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Article(id=1241720039863275630, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241720034091914228, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.06.09, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1674921600000, receivedDateStr=2023-01-29, revisedDate=null, revisedDateStr=null, acceptedDate=1709222400000, acceptedDateStr=2024-03-01, onlineDate=1773978727546, onlineDateStr=2026-03-20, pubDate=1719244800000, pubDateStr=2024-06-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773978727546, onlineIssueDateStr=2026-03-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773978727546, creator=13701087609, updateTime=1773978727546, updator=13701087609, issue=Issue{id=1241720034091914228, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='6', pageStart='401', pageEnd='480', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773978726169, creator=13701087609, updateTime=1773979021315, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241721272128828343, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241720034091914228, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241721272128828344, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241720034091914228, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=442, endPage=445, ext={EN=ArticleExt(id=1241720040123322494, articleId=1241720039863275630, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Application of remimazolam in elderly patients undergoing painless gastrointestinal endoscopy, columnId=1207314218647392369, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Original Article, runingTitle=null, highlight=null, articleAbstract=
AIM

To evaluate the effects of remimazolam on painless gastroenteroscopy in elderly patients.

METHODS

The aged patients scheduled for painless gastroenteroscopy were enrolled and randomly divided into 2 groups.The anesthesia induction regimen of the control group was sufentanil 0.1 μg·kg-1+ propofol 1.5 mg·kg-1, and the additional dose of propofol was 0.5 mg·kg-1 each time during the examination. The administration regimen of the experimental group was sufentanil 0.1 μg·kg-1 + remimazolam 0.15 mg·kg-1 induction, and each additional dose of remimazolam was 1/3 of the first dose during the examination. Heart rate, respiratory rate, mean arterial pressure, and blood oxygen saturation during anesthesia were recorded. The time of induction, recovery and exit, and adverse reactions such as injection pain, hypoxemia and hypotension were observed.

RESULTS

A total of 441 patients were included in the analysis, 225 in the control group and 116 in the experimental group. Compared with the control group, the mean arterial pressure of the experimental group was higher than that of the control group at 5 and 10 min after administration, and the difference was significant (P<0.05).The induction, recovery and exit time of the experimental group were (41.8±4.3) s, (5.7±4.4) and (10.2±6.5) min, and those in the control group were (32.6±2.7) s, (6.6±3.9) and (12.9±7.4) min, respectively. The induction time of the experimental group was longer than that of the control group, and the recovery and exit time of the control group were shorter, with significant differences (P<0.05). Compared with the control group, the incidence of injection pain (54.2% vs. 2.3%), hypotension (16.4% vs. 6.9%) and hypoxemia (19.6% vs. 14.8%) in the experimental groups was significantly reduced (P<0.05).

CONCLUSION

Remimazolam is safe and effective for painless gastroenteroscopy in elderly patients, and has the advantages of fast recovery and low incidence of adverse reactions.

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目的

评价瑞马唑仑用于老年患者无痛胃肠镜检查的效果。

方法

选择拟行无痛胃肠镜检查的老年患者，随机分为2组。对照组麻醉诱导方案为舒芬太尼0.1 μg·kg-1+丙泊酚1.5 mg·kg-1，检查过程中丙泊酚追加剂量为每次0.5 mg·kg-1；试验组的给药方案为舒芬太尼0.1 μg·kg-1 + 瑞马唑仑0.15 mg·kg-1诱导，检查过程中瑞马唑仑每次追加剂量为首剂的1/3。记录麻醉过程中患者心率、呼吸频率、平均动脉压、血氧饱和度，以及诱导、苏醒、出室时间，观察注射痛、低氧血症、低血压等不良反应的发生情况。

