Mg In Treatment Research Articles

Effectiveness and Safety of Silodosin in Treatment of Premature Ejaculation: Placebo Double Blind Control Study

Background: Premature ejaculation (PE) is a common sexual problem, many epidemiological reports have shown that approximately 20–30% of men have complaints of PE. Objective: The aim of this study was to evaluate the effectiveness of silodosin 4mg in treatment of premature ejaculation. Patients and methods: This study was conducted on 160 subjects with premature ejaculation. The patients were recruited from Dermatology and Andrology Outpatient Clinics in Al-Azhar University Hospitals . Results: According to our results, there is highly statistically significant difference (p-value < 0.001) between patient group (559.3 ± 159.9) and control group (248.4 ± 83.7) as regard intravaginal ejaculatory latency time (IVELT) post-treatment (p-value < 0.001). Also, we found highly statistically significant difference (p-value < 0.001) between premature ejaculation profile questionnaire (PEPQ) pre- and post-treatment in patients' group. As silodosin caused improvement of control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation and interpersonal difficulty. At the end of the study only 11 (13.75%) patients reported that they had a decreased semen volume as a side effect of silodosin, which disappeared completely after discontinuation of the drug. Conclusion: we found that, silodosin 4 mg is a promising idea in treatment of premature ejaculation, as it is effective, cheap, safe and available in Egyptian market. We recommend administration silodosin 4mg 2 hours before sexual intercourse for treatment of premature ejaculation.

Efficacy and Safety of On-Demand Clomipramine for the Treatment of Premature Ejaculation: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial

PurposeThe aim of the present trial is to assess the efficacy of on-demand clomipramine 15 mg administered before sexual intercourse for the treatment of premature ejaculation (PE). Materials & methodsA total of 159 patients at five centers in Korea were randomly assigned into two groups. The first group received placebo (n=53) and the second group received clomipramine 15 mg (n=106) for 12 weeks. All patients were evaluated at the beginning of the study and every 4 weeks. Patients were instructed to take a tablet approximately 2-6 hours before sexual intercourse. Efficacy was assessed using Intravaginal Ejaculation Latency Time (IELT) and Premature Ejaculation Diagnostic Tool (PEDT) scores. ResultsAnalyses of fold change of IELT in each group in the Intention-to-Treat (ITT) population revealed that the IELT of the clomipramine 15 mg group was significantly increased 12 weeks after administration compared with the placebo group (4.40±5.29 vs. 2.68±2.03, p <0.05). Fold change of IELT in the Per Protocol (PP) population was also significantly different between the clomipramine 15 mg group and the placebo group (4.66±5.64 vs. 2.80±2.19, p <0.05). There was a significant difference in the PEDT scores between the two groups (p <0.001). The most commonly reported adverse events were nausea (15.7%) and dizziness (4.9%) and were mild to moderate in severity. ConclusionsResults of this multicenter, randomized, double-blind, placebo-controlled, fixed-dose clinical phase III study suggest that use of on-demand clomipramine 15 mg for treatment of PE is effective and safe.

THU-307 - Ledipasvir 90 mg/sofosbuvir 400 mg for treatment of children with CHC genotype 4: Single Centre experience

THU-307 - Ledipasvir 90 mg/sofosbuvir 400 mg for treatment of children with CHC genotype 4: Single Centre experience

Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency

BackgroundImplantation of testosterone doses of at least 150 to 450 mg (ie, two to six pellets) is common clinical practice despite a lack of prospective data. AimTo evaluate pharmacokinetics, clinical efficacy, safety, and patient-reported outcomes in men with androgen deficiency who received implantation of testosterone pellets (900 mg) in an open-label study. MethodsMen with androgen deficiency (serum testosterone < 300 ng/dL [10.4 nmol/L]) were screened and received 12 testosterone pellets (900 mg). Serum hormone measurements (total and free testosterone, dihydrotestosterone, and estradiol) were obtained on days 1, 5, 8, 15, 29, 57, 85, and 113. All hormones were assayed using validated liquid chromatography and tandem mass spectrometry. OutcomesPharmacokinetics of selected hormones was determined. The patient-reported International Index of Erectile Function (IIEF), Center for Epidemiologic Studies Depression (CES-D), and Androgen Deficiency in the Aging Male (qADAM) questionnaires also were performed. Patients rated their satisfaction on a scale from 1 (very satisfied) to 5 (very dissatisfied). Adverse events were monitored throughout. ResultsFifteen patients were included (mean age = 54.5 years, SD = 8.6 years). Mean baseline total testosterone concentration was 241.6 ng/dL (SD = 88.8 ng/dL; mean = 8.4 nmol/L, SD = 3.1 nmol/L). Mean testosterone serum concentrations fluctuated during the first 2 weeks (range = 300–1,000 ng/dL, 10.4–34.7 nmol/L) but remained higher than or equal to 300 ng/dL (10.4 nmol/L) through day 113. Concentrations of free testosterone, dihydrotestosterone, and estradiol mirrored that of total testosterone. Male functioning (IIEF score), depression (CES-D total score), and androgen-deficiency symptoms (qADAM total score) improved from baseline. Most patients were “very satisfied” (40.0%) or “quite satisfied” (26.7%) with treatment. Testosterone pellets were well tolerated. Pellet extrusion and polycythemia occurred in one patient each. Clinical ImplicationsImplantation of high doses (900 mg) of testosterone pellets are generally well tolerated and could provide clinical benefit for some patients. Strengths and LimitationsThis study provides standardized data for the implantation of 12 testosterone pellets. However, the open-label uncontrolled design of this study and its small and ethnically non-diverse patient population limit the interpretation of these data, particularly the patient-reported outcomes. ConclusionImplantation of 12 testosterone pellets (900 mg) was well tolerated and provided adequate and sustained serum testosterone concentrations. Additional randomized controlled trials are needed to confirm efficacy and safety findings.McMahon CG, Shusterman N, Cohen B. Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency. J Sex Med 2017;14:883–890.

Network Meta-Analysis Comparing Overall Survival for Fulvestrant 500 mg Versus Alternative Therapies for Treatment of Postmenopausal, Estrogen Receptor-Positive Advanced Breast Cancer Following Failure on Prior Endocrine Therapy

BackgroundWe conducted a review of randomized trials to compare the overall survival (OS) with fulvestrant 500 mg versus alternative treatment for estrogen receptor-positive advanced breast cancer following endocrine therapy failure. Materials and MethodsHazard ratios (HRs) were obtained by modeling OS data with the Weibull distribution. A fixed-effect Bayesian network meta-analysis was conducted. The evidence network included anastrozole 1 mg, letrozole 2.5 mg, fulvestrant 250 mg, exemestane 25 mg, megestrol acetate 40 mg, and everolimus 10 mg plus exemestane 25 mg as comparators. Post-antiestrogen and post-aromatase inhibitor subgroup networks were analyzed. ResultsIn the overall analysis, the HRs suggested improved OS for fulvestrant 500 mg versus fulvestrant 250 mg and megestrol acetate 40 mg, and numerically favorable differences with fulvestrant 500 mg versus other comparators. In the antiestrogen subgroup, the HRs suggested improved OS for fulvestrant 500 mg versus fulvestrant 250 mg and megestrol acetate 40 mg; numerical differences in the HRs were seen versus anastrozole 1 mg and letrozole 2.5 mg. In the aromatase inhibitor subgroup, the HRs for OS numerically favored fulvestrant 500 mg versus fulvestrant 250 mg and exemestane 25 mg. ConclusionAcknowledging the limitations of the present network meta-analysis, these findings suggest that fulvestrant 500 mg might provide improved OS versus fulvestrant 250 mg and megestrol acetate 40 mg for treatment of estrogen receptor-positive ABC following endocrine therapy failure. Although OS efficacy versus everolimus 10 mg plus exemestane 25 mg (for overall evidence network), anastrozole 1 mg, exemestane 25 mg, and letrozole 2.5 mg is numerically favorable, additional studies are required to draw formal conclusions.

Randomized double blinded placebo controlled trial comparing diclofenac and piroxicam in management of acute renal colic and its clinical implications.

