What Is the Role of Hyperbaric Oxygen in the Management of Bisphosphonate-Related Osteonecrosis of the Jaw: A Randomized Controlled Trial of Hyperbaric Oxygen as an Adjunct to Surgery and Antibiotics
What Is the Role of Hyperbaric Oxygen in the Management of Bisphosphonate-Related Osteonecrosis of the Jaw: A Randomized Controlled Trial of Hyperbaric Oxygen as an Adjunct to Surgery and Antibiotics
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DOI：
10.1016/j.joms.2012.04.001
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发表时间：
2012-07-01
影响因子：
1.9
通讯作者：
Piantadosi, Claude A.
中科院分区：
文献类型：
--
作者：
Freiberger, John J.;Padilla-Burgos, Rebecca;Piantadosi, Claude A.
目的：本研究测试了高压氧 (HBO) 作为手术和抗生素的辅助治疗双膦酸盐相关颌骨坏死 (ONJ) 的效果，并评估了其对牙龈愈合、疼痛和生活质量的影响。 材料和方法：研究人员实施了一项随机对照试验，并纳入了由 ONJ 患者组成的样本，其中预测变量是 HBO 每天两次，每次 2 个大气压，作为常规治疗的辅助疗法，共 40 次治疗手术和抗生素联合治疗与单独常规治疗的比较。在接下来的 24 个月内，对口腔病变的大小和数量、疼痛和生活质量进行了评估。结果：46 名患者（平均年龄 66 岁；57% 为女性）为试验提供了数据。 HBO 组和标准治疗组之间用于评估随机化成功的变量分布没有统计学上的显着差异。 25 名接受 HBO 治疗的患者中有 17 名 (68%) 有所改善，而 21 名对照患者中有 8 名有所改善 (38.1%；P = .043，chi(2) 检验）。接受 HBO 治疗的患者的平均改善时间为 39.7 周（95% 置信区间 [CI]，22.4 至 57.0 周），而对照组为 67.9 周（95 CI，48.4 至 87.5 周）（P = 0.03，对数秩检验）。然而，25 名接受 HBO 治疗的患者中只有 14 名 (52%) 实现了牙龈完全愈合，而 21 名对照患者中有 7 名 (33.3%；P = 0.203，chi(2) 检验），且接受 HBO 治疗的患者的愈合时间为 59 周（95% CI，42.8% 至 75.8%），而愈合时间为 70 周（95 CI，52.2% 至 75.8%）。 88.36%）对于对照（P = .32，对数秩检验）。接受 HBO 治疗的受试者的疼痛减轻得更快（P < .01，线性回归）。对照组的身体健康 (P = .002) 和感知健康 (P = .043) 的生活质量评分在 6 个月时下降，而 HBO 组则没有。结论：ONJ 是多因素的，没有单一的治疗方式可能逆转它；然而，它是可以治疗的，甚至晚期症状也可以通过强化多模式治疗得到改善。临床上，HBO 似乎是 ONJ 治疗的有用辅助手段，特别是对于更严重的病例，尽管这项研究不足以完全支持这一说法。 (C) 2012 年，爱思唯尔公司代表美国口腔颌面外科医师协会出版 J Oral Maxillofac Surg 70:1573-1583, 2012
Purpose: This study tested hyperbaric oxygen (HBO) as an adjunct to surgery and antibiotics in the treatment of bisphosphonate-related osteonecrosis of the jaw (ONJ) and evaluated its effects on gingival healing, pain, and quality of life.Materials and Methods: The investigators implemented a randomized controlled trial and enrolled a sample composed of patients with ONJ, where the predictor variable was HBO administered at 2 atm twice a day for 40 treatments as an adjunct to conventional therapy of surgery and antibiotics versus conventional therapy alone. Over the next 24 months, oral lesion size and number, pain, and quality of life were assessed.Results: Forty-six patients (mean age, 66 yrs; 57% women) contributed data to the trial. There were no statistically significant differences in the distribution of variables used to assess randomization success between the HBO and standard treatment groups. Seventeen of 25 HBO-treated patients (68%) improved versus 8 of 21 controls (38.1%; P = .043, chi(2) test). Mean time to improvement was 39.7 weeks (95% confidence interval [CI], 22.4 to 57.0 weeks) for HBO-treated patients versus 67.9 weeks (95 CI, 48.4 to 87.5 weeks) for controls (P = .03, log-rank test). However, complete gingival healing occurred in only 14 of 25 HBO-treated patients (52%) versus 7 of 21 controls (33.3%; P = .203, chi(2) test), and time to healing was 59 weeks (95% CI, 42.8% to 75.8%) for HBO-treated patients versus 70 weeks (95 CI, 52.2% to 88.36%) for controls (P = .32, log-rank test). Pain decreased faster for HBO-treated subjects (P < .01, linear regression). Quality-of-life scores for physical health (P = .002) and perceived health (P = .043) decreased at 6 months for control group but for not the HBO group.Conclusions: ONJ is multifactorial and no single treatment modality is likely to reverse it; however, it is treatable and even advanced presentations can improve with intensive multimodal therapy. Clinically, HBO appears to be a useful adjunct to ONJ treatment, particularly for more severe cases, although this study was underpowered to fully support this claim. (C) 2012 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 70:1573-1583, 2012