结果

最终441例患者纳入分析，对照组225例，试验组116例。给药后5、10 min，试验组平均动脉压高于对照组，差异有显著意义（P<0.05）。试验组诱导、苏醒和出室时间分别为（41.8±4.3）s、（5.7±4.4）和（10.2±6.5）min，对照组分别为（32.6±2.7）s、（6.6±3.9）和（12.9±7.4）min，试验组诱导时间长于对照组，苏醒和出室时间短于对照组，均有显著差异（P<0.05）。与对照组相比，试验组注射痛（54.2% vs. 2.3%）、低血压（16.4% vs. 6.9%）和低氧血症（19.6% vs. 14.8%）发生率显著降低（P<0.05）。

结论

瑞马唑仑用于老年患者无痛胃肠镜检查安全有效，具有苏醒快、不良反应发生率低等优点。

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王颖林
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苏丹，女，住院医师，硕士，主要从事新型麻醉药物临床应用的研究，E-mail：

王颖林，男，主任医师，博士，主要从事围术期恶性高热机制及防治的研究，E-mail：

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苏丹，女，住院医师，硕士，主要从事新型麻醉药物临床应用的研究，E-mail：

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王颖林，男，主任医师，博士，主要从事围术期恶性高热机制及防治的研究，E-mail：

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王颖林，男，主任医师，博士，主要从事围术期恶性高热机制及防治的研究，E-mail：

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High fat diet, gut microbiome and gastrointestinal cancer[J]. Theranostics, 2021, 11（12）:5889-5910., articleTitle=High fat diet, gut microbiome and gastrointestinal cancer, refAbstract=null), Reference(id=1241720047115227482, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, doi=null, pmid=null, pmcid=null, year=2007, volume=56, issue=4, pageStart=456, pageEnd=457, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=PALMER KR, journalName=Gut, refType=null, unstructuredReference=PALMER KR. 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Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase Ⅱb/Ⅲ trial[J].J Anesth, 2020, 34（4）: 543-553., articleTitle=Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase Ⅱb/Ⅲ trial, refAbstract=null), Reference(id=1241720047580795241, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, doi=null, pmid=null, pmcid=null, year=2021, volume=43, issue=8, pageStart=820, pageEnd=822, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=吴 艳, 孟凡浩, 冯 硕, journalName=北京医学, refType=null, unstructuredReference=吴 艳, 孟凡浩, 冯 硕, 等. 脑电双频指数监测在老年患者无痛胃肠镜麻醉中的应用效果[J]. 北京医学, 2021, 43（8）:820-822., articleTitle=脑电双频指数监测在老年患者无痛胃肠镜麻醉中的应用效果, refAbstract=null), Reference(id=1241720047673069932, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, doi=null, pmid=null, pmcid=null, year=2021, volume=40, issue=5, pageStart=351, pageEnd=355, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=童珊珊, 闵 苏, journalName=中国新药与临床杂志, refType=null, unstructuredReference=童珊珊, 闵 苏. 新型镇静药瑞马唑仑的临床研究进展[J].中国新药与临床杂志, 2021, 40（5）: 351-355., articleTitle=新型镇静药瑞马唑仑的临床研究进展, refAbstract=null), Reference(id=1241720047756956014, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, doi=null, pmid=null, pmcid=null, year=2021, volume=40, issue=5, pageStart=351, pageEnd=355, url=null, language=null, rfNumber=[9], rfOrder=9, authorNames=TONG SS, MIN S, journalName=Chin J New Drugs Clin Rem, refType=null, unstructuredReference=TONG SS, MIN S.Research progress of new sedative drug remimazolam in clinical application [J]. 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Efficacy of pre-treatment with remimazolam on prevention of propofol-induced injection pain in patients undergoing abortion or curettage: a prospective, double-blinded, randomized and placebo-controlled clinical trial[J].Drug Des Devel Ther, 2021, 15: 4551-4558., articleTitle=Efficacy of pre-treatment with remimazolam on prevention of propofol-induced injection pain in patients undergoing abortion or curettage: a prospective, double-blinded, randomized and placebo-controlled clinical trial, refAbstract=null)], funds=[Fund(id=1241720046964232533, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, awardId=BCF-RE-VSQZTZJ-202011-059, language=CN, fundingSource=白求恩·围术期镇痛镇静研究项目(BCF-RE-VSQZTZJ-202011-059), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241720040660193424, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, xref=null, ext=[AuthorCompanyExt(id=1241720040668582034, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, companyId=1241720040660193424, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Anesthesiology, Shanghai East Hospital, Tongji University School of Medicine, SHANGHAI 200120, China), AuthorCompanyExt(id=1241720040672776339, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, companyId=1241720040660193424, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=同济大学附属东方医院 麻醉科，上海　200120)])], figs=[ArticleFig(id=1241720045043241285, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标对照组（n=225）试验组（n=216）
性别（男/女）/例116/109111/105
年龄/岁68.5±8.367.9±7.7
体重指数/kg·m-223.8±3.424.7±4.2
高血压病史/例（%）82（36.4）79（36.6）
糖尿病病史/例（%）42（18.7）38（17.6）
), ArticleFig(id=1241720045143904585, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, language=CN, label=表1, caption=