To compare the efficacy of sublingual piroxicam 40 mg with intramuscular diclofenac 75 mg in treatment of acute renal colic. The secondary objective was to look for factors that can affect the severity of the pain and pain relief in acute renal colic. One hundred patients with acute renal colic were randomized into two groups. Group A (n = 50) received intramuscular diclofenac and sublingual methylcobalamin. Group B (n = 50) received sublingual piroxicam 40 mg and intramuscular distilled water. Pain severity was measured using Visual Analog Scale (VAS) and verbal and facial response scales. They were followed up for 3 h. Intramuscular injection of pentazocine 30 mg with promethazine 25 mg were used as rescue drugs. Both groups were comparable for age, sex distribution, body mass index (BMI), and pain duration before presentation. Significant pain relief was noticed in both groups. Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75). Fifteen patients in group A and 13 patients in group B needed rescue drugs, 84% of group A and 76% of group B had complete pain relief at the end of 3 hours (P = .25). Decrease in pain by each scoring method was also comparable (P = .75). In multiple regression analysis, increasing age, positively affects the severity of pain and pain relief while increasing BMI negatively affect the initial pain relief. Acute renal colic seems to affect men more commonly than women, 81% of the study population were men. Patients with low initial pain score did not require any additional pain relief. Average pain duration before presenting to hospital is 260 min. Sixty percent of renal colics are due to stones below pelvic brim. The results show that sublingual piroxicam is as effective as intramuscular diclofenac. It can be easily self-administered and it overcomes the morbidity and time delay in getting intramuscular diclofenac.

PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Results from the Alzheimer’s Disease/Dementia Cohort (P7.109)

PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Results from the Alzheimer’s Disease/Dementia Cohort (P7.109)

PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Results from the Alzheimer's Disease/Dementia Cohort

depression. Therefore, we first demonstrate the SN dysfunction in LLD and further test the hypothesis that SN may be the underpinning neural circuit related not only to depression severity, but also to the cognitive model of LLD. Methods: Thirty-six late-onset non-demented late life depression patients and 32 elderly controls underwent resting state functional magnetic resonance imaging (fMRI). SN was delineated by seed based analysis with seeds in right and left anterior insular (RAI and LAI). Group difference in functional connectivity (FC) was selected as ROI in subsequent correlational analysis with psychometrics. Results: Compared to normal controls, LLD group showed significant decreased FC in left inferior orbital-frontal (OFC) with RAI as seed; right inferior OFC, left fusiform, right fusiform and right precuneous with LAI as seed. In LLD group, this decrease FC in right and left fusiform with LAI was negatively correlated with dysfunctional attitude. No significant correlation was found in FC and depression severity or its duration. Conclusions: We demonstrated that the FC of SN in patients of LLD was decreased, and this decrease was related to their dysfunctional attitude, a form of cognitive bias that served as schema of major depression. This finding may guide our further treatment and underscore the importance of cognitive behavior therapy in the treatment of LLD.

The effect of supplementary calcium on blood pressure in healthy adult women aged 18-30 years in Tehran, Iran.

Introduction:Cardiovascular disease is the major cause of mortality in developed countries and has an increasing trend in developing countries. There are some evidences that calcium supplementation may decrease blood pressure and consequently cardiovascular disease, but they are not conclusive and there is no agreement in this respect. The aim of the present study was to assess the effect of supplementary calcium on systolic and diastolic blood pressure in healthy adult women aged 18–30 years.Materials and Methods:Seventy-five normotensive volunteers were randomly divided into two groups, the treatment group received 1000 mg/day calcium (four doses of 625 mg calcium carbonate) for 1 month and the control group received placebo (dextrose). Systolic and diastolic blood pressure was determined before and after intervention in supine position after 10 min of rest.Results:The mean daily calcium intake from food was 773.9 mg in treatment and 721 mg in control group (no significant difference) but in both the groups dietary calcium intake was less than the recommended dietary allowance: After calcium supplementation, the mean change of systolic blood pressure was not significant in the two groups, but diastolic blood pressure reduced in treatment group and increased in control group (−4.9 vs 2.6 mmHg) (P < 0.05).Conclusions:These results suggest that, calcium supplementation does not have any effect on systolic blood pressure of our volunteers but can decrease diastolic blood pressure significantly and therefore it seems that calcium supplementation may be useful for people with increased diastolic blood pressure, especially for those who receive less calcium than recommended dietary allowance.

