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比较难治性胃灼热药物治疗与手术治疗的随机试验
Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn


Stuart J. Spechler ... 其他 • 2019.10.17
相关阅读
• 难治性胃灼热的治疗方法比较:随机试验

摘要


背景

虽经质子泵抑制剂(PPI)治疗,但仍然存在的胃灼热是一个常见的临床问题,有多种潜在的原因。PPI难治性胃灼热的治疗方法尚未被证明有效,这些治疗方法侧重于利用减少胃食管反流的药物(例如巴氯芬)或抗反流手术来控制胃食管反流,或者侧重于利用神经调质(例如地昔帕明)来抑制内脏高敏感。

 

方法

因PPI难治性胃灼热被转诊至美国退伍军人事务部(Veterans Affairs,VA)胃肠病诊所的患者接受了为期2周的每日2次、每次20 mg奥美拉唑治疗,治疗后有持续性胃灼热的患者接受了内镜检查、食管活检、食管测压和多通道腔内阻抗-pH监测。如果我们发现患者有与反流相关的胃灼热,则将其随机分组,分别接受手术治疗(腹腔镜尼森胃底折叠术[Nissen fundoplication])、活性药物治疗(奥美拉唑+巴氯芬,根据症状加用地昔帕明)或对照药物治疗(奥美拉唑+安慰剂)。主要结局是治疗成功,定义为1年时胃食管反流病(GERD)-健康相关生活质量评分(范围,0~50分,较高的评分表示较严重的症状)降低≥50%。

 

结果

本试验共纳入了366例患者(平均年龄,48.5岁;280例男性)。随机分组前的程序排除了288例患者:42例在2周奥美拉唑治疗期间胃灼热缓解,70例未完成试验程序,54例因其他原因被排除,23例患非GERD食管疾病,99例患功能性胃灼热(病因并非GERD或者其他组织病理学、动力或结构异常)。其余78例患者被随机分组。手术治疗的成功率(18/27例患者,67%)显著高于活性药物治疗(7/25例患者,28%;P=0.007)或者对照药物治疗(3/26例患者,12%;P<0.001)的成功率。活性药物治疗组和对照药物治疗组之间的治疗成功率差异为16个百分点(95%置信区间,-5~38;P=0.17)。

 

结论

在因PPI难治性胃灼热被转诊至VA胃肠病诊所的患者中,系统性检查显示仅少数患者真正患与反流相关的PPI难治性胃灼热。对于这一经过严格选择的亚组,手术治疗的效果优于药物治疗(由美国退伍军人事务部合作研究计划[Department of Veterans Affairs Cooperative Studies Program]资助;在ClinicalTrials.gov注册号为NCT01265550)。





作者信息

Stuart J. Spechler, M.D., John G. Hunter, M.D., Karen M. Jones, M.S., Robert Lee, M.D., Brian R. Smith, M.D., Hiroshi Mashimo, M.D., Ph.D., Vivian M. Sanchez, M.D., Kerry B. Dunbar, M.D., Ph.D., Thai H. Pham, M.D., Uma K. Murthy, M.D., Taewan Kim, M.D., Christian S. Jackson, M.D., Jason M. Wallen, M.D., Erik C. von Rosenvinge, M.D., Jonathan P. Pearl, M.D., Loren Laine, M.D., Anthony W. Kim, M.D., Andrew M. Kaz, M.D., Roger P. Tatum, M.D., Ziad F. Gellad, M.D., Sandhya Lagoo-Deenadayalan, M.D., Ph.D., Joel H. Rubenstein, M.D., Amir A. Ghaferi, M.D., Wai-Kit Lo, M.D., Ronald S. Fernando, M.D., Bobby S. Chan, M.D., Shirley C. Paski, M.D., Dawn Provenzale, M.D., Donald O. Castell, M.D., David Lieberman, M.D., Rhonda F. Souza, M.D., William D. Chey, M.D., Stuart R. Warren, Pharm.D., Anne Davis-Karim, Pharm.D., Shelby D. Melton, M.D., Robert M. Genta, M.D., Tracey Serpi, Ph.D., Kousick Biswas, Ph.D., and Grant D. Huang, Ph.D.
From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) — both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore — all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) — all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan — both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.). Address reprint requests to Dr. Spechler at Baylor University Medical Center at Dallas, 3500 Gaston Ave., 2 Hoblitzelle, Suite 250, Dallas, TX 75246, or at sjspechler@aol.com. Tracey Serpi, Ph.D., is deceased.

 

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