To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL)

Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and...

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Veröffentlicht in:PloS one 2017-03, Vol.12 (3), p.e0174497
Hauptverfasser: Rabi Das, Vidya Nand, Siddiqui, Niyamat Ali, Pal, Biplab, Lal, Chandra Shekhar, Verma, Neena, Kumar, Ashish, Verma, Rakesh Bihari, Kumar, Dhirendra, Das, Pradeep, Pandey, Krishna
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container_start_page e0174497
container_title PloS one
container_volume 12
creator Rabi Das, Vidya Nand
Siddiqui, Niyamat Ali
Pal, Biplab
Lal, Chandra Shekhar
Verma, Neena
Kumar, Ashish
Verma, Rakesh Bihari
Kumar, Dhirendra
Das, Pradeep
Pandey, Krishna
description Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients. In this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year. A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups. The lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment.
doi_str_mv 10.1371/journal.pone.0174497
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Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients. In this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year. A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. 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Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Advanced Technologies &amp; Aerospace Database</collection><collection>ProQuest Advanced Technologies &amp; Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rabi Das, Vidya Nand</au><au>Siddiqui, Niyamat Ali</au><au>Pal, Biplab</au><au>Lal, Chandra Shekhar</au><au>Verma, Neena</au><au>Kumar, Ashish</au><au>Verma, Rakesh Bihari</au><au>Kumar, Dhirendra</au><au>Das, Pradeep</au><au>Pandey, Krishna</au><au>Diemert, David Joseph</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL)</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2017-03-29</date><risdate>2017</risdate><volume>12</volume><issue>3</issue><spage>e0174497</spage><pages>e0174497-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients. In this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year. A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups. The lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>28355259</pmid><doi>10.1371/journal.pone.0174497</doi><tpages>e0174497</tpages><oa>free_for_read</oa></addata></record>
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identifier ISSN: 1932-6203
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issn 1932-6203
1932-6203
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source MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry
subjects Adolescent
Adult
Amphotericin B
Amphotericin B - administration & dosage
Amphotericin B - adverse effects
Analysis
Antifungal agents
Antiprotozoal Agents - administration & dosage
Antiprotozoal Agents - adverse effects
Biology and Life Sciences
Care and treatment
Child
Clinical medicine
Complications and side effects
Councils
Dextrose
Disease transmission
Dosage
Dosage and administration
Dose-Response Relationship, Drug
Drug dosages
Drug therapy
Female
Health risk assessment
Humans
Leishmania - drug effects
Leishmaniasis
Leishmaniasis, Cutaneous - drug therapy
Leishmaniasis, Cutaneous - parasitology
Leishmaniasis, Visceral - parasitology
Leishmaniasis, Visceral - pathology
Male
Medical research
Medicine
Medicine and Health Sciences
Molecular biology
Motivation
Parasite Load
Parasites
Parasitic diseases
Patient outcomes
Patients
Renal Insufficiency - chemically induced
Research and Analysis Methods
Safety
Sample size
Skin
Treatment Outcome
Tropical diseases
Vector-borne diseases
Visceral leishmaniasis
Young Adult
title To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL)
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