Article(id=1291404793692541061, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404681641713991, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.07.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1729612800000, receivedDateStr=2024-10-23, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824495957, onlineDateStr=2026-08-04, pubDate=1744819200000, pubDateStr=2025-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824495957, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824495957, creator=13701087609, updateTime=1785824495957, updator=13701087609, issue=Issue{id=1291404681641713991, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='7', pageStart='901', pageEnd='1050', issueExtLink='null', onlineDate='null', pubDate='1744819200000', pubDateStr='2025-04-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824469242, creator='13701087609', updateTime=1785824469242, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=906, endPage=910, ext={EN=ArticleExt(id=1291404794103582854, articleId=1291404793692541061, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of caffeine citrate combined with poractant alfa in the treament of respiratory distress syndrome in premature infants, 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 caffeine citrate injection combined with poractant alfa injection in the treatment of respiratory distress syndrome (RDS) in premature infants.

Methods

RDS premature infants were divided into control group and treatment group according to the cohort method. The control group was given 100-200 mg·kg-1 of poractant alfa injection by endotracheal tube injection and added 100 mg·kg-1 after 12 h, whereas the treatment group received intravenous injection of caffeine citrate injection on the basis of the control group (with the initial loading dose of 20 mg·kg-1 for 30 min, followed by an additional maintenance dose of 5 mg·kg-1 for 10 min every 24 h). Both groups were treated continuously for 7 days. The clinical efficacy, treatment-related indicators, blood gas indicators, serological indicators and complications were compared between groups, and the safety evaluation was performed.

Results

There were 57 cases in treatment group and 51 cases in control group. After treatment, the total effective rates in treatment group and control group were 94.74% (54 cases/57 cases) and 78.43% (40 cases/51 cases), respectively (P<0.05). After treatment, the mechanical ventilation time in treatment group and control group was (101.29±22.24) and (113.57±27.55) h; oxygen therapy time was (199.21±43.28) and (238.72±44.01) h; the hospitalization time was (25.63±3.37) and (29.98±4.90) d; the partial pressure of arterial blood oxygen (PaO2) values were (79.55±7.27) and (74.83±6.16) mmHg; the arterial partial pressure of carbon dioxide (PaCO2) values were (40.65±3.94) and (45.72±4.46) mmHg; blood pH values were 7.40±0.05 and 7.34±0.05; adrenocorticotropic hormone (ACTH) levels were (30.71±6.92) and (36.80±7.04) pg·mL-1; cortisol (Cor) levels were (272.90±34.51) and (306.47±30.11) ng·mL-1; interleukin-6 (IL-6) levels were (35.10±8.49) and (42.55±9.72) pg·mL-1, and compared with control group, the above indicators in treatment group were statistically different (all P<0.05). During treatment, the incidence rates of complications in treatment group and control group were 3.51% (2 cases/57 cases) and 5.88% (3 cases/51 cases), respectively (P>0.05). There were no adverse drug reactions such as hypotension, bradycardia and irritability in both groups during treatment.

Conclusion

Caffeine citrate injection combined with poractant alfa injection in the treatment of RDS in premature infants can improve the efficacy, shorten the mechanical ventilation time, oxygen therapy time and hospitalization time, improve the blood gas and serum oxidative stress and inflammatory indicators, and the safety is good.

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目的

观察枸橼酸咖啡因注射液联合猪肺磷脂注射液在早产儿呼吸窘迫综合征(RDS)治疗中的临床疗效及安全性。

方法

将RDS早产儿按照队列法分为对照组和试验组。对照组患儿予以100 ~200 mg·kg-1猪肺磷脂注射液经气管导管内注入,12 h后追加100 mg·kg-1;试验组患儿在对照组治疗的基础上,予以枸橼酸咖啡因注射液静脉注射,首次负荷剂量20 mg·kg-1,滴注30 min,之后每24 h追加维持剂量5 mg·kg-1,滴注10 min。2组患儿均持续治疗7 d。比较2组患儿的临床疗效、治疗相关指标、血气指标、血清学指标及并发症,并进行安全性评价。

