scholarly journals Effect of Butoconazole Nitrate 2% Vaginal Cream and Miconazole Nitrate 2% Vaginal Cream Treatments in Patients with Vulvovaginal Candidiasis

1996 ◽  
Vol 4 (6) ◽  
pp. 323-328
Author(s):  
Myra A. Lappin ◽  
Doris C. Brooker ◽  
Carol A. Francisco ◽  
Joan Dorfman
Keyword(s):  
Potassium Hydroxide ◽  
Signs And Symptoms ◽  
Vulvovaginal Candidiasis ◽  
Vaginal Cream ◽  
Miconazole Nitrate ◽  
Symptom Scores ◽  
Cure Rates ◽  
Lost To Follow Up ◽  
Butoconazole Nitrate

In a multicenter, randomized, invesgtigator-blind, parallel study, 398 patients were dispensed topical butoconazole nitrate 2% cream for 3 days (n = 199) or miconazole nitrate 2% cream for 7 days (n = 199) for vaginal use. Efficacy analyses included 254 patients with culture-confirmedCandida(119 butoconazole and 135 miconazole users). Of the 398 patients issued study medication, 9 were lost to follow-up. Therefore, safety analyses included 389 patients (197 butoconazole and 192 miconazole users). Evaluations upon admission and approximately 8 and 30 days post-treatment includedCandidacultures, potassium hydroxide (KOH) wet mounts, and vulvovaginal examinations, with rating of vulvovaginal signs and symptoms using a 4-point scale. Rates of clinical cure (based on sign/symptom scores), microbiologic cure (based on cultures and wet mounts), and therapeutic cure (both clinical and microbiologic cures) were assessed and were to be similar between the regimens. Therapeutic cure rates were 57.8% and 61.4% for butoconazole and miconazole, respectively. Three-day butoconazole treatment was as safe and effective as 7-day miconazole therapy in treating vulvovaginal candidiasis.

scholarly journals An Evaluation of Butoconazole Nitrate 2% Site Release®Vaginal Cream (Gynazole-1®) Compared to Fluconazole 150 mg Tablets (Diflucan®) in the Time to Relief of Symptoms in Patients With Vulvovaginal Candidiasis

2005 ◽  
Vol 13 (4) ◽  
pp. 197-206 ◽  
Author(s):  
Larry S. Seidman ◽  
Campbell K. Skokos
Keyword(s):  
Single Dose ◽  
Treatment Group ◽  
Adverse Events ◽  
Median Time ◽  
The United States ◽  
Vulvovaginal Candidiasis ◽  
Reinfection Rate ◽  
Vaginal Cream ◽  
Butoconazole Nitrate ◽  
Site Release

Background.It is estimated that as many as 13 million cases of vulvovaginal infection occur in the United States annually, the majority of which are the result ofCandida albicansinfection. The symptoms of vulvovaginal infections are often painful and distressing to the patient. The objective of this study was to compare the time to symptomatic relief of vulvovaginal candidiasis (VVC) with butoconazole nitrate 2% Site Release®vaginal cream (Gynazole-1®) and oral fluconazole 150 mg tablets (Diflucan®).Methods.This randomized, open-label, parallel study evaluated 181 female patients with moderate to severe symptoms of VVC. Patients were randomized to single-dose therapy with either butoconazole nitrate 2% Site Release®vaginal cream or fluconazole. The primary outcome measure was the time to onset of first relief of symptoms. Secondary measures included the time to overall relief of symptoms and the reinfection rate over the first 30 days following treatment. The overall safety of both products was investigated through the collection of adverse event reports.Results.The median time to first relief of symptoms occurred at 17.5 h for butoconazole patients as compared to 22.9 h for fluconazole patients (p< 0.001). The time at which 75% of patients experienced first relief of symptoms was 24.5 h versus 46.3 h for butoconazole and fluconazole, respectively (p< 0.001). By 12- and 24-h post-treatment, 44.4% and 72.8% of patients in the butoconazole treatment group reported first relief of symptoms versus 29.1% and 55.7% of patients in the fluconazole group (p= 0.044 andp= 0.024 respectively). In patients experiencing first relief of symptoms within 48 h of dosing, the median time to first relief of symptoms in the butoconazole treatment group was significantly shorter at 12.9 h compared to 20.7 h for the fluconazole treatment group (p= 0.048). There were no significant differences between the two groups with respect to time to total relief of symptoms or reoccurrence of infection within 30 days of treatment. Butoconazole therapy was shown to have fewer reported adverse events, including drug-related adverse events, than fluconazole therapy. Vulvovaginal pruritis and vulvovaginal burning were the most common drug-related adverse events attributed to butoconazole. Headache, diarrhea, nausea, upset stomach and skin sensitivity were the most common drugrelated adverse events attributable to fluconazole.Conclusions.Single-dose butoconazole nitrate 2% Site Release®vaginal cream provides statistically significant improvement in time to first relief of symptoms in the treatment of VVC compared to fluconazole. There is no difference between these two treatments with respect to total relief of symptoms or reinfection rate. Although there was no significant difference in the incidence of adverse events judged by the investigator to be treatment-related, butoconazole treatment did result in fewer patients experiencing adverse events than fluconazole.

