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Clinical Trial |
Malignant pleural effusions are commonly managed with tube thoracostomy drainage followed by chemical pleurodesis. Both tetracycline and bleomycin have been shown to be effective for intrapleural instillation, although neither agent has definitively proved advantages over the other. The aim of the present study was to compare these two agents in terms of response rate and toxicity profile. A prospective, randomized trial was carried out in a single centre. Between May 1993 and January 1996, 62 evaluable patients with proved malignant pleural effusion were allocated to receive either intrapleural tetracycline (1.5 g) or bleomycin (60 mg) after the same drainage procedure. Demographic, clinical and fluid parameter data were comparable in both groups. Response was evaluated at 1, 3 and 6 months after pleurodesis. Mean survival and time to relapse did not differ between the two groups. No statistically significant differences were found in terms of efficacy at each evaluation time. Overall, 16 (52%) and 20 (64%) patients had a recurrence of pleural effusion during follow-up in the tetracycline and bleomycin arms, respectively. Fever was most common in bleomycin-treated patients (p=0.024) while pain was most frequent in the tetracycline arm (nonsignificant). Since no study agent was superior to the other in this trial, we suggest that economic costs, drug availability and medical skill should be considered in the choice of a sclerosing agent.
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