ABSTRACT
Resumen Objetivo: Describir la efectividad del tratamiento antiparasitario intestinal brindado a niños de cuatro a nueve años atendidos en el centro de Salud de la Universidad del Quindío entre Julio de 2017 a marzo de 2018. Materiales y métodos: Estudio observacional prospectivo. Se extrajeron datos de historias clínicas de pacientes con rango de edad de 4 a 9 años, quienes consultaron en el Centro de Salud de la Universidad del Quindío y se diagnosticaron mediante coprológico con blastocistosis o giardiasis. Se seleccionaron las historias cuyo tratamiento fuese Nitazoxanida y tuviesen un coprológico control postratamiento. Se presentan estadísticas descriptivas; porcentaje de eficacia y tolerabilidad. Resultados: De 15 niños tratados con Nitazoxanida, respondieron al tratamiento 10, en quienes no se hallaron parásitos en el coprológico control. Con una eficacia del 83,3% (IC95% 60 - 100) en blastocistosis, 57,1% (IC95% 32 - 82%) en giardiasis. Conclusión: Se evidenciaron resultados porcentuales similares a los reportados en la literatura, siendo más eficaz en blastocisotisis que en giardiasis.
Abstract Objective: To describe the effectiveness of the intestinal antiparasitic treatment given to children ranging between 4 and 9 years old that were attended in the Health Center of the University of Quindío in the period of July 2017 and March 2018. Materials and methods: Prospective observational study. Data were extracted from medical records of patients with an age range of 4 to 9 years, who consulted at the Health Center of the University of Quindío and were diagnosed through coprological tests with Blastocystis and Giardiasis. The clinical records were selected by whose treatment was done with Nitazoxanide or Albendazole with coprological results of post-treatment check-up. Descriptive statistics are presented along with percentage of efficacy and tolerability. Results: From 15 children treated with Nitazoxanide, 10 responded to the treatment, who presented no parasites in the coprological check-up. The remaining population presented some type of parasitic infection (n = 5). With an efficiency of 83,3% (IC95% 32 - 82%) in blastocystis, and 57,1% (IC95% 32 - 82%) in giardiasis. Conclusion: Percentage results similar to those reported in the literature were evidenced, being more effective in blastocystis than in giardiasis.
ABSTRACT
Background: Benign prostatic hyperplasia (BPH) is defined as a progressive nonmalignant enlargement of smooth muscle and epithelial cells in the prostate. A lot of studies have been published on the efficacy and safety of phytotherapeutic agents against BPH, making it a daunting task to review comprehensively. Aim and Objectives: The present article aimed to review the existing systematic reviews of primary studies on the subject. Google Scholar and PubMed databases were used in searching the articles. Materials and Methods: After permission from the departmental ethics committee, the quality of the retrieved articles was assessed using a revised assessment of multiple systematic reviews scale. Results: Sixteen reviews were included, with the majority (11 out of 16) focusing on Serenoa repens extracts. Such evidence for other phytotherapeutic agents studied is either limited, conflicting, or lacking. Issues about the primary studies included in the reviews were discussed and some recommendations presented. Conclusion: The reviews that focused on the most widely studied hexanic extract of S. repens, Permixon, were consistent in their conclusions that the extract is beneficial in improving the symptoms of BPH.
ABSTRACT
O foco deste estudo é investigar a segurança e tolerabilidade da ETCC anódica em crianças e adolescentes com paralisia cerebral (PC). Participaram desse estudo dez crianças e adolescentes com PC do tipo hemiplégica e diplégica, com idade entre oito e 17 anos (média = 11,40, dp = 2,83). Os sujeitos participaram de cinco sessões de ETCC anódica no córtex parietal posterior (CPP) direito, com o cátodo posicionado no músculo deltoide esquerdo. Após cada sessão de estimulação foi aplicado um questionário padronizado para avaliação de efeitos adversos. Os resultados revelaram os seguintes efeitos adversos: as taxas de prurido (62%), sensação de queimação (16%) e formigamento (23%). A maior parte dos efeitos foi classificada como de intensidade leve pelos participantes, demonstrando a alta tolerabilidade e segurança da ETCC em crianças e adolescentes com PC.
