Abstract

Purpose

Hand–foot syndrome (HFS) is a frequent dose-limiting adverse reaction of fluoropyrimidine drugs like capecitabine and 5-flourouracil (5-FU) in breast and gastrointestinal cancers. It has been shown that conventional application of Lawsonia inermis L. (Henna) is effective in ameliorating of the skin lesions. To increase the patient compliance, in this study we formulated a standardized topical hydrogel (H.gel) containing the hydroalcoholic extract (10%) of Henna and evaluated its clinical efficacy for the management of fluorouracil associated HFS.

Material and methods

The topical dosage form was standardized based on its Lawsone content. Eighteen patients suffering from HFS were randomized to receive H.gel and the placebo four times a day for 2 weeks. At the baseline and at the end of the trial, HFS grades were determined.

Results and conclusions

Allergic reactions following administration of H.gel were observed in one patient, while no serious adverse events occurred in the others. No statistically significant differences between two arms were observed at the baseline (p-value = 0.133), after treatment (p-value = 0.590) and grade differences (p-value = 0.193). The applied hydrogel showed less efficacy compared to the traditional method of using Henna, meaning that Lawsone may not be a good indicator for standardizing the topical dosage form.

中文翻译：

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外用 Lawsonia inermis L. (Henna) 水凝胶在氟尿嘧啶诱导的手足综合征中的疗效：一项随机双盲安慰剂对照临床试验

摘要

目的

手足综合征 (HFS) 是氟嘧啶类药物如卡培他滨和 5-氟尿嘧啶 (5-FU) 在乳腺癌和胃肠道癌中常见的剂量限制性不良反应。已经表明，Lawsonia inermis L的常规应用。(Henna) 可有效改善皮肤损伤。为了提高患者的依从性，在本研究中，我们配制了一种含有 Henna 水醇提取物 (10%) 的标准化局部水凝胶 (H.gel)，并评估了其治疗氟尿嘧啶相关 HFS 的临床疗效。

材料与方法

局部剂型根据其 Lawsone 含量进行标准化。18 名 HFS 患者随机接受 H.gel 和安慰剂，每天 4 次，持续 2 周。在基线和试验结束时，确定 HFS 等级。

结果和结论

在一名患者中观察到 H.gel 给药后的过敏反应，而在其他患者中未发生严重的不良事件。在基线（ p值 = 0.133）、治疗后（p值 = 0.590）和等级差异（p值 = 0.193）未观察到两组之间的统计学显着差异。与使用 Henna 的传统方法相比，应用的水凝胶显示出较低的功效，这意味着 Lawsone 可能不是标准化局部剂型的良好指标。