in the afternoon on January 5, only for pneumoconiosis disease (pulmonary fibrosis) 1.1 class of new drugs in development for los oxime hydrochloride manufacturers burke creatures in Beijing announced the launch Ⅱ phase of clinical trials. It is understood that the drug in the national science and technology research funds and & other; 863 plan & throughout; In 2005 under the auspices of the founding start Ⅰ period clinical research, the research on the tolerability of pharmacokinetic and clinical research, and in 2010, completed Ⅰ clinical research summary report. At present it has entered the Ⅱ period clinical trial research stage, to participate in clinical trials of pneumoconiosis patients is still in recruitment.
pneumoconiosis: one of the most serious occupational disease in China
in China is the world’s pneumoconiosis against one of the most serious, pneumoconiosis is one of the most serious occupational disease in China, its characteristic is high incidence, serious fibrosis of patients with lung lesions, breathing problems and affect the labor force, even from the work site, the disease continued to progress. National health development planning commission according to the 2014 national occupational disease report released, pneumoconiosis is still in our country the head of the occupational disease, accounted for nearly ninety percent, the fatality rate of more than 20%, known as occupational disease & other Top killer & throughout; . It with coal workers pneumoconiosis, silicosis pneumoconiosis, the worst in pneumoconiosis patients more than half of coal workers pneumoconiosis. From the industry distribution, coal mining and washing industry, non-ferrous metal mining CaiXuanYe and auxiliary industry more cases of occupational diseases, accounted for 62.52% of the national report occupational disease. But experts found that the occupational disease diagnosis and can be done in the registration of the centers for disease control and prevention is only 10% ~ 20% of pneumoconiosis patients.
so far, according to incomplete statistics the 7.5 million pneumoconiosis patients, according to the relevant departments to a rough estimate, the our country each year because of the occupational disease, inductrial injury accident direct economic loss of billions. Given the pneumoconiosis is one of the most serious occupational disease in our country, numerous pneumoconiosis patients, but there is a kind of approved list, delay and block the effective therapy for pneumoconiosis disease progress, therefore, urgent need for high efficiency, low toxicity and convenient to use the drug for the treatment of pneumoconiosis.
pneumoconiosis: can’t breathe the pain of
pneumoconiosis disease is caused by long-term inhalation of a large number of fine dust and disabling disease is given priority to with lung fibrosis of the organs, common symptoms are chest tightness, chest pain, shortness of breath, cough, general weakness, the person that weigh lose labor ability, can’t even recumbent, even sleeping all kneel, finally because of lung function failure, difficulty in breathing die kneeling, the shape of miserably, an eyes.
silicosis also called silicosis, is one of the most common type of pneumoconiosis, is caused by long-term and inspiratory free silica dust, with tuberous main pathological changes of pulmonary fibrosis disease, characterized by chronic progressive exertional dyspnea and pulmonary dysfunction. Silicosis is the most common, the fastest progress in pneumoconiosis, harm one of the most serious type. In our country every year for 20000 cases of pneumoconiosis patients with new, there is no effective drug treatment.
pneumoconiosis make patients suffer not only physical and mental suffering, and make the patients lose labor ability gradually, to individuals, families and society bring heavy burden to patients.
burke creature: speed up the new drug clinical trials
in recent years, more and more people focus on the pneumoconiosis patients this special group, countries have introduced the corresponding measures. In January 2017, the country’s 10 ministries jointly issued the “on strengthening migrant workers pneumoconiosis disease prevention and control work opinion”; On December 13, the national health development planning commission issued “on the national health and family planning commission pneumoconiosis diagnosis expert committee notice, decided to set up the national health and family planning commission pneumoconiosis diagnosis expert committee.
hydrochloric acid for los oxime is found in the screening of more than 1000 kinds of compounds and Chinese herbal medicine on experimental silicosis has obvious curative effect of a drug, side effects and hydrochloric acid for los oxime is small. It is mainly used for silicosis and coal workers pneumoconiosis disease, hydrochloric acid for los oxime is the only country for pneumoconiosis disease (pulmonary fibrosis) 1.1 class of new drugs in development that jiangsu burke biological pharmaceutical co., LTD owns all intellectual property rights, is the only research and development and production units, the Chinese center for disease control and prevention of occupational health and poison control was developed.
biological pharmaceutical co., LTD., jiangsu burke by national & other One thousand people plan & throughout; Distinguished expert Dr Wang founded in June 2010, the registered capital is 118 million yuan RMB. Research and development of the management team of 61 people, bachelor degree or above 45 people, including six study overseas high-level talents, Dr. 8, master’s seven. Company focused on innovative drugs, functional food, medical and health management in four fields such as research, production and sales of the product.
