Article(id=1291404907068781371, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404875351449891, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.09.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1733760000000, receivedDateStr=2024-12-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824522988, onlineDateStr=2026-08-04, pubDate=1747411200000, pubDateStr=2025-05-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824522988, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824522988, creator=13701087609, updateTime=1785824522988, updator=13701087609, issue=Issue{id=1291404875351449891, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='9', pageStart='1201', pageEnd='1350', issueExtLink='null', onlineDate='null', pubDate='1747411200000', pubDateStr='2025-05-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824515426, creator='13701087609', updateTime=1785824515426, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1201, endPage=1206, ext={EN=ArticleExt(id=1291404908830389052, articleId=1291404907068781371, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of sivelestat sodium combined with ambroxol hydrochloride atomization in the treatment of patients with ARDS, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of sivelestat sodium for injection combined with atomized ambroxol hydrochloride injection in the treatment of acute respiratory distress syndrome patients.

Methods

The patients with acute respiratory distress syndrome were divided into treatment group and control group by block randomization method. All patients received high-flow nasal cannula oxygen therapy. The control group was given ambroxol hydrochloride injection 15 mg on this basis. The treatment group was treated with sivelestat sodium for injection 4.80 mg·kg-1 on the basis of control group. Both groups were treated for 7 days. Clinical score, respiratory function, pulmonary microvascular resistance index and 28-day mortality were compared between the two groups, and the safety was evaluated.

Results

Treatment group was enrolled 47 cases, 1 case dropped out, and 46 cases were finally included in the analysis; control group was enrolled 48 cases, 2 cases dropped out, and 46 cases were finally included in the analysis. After treatment, the total effective rate of the treatment group and the control group was 89.86% (40 cases / 46 cases) and 67.39% (31 cases / 46 cases), respectively, and the difference was statistically significant (P<0.05). After treatment, the scores of acute physiology and chronic health evaluation Ⅱ in the treatment group and control group were (12.38±2.54) and (14.16±2.79) points, respectively; the Murray lung injury scores were (0.93±0.22) and (1.06±0.27) points, respectively; the scores of sequential organ failure assessment were 5.43±1.22 and 6.14±1.59, respectively; partial pressure of carbon dioxide values were (37.43±3.62) and (39.51±4.11) mmHg, respectively; respiratory rates were (22.43±2.72) and (23.96±3.24) time·min-1, respectively; extra vascular lung water indexes were (8.54±1.62) and (9.37±1.85) mL·kg-1, respectively; pulmonary vascular permeability indexes were (2.58±0.52)% and (2.86±0.54)%, respectively; the fatality rates at 28 days were 10.87% (5 cases/46 cases) and 28.26% (13cases /46 cases), respectively. In comparison to the control group, the aforementioned indicators in the treatment group demonstrated notable statistical differences (all P<0.05). Abnormal liver function, indigestion and stomach burn were the main adverse reactions in treatment group and control group. The total incidence of adverse drug reactions in treatment group and control group were 8.70% (4 cases/46 cases) and 10.87% (5 cases/46 cases), respectively, with no statistical significance (P>0.05).

Conclusion

The use of sivelestat sodium for injection combined with atomized ambroxol hydrochloride injection in treating acute respiratory distress syndrome patients yields favorable clinical outcomes, alleviates patient symptoms, enhances respiratory function, lowers 28-day mortality rates, and is considered safe.

, authors=Yun PAN, Peng WANG, Yang HE, Min-xing LIU, Liang-fu HAN, authorsList=Yun PAN, Peng WANG, Yang HE, Min-xing LIU, Liang-fu HAN, authorCompany=null, correspAuthors=Liang-fu HAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404909245625149, articleId=1291404907068781371, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=西维来司他钠联合盐酸氨溴索雾化治疗ARDS患者的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的

观察注射用西维来司他钠联合盐酸氨溴索注射液雾化治疗急性呼吸窘迫综合征患者的临床疗效及安全性。

方法

用区组随机化法,将急性呼吸窘迫综合征患者均分为试验组和对照组。所有患者均实施经鼻高流量湿化氧疗。对照组在此基础上给予盐酸氨溴索注射液15 mg。试验组在对照组治疗的基础上,联合注射用西维来司他钠4.80 mg·kg-1治疗。2组患者均持续治疗7 d。比较2组患者的临床评分、呼吸功能、肺微血管阻力指标和28 d病死率,并评价安全性。

