ABSTRACT
Introduction: Malnutrition is common in patients withEnd Stage Renal Disease (ESRD) on Hemodialysis (HD).Depending on the parameter measured, the prevalence ofmalnutrition in the chronic dialysis population ranges from 10to 54%. It is related with the secretion of a number of proteins(adipokines), including leptin and adiponectin and alsocytokines such as IL-6. This study was planned with the aimof reviewing the association of nutritional status with serumleptin and CRP levels in hemodialysis patients.Material and methods: The present study was conducted inthe department of Medicine at Chattrapati Shivaji SubhartiHospital from August 2017 to March 2019; consisted of50 patients of End stage Renal Disease on maintenancehemodialysis admitted in Chattrapati Shivaji Subharti Hospitalduring the time period.Results: Out of the 50 subjects, 35 (70%) were male and15 (30%) were females. The Lean Body Mass (%) in thestudy subjects was 59.76±5.92. The overall mean leptinlevel distribution among the subjects was 1.51±0.36. Theoverall mean CRP level distribution among the subjects. was3.75±0.47. A positive correlation was found between CRPand BMI with statistical significance as p<0.05 (table 11).Similarly a highly positive correlation was found betweenLeptin and BMI as p<0.01.Conclusion: Our study point to possible use of serum leptinand CRP concentration as an indicator of nutritional status inHD patients based on observed significant positive correlationbetween serum leptin and CRP concentrations with BMIvalues.
ABSTRACT
Introduction: Iron and vitamin D are two essential nutrientswhich constitute an important worldwide health issue dueto their significant roles in biochemistry. The present studywas conducted to assess the prevalence and risk of anemiain a population of subjects with documented D25 deficiencycompared with those with normal D25 levels.Material and Methods: The present case control study wasconducted among 100 subjects (50 were cases and 50 werecontrols) in the department of Medicine at Chattrapati ShivajiSubharti Hospital. Total serum 25(OH)D concentrationwas analyzed using commercially available ELISA kits.According to the manufacturer’s instructions, concentrationsof 25(OH)D below 25 nmol/L were classified as a deficiency,and values of 25–75 nmol/L were considered a vitamin Dinsufficiency. Difference between two groups was determinedusing chi square test and student T test for categorical data andcontinuous data respectively. P-value of <0.05 was consideredas significant.Results: Hb<13 was found in 75% of the case group (male)and 25% of the control group (male). Hb<12 was found in64.29% of the case group (female) and 45.45% of the controlgroup (female). Mean iron (μg/dl) among the male and femalecase group was less as compared to the control group withstatistically significant difference as p<0.05.Conclusions: The results of the present study showed thatVitamin D metabolism is dependent on iron and its deficiencymight disturb Vitamin D activation
ABSTRACT
Introduction: Epidural anaesthesia and analgesia hasjustified use in the perioperative care of high-risk surgicalpatients, as they give better analgesia, and also improvedoutcome. Thoracic Epidural analgesia is an excellent methodof postoperative and post injury pain control in proceduresinvolving significant thoracic and abdominal injury weathertraumatically or surgically induced. Though Bupivacaine isconsidered to be the drug of choice, many other agents arebeing used for epidural anesthesia.Material and Methods: This study was carried out on 105ASA grade I and II nulliparous patients, between 20 to 70 yearsof age undergoing laparotomy, voluntary donor nephrectomyand renal surgeries. They were randomly divided in theBuprenorphine, Bupivacaine and Fentanyl Groups. Quality ofanalgesia and post-operative complications were monitored.Results: Analgesic failure was observed in all the threeGroups. But complete pain relief was better in theBuprenorphine Group. Also, complications (hypotension,bradycardia, sedation) were less in the Buprenorphine Groupthan in the Bupivacaine and Fentanyl Groups.Conclusion: Buprenorphine is safer and provides betterquality analgesia than Bupivacaine and Fentanyl.