graduated from the university of California, Berkeley, to obtain a doctorate in molecular and cell biology, Dr Wang from ordinary peasant migrant workers are concerned about: of pneumoconiosis & other; In Berkeley, I worked in a hereditary gene therapy research of cystic fibrosis. After repeated research, found that the new drug research of pneumoconiosis rarely at home and abroad, the developed countries do not have this disease, everybody is busy for the study of the diseases of the wealthy domestic medicine, my father had ever been migrant workers into the city in the 80 s, the huge crowd, for national modernization had now no one is willing to develop new drugs for them. Throughout the &;
in the summer of 2016, Dr Wang to public welfare organization & other; Big love cleaning & throughout; , lead the people of nearly 20 research group, braved the heat, rushed to hunan anhua.we will act qing tong town, village, in the eight Luo Dong ping, sinopec village, village, dragon depression WuTong Village 24 pneumoconiosis patients families in administrative villages, such as the field investigation and discussion, know their living conditions, medical records, medication categories, and the effect, the policy expectation.
because of pneumoconiosis treatment is expensive, most of the poor farmers cannot afford. Survey a patient told Dr. Wang: & other; Found is the third phase of pneumoconiosis, we really can’t afford to cure. Throughout the &; Said he picked up two boxes of medicine to Dr Wang, & other; You see, this medicine is several hundred dollars a box, only enough to eat for a month, and can only be maintained for the illness, the illness is a bottomless pit. Throughout the &;
yes, no medicine can cure pneumoconiosis, at present there are only some of the complications of the adaptive control, there is no specific drug for pneumoconiosis. Dr Wang is introduced: & other; Domestic treatment of pneumoconiosis treatments are being researched at present, only we burke creatures. Burke is the only creature pneumoconiosis drug resistance & ndash; & ndash; R&d and production of hydrochloric acid for los oxime unit, at present has been launched Ⅱ phase of clinical trials. We are to speed up the clinical trials, race against time, let the pneumoconiosis patients early cure, bring them hope! Throughout the &;
related: patients with stage II clinical trial research base of recruiting contact
clinical trial & middot; Recruitment conditions
all participants must meet the following conditions can only be selected:
1) aged 18 to 75 years old, men and women not limited;
2) according to the history and related inspection, diagnosis of silicosis patients with stage I or II;
3) (FVC), forced expiratory volume of expected value & ge; 40%, and the total amount of carbon monoxide diffusion (DLCO) of expected value & ge; 30%, and the quiet condition for indoor air arterial blood oxygen partial pressure (PaO2) & ge; 55 MMHG.
4) voluntarily signed informed consent.
subjects exclusion criteria:
one of the following is not included in this test:
1) not contacts from the dust;
2) no smoking cessation, and the application after bronchodilator forced expiratory volume in 1 second (FEV1/FVC) & lt; FEV1 accounted for 70%, is expected to value % & lt; 50%;
3) active tuberculosis or other infectious diseases in patients with acute stage;
4) uncontrolled bronchial asthma;
5) disease, bronchiectasis range> 1 lung segment;
6) other types of pneumoconiosis or interstitial lung disease;
7) serious irreversible eye diseases, such as visual field defect, retinopathy, etc;
8) with autoimmune disease or severe nervous system disease;
9) cardiovascular disease, like the ones below any standard: a. into the group of six weeks before grade 3 hypertension, and after the treatment was not controlled (& ge; 160/100 MMHG); B. into the group of the first six months of acute myocardial infarction; C. to enroll in unstable angina before 6 months;
10) merge pulmonary hypertension patients;
11) hemoglobin & le; 90 g/L or other blood system diseases patients;
12) liver and kidney dysfunction: alanine aminotransferase (ALT) or aspertate aminotransferase (AST) & gt; Upper limit of normal 2 times, or serum creatinine (Cr) & gt; Upper limit of normal 1.5 times;
13) cancer patients;
14) are patients with pregnancy patients or planning a pregnancy, lactation, or in the childbearing age and during the test and test within three months after the end of the patients can’t enough precautions (enough oral contraceptives, intrauterine device and barrier measures).
15) patients with mental illness, unable to cooperate to complete the research;
16) into groups within a month before the treated pulmonary fibrosis, such as taking overlooks the double benzyl ketone, class isoquinoline alkaloid (han has a plain), polyethylene pyrimidine nitrogen oxide silicon flat (g), piperaquine phosphate, hydroxy piperaquine phosphate and aluminium citrate;
17) is in other clinical subjects within 3 months or participated in other clinical subjects;
18) researchers think not appropriate to other situations.