包括相互排斥的患者：回顾性效率研究和调查研究。对接受至少 6 剂硼替佐米治疗的患者的医疗记录进行回顾性分析，以评估效率数据指标，包括输注椅时间和整体输注中心就诊时间。接受至少 1 剂皮下和静脉注射的患者接受了关于偏好、满意度、注射部位反应和生活质量措施的调查。使用数据库来确定研究各部分的合格患者。
结果
对 92 份病历的回顾显示，与静脉注射硼替佐米相比，皮下注射硼替佐米可使椅时间减少 38%（143 分钟比 89 分钟；p < 0.001），输注中心就诊时间减少 27%（169 分钟比 123 分钟；p < 0.001）。在 47 名符合条件的患者中，60%（28 名）完成了调查；其中 68%（19 名；p = 0.0002）更喜欢并对皮下注射硼替佐米的满意度更高。在接受调查的人群中，注射部位反应的总发生率为 39%（11 例），在这 2 个偏好组之间没有显著差异。该研究的局限性包括单中心设计、样本量小和未经验证的调查。
结论
与静脉注射硼替佐米相比，皮下注射硼替佐米对患者和医疗机构更有效率，并且比静脉注射硼替佐米更受患者的青睐。
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