Adjuvant interferon gamma in patients with pulmonary atypical Mycobacteriosis: A randomized, double-blind, placebo-controlled study

María T Milanés-Virelles; Idrian García-García; Yamilet Santos-Herrera; Magalys Valdés-Quintana; Carmen M Valenzuela-Silva; Gaspar Jiménez-Madrigal; Thelvia I Ramos-Gómez; Iraldo Bello-Rivero; Norma Fernández-Olivera; Reinaldo B Sánchez-de la Osa; Carmen Rodríguez-Acosta; Lidia González-Méndez; Gregorio Martínez-Sánchez; Pedro A López-Saura

doi:10.1186/1471-2334-8-17

BMC Infectious Diseases

Table 3 Clinical, radiological, bacteriological and overall outcomes during the trial.

From: Adjuvant interferon gamma in patients with pulmonary atypical Mycobacteriosis: A randomized, double-blind, placebo-controlled study

Evaluation	Month		IFN gamma	Placebo	P (test)
Overall response
Responders ^(a) (intention-to- treat)	6		13/18 (72.2%)	5/14 (35.7%)	0.037 (χ²)
	18		12/18 (66.7%)	4/14 (28.6%)	0.030 (χ²)
Responders (last evaluation)			15/18 (83.3%)	5/14 (35.7%)	0.005 (χ²)
Clinical
Dyspnea	0		15/18 (83.3%)	13/14 (92.9%)
	6		1/15 (6.7%)	3/9 (33.3%)	0.27 (FE)
	18		1/13 (7.7%)	3/8 (37.5%)	0.25 (FE)
BMI (kg/m²), mean ± SD	0		21.1 ± 3.5 (N = 18)	18.7 ± 2.8 (N = 14)
	6		21.8 ± 3.7 (N = 14)	19.4 ± 3.0 (N = 9)	0.88 (St)
	18		22.9 ± 4.4 (N = 13)	19.9 ± 3.9 (N = 8)	0.15 (St)
Good general status (intention-to-treat)	0		3/18 (16.7%)	4/14 (28.6%)
	6		13/18 (72.2%)	5/14 (35.7%)	0.037 (χ²)
	18		12/18 (66.7%)	4/14 (28.6%)	0.03 (χ²)
Improvement ^(b) (intention-to-treat)	6		13/18 (72.2%)	5/14 (35.7%)	0.037 (χ²)
	18		12/18 (66.7%)	4/14 (28.6%)	0.03 (χ²)
Radiological
Lesion extension	0	Adv	12 (66.7%)	11(78.6%)
		Mod	5 (27.8%)	3 (21.4%)
		Min	1 (5.6%)	0
	6	Adv	2 (13.3%)	5 (55.6%)	1.00^c (FE)
		Mod	12 (80.0%)	3 (33.3%)
		Min	1 (6.7%)	1 (11.1%)
	18	Adv	1 (7.7%)	2 (25.0%)	0.085^c (FE)
		Mod	5 (38.5%)	5 (62.5%)
		Min	7 (53.8%)^d	1 (12.5%)
Improvement (intention to treat)	6		12/18 (66.7%)	6/14 (42.8%)	0.32 (χ²)
	18		13/18 (72.2%)	4/14 (28.6%)	0.036 (χ²)
Cavitary lesions disappearance			5/12 (41.7%)	1/12 (8.3%)	0.15 (FE)
Bacteriological
Sputum- Direct (+)	0		14/18 (77.8%)	10/14 (71.4%)
	Cod.		7 ± 4	8 ± 8
	6		1/15 (6.7%)	2/10 (20.0%)	0.54 (FE)
	Cod.		0 ± 0	0 ± 2	0.28 (MW)
	18		1/13 (7.7%)	3/8 (37.5%)	0.253 (FE)
	Cod.		0 ± 0	0 ± 7	0.112 (MW)
	Relapse		1/13 (7.7%)	3/8 (37.5%)	0.25 (FE)
Sputum- Culture (+)	0		18 (100%)	14 (100%)
	Cod.		8 ± 2	9 ± 4
	6		2/15 (13.3%)	2/10 (20.0%)	1.00 (FE)
	Cod.		0 ± 0	0 ± 2	0.60 (MW)
	18		1/13 (7.7%)	4/8 (50.0%)	0.11 (FE)
	Cod.		0 ± 0	0 ± 8	0.042 (MW)
	Relapse		1/13 (7.7%)	3/8 (37.5%)	0.25 (FE)

(St): Student's t test; (MW): Mann-Whitney's U test; all binary variable comparisons were with the Fisher's exact test.
^(a) All overall responses were complete except for one IFN group case at month 6 with partial response.
^(b) General clinical status improvement if the patient passed from "bad" to "moderate" or from "moderate" to "good".
Adv: Advanced; Mod: Moderate; Min: Minimum; ^(c) Combining advanced-moderate;
^dOne of them had lesions disappearance at this time.

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