The focus of this study is to investigate the safety and tolerability of anodic tDCS in children and adolescents with cerebral palsy (CP). Ten children and adolescents with hemiplegic and diplegic PCs, aged eight to 17 years (mean = 11.40, dp = 2.83) participated in this study. The subjects participated in five sessions of anodic tDCS in the right posterior parietal córtex (PPC), with the cathode positioned in the left deltoid muscle. After each stimulation session, a standardized questionnaire was used to assess adverse effects. Results: the results showed the following adverse effects: pruritus rates (62%), burning sensation (16%) and tingling (23%). Most of the effects were classified as mild intensity by the participants, thus demonstrating the high tolerability and safety of tDCS in children and adolescents with CP.
ABSTRACT
Migraine is a recurrent throbbing or pulsing headache with moderate to severe pain intensity. The pain is often one side of the head with nausea and weakness symptoms. Around 12 percent of Americans, 9 percent of Asians experiences migraine and the prevalence is highest among South Koreans (22.3%). The outcome of chronic migraine treatment can be quite disheartening, causing patients to feel out of options who have tried multiple treatments with no results. Poor efficacy, tolerability and safety of migraine preventive therapy in clinical practice lead to poor compliance and failure of therapy. The mean change in number or frequency of headache is considered as the outcome measure of migraine prevention therapy. Upon comparing all migraine prevention therapy, the Fremanezumab, Eptinezumab, Galcanezumab and Erenumab were considered as the front runner in controlling the severity and frequency of migraine. Among these drugs, Erenumab was most effective in controlling the frequency of migraine episodes as it produces more than 50 percent reduction in the mean number of monthly migraine days (MMD) over week 9-week 12. In addition to drug therapy, adequate rest, balanced diet, yoga and meditation will help patients to get rid of migraine severity. A multi-dimensional approach is essential for better control over migraine symptoms.
ABSTRACT
T0001 is the first mutant of etanercept with a higher affinity to tumor necrosis factor α (TNF-α) than etanercept. In order to investigate the safety and tolerability of T0001, a study was carried out in healthy Chinese subjects. A first-in-human, dose escalation study was conducted in healthy Chinese subjects. Fifty-six subjects were divided into six dose cohorts (10 mg, 20 mg, 35 mg, 50 mg, 65 mg and 75 mg) to receive a single subcutaneous injection of T0001. Safety and tolerability assessment were based on the records of vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms and adverse events (AEs). All subjects were in good compliance and none withdraw due to AEs. No serious AEs occurred. A total of twenty-three AEs in sixteen subjects were recorded, and eighteen of these AEs were believed to be related to T0001. The most frequently reported AEs were injection site reactions and white blood cell count increase. All these AEs were of mild to moderate intensity and most of them recovered spontaneously within 14 days. In this study, no dose-limiting toxicity was observed, and the maximum tolerated dose was identified as 75 mg. T0001 was considered safe and generally well tolerated at doses up to 75 mg in healthy Chinese volunteers
Subject(s)
Humans , Male , Female , Adolescent , Adult , Safety , Volunteers , Single Dose/drug effects , Etanercept/analogs & derivatives , Physical Examination , Arthritis, Rheumatoid/pathology , Tumor Necrosis Factor-alpha/classification , Clinical Laboratory Techniques , Asian People/classification , Electrocardiography , Injection Site Reaction , Injections, Subcutaneous/classificationABSTRACT
Abstract Aim: To verify the acute effect of sodium bicarbonate (NaHCO3) supplementation on performance during CrossFit® workout. Methods: Nine experienced males (30.8 ± 3.5 years; 84.4 ± 9.5 kg; 177.5 ± 4.03 cm; 2.2 ± 1.0 years) in CrossFit® participated in this study. They were allocated to two conditions: a) supplementation with 0.3 g.kg-1 of body weight of NaHCO3 and b) supplementation with 0.045 g.kg-1 of body weight of sodium chloride (NaCl). Blood lactate was analyzed at two different moments: before (lac-pre) and after the training protocol (lac-post). The heart rate (HR) and the rating of perceived exertion (RPE) were also collected every two minutes during the execution of the training protocol, and the RPE was also collected after it was finished. At the end of the training protocol, a questionnaire to measure gastrointestinal side effects (GSE) was answered by the participants. Repetitions performed in the training protocol was computed to evaluate the performance during the workout. Results: The results showed that there were no differences found when comparing the conditions for all parameters. HR and RPE were different in the first few minutes (< 4-6 minutes) when compared to the final minutes (> 14 minutes) of the workout. The area under the curve of HR and RPE was significantly lower in the NaHCO3 condition. Conclusion: Acute NaHCO3 supplementation did not improve performance during workout 'Cindy' in experienced men. Supplementation also did not alter hemodynamic and perceptual parameters, nor did it cause any GSE. However, responses as a function of time were reduced with NaHCO3 supplementation.
