scholarly journals A Comparative Study of Safety and Efficacy of Oral Terbinafine and Itraconazole in Patients of Tinea Corporis/ Tinea Cruris Infection, A Randomized Open Label Parallel Group Study

2021 ◽  
Vol 14 (3) ◽  
pp. 1543-1549
Author(s):  
S. Brigida ◽  
Arul Amutha Elizabeth ◽  
G. Soujania ◽  
R. Poornima Poornima
Keyword(s):  
Public Health Problem ◽  
Tinea Corporis ◽  
Open Label ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Tinea Cruris ◽  
Oral Itraconazole ◽  
Group 2 ◽  
Oral Terbinafine ◽  
Group 1

Introduction: Superficial dermatophytosis is a common public health problem in India, due to its tropical climate with heat and humidity. Today, the triazoles, mainly Itraconazole and the allylamines, chiefly Terbinafine, are the main ammunitions against dermatophytes. This study is undertaken to compare the safety and efficacy of both the drugs. Materials and Methods: This study was conducted to find the efficacy of Oral Terbinafine and Oral Itraconazole in Tinea Corporis/Tinea Cruris infection. The primary efficacy parameter was change in composite score (pruritus, erythema, pigmentations) from baseline to end of the treatment period. And to compare the safety of Oral Terbinafine and Oral Itraconazole by comparing the following parameters, Liver enzymes - SGOT/SGPT before and after treatment with the study drugs. Drug Dosage: Group 1: Drug –Tab. Terbinafine: Dose 500 mg per day once daily at bedtime for 2 weeks. Group 2: Drug –Tab. Itraconazole: Dose 200 mg per day, once daily at bedtime for 2 weeks. Results: The study participants show significant reduction in itching at the second follow up (after 2 weeks of drug completion) in both groups. Pruritis was reduced in 92% subjects in group 1 and 97.5% subjects in group 2. There was 87% reduction in erythema in group 1 and 93% reduction in group 2. Pigmentations were seen in 2% subjects in both groups indicating relapse of infection. Conclusion: The significant outcome of the study was that oral Itraconazole 200mg/day for 14 days(2 weeks) can be the better antifungal.

scholarly journals Effects of Pleuran (Β–Glucan from Pleurotus Ostreatus) Supplementation on Incidence and Duration of COPD Exacerbations

2017 ◽  
Vol 5 (7) ◽  
pp. 893-898 ◽  
Author(s):  
Jordan Minov ◽  
Jovanka Bislimovska-Karadzhinska ◽  
Tatjana Petrova ◽  
Kristin Vasilevska ◽  
Sasho Stoleski ◽  
...  
Keyword(s):  
Vitamin C ◽  
Stable Disease ◽  
Pleurotus Ostreatus ◽  
Control Group ◽  
Open Label ◽  
Once Daily ◽  
Copd Patients ◽  
Group 2 ◽  
Group D ◽  
Group 1

BACKGROUND: 1,3/1,6-β–glucans are recognised as immunomodulators in human and veterinary medicine for over 50 years.AIM: To assess the effects of pleuran (1,3/1,6-β–glucan from Pleurotus ostreatus) on incidence and duration of bacterial exacerbations in patients with COPD.METHODS: We performed an observational, non-randomized, open-label study including 32 COPD patients (Group D) in whom besides the recommended chronic treatment for the stable disease were administered supplement combination containing pleuran 100 mg, vitamin C 60 mg and zinc 5 mg once daily over a three month-period (Group 1). Also, an equal number of Group D COPD patients who besides the recommended treatment for stable disease received the supplement combination containing vitamin C 60 mg and zinc 5 mg once daily, matched to the study subjects of the Group 1 by sex and age served as control (Group 2).RESULTS: Over the study period 57 exacerbations (24 in the Group 1 and 33 in the Group 2) were documented. A mean number of exacerbations over the study period was significantly lower in the Group1 (0.7 ± 0.4) as compared to their mean number in the Group 2 (1.0 ± 0.6) (P = 0.0218). Furthermore, a mean duration of exacerbations expressed in days needed for cure or clinical improvement (i.e. complete resolution of symptoms or return of the symptoms to their baseline severity) in the Group 1 (6.7 ± 0.8 days) was significantly shorter than the mean duration of exacerbations in the Group 2 (7.4 ± 1.3 days) (P = 0.0118). There was not reported any adverse effect during the study period by study subjects from both examined groups.CONCLUSION: Our findings indicated that pleuran might impact the incidence and duration of bacterial exacerbations in patients with COPD. There is a need for further studies for more precise determination of the influence of pleuran on the course of COPD.