Caractéristiques épidémio-cliniques de l’hypertension artérielle résistante du sujet noir africain

IntroductionFew studies in sub-Saharan Africa were interested in resistant hypertension. The objectives of this study were to determine the frequency of resistant hypertension in hypertensive black African population, and to describe its clinical and therapeutic features. Patients and methodsFrom May 1, 2010 to May 31, 2012, we included consecutively hypertensive followed in two hospitals in the city of Ouagadougou, under antihypertensive treatment at optimum dose and observant. Patients whose blood pressure was uncontrolled despite a triple antihypertensive therapy at the optimal dose including a diuretic associated with dietary measures have received ambulatory blood pressure monitoring. Following this examination, patients whose blood pressure was ≥135/85mmHg during the day and/or ≥120/70mmHg at night were considered resistant hypertension. We investigated the cardiovascular risk factors as well as target organ damages. We combined spironolactone 50mg in treatment when absence of contra-indication appreciated the evolution of blood pressure under this treatment. The measurement of plasma renin activity was not performed. Statistical analysis was performed using SPSS Version 17 for Windows. ResultsWe included 692 patients with 14.6% of resistant hypertension. The average age of patients was 54.8±11.1years in the general population, 56.5±11.8years in the subgroup of non-resistant hypertension and 64.2±5.4years in the subgroup of resistant hypertension. The symptoms were represented by headache (11.9%), dizziness (9.9%) and chest pain (8.9%). Modifiable cardiovascular risk factors were dominated by dyslipidemia, diabetes and obesity/overweight. These risk factors were significantly more frequent in the subgroup of resistant hypertension. The global cardiovascular risk was high in 24.9% of cases in the general population, 22.5% in the subgroup of non-resistant hypertension and 38.6% in the subgroup of resistant hypertension. The target organ damages were significantly more frequent in the same subgroup of resistant hypertension. After addition of spironolactone, 21.8% of resistant hypertensive patients were controlled. ConclusionThis study shows that resistant hypertension is common in black Africans. It is mostly subjects of the sixth decade, with limited economic income and living in rural areas. In the absence of contra-indication, spironolactone contributed to decrease the morbidity of this pathology.

Pharmacokinetics and pharmacodynamics of levofloxacin injection in healthy C hinese volunteers and dosing regimen optimization

What is known and objectiveThe pharmacokinetics (PK) and pharmacodynamics (PD) of levofloxacin were investigated following administration of levofloxacin injection in healthy Chinese volunteers for optimizing dosing regimen.MethodsThe PK study included single-dose (750 mg/150 mL) and multiple-dose (750 mg/150 mL once daily for 7 days) phases. The concentration of levofloxacin in blood and urine was determined using HPLC method. Both non-compartmental and compartmental analyses were performed to estimate PK parameters. Taking fCmax/MIC ≥5 and fAUC24 h/MIC ≥30 as a target, the cumulative fraction of response (CFR) of levofloxacin 750 mg for treatment of community-acquired pneumonia (CAP) was calculated using Monte Carlo simulation. The probability of target attainment (PTA) of levofloxacin at various minimal inhibitory concentrations (MICs) was also evaluated.Results and discussionThe results of PK study showed that the Cmax and AUC0–∞ of levofloxacin were 14·94 μg/mL and 80·14 μg h/mL following single-dose infusion of levofloxacin. The half-life and average cumulative urine excretion ratio within 72 h post-dosing were 7·75 h and 86·95%, respectively. The mean Css,max, Css,min and AUC0–τ of levofloxacin at steady state following multiple doses were 13·31 μg/mL, 0·031 μg/mL and 103·7 μg h/mL, respectively. The accumulation coefficient was 1·22. PK/PD analysis revealed that the CFR value of levofloxacin 750-mg regimen against Streptococcus pneumoniae was 96·2% and 95·4%, respectively, in terms of fCmax/MIC and fAUC/MIC targets.What is new and conclusionThe regimen of 750-mg levofloxacin once daily provides a satisfactory PK/PD profile against the main pathogenic bacteria of CAP, which implies promising clinical and bacteriological efficacy for patients with CAP. A large-scale clinical study is warranted to confirm these results.