Therapy Outcome in Childhood ALL: Experience from a Tertiary Care Centre in North India.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 916-916
Author(s):  
Ram Kumar Marwaha ◽  
Ketan Kulkarni ◽  
Amita Trehan ◽  
Deepak Bansal
Keyword(s):  
Platelet Count ◽  
Survival Data ◽  
Tertiary Care ◽  
Developed Countries ◽  
North India ◽  
Rank Test ◽  
Childhood All ◽  
Cure Rates ◽  
Lost To Follow Up

Abstract Survival in childhood ALL, in resource challenged nations, has not kept pace with cure rates of over 80% in developed countries. This descriptive study was designed to assess survival data and identify risk factors for adverse outcome. Data obtained from case records of 762 patients with ALL was analyzed. Information regarding the clinical-demographic profile, therapy and course of illness were recorded. Status and duration at last follow-up were utilized to generate Kaplan-Meier survival curves. The mean age at presentation was 5.7±0.23 years (M:F::3.2:1). Caretakers of 230 (30.2%) patients opted for no therapy. There were 68 and 60 deaths in induction and remission phases respectively. Besides these, 111 children either defaulted therapy (23) or were lost to follow up (88). Relapsed disease was documented in 125 cases. The 5 year overall and event-free survival was 46 and 34% respectively. The p values for survival analysis using the Log-rank test for groups formed according to the gender, age, symptom-diagnosis interval, TLC and platelet count were 0.19, 0.02, 0.08, <0.001, 0.001 respectively. Bulk disease (p=0.047), mediastinal adenopathy (p=0.045), TLC (p=0.016), platelet count (p=0.031) and administration of 2 intensification blocks (p=0.012) were found to be significant predictors of outcome by univariate and multivariate analysis. The holistic management of ALL in children requires financial resources, a strong psychosocial structure and access to quality supportive care. Almost one third of our patients opted for no therapy. The other problem areas identified were a high proportion of therapy defaulters, lost to follow up and infection related deaths during induction and remission phases. TLC >50000/microliter and platelet count <30000/microliter had an adverse impact on survival. The administration of both early and delayed intensification improved survival. The introduction of remedial measures for tapping the difficulties identified, would undoubtedly improve cure rates in children with ALL in developing nations.

scholarly journals Comparison of various regimens of itraconazole in treatment of acute vulvovaginal candidiasis

2021 ◽  
Vol 8 (2) ◽  
pp. 244-249
Author(s):  
Dhiraj Dhoot ◽  
Piyush Prabhat ◽  
Lalita Mayadeo ◽  
Harshal Mahajan
Keyword(s):  
Signs And Symptoms ◽  
Vulvovaginal Candidiasis ◽  
High Dose ◽  
Group Iii ◽  
Group I ◽  
Comparative Clinical Study ◽  
Current Scenario ◽  
Striking Change ◽  
Group Ii ◽  
Cure Rates

One of the most striking change in the current scenario is the increasing occurrence of non-albicans vulvovaginal candidiasis (VVC), which is considered as the major cause of recurrence, relapse and chronic VVC in India. In the present study we evaluated the effectiveness of three different regimens of itraconazole in the treatment of acute VVC.The present randomised, three arm comparative clinical study involved 123 women aged 18 years or above with symptomatic acute VVC. These patients were randomised (41 patients in each group) to receive either itraconazole 200 mg twice daily for 1 day (group I), 200 mg twice daily for 2 days (group II) or 100 mg twice daily for 3 days (group III). Effectiveness was evaluated on the basis of clinical cure (total symptom score), mycological cure (negative KOH test). All the groups were effective in relieving signs and symptoms (p&#60;0.05), but on comparison between all groups, there was statistical difference between Group II and Group I & III (p&#60;0.05) and Group III & I (p&#60;0.05). Complete cure i.e. disappearance of signs and symptoms and negative KOH test was maximum in group II (44%) as compared to groups I (12%) and III (17% of the patients). Relapse was least in seen in 11 patients (27%) in Group I, 3 patients (7%) in Group II and 7 patients (17%) in Group III. All the 3 regimens were well tolerated.In the present study, 2 day high dose itraconazole therapy was found to have better effectiveness compared to conventional regimens. Longer duration of therapy might be required to attain even better cure rates, especially when the incidence of Non Albicans vulvovaginal candidiasis is rising in all parts of the country.