Subject(s)
Humans , Exercise/physiology , Sodium Bicarbonate/administration & dosage , Muscle Fatigue/physiology , Lactic Acid/blood , Surveys and QuestionnairesABSTRACT
Eucalyptus (Eucalyptus globulus Labill.) is an evergreen tree found worldwide. The aqueous ethanolic extract of the leaves (eucalyptus leaf extract; ELE) is used as a functional food, and its active constituents are generally polyphenols. Toxicity and mutagenicity of ELE have been previously assessed using rodents, and no adverse effects were observed. Although clinical trials of low-dose ELE ingestion have been conducted on humans, safety evaluation of high-dose ELE has not yet been conducted. We conducted an open-label clinical trial as a pilot study to assess the safety of excessive oral intake of ELE in Japanese adult men. A powdery preparation of ELE, commercially sold as Eucagrandin®, was prepared using spray drying method and contained approximately 80% ELE. Test capsules were packed with the powdery ELE. Six male subjects (aged 47.3 ± 12.4 years, mean ± SD) orally consumed 2,592 mg of ELE per day for 4 consecutive weeks. The subjects were examined at the start of the intervention, 4 weeks after the start, and 2 weeks after the last intake of test capsules. During the study period, 2 adverse events were reported. However, the causal relationship with the consumption of ELE was denied in both events because one event was attributed to a bruise and the other, which was elevated CPK levels, was due to excessive exercise. No unusual changes related to ELE consumption were observed in physical examination and during medical interviews. Further, blood and urine tests were normal during the trial period. These results demonstrated that oral consumption of ELE at the indicated dose is safe for humans.
ABSTRACT
Background: Itopride and Levosulpiride both comes under the group of Prokinetic drugs. These drugs are used for the treatment of non-ulcer dyspepsia, heart burn, nausea and vomiting. Both drugs act on dopaminergic D2 receptor as antagonist and increases the concentration of acetylcholine so that gastric peristalsis will be increase and that time pressure at lower oesophageal sphincter will be increase thus gastric motility increases and there will be good gastro-duodenal co-ordination.Method: This study has to conduct on patients with complains of non-ulcer dyspepsia attended Medical outdoor and department of pharmacology of SKMCH Muzaffarpur, Bihar, India. The total 60 patients have to include in the study, which have to randomly divide in two groups. Group A (itopride) comprising of 30 patients and Group B (Levosulpiride) comprising of 30 patients. Patients have to randomly allocate to receive one tablet of itopride hydrochloride, 50 mg three times daily before meal and one tablet Levosulpiride of 75 mg three times daily before meal. Authors have to enroll the patients at the interval of two weeks and continue it upto 3 months.Results: Study did not found any remarkable change in biochemistry profile. Only QT prolongation changes were found in two patients, but no serious cardiac toxicity was observed with patient receiving Levosulpiride. Neither QT prolongation nor serious cardiac toxicity was observed with itopride hydrochloride therapy.Conclusions: In present study, efficacy of Itopride was comparable to Levosulpiride in relieving the symptoms of non-ulcer dyspepsia. Both the drugs were clinically and biochemically well tolerated. QT prolongation changes were found in two patients, but no serious cardiac toxicity was observed with patient receiving Levosulpiride. Itopride does not show cardiac toxicity and any changes in ECG.
