Clavo Bernardino, Robaina Francisco, Urrutia Gerard, Bisshopp Sara, Ramallo Yolanda, Szolna Adam, Caramés Miguel A, Fiuza María D, Linertová Renata
Research Unit, Dr. Negrín University Hospital, Las Palmas, Spain; Chronic Pain Unit, Dr. Negrín University Hospital, Las Palmas, Spain; Research Network on Health Services in Chronic Diseases (REDISSEC), Madrid, Spain; Instituto Universitario de Investigaciones Biomédicas y Sanitarias (IUIBS), BioPharm Group, Universidad de Las Palmas de Gran Canaria, Spain.
Chronic Pain Unit, Dr. Negrín University Hospital, Las Palmas, Spain.
Complement Ther Med. 2021 Jun;59:102724. doi: 10.1016/j.ctim.2021.102724. Epub 2021 May 5.
Surgery is the treatment of choice for symptomatic disc herniation after conservative management. Several studies have suggested the potential utility of intradiscal ozone infiltration in this pathology. The aim of this trial was to compare intradiscal ozone infiltration vs. oxygen infiltration vs. surgery.
This was a randomized, double-blinded, and controlled trial in patients on a waiting list for herniated disc surgery. There were three treatment groups: surgery; intradiscal ozone infiltration (plus foraminal infiltration of ozone, steroids, and anesthetic); intradiscal oxygen infiltration (plus foraminal infiltration of oxygen, steroids, and anesthetic).
The requirements for surgery.
Five years after the treatment of the last recruited patient (median follow-up: 78 months), the requirement for further surgery was 20 % for patients in the ozone group and 60 % for patients in the oxygen group. 11 % of patients initially treated with surgery also required a second surgery. Compared to the surgery group, the ozone group showed: 1) significantly lower number of inpatient days: median 3 days (interquartile range: 3-3.5 days) vs. 0 days (interquartile range: 0-1.5 days), p = 0.012; 2) significantly lower costs: median EUR 3702 (interquartile range: EUR 3283-7630) vs. EUR 364 (interquartile range: EUR 364-2536), p = 0.029.
Our truncated trial showed that intradiscal ozone infiltrations decreased the requirements for conventional surgery, resulting in decreased hospitalization durations and associated costs. These findings and their magnitude are of interest to patients and health services providers. Further validation is ongoing.
手术是保守治疗后有症状椎间盘突出症的首选治疗方法。多项研究表明椎间盘内臭氧注射在这种病理情况下可能具有效用。本试验的目的是比较椎间盘内臭氧注射与氧气注射及手术治疗的效果。
这是一项针对等待椎间盘突出症手术患者的随机、双盲对照试验。有三个治疗组：手术组；椎间盘内臭氧注射组（加椎间孔臭氧、类固醇和麻醉剂注射）；椎间盘内氧气注射组（加椎间孔氧气、类固醇和麻醉剂注射）。
手术需求情况。
在最后一名招募患者接受治疗五年后（中位随访时间：78个月），臭氧组患者进一步手术的需求率为20%，氧气组为60%。最初接受手术治疗的患者中有11%也需要二次手术。与手术组相比，臭氧组显示：1）住院天数显著减少：中位数为3天（四分位间距：3 - 3.5天），而手术组为0天（四分位间距：0 - 1.5天），p = 0.012；2）成本显著降低：中位数为3702欧元（四分位间距：3283 - 7630欧元），而手术组为364欧元（四分位间距：364 - 2536欧元），p = 0.029。
我们的截断试验表明，椎间盘内臭氧注射降低了传统手术的需求，从而缩短了住院时间并降低了相关成本。这些发现及其程度对患者和医疗服务提供者具有重要意义。进一步的验证正在进行中。
