Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Dermatol Ther. 2022 Jan;35(1):e15213. doi: 10.1111/dth.15213. Epub 2021 Nov 30.
Macular amyloidosis (MA) is a common form of cutaneous amyloidosis that manifests as dark spots consisting of brown pigments with a rippled pattern on the skin, and the treatment of this condition is highly challenging. The aim of this study was to compare the efficacy and safety of intralesional injection of tranexamic acid (TXA) and topical application of Kligman combination drug in the treatment of macular amyloidosis. In this double-blind clinical trial, a total of 43 patients, who were diagnosed with MA, were treated with two different methods of intralesional injection of tranexamic acid and topical application of Kligman combination drug. Both therapeutic methods were effective in improving MA and significantly reduced hyperpigmentation of the treated areas, but tranexamic acid was significantly more effective than the Kligman combination drug. Significantly, greater improvements were observed in the group of patients treated with tranexamic acid. In the tranexamic acid treatment group, ΔE was reduced from 11.39 in the first session to 8.53 in the third session, and in the Kligman treatment group, it was reduced from 8.79 in the first session to 6.32 in the third session (p < 0.05). In addition, the pruritus score in patients treated with topical tranexamic acid injection was lower compared to the patients treated with the topical application of the Kligman combination drug. The results of this study demonstrated the significant positive effects of both treatment methods, but in terms of reducing melanin content, intralesional injection of tranexamic acid was a more effective method. Both treatments considered safe for MA. In tranexamic acid group, patients logically experienced a tolerable pain during injection but they significantly had significantly lower local pruritic discomfort during study. So, based on the positive findings of this study we suggest to use tranexamic acid in combination with other effective therapeutic methods for treatment of MA especially use of its topically applied form in combination with non-aggressive needling that results in better drug delivery without the experience of injection pain. Selection of the best administration route of tranexamic acid for hyperpigmented lesions depends on the each patient characteristic and their previous theraputic results that may vary case by case.
黄斑淀粉样变（MA）是一种常见的皮肤淀粉样变，表现为皮肤上有波纹状棕色色素沉着的暗斑，这种病症的治疗极具挑战性。本研究旨在比较局部注射氨甲环酸（TXA）和 Kligman 联合药物局部应用治疗黄斑淀粉样变的疗效和安全性。在这项双盲临床试验中，共有 43 名 MA 患者接受了两种不同的局部注射氨甲环酸和 Kligman 联合药物局部应用的治疗方法。两种治疗方法均能有效改善 MA，显著减少治疗区域的色素沉着，但氨甲环酸的效果明显优于 Kligman 联合药物。值得注意的是，氨甲环酸治疗组的改善更为显著。在氨甲环酸治疗组中，ΔE 从第一次治疗的 11.39 降低到第三次治疗的 8.53，而在 Kligman 治疗组中，从第一次治疗的 8.79 降低到第三次治疗的 6.32（p<0.05）。此外，局部注射氨甲环酸治疗组患者的瘙痒评分低于 Kligman 联合药物局部应用组。本研究结果表明，两种治疗方法均有显著的积极效果，但在减少黑色素含量方面，局部注射氨甲环酸是一种更有效的方法。两种治疗方法均被认为对 MA 是安全的。在氨甲环酸组中，患者在注射时会感到可耐受的疼痛，但在研究过程中，他们的局部瘙痒不适感明显较低。因此，基于本研究的积极发现，我们建议将氨甲环酸与其他有效的治疗方法联合用于 MA 的治疗，特别是将其局部应用形式与非侵袭性针刺联合使用，以改善药物输送，同时避免注射疼痛。选择氨甲环酸治疗色素沉着过度病变的最佳给药途径取决于每位患者的特点和他们之前的治疗效果，这可能因病例而异。