scholarly journals Futility of combining griseofulvin and terbinafine in current epidemic of altered dermatophytosis in India: Results of a randomized pragmatic trial

2019 ◽  
Author(s):  
Sanjay Singh ◽  
Vinayak N Anchan ◽  
Radhika Raheja
Keyword(s):  
Pragmatic Trial ◽  
Tinea Corporis ◽  
Number Needed To Treat ◽  
Recent Past ◽  
Cure Rate ◽  
Once Daily ◽  
Tinea Cruris ◽  
Tinea Faciei ◽  
Treatment Responsiveness ◽  
Oral Terbinafine

AbstractBackgroundTreatment responsiveness of tinea has decreased considerably in recent past in India. We tested effectiveness of oral terbinafine plus griseofulvin versus terbinafine alone in tinea corporis, tinea cruris and tinea faciei in a randomized pragmatic open trial.MethodsOne hundred and thirty two microscopy confirmed patients were randomly allocated (ratio 1:1) to two groups, terbinafine (T) and terbinafine plus griseofulvin (T+G). Doses given were as follows: T, oral terbinafine (6 mg/kg/day, maximum 500 mg/day, once daily); T+G, terbinafine (as above) plus oral griseofulvin (children [<18 years] 10 mg/kg/day, adults [18 years or more] 10 mg/kg/day, but not <500 mg and not >1000 mg per day, in two divided doses). Patients were treated for 8 weeks or cure, whichever occurred earlier.ResultsAt 4 weeks, none of the patients were cured in both groups. At 6 weeks, 1(1.5%) and 4 (6.1%) patients were cured in T and T+G groups, respectively (P=0.417). At 8 weeks, 17 (25.8%) and 19 (28.8%) patients were cured in T and T+G groups, respectively (P=0.845). For cure rate at 8 weeks, number needed to treat (NNT) for T+G (versus T), was 33.ConclusionsAddition of griseofulvin to terbinafine does not increase effectiveness of terbinafine in current epidemic of altered dermatophytosis in India.

scholarly journals A comparative study of atorvastatin and rosuvastatin in dyslipidemia

2017 ◽  
Vol 6 (11) ◽  
pp. 2551 ◽  
Author(s):  
Rudip Thapa ◽  
Prakash Rai ◽  
Laxmi Mahara ◽  
Sudarsana Chetty
Keyword(s):  
Age Group ◽  
Open Label ◽  
Once Daily ◽  
Atorvastatin Group ◽  
Cholesterol Levels ◽  
Parallel Group ◽  
Group 2 ◽  
Comparative Prospective Study ◽  
Group 1

Background: To compare the drugs: Atorvastatin (10mg) and Rosuvastatin (5mg) in patients with Dyslipidemia.Methods: This open-label, randomized, parallel group, comparative, prospective study of six months duration included 100 patients. The age group of patients varied from 30 to 69 years with dyslipidemia. Patients were divided in to 2 groups. 50 patients in group-1 received Atorvastatin 10mg once daily and 50 patients in group-2 received Rosuvastatin 5 mg once daily. The level of TC, TG, LDL, VLDL and HDL were assessed at baseline and at the end of 3 months and 6 months.Results: At 3 months, LDL was reduced significantly more with 5mg Rosuvastatin than with Atorvastatin 10 mg [43.68% vs. 40.74% (P 0.0049)]. At 6 months, Rosuvastatin 5mg reduced LDL significantly more than Atorvastatin 10 mg [48.69% vs. 43.85% (P 0.00)]. TC, HDL, TG and VLDL were more favourably modified by Rosuvastatin at 6 months (P <0.005). Reduction of total cholesterol levels in Rosuvastatin group was not statistically significant when compared with Atorvastatin group (P 0.103).Conclusions: Rosuvastatin 5mg was more efficacious than Atorvastatin 10mg for the improvement of lipid profile during the period of 6 months follow-up drug therapy in patients with dyslipidemia.

