• Evidence of multiorgan failure (即除肺之外还有一个关键内脏衰竭就不行了。肺本身算一个organ)
• The use of more than one pressor for septic shock (the use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed)
1. patients diagnosed as Pneumonia caused by new coronavirus infection (2019-nCoV); 2. virus turned negative after treatment; 3. Patients diagnosed with pulmonary fibrosis; 4. aged 18-70 years old; 5. patients with clear consciousness; 6. Signing the informed consent form.
[table=98%]
sion criteria： 1. Patients with serious illnesses, such as heart, liver, kidney, endocrine diseases and hematopoietic system disease; 2. Pregnant or lactating women; 3. Patients who have mental confusion, who with a history of drug abuse or dependence, who allergic to study medication, who have participated in another clinical trial within 3 months, or who have other conditions not suitable for clinical study.
[table=98%]
Inclusion criteria 1. Adult aged >= 18 years old; 2. Patients with unexplained viral pneumonia that have been clinically diagnosed or patients with novel coronavirus serum antibody (IgM or IgG) positive or patients with novel coronavirus infection confirmed by PCR when no rapid diagnostic kit has been developed; 3. The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
[table=98%]
Exclusion criteria： 1) Any situation that makes the programme cannot proceed safely; 2) patients who have used Kaletra or remdesivir; 3) no clinical or chest imaging manifestations; 4) In the state of no oxygen at rest, the patient's SPO2 <= 94% or the oxygenation index is less than 300mmHg respiratory rate >= 24/min; 5) Patients who need to be admitted to ICU judged by clinicians; 6) Known allergy or hypersensitivity reaction to lopinavir / ritonavir; 7) Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 3 times the upper limit of normal; 8) Drugs that are forbidden to be treated with lopinavir / ritonavir and cannot be replaced or stopped during the study period, such as afzosin, amiodarone, fusidic acid, astemizole, terfenadine, piperazine, dihydroergomethane, ergometrine Alkali, ergotamine, methylergometrine, cisapride, lovastatin, simvastatin, sildenafil, vartanafi, midazolam, triazolam, St. John's wort (Hypericum perforatum extract), etc.; 9) Pregnancy: positive pregnancy test for women of childbearing age; 10) lactating women did not stop lactation; 11) Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs; 12) Patient likely to be transferred to a non-participating hospital within 72 hours.
[table=98%] Inclusion criteria (1) aged 18 to 70 years; (2) Light and heavy patients with new coronavirus infection confirmed by etiology.
[table=98%] Exclusion criteria： (1) any situation in which the program cannot proceed safely; (2) allergic constitution; (3) serious basic diseases affecting survival, including uncontrolled malignant tumors with multiple metastases that cannot be resected, blood diseases, malignant fluid, active bleeding, severe malnutrition, HIV, etc.; The main organ function is abnormal (4) liver function was obviously abnormal: ALT/AST increased by more than 5 times the normal upper limit, increase of total bilirubin more than 2 times of normal upper limit; (5) obstructive pneumonia, severe pulmonary fibrosis, alveolar proteinosis and allergic alveolitis caused by lung tumors; (6) pregnancy: positive pregnancy test for women of child-bearing age; (7) the patient may be transferred to a non-participating hospital within 72h; (8) continuous use of immunosuppressants or organ transplants within the past 6 months; (9) in vitro life support patients (ECMO, ECCO2R, RRT); (10) expected survival no more than 48 hours.
1. patients diagnosed as Pneumonia caused by new coronavirus infection (2019-nCoV); 2. virus turned negative after treatment; 3. Patients diagnosed with pulmonary fibrosis; 4. aged 18-70 years old; 5. patients with clear consciousness; 6. Signing the informed consent form.
[table=98%]
sion criteria： 1. Patients with serious illnesses, such as heart, liver, kidney, endocrine diseases and hematopoietic system disease; 2. Pregnant or lactating women; 3. Patients who have mental confusion, who with a history of drug abuse or dependence, who allergic to study medication, who have participated in another clinical trial within 3 months, or who have other conditions not suitable for clinical study.
75% The majority of patients (75 percent) were men over the age of 60 years with comorbid conditions, including hypertension, diabetes, hyperlipidemia and asthma. Combined, all three of these factors have been associated with adverse outcomes of COVID-19.
• Evidence of multiorgan failure (即除肺之外还有一个关键内脏衰竭就不行了。肺本身算一个organ)
• The use of more than one pressor for septic shock (the use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed)
After 28 days of follow-up, the cumulative incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale, was 84 percent according to Kaplan-Meier analysis.
