Four important patients respond well to the new drug. Needs to be verified, experts say-Mumbai News

Four very important Covid-19 patients (complications caused by the Sars-CoV-2 virus) who had ventilator support due to extensive scarring of lung tissue leading to low oxygen levels Arrived at home with minimal oxygen support after a pulmonologist, the Army Institute of Cardiothoracic Sciences (AICTS) has implemented a new treatment using the antifibrotic drug nintedanib.

“We lost hope in these four patients, but when we administered nintedanib in a combination of steroids, those conditions improved. Very safe and without complications or side effects. We were able to send them home with minimal oxygen support,” said Brigadier (Medical) HQ MG&G (Maharashtra, Gujarat, Goa) region, with clear evidence that this subset of patients suffered. Added pulmonary fibrosis on CT scan. Nintedanib costs about ₹65,000 or less per month (60 tablets).

Pulmonary fibrosis is usually detected late and is found in patients with extensive pneumonia. Often, despite anti-inflammatory therapies such as steroids, it becomes difficult to pull these patients away from oxygen and remain in the intensive care unit for a long time.

Patients infected with the novel coronavirus-associated pulmonary fibrosis are on high-flow oxygen or other ventilatory support because they cannot maintain normal oxygen saturation levels themselves. Oxygen saturation in most healthy individuals is about 95% or higher, but can drop to 75% in Covid-19 patients, which can be fatal.

Dr. Lancelot Pinto, a respiratory specialist at the Hinduja Hospital, said antifibrotic drugs such as pirfenidone and nintedanib may have antifibrotic effects, but their efficacy was randomized controlled trials (RCTs). ) Need to verify.

“We have seen patients with high oxygen demand and bilateral lung disease gradually improve and withdraw oxygen over time. Recovery can be slow, and sometimes we are at home with oxygen support. He discharged the patient and eventually let them go.

“In the absence of a control arm, it is impossible to know if it was the drug or time that caused the elucidation of its clinical and radiological characteristics. Already assessing the safety and efficacy of pirfenidone The RCT is in progress and we look forward to the results.”

“There are a number of observational studies of Covid’s drugs (such as HCQ) that have shown promising results, but have failed to be more effective than placebo in clinical trials. Based on a case series of four patients, We definitely should not change practice.

The team said antifibrotic drugs are commonly used to treat other types of lung fibrosis, rheumatoid arthritis, and idiopathic pulmonary fibrosis (IPF) secondary to autoimmune diseases.

“Nintedanib is a disease that some immunologists and rheumatologists make when the lungs develop fibrosis as a result of an autoimmune disease in which the body’s immune system becomes unstable and it begins to recognize its own organs as foreign and initiate attacks. It’s a drug often used by specialists, said a spokesperson for the team. “In some of these conditions, lungs develop fibrosis, and nintedanib is an expensive drug that can be used effectively in the clinical management of the condition. Has been done,” the spokesperson added.

With this as a clue, AICTS’s Department of Respiratory Care in four patients with Covid-19-related pulmonary fibrosis, who had difficulty scavenging oxygen due to widespread pulmonary fibrosis, had a steadily worsening I decided to try a combination of steroids and nintedanib. Doctors said antifibrotic drugs were used in four patients at a highly advanced stage of Covid-19 in need of powerful treatment

As they recovered, these patients should receive minimal oxygen support at home, even after negative Covid-19, and follow-up continued clinically and through laboratory investigations and CT scan imaging. Will be done. The team said that although nintedanib is fairly safe, it can cause diarrhea and, in some people, liver dysfunction.

“Patients cannot be discharged from the hospital unless they have an oxygen saturation above 93-94% to help them continue their daily lives. Why are these four patients requiring low levels of oxygen and follow-up? , Stationery (like sitting) saturates at 93-94%, but falls to 90-91% with little activity.

As an observational study, a report is included in the pipeline of an internationally peer-reviewed scientific journal on clinical management using ninetedanib in these four patients. In the future, the team will recognize a similar subset and propose to utilize the same treatment protocol.

The team currently says there are no published case reports of the drug used in patients with severe lung fibrosis caused by Covid-19 who are unable to withdraw from the ventilator.

How to choose a patient

Patients with Covid-19 are detected and/or progressed to critical stages of the disease (that is, oxygen saturation cannot be maintained without high-flow oxygen or ventilator support) and are evaluated extensively.

Computed tomography pulmonary angiography is done to rule out the possibility of pulmonary embolism (coagulation of the lungs) and to check the extent of fibrosis that may have occurred in the lungs.

Patients also undergo various blood tests to look for ongoing inflammation by assessing markers of inflammation among other parameters.

Inflammation is controlled by steroids (the first line of Covid-19) and CT images reveal evidence of prominent fibrosis leading to patients in need of continuous oxygen supplementation, making withdrawal difficult If so, treatment with nintedabine will begin.