Symptom Combinations Associated with Outcome and Therapeutic Effects in a Cohort of Cases with SARS

2006 ◽  
Vol 34 (06) ◽  
pp. 937-947 ◽  
Author(s):  
Shao Li ◽  
Ruiqin Wang ◽  
Yulong Zhang ◽  
Xuegong Zhang ◽  
A. Joseph Layon ◽  
...  
Keyword(s):  
Combined Treatment ◽  
Clinical Manifestations ◽  
Signs And Symptoms ◽  
Adverse Outcomes ◽  
Therapeutic Effects ◽  
Treatment Protocols ◽  
Oxyhemoglobin Saturation ◽  
Treatment Groups ◽  
Lost To Follow Up

Severe acute respiratory syndrome (SARS) is an infectious disease and some of its symptoms were clinically indistinguishable of those from similar diseases. This study aimed to find the symptom combinations associated with adverse outcome and the therapeutic effects in a cohort of patients with probable SARS retrospectively. In 2003, 123 SARS cases in Beijing were subjected to a strictly western medicine (WM) treatment, or a combined treatment (WM plus Herba houttuyniae injection, addition of individualized herbal treatments when necessary), of which 115 were followed till death or discharge; 8 were transferred and lost to follow-up. In both treatment groups, clinical manifestations were evaluated daily; development of signs and symptoms, and their possible relationship with outcome, were assessed. The relationships between these sign/symptom complexes and outcome under two treatment protocols were evaluated and differences were noted. Dynamic symptom combinations, dividing into the early, the medium-term and the durational symptom clusters, were identified as likely being related to the adverse outcomes of SARS ( p < 0.05, p < 0.01). Compared with a strictly WM treatment, the combined treatment resulted in a longer hospital stay ( p = 0.028), a non-statistically significant mortality rate decrease (combined treatment: 9.6% versus WM: 11.1%), and a significant improvement of arthralgia and myalgia ( p < 0.05) in the early symptom cluster. Additionally, the combined protocol improved arterial oxyhemoglobin saturation significantly at day 22 ( p < 0.05). In conclusion, the progress and outcome of SARS may be associated with specific temporal patterns of development in combination of several non-specific signs and symptom complexes, which are also helpful for evaluating the therapeutic effects on SARS patients.

Cranialization of the frontal sinus—the final remedy for refractory chronic frontal sinusitis

2012 ◽  
Vol 116 (3) ◽  
pp. 531-535 ◽  
Author(s):  
J. Marc C. van Dijk ◽  
Michiel Wagemakers ◽  
Astrid G. W. Korsten-Meijer ◽  
C. T. Kees Buiter ◽  
Bernard F. A. M. van der Laan ◽  
...  
Keyword(s):  
Frontal Sinus ◽  
Signs And Symptoms ◽  
Anatomical Location ◽  
Frontal Sinusitis ◽  
Long Term Effects ◽  
Assess Patient Satisfaction ◽  
Long Term Follow Up ◽  
Lost To Follow Up

Object Chronic sinusitis can be a debilitating disease with significant impact on quality of life. Frontal sinusitis has a relatively low prevalence, but complications can be severe due to its anatomical location. After failure of conservative measures, typically endoscopic procedures are performed to improve the drainage of the frontal sinus. The cranialization of the frontal sinus is the final surgical measure, in which the affected frontal sinus is truly removed. In this study the authors describe the surgical technique of cranialization of the frontal sinus for refractory chronic frontal sinusitis, systematically search the literature for its application, and assess patient satisfaction in a cohort of consecutively treated patients after long-term follow-up. Methods A consecutive cohort of 15 patients with refractory chronic frontal sinusitis was treated by cranialization of the frontal sinus and followed over a 20-year period (1989–2008) for the direct results and complications of the surgery. Long-term follow-up (mean 6.5 years) was obtained to assess the long-term effects of the cranialization. Results In all patients the signs and symptoms of chronic frontal sinusitis responded very well to the cranialization. Five patients had surgical complications, of which 2 were serious. One patient died of an unrelated cause and 1 patient was lost to follow-up. The remaining 13 patients had a long-term follow-up, which revealed that 12 of them thought that their life was better after the surgical procedure. Conclusions Cranialization of the frontal sinus deserves consideration as the final remedy for refractory chronic frontal sinusitis after definite failure of other options.

