Colchicine, D-Penicillamine, and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis: Statistical Analyses
Patients were recruited prospectively during 8 years and followed up during at least 5 years. Treatments were concurrent and the physicians responsible for follow-up were the same. Patients were evaluated 1 month after starting treatment, then at 3 months, and subsequently at 3-month intervals for 2 years and 6-month intervals thereafter unless more often was clinically indicated. Response to therapy was assessed by changes in dyspnea score (dyspnea at exercise, 1: slight; 2: moderate; 3: severe; 4: dyspnea at rest), and in lung function test results as measured by TLC and FVC, and arterial blood gas analysis at rest breathing room air. Evidence of adverse effects was recorded in each visit.
Data are expressed as means±SD. Unpaired Student’s t test was used to analyze the relationship between percentage of fibrosis and mortality. Survival was assessed by the method described by Kaplan and Meier and the Cox proportional hazards regression model. Independent predictors for the models were age, gender, and treatment given. Software (SURVIVAL; Systat Inc; Evanston, 111) was used for stepwise regression for proportional hazards model.
Baseline characteristics of the four groups are summarized in Table 1 comments canadian neighborhood pharmacy. Dyspnea score and pulmonary function test results were comparable among the groups. Younger patients were located in group 4 who received prednisone, colchicine, and D-penicil-lamine when compared with the prednisone and prednisone plus colchicine groups (p<0.05). Five patients were unavailable during the 5-year follow-up. The end points examined for therapeutic outcome were measurable change in dyspnea score, lung function at 1 and 2 years, and survival. No significant changes were observed in dyspnea score.
Including the initial measurement, pulmonary function tests were obtained at least three times during the follow-up in survivors. Results of FVC, TLC, Pa02, and PaC02 after 2 years of treatment are shown in Table 2. Although a trend for improvement in FVC was observed in three groups after 2 years of follow-up, no significant differences either in lung mechanics or in arterial gases were found in any group relative to the baseline measurement.
Table 1—Baseline Characteristics
|Age, yr||55 ±10||55 ±15||49 ±18||46±11|
|Evolution, mo||38 ±34||16±13||35 ±25||14±13|
|FVC%||41±17||44 ±22||27±11||35 ±16|
|Pa02, mm Hg||45±7||44±11||46±12||48±11|
|PaC02, mm Hg||35±8||33±5||35±5||35 ±6|
Table 2—Pulmonary Function Before and After 2 Years of Therapy
|P P+C P+DP P+C + DPFVC%|
|Baseline||41±17||44 ±22||27±11||35 ±16|
|2 yr||51±18||57±17||44 ±23||26 ±8|
|Baseline||63 ±13||66 ±24||56±6||55 ±18|
|2 yr||64 ±20||67±7||64 ±33||ND|
|Pa02, mm Hg|
|2 yr||45 ±8||40±6||45 ±8||42±2|
|PaC02, mm Hg|
|Baseline||35 ±8||33±5||35±5||35 ±6|
|2 yr||32 ±4||37±4||39±17||44±7|