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美皮贴薄膜预防头颈部癌症急性放射性皮炎的系统评价和随机对照试验荟萃分析。

Mepitel Film for the prevention of acute radiation dermatitis in head and neck cancer: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Radiation Oncology, National University Cancer Institute, National University Hospital, Singapore, 119228, Singapore.

Department of Clinical Oncology, Tuen Mun Hospital, New Territories West Cluster, Hospital Authority, Tuen Mun, Hong Kong.

出版信息

Support Care Cancer. 2023 Aug 18;31(9):527. doi: 10.1007/s00520-023-07988-w.

Abstract

PURPOSE

This systematic review and meta-analysis evaluates the efficacy of Mepitel Film in preventing acute radiation dermatitis (RD) in patients with head and neck cancer (HNC) across randomized controlled trials (RCTs).

METHODS

Embase, MEDLINE, and Cochrane Central Register of Controlled Trials were searched on 5 March 2023 to identify relevant RCTs. RD assessment tools and outcomes were compared across studies. Pooled effect sizes and 95% confidence intervals (CI) were estimated based on random-effects analysis using RevMan 5.4.

RESULTS

Three RCTs conducted between 2018 and 2020 were included. Mepitel Film decreased RD severity when compared to Sorbolene or Biafine but not when compared to mometasone. A per-protocol analysis of two of the trials revealed that, overall, Mepitel Film significantly reduced the incidence of grade 2-3 RD (odds ratio (OR), 0.24; 95% CI, 0.09-0.65; p = 0.005) and moist desquamation (OR, 0.21; 95% CI, 0.10-0.46; p < 0.0001) and decreased average patient, researcher, and combined components of the Radiation-Induced Skin Reaction Assessment Scale (the standardized mean difference (SMD) for patient ratings, - 2.56; 95% CI, - 3.15 to - 1.96, p < 0.00001; SMD for researcher ratings, - 3.47; 95% CI, - 6.63 to - 0.31, p = 0.03; SMD for combined scores, - 3.68; 95% CI, - 6.43 to - 0.92, p = 0.009). Noted issues with Mepitel Film included itchiness and poor adherence.

CONCLUSION

While there were discrepancies across studies, Mepitel Film demonstrated a decrease in the incidence of grade 2-3 RD and moist desquamation. These findings emphasize the need for further examining Mepitel Film's efficacy across diverse patient groups and the importance of standardizing RD severity assessment methodologies and control arms.

摘要

目的

本系统评价和荟萃分析评估了 Mepitel Film 在预防头颈部癌症 (HNC) 患者急性放射性皮炎 (RD) 方面的疗效,研究对象为随机对照试验 (RCT)。

方法

于 2023 年 3 月 5 日检索 Embase、MEDLINE 和 Cochrane 对照试验中心注册库,以确定相关 RCT。比较研究间 RD 评估工具和结局。使用 RevMan 5.4 基于随机效应分析,估算合并效应量和 95%置信区间 (CI)。

结果

纳入了 2018 年至 2020 年期间开展的 3 项 RCT。与 Sorbolene 或 Biafine 相比,Mepitel Film 降低 RD 严重程度,但与 mometasone 相比则不然。两项试验的方案分析显示,总体而言,Mepitel Film 显著降低了 2-3 级 RD 的发生率(比值比 (OR),0.24;95%CI,0.09-0.65;p = 0.005)和湿性脱皮(OR,0.21;95%CI,0.10-0.46;p < 0.0001),并降低了患者、研究者和综合评分的 Radiation-Induced Skin Reaction Assessment Scale 评分(患者评分的标准化均数差 (SMD),-2.56;95%CI,-3.15 至 -1.96;p < 0.00001;研究者评分的 SMD,-3.47;95%CI,-6.63 至 -0.31;p = 0.03;综合评分的 SMD,-3.68;95%CI,-6.43 至 -0.92;p = 0.009)。Mepitel Film 存在的问题包括瘙痒和黏附性差。

结论

尽管各研究间存在差异,但 Mepitel Film 显示出降低 2-3 级 RD 和湿性脱皮发生率的效果。这些发现强调了需要进一步研究 Mepitel Film 在不同患者群体中的疗效,并强调了 RD 严重程度评估方法和对照臂标准化的重要性。

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