scholarly journals Ibrexafungerp versus placebo for vulvovaginal candidiasis treatment: a phase 3, randomized, controlled superiority trial (VANISH 303)

2021 ◽  
Author(s):  
Jane R Schwebke ◽  
Ryan Sobel ◽  
Janet K Gersten ◽  
Steven A Sussman ◽  
Samuel N Lederman ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Clinical Cure ◽  
Oral Treatment ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Current Treatment ◽  
Vulvovaginal Candidiasis ◽  
Symptom Resolution ◽  
Superiority Trial

Abstract Background Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC. Study Design Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS]=0) at test-of-cure (day 11±3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS≤1) at test-of-cure, and symptom resolution at follow-up (day 25±4). Results Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P=0.001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P&lt;0.001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P&lt;0.001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P=0.009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for African American patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index &gt;35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity. Conclusion Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.

scholarly journals Acompanhamento longitudinal do manejo de sintomas em serviço especializado de cuidados paliativos oncológicos

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Karine Marques Costa dos Reis ◽  
Cristine Alves Costa de Jesus
Keyword(s):  
Palliative Care ◽  
Cancer Patients ◽  
Signs And Symptoms ◽  
Longitudinal Assessment ◽  
Significance Level ◽  
Parametric Test ◽  
Symptom Scores ◽  
Diagnosis Of Cancer ◽  
Specialized Unit

Objetivo: Analisar a funcionalidade e os sintomas de pacientes oncológicos em fim de vida durante internação em unidade especializada em cuidados paliativos. Método: Trata-se de avaliação longitudinal da admissão até o óbito, com monitorização semanal da funcionalidade e score de sintomas, de 59 participantes. Utilizou-se o teste paramétrico Wilcoxon pareado, para avaliação da mediana dos scores de sintomas e funcionalidade com nível de significância de 5%. Resultados: A amostra do estudo consistiu em indivíduos do sexo feminino, com idade média de 60 anos e funcionalidade limitada. Predominou o diagnóstico de câncer do trato digestório. Quanto a avaliação dos sintomas e funcionalidade, considerando a segunda e terceira semana de internação observou-se melhora do score dor, cansaço e tristeza, como também da função. Conclusão: Apesar de internação tardia e com grande extensão da doença, o participante apresentou melhora de alguns sintomas sugerindo o benefício dos cuidados paliativos. Em unidade especializada, houve melhora dos sintomas dor, cansaço e tristeza, com também da funcionalidade dos participantes em duas semanas de internação. Assim, esses achados corroboram quanto a importância do cuidado baseado no conforto e auxiliará na elaboração de políticas públicas e no planejamento do cuidado do enfermeiro.Descritores:  Cuidados Paliativos; Sinais e Sintomas; Neoplasias; Enfermagem. Longitudinal follow-up of the management of symptoms in specialized palliative oncological care serviceObjective: To analyze the functionality and symptoms of end-of-life cancer patients during hospitalization in a specialized unit in palliative care. Method: This is a longitudinal assessment from admission to death, with weekly monitoring of functionality and symptom score, of 59 participants. The paired Wilcoxon parametric test was used to assess the median of symptom scores and functionality with a significance level of 5%. Results: The study sample consisted of female individuals, with an average age of 60 years and limited functionality. The diagnosis of cancer of the digestive tract predominated. Regarding the assessment of symptoms and functionality, considering the second and third week of hospitalization, an improvement was noted in the pain, tiredness and sadness score, as well as in function. Conclusion: Despite late hospitalization and with a large extent of the disease, the participant showed improvement in some symptoms suggesting the benefit of palliative care. In a specialized unit, the symptoms of pain, tiredness and sadness, as well as the functionality of the participants in the weeks of hospitalization. Therefore, these results corroborate the importance of care based on convenience and assistance in the development of public policies and guide the planning of care for the sick.Descriptor: Palliative Care; Signs and Symptoms; Neoplasms; Nursing.Seguimiento longitudinal del manejo de sintomas en servicio especializado de atención oncológica paliativaObjetivo: Analizar la funcionalidad y los síntomas de los pacientes con cáncer al final de la vida durante la hospitalización en una unidad especializada de atención paliativa. Método: Esta es una evaluación longitudinal desde el ingreso hasta la muerte, con monitoreo semanal de la funcionalidad y la puntuación de los síntomas, de 59 participantes. La prueba de Wilcoxon paramétrica pareada se utilizó para evaluar la mediana de las puntuaciones de los síntomas y la funcionalidad con un nivel de significación del 5%. Resultados: La muestra del estudio consistió en individuos femeninos, con una edad promedio de 60 años y funcionalidad limitada. Predominó el diagnóstico de cáncer del tracto digestivo. En cuanto a la evaluación de los síntomas y la funcionalidad, considerando la segunda y tercera semana de hospitalización, se observó una mejora en el puntaje de dolor, cansancio y tristeza, así como en la función. Conclusión: A pesar de la hospitalización tardía y con una gran extensión de la enfermedad, el participante mostró una mejoría en algunos síntomas que sugieren el beneficio de los cuidados paliativos. En una unidad especializada, los síntomas de dolor, cansancio y tristeza, así como la funcionalidad de los participantes en las semanas de hospitalización. Por lo tanto, estos resultados corroboran la importancia de la atención basada en la conveniencia y la asistencia en el desarrollo de políticas públicas y guían la planificación de la atención a los enfermos.Descriptor: Cuidados Paliativos; Signos Y Síntomas; Neoplasias; Enfermería.

