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논문 기본 정보

자료유형
학술저널
저자정보
Gyu Yeul Ji (Yonsei University College of Medicine) Chang Hyun Oh (Guro Teun Teun Hospital) Byung Gwan Moon (Eulji University School of Medicine) Seong Yi (Yonsei University College of Medicine) 한인보 (차의과학대학교) Dong Hwa Heo (The Leon Wiltse Memorial Hospital) Ki-Tack Kim (Kyung Hee University) 신동아 (Yonsei University College of Medicine) 김긍년 (Yonsei University College of Medicine)
저널정보
대한척추신경외과학회 Neurospine 대한척추신경외과학회지 제12권 제2호
발행연도
2015.1
수록면
41 - 47 (7page)

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Objective: Epidural injection of hyaluronic acid may prevent adhesion formation after spine surgery, but the compounds used to stabilize hyaluronidase could interfere with its anti-adhesion effects. The present study was conducted as a clinical trial to evaluate the efficacy and safety of an experimental medical gel in preventing adhesion formation. Methods: This study was designed as a multicenter, randomized, double-blind, and comparative controlled clinical trial with an observation period of 6 weeks. Subjects were randomly assigned into two groups: group A with sodium hyaluronate + 1,4-butanediol diglycidyl ether (BDDE) and group B with sodium hyaluronate + sodium carboxymethylcellulose (CMC). Visual analogue scale (VAS) of back and leg pain and the Oswestry disability index (ODI) and scar score ratings were assessed after surgery. Results: Mean scar grade was 2.37±1.13 in group A and 2.75±0.97 in group B, a statistically significant difference (p=0.012). VAS of back and leg pain and ODI scores decreased significantly from baseline to 3 and 6 weeks postoperatively in both groups (p<0.001). However, VAS and ODI scores were not statistically different between groups A and B at baseline or at 3 and 6 weeks after operation (p>0.3). The number of adverse reactions related to the anti-adhesion gels was not statistically different (p=0.569), but subsequent analysis of nervous adverse reactions showed group B was superior with a statistically difference (p=0.027). Conclusion: Sodium hyaluronate with BDDE demonstrated similar anti-adhesion properties to sodium hyaluronate with CMC. But, care should be used to nervous adverse reactions by using sodium hyaluronate with BDDE.

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