Sundar S, Jha T K, Thakur C P, Mishra M, Singh V P, Buffels R
Kala-azar Medical Research Center, Banaras Hindu University, Varanasi, 221 005, India.
Clin Infect Dis. 2003 Sep 15;37(6):800-4. doi: 10.1086/377542. Epub 2003 Aug 28.
Widespread antimony resistance renders conventional amphotericin B the only option for the treatment of visceral leishmaniasis (VL) in North Bihar, India. Because of its excellent safety profile, a large dose (7.5 mg/kg) of liposomal amphotericin B (L-AmB) was given to each of 203 patients with VL at 4 treatment centers, and the patients were discharged the next day. At initial clinical and parasitological follow-up, performed on day 30 after treatment, evidence of a cure was seen in 195 (96%) of 203 patients (95% CI, 92-98); 4 patients experienced treatment failure. Two patients were lost to follow-up, 2 died (one due to progressive disease and another, 5 months after treatment, due to an unrelated illness), and 12 experienced relapses during follow-up. Thus, 183 patients (90%; 95% CI, 85-94) had obtained final cure 6 months after treatment. Very few adverse events (fever with rigor, in 9.8% of patients) were seen. Single-dose L-AmB (7.5 mg/kg) treatment is safe and effective, and it may be used for the mass treatment of VL in India.
广泛的锑耐药性使得传统两性霉素B成为印度北比哈尔邦治疗内脏利什曼病（VL）的唯一选择。鉴于其出色的安全性，4个治疗中心的203例VL患者均接受了大剂量（7.5mg/kg）的脂质体两性霉素B（L-AmB）治疗，且患者于次日出院。在治疗后第30天进行的初始临床和寄生虫学随访中，203例患者中有195例（96%）（95%CI，92-98）有治愈迹象；4例患者治疗失败。2例患者失访，2例死亡（1例死于疾病进展，另1例在治疗5个月后死于无关疾病），12例在随访期间复发。因此，183例患者（90%；95%CI，85-94）在治疗6个月后获得最终治愈。观察到的不良事件极少（9.8%的患者出现寒战发热）。单剂量L-AmB（7.5mg/kg）治疗安全有效，可用于印度VL的大规模治疗。
