埃塞俄比亚西北部脂质体两性霉素B治疗无HIV患者复杂性内脏利什曼病的安全性和疗效
Safety and efficacy of liposomal amphotericin B for treatment of complicated visceral leishmaniasis in patients without HIV, North-West Ethiopia.
作者信息
Tamiru Aschalew, Tigabu Bethlehem, Yifru Sisay, Diro Ermias, Hailu Asrat
机构信息
Leishmaniasis Research and Treatment Center, University of Gondar, College of Medicine and Health Science, Gondar, Ethiopia.
Tuberculosis Clinic, University of Gondar, College of Medicine and Health Science, Gondar, Ethiopia.
出版信息
BMC Infect Dis. 2016 Oct 10;16(1):548. doi: 10.1186/s12879-016-1746-1.
BACKGROUND
Visceral leishmaniasis (VL) is a protozoan disease that is invariably fatal if left untreated. The disease is found in 70 countries with incidence of 0.2 - 0.4 million cases. The mainstay of treatment in resource limited countries like Ethiopia is antimonials, while use of liposomal amphotericin B is reserved for treatment of complicated VL cases. The aim of this study was to assess the safety and efficacy of liposomal amphotericin B in HIV negative VL patients diagnosed with complications.
METHODS
A retrospective chart review was conducted involving records of patients admitted between January 2009 and December 2014. Baseline sociodemographic, clinical, and treatment outcome data were collected. The doses of liposomal amphotericin B and adverse events related to treatment were retrieved. Categorical and continuous variables respectively were analyzed by Chi-square and Mann-Whitney U tests. A p-value of less than 0.05 was considered statistically significant.
RESULTS
A total of 147 patients with severe VL were treated with liposomal amphotericin B in total dose ranges of 20 mg/kg to 35 mg/kg. In the overall treatment outcome analysis, initial cure (30 days after start of treatment) was observed in 128 (87.1 %), treatment failures in 10 (6.8 %), interruptions in 2(1.4 %) and deaths in 7 (4.8 %) patients. Initial cure rate at high dose (24-35 mg/kg total dose) was 96.7 % (59/61) versus 80.2 % (69/86) at lower doses (<24 mg/kg); which was significantly higher (P < 0.01), OR = 4.56: 95 %, Confidence Interval (CI) = 1.17 - 20.78). Ten cases (11.8 %) of treatment failure occurred in the low dose treatment group. The most common adverse events (AEs) were hypokalemia in 39 cases (26.5 %) and infusion related reactions in 16 (10.9 %). The frequency of hypokalemia and infusion related reactions were not significantly different between the low and high dose liposomal amphotericin B.
CONCLUSION
In HIV negative complicated VL patients, high dose of liposomal amphotericin B was found to have high cure rate at the end of treatment. The appropriate dose for better efficacy needs to be determined. Monitoring serum potassium level during treatment with liposomal amphotericin B should be an essential component of the clinical management of VL.
背景
内脏利什曼病（VL）是一种原生动物疾病，若不治疗往往会致命。该病在70个国家有发现，发病率为20万至40万例。在像埃塞俄比亚这样资源有限的国家，主要的治疗药物是锑剂，而脂质体两性霉素B则用于治疗复杂的VL病例。本研究的目的是评估脂质体两性霉素B在诊断为有并发症的HIV阴性VL患者中的安全性和疗效。
方法
进行了一项回顾性病历审查，涉及2009年1月至2014年12月期间入院患者的记录。收集了基线社会人口统计学、临床和治疗结果数据。检索了脂质体两性霉素B的剂量和与治疗相关的不良事件。分类变量和连续变量分别通过卡方检验和曼-惠特尼U检验进行分析。p值小于0.05被认为具有统计学意义。
结果
共有147例严重VL患者接受了脂质体两性霉素B治疗，总剂量范围为20mg/kg至35mg/kg。在总体治疗结果分析中，128例（87.1%）患者在治疗开始后30天实现初始治愈，10例（6.8%）治疗失败，2例（1.4%）治疗中断，7例（4.8%）患者死亡。高剂量组（总剂量24 - 35mg/kg）的初始治愈率为96.7%（59/61），而低剂量组（<24mg/kg）为80.2%（69/86）；高剂量组显著更高（P < 0.01），OR = 4.56: 95%，置信区间（CI）= 1.17 - 20.78）。低剂量治疗组发生了10例（11.8%）治疗失败。最常见的不良事件（AE）是低钾血症39例（26.5%）和输液相关反应16例（10.9%）。低剂量和高剂量脂质体两性霉素B组的低钾血症和输液相关反应频率无显著差异。
结论
在HIV阴性的复杂VL患者中，高剂量的脂质体两性霉素B在治疗结束时治愈率较高。需要确定更佳疗效的合适剂量。在用脂质体两性霉素B治疗期间监测血清钾水平应是VL临床管理的重要组成部分。
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