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小肠磁共振检验术前果糖冰淇淋的小肠排空:一项随机解读非劣效适度研究
BACKGROUND: Tools for the evaluation of gastric emptying(小肠排空) he evolved over time. The purpose of this study was to show that the risk of pulmonary aspiration(肺误吸) is not increased with carbohydrate drink, by demonstrating that the gastric antral cross-sectional area (CSA)(小肠窦横切面容) of the NO-NPO group is either equivalent to or less than that of the NPO (nil per os) group.
背景:检验小肠排空的工具随着时间的推移而发展。本研究的最终目标是通过验证NO-NPO两组的小肠窦横切面容(CSA)等于或极小NPO两组，来验证果糖冰淇淋不会提高肺误吸的安全适度。
METHODS: Sixty-four patients scheduled for elective laparoscopic(MRI的)benign(良适度的) gynecologic(妇科外科的) surgery were enrolled and randomly assigned to the NPO group (n = 32) or the NO-NPO group (n = 32). After hing a regular meal until midnight before surgery, the NPO group fasted(苦行)until surgery, while the NO-NPO group ingested 400 mL of a carbohydrate drink at midnight and freely up to 2 hours before anesthesia. The primary outcome was the gastric antral CSA by gastric ultrasound（小肠部磁共振) in right lateral decubitus position (RLDP)（右侧侧卧位). Noninferiority was defined as a mean difference of CSA 1.5ml/kg, and Perlas grade.
新方法:选择64举例择期MRI良适度妇科手术病人，随机分为NPO两组(n = 32)和NO-NPO两组(n = 32)。NPO两组在术前正常进食至午后后苦行至手术，而NO-NPO两组在午后进食400毫升果糖冰淇淋，并在前2小时自由进食。主要仔细观察结果为右侧侧卧位(RLDP)小肠磁共振小肠窦CSA。非劣效适度定义为CSA 1.5 mL/kg和Perlas级。
所示1 小肠窦部横切面容校准代所列所示
推测CSA在2个横向方向上直径的校准
所列1 病人的终端特征
资料以最低新标准偏顶多、中值(四分位覆盖范围)或十六进制(%)说明
所示2 此研究流程所示
所列2 小肠窦CSA, PerlasAO，小肠体容，小肠磁共振检验危险小肠发生率
资料以最低新标准偏顶多、中值(四分位覆盖范围)或十六进制(%)说明
所示3 NPO两组与NO-NPO两组右侧侧卧位小肠窦部横切面容最低顶多的非劣效所示
虚线说明非劣效界线(Δ)。误顶多条说明横切面面容相似之处(NO-NPO两组−NPO两组)的95% CI。该所示描述了两组密切关系的非劣效适度(等效适度)
RESULTS: CSA in RLDP was not different between the NPO group (6.25 ± 3.79cm2) and the NO-NPO group (6.21 ± 2.48 cm2; P=.959). The mean difference of CSA in RLDP (NO-NPO group − NPO group) was 0.04 (95%l [CI],−1.56 to 1.64), which was within the noninferiority margin of 2.8 cm2. CSA was not different between the 2 groups (4.17 ± 2.34cm2 in NPO group versus 4.28 ± 1.23cm2 in NO-NPO group; P=.828). GV in NPO group (70 ± 56 mL) was not different from NO-NPO group (66 ± 36 mL; mean difference,3.66; 95%CI,−20 to 27; P=.756). GV/kg in the NPO group (1.25±1.00mL/kg) was not different from the NO-NPO group (1.17±0.67mL/kg;P=.694). The incidence of GV/kg> 1.5 mL/kg was not different between NPO (31.3%) and NO-NPO group (21.9%;P=.768). The median (interquartile range) of the Perlas grade was 1 (0–1) in NPO group and 0.5 (0–1) in NO-NPO group (P=.871).
结果:RLDP CSA在NPO两组(6.25±3.79cm2)和NO-NPO两组(6.21±2.48cm2)密切关系无异质适度相似之处;P=.959)。RLDP (NO-NPO两组-NPO两组)CSA的最低顶多为0.04, 95%[CI]:−1.56-1.64)，在2.8 cm2的非劣势覆盖区域内。两组间CSA无相似之处(NPO两组为4.17±2.34 cm2, NO-NPO两组为4.28±1.23cm2;P=.828)。NPO两组GV(70±56 mL)与NO-NPO两组(66±36 mL)无明显相似之处;最低顶多,3.66;95% Cl:20-27,P=.756) NPO两组GV/kg(1.25±1.00mL/kg)与NO-NPO两组GV/kg(1.17±0.67 mL/kg)无显著相似之处;P=.694)。PerlasAO的中值(四分小数覆盖范围)在NPO两组为1 (0-1)，在NO-NPO两组为0.5 (0-1)(P=.871)。
CONCLUSIONS:Preoperative carbohydrates ingested up to 2 hours before anesthesia do not delay gastric emptying compared to midnight fasting(午后苦行), as evaluated with gastric ultrasound.
正确性:根据小肠磁共振检验，与午后苦行相对于，前2小时摄取果糖不会延迟小肠排空。
词汇所列：ASA =美国学者研习; BMI =体重指数;新联盟=综合通报试验新标准; ci =置信区间; CSA =横切面容; GV =小肠体容; ICC =脑内相后山系数; IQS =所示像质量分数; IVC =下脊柱; l =肝脏; LD =最长直径;每个OS的NPO = NIL; p =胰腺; RLDP =右侧侧褥疮右侧方; SD =最短直径; SMD =新标准化最低相似之处; SPSS =社会科学的统计包
学习原稿
1
外科术语
gastric 小肠的
gastric emptying 小肠排空
gastric volume 小肠体容
gastric ultrasound assessing小肠磁共振检验
gastric antral 小肠窦
cross-sectional area 横切面容
pulmonary 肺部的
pulmonary aspiration 肺误吸
laparoscope MRI
laparoscopic MRI的
gynecology 妇科
gynecologic妇科外科的
fast 苦行
midnight fasting 午后苦行
ingest 摄取
right lateral decubitus position 右侧侧卧位
decubitus 褥疮；卧位
supine position 仰卧位
2
知识扩展
非劣效适度试验：一种随机解读临床试验（RCT）。在这种试验中，研究成果将一种新的化学疗法新方法与一种新标准的有活适度的化学疗法（不是与治化学疗法或不进行化学疗法的解读两组）进行比较，试所示证实新化学疗法新方法的不比解读化学疗法顶多。当预估一种新药与对比药有完全相同有效适度但同时能提供某些比解读药绝佳之处时，可以采行非劣效适度试验。
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