直腸癌手術の感染予防にゲンタマイシンのコラーゲンスポンジ


 どんなものか想像もつかないのですが、感染予防にゲンタマイシンのコラーゲンスポンジが海外では使用されているそうです。ゲンタマイシンのコラーゲンスポンジは、直腸癌手術患者のSSI予防効果は有効でなく、反対にSSIが有意に高い結果。

 抗生剤の全身投与にもかかわらず、SSI(手術部位感染)は、直腸癌手術後の死亡率とコストを増加させている。ゲンタマイシンのコラーゲンスポンジは、局所抗生剤として54カ国で承認されており、1985年移行100万人以上の患者に使用されている。

 フェーズ3試験として602名の患者に、開腹、または腹腔鏡下で、ゲンタマイシンのコラーゲンスポンジの使用と、使用しない群で無作為に割り付けをした。すべての患者は、抗生剤の全身投与をはじめとする標準的なケアを受けた。第一のエンドポイントは、手術後60日目までの手術部位感染症の発症。

結果

SSIの発生率は、スポンジを使用した群の方が、プラセボ群よりも有意に高かった。

感染率 the sponge group the control group 有意差
SSI 90 of 300 patients [30.0%] 63 of 302 patients [20.9%] P=0.01
表層SSI 20.3% 13.6% P=0.03
深部SSI 8.3% 6.0% P=0.26

*副作用は、両群で差なし

気づき)

 ・何度かこのGentamicinスポンジは、報告されていますね。

 ・実物はどんなものなのでしょう?

Gentamicin Collagen Sponge for Infection Prophylaxis in Colorectal Surgery

N Engl J Med 2010; 363:1038-1049September 9, 2010

BACKGROUND

Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin?collagen sponge, an implantable topical antibiotic agent, is approved for surgical implantation in 54 countries. Since 1985, more than 1 million patients have been treated with the sponges.

METHODS

In a phase 3 trial, we randomly assigned 602 patients undergoing open or laparoscopically assisted colorectal surgery at 39 U.S. sites to undergo either the insertion of two gentamicin?collagen sponges above the fascia at the time of surgical closure (the sponge group) or no intervention (the control group). All patients received standard care, including prophylactic systemic antibiotics. The primary end point was surgical-site infection occurring within 60 days after surgery, as adjudicated by a clinical-events classification committee that was unaware of the study-group assignments.

RESULTS

The incidence of surgical-site infection was higher in the sponge group (90 of 300 patients [30.0%]) than in the control group (63 of 302 patients [20.9%], P=0.01). Superficial surgical-site infection occurred in 20.3% of patients in the sponge group and 13.6% of patients in the control group (P=0.03), and deep surgical-site infection in 8.3% and 6.0% (P=0.26), respectively. Patients in the sponge group were more likely to visit an emergency room or surgeon’s office owing to a wound-related sign or symptom (19.7%, vs. 11.0% in the control group; P=0.004) and to be rehospitalized for surgical-site infection (7.0% vs. 4.3%, P=0.15). The frequency of adverse events did not differ significantly between the two groups.

CONCLUSIONS

Our large, multicenter trial shows that the gentamicin?collagen sponge is not effective at preventing surgical-site infection in patients who undergo colorectal surgery; paradoxically, it appears to result in significantly more surgical-site infections.

(Funded by Innocoll Technologies; ClinicalTrials.gov number, NCT00600925.)

これから)薬局長会議、1年分のポートフォリオ手法10名のフォローワー側からのふりかえり、集中する問題の整理

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