结果

试验组入组47例,脱落1例,最终有46例纳入统计分析;对照组入组48例,脱落2例,最终有46例纳入统计分析。治疗后,试验组和对照组的总有效率分别为89.86%(40例/46例)和67.39%(31例/46例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的急性生理学与慢性健康状况评分分别为(12.38±2.54)和(14.16±2.79)分,Murray肺损伤评分分别为(0.93±0.22)和(1.06±0.27)分,序贯器官衰竭评估评分分别为(5.43±1.22)和(6.14±1.59)分,二氧化碳分压分别为(37.43±3.62)和(39.51±4.11)mmHg,呼吸频率分别为(22.43±2.72)和(23.96±3.24)time·min-1,血管外肺水指数分别为(8.54±1.62)和(9.37±1.85)mL·kg-1,肺毛细血管通透指数分别为(2.58±0.52)%和(2.86±0.54)%,28 d病死率分别为10.87%(5例/46例)和28.26%(13例/46例)。试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应主要有肝功能异常、消化不良和胃部灼热。试验组和对照组的总药物不良反应发生率分别为8.70%(4例/46例)和10.87%(5例/46例),在统计学上差异无统计学意义(P>0.05)。

结论

注射用西维来司他钠联合盐酸氨溴索注射液雾化治疗急性呼吸窘迫综合征患者的临床效果良好,可以显著减轻患者的临床症状,改善患者的呼吸功能,降低28 d病死率,且安全性较好。

, authors=潘赟, 王鹏, 贺阳, 刘敏星, 韩良富, authorsList=潘赟, 王鹏, 贺阳, 刘敏星, 韩良富, authorCompany=null, correspAuthors=韩良富, authorNote=

潘赟(1987-),男,硕士研究生,主治医师,主要从事急诊医学临床方面的工作

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韩良富,副主任医师 MP: 13584859497 E-mail:
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西维来司他钠联合盐酸氨溴索雾化治疗ARDS患者的临床研究
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潘赟 , 王鹏 , 贺阳 , 刘敏星 , 韩良富
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(9): 1201-1206
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (9) : 1201 -1206
西维来司他钠联合盐酸氨溴索雾化治疗ARDS患者的临床研究
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潘赟, 王鹏, 贺阳, 刘敏星, 韩良富
作者信息
  • 苏州大学 附属第一医院 急诊科,江苏 苏州 215006
通讯作者:
韩良富,副主任医师 MP: 13584859497 E-mail:
作者简介:

潘赟(1987-),男,硕士研究生,主治医师,主要从事急诊医学临床方面的工作

Clinical trial of sivelestat sodium combined with ambroxol hydrochloride atomization in the treatment of patients with ARDS
Yun PAN, Peng WANG, Yang HE, Min-xing LIU, Liang-fu HAN
Affiliations
  • Department of Emergency, The First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, China
出版时间: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.001
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目的

观察注射用西维来司他钠联合盐酸氨溴索注射液雾化治疗急性呼吸窘迫综合征患者的临床疗效及安全性。

方法

用区组随机化法,将急性呼吸窘迫综合征患者均分为试验组和对照组。所有患者均实施经鼻高流量湿化氧疗。对照组在此基础上给予盐酸氨溴索注射液15 mg。试验组在对照组治疗的基础上,联合注射用西维来司他钠4.80 mg·kg-1治疗。2组患者均持续治疗7 d。比较2组患者的临床评分、呼吸功能、肺微血管阻力指标和28 d病死率,并评价安全性。

结果

试验组入组47例,脱落1例,最终有46例纳入统计分析;对照组入组48例,脱落2例,最终有46例纳入统计分析。治疗后,试验组和对照组的总有效率分别为89.86%(40例/46例)和67.39%(31例/46例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的急性生理学与慢性健康状况评分分别为(12.38±2.54)和(14.16±2.79)分,Murray肺损伤评分分别为(0.93±0.22)和(1.06±0.27)分,序贯器官衰竭评估评分分别为(5.43±1.22)和(6.14±1.59)分,二氧化碳分压分别为(37.43±3.62)和(39.51±4.11)mmHg,呼吸频率分别为(22.43±2.72)和(23.96±3.24)time·min-1,血管外肺水指数分别为(8.54±1.62)和(9.37±1.85)mL·kg-1,肺毛细血管通透指数分别为(2.58±0.52)%和(2.86±0.54)%,28 d病死率分别为10.87%(5例/46例)和28.26%(13例/46例)。试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应主要有肝功能异常、消化不良和胃部灼热。试验组和对照组的总药物不良反应发生率分别为8.70%(4例/46例)和10.87%(5例/46例),在统计学上差异无统计学意义(P>0.05)。

