Khamesipour Ali, Mohammadi Akram, Jaafari Mahmoud, Eskandari Seyed, Tasbihi Minoo, Javadi Amir, Afshari Farzaneh, Mortazavi Hossein, Firooz Alireza
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran.
Department of Pharmaceutical Nanotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Islamic Republic of Iran.
East Mediterr Health J. 2022 Sep 29;28(9):658-663. doi: 10.26719/emhj.22.070.
Topical nanoliposomes containing 0.4% amphotericin B (Lip-AmB 0.4%) have shown promising safety results in preclinical and phase 1 clinical trials in healthy volunteers.
To evaluate safety and efficacy of Lip-AmB 0.4% in cutaneous leishmaniasis patients.
Fourteen patients with a total of 84 lesions received national standard treatment of weekly intralesional meglumine antimoniate with biweekly cryotherapy, or daily intramuscular meglumine antimoniate (20 mg/kg/day for 14 days), and topical Lip-AmB 0.4% twice daily for 28 days. Twenty-two patients with a total of 46 lesions (7 at most) were treated with topical Lip-AmB 0.4% alone twice daily for 28 days. Thirty patients with a total of 68 lesions received national standard treatment of weekly intralesional meglumine antimoniate (to blanch around the lesion) and biweekly cryotherapy.
Sixty-six patients with cutaneous leishmaniasis lesions completed the study. In the safety evaluation, 2 of the 36 patients evaluated reported a tolerable burning sensation and they preferred to continue treatment. Twelve (92%) of 14 patients with 84 lesions who received national standard treatment combined with Lip-AmB 0.4% completed the study with complete cure. In 1 of the patients with 4 lesions, 1 lesion showed complete cure and 3 showed partial cure. Among 22 patients with 46 lesions who received only topical LipAmB 0.4%, 19 completed the study and 18 showed complete cure (95% efficacy). In the 30 patients who received national standard treatment alone, 33 lesions in 15 patients showed complete cure (48.5%) on day 42 follow-up.
Lip-AmB 0.4% alone or in combination with national standard treatment is safe with high-efficacy rate and warrants further investigation during phase 3 clinical trials.
含0.4%两性霉素B的纳米脂质体（Lip-AmB 0.4%）在健康志愿者的临床前和1期临床试验中已显示出有前景的安全性结果。
评估Lip-AmB 0.4%在皮肤利什曼病患者中的安全性和疗效。
14例患者共84处皮损，接受每周皮损内注射葡甲胺锑酸盐联合每两周一次冷冻疗法的国家标准治疗，或每日肌肉注射葡甲胺锑酸盐（20mg/kg/天，共14天），并每日两次外用Lip-AmB 0.4%，共28天。22例患者共46处皮损（最多7处），仅每日两次外用Lip-AmB 0.4%，共28天。30例患者共68处皮损，接受每周皮损内注射葡甲胺锑酸盐（使皮损周围变白）联合每两周一次冷冻疗法的国家标准治疗。
66例有皮肤利什曼病皮损的患者完成了研究。在安全性评估中，36例接受评估的患者中有2例报告有可耐受的烧灼感，他们更愿意继续治疗。14例有84处皮损且接受国家标准治疗联合Lip-AmB 0.4%的患者中有12例（92%）完成研究并完全治愈。在1例有4处皮损的患者中，1处皮损完全治愈，3处部分治愈。在22例有46处皮损且仅接受外用Lip-AmB 0.4%治疗的患者中，19例完成研究，18例完全治愈（有效率95%）。在30例仅接受国家标准治疗的患者中，15例患者的33处皮损在随访第42天时完全治愈（48.5%）。
Lip-AmB 0.4%单独使用或与国家标准治疗联合使用安全且有效率高，值得在3期临床试验中进一步研究。
