世界臭氧治疗联合会副主席发表COVID19和臭氧疗法治疗新冠（Covid19 and the new title of ozone therapy）
世界臭氧治疗联合会(WFOT)是一个国际非营利性组织，于2005年4月9日在印度新德里成立。其目的是促进臭氧(多原子氧)在所有可能的医疗方面的使用。为了实现目标，WFOT致力于在全世界范围内，在所有拥有相同目标的国家协会之间建立一个联营体，并设立一个真正的协会联盟。WFOT希望成为所有应用臭氧治疗的卫生专业人员的日常实践和研究的里程碑。
JoséBaeza Noci医生 - WFOT主席2014-2016
JoséBaeza Noci医生，毕业于西班牙巴伦西亚大学医学院。他于1989年以优异的表现获得了医学学位。1992年，他获得了医学博士学位，并以Cum Laude latin荣誉毕业。他的论文由瓦伦西亚大学的Morfological Sciences部门发表，题为“Escoliosis experimental porlesióndirecta delcartílagoneurocentral”
COVID19 and ozone therapy (ver 1.2)by Prof. José Baeza-Noci
WFOT Vice-President
COVID19和臭氧疗法(1.2版)
José Baeza-Noci教授世界臭氧治疗联合会副主席
INTRODUCTION.SARS-Cov2 has a mean incubation period of 5 days, although it can reach up to 2 weeks. Infected patients evolve differently and extreme cases die after 10 days of being infected. Most patients ask for medical help after 5 days of suffering a catarrhal syndrome that worsens. They usually remain in-hospital for 3 weeks before discharge but according to age and concomitant pathology, 10% go to ICU. The prognosis there is also related with age and concomitant diseases as indicated by WHO.
介绍
SARS-Cov2的平均潜伏期为5天，但最长可达2周。感染者的进化不同，极端病例在感染10天后死亡。大多数患者在卡他性综合征恶化5天后寻求医疗帮助。他们通常在出院前住院3周，但根据年龄和伴随的病理学，10%的人会去ICU。世卫组织指出，该病的预后还与年龄和伴发疾病有关。
Ozone therapy and viral diseases.Bocci and cols. tested in vivo effects of ozone in patients with different infections and discovered the following facts:
1- Ozone improves lung and peripheral tissue oxygenation and gases exchange because of peripheral vase-dilatation mediated by nitrosotyols and enhanced glucolysis in erythrocytes that produce more ATP and secondary higher 2,3-DPG levels (Bohr effect) and more elasticity because an optimal functioning of Na/K+ membrane pump.
2- Ozone modulates the NRF2 and this produces three effects.
First, normalize the redox balance through the increase in antioxidants in cytoplasma, mitochondria and finally, plasma, mainly glutatione peroxidase, but also glutatione reductase, NADPH and SOD.
Second, induces the production of HO-1, a protective enzyme, together heat-shock proteins like HSP60, HSP70 and HSP90.
Third, activates the NFKbeta that modulates the production of proinflammatory interleukines in inflammated tissues.
All three effects contribute to restore the normal functioning of the inflammated tissues and decrease the amount of plasma interleukines.
臭氧疗法和病毒性疾病。
Bocci and cols研究发现在不同感染患者体内测试臭氧的影响，发现以下事实：
1.臭氧改善了肺和周围组织的氧合和气体交换，这是由nitrosotyols介导的外周血管扩张和红细胞糖酵解增强所致，红细胞产生更多的ATP和更高的2,3-DPG水平(玻尔效应)和更大的弹性，因为Na/K+膜泵的最佳功能。
2.臭氧调节NRF2产生三种效应。
首先，通过增加细胞质、线粒体中的抗氧化剂，使氧化还原平衡正常化，最后，血浆中主要是谷胱甘肽过氧化物酶，还包括谷胱甘肽还原酶、NADPH和SOD。
其次，诱导保护酶HO-1与HSP60、HSP70、HSP90等热休克蛋白共同产生。
第三，激活NFKB调节炎症组织中促炎性白介素的产生。
这三种作用都有助于恢复发炎组织的正常功能和减少血浆白细胞介素的含量。
Ozone administration ways.Ozone for systemic diseases should be used in a systemic way:
A. Indirect Endovenous Administration (IEV). As ozone is a gas, it cannot be directly injected into the blood mainstream, to avoid gas embolism. Special medical devices have been manufactured and EU certificated by different manufacturers to allow ozone dissolve into the patients’ blood risk free. For details on this technique, please read World Federation of Ozone Therapy - WFOT’s book.
Based on the information from the three Chinese Hospitals7,8,9 that are presently performing and official clinical trial and also on the protocol presented and pre-accepted in Universitá della Sapienza in Rome, the proposed treatment will be:
- 100 mL of blood and 100 mL of ozone gas at 30 mcgr/mL concentration.
- In-hospital patients: each 12 hours application for minimum 14 weeks.
- ICU patients: each 8 hours until the patients starts improving; later, each 12 hours application til discharge to in-hospital care.
臭氧应用方法。
系统性疾病应采用臭氧：
A、 间接静脉内给药(IEV)。由于臭氧是一种气体，不能直接注入血液主流，避免气体栓塞。目前有专门的制备医用三氧的设备及操作用耗材，并且通过了不同制造商的欧盟认证，使得臭氧能够方便溶解到病人的血液中。有关这项技术的详细信息，请阅读世界臭氧治疗联合会-WFOT的书。
根据目前正在进行和正式临床试验的三家中国医院的信息，以及罗马Universitá della Sapienza提出和预先接受的方案，拟议的治疗方案为：
-浓度为30μg/mL的100毫升臭氧气体和100毫升血液。
-住院患者：每12小时一次，至少14周。
-ICU患者：每8小时一次，直到患者开始好转;之后，每12小时一次，在院期间持续治疗，直到出院。
B. Rectal Inssuflation (RI). Rectal inssuflation is not so exact as IEV but it can be the only option for patients where peripheral veins don’t allow the previous technique. For details on this technique, please read World Federation of Ozone Therapy - WFOT’s book.
