[Effect of AM3 on health-related quality of life in patients with chronic obstructive pulmonary disease belonging to risk groups].
OBJECTIVE
AM3 is an immunomodulator that significantly improves the quality of life of patients with chronic obstructive pulmonary disease (COPD). This study examined the effect of AM3 on the quality of life of patients in different risk groups and identified the factors associated with change in this variable.


METHODS
This was a randomized, double-blind, placebo-controlled trial involving parallel groups of patients. The duration of the trial was 6 months. The study involved 253 patients with a mean (standard deviation) age of 67.7 (8.1) years and a mean forced expiratory volume in one second (FEV1) of 49.7% (10.2%).


RESULTS
Only 121 patients (47.8%) suffered at least one exacerbation during the 6 months period. At the end of the study period, the improvement in St. George's Respiratory Questionnaire (SGRQ) score in those patients who suffered an exacerbation but who received AM3 was significantly greater than that experienced by similar placebo-treated patients (-8.10 compared to -2.5 units; p=0.034). Patients treated with inhaled corticoids also improved more with AM3 than with placebo (-9.17 compared to -4.44; p=0.035). In the 108 patients with an FEV1 of <50%, the improvements were not significantly different (-9.57 vs. -6.57; p=0.23). The factors influencing the change in SGRQ score were baseline SGRQ (p<0.001), exacerbations (p<0.008), an FEV1 of <50% (p<0.032) and treatment with AM3 (p<0.004).


CONCLUSIONS
Among the patients who experienced exacerbations, treatment with AM3 helped prevent the deterioration of their quality of life. Along with AM3 treatment, the factors that independently influenced the change in SGRQ score were suffering from an exacerbation and poorer pulmonary function.
Miravitlles
Marc
M
Servicio de Neumología, Institut Clínic del Tòrax (IDIBAPS), Hospital Clínic, Barcelona, España. marcm@clinic.ub.es
Murio
Cristina
C
Morera
Josep
J
Callol
Luis
L
Alvarez-Sala
José Luis
JL
Alvarez-Mon
Melchor
M
D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D017610:Calcium Compounds; D002130:Calcium Phosphates / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006020:Glycopeptides / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D011788:Quality of Life / Q000523:psychology*; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology; D013440:Sulfides; D011795:Surveys and Questionnaires
D000893:Anti-Inflammatory Agents; D017610:Calcium Compounds; D002130:Calcium Phosphates; D006020:Glycopeptides; D007155:Immunologic Factors; D013440:Sulfides; C033907:calcium sulfide; C038773:Immunoferon