Creighton University/Methodist Hospital, Omaha, NE, USA.
Respir Med. 2012 May;106(5):716-23. doi: 10.1016/j.rmed.2012.02.005. Epub 2012 Mar 6.
A double blind randomized cross over trial to compare the rate of decortication, safety and efficacy of intrapleural instillation of Alteplase vs. Placebo in empyema and complicated parapneumonic effusions (CPE).
Patients diagnosed with empyema or CPE and considered for surgery were given the option to enter into this trial. Intrapleural instillation of the 'Drug' was given daily for three days. Patient that failed the first arm of the trial were offered surgery or to cross over to the second arm. Failure was documented if pleural effusions did not improve by 50% on CT scans after three doses of the 'Drug' or if these effusions recurred within six weeks.
One hundred and eight patients were evaluated and one hundred enrolled in the trial. 32 patients were excluded, 29 for noninfectious loculated effusions, two for protocol violation and one for bleeding at chest tube site. There were 17 patients with empyema and 51 patients with CPE. 58 of the 61 patients (26 crossed over) with empyema/CPE resolved with Alteplase therapy compared to 4 of the 32 patients (one crossed over) treated with Placebo (p value <0.001). None of the patients went to surgery. Adverse events with Alteplase therapy compared to Placebo were not statistically significant, with chest pain and bleeding complications being the most common.
Intrapleural instillation of Alteplase is significantly more effective than Placebo in patients with empyema and PPE (95% vs.12%). This study demonstrates it is safe and efficacious with minimal adverse reactions.
一项双盲随机交叉试验，旨在比较胸腔内注射阿替普酶与安慰剂治疗脓胸和复杂性肺炎旁胸腔积液（CPE）的剥脱率、安全性和疗效。
诊断为脓胸或 CPE 且需要手术的患者可选择参加本试验。每天向胸腔内注入“药物”，连续三天。首次治疗失败的患者可选择手术或交叉至第二组。如果胸腔积液在三次“药物”剂量后 CT 扫描显示无 50%改善，或者这些积液在 6 周内复发，则记录为治疗失败。
共有 108 例患者接受评估，100 例患者入组试验。32 例患者被排除，其中 29 例为非感染性包裹性积液，2 例因违反方案，1 例因胸腔引流管部位出血。17 例患者为脓胸，51 例患者为 CPE。在脓胸/CPE 患者中，58 例（26 例交叉）接受阿替普酶治疗后痊愈，而 32 例（1 例交叉）接受安慰剂治疗的患者中仅 4 例痊愈（p 值<0.001）。没有患者进行手术。与安慰剂相比，阿替普酶治疗的不良反应无统计学意义，胸痛和出血并发症最常见。
与安慰剂相比，胸腔内注射阿替普酶治疗脓胸和 PPE 更有效（95%比 12%）。本研究表明，该治疗方法安全有效，不良反应最小。
