From the Academic Respiratory Unit, University of Bristol (R.B., S.P.W., A.C.B., N.A.M.), and North Bristol NHS Trust (R.B., E.K.K., A.J.M., S.P.W., A.C.B., S.S., L.J.S., N.J.Z.-E., J.E.H., N.A.M.), Bristol, the Pragmatic Clinical Trials Unit, Queen Mary University of London (B.C.K.), Guy's and St. Thomas' NHS Foundation Trust (L.A., A.W.), King's College School of Medicine, King's College University (L.A.), and the Institute for Global Health, University College London (R.F.M.), London, Great Western Hospitals NHS Foundation Trust, Swindon (A.E.S.), University Hospital of North Midlands NHS Trust, Stoke-on-Trent (M.H.), the School of Medicine, Keele University, Newcastle-under-Lyme (M.H.), North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (R.N.H.), South Tees Hospitals NHS Foundation Trust, Middlesbrough (R.A.M.), Portsmouth Hospitals NHS Trust, Portsmouth (L.J.B.), Manchester University NHS Foundation Trust, Manchester (J. Holme, M.E.), Lancashire Teaching Hospitals NHS Foundation Trust, Preston (M.M.), Cambridge University Hospitals NHS Foundation Trust, Cambridge (P.S., J. Herre), Northumbria Healthcare NHS Foundation Trust, North Shields (D.C.), Sherwood Forest Hospitals NHS Foundation Trust, Sutton-in-Ashfield (M.R.), NHS Ayrshire and Arran, Ayr (A.G.), Worcester Acute Hospitals NHS Trust, Worcester (C.H.), Royal United Hospitals Bath NHS Foundation Trust, Bath (J.W.), Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool (T.S.S.), Aintree University Hospitals NHS Foundation Trust, Liverpool (B.C.), Hampshire Hospitals NHS Foundation Trust, Winchester (S.G.), and the Oxford Respiratory Trials Unit, University of Oxford (I.P., N.M.R.), the Oxford University Hospitals NHS Foundation Trust (I.P., N.M.R.), and the Oxford NIHR Biomedical Research Centre (N.M.R.), Oxford - all in the United Kingdom; and the Institute for Respiratory Health, University of Western Australia, and Sir Charles Gairdner Hospital, Perth, WA, Australia (Y.C.G.L.).
N Engl J Med. 2018 Apr 5;378(14):1313-1322. doi: 10.1056/NEJMoa1716883.
Malignant pleural effusion affects more than 750,000 persons each year across Europe and the United States. Pleurodesis with the administration of talc in hospitalized patients is the most common treatment, but indwelling pleural catheters placed for drainage offer an ambulatory alternative. We examined whether talc administered through an indwelling pleural catheter was more effective at inducing pleurodesis than the use of an indwelling pleural catheter alone.
Over a period of 4 years, we recruited patients with malignant pleural effusion at 18 centers in the United Kingdom. After the insertion of an indwelling pleural catheter, patients underwent drainage regularly on an outpatient basis. If there was no evidence of substantial lung entrapment (nonexpandable lung, in which lung expansion and pleural apposition are not possible because of visceral fibrosis or bronchial obstruction) at 10 days, patients were randomly assigned to receive either 4 g of talc slurry or placebo through the indwelling pleural catheter on an outpatient basis. Talc or placebo was administered on a single-blind basis. Follow-up lasted for 70 days. The primary outcome was successful pleurodesis at day 35 after randomization.
The target of 154 patients undergoing randomization was reached after 584 patients were approached. At day 35, a total of 30 of 69 patients (43%) in the talc group had successful pleurodesis, as compared with 16 of 70 (23%) in the placebo group (hazard ratio, 2.20; 95% confidence interval, 1.23 to 3.92; P=0.008). No significant between-group differences in effusion size and complexity, number of inpatient days, mortality, or number of adverse events were identified. No significant excess of blockages of the indwelling pleural catheter was noted in the talc group.
Among patients without substantial lung entrapment, the outpatient administration of talc through an indwelling pleural catheter for the treatment of malignant pleural effusion resulted in a significantly higher chance of pleurodesis at 35 days than an indwelling catheter alone, with no deleterious effects. (Funded by Becton Dickinson; EudraCT number, 2012-000599-40 .).
恶性胸腔积液每年影响欧洲和美国超过 75 万人。在住院患者中用滑石粉进行胸膜固定术是最常见的治疗方法，但留置胸腔导管用于引流提供了一种可行的替代方法。我们研究了通过留置胸腔导管给予滑石粉是否比单独使用留置胸腔导管更能有效地诱导胸膜固定术。
在 4 年的时间里，我们在英国的 18 个中心招募了恶性胸腔积液患者。在插入留置胸腔导管后，患者在门诊定期进行引流。如果在 10 天内没有明显的肺束缚（无弹性肺，由于内脏纤维化或支气管阻塞，肺扩张和胸膜贴附不可能），则患者随机分配接受门诊单次使用 4 克滑石粉混悬液或安慰剂通过留置胸腔导管。滑石粉或安慰剂采用单盲法给药。随访持续 70 天。主要结局是随机分组后 35 天成功胸膜固定术。
在接触了 584 名患者后，达到了随机分组 154 名患者的目标。在第 35 天，滑石组 69 名患者中有 30 名（43%）胸膜固定术成功，而安慰剂组 70 名患者中有 16 名（23%）（危险比，2.20；95%置信区间，1.23 至 3.92；P=0.008）。两组之间胸腔积液大小和复杂性、住院天数、死亡率或不良事件数量均无显著差异。滑石组未发现留置胸腔导管明显阻塞增多。
在没有明显肺束缚的患者中，门诊使用留置胸腔导管给予滑石粉治疗恶性胸腔积液可显著提高 35 天胸膜固定术的机会，且无不良影响。（由 Becton Dickinson 资助；EudraCT 编号，2012-000599-40）。
