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8%曲尼司特脂质体凝胶与安慰剂对剖宫产术后手术瘢痕的影响:一项前瞻性双盲半侧瘢痕研究。

The Effect of Tranilast 8% Liposomal Gel Versus Placebo on Post-Cesarean Surgical Scars: A Prospective Double-Blind Split-Scar Study.

作者信息

Kohavi Libi, Sprecher Eli, Zur Eyal, Artzi Ofir

机构信息

*Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; †Department of Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; ‡LogiPharm Compounding Pharmacy, Tel-Mond, Israel.

出版信息

Dermatol Surg. 2017 Sep;43(9):1157-1163. doi: 10.1097/DSS.0000000000001140.

DOI:10.1097/DSS.0000000000001140
PMID:28825957
Abstract

BACKGROUND

Tranilast (N-[3, 4-dimethoxycinnamoyl] anthranilic acid), an antiallergic drug, has been shown to attenuate scar formation possibly through inhibition of transforming growth factor beta 1 activity and consequent suppression of collagen synthesis in fibroblasts.

OBJECTIVE

The authors aimed at evaluating the efficacy and safety of tranilast 8% gel in improving the appearance and symptoms of new post-cesarean section surgical wounds.

METHODS

In this prospective double-blind split-scar study, the authors treated each half scar of 26 women with either tranilast 8% liposomal gel or tranilast-free liposomal gel (placebo). Treatment was applied twice daily for 3 months. Twenty women completed the trial. Scar halves were evaluated by 2 investigators and by the patients 9 months after the last application using the Patient and Observer Scar Assessment Scale (POSAS). The participants also rated overall satisfaction and recorded side effects of the treatment.

RESULTS

The mean POSAS scores at 9 months post-treatment were significantly lower for tranilast-treated half scars compared with placebo-treated half scars (p < .001). The women were significantly more satisfied with the tranilast-treated half-scar appearance (p = .002). Three participants reported itching and erythema on the tranilast-treated side.

CONCLUSION

Topical tranilast 8% gel provided significantly better postcaesarian section scar cosmesis and user satisfaction compared with placebo.

摘要

背景

曲尼司特(N-[3,4-二甲氧基肉桂酰]邻氨基苯甲酸)是一种抗过敏药物,已被证明可能通过抑制转化生长因子β1活性以及随后抑制成纤维细胞中的胶原蛋白合成来减轻瘢痕形成。

目的

作者旨在评估8%曲尼司特凝胶改善剖宫产术后新手术伤口外观和症状的疗效和安全性。

方法

在这项前瞻性双盲半瘢痕研究中,作者用8%曲尼司特脂质体凝胶或不含曲尼司特的脂质体凝胶(安慰剂)治疗26名女性的每一半瘢痕。每天给药两次,持续3个月。20名女性完成了试验。在最后一次用药9个月后,由2名研究人员和患者使用患者和观察者瘢痕评估量表(POSAS)对瘢痕半侧进行评估。参与者还对总体满意度进行评分并记录治疗的副作用。

结果

与安慰剂治疗的瘢痕半侧相比,曲尼司特治疗的瘢痕半侧在治疗后9个月时的平均POSAS评分显著更低(p <.001)。女性对曲尼司特治疗的瘢痕半侧外观的满意度显著更高(p =.002)。3名参与者报告在曲尼司特治疗侧出现瘙痒和红斑。

结论

与安慰剂相比,局部应用8%曲尼司特凝胶在剖宫产术后瘢痕美容效果和用户满意度方面显著更好。

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