Writer : Shi Huanzhong, http://blog.sciencenet.cn/u/shihuanzhong
Translation, editing : Gan Yung Chyan
/ KUCINTA SETIA
Image : Web Screenshot
On 17 July 2020, the New England Journal of Medicine published online the results of a large randomized controlled trial (RCT) of glucocorticoids (hormones) in the treatment of novel coronavirus pneumonia (covid, in short) (N Engl J Med 10.1056/NEJMoa2021436). Now, people finally have strong enough clinical evidence to safely give short-term oral or intravenous small doses of hormones to patients with covid who need oxygen or non-invasive ventilator. The most important result of the study is that hormones can greatly reduce the mortality of patients within 28 days. The medical circles all over the world have tossed for so long and finally found a "magic medicine" that can definitely reduce the mortality rate of new coronary pneumonia, and the "magic medicine" is actually an old and old medicine.
Most covid patients are asymptomatic or mild to moderate, and patients who need oxygen are only a small part of them. It is known that the pathophysiological characteristics of critically ill patients are rapid development of acute lung inflammation; pathological characteristics include diffuse alveolar injury, inflammatory exudation, and microvascular thrombosis. In the early stages of the covid pandemic, most doctors in Hubei chose to give patients hormones to suppress the strong inflammatory response in the lungs. At that time, the use of hormones was entirely based on professional knowledge, and there was no evidence to support it. Now there is large-scale RCT evidence, which shows that the original idea was correct. It is reasonable to believe that it is precisely because of the early aggressive use of hormones by Hubei doctors that many lives have been saved.
Let us take a look at the value of this research. Its biggest advantage lies in multi-center group operations. The research unit involves 176 medical units in the UK. A total of 2,104 patients were randomly assigned to the hormone group, and 4321 patients entered the control group. The hormone medication is dexamethasone, the dose is 6 mg per day for no more than 10 days. The above published papers are only preliminary research reports, and the main observation index is the case fatality rate within 28 days.
The results showed that 482 patients (22.9%) and 1110 patients (25.7%) in the hormone group and the control group died within 28 days after randomization (age adjustment rate 0.83; 95% CI 0.75 to 0.93; P <0.001). The former is significantly lower than the latter. Subgroup analysis showed that the more severe the disease, the more obvious the hypoxia is, the greater the benefit of using hormones. For patients who require non-invasive ventilation, the fatality rate of the hormone group (29.3%) is significantly lower than that of the control group (ratio 0.64; 95% CI 0.51 to 0.81); for patients who simply inhale oxygen through the catheter, The fatality rate of 23.3% in the hormone group was also lower than the 26.2% in the control group (ratio 0.82; 95% CI 0.72 to 0.94), but the difference was not significant in the part of patients requiring non-invasive ventilation. However, for patients who do not require oxygen therapy, the fatality rate of the hormone group (17.8%) and the control group (14.0%) are similar, and the difference is not statistically significant. In other words, patients with mild covid do not need to use hormone therapy.
It should be emphasized that the paper just published is just a preliminary report of the 28-day case fatality rate. We continue to look forward to the author's next observation and analysis report, such as the case fatality rate of 60 days, 3 months, and 1 year, and research data on hormone-related side effects. Hormones are a double-edged sword. During treatment, they interfere with glucose metabolism and increase the chance of secondary infection. Some patients may die due to secondary infection, and they will also affect bone metabolism in the long term. All these doubts can be answered only by the follow-up data of the study. However, according to common sense, because the use of hormones is a short-term, small-dose, it is estimated that no serious adverse reactions will occur overall.
This study not only clearly answers a very important clinical question about the treatment of covid, but also has directional participation value for hormone treatment of other viral pneumonia such as influenza, SARS and MERS. It is expected that the follow-up data will draw conclusions similar to the preliminary report, that is, hormones can reduce the fatality rate of patients with obvious hypoxia to nearly 30%. In this way, we can be more assured that hormones are the "magic medicine" for the treatment of covid. In the future, when covid patients are admitted, as long as they are found to need oxygen or a non-invasive ventilator to relieve hypoxia, they should promptly give small doses of hormones for a short time.
As mentioned above, the characteristics of covid cases also include microvascular thrombosis. Based on this speculation, the next miraculous drug for covid may be anticoagulant drugs, such as low-dose heparin or rivaroxaban.
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