经颅激光疗法治疗急性中风：神经治疗有效性和安全性试验3的结果，一项III期临床终点器械试验
Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial.
作者信息
Hacke Werner, Schellinger Peter D, Albers Gregory W, Bornstein Natan M, Dahlof Bjorn L, Fulton Rachael, Kasner Scott E, Shuaib Ashfaq, Richieri Steven P, Dilly Stephen G, Zivin Justin, Lees Kennedy R
机构信息
From the Department of Neurology, Heidelberg University, Heidelberg, Germany (W.H.); Department of Neurology, Johannes Wesling Klinikum Minden, Minden, Germany (P.D.S.); Department of Neurology, Stanford Stroke Center, Palo Alto, CA (G.W.A.); Department of Neurology, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel (N.M.B.); Department of Internal Medicine, Sahlgrenski University Hospital Östra, Göteborg University, Göteborg, Sweden (B.L.D.); Institute of Cardiovascular and Medical Sciences, Gardiner Institute, Western Infirmary and Faculty of Medicine, University of Glasgow, Glasgow, United Kingdom (R.F., K.R.L.); Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia (S.E.K.); Division of Neurology, University of Alberta, Edmonton, Alberta, Canada (A.S.); Banyan Biomarkers, San Diego, CA (S.P.R.); Allergen Research Cooperation, San Mateo, CA (S.G.D.); and Department of Neurology, School of Medicine, University of California, San Diego (J.Z.).
出版信息
Stroke. 2014 Nov;45(11):3187-93. doi: 10.1161/STROKEAHA.114.005795. Epub 2014 Oct 7.
BACKGROUND AND PURPOSE
On the basis of phase II trials, we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke.
METHODS
We studied transcranial laser therapy in a double-blind, sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated ≤24 hours after stroke onset and who did not undergo thrombolytic therapy. The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale, with hierarchical Bayesian analysis incorporating relevant previous data. Interim analyses were planned after 300 and 600 patients included.
RESULTS
The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point (transcranial laser therapy 140/282 [49.6%] versus sham 140/284 [49.3%] for good functional outcome; modified Rankin Scale, 0-2). The results remained stable after inclusion of all 630 randomized patients (adjusted odds ratio, 1.024; 95% confidence interval, 0.705-1.488).
CONCLUSIONS
Once the results of the interim futility analysis became available, all study support was immediately withdrawn by the capital firms behind PhotoThera, and the company was dissolved. Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera, the CRO Parexel and members of the steering and the safety committees. We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT01120301.
背景与目的
基于II期试验，我们认为经颅激光治疗可能对急性缺血性卒中患者具有神经保护作用。
方法
我们在一项双盲、假对照随机临床试验中研究经颅激光治疗，该试验计划纳入1000例急性缺血性卒中患者，这些患者在卒中发作后≤24小时接受治疗且未接受溶栓治疗。主要疗效指标是改良Rankin量表评估的90天功能结局，采用纳入相关既往数据的分层贝叶斯分析。计划在纳入300例和600例患者后进行中期分析。
结果
在对566例完成试验的患者进行无效性分析后发现主要终点无差异（经颅激光治疗组功能结局良好者为140/282[49.6%]，假治疗组为140/284[49.3%]；改良Rankin量表评分，0 - 2），数据监测委员会建议终止该研究。纳入所有630例随机分组患者后结果保持稳定（校正比值比，1.024；95%置信区间，0.705 - 1.488）。
结论
一旦中期无效性分析结果可用，PhotoThera背后的资本公司立即撤回了所有研究支持，该公司随后解散。试验的妥善终止困难重重，但最终通过PhotoThera的前员工、合同研究组织Parexel以及指导委员会和安全委员会成员的特别努力得以实现。我们得出结论，急性缺血性卒中患者在卒中发作后24小时内应用经颅激光治疗没有可测量的神经保护作用。
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