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一项前瞻性随机研究,旨在评估肝素外用溶液(1000 IU/ml)与肝素外用凝胶(200 IU/g)在预防输液相关静脉炎方面的安全性和有效性。

A prospective randomized study to evaluate safety and efficacy of heparin topical solution (1000 IU/ml) compared to heparin topical gel (200 IU/g) in prevention of infusion-associated phlebitis.

作者信息

Saini Vikas, Samra Tanvir, Ahuja Nitin, Sethi Sameer

机构信息

Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Indian J Pharmacol. 2018 Nov-Dec;50(6):344-349. doi: 10.4103/ijp.IJP_201_17.

DOI:10.4103/ijp.IJP_201_17
PMID:30783328
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6364337/
Abstract

OBJECTIVES

Thrombosis and thrombophlebitis of the superficial venous system are common in hospitalized patients. Efficacy and safety of topical quick penetrating solution (QPS) of heparin were compared to heparin sodium topical gel for the prevention of infusion-associated phlebitis.

MATERIALS AND METHODS

Patients aged 18-65 years undergoing intravenous cannulation for at least 72 h were enrolled and randomized to receive 6-8 drops of topical solution of heparin (Group sodium topical solution [QPS]) or1 g of topical gel (Group GEL) over the cannulated vein every 8 hourly for a total of 10 doses. Enrolled patients were monitored every 8 ± 1 h for phlebitis using visual infusion phlebitis scale. The primary aim was to compare the proportion of patients with Grade 0, I, and II phlebitis at the end of 72 h of treatment period.

RESULTS

Number of patients assessed for eligibility was 110; 26 excluded and 84 randomized. Analysis was done for 41 administered heparin QPS and 33 administered heparin gel as the rest were lost to follow-up. No phlebitis was reported in 32% of patients in QPS group and 9% in GEL group ( =0.0019). Proportion of patients with Grade I and Grade II phlebitis was 22.9% and 13.5% with QPS and 35.13% and 22.97% with gel, respectively, and the difference was statistically significant. Mean time to develop Grade I (Group QPS = 59.7 h; Group GEL = 58.46 h; = 0.949) and Grade II (Group QPS = 62.4 h; Group GEL = 61.17 h; = 0.732) phlebitis was comparable no adverse effects were reported in either group.

CONCLUSION

Heparin QPS was more effective in he prevention of infusion-associated phlebitis with similar safety profile as heparin gel.

摘要

目的

浅表静脉系统血栓形成和血栓性静脉炎在住院患者中很常见。将肝素局部快速渗透溶液(QPS)与肝素钠局部凝胶预防输液相关静脉炎的有效性和安全性进行比较。

材料与方法

纳入年龄在18 - 65岁、静脉置管至少72小时的患者,随机分为两组,分别在置管静脉上每8小时给予6 - 8滴肝素局部溶液(QPS组)或1 g局部凝胶(凝胶组),共给药10次。使用视觉输液静脉炎量表每8±1小时对纳入患者进行静脉炎监测。主要目的是比较治疗72小时结束时0级、I级和II级静脉炎患者的比例。

结果

评估合格的患者有110例;26例被排除,84例被随机分组。对41例接受肝素QPS治疗和33例接受肝素凝胶治疗的患者进行分析,其余患者失访。QPS组32%的患者未报告静脉炎,凝胶组为9%(P = 0.0019)。QPS组I级和II级静脉炎患者的比例分别为22.9%和13.5% ,凝胶组分别为35.13%和22.97%,差异有统计学意义。发生I级静脉炎的平均时间(QPS组= 59.7小时;凝胶组= 58.46小时;P = 0.949)和II级静脉炎的平均时间(QPS组= 62.4小时;凝胶组= 61.17小时;P = 0.732)相当,两组均未报告不良反应。

结论

肝素QPS预防输液相关静脉炎更有效,且安全性与肝素凝胶相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80ba/6364337/7084456e22c5/IJPharm-50-344-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80ba/6364337/d49a7fbf2f0d/IJPharm-50-344-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80ba/6364337/8a09e0176757/IJPharm-50-344-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80ba/6364337/7084456e22c5/IJPharm-50-344-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80ba/6364337/d49a7fbf2f0d/IJPharm-50-344-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80ba/6364337/8a09e0176757/IJPharm-50-344-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80ba/6364337/7084456e22c5/IJPharm-50-344-g003.jpg

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