The use of antiviral drug based on technologically processed antibodies to interferon-γ, CD4 receptor and histamine in the treatment of influenza in adults: results of a multicenter open-label randomized comparative trial with oseltamivir

2021 ◽  
Vol 19 (1) ◽  
pp. 39-57
Author(s):  
K.V. Zhdanov ◽  
◽  
R.F. Khamitov ◽  
V.V. Rafalsky ◽  
M.P. Mikhaylusova ◽  
...  
Keyword(s):  
Immune Response ◽  
B Cell ◽  
Open Label ◽  
Virus Elimination ◽  
Antiviral Immune Response ◽  
Cd4 Receptor ◽  
Antiviral Efficacy ◽  
Ifn Γ ◽  
Group 2 ◽  
Group 1

Objective. A multicenter open-label randomized controlled clinical trial was aimed to compare the efficacy of the study drug (SD) containing technologically processed affinity purified antibodies (high dilutions) to IFN-γ, CD4 receptor and histamine (Ergoferon) with oseltamivir, and evaluate the influence of SD on the antiviral immune response in adults with seasonal influenza. Patients and methods. 184 outpatients aged 18–70 with confirmed influenza of mild/moderate severity were included and randomized into 2 groups (in a 1:1 ratio). Patients received SD (Group 1, n = 92) or oseltamivir (Group 2, n = 92), according to the instructions for medical use for 5 days. As the primary endpoint, the percentage of patients with recovery/improvement was assessed (according to the data of the patient's diary on days 2–7 and according to the clinical examination on days 3 and 7). Additionally, the duration and severity of influenza symptoms, the percentage of patients with virus elimination (according to RT-PCR of nasopharyngeal samples), the percentage of patients with complications, the percentage of patients prescribed antipyretic drugs, the change in concentration of T cell (IL-2, IL-18, IFN-γ) and B cell antigen-specific (IL-4, IL-16) immune response regulators in serum, the leukocyte phenotypes on days 1, 3 and 7 were evaluated. Statistical analysis was performed using a “Non-Inferiority” design (or no less efficiency/safety). Intention-to-Treat (ITT) analysis data are presented. Results. According to patients’ self-assessment, 53.3% of patients in Group 1 recovered/improved on the 6th day in the morning and 65.2% – in the evening (vs. 53.3% and 57.6% in Group 2, respectively). There were 73.9% recovered/ improved patients on the 7th day in the morning (vs. 67.4% in Group 2). A generalized analysis showed that the treatment results in both groups were comparable (p < 0.0001). According to objective medical examination, 79.3% of patients in the SD group and 74.0% of patients in the Оseltamivir group recovered/improved on the 7th day (p < 0.0001). The antiviral efficacy of SD was not inferior to oseltamivir, which was confirmed by comparable periods of virus elimination, duration and severity of fever and other influenza symptoms. A moderate activating effect of SD on the immune system was evaluated. A significant, compared to oseltamivir, increase in the concentration of IL-2 and IL-4 on the 3rd day of treatment (p = 0.03 and p = 0.04 vs. the oseltamivir group), and IFN-γ on the 3rd and the 7th days (p = 0.012 and p < 0.0001, respectively, vs. the oseltamivir group). No stimulating effect of SD on the growth and differentiation of immune cells was found. Conclusion. SD is effective and safe in the treatment of patients with influenza. The therapeutic and antiviral efficacy of SD is comparable to that of oseltamivir. The antiviral activity of SD affects the interferon system and the concentration of the cytokines IL-2 and IL-4, regulators of the T and B cell immune response. At the same time, there is no significant stimulation of interferon production with further development of hyporeactivity. Key words: influenza, oseltamivir, therapy, cytokines, Еrgoferon

scholarly journals A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension

2012 ◽  
Vol 46 (4) ◽  
pp. 172-176
Author(s):  
Sukhsagar Ratol ◽  
Rani Walia ◽  
Mridu Chaudhry
Keyword(s):  
Ocular Hypertension ◽  
Primary Open Angle Glaucoma ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Eye Drops ◽  
Open Angle ◽  
Once Daily ◽  
Group 2 ◽  
Diurnal Iop ◽  
Group 1

