Biomaterial Database

[The first Italian clinical experience with almitrine bismesylate]. 1985

V Grassi, and G Bottino, and A Blasi, and C Grassi

A double blind randomised multicentre clinical trial against placebo was performed in Italy on 128 patients with chronic airflow obstruction and hypoxaemia. On entry to the study all the patients were hypoxaemic (PaO2 less than or equal to 70 mmHg), 22 were normocapnic (PaCO2 less than or equal to 41 mmHg), 106 hypercapnic (PaCO2 greater than or equal to 43 mmHg). The patients (107 males and 21 females) with a mean age of 64 received oral Almitrine bismesylate for two months in a dose of 100 mg per day or placebo taken in two doses with the main meals. After inclusion in the study (TO), patients were reviewed after 30 and 60 days of treatment to evaluate pulmonary function and blood gases. The results were as follows: Almitrine bismesylate did not produce any significant variations in lung volumes, tests of airflow obstruction (for large or small airways) or the distribution of intra-pulmonary inspired air. The blood gas values at the end of treatment showed statistically significant changes (p less than 0.001: PaCO2 + 7.6 mmHg in patients overall and PaCO2 - 4.1 mmHg in those patients with hypercapnia.) The changes in arterial blood, already apparent after 30 days, were even more marked at the end of the study. These favourable blood gas changes might be the result (for the greater part) of the intra-pulmonary haemodynamic effect induced by Almitrine bismesylate (improved VA/QC ratios described in the literature) and (for a smaller part) a better ventilatory pattern with a reduction in the (A-a) DO2 and the functional dead space.(ABSTRACT TRUNCATED AT 250 WORDS)

UI	MeSH Term	Description	Entries
D007558	Italy	A country in southern Europe, a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. The capital is Rome.	Sardinia
D008173	Lung Diseases, Obstructive	Any disorder marked by obstruction of conducting airways of the lung. AIRWAY OBSTRUCTION may be acute, chronic, intermittent, or persistent.	Obstructive Lung Diseases,Obstructive Pulmonary Diseases,Lung Disease, Obstructive,Obstructive Lung Disease,Obstructive Pulmonary Disease,Pulmonary Disease, Obstructive,Pulmonary Diseases, Obstructive
D008297	Male		Males
D010101	Oxygen Consumption	The rate at which oxygen is used by a tissue; microliters of oxygen STPD used per milligram of tissue per hour; the rate at which oxygen enters the blood from alveolar gas, equal in the steady state to the consumption of oxygen by tissue metabolism throughout the body. (Stedman, 25th ed, p346)	Consumption, Oxygen,Consumptions, Oxygen,Oxygen Consumptions
D010879	Piperazines	Compounds that are derived from PIPERAZINE.
D011659	Pulmonary Gas Exchange	The exchange of OXYGEN and CARBON DIOXIDE between alveolar air and pulmonary capillary blood that occurs across the BLOOD-AIR BARRIER.	Exchange, Pulmonary Gas,Gas Exchange, Pulmonary
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation