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Lung & Respiration Diseases Asthma

What is asthma?

Asthma is a serious condition in which the small airways of the affected person's lungs suddenly constrict when they are exposed to certain triggers, such as dust mites, pollen, exercise, or even dry air. During an asthma ‘attack', the person's airway lining rapidly becomes inflamed and swollen, the muscles around the airways tighten, and excess mucus is produced as the body reacts to the trigger. This reaction causes reduced airflow into and out of the lungs, and the person has to gasp for breath.

Asthma is a major public health problem affecting 52 million people around the world, including 2million Australians and 15 million Americans. The disease is usually life-long and each year claims around 400 lives in Australia and 4,500 lives in the US. Recent studies have shown that the incidence of asthma in Australian children is increasing.

The disease has a major impact on the quality of life of asthmatics and their families, with many sufferers requiring daily medication and modifications in their lifestyle. In addition to the human price, asthma is a major component of the cost of the healthcare system. For example, the cost to the US healthcare system is in excess of US$15 billion per year. 
 

How is asthma currently managed?

The effective diagnosis, monitoring and management of asthma remain key challenges for doctors and asthmatics. The primary method currently used to diagnose asthma has remained unchanged for many years, with a diagnosis arrived at through a detailed history and physical examination of the patient.

Exercise challenge tests and methacholine inhalation tests are procedures used most frequently in clinical laboratories to evaluate airway responsiveness. While these tests can indicate the presence of asthma, they are not sensitive or specific enough for asthma, nor do they give a precise or objective measure of the seriousness of the patient's condition. As a consequence, under-diagnosis and misdiagnosis of asthma continue to be serious medical issues that impact extensively onpeople's health and quality of life. There are a number of therapeutic options to treat the symptoms of asthma, including inhalers that expand the airways, and preventative measures such as anti-inflammatory medications.

The absence of an accurate test not only hinders the diagnosis of asthma, but also makes it difficult for doctors to monitor the severity of their patients' asthma to ensure they receive the most appropriate dose of medication.

Many asthma sufferers have poor control of their disease, placing an over reliance on bronchodilators to control their asthma symptoms. At the other extreme, many people with asthma have few outward symptoms and can become less diligent with their asthma management.

Much of the deterioration in the quality of life of asthma sufferers could be prevented through correct early diagnosis of the disease, appropriate treatment, and effective ongoing monitoring. Pharmaxis is committed to meeting this medical need. 

Cystic Fibrosis

 

What is cystic fibrosis?

Cystic fibrosis (CF) is an inherited, life-limiting disease that affects the body's exocrine glands,which produce mucus, saliva, sweat and tears. In CF, a genetic mutation disrupts the delicate balance of sodium, chloride and water within cells,causing the exocrine glands to secrete fluids that are poorly hydrated and therefore thicker and stickier than fluids in people without CF. This leads to chronic problems in various systems of the body, particularly the lungs and pancreas, and the digestive and reproductive systems.In the lungs of a CFpatient, the thick mucus and the thinning of the airway surface liquid make it nearly impossible for the cilia to clear bacteria from the airway. This severely impairs the natural airway-clearing processes and increases the potential for bacteria to be trapped, leading to respiratory infections that may require hospitalisation. Impairments in these vital lung defence mechanisms typically begin in early childhood and often result in chronic secondary infections, leading to progressive lung dysfunction and deterioration.Although the life expectancy of CF sufferers has increased over the past few decades due to better management of the disease, the median life expectancy today for patients with cystic fibrosis is only 31 years of age.There are 33,000diagnosed CF patients in the US and 75,000 in the eight major pharmaceutical markets. In Australia, 2,500 people suffer from the disease, a quarter of whom are children under five years of age.

 

How is cystic fibrosis currently managed?

 

Currently, there is no cure for CF. The goal for doctors treating CF sufferers is to hydrate, breakdown and move the excessive, sticky mucus secretions to improve lung function and reduce the number and severity of secondary lung infections. CF sufferers and their carers are generally able to manage the condition at home using a combination of exercise, daily physiotherapy, postural drainage, and chest percussion (to assist the sufferer to expel mucus from their lungs). Depending on the severity of the condition, caring for a person with CF can take several hours of at-home treatment every day.

Medications to treat CF are limited, and not beneficial in all patients. Nebulised medications,delivered by aerosol or a face mask, are used to make the mucus less thick andsticky and open up the airways. Antibiotics, either nebulised or by oral or intravenous administration may also be required to treat secondary infections.
  

Chronic Obstructive Pulmonary Disease (COPD)

 

What is COPD?

 

Chronic Obstructive Pulmonary Disease, or COPD, is a generalized term for a group of diseases that involve progressive narrowing of the airways that service the lungs. This airway narrowing cannot generally be reversed resulting in labored breathing and poor oxygen transfer from the lungs. People with COPD have excessive mucus build up in their airways and a chronic troublesome cough. The most common diseases classified as COPD are emphysema, chronic bronchitis and bronchiectasis. In chronic bronchitis, the airways become inflamed, and the bronchial walls thicken. These changes and the loss of supporting alveoli limit airflow by allowing the airway walls to deform and narrow.
Emphysema is an abnormal, permanent enlargement of the alveoli that ultimately results in destruction of the alveoli walls.