ABSTRACT Background Glaucoma is a leading cause of irreversible blindness. The fundamental problem in medical management of glaucoma is of patient compliance. An ideal drug or a drug combination is needed to slow the progression of this majorly symptomless disease. Aim To compare the efficacy and tolerability of the fixed combination latanoprost and timolol instilled once daily in the evening vs fixed combination of dorzolamide and timolol instilled twice daily in primary open angle glaucoma or ocular hypertension. Materials and methods A 12-week, randomized, open, parallel group study including 50 patients with primary open angle glaucoma or ocular hypertension was conducted at a tertiary care hospital. Patients were randomized to group 1, (fixed combination (FC) latanoprost and timolol eye drops, once daily in evening) and group 2, (FC dorzolamide and timolol eye drops, twice daily). At baseline, 2, 4 and 12 weeks, IOP was recorded at 9 AM and 12 noon. The difference in IOP reduction in two treatment groups from baseline to 12 weeks was the main outcome measure. Results Mean diurnal IOP was similar at baseline for both groups. Mean reduction in IOP from baseline to 12 weeks was 9.92 mm Hg (p = 0.001) in group 1 and 9.22 (p = 0.001) in group 2. The reduction in IOP in both groups 1 and 2 was statistically significant at all time intervals. There was a statistically significant advantage for group 1 at 12 weeks for both time readings (p = 0.013 and 0.002 respectively) as compared to group 2. Conclusion The fixed combination of latanoprost and timolol was more effective than that of dorzolamide and timolol in reducing mean diurnal IOP and both treatments were well tolerated. To confirm further such studies are required. How to cite this article Ratol S, Walia R, Chaudhry M. A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension. J Postgrad Med Edu Res 2012;46(4):172-176.

scholarly journals Ethanolic Extract of Herb Pugun Tanoh (Picria fel-terrae Lour.) Modulates TCD4+ and TCD8+ Cell Profile of Doxorubicin-Induced Immuno-Suppressed Rats

2019 ◽  
Vol 7 (22) ◽  
pp. 3774-3776
Author(s):  
Mustafa Ridwan Lubis ◽  
Reny Haryani ◽  
Safriana Safriana ◽  
Denny Satria
Keyword(s):  
Ethanolic Extract ◽  
Immune Functions ◽  
Sprague Dawley ◽  
Immunomodulatory Effects ◽  
Once Daily ◽  
Sprague Dawley Rats ◽  
Group 3 ◽  
Group 2 ◽  
Cell Profile ◽  
Group 1

AIM: To evaluate the immunomodulatory effects of ethanolic extract of herb pugun tanoh on TCD4 and TCD8 cells in Doxorubicin-induced rats. METHODS: Fifteen male Sprague Dawley rats were divided into five groups consisting of six rats each as follows: Group 1, DOX-treated rats (4.67 mg/kg BW body weight on day 1 and 4) and were administered normal saline 0.9% orally once daily for 7 consecutive days, Group 2, receiving Ethanolic Extract of Herb Pugun Tanoh (Picria fel-terrae Lour.) of dose 150 mg/kg BW orally, Group 3, receiving dose Ethanolic Extract of Herb Pugun Tanoh (Picria fel-terrae Lour.) 300 mg/kg BW orally. The rats of group 2-3 were intramuscularly administered with doxorubicin at a dose of 4.67 mg/kg BW at the days 1-4 to suppress immune functions. RESULTS: Treatment of 300 mg/kg BW of Ethanolic Extract of Herb Pugun Tanoh (Picria fel-terrae Lour.) succeeded in reducing side effect doxorubicin based on increasing the TCD4+ and TCD8+ blood level. CONCLUSION: Ethanolic Extract of Herb Pugun Tanoh (Picria fel-terrae Lour.) could increase the level of TCD4+ and TCD8+ in rats which induced by doxorubicin.