A Randomized, Double-Blind, Placebo-Controlled Study of an Oral, Extended-Release Formulation of Phentermine/Topiramate for the Treatment of Obstructive Sleep Apnea in Obese Adults

To evaluate safety and efficacy of phentermine 15 mg plus extended-release topiramate 92 mg for treatment of moderate to severe obstructive sleep apnea (OSA) in obese adults. This phase 2, randomized, double-blind, placebo-controlled study included 2-week screening and 28-week treatment periods. Overnight polysomnography was performed at baseline, Week 8, and Week 28. Single-center study conducted from August 2008 to September 2009. Forty-five subjects with moderate to severe OSA not receiving positive airway pressure (PAP) treatment with body mass index of 30-40 kg/m(2). Subjects were randomized to receive placebo (n = 23) or phentermine 15 mg plus extended-release topiramate 92 mg (n = 22). Both groups received lifestyle-modification counseling. Primary endpoint, change in apnea-hypopnea index (AHI), significantly favored phentermine 15 mg plus extended-release topiramate 92 mg (-31.5 events/h, 95% CI: -40.0, -22.9) over placebo (-16.6 events/h, 95% CI: -25.0, -8.2) at Week 28 (P =0.0084). At Week 28, there was a 10.2% (95% CI: -12.7, -7.6; 10.8 kg, 95% CI: -13.5, -8.0) mean decrease in weight in the phentermine 15 mg plus extended-release topiramate 92 mg group compared with 4.3% (95% CI: -6.6, -2.0; 4.7 kg, 95% CI: -7.2, -2.2) in the placebo group (P = 0.0006) and a positive, significant (P = 0.0003) correlation between percent change in weight and change in AHI. Significant improvements in overnight oxygen saturation and reduction in blood pressure compared with placebo were observed. Phentermine 15 mg plus extended-release topiramate 92 mg was well tolerated with low adverse event rates. Phentermine 15 mg plus extended-release topiramate 92 mg induced significant weight reductions and concomitant improvements in OSA and related symptoms vs placebo. This suggests weight loss mediated by phentermine 15 mg plus extended-release topiramate 92 mg may be useful in treatment of moderate to severe OSA in obese subjects unable or unwilling to comply with PAP treatment.

Efficacy of S-Pantoprazole 20 mg Compared with Pantoprazole 40 mg in the Treatment of Reflux Esophagitis: A Randomized, Double-Blind Comparative Trial

S-isomer (S) pantoprazole is known to be more effective and less dependent on cytochrome 2C19 than R-isomer (R)-pantoprazole. The purpose of this study was to compare the efficacy and safety of S-pantoprazole 20 mg versus pantoprazole 40 mg for treatment of reflux esophagitis. This multi-center, double-blind, randomized trial enrolled patients with endoscopically documented reflux esophagitis. Patients were assigned to receive either 20 mg S-pantoprazole or 40 mg pantoprazole once daily for 4 weeks. Endoscopy and symptoms were assessed after 4 weeks of treatment. In patients whose reflux esophagitis was not resolved at 4 weeks, treatment was extended to 8 weeks and symptoms were reassessed. Heartburn, chest pain, acid regurgitation, globus, and overall symptoms were rated. The primary efficacy endpoint was healing of esophagitis, and secondary endpoints were symptomatic and endoscopic improvement. Sixty-seven patients in the S-pantoprazole group (52 male, mean age 51 years) and 62 in the pantoprazole group (61 male, mean age 50 years) were analyzed per protocol. The healing rate of reflux esophagitis was 85 % at 4 weeks and 94 % at 8 weeks in the S-pantoprazole group, which did not differ from those in the pantoprazole group (84 and 97 %, respectively). After treatment, individual and overall gastroesophageal reflux disease (GERD) symptoms and esophagitis improved compared with baseline inflammation in both groups. Intergroup differences in symptoms and endoscopic healing were not significant. The efficacy and safety of 20 mg S-pantoprazole were comparable to those of 40 mg pantoprazole for treatment of reflux esophagitis and symptomatic improvement of GERD.