 

COPD was responsible for 3 million deaths in 2005 and the WHO predicts that by 2030, it will be the third largest cause of mortality worldwide.

 

More than 12 million people in the U.S. are diagnosed with COPD, although, because the disease develops slowly, many people have may have the disease and not be diagnosed. The symptoms of COPD often worsen over time and when the disease becomes severe will prevent the conducting of even basic activities such as walking, cooking, or washing. As symptoms worsen, there is an increased risk of an acute exacerbations (or worsening of symptoms) of the condition, that usually results in hospitalisation of the patient.

 

More than 30 million people are affected with COPD in the seven major pharmaceutical markets. In 2005 there were more than 10 million physician office visits and two million hospitalizations per year. The disease was estimated to cost the U.S. healthcare system U.S.$30 billion in 2000.

 

Increasing prevalence of COPD

 

While the worldwide prevalence of COPD is growing, much of this is due to developing countries where smoking rates remain high. Western markets are estimated to have a growth rate of +1.5% year on year as screening rates for COPD detection improve, despite long-term smoking rates starting to decrease.

 

How is COPD currently managed?

 

While many medications are available to treat COPD, no drug has demonstrated effectiveness in halting the progression of the disease. Rather, the goal of drug therapy at this time is to maintain control of symptoms and prevent COPD exacerbation. For example, tiotropium is used to control the symptoms of COPD. Tiotropium is a prescription medicine used once every day to relax the airways and keep them open. Tiotropium also reduces the likelihood of flare-ups and worsening of COPD symptoms (exacerbations). In 2008, the worldwide sales of tiotropium were US$3 billion

 

Management of COPD generally involves bronchodilators such as tiotropium and inhaled steroids. However, only an estimated 20%-25% of patients respond positively to steroids and it is currently not practical to determine in advance which patients will respond to steroids. Therefore, as with asthma, there is room to improve both the diagnosis and management of COPD.

 

While the asthma market is relatively well served by existing treatments controlling
the disease, thus allowing patients to enjoy a good quality of life, there is a
significant need for better therapies to treat COPD, which remains a progressive
disease.

 

Bronchiectasis

 

What is bronchiectasis?

 

Bronchiectasis is a progressive lung disease, affecting 600,000 people worldwide. It is often mistaken for asthma or pneumonia and misdiagnosis is common.In this disease the airway walls are chronically inflamed, with poor clearing of the increased mucus production. Chronic inflammation of the walls of the airway is common to all types of bronchiectasis. This is often a result of a vicious cycle of bacterial infection, in which damage to the lungs further predisposes the lung to more infections. The body repairs the damaged lung tissue by forming tough,fibrous material, which leads to changes that impair normal lung structure and function. Effects include:

·         Reduced lung capacity;

·         Poor gas-exchange;

·         Changes of the organisation of blood vessels; and

·         Overall increased blood flow through the lungs.

These changes can ultimately lead to heart failure. Recurrent lung infections commonly reduce patients' quality of life; progressive respiratory insufficiency is the most common cause of death.Most cases of bronchiectasis develop during childhood, and can be a result of infections such as pneumonia or the inhalation of noxious substances.

 

How is bronchiectasis currently managed?

 

Treatment today is aimed at controlling infections, secretions, airway obstructions and complications. There are no therapeutic products available to effectively clear excess mucus secretions and improve the quality of life of sufferers.Current management of bronchiectasis often involves:

·         Bronchodilators, to dilate the airways to help mucus clearance;

·         Steroids. However, only a minority of mild-moderate bronchiectatic patients respond positively to steroids;

·         Antibiotics to clear infections; and

·         Regular, daily postural drainage to remove bronchial secretions.

 

 

Nonalcoholic steatohepatitis (NASH)

 

What is NASH?

 

The most common cause of chronic liver among children and adults in the western world is non-alcoholic fatty liver disease (NAFLD).  NAFLD ranges from simple steatosis to non-alcoholic steatohepatitis (NASH).  While NAFL can be quite unobtrusive, NASH is a serious condition, with nearly a quarter of affected patients developing cirrhosis, which, in turn, increases the risk of subsequent progression to hepatocellular carcinoma (HCC). NASH is an often “silent” liver disease. It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage. Most people with NASH feel well and are not aware that they have a liver problem. Nevertheless, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to work properly.

NASH is an increasingly common chronic liver disease with worldwide distribution that is closely associated with diabetes and obesity, which have both reached epidemic proportions. It is estimated that there are at least 1.46 billion obese adults worldwide. NASH affects 2 to 5 percent of Americans. An additional 10 to 20 percent of Americans have fat in their liver, but no inflammation or liver damage, a condition called “fatty liver.” Approximately 6 million individuals in the USA are estimated to have progressed to NASH and some 600,000 to NASH-related cirrhosis.

