世界臭氧治療聯合會副主席發表COVID19和臭氧療法治療新冠（Covid19 and the new title of ozone therapy）
世界臭氧治療聯合會(WFOT)是一個國際非營利性組織，于2005年4月9日在印度新德里成立。其目的是促進臭氧(多原子氧)在所有可能的醫療方面的使用。為了實現目標，WFOT致力于在全世界范圍內，在所有擁有相同目標的國家協會之間建立一個聯營體，并設立一個真正的協會聯盟。WFOT希望成為所有應用臭氧治療的衛生專業人員的日常實踐和研究的里程碑。
JoséBaeza Noci醫生 - WFOT主席2014-2016
JoséBaeza Noci醫生，畢業于西班牙巴倫西亞大學醫學院。他于1989年以優異的表現獲得了醫學學位。1992年，他獲得了醫學博士學位，并以Cum Laude latin榮譽畢業。他的論文由瓦倫西亞大學的Morfological Sciences部門發表，題為“Escoliosis experimental porlesióndirecta delcartílagoneurocentral”
COVID19 and ozone therapy (ver 1.2)by Prof. José Baeza-Noci
WFOT Vice-President
COVID19和臭氧療法(1.2版)
José Baeza-Noci教授世界臭氧治療聯合會副主席
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.
介紹
SARS-Cov2的平均潛伏期為5天，但最長可達2周。感染者的進化不同，極端病例在感染10天后死亡。大多數患者在卡他性綜合征惡化5天后尋求醫療幫助。他們通常在出院前住院3周，但根據年齡和伴隨的病理學，10%的人會去ICU。世衛組織指出，該病的預后還與年齡和伴發疾病有關。
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.
臭氧療法和病毒性疾病。
Bocci and cols研究發現在不同感染患者體內測試臭氧的影響，發現以下事實：
1.臭氧改善了肺和周圍組織的氧合和氣體交換，這是由nitrosotyols介導的外周血管擴張和紅細胞糖酵解增強所致，紅細胞產生更多的ATP和更高的2,3-DPG水平(玻爾效應)和更大的彈性，因為Na/K+膜泵的最佳功能。
2.臭氧調節NRF2產生三種效應。
首先，通過增加細胞質、線粒體中的抗氧化劑，使氧化還原平衡正常化，最后，血漿中主要是谷胱甘肽過氧化物酶，還包括谷胱甘肽還原酶、NADPH和SOD。
其次，誘導保護酶HO-1與HSP60、HSP70、HSP90等熱休克蛋白共同產生。
第三，激活NFKB調節炎癥組織中促炎性白介素的產生。
這三種作用都有助于恢復發炎組織的正常功能和減少血漿白細胞介素的含量。
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.
臭氧應用方法。
系統性疾病應采用臭氧：
A、 間接靜脈內給藥(IEV)。由于臭氧是一種氣體，不能直接注入血液主流，避免氣體栓塞。目前有專門的制備醫用三氧的設備及操作用耗材，并且通過了不同制造商的歐盟認證，使得臭氧能夠方便溶解到病人的血液中。有關這項技術的詳細信息，請閱讀世界臭氧治療聯合會-WFOT的書。
根據目前正在進行和正式臨床試驗的三家中國醫院的信息，以及羅馬Universitá della Sapienza提出和預先接受的方案，擬議的治療方案為：
-濃度為30μg/mL的100毫升臭氧氣體和100毫升血液。
-住院患者：每12小時一次，至少14周。
-ICU患者：每8小時一次，直到患者開始好轉;之后，每12小時一次，在院期間持續治療，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、 直腸灌注(RI)。直腸灌注治療不如IEV精確，但對于周圍靜脈不允許使用先前技術的患者，直腸灌注是更好的選擇。有關這項技術的詳細信息，請閱讀世界臭氧治療聯合會-WFOT的書。
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.
我們提出以下協議：
-第1天：100毫升，濃度為30μg/mL。
-第2天：150毫升，濃度為30μg/mL。
-第3-14天：濃度為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小時一次，至少14周。
-ICU病人：每8小時一次，直到病人開始好轉;之后，住院期間持續治療每12小時一次直到出院。
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.
臭氧補充治療。
為了幫助臭氧效應，建議在臭氧處理期間進行以下管理，盡管不是強制性的：
-維生素C:3克每12小時，6小時后臭氧管理。每12小時1g在意大利和西班牙的COVID19協議中是標準化的。
-谷胱甘肽：每12小時600毫克，臭氧注射后6小時。服用這種物質是因為臭氧的影響部分是基于它，老年患者可能有低血谷胱甘肽水平。
TRIAL DESING.
評判標準
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.停止血細胞間因子風暴。
3.減少轉入ICU的病人。
4.縮短住院時間。
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”.
納入標準：
1.確診患者(或法定監護人)簽署書面知情同意書。
2.年齡在18至80歲之間，男性或女性。
3.2019例新型冠狀病毒肺炎患者呼吸道標本或血液標本熒光RT-PCR檢測陽性。
4.根據《COVID-19手冊》將不在ICU的輕度和重度患者分組預防和治療。
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.
排除標準：
1.可能在72小時內轉移到其他未納入試驗的醫院的患者。
2.G-6-PD缺乏(主要指蠶豆病)。
3.懷孕，尤指早孕。
4.持續使用免疫抑制劑或在6個月內接受器官移植的患者。
5.正在接受其他臨床試驗的患者。
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.
干預措施：
我們應該將患者隨機分為對照組和對照組：
1.對照組。60個病人。常規治療。
2.輕度病人：15例。常規處理+臭氧協議A(IEV)。
3.輕度病人：15例。常規處理+臭氧協議B(RI)。
4.重癥患者：15例。常規處理+臭氧協議A。
5.重癥患者：15例。常規處理+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.
結果：
一。主要指標：
1.胸部CT或x光片：間質型。
2.全血細胞分析：白細胞計數。
3.氧合指數：SpO2。
4.炎癥指數：PCR。(可選：IL6、降鈣素原、鐵蛋白、D-二聚體)
5.體溫：腋窩溫度。
二。次要指標：
6.恢復率。
7.重癥患者的轉化率。
8.死亡率。
注：翻譯可能存在紕漏，請見諒
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