Fernández-Cuadros Marcos Edgar, Albaladejo-Florín María Jesús, Álava-Rabasa Sandra, Gallego-Galiana Juan, Pérez-Cruz Gerardo Fabiel, Usandizaga-Elio Isabel, Pacios Enrique, Torres-García David E, Peña-Lora Daiana, Casique-Bocanegra Luz, López-Muñoz María Jesús, Rodríguez-de-Cía Javier, Pérez-Moro Olga Susana
Servicio de Medicina Física y Rehabilitación, Hospital Universitario Santa Cristina, Calle del Maestro Vives 2 y 3, 28009 Madrid, Spain.
Servicio de Medicina Interna, Hospital Universitario Santa Cristina, Madrid, Spain.
SN Compr Clin Med. 2021;3(5):1185-1199. doi: 10.1007/s42399-021-00849-9. Epub 2021 Mar 22.
To evaluate effect of rectal ozone in severe COVID-19 pneumonia and to compare it to standard of care (SOC).
In a case-control study, 14 patients with severe bilateral COVID-19 pneumonia (positive RT-PCR), treated with SOC and rectal ozone, were evaluated before-and-after treatment and compared with SOC (14 patients) in a 10-day follow-up period. Ozone protocol consisted of 8 sessions (1 session/day) of intra-rectal ozone (150 mL volume, 35 μg/mL concentration [5.25mg total dose]). The SOC protocol included O supply, antivirals (Remdesivir), corticosteroids (Dexamethasone/Metilprednisolone), monoclonal antibodies (Anakinra/Tocilizumab), antibiotics (Azytromicine), and anticoagulants (Enoxaparine). Primary outcome variables were the following: (a) clinical (O saturation and O supply); (b) biochemical (lymphocyte count, fibrinogen, D-dimer, urea, ferritin, LDH, IL-6, and CRP); (c) radiological Taylor's scale. Secondary outcome variables were the following: (a) hospitalization length of stay, (b) mortality rate.
At baseline, ozone/SOC groups were not different on age, comorbidities, O saturation, and O supply. Patients in the ozone group improved O saturation and decrease O supply. SOC maintained O saturation and required more O supply. Lymphocyte count improved only in the ozone group and with statistical difference (<0.05). Biomarkers of inflammation (fibrinogen, D-dimer, urea, LDH, CRP, and IL-6) decreased in both groups, but only significantly in favor of the ozone group (<0.05). Ferritin showed a significant decrease in the ozone group but an increase on the SOC group. Radiological pneumonitis decreased on both groups but the decrease was only significant in the ozone group (<0.0001). Mortality and length of stay, although not significant, were inferior in the ozone group.
Compassionate use of rectal ozone improved O saturation, reduced O supply, decreased inflammation biomarkers, and improved Taylor's radiological scale significantly when compared to the SOC group. Mortality and length of stay were inferior in the ozone group, but this difference was not significant.
评估直肠臭氧疗法对重症新型冠状病毒肺炎（COVID-19）的疗效，并与标准治疗（SOC）进行比较。
在一项病例对照研究中，对14例双侧重症COVID-19肺炎（逆转录聚合酶链反应[RT-PCR]呈阳性）患者进行了研究，这些患者接受了标准治疗和直肠臭氧疗法，并在治疗前后进行了评估，并在10天的随访期内与接受标准治疗的14例患者进行了比较。臭氧治疗方案包括8次（每天1次）直肠内臭氧治疗（体积150 mL，浓度35 μg/mL[总剂量5.25 mg]）。标准治疗方案包括氧气供应、抗病毒药物（瑞德西韦）、皮质类固醇（地塞米松/甲泼尼龙）、单克隆抗体（阿那白滞素/托珠单抗）、抗生素（阿奇霉素）和抗凝剂（依诺肝素）。主要结局变量如下：（a）临床指标（血氧饱和度和氧气供应）；（b）生化指标（淋巴细胞计数、纤维蛋白原、D-二聚体、尿素、铁蛋白、乳酸脱氢酶、白细胞介素-6和C反应蛋白）；（c）放射学泰勒量表。次要结局变量如下：（a）住院时间；（b）死亡率。
在基线时，臭氧治疗组/标准治疗组在年龄、合并症、血氧饱和度和氧气供应方面无差异。臭氧治疗组患者的血氧饱和度得到改善，氧气供应减少。标准治疗组维持了血氧饱和度，但需要更多的氧气供应。仅臭氧治疗组的淋巴细胞计数有所改善，且有统计学差异（<0.05）。两组炎症生物标志物（纤维蛋白原、D-二聚体、尿素、乳酸脱氢酶、C反应蛋白和白细胞介素-6）均下降，但仅臭氧治疗组有显著下降（<0.05）。铁蛋白在臭氧治疗组显著下降，但在标准治疗组有所上升。两组放射性肺炎均有所减轻，但仅臭氧治疗组的减轻具有显著性（<0.0001）。臭氧治疗组的死亡率和住院时间虽无显著性差异，但较低。
与标准治疗组相比，同情使用直肠臭氧疗法可显著改善血氧饱和度、减少氧气供应、降低炎症生物标志物，并改善泰勒放射学量表评分。臭氧治疗组的死亡率和住院时间较低，但差异不显著。
