中国药物警戒 ›› 2012, Vol. 9 ›› Issue (8): 456-459.

• 基础及临床研究 • 上一篇    下一篇

Proviewer一次性使用软组织阻隔装置在颅内手术操作有效性及安全性的随机对照临床研究

曹胜武1, 李海林1, 骆慧1, 赵鹏1, 陶超1, 傅震1, 周民2*   

  1. 1 南京医科大学第一附属医院神经外科,江苏 南京 210029；
    2 天健医疗科技苏州有限公司,江苏 苏州 215128
  • 收稿日期:2012-05-23 出版日期:2012-08-10 发布日期:2015-08-07
  • 通讯作者: 周民,男,工程师,药品与医疗器械临床试验管理 。
  • 作者简介:曹胜武,男,博士,副主任医师,神经外科临床。

A Randomized, Controlled Study of the Efficacy and Safety of Proviewer Soft Tissue Access System used in Intracranial Operations

CAO Sheng-wu1, LI Hai-lin1, LUO Hui1, ZHAO Peng1, TAO Chao1, FU Zhen1, ZHOU Min2   

  1. 1 Neurosurgery, The First Affiliated Hospital With Nanjing Medical University, Jiangsu Nanjing 210029, China;
    2 Promed Medical Tech(Suzhou)Co., Ltd, Jiangsu Suzhou 215128, China
  • Received:2012-05-23 Online:2012-08-10 Published:2015-08-07

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摘要： 目的评价Proviewer一次性使用软组织阻隔装置在颅内手术操作过程中的有效性和安全性,为推广应用提供科学依据。方法采用前瞻性随机对照的临床研究方法,以应用Proviewer一次性使用软组织阻隔装置为试验组,以传统脑压板手术为对照,比较两组手术间临床疗效及手术安全性的差异。结果从2011年06月至2011年12月,共有19例患者纳入全分析集（FAS）,其中试验组10例,对照组9例。因为年龄违反入选标准而排除2例,故符合方案集（PPS）共有17例,其中试验组9例,对照组8例。纳入安全性分析集的19例,其中试验组10例,对照组9例。以临床效果综合计分作为主要疗效指标。试验组和对照组比较,在FAS和PPS的差异均具有统计学意义（P <0.05）,试验组优于对照组。进一步对视野观察计分和主述性观察计分指标进行比较,表现出相同的结果,即在FAS和PPS的差异均具有统计学意义（P <0.05）,试验组优于对照组。以不良事件作为安全性评价指标。试验组共出现1人（10.00%）,对照组共出现1人（11.11%）。两组不良事件发生率差别无统计学意义（P >0.05）。所有不良事件均与治疗器械无关,且在病人出院前消除。结论Proviewer一次性使用软组织阻隔装置与传统脑压板相比,在颅内手术操作过程中能为手术者提供更好的观察视野、便利的手术操作,减少术中出血量;且未产生与医疗器械有关的不良反应,有较高的临床应用价值,值得临床推广使用。

关键词: Proviewer一次性使用软组织阻隔装置, 随机对照试验, 颅脑手术

Abstract: ObjectiveTo evaluate the efficacy and safety of Proviewer soft tissue access system used in intracranial operations and provide the scientific evidence for promotion and application. MethodsA prospective, randomized, controlled study was deployed. Proviewer is used in the treatment group and brain spatula in the control group to compare the clinical efficacy and the safety of operation between two groups. Results19 patients are fit into Full-Analysis Set(FAS) in our hospital(the First Affiliated Hospital With Nanjing Medical University) from June 2011 to Dec 2011, 10 patients are in treatment group and 9 in control group. 2 patients are removed because of age. There are 17 patients in Per-Protocol Set(PPS), 9 patients in the treatment group and 8 in the control group. There are 19 patients in Safety Set(SAS), 10 patients in the treatment group and 9 in the control group. The primary efficacy endpoint is clinical efficacy balanced score. There is statistical difference in FAS and PPS between two groups(P<0.05). The treatment group is superior to controlled group. And the same result is appeared in visual score and subjective description score(P<0.05) Adverse events are evaluated in safety. There is one patient(10.00%) in the treatment group and one patient(11.11%) in the controlled group. There is no statistic different in adverse events between two groups(P >0.05). All adverse events are not caused by the therapeutic device and disappear before leaving hospital. ConclusionCompared with the brain spatula, Proviewer soft tissue access system can provide better field of vision, convenient operation and decrease amount of bleeding in the operation. No adverse events appear related with the therapeutic device and it is worth popularization because of higher value of clinical application

Key words: Proviewer soft tissue access system, randomized controlled study, craniocerebral operation.