• Evidence of multiorgan failure (即除肺之外还有一个关键内脏衰竭就不行了。肺本身算一个organ)
• The use of more than one pressor for septic shock (the use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed)
• Evidence of multiorgan failure (即除肺之外还有一个关键内脏衰竭就不行了。肺本身算一个organ)
• The use of more than one pressor for septic shock (the use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed)
这位是没看过几个病例的小医生吧？在你的帖子里你唯一的本事就是推荐鸡汤。上面已经有人说了，瑞德西韦的同情用药已经有1700多例了，和你说的全美20多例严重不符，由此可见你其它的说法可信度也成疑。
请问"不需要药物治疗的早期基础病"的出处
我记得我以前看筛选对象有要求前一个月不实用药物治疗，
这不就是 不需要药物治疗的早期基础病 吗？
同情用药迄今已有1800例，但治疗后随访满28天的人应该不多，不知道这篇文章里的病例数是否全部包括进去了。
但就算全包括进去也价值不大，因为这是观察性研究，没有随机对照的过程，其结果受数据偏移和混杂因素的干扰很大。
我不明白，为什么不采用倾向评分匹配的方式进行干预效应分析，这些年国内外采用这种统计分析方法研究抗病毒疗效的大paper不少。
要么是没这个条件。
为了证明你没记错，给个出处呗至少这里没有这一条
[table=98%]
1. patients diagnosed as Pneumonia caused by new coronavirus infection (2019-nCoV);
2. virus turned negative after treatment;
3. Patients diagnosed with pulmonary fibrosis;
4. aged 18-70 years old;
5. patients with clear consciousness;
6. Signing the informed consent form.
[table=98%]
sion criteria：
1. Patients with serious illnesses, such as heart, liver, kidney, endocrine diseases and hematopoietic system disease;
2. Pregnant or lactating women;
3. Patients who have mental confusion, who with a history of drug abuse or dependence, who allergic to study medication, who have participated in another clinical trial within 3 months, or who have other conditions not suitable for clinical study.
[table=98%]
Inclusion criteria
1. Adult aged >= 18 years old;
2. Patients with unexplained viral pneumonia that have been clinically diagnosed or patients with novel coronavirus serum antibody (IgM or IgG) positive or patients with novel coronavirus infection confirmed by PCR when no rapid diagnostic kit has been developed;
3. The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
[table=98%]
Exclusion criteria：
1) Any situation that makes the programme cannot proceed safely;
2) patients who have used Kaletra or remdesivir;
3) no clinical or chest imaging manifestations;
4) In the state of no oxygen at rest, the patient's SPO2 <= 94% or the oxygenation index is less than 300mmHg respiratory rate >= 24/min;
5) Patients who need to be admitted to ICU judged by clinicians;
6) Known allergy or hypersensitivity reaction to lopinavir / ritonavir;
7) Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 3 times the upper limit of normal;
8) Drugs that are forbidden to be treated with lopinavir / ritonavir and cannot be replaced or stopped during the study period, such as afzosin, amiodarone, fusidic acid, astemizole, terfenadine, piperazine, dihydroergomethane, ergometrine Alkali, ergotamine, methylergometrine, cisapride, lovastatin, simvastatin, sildenafil, vartanafi, midazolam, triazolam, St. John's wort (Hypericum perforatum extract), etc.;
9) Pregnancy: positive pregnancy test for women of childbearing age;
10) lactating women did not stop lactation;
11) Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs;
12) Patient likely to be transferred to a non-participating hospital within 72 hours.
[table=98%]
Inclusion criteria (1) aged 18 to 70 years;
(2) Light and heavy patients with new coronavirus infection confirmed by etiology.
[table=98%]
Exclusion criteria： (1) any situation in which the program cannot proceed safely;
(2) allergic constitution;
(3) serious basic diseases affecting survival, including uncontrolled malignant tumors with multiple metastases that cannot be resected, blood diseases, malignant fluid, active bleeding, severe malnutrition, HIV, etc.;
The main organ function is abnormal
(4) liver function was obviously abnormal: ALT/AST increased by more than 5 times the normal upper limit, increase of total bilirubin more than 2 times of normal upper limit;
(5) obstructive pneumonia, severe pulmonary fibrosis, alveolar proteinosis and allergic alveolitis caused by lung tumors;
(6) pregnancy: positive pregnancy test for women of child-bearing age;
(7) the patient may be transferred to a non-participating hospital within 72h;
(8) continuous use of immunosuppressants or organ transplants within the past 6 months;
(9) in vitro life support patients (ECMO, ECCO2R, RRT);
(10) expected survival no more than 48 hours.
哪里说一个月不能用药？
我还在找呢， 😄，找不到了，不过这点我应该还比较确定。
有看到6个月内不能使用免疫抑制的。
我说，paper里明确列举了病人的各种coexisting conditions
你非要凭自己的印象说这些conditions即使有也等于没有
连事实都无法厘清
那还有什么值得辩的
等于没有把，我找不到我看到过的东西了，或者我自己扭曲了事实。😂。
手动点赞，文章说的很清楚，74%的病人合并有基础疾病，24%的病人合并的是糖尿病
75%
The majority of patients (75 percent) were men over the age of 60 years with comorbid conditions, including hypertension, diabetes, hyperlipidemia and asthma. Combined, all three of these factors have been associated with adverse outcomes of COVID-19.
