A prospective randomized, comparative, open-label trial of the safety and efficacy of paromomycin (aminosidine) plus sodium stibogluconate versus sodium stibogluconate alone for the treatment of visceral leishmaniasis
A prospective randomized, comparative, open-label trial of the safety and efficacy of paromomycin (aminosidine) plus sodium stibogluconate versus sodium stibogluconate alone for the treatment of visceral leishmaniasis
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DOI：
10.1016/s0035-9203(00)90130-5
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发表时间：
2000-07-01
影响因子：
2.2
通讯作者：
Olliaro, P
中科院分区：
文献类型：
--
作者：
Thakur, CP;Kanyok, TP;Olliaro, P
对有机五价锑剂治疗的反应是内脏利什曼病（VL）的标准一线治疗，自其引入印度以来一直在下降。葡萄糖酸锑钠（SB）与巴龙霉素（PM）联合治疗可能是单药治疗的有效替代方案。该试验旨在评估PM 12或18 mg/kg每日加SE 20 mg/kg每日持续21天与单独SE持续30天相比的安全性和有效性。1996年，150例患者被随机分配到3种治疗中的1种，并随访180天。治疗结束时，52例接受PM 12 +SB的患者中有49例治愈，48例接受PM 18 +SB的患者中有46例治愈，49例接受SE的患者中有27例治愈。在随访期间，每个治疗组均有1例复发，最终治愈率为：PM 12 +SB组48/52例（92.3%），PM 18 +SB组45/48例（93.8%），SE组26/49例（53.1%）。PM加SE每日12或18 mg/kg 21天比SE单独30天显著更有效（χ（2）P < 0.001）。1例患者（仅SB）在第8天发生了严重不良事件：心脏毒性（心肌炎和ECG变化），导致退出研究。PM治疗组入组的100例患者中仅19例进行了完整的听力图系列，因此难以评估耳毒性。在印度比哈尔邦，PM 12或18 mg/kg每日一次加标准剂量SE持续21天在最终治愈VL患者方面比SE更有效，具有统计学意义。
Response to treatment with organic pentavalent antimonials, the standard first-line treatment for visceral leishmaniasis (VL), has been decreasing since their introduction into India. Combining sodium stibogluconate (SB) with paromomycin (PM) may be an efficient alternative to single-agent therapy. This trial was designed to assess the safety and efficacy of PM 12 or 18 mg/kg daily plus SE 20 mg/kg daily for 21 days compared to SE alone for 30 days. One hundred and fifty patients were randomly assigned in 1996 to 1 of the 3 treatments and followed-up for 180 days. At the end of treatment, 49 of 52 patients receiving PM12+SB, 46 of 48 receiving PM18+SB, and 27 of 49 patients receiving SE alone, were cured. During follow-up there was 1 relapse in each of the treatment groups, giving final cure rates of 48 of 52 (92.3%) for PM12+SB, 45 of 48 (93.8%) for PM18+SB, and 26 of 49 (53.1%) for SE. PM plus SE for 21 days at either 12 or 18 mg/kg daily was significantly more effective than SE alone for 30 days (chi(2) P < 0.001). One patient (SB alone) had experienced a serious adverse event: cardiotoxicity at day 8 (myocarditis and ECG changes) which caused withdrawal from the study. Only 19 of 100 patients enrolled in the PM treatment arms had a complete audiogram series conducted thus making it difficult to assess oto-toxicity. PM 12 or 18 mg/kg daily plus a standard dose of SE for 21 days was statistically more effective than SE in producing a final cure for patients with VL in Bihar, India.