Martínez-Moragón E, Aparicio J, Rogado M C, Sanchis J, Sanchis F, Gil-Suay V
Dept of Pneumology, La Fe University Hospital, Valencia, Spain.
Eur Respir J. 1997 Oct;10(10):2380-3. doi: 10.1183/09031936.97.10102383.
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.
恶性胸腔积液通常采用胸腔闭式引流,随后进行化学性胸膜固定术进行治疗。四环素和博来霉素已被证明用于胸腔内灌注均有效,尽管尚未明确证明其中一种药物比另一种具有优势。本研究的目的是比较这两种药物在有效率和毒性方面的差异。在一个单一中心进行了一项前瞻性随机试验。1993年5月至1996年1月期间,62例经证实的恶性胸腔积液可评估患者在相同的引流程序后,被分配接受胸腔内注射四环素(1.5g)或博来霉素(60mg)。两组的人口统计学、临床和液体参数数据具有可比性。在胸膜固定术后1、3和6个月评估疗效。两组的平均生存期和复发时间无差异。在每个评估时间点,在疗效方面未发现统计学上的显著差异。总体而言,四环素组和博来霉素组分别有16例(52%)和20例(64%)患者在随访期间出现胸腔积液复发。发热在接受博来霉素治疗的患者中最为常见(p=0.024),而疼痛在四环素组最为频繁(无显著性差异)。由于在本试验中没有研究药物比另一种更具优势,我们建议在选择硬化剂时应考虑经济成本、药物可及性和医疗技术。