ABSTRACT
@#Abstract Objective: There have been five documented outbreaks of Ebola Reston virus (RESTV) in animals epidemiologically linked to the Philippines. This assessment was conducted to determine the risk of RESTV occurring in humans in the Philippines and its potential pathogenicity in humans. Methods: The World Health Organization Rapid Risk Assessment of Acute Public Health Events Manual was used for the assessment. A literature review was done and a risk assessment matrix was used for the risk characterization of the outbreaks in the Philippines. The risk assessment was conducted by the Philippines Field Epidemiology Training Program. Results: The risk of RESTV occurring in humans in the Philippines and its potential pathogenicity in humans were both assessed as moderate. Animals involved in RESTV outbreaks in the Philippines were non-human primates and domestic pigs. The presence of RESTV in pigs poses a possibility of genetic evolution of the virus. Although RESTV has been identified in humans, there was no death or illness attributed to the infection. The Philippines Inter-agency Committee on Zoonoses oversees collaboration between the animal and human health sectors for the prevention and control of zoonoses. However, there is no surveillance of risk animals or previously affected farms to monitor and facilitate early identification of cases. Discussion: The moderate risk of RESTV recurring among humans in the Philippines and its potential pathogenicity in humans reinforces the need for early detection, surveillance and continued studies of RESTV pathogenesis and its health consequences. The One Health approach, with the involvement and coordination of public health, veterinary services and the community, is essential in the detection, control and management of zoonosis.
ABSTRACT
Introduction@#In April 2016, the Department of Health in Zamboanga Peninsula reported an increase in the number of acute gastroenteritis cases reported from Zamboanga City. An epidemiologic investigation was conducted to verify the existence of an outbreak, determine source/mode of transmission and recommend control measures.@*Methods@#A line list of cases was compiled from the 11 hospitals within Zamboanga City and a case-series study was conducted. Suspected cases were any persons from Zamboanga City who had three or more episodes of acute diarrhoea within 24 hours from 15 March to 29 May 2016. Confirmed cases were suspected cases with active symptoms during the investigation who had a stool sample collected with rotavirus detected. Water samples were also collected for viral detection.@*Results@#There were 2936 suspected cases with 22 deaths (case fatality rate: 0.75%), an age range of 8 days to 89 years (median: 2 years), with those aged less than 5 years the most affected age group (1903/2936, 65%). The majority were males (1549/2936, 53%). From the 138 active case patients included in the case-series study, the majority reported contact with a family member who had diarrhoea (89/138, 64%) and using water refilling stations as their major source of drinking water (88/134, 64%). Of the 93 stool specimens collected, 56 (60%) were positive for rotavirus. Five samples from water refilling stations where case patients reported collecting drinking water were all positive for rotavirus.@*Discussion@#Strict regulation of water refilling stations and boiling drinking water in households were implemented, immediately controlling the outbreak. After complying with all the requirements set by the Department of Health, a water safety certificate was awarded to Zamboanga City in September 2018.
ABSTRACT
Introduction@#On 18 August 2014, cases of food poisoning in San Vicente Village were reported to the Event-Based Surveillance & Response Unit of the Philippine Department of Health. An investigation was conducted to identify the implicated source, describe the outbreak and evaluate the risk factors.@*Methods@#A case-control study was conducted. A suspected case was a previously well individual of Medina who attended the village festival and developed abdominal pain and vomiting with or without nausea, diarrhoea and fever from 18 to 19 August. A confirmed case was a suspected case with a rectal swab positive for bacterial culture. Rectal swabs, water and food samples were sent to the national reference laboratories. Food source and consumption interviews and environmental inspections were conducted.@*Results@#Sixty-four cases and 123 unmatched controls were identified. The median incubation period was 1 hour 15 minutes. Five cases (8%) were positive for Staphylococcus aureus, one (2%) for Aeromonas hydrophilia and one (2%) for Shigella boydii. One (14%) water sample was positive for Aeromonas spp. Of the collected food samples, beef steak was positive for Staphylococcus aureus. Risk factors were consumption of Filipino-style beef stew (odds ratio [OR]: 6.62; 95% confidence interval [CI]: 2.90–15.12) and stir-fried noodles (OR: 3.15; 95% CI: 1.52–6.50). Prolonged serving time and improper food storage were noted.@*Discussion@#In this foodborne outbreak, Staphylococcus aureus was the likely causative agent. Meals were contaminated due to improper food handling practices. We recommend that a policy be created to mandate that village-appointed food handlers undergo food safety training.