Placebo-Controlled Trial of Intravaginal Clindamycin 2% Cream for the Treatment of Bacterial Vaginosis

1993 ◽  
Vol 27 (11) ◽  
pp. 1343-1345 ◽  
Author(s):  
Gary E. Stein ◽  
Sharon L. Christensen ◽  
Nancy L. Mummaw ◽  
David E. Soper
Keyword(s):  
Bacterial Vaginosis ◽  
Clinical Success ◽  
Controlled Trial ◽  
Signs And Symptoms ◽  
Controlled Clinical Trial ◽  
Success Rates ◽  
Double Blind ◽  
Treatment Groups ◽  
Vaginal Cream

OBJECTIVE: To compare the safety and efficacy of intravaginal clindamycin 2% cream with placebo in nonpregnant women with bacterial vaginosis. DESIGN: A randomized, double-blind, placebo-controlled clinical trial. SETTING: Ambulatory patients in the general community. PATIENTS: Two hundred fifteen nonpregnant outpatients with a diagnosis of bacterial vaginosis were entered into this study. Of the 134 evaluable patients, 65 received clindamycin and 69 placebo. Demographic parameters were comparable between the two treatment groups. INTERVENTION: Study subjects were equally randomized to receive either 5 g of clindamycin 2% vaginal cream or placebo cream for seven nights. MAIN OUTCOME MEASURES: Clinical and microbiologic follow-up evaluations were scheduled for 5–10 days and 25–39 days posttreatment. Patients were interviewed about signs and symptoms, adverse events, and compliance. Diagnostic examinations were performed. RESULTS: Clinical success rates (cure and improvement) occurred in 50 of 65 patients who received clindamycin (77 percent) and 17 of 69 patients who received placebo (25 percent) by the first posttreatment visit (p<0.001). Microbiologic cures or improvement were observed in 59 of the 65 patients treated with clindamycin (91 percent) compared with 20 of 69 placebo-treated patients (29 percent) (p<0.001). At the end of the study, clinical and microbiologic cures or improvement were evident in 45 of 57 (79 percent) and 37 of 57 clindamycin-treated patients (65 percent), respectively, and 18 of 51 (35 percent) and 14 of 51 (28 percent) of the placebo-treated patients, respectively. The success rates with clindamycin 2% cream were statistically higher than those with placebo. The adverse-effect profiles in the two groups were similar and no serious adverse effects were reported. Patients who received clindamycin had a statistically higher incidence of nonbacterial vaginitis/cervicitis (18.5 vs. 7.5 percent, p=0.003). CONCLUSIONS: Intravaginal clindamycin 2% cream appears to be an effective and safe treatment of symptomatic bacterial vaginosis in nonpregnant women.

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