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滑石粉与碘伏预防改良根治性乳房切除术后血清肿形成的随机II期研究。

Randomized Phase II Study of Talc Versus Iodopovidone for the Prevention of Seroma Formation Following Modified Radical Mastectomy.

作者信息

Garza-Gangemi Adrián M, Barquet-Muñoz Salim A, Villarreal-Colín Silvia P, Medina-Franco Heriberto, Cortés-González Rubén, Vilar-Compte Diana, Cantú-de-León David

机构信息

Oncology Surgery Unit, Department of Surgery, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

Department of Breast Cancer Surgery, Instituto Nacional de Cancerología, Mexico City, Mexico.

出版信息

Rev Invest Clin. 2015 Nov-Dec;67(6):357-65.

PMID:26950740
Abstract

BACKGROUND

The most common complication following modified radical mastectomy is seroma formation. Numerous approaches have been attempted to prevent this complication, ranging from the use of chemical substances to mechanical means, and none of these have proven to be consistently reliable.

AIM

The aim of this study was to evaluate the safety and efficacy of talc in preventing postoperative seromas compared with iodine and standard care.

METHODS

Patients with breast cancer undergoing modified radical mastectomy were randomly assigned to one of three study groups: control, subcutaneous talc, or iodine application. The primary endpoint was frequency of seroma formation. Secondary outcomes included wound complications (surgical site infection, flap necrosis, and wound dehiscence), analgesic use, postoperative pain, total drain outputs, and drainage duration.

RESULTS

Of the 86 patients randomized in the study, 80 were analyzed. After interim analysis, the iodine intervention was discontinued because of increased adverse outcomes (drainage duration and total amount of fluid drained). Talc failed to demonstrate that its application in subcutaneous breast tissue prevents seroma formation (19.4% for talc group vs. 23.3% for control group; p = 0.70). However, patients who developed seroma in the talc group had fewer aspirations per patient seroma and less volume drained when compared with the control group (88.2 ± 73 vs. 158.3 ± 90.5; p = 0.17).

CONCLUSIONS

Subcutaneous talc application was safe in the short term, but there was not sufficient evidence to support its use for seroma prevention following modified radical mastectomy in patients with breast cancer.

摘要

背景

改良根治性乳房切除术后最常见的并发症是血清肿形成。人们尝试了许多方法来预防这种并发症,从使用化学物质到采用机械手段,但这些方法都未被证明始终可靠。

目的

本研究的目的是评估与碘和标准护理相比,滑石粉在预防术后血清肿方面的安全性和有效性。

方法

接受改良根治性乳房切除术的乳腺癌患者被随机分配到三个研究组之一:对照组、皮下注射滑石粉组或碘应用组。主要终点是血清肿形成的频率。次要结果包括伤口并发症(手术部位感染、皮瓣坏死和伤口裂开)、镇痛药使用情况、术后疼痛、总引流量和引流持续时间。

结果

在该研究随机分组的86例患者中,对80例进行了分析。中期分析后,由于不良后果增加(引流持续时间和引流液总量),碘干预被停止。滑石粉未能证明其在皮下乳腺组织中的应用可预防血清肿形成(滑石粉组为19.4%,对照组为23.3%;p = 0.70)。然而,与对照组相比,滑石粉组发生血清肿的患者每人血清肿的抽吸次数更少,引流量也更少(88.2±73对158.3±90.5;p = 0.17)。

结论

皮下应用滑石粉在短期内是安全的,但没有足够的证据支持其在乳腺癌患者改良根治性乳房切除术后用于预防血清肿。

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