ABSTRACT
Introduction@#Ciguatera fish poisoning (CFP) is common in tropical and subtropical waters. On 13 November 2015, eight Filipino seafarers from a cargo ship sailing in the Caribbean Sea experienced a range of symptoms after consuming a barracuda. Upon their return to the Philippines, an investigation was conducted to describe the cases.@*Methods@#A case-series was conducted. A CFP case was defined as a previously well individual on the ship who developed at least one gastrointestinal symptom and at least one neurologic manifestation after eating barracuda on 13 November 2015. All cases were admitted to hospital in Manila, Philippines and were interviewed using a standard questionnaire. Urine and serum samples of cases were collected for ciguatoxin (CTX) testing by radiological and receptor-binding assay.@*Results@#Eight of the 25 seafarers on the ship ate the barracuda; all eight met the CFP case definition. The age of cases ranged from 37 to 58 years (median: 47 years) and all were males. Onset of symptoms ranged from 1 to 3 hours (median: 2 hours) from the time of ingestion of the barracuda. All cases experienced gastrointestinal (nausea, vomiting, diarrhoea) and neurologic (temperature allodynia, itchiness) symptoms but no cardiovascular manifestations. Urine and serum specimens of all eight cases showed CTX below the detection limit.@*Discussion@#The Philippines Epidemiology Bureau recommended that the Philippine Maritime Authority include CTX poisoning and its health risks in seafarers’ training to prevent future cases of CFP. The Event-based Surveillance and Response system will continue to provide a mechanism for the reporting and appropriate management of CFP cases.
ABSTRACT
Objective@#On 2 October 2015, the Event-Based Surveillance and Response Unit of the Department of Health (DOH), Philippines received a report of foodborne illness cases in Santa Cruz, Davao del Sur. A team from DOH was sent to conduct an investigation to identify the implicated source and determine risk factors.@*Methods@#A retrospective cohort study was done. A suspect case was defined as a previously well individual in Compound A, Santa Cruz who developed abdominal pain, headache, dizziness, diarrhoea or vomiting on either 1 or 2 October 2015. A confirmed case was a suspect case positive for cyanide in urine. Family members who prepared the food were interviewed. Urine specimens were collected to test for thiocyanate, and cassava tuber and soil samples were tested for cyanide and other chemicals.@*Result@#Fourteen cases with two deaths were identified (case fatality ratio: 14%). All cases consumed cassava on 1 October 2015 except for one child who spat it out. Urine samples were all negative (36, 100%) for thiocyanate so there were no confirmed cases. The cassava sample had a cyanide level of 68.94 ug/g and was identified as bitter cassava, also known as a potentially dangerous kind. Insufficient food preparation was noted. In the retrospective cohort study, intake of cassava (RR = 208, 95% CI: 19.94–2169.32) was associated with the illness.@*Discussion@#This study identified insufficiently processed cassava root crop as the source of the foodborne illness. The cassava consumed was the bitter variety that contains greater than 50 ug/g of hydrogen cyanide and requires thorough preparation before consumption. Community education was provided on identifying and preparing cassava appropriately.
ABSTRACT
Introduction: Measles is a highly infectious viral illness that remains one of the leading causes of death among children worldwide. In the Philippines, decreasing routine vaccination coverage from 2007 to 2011 led to local measles outbreaks. A team investigated a measles outbreak reported in Cordillera of the Philippines in May 2013. Methods: Measles case data with symptom onset from 2 February to 27 May 2013 were obtained from official sources and verified on site. Data included age, sex, residential address, signs and symptoms and vaccination status. Active case-findings were also conducted for contacts of these cases. The living environments of the cases were investigated. A survey was conducted with the cases and caregivers to understand their knowledge and attitudes about measles. Results: There were 50 measles cases identified with an age range from six months to 32 years (median: 16 years). Thirty-two were male (64%). Twenty (40%) were hospitalized with one death. Thirty-two (64%) cases were laboratory confirmed, and 36 (72%) received a single dose of measles vaccine. Overcrowded living environments were observed among many cases. The majority of respondents (46/48, 96%) knew about measles, but there were misconceptions about the cause of measles and how it can be prevented and managed. Conclusion: This measles outbreak occurred in an area with low immunization coverage. Achieving 95% measles immunization coverage and strengthening routine immunization strategies to address high-risk populations are recommended. Also, we recommend health education campaigns to include components that address misconceptions about measles.