scholarly journals Pharmacokinetics, Safety, and Clinical Outcomes of Omadacycline in Women with Cystitis: Results from a Phase 1b Study

2019 ◽  
Vol 63 (5) ◽  
Author(s):  
J. Scott Overcash ◽  
Pouru Bhiwandi ◽  
Lynne Garrity-Ryan ◽  
Judith Steenbergen ◽  
Stephen Bai ◽  
...  
Keyword(s):  
Clinical Success ◽  
Open Label ◽  
Once Daily ◽  
Open Label Study ◽  
End Of Treatment ◽  
Urine Concentrations ◽  
Phase 1B ◽  
Blood And Urine Samples ◽  
Group 3 ◽  
Group 2

ABSTRACT Omadacycline, an aminomethylcycline antibiotic, is approved as once-daily intravenous (i.v.) and oral (p.o.) monotherapy for acute bacterial skin and skin structure infections and for community-acquired bacterial pneumonia, and it is under development for treatment of urinary tract infection (UTI). This is a phase 1b, randomized, open-label study of omadacycline in women with cystitis (defined as UTI symptoms and a positive urine leukocyte esterase test). Patients received omadacycline for 5 days (group 1: 200 mg intravenously on day 1, then 300 mg orally every 24 h [q24h]; group 2: 300 mg orally every 12 h [q12h] on day 1, then 300 mg orally q24h; group 3: 450 mg orally q12h on day 1, then 450 mg orally q24h). Blood and urine samples were collected over 5 days. Investigator-assessed clinical response was determined at end of treatment (EOT; day 6) and posttreatment evaluation (PTE; 5 to 9 days after last dosing). A total of 31 women were treated. At steady state (day 5), the range of mean omadacycline urine concentrations over 24 h across the groups was 17.94 to 48.12 μg/ml. The most common treatment-emergent adverse events were gastrointestinal (including nausea [60% to 73%] and vomiting [20% to 40%]) and were generally mild and transient. Investigator-determined clinical success was observed in 94% and 84% of patients at EOT and PTE, respectively, with similar results across groups. A favorable microbiological response at PTE was observed in 78% of patients who had a baseline pathogen. Omadacycline is partially excreted in urine and appears to be safe and well tolerated. These preliminary results indicate that omadacycline warrants further evaluation in larger controlled UTI studies.

E7389, a novel anti-tubulin, in patients with refractory breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 653-653 ◽  
Author(s):  
J. BlumL. Forero ◽  
M. K. Heiskala ◽  
N. Meneses ◽  
K. Chandrawansa ◽  
F. Fang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Performance Status ◽  
Safety Data ◽  
Synthetic Analog ◽  
Open Label ◽  
Ecog Performance Status ◽  
Group 2 ◽  
Grade 3 ◽  
Cycle Group ◽  
Group 1

