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含洋葱提取物和尿囊素的贴片用于剖宫产疤痕的有效性和耐受性

Effectiveness and Tolerability of a Patch Containing Onion Extract and Allantoin for Cesarean Section Scars.

作者信息

Conti Valeria, Corbi Graziamaria, Iannaccone Teresa, Corrado Bianca, Giugliano Luigi, Lembo Serena, Filippelli Amelia, Guida Maurizio

机构信息

Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Baronissi, Italy.

Department of Medicine and Health Sciences, University of Molise, Campobasso, Italy.

出版信息

Front Pharmacol. 2020 Sep 25;11:569514. doi: 10.3389/fphar.2020.569514. eCollection 2020.

Abstract

BACKGROUND

The prevention or early treatment of pathological scars is the most appropriate therapeutic approach. Gels and patches containing onion extract and allantoin are safe and effective in patients with scars of various origins and severity. However, no controlled studies have evaluated the effects of the patch formulation in women after Cesarean delivery. This study aimed to investigate the effects of a patch containing Allium cepa and allantoin on Cesarean section (C-section) scars.

METHODS

This is an observational study. Women were consecutively recruited at the University Hospital of Salerno and subdivided into two groups considering the number of C-section. Group A included subjects without and group B with a history of C-section. Scars assessment was made using digital photographs and the Patient and Observer Scar Assessment Scale (POSAS). After 4 weeks, the C-section of the women who had applied a patch containing Allium cepa and allantoin and those of women who had not used any products (controls) were re-evaluated as at baseline. The Observers independently performed the scars assessment at baseline and after 4 weeks. Data are expressed as the difference of the POSAS scores after 4 weeks minus the POSAS scores at baseline. The statistical significance was established at a p value <0.05.

RESULTS

Ninety-three subjects completed the study (47 in group A and 46 in group B). Women who had used a patch showed an improvement in total score by observer scale when compared with controls (p = 0.013). By the patient scale, no significant changes from baseline were found in group A and group B. Group B with patch showed changes in scars' pigmentation (p = 0.015), relief (p = 0.039), and pliability (p = 0.046) in comparison of controls. Digital photographs confirmed such improvements in women who had already undergone previous C-section, while no significant changes from baseline were found in women without a history of C-section.

CONCLUSIONS

Intense treatment of just 4 weeks with a patch containing Alium Cepa extract and allantoin was able to improve pigmentation, relief, and pliability of C-section scars in women with a history of C-section.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, identifier NCT04046783.

摘要

背景

病理性瘢痕的预防或早期治疗是最合适的治疗方法。含有洋葱提取物和尿囊素的凝胶和贴片对各种来源和严重程度的瘢痕患者是安全有效的。然而,尚无对照研究评估贴片制剂对剖宫产术后女性的效果。本研究旨在探讨含有洋葱和尿囊素的贴片对剖宫产(C 型剖宫产)瘢痕的影响。

方法

这是一项观察性研究。在萨勒诺大学医院连续招募女性,并根据剖宫产次数将其分为两组。A 组包括无剖宫产史的受试者,B 组包括有剖宫产史的受试者。使用数码照片和患者及观察者瘢痕评估量表(POSAS)进行瘢痕评估。4 周后,对使用含有洋葱和尿囊素贴片的女性以及未使用任何产品的女性(对照组)的剖宫产瘢痕进行重新评估,评估方式同基线时。观察者在基线时和 4 周后独立进行瘢痕评估。数据表示为 4 周后的 POSAS 评分减去基线时的 POSAS 评分的差值。统计学显著性设定为 p 值<0.05。

结果

93 名受试者完成了研究(A 组 47 名,B 组 46 名)。与对照组相比,使用贴片的女性在观察者量表上的总分有所改善(p = 0.013)。在患者量表上,A 组和 B 组与基线相比均未发现显著变化。与对照组相比,使用贴片的 B 组在瘢痕色素沉着(p = 0.015)、平整度(p = 0.039)和柔韧性(p = 0.046)方面有变化。数码照片证实了既往有剖宫产史的女性有上述改善,而无剖宫产史的女性与基线相比未发现显著变化。

结论

仅使用含有洋葱提取物和尿囊素的贴片进行 4 周的强化治疗,就能改善有剖宫产史女性的剖宫产瘢痕的色素沉着、平整度和柔韧性。

临床试验注册

ClinicalTrials.gov,标识符 NCT04046783。

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