ABSTRACT
Background: The efficacy and safety of Pregabalin and Nortriptyline have been proved individually in low backache with radicular pain. However, there are limited number of studies comparing the efficacy of Pregabalin and Nortriptyline in Chronic Low Backache (CLBA) with radicular pain. Hence the present study was designed to determine the efficacy as well as tolerability of Pregabalin in comparison with that of Nortriptyline for reduction of pain in CLBA. The present study was an open label prospective observational study.Methods: Patients with CLBA, 15-60 years of age without specific cause and significant neurological deficit were included in the study. Severity of pain was assessed by Visual Analogue Scale (VAS). Patients were followed up at 2 and 4 weeks and their VAS scores and side effects were noted.Results: Both Pregabalin and Nortriptyline were effective in reducing pain, from baseline to 2 weeks and up to 4 weeks of treatment in chronic low backache with radicular pain, but there was no statistically significant difference between the two treatment groups. The incidences of side effects were less in the Nortriptyline treatment group as compared to Pregabalin.Conclusions: From the results of the present study it can be concluded that both Pregabalin and Nortriptyline were equally effective in the treatment of chronic low backache with radicular pain, but the incidence of adverse effects were more with Pregabalin as compared to Nortriptyline.
ABSTRACT
Background:Anemia is one of major contributing factor in maternal mortality and morbidity in third world countries and according to the WHO, contributes to 40% maternal deaths. Postpartum anemia is observed in up to 27% of wom-en.It is a common problem throughout the world. Treatment of postpartum iron deficiency anemia includes oral and parenteral iron supplmentaion as well as blood transfusion in severe cases. Methods: This was a prospective longitudi-nal study carried out in Department of Obstetrics & Gynaecology of PRH, Loni. Total 80 women suffering from post-partum anemia of age above 18 years with haemoglobin (HB) level below 11gm/dl and above 6gm/dl were included for the study. After history taking, clinical examination and baseline Hb level, all of them were administered intrave-nous iron sucrose 200 mg per dose per day till the total calculated dose was administered. The post therapy evaluation was done with the estimation of Hb on day 1, day 7, day 14 and day 21. Results:31.25% women belonged to the age group each of 19-21 years and 22-24 years. Maximum number of patients received 3 doses of IV Iron sucrose (i.e. total 600mg) followed by 2 doses (i.e. total 400mg), 4 doses (i.e. total 800mg) and 5 doses (i.e. total 1000mg) respec-tively. Hb level rises extremely significantly (p<0.001) after IV Iron Sucrose administration on day 1, 7, 14 & 21 as compared to corresponding values before delivery as analyzed by Friedman Test (Nonparametric Repeated Measures ANOVA) . 16 patients (20%) experienced thrombophlebitis to IV Iron Sucrose administration. About 12 (15%) pa-tients experienced rigor followed by sweating in 10 patients (12.5%) and fever in 8 patients (10%). About 62 patients (77.5%) from total 80 reported well tolerability to IV Iron Sucrose while remaining 18 patients (22.5%) reported poor tolerability to IV Iron Sucrose Conclusion:Intravenous iron sucrose increases the haemoglobin more rapidly in first week as compared to second and third week in women with postpartum iron deficiency anemia. Hypersensitivity reac-tion, chest pain, dyspnoea reported with iron dextran and iron sorbitol citric acid were not observed with iron sucrose. Intravenous iron sucrose can be used safely to fill a rift between blood transfusion and oral iron in treatment of post-partum iron deficiency anemia.
ABSTRACT
OBJECTIVE: The present study aimed to observe potential benefit of aripiprazole augmentation in the treatment of major depressive disorder with mixed specifier (MDDM) in naturalistic treatment setting. METHODS: Data were collected from MDDM patients using a retrospective chart review for 8 weeks (week –8 and week 0) in routine practice. All patients were on current antidepressants upon starting of aripiprazole. Patients were treated without restriction of doses of aripiprazole. The primary endpoint was the mean change of Montgomery–Åsberg Depression Rating Scale (MADRS) total scores along with various secondary endpoint measures. RESULTS: In total 38 patients were analyzed. The changes of MADRS, Clinical Global Impression (CGI)-severity, Young Mania Rating Scale, Sheehan Disability Scale, and CGI-clinical benefit total scores from baseline to the endpoint were −7.1, −0.8, −4.9, −4.1, and −3.6, respectively (all p < 0.0001). At the endpoint, the responder and remitter rates by MADRS score criteria were approximately 32% and 21%, respectively. CONCLUSION: The present findings have clearly shown the effectiveness and tolerability of aripiprazole augmentation for MDDM patients in routine practice. The present study warrants subsequent, adequately-powered, well-controlled studies for generalizability near future.
