一项针对印度比哈尔邦抗锑内脏利什曼病病例的两性霉素 B 去氧胆酸盐与喷他脒对照治疗的对照、随机、非盲临床试验，以评估其疗效。
A controlled, randomized nonblinded clinical trial to assess the efficacy of amphotericin B deoxycholate as compared to pentamidine for the treatment of antimony unresponsive visceral leishmaniasis cases in Bihar, India.
机构信息
Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Patna, Bihar, India;
出版信息
Ther Clin Risk Manag. 2009 Feb;5(1):117-24. Epub 2009 Mar 26.
BACKGROUND
There is significant variation in Amphotericin B (AMB) efficacy and relapses in antimony unresponsive visceral leishmaniasis (VL) cases over a period of time (10-15 years). Keeping in mind the above mentioned view this study was undertaken with an objective to assess the magnitude of cure and relapse rates of AMB in the treatment of antimony unresponsive VL cases.
METHODS
In a controlled, randomized nonblinded clinical trial, we evaluated the cure and relapse rate of Amphotericin B deoxycholate as compared to pentamidine. A total of 82 sodium stibogluconate (SSG) unresponsive and parasitologically confirmed VL cases were included in this study and randomized into two groups, test (Amphotericin B) and control (Pentamidine). Both the groups were treated with recommended dosages (as per World Health Organization guidelines) of respective medicines. All the patients were followed up on 1st, 2nd, and 6th month after end of treatment.
RESULTS
Apparent cure rate in the Amphotericin B group was found to be 95% (39/41) compared with 83% (34/41) in the Pentamidine group, which shows significant statistical difference (p = 0.05). The ultimate cure rate was found 92% (38/41) in the Amphotericin B group compared to 73% (30/41) in the Pentamidine group, which shows a significant statistical difference (Yates corrected chi-square = 4.42, p = 0.04). Similarly, significant statistical difference was observed in the relapse rate of the Amphotericin group compared to the Pentamidine group (p = 0.03).
CONCLUSIONS
AMB may still be the drug of choice in the management of resistant VL cases in Bihar, India. This is due to its consistent apparent cure rate (95%), low relapse rate (2.5%), and cost effectiveness compared with other available antileishmanial drugs. It is a safe drug even in case of pregnancy. Efforts should be taken to form a future strategy so that this drug and coming newer drugs do not meet a similar fate as has happened to SSG and pentamidine over a span of 10-15 years.
背景
在一段时间内（10-15 年），两性霉素 B（AMB）在治疗锑无反应性内脏利什曼病（VL）病例中的疗效和复发存在显著差异。考虑到上述观点，本研究旨在评估 AMB 治疗锑无反应性 VL 病例的治愈率和复发率。
方法
在一项对照、随机、非盲临床试验中，我们评估了两性霉素 B 脱氧胆酸盐与喷他脒的治愈率和复发率。共有 82 例葡萄糖酸锑钠（SSG）无反应和寄生虫学证实的 VL 病例纳入本研究，并随机分为两组，实验组（两性霉素 B）和对照组（喷他脒）。两组均按照世界卫生组织指南推荐的剂量（）使用各自的药物进行治疗。所有患者在治疗结束后第 1、2 和 6 个月进行随访。
结果
实验组 AMB 的显效率为 95%（39/41），对照组喷他脒为 83%（34/41），差异有统计学意义（p=0.05）。实验组最终治愈率为 92%（38/41），对照组为 73%（30/41），差异有统计学意义（Yates 校正卡方=4.42，p=0.04）。同样，实验组的复发率与对照组相比差异有统计学意义（p=0.03）。
结论
AMB 可能仍然是印度比哈尔邦耐药性 VL 病例管理的首选药物。这是因为与其他可用的抗利什曼原虫药物相比，它具有一致的显效率（95%）、低复发率（2.5%）和成本效益。即使在怀孕期间，它也是一种安全的药物。应努力制定未来的策略，以避免 AMB 和即将推出的新药重蹈 SSG 和喷他脒在 10-15 年内的覆辙。
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