ABSTRACT
Background：In May 2012, there were increasing diarrhoea cases and deaths reported from Nabua, Camarines Sur to the Philippines event-based surveillance system. An investigation was conducted to identify risk factors and determine transmission dynamics.Methods：A suspected case was defined as a resident of Nabua with at least three episodes of watery diarrhoea per day from 16 March to 22 June 2012. A confirmed case was defined as a suspected case positive for Vibrio cholerae. An environmental investigation was conducted and rectal swabs and water samples sent to the national reference laboratory for bacterial isolation. A 1:2 case-control study matching for age and sex was conducted. Data were analysed using Epi Info.Results：There were 309 suspected cases with two deaths, and the most affected age group was children under five years (45%). Eight cases were positive for Vibrio cholerae Ogawa El Tor and one for Non-01. Water samples were positive for faecal coliforms and Aeromonas caviae. The case-control study showed that cases had a higher odds than controls of using unchlorinated water sources (odds ratio [OR] = 3.6; 95% confidence interval [CI]:1.6–8.5) and having toilets located within 20 m of a septic tank (OR = 2.7; 95% CI: 1.4–5.3). In multivariate analysis, the only significant factor was drinking from piped water (OR = 0.21; 95% CI: 0.09–0.49).Discussion：In this cholera outbreak, drinking-water from unchlorinated wells was a significant risk factor. Future cholera control efforts should include not just improving water and sanitation systems but also intensified behaviour change campaigns.
ABSTRACT
Background：In July 2012, the Philippines National Epidemiology Center received a report of a suspected chikungunya fever outbreak in San Pablo City, Laguna Province, the first chikungunya cases reported from the city since surveillance started in 2007. We conducted an outbreak investigation to identify risk factors associated with chikungunya.Methods：A case was defined as any resident of Concepcion Village in San Pablo City who had fever of at least two days duration and either joint pains or rash between 23 June and 6 August 2012. Cases were ascertained by conducting house-to-house canvassing and medical records review. An unmatched case-control study was conducted and analysed using a multivariate logistic regression. An environmental investigation was conducted by observing water and sanitation practices, and 100 households were surveyed to determine House and Breteau Indices. Human serum samples were collected for confirmation for chikungunya IgM through enzyme-linked immunosorbent assay.Results：There were 98 cases identified. Multivariate analysis revealed that having a chikungunya case in the household (adjusted odds ratio [aOR]: 6.2; 95% confidence interval [CI]: 3.0–12.9) and disposing of garbage haphazardly (aOR: 2.7; 95% CI: 1.4–5.4) were associated with illness. House and Breteau Indices were 27% and 28%, respectively. Fifty-eight of 84 (69%) serum samples were positive for chikungunya IgM.Conclusion：It was not surprising that having a chikungunya case in a household was associated with illness in this outbreak. However, haphazard garbage disposal is not an established risk factor for the disease, although this could be linked to increased breeding sites for mosquitoes.