653 Background: E7389 is a synthetic analog of halichondrin B, with a broad anti- proliferative activity against tumor cells. Methods: E7389 was evaluated in an open-label, single-arm Phase II trial as monotherapy for patients with refractory breast cancer (≥2 prior chemotherapy regimens, which must have included an anthracycline and a taxane). E7389 was administered as an IV bolus of 1.4 mg/m2 on Days 1, 8, and 15 of a 28-day cycle (group 1), or on Days 1 and 8 of a 21-day cycle (group 2). The primary efficacy endpoint was ORR. Results: As of 9 December 2005, 88 patients had received treatment, 68 in group 1 and 20 in group 2. Median age was 55 yrs (range 36–84) and ECOG performance status 0–1. Sixty-six percent of the tumors were ductal carcinomas, 6% lobular, and 27% were unclassified. Sixty percent of the tumors were ER+, 47% PR+, and 17% Her2/neu 3+. The patients had received at least two previous regimens, with a median number of 5 (range 2–14). Forty-eight percent of the patients had also used hormonal therapy. Forty-nine patients in group 1 and 12 patients in group 2 had completed their 2nd cycle of treatment, and twenty-one in group1 and 1 in group 2 their 4th cycle. Safety: The major toxicity related to study drug was neutropenia. Among 73 patients with preliminary safety data available, two patients had Grade 3 febrile neutropenia, and 31 had Grade 3 or 4 neutropenia or leukopenia. The other Grade 3 toxicities encountered in more than two patients were dehydration (4 patients) and dyspnea (4 patients). Grade 3 peripheral neuropathy was reported in 2 patients. Efficacy: At the end of cycle four there were 10 (15.2%) confirmed partial responses (PRs) out of 66 evaluable patients in group 1, and 1 confirmed PR (5.6%) out of 18 evaluable patients in group 2. The median duration of confirmed responses was 113 days. Conclusions: Based on the safety and efficacy in this refractory breast cancer population, E7389 appears to be a therapy worthy of continued investigation in patients with heavily pretreated breast cancer. In order to comply with the current demand for individualized cancer care, bio-markers which would predict the sensitivity to E7389 are being searched in the tumor samples of the patients in the current and forthcoming studies. [Table: see text]

Phase I-II open label multicenter study of PD0332991 in BRAFV600mut metastatic melanoma patients harboring CDKN2A loss and RB1 expression and treated with vemurafenib.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9545-9545
Author(s):  
Baptiste Louveau ◽  
Matthieu Resche-Rigon ◽  
Thierry Lesimple ◽  
Marc Pracht ◽  
Barouyr Baroudjian ◽  
...  
Keyword(s):  
Cell Cycle ◽  
Phase I ◽  
Clinical Response ◽  
Metastatic Melanoma ◽  
Maximum Tolerated Dose ◽  
Fixed Dose ◽  
Open Label ◽  
Melanoma Patients ◽  
Group 2 ◽  
Group 1

9545 Background: Among mechanisms of resistance to BRAF inhibitors (BRAFi), cell cycle effectors including CDK4 have been involved in ERK reactivation. In this phase I-II open label study, we aimed to establish the Maximum Tolerated Dose (MTD) of PD0332991, an inhibitor of CDK4/6, when added to vemurafenib (VM) in metastatic melanoma patients. Methods: Patients with BRAFV600E/K mutated metastatic melanoma harbouring CDKN2A loss and RB1 expression were included. Patients were treated with a 14 days followed by 7 days rest daily dosing schedule of PD0332991 + continuous BID dosing of VM, and stratified into 2 groups according to previous BRAFi treatment (no group 1, yes group 2). Dose levels (PD0332991 (mg/QD)/VM (mg/BID) ranged from 25/720 to 200/960. The primary endpoint was the occurrence of a DLT within the first 2 cycles of therapy. Secondary endpoints included best response (RECIST), OS, PFS, pharmacokinetics parameters, tumour molecular profiling on baseline lesions using transcriptomic and NGS analysis. Results: Nineteen patients were enrolled, among them 16 (84%) in group 2, with 18.5 months median follow-up. Characteristics at baseline were: male 11 (58%), median age 54.4 years, unresectable stage IIIC 2 (11%), stage IV 17 (89%), M1C 12 (67%), high LDH 9 (47%), median time from advanced melanoma diagnosis to inclusion 26.8 months, ≥ 2 lines therapy 13 (68%). A DLT was observed for 1 and 5 patients in group 1 and 2 respectively, defining the MTD at PD0332991 25mg and VM 960mg in group 2. No significant evidence for drug-drug interaction between PD0332991 and VM was highlighted. In group 2, ORR was estimated to 4 (25%), SD to 8 (50%), median PFS to 9.3 months and median OS to 13.2 months. Baseline transcriptomic analysis revealed high alteration rate associated with clinical response and enrichment in genes related to MAPK, cell cycle and apoptosis pathways. Conclusions: While combination of fixed dose of PD0332991 + VM did not allow us to increase PD0332991 dosage above 25mg, significant clinical benefit was achieved in heavily pretreated patients; baseline molecular analysis revealed an association between transcriptomic data and clinical response. Clinical trial information: NCT02202200.

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