Both NASH and NAFLD are becoming more common, possibly because of the greater number of Americans with obesity. In the past 10 years, the rate of obesity has doubled in adults and tripled in children. Obesity also contributes to diabetes and high blood cholesterol, which can further complicate the health of someone with NASH. Diabetes and high blood cholesterol are also becoming more common among Americans.

 

Diagnosis

 

NASH is usually first suspected in a person who is found to have elevations in liver tests that are included in routine blood test panels, such as alanine aminotransferase (ALT) or aspartate aminotransferase (AST). When further evaluation shows no apparent reason for liver disease (such as medications, viral hepatitis, or excessive use of alcohol) and when x rays or imaging studies of the liver show fat, NASH is suspected. The only means of proving a diagnosis of NASH and separating it from simple fatty liver is a liver biopsy. Currently, no blood tests or scans can reliably provide this information.

Symptoms

 

NASH is usually a silent disease with few or no symptoms. Patients generally feel well in the early stages and only begin to have symptoms—such as fatigue, weight loss, and weakness—once the disease is more advanced or cirrhosis develops. The progression of NASH can take years, even decades. The process can stop and, in some cases, reverse on its own without specific therapy. Or NASH can slowly worsen, causing scarring or “fibrosis” to appear and accumulate in the liver. As fibrosis worsens, cirrhosis develops; the liver becomes seriously scarred, hardened, and unable to function normally. Not every person with NASH develops cirrhosis, but once serious scarring or cirrhosis is present, few treatments can halt the progression. A person with cirrhosis experiences fluid retention, muscle wasting, bleeding from the intestines, and liver failure. Liver transplantation is the only treatment for advanced cirrhosis with liver failure, and transplantation is increasingly performed in people with NASH. NASH ranks as one of the major causes of cirrhosis in America, behind hepatitis C and alcoholic liver disease.

Causes

 

Although NASH has become more common, its underlying cause is still not clear. It most often occurs in persons who are middle-aged and overweight or obese. Many patients with NASH have elevated blood lipids, such as cholesterol and triglycerides, and many have diabetes or prediabetes, but not every obese person or every patient with diabetes has NASH. Furthermore, some patients with NASH are not obese, do not have diabetes, and have normal blood cholesterol and lipids. NASH can occur without any apparent risk factor and can even occur in children. Thus, NASH is not simply obesity that affects the liver.

While the underlying reason for the liver injury that causes NASH is not known, factors including insulin resistance, the release of toxic inflammatory proteins by fat cells and oxidative stress (deterioration of cells) inside liver cells are possible candidates:

Treatment

 Currently, no specific therapies for NASH exist. A major attempt should be made to lower body weight into the healthy range. Weight loss can improve liver tests in patients with NASH and may reverse the disease to some extent. People with NASH often have other medical conditions, such as diabetes, high blood pressure, or elevated cholesterol. These conditions should be treated with medication and adequately controlled; having NASH or elevated liver enzymes should not lead people to avoid treating these other conditions.

Experimental approaches under eveluation in patients with HASH include antioxidants, which act by reducing the oxidative stress that appears to increase inside the liver in patients with NASH.

Patients with chronic bronchitis experience persistent airway inflammation and airflow obstruction, with symptoms including a chronic mucus-producing cough and shortness of breath. Due to the difficulties they have in clearing mucus from their lungs, sufferers are prone to periodic bacterial infections where their cough worsens, mucus production increases and breathing becomes more difficult.These episodes damage and scar the bronchial lining and contribute to continued chronic inflammation and immune-mediated cell damage as the body struggles tofight the infections. This cycle of infection and internal scarring may cause a progressive decline in lung function, reducing quality of life and ultimately causing death.

Many of the deaths associated with chronic bronchitis are included in the COPD figure that now accounts for over 100,000 deaths a year in the U.S. The disease is predominately caused by inhaling some form of lung irritant repeatedly for many years, usually cigarette smoke. Chronic bronchitis is slow to develop and is often not diagnosed until the sufferer is in their 40s or 50s.

 

Pulmonary Fibrosis

 

What is pulmonary fibrosis?

 

Pulmonary fibrosis is a serious disease that causes progressive scarring of the lung tissue. The scar formation is preceded by, and associated with, inflammation. Some common and some rare diseases can cause pulmonary fibrosis, but in the majority of cases the cause is never found. Pulmonary fibrosis can be a mild or severe disease; it can be so mild as to cause few symptoms, or it can be fatal. If the disease progresses, the lung tissues eventually thicken and become stiff.The work of breathing then becomes difficult, causing breathlessness. It can run a gradual course, remain unchanged or run a rapid course. It can also be fatal. Pulmonary fibrosis most often begins with repeated injury to the tissue within and between the tiny air sacs (alveoli) in your lungs. The damage eventually leads to scarring or fibrosis, which stiffens the lungs and makes breathing difficult. The most common symptoms are shortness of breath and a dry cough.
 

How is pulmonary fibrosis currently managed?

 

Current treatments for pulmonary fibrosis include medications and therapy to improve lung function and quality of life. A number of new therapies for pulmonary fibrosis are in clinical trials. In the meantime, a lung transplant may be anoption for some people with pulmonary fibrosis.