一般资料组间比较

, figureFileSmall=null, figureFileBig=null, tableContent=
指标对照组（n=225）试验组（n=216）
性别（男/女）/例116/109111/105
年龄/岁68.5±8.367.9±7.7
体重指数/kg·m-223.8±3.424.7±4.2
高血压病史/例（%）82（36.4）79（36.6）
糖尿病病史/例（%）42（18.7）38（17.6）
), ArticleFig(id=1241720046628688204, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别时间MAP/mmHgHR/次·min-1RR/次·min-1SpO2/%
对照
（n=225）		T081.7±7.282.3±16.218.2±2.196.8±0.9
T183.4±6.9102.6±14.415.7±1.294.6±1.1
T269.6±6.479.4±12.814.4±1.594.9±2.3
T372.1±7.176.1±10.313.8±1.497.4±1.6
T473.8±7.475.8±10.614.3±1.698.2±1.4
T580.3±8.289.7±11.516.7±2.298.6±1.2
试验
（n=216）		T082.3±7.4a85.1±15.5a18.7±2.6a96.5±1.5a
T183.2±6.5a96.2±13.8b15.2±1.7a95.4±1.0a
T273.9±7.0b81.3±12.2a14.5±1.7a96.1±2.8a
T374.5±6.8b75.3±11.5a14.0±1.1a97.7±2.4a
T475.2±7.7a77.6±11.9a14.2±1.3a98.4±1.6a
T578.8±7.9a88.3±13.4a16.3±2.4a98.5±0.7a
), ArticleFig(id=1241720046712574284, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, language=CN, label=表2, caption=

生命体征指标组间比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别时间MAP/mmHgHR/次·min-1RR/次·min-1SpO2/%
对照
（n=225）		T081.7±7.282.3±16.218.2±2.196.8±0.9
T183.4±6.9102.6±14.415.7±1.294.6±1.1
T269.6±6.479.4±12.814.4±1.594.9±2.3
T372.1±7.176.1±10.313.8±1.497.4±1.6
T473.8±7.475.8±10.614.3±1.698.2±1.4
T580.3±8.289.7±11.516.7±2.298.6±1.2
试验
（n=216）		T082.3±7.4a85.1±15.5a18.7±2.6a96.5±1.5a
T183.2±6.5a96.2±13.8b15.2±1.7a95.4±1.0a
T273.9±7.0b81.3±12.2a14.5±1.7a96.1±2.8a
T374.5±6.8b75.3±11.5a14.0±1.1a97.7±2.4a
T475.2±7.7a77.6±11.9a14.2±1.3a98.4±1.6a
T578.8±7.9a88.3±13.4a16.3±2.4a98.5±0.7a
), ArticleFig(id=1241720046796460367, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应对照组（n=225）试验组（n=216）
低血压37（16.4）15（6.9）b
低氧血症44（19.6）32（14.8）b
心动过速18（8.0）15（6.9）a
心动过缓59（26.2）49（22.7）a
体动21（9.3）24（11.1）a
注射痛122（54.2）5（2.3）b
), ArticleFig(id=1241720046863569234, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241720039863275630, language=CN, label=表3, caption=

