Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 ...Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas(subdistricts)of 26 districts(these include VL,PKDL,treatment failure,and relapse VL and cutaneous leishmaniasis cases).This study aimed to investigate the feasibility of using focused pharmacovigilance for VL(VLPV)in Bangladesh’s National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions(ADRs).Methods:This activity has been going on since December 2014.Activity area includes secondary public hospital or Upazila health complex(UHC)in hundred sub districts and Surya Kanta Kala-azar Research Center(SKKRC)in Mymensingh District,a specialized center for management of complicated VL and PKDL cases.Communicable Disease Control(CDC)of the Directorate General of Health Services(DGHS)assigned twenty five of hundred UHCs and SKKRC(total 26)as treatment centers depending on their suitable geographical location.This was implemented for better management of VL cases with Liposomal Amphotericin B(AmBisome®)to ensure patient convenience and proper utilization of this expensive donated drug.A VLPV expert committee and a UHC VLPV team were established,an operational manual and pharmacovigilance report forms were developed,training and refresher training of health personnel took place at UHCs and at the central level,collected information such as patient data including demographics,treatment history and response,adverse events were analyzed.This report includes information for the period from December 2014 to December 2016.Results:From December 2014 to December 2016,1327 leishmaniasis patients were treated and 1066(80%)were available for VLPV.Out of these,57,33,9,and 1%were new VL,PKDL,VL relapse,and other cases,respectively.Liposomal amphotericin B was mostly used(82%)for case management,followed by miltefosine(20%)and paromomycin(3%).Out of the 1066 patients,26%experienced ADRs.The most frequent ADR was fever(17%,176/1066),followed by vomiting(5%,51/1066).Thirteen serious adverse events(SAEs)(eight deaths and five unexpected SAEs)were observed.The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment.Out of the five unexpected SAEs,four were miltefosine-induced ophthalmic complications and the other was an AmBisome^(■)-induced avascular necrosis of the nasal alae.The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre(WHO-UMC)VigiFlow database.Conclusions:This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs.展开更多
We report on the use of a novel non-instrumented platform to enable a Loop Mediated isothermal Amplification(LAMP) based assay for Salmonella enterica.Heat energy is provided by addition of a small amount(<150 g) o...We report on the use of a novel non-instrumented platform to enable a Loop Mediated isothermal Amplification(LAMP) based assay for Salmonella enterica.Heat energy is provided by addition of a small amount(<150 g) of boiling water,and the reaction temperature is regulated by storing latent energy at the melting temperature of a lipid-based engineered phase change material.Endpoint classification of the reaction is achieved without opening the reaction tube by observing the fluorescence of sequence-specific FRET-based assimilating probes with a simple handheld fluorometer.At or above 22℃ ambient temperature the non-instrumented devices could maintain reactions above a threshold temperature of 61℃ for over 90 min-significantly longer than the 60 min reaction time.Using the simple format,detection limits were less than 20 genome copies for reactions run at ambient temperatures ranging from 8 to 36℃.When used with a pre-enrichment step and non-instrumented DNA extraction device,trace contaminations of Salmonella in milk close to 1 CFU/mL could be reliably detected.These findings illustrate that the non-instrumented amplification approach is a simple,viable,low-cost alternative for field-based food and agricultural diagnostics or clinical applications in developing countries.展开更多
基金This activity was supported by funds from PATH,USA.The funders had no role in the study’s design,data collection and analysis,decision to publish,or preparation of the paper.
文摘Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas(subdistricts)of 26 districts(these include VL,PKDL,treatment failure,and relapse VL and cutaneous leishmaniasis cases).This study aimed to investigate the feasibility of using focused pharmacovigilance for VL(VLPV)in Bangladesh’s National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions(ADRs).Methods:This activity has been going on since December 2014.Activity area includes secondary public hospital or Upazila health complex(UHC)in hundred sub districts and Surya Kanta Kala-azar Research Center(SKKRC)in Mymensingh District,a specialized center for management of complicated VL and PKDL cases.Communicable Disease Control(CDC)of the Directorate General of Health Services(DGHS)assigned twenty five of hundred UHCs and SKKRC(total 26)as treatment centers depending on their suitable geographical location.This was implemented for better management of VL cases with Liposomal Amphotericin B(AmBisome®)to ensure patient convenience and proper utilization of this expensive donated drug.A VLPV expert committee and a UHC VLPV team were established,an operational manual and pharmacovigilance report forms were developed,training and refresher training of health personnel took place at UHCs and at the central level,collected information such as patient data including demographics,treatment history and response,adverse events were analyzed.This report includes information for the period from December 2014 to December 2016.Results:From December 2014 to December 2016,1327 leishmaniasis patients were treated and 1066(80%)were available for VLPV.Out of these,57,33,9,and 1%were new VL,PKDL,VL relapse,and other cases,respectively.Liposomal amphotericin B was mostly used(82%)for case management,followed by miltefosine(20%)and paromomycin(3%).Out of the 1066 patients,26%experienced ADRs.The most frequent ADR was fever(17%,176/1066),followed by vomiting(5%,51/1066).Thirteen serious adverse events(SAEs)(eight deaths and five unexpected SAEs)were observed.The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment.Out of the five unexpected SAEs,four were miltefosine-induced ophthalmic complications and the other was an AmBisome^(■)-induced avascular necrosis of the nasal alae.The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre(WHO-UMC)VigiFlow database.Conclusions:This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs.
基金Financial support at UH was provided by USDA-Hatch project HA-517NINA concepts and prototypes developed at PATH were supported by grants under the Health Innovations Portfolio,which is supported by the United States Agency for International Development,private foundations,and individual donors
文摘We report on the use of a novel non-instrumented platform to enable a Loop Mediated isothermal Amplification(LAMP) based assay for Salmonella enterica.Heat energy is provided by addition of a small amount(<150 g) of boiling water,and the reaction temperature is regulated by storing latent energy at the melting temperature of a lipid-based engineered phase change material.Endpoint classification of the reaction is achieved without opening the reaction tube by observing the fluorescence of sequence-specific FRET-based assimilating probes with a simple handheld fluorometer.At or above 22℃ ambient temperature the non-instrumented devices could maintain reactions above a threshold temperature of 61℃ for over 90 min-significantly longer than the 60 min reaction time.Using the simple format,detection limits were less than 20 genome copies for reactions run at ambient temperatures ranging from 8 to 36℃.When used with a pre-enrichment step and non-instrumented DNA extraction device,trace contaminations of Salmonella in milk close to 1 CFU/mL could be reliably detected.These findings illustrate that the non-instrumented amplification approach is a simple,viable,low-cost alternative for field-based food and agricultural diagnostics or clinical applications in developing countries.
