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印度比哈尔邦单剂量脂质体两性霉素B治疗内脏利什曼病患者的治疗结果及影响疗效的因素

Treatment Outcomes of Single-Dose Liposomal Amphotericin B-Treated Visceral Leishmaniasis Patients and Factors Affecting Outcome in Bihar, India.

作者信息

Siddiqui Niyamat Ali, Ansari Mohd Zahid, Sinha Sanjay Kumar, Pal Biplab, Singh Ashish Kumar, Singh Subhankar Kumar, Topno Roshan Kamal, Rabi Das Vidya Nand, Pandey Krishna

机构信息

Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India.

Department of Pharmacology, School of Pharmaceutical Science, Lovely Professional University, Phagwara, India.

出版信息

Am J Trop Med Hyg. 2024 Oct 8;111(6):1198-1205. doi: 10.4269/ajtmh.23-0640. Print 2024 Dec 4.

Abstract

An assessment of the treatment outcomes of single-dose liposomal amphotericin B, implemented in 2010, had not been conducted until this study. This prospective cross-sectional study encompassed 527 cases, comprising 470 (89%) cases of visceral leishmaniasis (VL) and 57 (11%) cases of post-kala-azar dermal leishmaniasis (PKDL). The male proportion was higher (55% for VL), and the mean (±SD) age was 39.2 (±33.9) years. Among VL cases (426) treated with single-dose liposomal amphotericin B, 402 cases were cured at the 6-month follow-up, resulting in a cure rate of 95%, whereas fewer than 1% (0.9%) experienced unsuccessful outcomes and 4.1% faced relapse. A statistically highly significant difference in treatment outcomes (successful versus unsuccessful) was observed between males and females (P = 0.0005). Males had higher odds of successful outcomes compared with females, with an odds ratio of 5.03 (95% CI: 1.84-13.74). Those aged ≤23 years had higher odds of successful outcomes than unsuccessful outcomes, with an odds ratio of 6.82 (95% CI: 2.29-20.33). Patients with PKDL had a mean (±SD) age of 28.5 (±10.6) years, with 63% being male. Among the 57 PKDL cases, 21 (37%) had been treated with single-dose liposomal amphotericin B, whereas others had received alternative drugs. The median duration of PKDL development for single-dose liposomal amphotericin B was significantly shorter (14.5 months), with a statistically significant difference (P <0.001) compared with other drugs. The current treatment strategy necessitates continuous close monitoring and reviews to ensure consistent and improved outcomes.

摘要

直到本研究开展之前,一直未对2010年实施的单剂量脂质体两性霉素B的治疗效果进行评估。这项前瞻性横断面研究涵盖了527例病例,其中包括470例(89%)内脏利什曼病(VL)和57例(11%)黑热病后皮肤利什曼病(PKDL)。男性比例更高(VL患者中为55%),平均(±标准差)年龄为39.2(±33.9)岁。在接受单剂量脂质体两性霉素B治疗的VL病例(426例)中,402例在6个月随访时治愈,治愈率为95%,而不到1%(0.9%)的患者治疗失败,4.1%的患者复发。在治疗效果(成功与失败)方面,男性和女性之间存在统计学上的高度显著差异(P = 0.0005)。与女性相比,男性成功治疗的几率更高,优势比为5.03(95%置信区间:1.84 - 13.74)。年龄≤23岁的患者成功治疗的几率高于治疗失败的几率,优势比为6.82(95%置信区间:2.29 - 20.33)。PKDL患者的平均(±标准差)年龄为28.5(±10.6)岁,63%为男性。在57例PKDL病例中,21例(37%)接受了单剂量脂质体两性霉素B治疗,其他患者接受了替代药物治疗。单剂量脂质体两性霉素B导致PKDL发生的中位持续时间明显更短(14.5个月),与其他药物相比存在统计学上的显著差异(P <0.001)。当前的治疗策略需要持续密切监测和评估,以确保取得持续且改善的治疗效果。

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