不良反应发生情况组间比较

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应对照组（n=225）试验组（n=216）
低血压37（16.4）15（6.9）b
低氧血症44（19.6）32（14.8）b
心动过速18（8.0）15（6.9）a
心动过缓59（26.2）49（22.7）a
体动21（9.3）24（11.1）a
注射痛122（54.2）5（2.3）b
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瑞马唑仑在老年患者无痛胃肠镜检查中的应用
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苏丹 , 梁涛 , 陈超然 , 季中华 , 张微 , 姚秀秀 , 王颖林
中国新药与临床杂志 | 论著 2024,43(6): 442-445
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中国新药与临床杂志 | 论著 2024, 43(6): 442-445
瑞马唑仑在老年患者无痛胃肠镜检查中的应用
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苏丹 , 梁涛, 陈超然, 季中华, 张微, 姚秀秀, 王颖林
作者信息
  • 同济大学附属东方医院 麻醉科，上海　200120

    • 苏丹，女，住院医师，硕士，主要从事新型麻醉药物临床应用的研究，E-mail：

    王颖林，男，主任医师，博士，主要从事围术期恶性高热机制及防治的研究，E-mail：

通讯作者:

王颖林
Application of remimazolam in elderly patients undergoing painless gastrointestinal endoscopy
Dan SU , Tao LIANG, Chao-ran CHEN, Zhong-hua JI, Wei ZHANG, Xiu-xiu YAO, Ying-lin WANG
Affiliations
  • Department of Anesthesiology, Shanghai East Hospital, Tongji University School of Medicine, SHANGHAI 200120, China
出版时间: 2024-06-25 doi: 10.14109/j.cnki.xyylc.2024.06.09
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摘要
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目的

评价瑞马唑仑用于老年患者无痛胃肠镜检查的效果。

方法

选择拟行无痛胃肠镜检查的老年患者，随机分为2组。对照组麻醉诱导方案为舒芬太尼0.1 μg·kg-1+丙泊酚1.5 mg·kg-1，检查过程中丙泊酚追加剂量为每次0.5 mg·kg-1；试验组的给药方案为舒芬太尼0.1 μg·kg-1 + 瑞马唑仑0.15 mg·kg-1诱导，检查过程中瑞马唑仑每次追加剂量为首剂的1/3。记录麻醉过程中患者心率、呼吸频率、平均动脉压、血氧饱和度，以及诱导、苏醒、出室时间，观察注射痛、低氧血症、低血压等不良反应的发生情况。

结果

最终441例患者纳入分析，对照组225例，试验组116例。给药后5、10 min，试验组平均动脉压高于对照组，差异有显著意义（P<0.05）。试验组诱导、苏醒和出室时间分别为（41.8±4.3）s、（5.7±4.4）和（10.2±6.5）min，对照组分别为（32.6±2.7）s、（6.6±3.9）和（12.9±7.4）min，试验组诱导时间长于对照组，苏醒和出室时间短于对照组，均有显著差异（P<0.05）。与对照组相比，试验组注射痛（54.2% vs. 2.3%）、低血压（16.4% vs. 6.9%）和低氧血症（19.6% vs. 14.8%）发生率显著降低（P<0.05）。

结论

瑞马唑仑用于老年患者无痛胃肠镜检查安全有效，具有苏醒快、不良反应发生率低等优点。

瑞马唑仑  /  胃镜检查  /  结肠镜检查  /  老年人  /  低血压
AIM

To evaluate the effects of remimazolam on painless gastroenteroscopy in elderly patients.

METHODS

The aged patients scheduled for painless gastroenteroscopy were enrolled and randomly divided into 2 groups.The anesthesia induction regimen of the control group was sufentanil 0.1 μg·kg-1+ propofol 1.5 mg·kg-1, and the additional dose of propofol was 0.5 mg·kg-1 each time during the examination. The administration regimen of the experimental group was sufentanil 0.1 μg·kg-1 + remimazolam 0.15 mg·kg-1 induction, and each additional dose of remimazolam was 1/3 of the first dose during the examination. Heart rate, respiratory rate, mean arterial pressure, and blood oxygen saturation during anesthesia were recorded. The time of induction, recovery and exit, and adverse reactions such as injection pain, hypoxemia and hypotension were observed.