结果

试验组和对照组分别入组57和51例。治疗后,试验组和对照组的总有效率分别为94.74%(54例/57例)和78.43%(40例/51例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的机械通气时间分别为(101.29±22.24)和(113.57±27.55)h,氧疗时间分别为(199.21±43.28)和(238.72±44.01)h,住院时间分别为(25.63±3.37)和(29.98±4.90)d,动脉血氧分压(PaO2)分别为(79.55±7.27)和(74.83±6.16)mmHg,动脉二氧化碳分压(PaCO2)分别为(40.65±3.94)和(45.72±4.46)mmHg,血液pH分别为7.40±0.05和7.34±0.05,促肾上腺皮质激素(ACTH)水平分别为(30.71±6.92)和(36.80±7.04)pg·mL-1,皮质醇(Cor)水平分别为(272.90±34.51)和(306.47±30.11)ng·mL-1,白细胞介素-6(IL-6)水平分别为(35.10±8.49)和(42.55±9.72)pg·mL-1,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)。治疗期间,试验组和对照组的并发症发生率分别为3.51%(2例/57例)和5.88%(3例/51例),在统计学上差异无统计学意义(P>0.05)。2组患儿治疗期间均未出现低血压、心动过缓、烦躁等药物不良反应。

结论

枸橼酸咖啡因注射液联合猪肺磷脂注射液治疗早产儿RDS可以显著提高临床疗效,缩短机械通气、氧疗和住院时间,改善血气、血清氧化应激和炎症指标,且安全性较好。

, authors=吴慧明, 李玉峰, 周金君, 张小华, authorsList=吴慧明, 李玉峰, 周金君, 张小华, authorCompany=null, correspAuthors=张小华, authorNote=

吴慧明(1988-),女,主治医师,主要从事儿科方面的临床诊疗工作和相关研究

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张小华,主任医师,硕士生导师 MP: 15906292218 E-mail:
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枸橼酸咖啡因联合猪肺磷脂治疗早产儿呼吸窘迫综合征的临床研究
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吴慧明 , 李玉峰 , 周金君 , 张小华
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(7): 906-910
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (7) : 906 -910
枸橼酸咖啡因联合猪肺磷脂治疗早产儿呼吸窘迫综合征的临床研究
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吴慧明, 李玉峰, 周金君, 张小华
作者信息
  • 南通大学 附属南通妇幼保健院 儿科,江苏 南通 226000
通讯作者:
张小华,主任医师,硕士生导师 MP: 15906292218 E-mail:
作者简介:

吴慧明(1988-),女,主治医师,主要从事儿科方面的临床诊疗工作和相关研究

Clinical trial of caffeine citrate combined with poractant alfa in the treament of respiratory distress syndrome in premature infants
Hui-ming WU, Yu-feng LI, Jin-jun ZHOU, Xiao-hua ZHANG
Affiliations
  • Department of Pediatrics, Affiliated Maternity and Child Health Care Hospital of Nantong University, Nantong 226000, Jiangsu Province, China
出版时间: 2025-04-17 doi: 10.13699/j.cnki.1001-6821.2025.07.002
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目的

观察枸橼酸咖啡因注射液联合猪肺磷脂注射液在早产儿呼吸窘迫综合征(RDS)治疗中的临床疗效及安全性。

方法

将RDS早产儿按照队列法分为对照组和试验组。对照组患儿予以100 ~200 mg·kg-1猪肺磷脂注射液经气管导管内注入,12 h后追加100 mg·kg-1;试验组患儿在对照组治疗的基础上,予以枸橼酸咖啡因注射液静脉注射,首次负荷剂量20 mg·kg-1,滴注30 min,之后每24 h追加维持剂量5 mg·kg-1,滴注10 min。2组患儿均持续治疗7 d。比较2组患儿的临床疗效、治疗相关指标、血气指标、血清学指标及并发症,并进行安全性评价。

结果

试验组和对照组分别入组57和51例。治疗后,试验组和对照组的总有效率分别为94.74%(54例/57例)和78.43%(40例/51例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的机械通气时间分别为(101.29±22.24)和(113.57±27.55)h,氧疗时间分别为(199.21±43.28)和(238.72±44.01)h,住院时间分别为(25.63±3.37)和(29.98±4.90)d,动脉血氧分压(PaO2)分别为(79.55±7.27)和(74.83±6.16)mmHg,动脉二氧化碳分压(PaCO2)分别为(40.65±3.94)和(45.72±4.46)mmHg,血液pH分别为7.40±0.05和7.34±0.05,促肾上腺皮质激素(ACTH)水平分别为(30.71±6.92)和(36.80±7.04)pg·mL-1,皮质醇(Cor)水平分别为(272.90±34.51)和(306.47±30.11)ng·mL-1,白细胞介素-6(IL-6)水平分别为(35.10±8.49)和(42.55±9.72)pg·mL-1,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)。治疗期间,试验组和对照组的并发症发生率分别为3.51%(2例/57例)和5.88%(3例/51例),在统计学上差异无统计学意义(P>0.05)。2组患儿治疗期间均未出现低血压、心动过缓、烦躁等药物不良反应。