Subject(s)
Humans , Antidepressive Agents , Aripiprazole , Bipolar Disorder , Depression , Depressive Disorder , Depressive Disorder, Major , Retrospective StudiesABSTRACT
PURPOSE: Temsirolimus is effective in the treatment for metastatic non-clear cell renal cell carcinoma (nccRCC) with poor prognosis. We aim to investigate the efficacy and tolerability of temsirolimus in treatment of naïve Asian patients with metastatic/recurrent nccRCC. MATERIALS AND METHODS: From January 2008 to July 2017, data of treatment-naïve, metastatic/recurrent nccRCC patients, who were treated with temsirolimus according to the standard protocol, were collected. The primary end-point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR), and tolerability of temsirolimus. RESULTS: Forty-four metastatic/recurrent nccRCC patients, 10 from prospective and 34 from retrospective groups, were enrolled; 24 patients (54%) were papillary type, and other histology subtypes included 11 chromophobes (25%), two collecting ducts (5%), one Xp11.2 translocation (2%), and six others (14%). The median PFS and OS were 7.6 months and 17.6 months, res-pectively. ORR was 11% and disease control rate was 83%. Patients with prior nephrectomy had longer PFS (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.06 to 0.42; p < 0.001) and OS (HR, 0.15; 95% CI, 0.05 to 0.45; p < 0.001). Compared to favorable/intermediate prognosis group, poor prognosis group had shorter median PFS (4.7 months vs. 7.6 months [HR, 2.91; 95% CI, 1.39 to 6.12; p=0.005]) and median OS (9.2 months vs. 17.6 months [HR, 2.84; 95% CI, 1.23 to 6.56; p=0.015]). CONCLUSION: Temsirolimus not only benefits poor-risk nccRCC patients, but it is also effective in favorable or intermediate-risk group in Asians. Temsirolimus was well-tolerated with manageable adverse events.
Subject(s)
Humans , Asian People , Carcinoma, Renal Cell , Disease-Free Survival , Nephrectomy , Prognosis , Prospective Studies , Retrospective StudiesABSTRACT
PURPOSE: There is limited data on the use of perampanel in children under 12 years of age. We evaluated the efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy. METHODS: This retrospective observational study was performed in Kyungpook National University Hospital from July 2016 to March 2018. A responder was defined as a patient with ≥50% reduction in monthly seizure frequency compared with the baseline. Adverse events and discontinuation data were obtained to evaluate tolerability. RESULTS: Twenty-two patients (8 males, 14 females) aged 3.1–11.4 years (mean, 8.0±2.5 years) were included in this study. After an average of 9.2 months (range, 0.5–19 months) of follow-up, 15 patients (68%) showed a reduction in seizure frequency, including 5 patients (23%) with seizure freedom. The age at epilepsy onset was significantly lower (P=0.048), and the duration of epilepsy was significantly longer (P=0.019) in responders than in nonresponders. Nine patients (41%) experienced adverse events, including somnolence (23%), respiratory depression (9%), violence (4.5%), and seizure aggravation (4.5%). The most serious adverse event was respiratory depression, which required mechanical ventilation in 2 patients (9%). Eight patients (36%) discontinued perampanel due to lack of efficacy or adverse events. Three out of 4 patients (75%) who discontinued perampanel due to adverse events had an underlying medical condition. CONCLUSION: Perampanel offers a treatment option for refractory epilepsy in children. Adjunctive treatment with perampanel requires special consideration in those with underlying medical conditions to prevent serious adverse events.