ABSTRACT
Background：Middle East respiratory syndrome (MERS) is an illness caused by a coronavirus in which infected persons develop severe acute respiratory illness. A person can be infected through close contacts. This is an outbreak investigation report of the first confirmed MERS case in the Philippines and the subsequent contact tracing activities.Methods：Review of patient records and interviews with health-care personnel were done. Patient and close contacts were tested for MERS-coronavirus (CoV) by real time-polymerase chain reaction. Close contacts were identified and categorized. All traced contacts were monitored daily for appearance of illness for 14 days starting from the date of last known exposure to the confirmed case. A standard log sheet was used for symptom monitoring.Results：The case was a 31-year-old female who was a health-care worker in Saudi Arabia. She had mild acute respiratory illness five days before travelling to the Philippines. On 1 February, she travelled with her husband to the Philippines while she had a fever. On 2 February, she attended a health facility in the Philippines. On 8 February, respiratory samples were tested for MERS-CoV and yielded positive results. A total of 449 close contacts were identified, and 297 (66%) were traced. Of those traced, 15 developed respiratory symptoms. All of them tested negative for MERS.Discussion：In this outbreak investigation, the participation of health-care personnel in conducting vigorous contact tracing may have reduced the risk of transmission. However, being overly cautious to include more contacts for the outbreak response should be further reconsidered.
ABSTRACT
Recently, a chelonitoxism (turtle poisoning) outbreak in Arteche, Eastern Samar, Philippines was featured by the Western Pacific Surveillance and Response Journal (WPSAR) describing the dangers of turtle meat consumption.
ABSTRACT
Background：In July 2013, the Philippines’ Event-Based Surveillance & Response Unit received a paralytic shellfish poisoning (PSP) report from Tarangnan, Western Samar. A team from the Department of Health conducted an outbreak investigation to identify the implicated source and risk factors in coastal villages known for green mussel production and exportation.Methods：A case was defined as a previously well individual from Tarangan, Western Samar who developed gastrointestinal symptoms and any motor and/or sensory symptoms after consumption of shellfish from 29 June to 4 July 2013 in the absence of any known cause. The team reviewed medical records, conducted active case finding and a case-control study. Relatives of cases who died were interviewed. Sera and urine specimens, green mussel and seawater samples were tested for saxitoxin levels using high performance liquid chromatography.Results：Thirty-one cases and two deaths were identified. Consumption of > 1 cup of green mussel broth was associated with being a case. Seawater sample was positive for Pyrodinium bahamense var. compressum and green mussel samples were positive for saxitoxin. Inspection revealed villagers practice open defecation and improper garbage disposal.Conclusion：This PSP outbreak was caused by the consumption of the green mussel broth contaminated by saxitoxin. As a result of this outbreak, dinoflagellate and saxitoxin surveillance was established, and since the outbreak, there have been no harmful algal blooms event or PSP case reported since. A “Save Cambatutay Bay” movement, focusing on proper waste disposal practice and clean-up drives has been mobilized.
ABSTRACT
Background：On 21 August 2013, the Event-based Surveillance and Response system of the Department of Health, Philippines captured a foodborne illness event among residents of a coastal village in Eastern Samar, Philippines. The suspected cause was the consumption of a sea turtle found near the village. A team from the Department of Health was sent to conduct an outbreak investigation.Methods：A case was defined as any person in Arteche, Eastern Samar, who developed dry mouth and burning sensation in the throat from 15 August to 27 August, 2013. Severity of the disease was classified as mild, moderate or severe. We conducted records review, environmental investigation, interviews of key informants and a retrospective cohort study.Results：Sixty-eight cases were identified; four died (case fatality rate = 6%). All cases had a history of turtle meat consumption. Dose-dependent relationship was noted between amount of turtle meat consumed and the risk of illness. In the cohort study, consumption of turtle meat and turtle meat soup were associated with illness.Conclusion：This study identified turtle meat as the source of this foodborne outbreak and emphasized the dangers of consuming turtle meat. Other reported cases of turtle meat poisoning in the Philippines suggest that turtle consumption is an ongoing practice in the country. By publishing information about sea turtle poisoning outbreaks in the Philippines, we hope to raise awareness of the potential severe health effects from ingesting these endangered sea creatures.
