Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India
Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India
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DOI：
10.1086/380638
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发表时间：
2004-01-15
影响因子：
11.8
通讯作者：
Berman, JD
中科院分区：
文献类型：
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作者：
Bhattacharya, SK;Jha, TK;Berman, JD
米替福新先前已被证明可以治愈97%的印度成人内脏利什曼病（VL）病例。由于大约一半的VL病例发生在儿童中，我们在一项开放标签临床试验中评估了80名经寄生虫学证实感染的印度儿童（年龄，2 - 11岁）使用成人剂量的米替福新（2.5 mg/kg/天，持续28天）。在治疗结束时和6个月后重新评估临床和寄生虫学参数。1例患者在第6天死于并发肺炎。其他79名患者在治疗后没有表现出寄生虫，有明显的临床改善，并被认为初步治愈。3例患者复发，1例患者失访。所有入组患者的最终治愈率为94%，可评价患者的最终治愈率为95%。副作用包括轻度至中度呕吐或腹泻（各占25%）和治疗早期天冬氨酸转氨酶水平轻度至中度一过性升高（55%）。这项试验表明，米替福新在印度VL儿童中与成人一样有效且耐受性良好，可以推荐为印度儿童VL治疗的首选。
Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2 - 11 years) with parasitologically confirmed infection in an open-label clinical trial. Clinical and parasitological parameters were reassessed at the end of treatment and 6 months later. One patient died of intercurrent pneumonia on day 6. The other 79 patients demonstrated no parasites after treatment, had marked clinical improvement, and were deemed initially cured. Three patients had relapse, and 1 patient was lost to follow-up. The final cure rate was 94% for all enrolled patients and 95% for evaluable patients. Side effects included mild-to-moderate vomiting or diarrhea (each in similar to25% of patients) and mild-to-moderate, transient elevations in the aspartate aminotransferase level during the early treatment phase (in 55%). This trial indicates that miltefosine is as effective and well tolerated in Indian children with VL as in adults and that it can be recommended as the first choice for treatment of childhood VL in India.