RESULTS

A total of 441 patients were included in the analysis, 225 in the control group and 116 in the experimental group. Compared with the control group, the mean arterial pressure of the experimental group was higher than that of the control group at 5 and 10 min after administration, and the difference was significant (P<0.05).The induction, recovery and exit time of the experimental group were (41.8±4.3) s, (5.7±4.4) and (10.2±6.5) min, and those in the control group were (32.6±2.7) s, (6.6±3.9) and (12.9±7.4) min, respectively. The induction time of the experimental group was longer than that of the control group, and the recovery and exit time of the control group were shorter, with significant differences (P<0.05). Compared with the control group, the incidence of injection pain (54.2% vs. 2.3%), hypotension (16.4% vs. 6.9%) and hypoxemia (19.6% vs. 14.8%) in the experimental groups was significantly reduced (P<0.05).

CONCLUSION

Remimazolam is safe and effective for painless gastroenteroscopy in elderly patients, and has the advantages of fast recovery and low incidence of adverse reactions.

remimazolam  /  gastroscopy  /  colonoscopy  /  aged  /  hypotension
苏丹, 梁涛, 陈超然, 季中华, 张微, 姚秀秀, 王颖林. 瑞马唑仑在老年患者无痛胃肠镜检查中的应用. 中国新药与临床杂志, 2024 , 43 (6) : 442 -445 . DOI: 10.14109/j.cnki.xyylc.2024.06.09
Dan SU, Tao LIANG, Chao-ran CHEN, Zhong-hua JI, Wei ZHANG, Xiu-xiu YAO, Ying-lin WANG. Application of remimazolam in elderly patients undergoing painless gastrointestinal endoscopy[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (6) : 442 -445 . DOI: 10.14109/j.cnki.xyylc.2024.06.09
正文
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胃肠道癌是目前癌症死亡的主要原因之一，早期诊断和治疗对于降低死亡率、提高患者生存质量至关重要[1]。消化内镜检查是早期消化道肿瘤诊断的最佳方法，虽是无创操作但可引起内脏痛，且术后恶心呕吐发生率较高，如果操作时间过长会引发患者疼痛、痉挛，甚至出现心脑血管意外[2]。因此，有效的麻醉尤为重要。由于我国老龄化进程的加速，需要进行胃肠镜检的老年人数量与日俱增[3]，但接受麻醉的老年患者存在血流动力学不稳定、呼吸抑制等潜在风险，尤其是合并心肺疾病的患者，老年患者行胃肠镜检查时麻醉药物的选择尤为重要[4]。瑞马唑仑是一种新型超短效苯二氮䓬类药物，为γ-氨基丁酸A亚型（GABAA）受体激动剂，具有起效迅速、维持和恢复时间短、无蓄积、代谢不依赖肝肾功能、无严重心血管及呼吸系统不良反应等特点[5]，已在青年人胃肠镜检查中表现出良好的应用前景[6]。本研究拟评价瑞马唑仑用于老年患者无痛胃肠镜检查中的效果，以优化老年患者胃肠镜检查的麻醉方案。