Subject(s)
Child , Humans , Male , Epilepsy , Follow-Up Studies , Freedom , Observational Study , Respiration, Artificial , Respiratory Insufficiency , Retrospective Studies , Seizures , ViolenceABSTRACT
@#The international, multicenter Chronic Migraine OnabotulinumtoxinA Prolonged Efficacy Open Label (COMPEL) study evaluated long-term safety and efficacy of onabotulinumtoxinA in individuals with chronic migraine (CM). This post hoc analysis evaluates the safety and efficacy of onabotulinumtoxinA in South Korean patients for up to 108 weeks of treatment. OnabotulinumtoxinA 155 U was administered every 12 weeks for 9 treatment cycles (108 weeks). The primary efficacy measure was change from baseline in heads he-day frequency for the 28-day period ending at week 108. Additional outcome measures included change in 6-item Headache Impact Test (HIT-6) scores and measures of migrainerelated disability and quality of life. Safety and tolerability were assessed from the frequency of adverse events (AEs). Of 716 patients in the United States, South Korea, and Australia, 80 were from South Korean study sites; 58 (72.5%) South Koreans and 315 (49.5%) non-Koreans completed the study. Within-group improvements in all efficacy measures from baseline to week 108 were statistically significant (P<0.05). Mean change in headache-day frequency (SD) at week 108 was similar for South Koreans and non-Koreans (–11.8 [7.8] vs –10.6 [6.2]; P=0.115). However, at week 108, the South Korean subgroup showed significantly greater reductions in moderate to severe headache days (–10.8[7.0] vs –9.3 [5.9]; P=0.040) and in HIT-6 scores (–9.8 [8.6] vs –6.7 [7.0]; P<0.001). Treatment related AEs occurred less frequently in South Koreans than non-Koreans (7.5% vs 19.7%). In the COMPEL study, onabotulinumtoxinA was an effective and well-tolerated preventive treatment for South Koreans with CM.
ABSTRACT
Background: Studies have shown that doxofylline is endowed with a remarkable bronchodilator activity with less extra respiratory effects than other methylxanthines. To compare the efficacy and tolerability of doxofylline over other methylxanthines in mild to moderate persistent bronchial Asthma patients.Methods: It is a comparative study conducted in patients of mild to moderate persistent bronchial Asthma in the outpatient department of regional chest hospital. The subjects were randomly assigned into 2 groups, one group treated with oral doxofylline and the other with theophylline oral or Deriphylline. Efficacy was measured objectively using spirometric parameters like FEV1 (Forced Expiratory Volume at the end of 1 second), FVC (Forced Vital Capacity), FEV1/FVC and PEFR (Peak Expiratory flow Rate), Subjectively by the Asthma control test questionnaire, subjective rating of Asthma control and the need for use of rescue medications like β2 agonists in the previous four weeks. Tolerability were done at base line and at the end of study.Results: Doxofylline compared to other methylxanthines groups was statistically better with respect to subjective parameters like Asthma control tests questionnaire, subjective rating of Asthma control. Doxofylline had equal efficacy with spirometric parameters compared to other methylxanthines. Doxofylline was significantly better tolerated with adverse drug reactions noted in 10% compared to 28% in other methylxanthins group.Conclusions: Doxofylline with better tolerability profile and equivalent efficacy seemed to be a good alternative to other methylxanthines in the treatment of bronchial Asthma.
ABSTRACT
Background: Diarrheal disorders in childhood account for a large proportion (18%) of childhood mortality. Among diarrheal diseases, dysentery is a major cause of childhood morbidity and mortality, especially in developing countries.Methods: This is an open labelled, prospective, randomised, comparative study carried out at Dr. B. R. Ambedkar Medical College Hospital, Bangalore from November 2014 to November 2015 after Institutional Ethics Committee approval. A total of 80 Paediatric patients who met the inclusion criteria were included in the study after taking written informed consent from parents and assigned into two groups, Group A- Inj. Ceftriaxone (50-100mg/kg/day) and Group B- Inj. Cefotaxime (100 mg/kg/day) in divided doses for a period of 3-5 days based on requirement.Results: In this study, Cefotaxime was non inferior to Ceftriaxone as the Mean Duration of Hospitalisation was 3.30±0.72 days in Group A and 3.30± 0.72 days in Group B with p value of 1.000, showing no statistically significant difference. Both were well tolerated without any reports of ADR (Adverse Drug Reaction).Conclusions: In this study shows that Inj. Cefotaxime is equally efficacious and well tolerated as Inj. Ceftriaxone in the treatment of Acute Bacillary Dysentery in paediatric patients.