ABSTRACT
BACKGROUND: Three weeks after Typhoon Haiyan, an increasing number of acute gastroenteritis cases were reported in Kananga, Leyte, an area where evacuated residents had returned home two days after the disaster. An outbreak investigation was conducted to identify the source and risk factors associated with the increase of gastroenteritis. METHODS: A case was defined as any person in Kananga who developed acute diarrhoea (≥ 3 times/24 hours) and any of the following symptoms: fever, nausea, vomiting or abdominal pain from 11 November 2013 to 10 December 2013. Active case finding was conducted by reviewing medical records, and a case-control study was conducted. Rectal swabs and water samples were tested for bacteriological examination. RESULTS: One hundred and five cases were identified. Multivariate analysis revealed that consumption of untreated drinking-water was associated with illness (adjusted odds ratio: 18.2). Both rectal swabs and municipal water samples tested positive for Aeromonas hydrophila. On inspection of the municipal water system, breaks in the distribution pipes were found with some submerged in river water. CONCLUSION: This acute gastroenteritis outbreak was most likely caused by Aeromonas hydrophila and transmitted through a contaminated water source. This study highlights that areas less damaged by a disaster that do not require ongoing evacuation centres can still have acute gastroenteritis outbreaks. All affected areas should be monitored during a disaster response, not just those with evacuation centres. Boiling or chlorinating of water should also be recommended for all areas affected by disaster.
ABSTRACT
Objetivo. Comparar la bioequivalencia de tres formulas farmacéuticas nasales de propionato de fluticasona administradoscon un rociador nasal. Materiales y métodos. Ensayo clínico aleatorizado, abierto, de dosis única, cruzado a tresbrazos en 60 voluntarios sanos de ambos sexos entre 18 y 55 años de edad. El tratamiento consistió en una dosis nasalúnica (800 mcg) de rociador nasal de propionato de fluticasona (RNF), Flonase®, y Flixonase® en cinco visitas: una visita de selección, tres visitas de administración del medicamento y una de evaluación final. Se obtuvo muestras desangre a intervalos apropiados para análisis farmacocinético. El parámetro primario para determinar la bioequivalencia de las fórmulas farmacéuticas estudiadas fue el área bajo la curva de concentración-tiempo (AUC0-t). Como parámetro secundario se consideró la concentración máxima de la droga (Cmax). RNF se comparó separadamente a Flonase® y Flixonase®. Resultados. Se demostró bioequivalencia entre RNF y Flonase® (n=55) utilizando la transformación logarítmica invertida de AUC0-t (relación RNF a Flonase® = 1,021; IC90 por ciento, 0,88 a 1,19), y Cmax (relación = 0,995; IC90 por ciento, 0,92 a 1,07). Ambas medidas se encuentran dentro del rango aceptable de bioequivalencia (0,80 a 1,25). También se demostró la bioequivalencia entre RNF y Flixonase® (n=54) para AUC0-t (relación = 0,949; IC 90 por ciento 0,81 a 1,10) y Cmax (relación = 0,939, IC90 por ciento, 0,87 a 1,02). Se encontró que los tres tratamientos presentaron relativamente pocos efectos adversos. Conclusiones. RNF a una dosis de 800 mcg es bioequivalente tanto a Flonase® como Flixonase® administradas a voluntarios sanos. El perfil de seguridad de RNF es consistente con los de Flonase® y Flixonase®.
Objective: Comparison of the bioequivalence of three pharmaceutical formulations of fluticasone propionate nasal administered with a nasal spray (FANS). Materials y Methods: A randomized, open-label, single-dose, three-way crossover study in 60 healthy volunteers of both sexes between 18 and 55 years old. Subjects received a single intranasal dose (800 mcg) of FANS, Flonase®, and Flixonase® in 5 visits: screening, 3 dosing visits, and end of study. Forty-eight hours to 7 days were allowed between dosing visits. Blood was drawn for pharmacokinetics analysis at appropriate intervals. The primary pharmacokinetic parameter for determination of bioequivalence of the formulations was the areaunder the plasma concentration-time curve (AUC0-t). Secondary parameters included the maximum plasma concentration (Cmax). FANS was compared to Flonase® and to Flixonase® separately. Results: Bioequivalence between FANS and Flonase® (n=55) was demonstrated by the inverse log transformed AUC0-t (ratio FANS to Flonase® = 1.021; 90 per cent CI, 0.88 to 1.19), and Cmax, (ratio = 0.995; 90 per cent CI, 0.92 to 1.07), which are within the acceptable range of 0.80 to 1.25. Bioequivalence between FANS and Flixonase® (n=54) was also demonstrated for AUC0-t (ratio = 0.949; 90 per cent CI 0.81 to 1.10) and Cmax (ratio = 0.939, 90 per cent CI, 0.87 to 1.02). Active treatments were well tolerated and there were relatively few adverse events. Conclusions: A single dose of FANS 800 mcg is pharmacokinetically bioequivalent to both Flonase® and Flixonase® when administered to healthy subjects. The safety profile of FANS was consistent with that noted for Flonase® and Flixonase®.
