Coulibaly Yaya I, Diabate Abdoul F, Sangare Moussa, Thera Sekou O, Dolo Housseini, Doumbia Salif S, Coulibaly Siaka Y, Diarra Ayouba, Diarra Lamine, Tanapo Diadje, Coulibaly Michel E, Soumaoro Lamine, Diallo Abdallah A, Zeguime Amatigue, Sanogo Yacouba, Berthe Adama, Konipo Fatoumata Dite Nene, Mackenzie Charles, Stephens Mariana, Shott Joseph P, Norman Jayla, Klarmann-Schulz Ute, Hoerauf Achim, Majewski Andrew, Horton John, Sullivan Sarah, Ottesen Eric A, Nutman Thomas B
International Center for Excellence in Research, Bamako, Mali.
Dermatology Hospital of Bamako, Bamako, Mali.
Am J Trop Med Hyg. 2024 Jul 16;111(4_Suppl):22-32. doi: 10.4269/ajtmh.23-0908. Print 2024 Oct 1.
Lymphedema (LE) is one the most disfiguring chronic manifestations of lymphatic filariasis. Its management relies primarily on limb hygiene and local care. A previous study in Ghana demonstrating a beneficial effect of doxycycline on LE led to the current multicenter trial on the efficacy of doxycycline in filarial LE. A randomized placebo-controlled trial was initiated in two rural health districts in Mali. Patients with LE stages 1-3 were randomized to receive either doxycycline (200 mg/day) or placebo over a 6-week monitored treatment period and were then followed every 6 months for 2 years. Both groups received materials for limb hygiene that was carried out daily for the entire 2-year study. The primary endpoint was lack of progression in LE stage at 24 months. One hundred patients were enrolled in each study arm. The baseline sociodemographic characteristics of each group were largely similar. There was no significant difference at month 24 after treatment initiation in the number of subjects showing progression in LE stage between the two treatment arms (P = 0.5921). Importantly, however, the number of attacks of acute adenolymphangitis (ADLA) was reduced in both arms, but there was no significant difference between the two groups at any follow-up time point (all P >0.23). Doxycycline was well tolerated in those receiving the drug. When added to daily self-administered limb hygiene, a 6-week course of doxycycline (200 mg) was not superior to placebo in increasing the improvement associated with hygiene alone in LE volume, stage, or frequency of ADLA attacks over a 24-month period.
淋巴水肿（LE）是淋巴丝虫病最具毁容性的慢性表现之一。其治疗主要依赖于肢体卫生和局部护理。加纳此前一项表明强力霉素对淋巴水肿有有益作用的研究促成了目前关于强力霉素治疗丝虫性淋巴水肿疗效的多中心试验。在马里的两个农村卫生区开展了一项随机安慰剂对照试验。1-3期淋巴水肿患者被随机分配在为期6周的监测治疗期内接受强力霉素（200毫克/天）或安慰剂治疗，然后每6个月随访一次，为期2年。两组在整个2年研究期间每天都接受肢体卫生护理材料。主要终点是24个月时淋巴水肿分期无进展。每个研究组招募了100名患者。每组的基线社会人口统计学特征基本相似。治疗开始后24个月，两个治疗组中淋巴水肿分期有进展的受试者数量没有显著差异（P = 0.5921）。然而，重要的是，两组急性腺淋巴管炎（ADLA）发作次数均减少，但在任何随访时间点两组之间均无显著差异（所有P>0.23）。接受该药物的患者对强力霉素耐受性良好。在为期24个月的时间里，在日常自我进行肢体卫生护理的基础上，6周疗程的强力霉素（200毫克）在增加与单纯卫生护理相关的淋巴水肿体积、分期或ADLA发作频率改善方面并不优于安慰剂。