资料与方法
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病例选择和分组
本研究是一项单中心、单盲、随机对照试验，已通过本院伦理委员会审核，批件号：［2021］研审第（021）号，并已在中国临床试验中心申请注册（注册号：ChiCTR2100054129）。所有患者均知晓且自愿参加此项临床试验，并签署知情同意书。纳入标准：（1）经内镜医生判断需接受胃肠镜检查；（2）年龄>60周岁，性别不限；（3）ASA分级Ⅰ~Ⅲ级；（4）体重指数（BMI）18.5~30 kg·m-2；（5）知情同意，自愿参加该试验，并签署知情同意书。排除标准：（1）明确拒绝参加本研究；（2）被判定为呼吸道管理困难（改良马氏评分为Ⅳ级）；（3）贫血，血红蛋白<90 g·L-1；（4）肝肾功能异常；（5）经降压药物治疗血压未获满意控制（坐位收缩压≥160 mmHg/舒张压≥100 mmHg）；（6）坐位收缩压≤90 mmHg；（7）对苯二氮䓬类药物、阿片类药物、丙泊酚、利多卡因及其药物组分过敏或有禁忌；（8）既往有异常手术麻醉恢复史；（9）研究者认为不宜参加此研究的受试者。选择2022年7月至2022年12月在本院行无痛胃肠镜检查的老年患者，入组后使用抽签法，将患者随机分为对照组和试验组。
样本量计算
根据临床实际情况和Ⅲ期试验结果[7]，使用PASS.15软件，假设2个试验组的非劣效性界值均3个百分点，又根据Bonferroni校正alpha为0.025，为达到80%以上的检验效能，最小样本量为每组203例。考虑到脱落率（20%）和实际入组的难易度，最终确定每组入组243例，共486例。
麻醉方法
检查前禁水4 h，禁食6 h，进入麻醉准备室后常规建立静脉通道，由1位高年资麻醉医师实施麻醉管理。患者进入检查室后，常规监测血压、心率（HR）、脉搏氧饱和度（SpO2）等生命体征和脑电双频指数（BIS），予鼻导管吸氧3L·min-1。对照组麻醉诱导方案为舒芬太尼0.1 μg·kg-1+丙泊酚1.5 mg·kg-1，检查过程中丙泊酚追加剂量为每次0.5 mg·kg-1；试验组的给药方案为舒芬太尼0.1 μg·kg-1 + 瑞马唑仑0.15 mg·kg-1，检查过程中瑞马唑仑每次追加剂量为首剂的1/3。2组均先静脉注射（静注）舒芬太尼0.1 μg·kg-1，30 s后按给药方案，分别给与丙泊酚和瑞马唑仑，静注时间均为（30±5）s。初始剂量给药结束后1 min内（包括1 min），如果患者BIS达到40~60[8]，即开始胃镜进镜操作；如果患者BIS>60或BIS≤60但尝试胃镜进镜失败，在初始剂量给药结束1 min后允许追加给药。进镜后，维持BIS 40~60，当BIS>60或BIS≤60但患者体动影响内镜检查操作，则追加给药，每次追加给药至少间隔1 min。术中SpO2低于90%则托起下颌，若低于85%，则增加鼻导管氧流量至6 L·min-1，如果SpO2仍然低于85%则暂停检查，行面罩正压通气，如果仍然无法纠正则进行气管插管控制呼吸。
观察指标
由1名麻醉住院医师负责收集患者年龄、身高、体重、性别、血压、心率、既往史、麻醉史等资料。记录患者基线即给药前（T0）、给药后1 min（T1）、给药后5 min（T2）、给药后10 min（T3）、给药后15 min（T4）、检查结束（T5）时的呼吸频率、HR、平均动脉压（MAP）和SpO2。观察并记录诱导时间（给药至BIS达40~60，内镜医师可行进镜操作的时间）、苏醒时间［末次追加给药至患者改良警觉/镇静（MOAA/S）评分≥4分的时间］、出室时间（检查结束至患者完全清醒，MOAA/S评分5分，可以离开苏醒室的时间）。观察麻醉过程中注射痛、低血压（收缩压低于基线80%或MAP<65 mmHg）、低氧血症（SpO2低于90%）等不良反应的发生情况。
统计学分析
采用SPSS 21.0统计学软件进行分析。计数资料以率或百分比表示，组间比较采用χ2检验；计量资料以均数±标准差表示，组间比较采用t检验。P<0.05为差异有显著意义。
结果
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一般资料