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Therapeutic Equivalency , Pharmacokinetics , Drugs, Generic , Rhinitis, Allergic, PerennialABSTRACT
Objetivo. Establecer la equivalencia clínica de un rociador nasal de propionato de fluticasona (RNF) genérico comparadocon dos formulas farmacéuticas comerciales del mismo producto (Flonase® y Flixonase®) durante la estación de polinización del cedro de montaña (Juniperus ashei) en Texas, EEUU. Materiales y métodos. Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, en grupos paralelos diseñado para investigar la seguridad y eficacia de RNF (200 mcg una vez al día), Flonase® (200 mcg una vez al día) y Flixonase® (200 mcg una vez al día), comparados con placebo, administrados por 13 a 15 días. Los pacientes registraron diariamente, en la mañana y en la tarde, sus síntomas nasales totales (SNT). La variable de desenlace primaria fue la suma de SNT en la mañana y tarde + 1. Las variables de desenlace secundarias fueron los SNT AM + 1 y SNT PM + 1, y la evaluación de seguridad. Resultados. No se observó diferencia estadísticamente significativa en ningún día de estudio, ni en todo el periodo de tratamiento, ni al punto de final entre SNT promedio tanto de Flonase® como Flixonase® y RNF. La equivalencia clínica entre RNF yFlonase® (cociente= 0,98; intervalo de confianza [IC] al 90 por ciento, 0,91 a 1,06), y entre RNF y Flixonase® (cociente= 1,02; IC 90 por ciento, 0,94 a 1,10) fue demostrada tanto para la variable de desenlace primaria como para las otras variables de eficacia. Conclusiones. Estos resultados respaldan la equivalencia clínica entre RNF 200 mcg una vez al día tanto con Flonase®como Flixonase® en el tratamiento de rinitis alérgica estacional.
Objective. The primary objective of this study was to establish the clinic equivalence of a new Fluticasone Propionate Aqueous Nasal Spray (FANS) compared to two commercially available active treatments of fluticasone propionate nasal spray (Flonase® and Flixonase®) during the mountain cedar (Juniperus ashei) pollen season in Texas. Material and methods. This was a multicenter, randomized, double-blind, double-dummy, active-controlled and placebo-controlled, parallel group study designed to investigate the safety and efficacy of FANS (200 mcg QD), Flonase® and Flixonase® (200 mcg QD) compared to placebo administered for 13 to 15 days. Patients recorded the total nasal symptoms dcores (TNSS) in a diary in the morning and evening every day. The primary endpoint was the patient-rated am and pm TNSS +1. Other key efficacy endpoints were patient-rated AM TNSS+1, patient-rated PM TNSS+1, and safety. Results. Mean TNSS values for Flonase® and Flixonase® were not statistically significantly different from FANS during any study day, over the entire treatment period, or at endpoint. Bioequivalence between FANS and Flonase® (ratio= 0.98, 90 per cent CI 0.91 to 1.06) as well as FANS and Flixonase® (ratio=1.02, 90 per cent CI 0.94 to 1.10) was demonstrated for the primary endpoint [Patient-Rated am and pm TNSS +1] as well as for the other key efficacy endpoints. Conclusions. The findings from this study support that FANS 200 mcg QD is therapeutically bioequivalent to both Flonase® and Flixonase® in the control ofthe symptoms of seasonal allergic rhinitis.