B、 直肠灌注(RI)。直肠灌注治疗不如IEV精确，但对于周围静脉不允许使用先前技术的患者，直肠灌注是更好的选择。有关这项技术的详细信息，请阅读世界臭氧治疗联合会-WFOT的书。
We propose the following protocol:
- Day 1: 100 mL at 30 mcgr/mL concentration.
- Day 2: 150 mL at 30 mcgr/mL concentration.
- Day 3 - 14: 200 mL at 30 mcgr/mL concentration.
我们提出以下协议：
-第1天：100毫升，浓度为30μg/mL。
-第2天：150毫升，浓度为30μg/mL。
-第3-14天：浓度为30μg/mL的200 mL。
- In-hospital patients: each 12 hours application for minimum 14 weeks.
- ICU patients: each 8 hours until the patients starts improving; later, each 12 hours application til discharge to in-hospital care.
-住院患者：每12小时一次，至少14周。
-ICU病人：每8小时一次，直到病人开始好转;之后，住院期间持续治疗每12小时一次直到出院。
Complementary treatments to ozone administration.To help ozone effect, it is advisable although not mandatory, the administration during the ozone treatment of:
- Vitamine C: 3 gr each 12 hours, 6 hours after ozone administration. 1 gr each 12 hours is standardize in Italy and Spain protocols for COVID19.
- Glutatione: 600mg each 12 hours, 6 hours after ozone administration. This substance is administered because ozone effect is partially based on it and old patients may have a low blood glutatione level.
臭氧补充治疗。
为了帮助臭氧效应，建议在臭氧处理期间进行以下管理，尽管不是强制性的：
-维生素C:3克每12小时，6小时后臭氧管理。每12小时1g在意大利和西班牙的COVID19协议中是标准化的。
-谷胱甘肽：每12小时600毫克，臭氧注射后6小时。服用这种物质是因为臭氧的影响部分是基于它，老年患者可能有低血谷胱甘肽水平。
TRIAL DESING.
评判标准
Purpose:1. Enhance respiratory function.
2. Stop the blood interleukine storm.
3. Limit patients needing ICU.
4. Shorten the time in hospital.
目的：
1.改善呼吸功能。
2.停止血细胞间因子风暴。
3.减少转入ICU的病人。
4.缩短住院时间。
Inclusion criteria:1. Confirmed patients (or legal guardian) sign a written informed consent form.
2. Aged from 18 to 80 years, male or female.
3. Patients with positive detection of 2019 Novel Coronavirus Pneumonia fluorescence RT-PCR in respiratory specimens or blood samples.
4. Mild ill and severe ill patients NOT IN ICU are grouped based on the “Handbook of COVID-19 Prevention and Treatment”.
纳入标准：
1.确诊患者(或法定监护人)签署书面知情同意书。
2.年龄在18至80岁之间，男性或女性。
3.2019例新型冠状病毒肺炎患者呼吸道标本或血液标本荧光RT-PCR检测阳性。
4.根据《COVID-19手册》将不在ICU的轻度和重度患者分组预防和治疗。
Exclusion criteria:1. Patients who may be transferred to other hospitals that are not included in the trial within 72hours.
2. G-6PD defect (Major Favism).
3. Pregnancy, especially early pregnancy.
4. Patients who continually use immunosuppressant, or are organ transplant recipients within 6months.
5. Patients who are receiving other clinical trials.
排除标准：
1.可能在72小时内转移到其他未纳入试验的医院的患者。
2.G-6-PD缺乏(主要指蚕豆病)。
3.怀孕，尤指早孕。
4.持续使用免疫抑制剂或在6个月内接受器官移植的患者。
5.正在接受其他临床试验的患者。
Interventions:WE SHOULD RANDOMIZE the patients going for control IEV or RI groups:
1. Control group. 60 patients. Conventional treatment.
2. Mild ill patients: 15 patients. Conventional treatment + ozone protocol A (IEV).
3. Mild ill patients: 15 patients. Conventional treatment + ozone protocol B (RI).
4. Severe patients: 15 patients. Conventional treatment + ozone protocol A.
5. Severe patients: 15 patients. Conventional treatment + ozone protocol B.
干预措施：
我们应该将患者随机分为对照组和对照组：
1.对照组。60个病人。常规治疗。
2.轻度病人：15例。常规处理+臭氧协议A(IEV)。
3.轻度病人：15例。常规处理+臭氧协议B(RI)。
4.重症患者：15例。常规处理+臭氧协议A。
5.重症患者：15例。常规处理+臭氧方案B。
Outcomes:1. Primary:
1. Chest CT or XRay: interstitial pattern.
2. Whole blood cell analysis: leucocytes recount.
3. Oxygenation index: SpO2.
4. Inflammation index: PCR. (optional: IL6, procalcitonin, ferritin, D-dimer)
5. Fever: axillary temperature.2. Secondary:
6. Recovery rate.
7. Conversion rate of severe patients.
8. Mortality rate.
结果：
一。主要指标：
1.胸部CT或x光片：间质型。
2.全血细胞分析：白细胞计数。
3.氧合指数：SpO2。
4.炎症指数：PCR。(可选：IL6、降钙素原、铁蛋白、D-二聚体)
5.体温：腋窝温度。
二。次要指标：
6.恢复率。
7.重症患者的转化率。
8.死亡率。
注：翻译可能存在纰漏，请见谅
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