Kobayashi Nobuo, Noguchi Tomoyuki, Kobayashi Daiki, Saito Hiroya, Shimoyama Keiji, Tajima Tsuyoshi, Sosogi Sho, Kobayashi Kiyokazu, Shida Yoshitaka, Hasebe Terumitsu, Numaguchi Yuji
Department of Radiology, St. Luke's International Hospital, Japan.
Center for Clinical Epidemiology and Health Technology Assessment, St. Luke's International University, Japan.
Interv Radiol (Higashimatsuyama). 2021 Jun 7;6(2):21-28. doi: 10.22575/interventionalradiology.2020-0032. eCollection 2021 Jul 1.
Bone cement enhancement by percutaneous vertebroplasty (PVP) for the treatment of osteoporotic vertebral compression fractures remains unapproved, as it has not been fully evaluated in Japan. The current multicenter study was conducted in Japan to verify the safety and efficacy of PVP in patients with painful osteoporotic vertebral fractures.
In this retrospective study, we referred to previous studies to evaluate the non-inferiority of PVP to balloon kyphoplasty (BKP). We reviewed consecutive patient data from April 2017 to March 2018 from four institutions based on the medical records of the intervention. We statistically investigated the adverse events due to cement leakage or other factors associated with PVP, and new vertebral compression fractures after PVP were evaluated for safety, pain relief, and gait improvement.
This study included 485 patients; most of whom were in the middle- to oldest- age groups (mean age, 81.4 years). No serious adverse events were reported in patients available for safety evaluation (n = 485). Cement leakage and new vertebral compression fractures occurred in 35.7% and 18.6% (26.2%-38.4% and 8.9%-20.7%) of the patients undergoing PVP, respectively, both of which were also judged to be equivalent to those of BKP. The pain score improved in those undergoing PVP, and this improvement was maintained during a one-year follow-up. Of the 206 patients who had difficulty walking at baseline, 156 had restored walking at discharge.
PVP was shown to be a safe and effective treatment, even in elderly patients with painful osteoporotic vertebral fractures.
经皮椎体成形术（PVP）用于增强骨水泥治疗骨质疏松性椎体压缩骨折在日本仍未获批，因为其在日本尚未得到充分评估。本多中心研究在日本开展，以验证PVP治疗疼痛性骨质疏松性椎体骨折患者的安全性和有效性。
在这项回顾性研究中，我们参考既往研究来评估PVP相对于球囊扩张椎体后凸成形术（BKP）的非劣效性。我们基于干预的医疗记录，回顾了2017年4月至2018年3月期间来自四个机构的连续患者数据。我们对因骨水泥渗漏或与PVP相关的其他因素导致的不良事件进行了统计学调查，并对PVP术后新发生的椎体压缩骨折进行了安全性、疼痛缓解及步态改善方面的评估。
本研究纳入485例患者；其中大多数为中老年人（平均年龄81.4岁）。在可进行安全性评估的患者（n = 485）中未报告严重不良事件。接受PVP的患者中，骨水泥渗漏和新发生椎体压缩骨折的发生率分别为35.7%和18.6%（95%CI分别为26.2%-38.4%和8.9%-20.7%），二者也被判定与BKP相当。接受PVP的患者疼痛评分改善，且在一年随访期间得以维持。基线时206例行走困难的患者中，156例在出院时恢复了行走能力。
即使对于患有疼痛性骨质疏松性椎体骨折的老年患者，PVP也是一种安全有效的治疗方法。
