Abstract | BACKGROUND: AIM: To see whether the advantages of prednisolone and open drainage were maintained up to 10 years. DESIGN: Follow-up of randomized, double-blind, placebo-controlled trials. METHODS: All 383 patients (143 constriction, 240 effusion) received the same anti- tuberculosis chemotherapy. They were randomized to prednisolone or placebo for the first 11 weeks, and were followed-up over 10 years. Among the 240 with effusion, 122 were also randomized to immediate open surgical drainage of pericardial fluid versus pericardiocentesis as required. Adverse outcomes were: death from pericarditis, pericardiectomy, repeat pericardiocentesis, and subsequent open drainage. RESULTS: The 10-year follow-up rate was 96%. In constriction patients, adverse outcomes occurred in 19/70 (27%) prednisolone vs. 28/73 (38%) placebo (p = 0.15), deaths from pericarditis being 2 (3%) vs. 8 (11%), respectively (p = 0.098, Fisher's exact test). In effusion patients, adverse outcomes occurred in 14/27 (52%) with neither drainage nor prednisolone, vs. 4/29 (14%) drainage and prednisolone, 4/35 (11%) drainage and placebo, and 6/31 (19%) prednisolone and no drainage (p = 0.08 for interaction). Drainage eliminated the need for repeat pericardiocentesis. In the 176 with effusion and no drainage, adverse outcomes occurred in 17/88 (19%) prednisolone vs. 35/88 (40%) placebo patients (p = 0.003), with repeat pericardiocentesis 20 (23%) placebo vs. 9 (10%) prednisolone (p = 0.025). In a multivariate survival analysis (stratified by type of pericarditis), prednisolone reduced the overall death rate after adjusting for age and sex (p = 0.044), and substantially reduced the risk of death from pericarditis (p = 0.004). At 10 years, the great majority of surviving patients in all treatment groups were either fully active or out and about, even if activity was restricted. DISCUSSION:
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Authors | J I G Strang, A J Nunn, D A Johnson, A Casbard, D G Gibson, D J Girling |
Journal | QJM : monthly journal of the Association of Physicians
(QJM)
Vol. 97
Issue 8
Pg. 525-35
(Aug 2004)
ISSN: 1460-2725 [Print] England |
PMID | 15256610
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antitubercular Agents
- Prednisolone
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Topics |
- Adolescent
- Antitubercular Agents
(adverse effects, therapeutic use)
- Child
- Child, Preschool
- Drainage
(methods)
- Female
- Follow-Up Studies
- Humans
- Male
- Pericarditis, Constrictive
(drug therapy, mortality)
- Pericarditis, Tuberculous
(drug therapy, mortality)
- Prednisolone
(adverse effects, therapeutic use)
- South Africa
- Survival Analysis
- Treatment Outcome
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