Salgueiro Martin, Stribos Michael, Zhang Li Fang, Stevens Mark, Awad Mohamed E, Elsalanty Mohammed
1Oral and Maxillofacial Surgery Department, Dental College of Georgia, Augusta University, Augusta, GA USA.
2Medical Student, Medical College of Georgia, Augusta University, Augusta, GA USA.
EPMA J. 2019 Jan 24;10(1):21-29. doi: 10.1007/s13167-019-0160-3. eCollection 2019 Mar.
The low incidence yet severe presentation of medication-related osteonecrosis of the jaw (MRONJ) makes it necessary to develop reliable predictive and preventive strategies. This study explored the value of pre-operative carboxy-terminal collagen crosslinks (CTX) serum level in the prediction of osteonecrosis-related complications in patients on bisphosphonate therapy.
We examined patient records over 4 years (a total of 137 patients). Biometric data were extracted, in addition to type of treatment, CTX levels, drug holiday, procedure, complications, and co-morbidities. Non-parametric Wilcoxon two-sample tests were used to test the effect of initial CTX level in IV or PO and whether it was predictive of complications. Two independent proportion tests were used for testing the two different complication incident rates before or after the drug holiday.
A total of 93 patients were included in the study, of whom 88.17% were female. A total of 11 patients were receiving IV bisphosphonates at the time of initial presentation, 82 oral bisphosphonates. Out of 64 patients who underwent invasive dental procedure (IDP) before a drug holiday, eight were on IV bisphosphonates. Three patients in this group experienced osteonecrosis-related complications (37.5%). Out of the remaining 56 patients on oral bisphosphonates, four (7.14%) developed complications, significantly lower than the IV bisphosphonate group ( = 0.0364). On the other hand, of the 34 patients placed on a drug holiday prior to IDP, only one subject developed complications related to osteonecrosis. Five subjects who had operations both before and after drug holiday did not experience any complications. No statistical difference was detected in complication rates based on initial CTX level (above versus below 150 pg/ml), gender, comorbidities, or total duration of bisphosphonate treatment ( = 0.2675). The sensitivity and specificity of CTX cutoff of 150 pg/ml in predicting osteonecrosis were 37.5% and 57.7, respectively.
Serum levels of CTX by itself are not reliable as a predictive or preventive measure for such complications. Our data also suggested that a drug holiday of 5 months was not helpful in preventing osteonecrosis-related complications in patients on intravenous bisphosphonates. Further studies are urgently needed to develop adequate predictive and preventive strategies of MRONJ.
颌骨药物相关性骨坏死(MRONJ)发病率低但表现严重,因此有必要制定可靠的预测和预防策略。本研究探讨术前血清羧基末端胶原交联(CTX)水平在预测双膦酸盐治疗患者骨坏死相关并发症中的价值。
我们检查了4年期间的患者记录(共137例患者)。除治疗类型、CTX水平、药物假期、手术、并发症和合并症外,还提取了生物统计学数据。采用非参数Wilcoxon双样本检验来测试静脉注射或口服时初始CTX水平的影响,以及它是否能预测并发症。采用两个独立比例检验来测试药物假期前后两种不同的并发症发生率。
本研究共纳入93例患者,其中88.17%为女性。初次就诊时,共有11例患者接受静脉注射双膦酸盐治疗,82例接受口服双膦酸盐治疗。在64例在药物假期前接受侵入性牙科手术(IDP)的患者中,8例使用静脉注射双膦酸盐。该组中有3例患者出现骨坏死相关并发症(37.5%)。在其余56例口服双膦酸盐的患者中,有4例(7.14%)出现并发症,明显低于静脉注射双膦酸盐组(P = 0.0364)。另一方面,在34例在IDP前进行药物假期的患者中,只有1例出现与骨坏死相关的并发症。5例在药物假期前后均接受手术的患者未出现任何并发症。基于初始CTX水平(高于或低于150 pg/ml)、性别、合并症或双膦酸盐治疗总时长,未检测到并发症发生率有统计学差异(P = 0.2675)。CTX临界值为150 pg/ml时预测骨坏死的敏感性和特异性分别为37.5%和57.7%。
血清CTX水平本身作为此类并发症的预测或预防措施并不可靠。我们的数据还表明,5个月的药物假期对预防静脉注射双膦酸盐患者的骨坏死相关并发症并无帮助。迫切需要进一步研究以制定充分的MRONJ预测和预防策略。