结论

注射用西维来司他钠联合盐酸氨溴索注射液雾化治疗急性呼吸窘迫综合征患者的临床效果良好,可以显著减轻患者的临床症状,改善患者的呼吸功能,降低28 d病死率,且安全性较好。

注射用西维来司他钠  /  盐酸氨溴索注射液  /  急性呼吸窘迫综合征  /  高流量湿化氧疗  /  呼吸功能
Objective

To observe the clinical efficacy and safety of sivelestat sodium for injection combined with atomized ambroxol hydrochloride injection in the treatment of acute respiratory distress syndrome patients.

Methods

The patients with acute respiratory distress syndrome were divided into treatment group and control group by block randomization method. All patients received high-flow nasal cannula oxygen therapy. The control group was given ambroxol hydrochloride injection 15 mg on this basis. The treatment group was treated with sivelestat sodium for injection 4.80 mg·kg-1 on the basis of control group. Both groups were treated for 7 days. Clinical score, respiratory function, pulmonary microvascular resistance index and 28-day mortality were compared between the two groups, and the safety was evaluated.

Results

Treatment group was enrolled 47 cases, 1 case dropped out, and 46 cases were finally included in the analysis; control group was enrolled 48 cases, 2 cases dropped out, and 46 cases were finally included in the analysis. After treatment, the total effective rate of the treatment group and the control group was 89.86% (40 cases / 46 cases) and 67.39% (31 cases / 46 cases), respectively, and the difference was statistically significant (P<0.05). After treatment, the scores of acute physiology and chronic health evaluation Ⅱ in the treatment group and control group were (12.38±2.54) and (14.16±2.79) points, respectively; the Murray lung injury scores were (0.93±0.22) and (1.06±0.27) points, respectively; the scores of sequential organ failure assessment were 5.43±1.22 and 6.14±1.59, respectively; partial pressure of carbon dioxide values were (37.43±3.62) and (39.51±4.11) mmHg, respectively; respiratory rates were (22.43±2.72) and (23.96±3.24) time·min-1, respectively; extra vascular lung water indexes were (8.54±1.62) and (9.37±1.85) mL·kg-1, respectively; pulmonary vascular permeability indexes were (2.58±0.52)% and (2.86±0.54)%, respectively; the fatality rates at 28 days were 10.87% (5 cases/46 cases) and 28.26% (13cases /46 cases), respectively. In comparison to the control group, the aforementioned indicators in the treatment group demonstrated notable statistical differences (all P<0.05). Abnormal liver function, indigestion and stomach burn were the main adverse reactions in treatment group and control group. The total incidence of adverse drug reactions in treatment group and control group were 8.70% (4 cases/46 cases) and 10.87% (5 cases/46 cases), respectively, with no statistical significance (P>0.05).

Conclusion

The use of sivelestat sodium for injection combined with atomized ambroxol hydrochloride injection in treating acute respiratory distress syndrome patients yields favorable clinical outcomes, alleviates patient symptoms, enhances respiratory function, lowers 28-day mortality rates, and is considered safe.

sivelestat sodium for injection  /  ambroxol hydrochloride injection  /  acute respiratory distress syndrome  /  high-flow nasal cannula oxygen therapy  /  respiratory function
潘赟, 王鹏, 贺阳, 刘敏星, 韩良富. 西维来司他钠联合盐酸氨溴索雾化治疗ARDS患者的临床研究. 中国临床药理学杂志, 2025 , 41 (9) : 1201 -1206 . DOI: 10.13699/j.cnki.1001-6821.2025.09.001
Yun PAN, Peng WANG, Yang HE, Min-xing LIU, Liang-fu HAN. Clinical trial of sivelestat sodium combined with ambroxol hydrochloride atomization in the treatment of patients with ARDS[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1201 -1206 . DOI: 10.13699/j.cnki.1001-6821.2025.09.001

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doi: 10.13699/j.cnki.1001-6821.2025.09.001
  • 接收时间:2024-12-10
  • 首发时间:2026-08-04
  • 出版时间:2025-05-17
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  • 收稿日期:2024-12-10
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    苏州大学 附属第一医院 急诊科,江苏 苏州 215006

通讯作者:

韩良富,副主任医师 MP: 13584859497 E-mail:
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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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