Inhaled granulocyte-macrophage colony stimulating factor for mild-to-moderate autoimmune pulmonary alveolar proteinosis - a six month phase II randomized study with 24 months of follow-up

Table 1 Demographic features of autoimmune pulmonary alveolar proteinosis (aPAP) patients at baseline

Parameter		Control group (n = 17)	Treatment group (n = 19)	P value
Age (year)		42.88 ± 12.75	43.53 ± 12.89	0.881
Sex (female/male)		4/13	6/13	0.717
Duration of the disease (months)^a		6 (6–60)	6 (0.5–60)	0.852
Smoking status	Never	7	7	0.965
	Ex-smoker	5	6
	Current smoker	5	6
Disease Severity Score	1	0	0	0.409
	2	13	11
	3	4	8
Hb (g/dL)		16.11 ± 1.61	16.00 ± 1.64	0.839
HCT (%)		46.07 ± 3.7	45.74 ± 4.47	0.810
LDH (U/L)		244.06 ± 53.02	233.82 ± 43.43	0.547
CEA (U/L)		5.34 ± 4.96	4.74 ± 3.41	0.678
FEV₁ pred (%)		78.09 ± 14.12	79.16 ± 15.68	0.832
FVC pred (%)		79.14 ± 13.42	79.71 ± 13.70	0.900
TLC pred (%)		74.59 ± 9.65	74.82 ± 10.78	0.946
DLCO pred (%)		69.50 ± 13.94	68.41 ± 16.90	0.835
DLCO/VA pred (%)		98.58 ± 18.45	98.67 ± 24.32	0.990
PaO₂ (mmHg)		77.51 ± 8.53	76.88 ± 11.23	0.854
A-aDO₂ (mmHg)		28.32 ± 9.09	28.74 ± 11.04	0.902
SGRQ symptom		24.06 ± 13.55	29.17 ± 29.75	0.506
SGRQ activity		30.70 ± 18.46	30.33 ± 16.55	0.949
SGRQ effect		24.20 ± 16.10	21.83 ± 21.29	0.712
SGRQ total		26.47 ± 14.74	27.38 ± 19.75	0.878
6MWD		495.25 ± 79.39	477.95 ± 65.68	0.485
SpO₂ at the end of 6MWD		94.87 ± 2.70	94.58 ± 5.20	0.847
Mean lung density		− 718.62 ± 82.70	− 687.25 ± 68.48	0.315
Total lung volume radiological measurement (ml)		4556.08 ± 841.15	4461.08 ± 1399.60	0.841
GM-CSF antibody (μ g/ml)		75.86 ± 93.94	73.30 ± 58.65	0.922
Treatment before the trial	Never	13	14	0.489
	WLL	3	5
	Others^b	1	0

Abbreviations: aPAP autoimmune pulmonary alveolar proteinosis, A-aO₂ alveolar arterial oxygen gradient, CEA carcinoembryonic antigen, DLCO: DLCO_: diffusing capacity for carbon monoxide, DLCO/VA diffusing capacity for carbon monoxide corrected for alveolar volume, FEV1 forced expiratory volume in the first second, FVC forced vital capacity, GM-CSF granulocyte macrophage colony stimulating factor, Hb hemoglobin, HCT hematocrit, LDH lactate dehydrogenase, PaO₂ partial pressure of oxygen, SGRQ St George Respiratory Questionnaire, SpO₂ oxygen saturation in pulse oximetry, TLC total lung capacity, 6MWD 6 min walking distance (test)
^a: median (inter-quartile range)
^b:Traditional medicine treatment

ISSN: 1750-1172