结论

枸橼酸咖啡因注射液联合猪肺磷脂注射液治疗早产儿RDS可以显著提高临床疗效,缩短机械通气、氧疗和住院时间,改善血气、血清氧化应激和炎症指标,且安全性较好。

猪肺磷脂注射液  /  枸橼酸咖啡因注射液  /  早产儿  /  呼吸窘迫综合征
Objective

To observe the clinical efficacy and safety of caffeine citrate injection combined with poractant alfa injection in the treatment of respiratory distress syndrome (RDS) in premature infants.

Methods

RDS premature infants were divided into control group and treatment group according to the cohort method. The control group was given 100-200 mg·kg-1 of poractant alfa injection by endotracheal tube injection and added 100 mg·kg-1 after 12 h, whereas the treatment group received intravenous injection of caffeine citrate injection on the basis of the control group (with the initial loading dose of 20 mg·kg-1 for 30 min, followed by an additional maintenance dose of 5 mg·kg-1 for 10 min every 24 h). Both groups were treated continuously for 7 days. The clinical efficacy, treatment-related indicators, blood gas indicators, serological indicators and complications were compared between groups, and the safety evaluation was performed.

Results

There were 57 cases in treatment group and 51 cases in control group. After treatment, the total effective rates in treatment group and control group were 94.74% (54 cases/57 cases) and 78.43% (40 cases/51 cases), respectively (P<0.05). After treatment, the mechanical ventilation time in treatment group and control group was (101.29±22.24) and (113.57±27.55) h; oxygen therapy time was (199.21±43.28) and (238.72±44.01) h; the hospitalization time was (25.63±3.37) and (29.98±4.90) d; the partial pressure of arterial blood oxygen (PaO2) values were (79.55±7.27) and (74.83±6.16) mmHg; the arterial partial pressure of carbon dioxide (PaCO2) values were (40.65±3.94) and (45.72±4.46) mmHg; blood pH values were 7.40±0.05 and 7.34±0.05; adrenocorticotropic hormone (ACTH) levels were (30.71±6.92) and (36.80±7.04) pg·mL-1; cortisol (Cor) levels were (272.90±34.51) and (306.47±30.11) ng·mL-1; interleukin-6 (IL-6) levels were (35.10±8.49) and (42.55±9.72) pg·mL-1, and compared with control group, the above indicators in treatment group were statistically different (all P<0.05). During treatment, the incidence rates of complications in treatment group and control group were 3.51% (2 cases/57 cases) and 5.88% (3 cases/51 cases), respectively (P>0.05). There were no adverse drug reactions such as hypotension, bradycardia and irritability in both groups during treatment.

Conclusion

Caffeine citrate injection combined with poractant alfa injection in the treatment of RDS in premature infants can improve the efficacy, shorten the mechanical ventilation time, oxygen therapy time and hospitalization time, improve the blood gas and serum oxidative stress and inflammatory indicators, and the safety is good.

poractant alfa injection  /  caffeine citrate injection  /  premature infants  /  respiratory distress syndrome
吴慧明, 李玉峰, 周金君, 张小华. 枸橼酸咖啡因联合猪肺磷脂治疗早产儿呼吸窘迫综合征的临床研究. 中国临床药理学杂志, 2025 , 41 (7) : 906 -910 . DOI: 10.13699/j.cnki.1001-6821.2025.07.002
Hui-ming WU, Yu-feng LI, Jin-jun ZHOU, Xiao-hua ZHANG. Clinical trial of caffeine citrate combined with poractant alfa in the treament of respiratory distress syndrome in premature infants[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (7) : 906 -910 . DOI: 10.13699/j.cnki.1001-6821.2025.07.002

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2025年第41卷第7期
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doi: 10.13699/j.cnki.1001-6821.2025.07.002
  • 接收时间:2024-10-23
  • 首发时间:2026-08-04
  • 出版时间:2025-04-17
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  • 收稿日期:2024-10-23
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    南通大学 附属南通妇幼保健院 儿科,江苏 南通 226000

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张小华,主任医师,硕士生导师 MP: 15906292218 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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