共募集老年患者535例，根据纳排标准排除81例，其中明确拒绝参加试验9例；BMI<18.5 kg·m-2 5例，BMI>30 kg·m-2 1例；贫血或者血小板减少42例；肝肾功能异常11例；血压未获满意控制13例。共454例患者纳入研究，有13例样本脱落或被判定为试验中止，最终441例患者纳入分析，其中对照组225例，试验组216例。2组患者年龄、BMI、高血压病史与糖尿病病史均无显著差异（P>0.05），见表1。
生命体征
对照组T1的HR高于试验组，差异有显著意义（P<0.05）。对照组T2、T3的MAP低于试验组，有显著差异（P<0.05）。其余各观察时节点，各项指标组间比较均无显著差异（P>0.05）。见表2。
麻醉效果
对照组麻醉诱导、苏醒和出室时间分别为（32.6±2.7）s、（6.6±3.9）min和（12.9±7.4）min，试验组分别为（41.8±4.3）s、（5.7±4.4）min和（10.2±6.5）min。试验组诱导时间长于对照组，苏醒和出室时间短于对照组，差异均有显著意义（P<0.05）。
不良反应
与对照组比较，试验组低血压、低氧血症和注射痛发生率降低，差异有显著意义（P<0.05）；心动过速、心动过缓和体动发生率无显著差异（P>0.05）。见表3。
讨论
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瑞马唑仑不依赖细胞色素氧化酶代谢，主要经非特异性酯酶降解为没有催眠活性的代谢产物CNS7054，失效也快[9]。基于这一特性，瑞马唑仑在各种内镜检查、日间短小手术中展现出良好的应用前景。最初的动物实验证实，瑞马唑仑还具有不过度抑制心肺功能，引起血流动力学波动小等特点[10]，这与本研究观察到的结果一致，本研究中试验组低血压的发生率显著低于对照组，且试验组T2、T3的MAP显著高于对照组。与丙泊酚相比，瑞马唑仑另一个显著优点是呼吸抑制作用减弱，本研究中试验组低氧血症发生率也显著低于对照组。临床中患者在给予丙泊酚后出现舌根后坠的概率较高，而给予瑞马唑仑后舌根仍然保持一定紧张性，减少了呼吸道梗阻的发生率，这可能是瑞芬太尼呼吸抑制作用减弱的原因，可使患者维持良好通气量和氧合。丙泊酚因其脂溶性的特质，外周静脉应用时产生注射痛的几率很大，给患者带来不良的麻醉体验[11]；瑞马唑仑因其水溶性、无刺激的特性，引发注射痛的概率极低[12]，本研究试验组注射痛发生率显著低于对照组。有研究显示，在给予丙泊酚或者依托咪酯等刺激性药物前，小剂量应用瑞马唑仑可有效减少注射痛发生率[12]。
综上，瑞马唑仑可安全有效地用于老年患者无痛胃肠镜检查，具有苏醒快、低血压和低氧血症发生率低、无注射痛等优点，为老年患者无痛胃肠镜检查的麻醉方案提供了新选择。但本试验是一项单中心研究，且观察指标欠全面，如缺乏内镜医师和患者主观满意度评价等，瑞马唑仑用于老年患者无痛胃肠镜检查的最佳诱导剂量、诱导时间与镇静深度如何平衡等问题，仍有待大样本随机对照试验进一步探讨。
基金
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  • 白求恩·围术期镇痛镇静研究项目(BCF-RE-VSQZTZJ-202011-059)
文献
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2024年第43卷第6期
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文章信息
doi: 10.14109/j.cnki.xyylc.2024.06.09
  • 接收时间：2023-01-29
  • 首发时间：2026-03-20
  • 出版时间：2024-06-25
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  • 收稿日期：2023-01-29
  • 录用日期：2024-03-01
基金
白求恩·围术期镇痛镇静研究项目(BCF-RE-VSQZTZJ-202011-059)
作者信息
    同济大学附属东方医院 麻醉科，上海　200120

通讯作者:

王颖林
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https://castjournals.cast.org.cn/joweb/zgxyylczz/CN/10.14109/j.cnki.xyylc.2024.06.09
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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