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接受肠内营养患者口服750毫克环丙沙星与静脉注射400毫克环丙沙星的临床等效性:系统评价

Clinical Equivalency of Ciprofloxacin 750 mg Enterally and 400 mg Intravenously for Patients Receiving Enteral Feeding: Systematic Review.

作者信息

Chui Donna, Cheng Lily, Tejani Aaron M

机构信息

, BSc(Pharm), ACPR, is a clinical pharmacist with Fraser Health Pharmacy Services, Burnaby, British Columbia. She was a hospital pharmacy resident at the time of writing.

出版信息

Can J Hosp Pharm. 2009 Mar;62(2):127-34. doi: 10.4212/cjhp.v62i2.441.

Abstract

BACKGROUND

Concomitant enteral administration of ciprofloxacin with products containing magnesium, aluminum, and calcium (e.g., as enteral feeds) decreases the oral bioavailability of this antibiotic. The manufacturer currently recommends holding enteral feeds for a total of 8 h after ciprofloxacin is given, but this is not feasible for patients who are receiving continuous enteral feeding. A previous study demonstrated that a higher dose of oral ciprofloxacin (750 mg BID) may compensate for the reduced bioavailability associated with this drug-food interaction, allowing adequate concentrations for effective bactericidal activity.

OBJECTIVE

To evaluate whether ciprofloxacin 750 mg administered enterally is a clinically feasible alternative to ciprofloxacin 400 mg administered intravenously for adults receiving enteral feeds.

METHODS

A literature search was conducted in EMBASE (January 1980 to April 2008) and MEDLINE (January 1949 to April 2008), with no language restrictions, using the key words "ciprofloxacin", "fluoroquinolone", "tube feed", and "enteral". For trials that remained after screening of the abstract, the full text was reviewed and the reference lists were hand-searched to identify additional trials. The following outcomes were prespecified: death, serious adverse events, clinical cure, microbiological cure, re-infection, total adverse events, ratio of area under the curve (AUC, in microgram-hours per millilitre) to minimum inhibitory concentration (MIC, in micrograms per millilitre), ratio of maximum serum concentration (C(max), in micrograms per millilitre) to MIC, and C(max).

RESULTS

The search identified 121 potentially eligible studies, which were screened on the basis of information provided in the abstract. From this initial screening, it was clear that 113 studies did not meet the inclusion criteria. The remaining 8 studies were subjected to a full-text review, which revealed that only 1 study met the inclusion criteria. In that study, ciprofloxacin 750 mg given enterally yielded an AUC similar to that achieved with 400 mg given parentally, but the C(max) was lower. No clinical outcomes were reported.

CONCLUSIONS

There is insufficient evidence from this systematic review to determine whether patients receiving enteral feeds concomitantly with enteral ciprofloxacin 750 mg BID will achieve clinical outcomes similar to those receiving parenteral ciprofloxacin 400 mg BID.

摘要

背景

环丙沙星与含镁、铝和钙的产品(如肠内营养制剂)同时经肠内给药会降低该抗生素的口服生物利用度。目前制造商建议在给予环丙沙星后总共暂停肠内营养8小时,但这对于接受持续肠内喂养的患者而言并不可行。先前的一项研究表明,较高剂量的口服环丙沙星(750毫克,每日两次)可能弥补与这种药物 - 食物相互作用相关的生物利用度降低,从而达到有效杀菌活性所需的足够浓度。

目的

评估对于接受肠内喂养的成年人,肠内给予750毫克环丙沙星是否是静脉给予400毫克环丙沙星的临床可行替代方案。

方法

在EMBASE(1980年1月至2008年4月)和MEDLINE(1949年1月至2008年4月)中进行文献检索,无语言限制,使用关键词“环丙沙星”、“氟喹诺酮”、“管饲”和“肠内”。对于筛选摘要后留存的试验,查阅全文并手工检索参考文献列表以识别其他试验。预先设定了以下结局:死亡;严重不良事件;临床治愈;微生物学治愈;再感染;总不良事件;曲线下面积(AUC,单位为微克 - 小时/毫升)与最低抑菌浓度(MIC,单位为微克/毫升)之比;最大血清浓度(C(max),单位为微克/毫升)与MIC之比;以及C(max)。

结果

检索到121项潜在符合条件的研究,根据摘要中提供的信息进行筛选。从初步筛选中可以明显看出,113项研究不符合纳入标准。其余8项研究进行了全文审查,结果显示只有1项研究符合纳入标准。在该研究中,肠内给予750毫克环丙沙星产生的AUC与静脉给予400毫克环丙沙星相似,但C(max)较低。未报告临床结局。

结论

该系统评价的证据不足,无法确定同时接受肠内喂养和肠内给予750毫克每日两次环丙沙星的患者是否能取得与接受静脉给予400毫克每日两次环丙沙星的患者相似的临床结局。

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