Management of Miscarriage: Expectant, Medical, or Surgical? Results of Randomised Controlled Trial (Miscarriage Treatment [MIST] Trial)
Management of Miscarriage: Expectant, Medical, or Surgical? Results of Randomised Controlled Trial (Miscarriage Treatment [MIST] Trial)
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DOI：
10.1097/01.aog.0000227084.66888.27
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发表时间：
2006-05
影响因子：
7.2
通讯作者：
Paul E O'Brien;John B. Dixon;Cheryl P. Laurie;Stewart Skinner;Joe Proietto;John McNeil;Boyd Strauss;Sharon Marks;Linda M. Schachter;Leon Chapman;Margaret L. Anderson
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文献类型：
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作者：
Paul E O'Brien;John B. Dixon;Cheryl P. Laurie;Stewart Skinner;Joe Proietto;John McNeil;Boyd Strauss;Sharon Marks;Linda M. Schachter;Leon Chapman;Margaret L. Anderson
背景肥胖是一个主要的、日益严重的健康问题。观察性研究表明，减肥手术比非手术治疗更有效，但没有随机对照试验证实这一点。目的确定手术治疗肥胖是否比非手术治疗更能达到减肥、健康和生活质量的目的。设计随机对照试验。设置大学内外科系及附属私立医院。患者80名来自普通社区的轻度至中度肥胖（体重指数，30 kg/m2至35 kg/m2）成人。干预患者被分配到一个非常低热量的饮食，药物治疗和生活方式的改变24个月（非手术组）或放置腹腔镜可调节胃束带（LAP-BAND系统，INAMED健康，圣巴巴拉，加州）（手术组）。结果测量指标为体重变化、代谢综合征的存在和2年时生活质量的变化。结果2年时，手术组体重减轻更明显，平均为21.6%（95% CI，19.3%至23.9%）初始体重减轻和87.2%（CI，77.7%至96.6%），而非手术组的体重减轻了5.5%初始体重（CI，3.2%~ 7.9%）和超重（CI，11.9%~ 31.6%）的21.8%（P < 0.001）。每组中最初有15例（38%）患者存在代谢综合征，在研究完成时，8例（24%）非手术患者和1例（3%）手术患者存在代谢综合征（P < 0.002）。手术组的生活质量改善（简表-36的8个分项评分中的8个）比非手术组（8个分项评分中的3个）更显著。局限性研究包括轻度和中度肥胖的参与者，没有动力比较不良事件，只检查了24个月的结果。结论：在24个月的治疗计划中，使用腹腔镜可调节胃束带的手术治疗在减轻体重、解决代谢综合征和改善生活质量方面比非手术治疗在统计学上更有效。
BACKGROUND Obesity is a major, growing health problem. Observational studies suggest that bariatric surgery is more effective than nonsurgical therapy, but no randomized, controlled trials have confirmed this. OBJECTIVE To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy. DESIGN Randomized, controlled trial. SETTING University departments of medicine and surgery and an affiliated private hospital. PATIENTS 80 adults with mild to moderate obesity (body mass index, 30 kg/m2 to 35 kg/m2) from the general community. INTERVENTIONS Patients were assigned to a program of very-low-calorie diets, pharmacotherapy, and lifestyle change for 24 months (nonsurgical group) or to placement of a laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) (surgical group). MEASUREMENTS Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years. RESULTS At 2 years, the surgical group had greater weight loss, with a mean of 21.6% (95% CI, 19.3% to 23.9%) of initial weight lost and 87.2% (CI, 77.7% to 96.6%) of excess weight lost, while the nonsurgical group had a loss of 5.5% (CI, 3.2% to 7.9%) of initial weight and 21.8% (CI, 11.9% to 31.6%) of excess weight (P < 0.001). The metabolic syndrome was initially present in 15 (38%) patients in each group and was present in 8 (24%) nonsurgical patients and 1 (3%) surgical patient at the completion of the study (P < 0.002). Quality of life improved statistically significantly more in the surgical group (8 of 8 subscores of Short Form-36) than in the nonsurgical group (3 of 8 subscores). LIMITATIONS The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months. CONCLUSIONS Surgical treatment using laparoscopic adjustable gastric banding was statistically significantly more effective than nonsurgical therapy in reducing weight, resolving the metabolic syndrome, and improving quality of life during a 24-month treatment program.