连数字都无法厘清
那还有什么值得辩的
Good question
非常不好的问题，因为轻症， 80%人的会自愈。抑制病毒，其实是抑制你的免疫，没搞好，把80%本可以自愈的人，因为免疫系统被干扰，有意想不到的结果。
我说的就是randomized experiment啊
不管你说哪种缘故，就是lift不高才需要4000人吧
这要求有点高了，COVID-19面世也没有几个月，单独做一个II期需要多长时间你应该有概念吧？查了有adaptive，不知道是II/III seamless
赞一下
...
我记得3/22之后药厂发了声明的，原来的同情用药申请太多处理不过来，后来改成以医院为单位申请，一旦下发到某个医院，医院的医生可以自行决定，那就快一些了
跑去看了一眼微博，嗯，主要报道副作用了，呵呵
入组排除条件是因为理论上觉得这个药对这些病人不会有收益。就像张文宏说的，药方在每个病人身上，要根据每个病人情况选药。根据这个药的机理，开始并不认为会对危重病人有用，如果在一部分危重症病人上有效，本身就是超出预期的。
这篇知乎真把我给看笑了，真的，当然，笑中带泪的那种。
你大概没看过我之前发过的帖子
没错！没对照组，这个数据有啥意义？如果对照组的人7天后全部死亡，那这个药效果太明显了！！！
那么对照组的人情况如何？如果对照组的没有一个活过18天的。那这个药效太明显了。
曹彬医生的话给你借鉴
曹彬：感谢您的问题。刚才我已经说了，我们为什么能够锁定洛匹拉韦/利托那韦和瑞德西韦这两个药呢？就是因为看书、看文献，如果不读书、不读文献的话，怎么会知道这个世界上还有这两种药物呢？我觉得这是第一步的要求。 第二个要求是“需要怀疑”，千万千万不能听说某种药有效，就敢给病人普遍临床应用。做为一个受过医学训练的人，贸然用药是很可怕的一件事情。另外，我们在对医学生、进修医生的培养教育方面，经常反复说一件事，就是“工作时间长不代表有经验”。事实上，我们经验的积累一定是建立在循证的基础上建起来的。因为我们专业主要是做肺炎方面，例如，一个医疗组一个月间收治了100个病人，这100个患者中，有几个真真正正能够把故事讲清楚的？病原学明确了吗？根据病原学药敏结果用药，患者是否像预期结果一样治疗好了？而且临床表现是不是和我们所掌握的基本规律是一致的？ 在咱们临床看到的100个患者当中，我们真正能够拿到循证医学证据的，我觉得不超过两位数，甚至个位数。在病原学诊断能力比较强的医院，可能能够达到20、30位，但是有的医院我觉得可能就是0。但是大家千万不要因为所在的医院病原学诊断的能力比较弱，就不追求病原学诊断了，这是完全错误的！哪怕一个月管的100个患者中，只有1个病人有循证医学证据，那就是非常宝贵的经验。这1个病人才叫经验，你管理其他99个病人都不会获得有价值的经验，而且有可能还把错误的经验当经验了，那就更加会伤害你的下一个病人。 提起这点我有点激动，刚才提到“素质”，我觉得这还和素质没有任何关系，就只是平时管病人时的习惯、态度，你读不读书，就直接决定你会不会受不良的信息的影响。做临床医生，刚才我们提到要读书、要怀疑，要自己做独立判断，这点这一点非常重要。最后，经验的积累，一定要建立在证据的基础上，没有证据，谈什么经验？
第一轮结果好像也出不来了。中国那个trial中国那边给停了，连partial的数据也不给gilead。中国政府操作骚得很。
中共已经会仿制了，这种做法是邪恶
反正我已经几年时间就从粉红变激进的反贼了。真是服了包子。
你们国内的双盲实验结束了，不给公司数据是什么操作？是不是你们圈子的标准操作？
这么紧急的时候，整理数据要一个月非常不正常。正式报告可以一个月，前面的preliminary data应该快得多。
说不给数据，我个人目前没有收到这个消息，请给出处？
特地去clinicaltrial.gov上查了下，国内曹彬教授牵头的重症新冠的双盲研究，结束日期是5月1号。现在还在双盲期，请问怎么出数据？
我当然不是什么名人，但我之前帖子里表现了我的背景和行业，我之前发的消息也都是真的并无虚假。你什么不了解就来喷我，这种做法很令人得意吗？
放屁！重症组人不够，但是轻中正继续
4月27日才是双盲试验结束的日子，公布瑞德西韦临床试验结果
看看这事2月25日的新闻
http://www.gov.cn/xinwen/2020-02/25/content_5483043.htm
"到目前為止是最有機會有療效的藥物"
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