ABSTRACT
Background and objectives: NuvaRing is a novel nonoral combined hormonal contraceptive. Present study aims to compare the efficacy, compliance, acceptability and tolerability of NuvaRing with COCs. Method: Prospective randomized, controlled study. Total 430 women fulfilling inclusion and exclusion criteria enrolled for study ,randomly divided in two groups of 215 each. Women in NuvaRing group were given NuvaRing for 12 cycles and women in COC group were given Mala N tablets for 12 cycles. Two groups were compared for efficacy, acceptability, compliance and tolerability by filling questionnaires. Results: There was no significant difference in efficacy, compliance and acceptability. NuvaRing group had more complaints of vaginal discharge and incidence of nausea was significantly higher in COC group. None of the women discontinued use due to side effects. Conclusion: NuvaRing has comparable efficacy, compliance, acceptability and tolerability as compared to COCs with the advantage to once a month dosing
ABSTRACT
OBJECTIVE: Citalopram (CITA) is a widely used and well-tolerated selective serotonin reuptake inhibitor. The aim of the study was to evaluate the possible influences of serum concentrations of CITA and its major metabolite n-desmethylcitalopram (NDCITA) on the efficacy and tolerability of CITA in patients with major depressive disorder. METHODS: The study included 46 outpatients with major depressive disorder who received CITA. The efficacy and tolerability were assessed for 6 weeks. Serum CITA and NDCITA levels were measured at the 4th week. RESULTS: The HDRS17 total scores of the patients with high NDCITA and CITA & NDCITA concentrations showed a more significant reduction compared to the patients with expected and low serum NDCITA and CITA & NDCITA concentrations. However, we did not observe a correlation between the serum concentrations and the side effects of CITA, NDCITA, and CITA & NDCITA. CONCLUSION: Our results suggested the potential contribution of NDCITA to the antidepressant effect of CITA. Further studies involving larger clinical samples are required to confirm the impact of serum NDCITA concentrations on the efficacy of CITA.
Subject(s)
Humans , Citalopram , Depression , Depressive Disorder, Major , Outpatients , SerotoninABSTRACT
Objective To investigate the 2-year retention rates and tolerability of levetiracetam (LEV), Lamotrigine(LTG), and Oxcarbazepine(OXC) in pediatric patients with epilepsy.Methods 310 pediatric patients with epilepsy were included in this study: LEV (n=145), LTG (n=101), and OXC (n=64). The clinical efficacy, first discontinuation time and discontinuation reasons were recorded and compared. The retention rates at 12, 24, 52 and 104 weeks were evaluated. Results At the two-year follow up:Clinical efficacy didn't significantly differ among the three groups (P = 0.190); The 2-year retention rates for LEV, LTG, and OXC, were 68.28%, 72.28%, and 48.44%, respectively (P = 0.002). LEV and LTG had equivalent retention rates, whereas OXC retention was significantly inferior to the LEV and LTG retention (P<0.05). The common reasons for drug discontinuation were adverse effects (47.66%) and lack of efficacy (42.10%), while the rate of adverse effects leading to drug withdrawal of OXC (66.77%) was higher than that of LEV (36.96%, P = 0.003) and LTG (42.86%, P = 0.023). Conclusion These results suggested that LEV, LTG and OXC had similar clinical efficacy. LEV and LTG had comparable retention profiles and long-term tolerability in the 2-year treatment, while OXC therapy seemed to be relatively less useful. If there are no specific contradictions, pediatric patients with epilepsy could be better receiving LEV and LTG antiepileptic treatment.
ABSTRACT
Huperzine A is a potent,reversible,and blood-brain barrier permeable acetylcholinesterase irhibitor.The aim of this study was to compare the pharmacokinetics,tolerability,and bioavailability of two formulations with the established reference formulation of huperzine A in a fasting,healthy Chinese male population.This was a randomized,single-dose,3-period,6-sequence crossover study.The plasma concentrations of huperzine A were determined by liquid chromatography tandem mass spectrometry.Tolerability was assessed based on subject interview,vital sign monitoring,physical examination,and routine blood and urine tests.The mean (SD) pharmacokinetic parameters of the reference drug were Cmax,1.550 (0.528) ng/mL;t1/2,12.092 (1.898) h;AUC0-72h,17.550 (3.794) ng.h/mL.Those of the test formulation A and test formulation B were Cmax,1.412 (0.467),1.521 (0.608) ng/mL;t1/2,12.073 (2.068),12.271 (1.678) h;AUC0-72h,15.286 (3.434) ng.h/mL,15.673 (3.586) ng.h/mL.The 90％ confidence intervals for the AUC0-72h and Cmax were between 0.80 and 1.25.No adverse events were reported by the subjects or found with results of clinical laboratory test.The test and reference products met the regulatory criteria for bioequivalence in these fasting,healthy Chinese male volunteers.All three formulations appeared to be well tolerated.