Department of Dermatology, Venereology and Leprosy, Hindu Rao Hospital, New Delhi, India.
Department of Preventive and Social Medicine, Hindu Rao Hospital, New Delhi, India.
Indian J Dermatol Venereol Leprol. 2019 Jan-Feb;85(1):39-43. doi: 10.4103/ijdvl.IJDVL_801_16.
Melasma poses a great challenge as its treatment modalities are unsatisfactory. Treatment using tranexamic acid is a novel concept.
This study aimed to compare the therapeutic efficacy and safety of oral tranexamic acid and tranexamic acid microinjections in patients with melasma.
This is a prospective, randomized, open-label study with a sample size of 64, 32 in each treatment arm. Thirty-two patients were administered localized microinjections (4 mg/ml) of tranexamic acid monthly in 1 arm, while in the other arm, 32 were given oral tranexamic acid 250 mg twice a day. Patients were followed up for 3 consecutive months. Clinical photographs were taken at each visit, and a modified melasma area and severity index scoring was performed at the beginning and end of treatment.
Improvement in melasma area and severity index score in the oral group was 57.5% as compared to 43.5% in the intralesional group. All 32 patients in the oral group (100%) showed >50% improvement, out of which 8 showed >75% improvement. In the intralesional group, 17 (53%) patients had >50% improvement, of which 3 had >75% improvement. The remaining 15 patients in this group had <50% improvement. Thus, the oral group showed a more significant response as compared to the intralesional group. No major adverse effects were observed in both the groups. At 6-month follow-up, two patients (6.2%) in the oral group had recurrence as compared to three patients (9.4%) in the intralesional group.
A small sample size was one of the limitations in this study. The dose of tranexamic acid in microinjections and the frequency of injections could have been increased.
Tranexamic acid provides rapid and sustained improvement in the treatment of melasma. It is easily available and affordable. Oral route is undoubtedly efficacious, but the results of microinjections, while encouraging, can probably be enhanced by either increasing the frequency of injections or increasing the concentration of the preparation.
黄褐斑的治疗效果并不理想，这是一个巨大的挑战。氨甲环酸的治疗方法是一种新的概念。
本研究旨在比较氨甲环酸口服和氨甲环酸微注射治疗黄褐斑的疗效和安全性。
这是一项前瞻性、随机、开放标签研究，样本量为 64 例，每组 32 例。一组患者每月接受局部微注射（4mg/ml）氨甲环酸，另一组患者每天口服氨甲环酸 250mg，每日两次。患者随访 3 个月。每次就诊时拍摄临床照片，并在治疗开始和结束时进行改良黄褐斑面积和严重程度指数评分。
口服组的黄褐斑面积和严重程度指数评分改善率为 57.5%，而局部注射组为 43.5%。口服组 32 例患者（100%）均>50%改善，其中 8 例>75%改善。局部注射组 17 例（53%）患者>50%改善，其中 3 例>75%改善。其余 15 例患者改善<50%。因此，口服组的反应明显优于局部注射组。两组均未观察到严重不良反应。在 6 个月随访时，口服组有 2 例（6.2%）患者复发，而局部注射组有 3 例（9.4%）患者复发。
本研究的局限性之一是样本量小。局部注射的氨甲环酸剂量和注射频率本可以增加。
氨甲环酸能迅速、持续改善黄褐斑的治疗效果。它易于获得且价格合理。口服途径无疑是有效的，但微注射的结果虽然令人鼓舞，但可能通过增加注射频率或增加制剂浓度来增强。