PSY31 Economic Evaluation of Eletriptan 40mg for Migraine Therapy in Korea

Migraine is a common central nervous system disorder. The burden of migraine is substantial due to its high prevalence and prominent temporary disability. This study investigates the application of cost-effectiveness analysis, from the Korean health care system perspective, for the comparison of eletriptan 40mg and sumatriptan 50mg in the acute treatment of migraine attack. A decision tree model was developed to estimate migraine treatment cost and efficacy. Clinical data was derived from a clinical trial comparing oral eletriptan to oral sumatriptan (G. Sandrini, 2002). Efficacy measures consisted of “pain-free at 2 hours (PF2)” and “sustained pain free for 2-24 hours (SPF)”. Drug costs for initial dosing, second dosing for relapse, physician visit cost, and emergency visit cost were taken into account. Citing 2008 HIRA report, physician visit cost and emergency visit cost were calculated. All costs converted into 2011 Korean Won (KRW). The time horizon was a single migraine attack. In the base-case analysis, assuming the eletriptan 40mg drug cost (4,775 KRW) is 20% higher than sumatriptan 50mg drug cost (3,979 KRW), the average cost-effectiveness ratio (ACER) were 23,702 KRW and 36,239 KRW (per attack at which PF2 is achieved) for eletriptan 40mg and sumatriptan 50mg, respectively. Also, ACER for SPF per attack is achieved was 26,054 KRW and 40,837 KRW for eletriptan 40mg and sumatriptan 50mg, respectively. Although eletriptan 40mg is more costly than sumatriptan 50mg, because of eletriptan 40mg's superior efficacy, the ACER of eletriptan 40mg was lower than sumatriptan 50mg in the treatment of migraine attack, with respect to PF2 and SPF aspects. Eletriptan 40mg has a potentially important role to play in the cost-effective management of migraine.

Long‐Term, Open‐Label Safety Study of Oral Almotriptan 12.5 mg for the Acute Treatment of Migraine in Adolescents

This study evaluated the long-term safety of oral almotriptan 12.5 mg for the treatment of multiple migraine episodes in adolescents over a 12-month period. Efficacy outcomes were assessed as a secondary objective. Adolescent migraineurs aged 12-17 years were enrolled in this 12-month, open-label study (Study ID CR002827). Patients were instructed to record their assessments on paper headache records whenever they experienced a migraine headache that they treated with study medication. Safety was assessed descriptively and assessments included adverse event (AE) recording, change in laboratory values, vital signs, and electrocardiogram parameters. Efficacy outcomes were assessed descriptively and outcomes included rates for 2- and 24-hour pain relief and sustained pain relief, 2- and 24-hour pain-free and sustained pain-free, and presence of migraine-associated symptoms of photophobia, phonophobia, nausea and vomiting. Overall, 67.1% of patients reported >or=1 AE over the course of the trial, 7.6% had an AE judged by the study investigator to be related to treatment with almotriptan, 2.4% discontinued because of an AE, and 1.9% reported serious AEs. The most commonly reported treatment-related AEs (occurring in >or=1% of patients) were nausea (1.4%) and somnolence (1.4%). Pain relief responses for treated migraines of moderate or severe intensity at baseline were 61.7% and 68.6%, at 2 and 24 hours, respectively; the sustained pain relief rate was 55.5%. Pain-free responses were reported for 40.5% of all treated migraines at 2 hours and 65.9% of treated migraines at 24 hours; the sustained pain-free rate was 38.4%. The proportion of migraines that achieved the pain relief, sustained pain relief, pain-free and sustained pain-free endpoints were similar in the 12- to 14-year and 15- to 17-year age groups. Treating with almotriptan 12.5 mg when headache pain was mild was associated with higher rates of pain relief and pain-free at 2 and 24 hours, and sustained pain relief and sustained pain-free, compared with treatment initiated when pain was severe. Almotriptan 12.5 mg was well tolerated in this adolescent population over a 12-month period. No unexpected safety or tolerability concerns were revealed over the course of this study. The results are consistent with almotriptan 12.5 mg being effective for the acute treatment of pain and symptoms associated with migraine in both younger and older adolescents.

P561 Efficacy and tolerance of metronidazole 750 mg and miconazole nitrate 200 mg in treatment of vaginitis

P561 Efficacy and tolerance of metronidazole 750 mg and miconazole nitrate 200 mg in treatment of vaginitis

Intérêt des injections intravitréennes de ranibizumab dans le traitement des néovascularisations choroïdiennes péripapillaires étendues

To evaluate the safety and explore the efficacy of intravitreal injection of ranibizumab 0.5mg in treatment of large peripapillary choroidal neovascularization. This single-center, prospective, interventional, noncomparative, nonrandomized clinical case series study included six consecutive patients with large or recurrent peripapillary choroidal neovascularization. Ranibizumab 0.5mg was administered at baseline, and then monthly following the development of hemorrhage or subretinal fluid associated with visual symptoms. The response to treatment was assessed in terms of changes in lesion characteristics as measured by FA and change in visual acuity (VA). Six patients (seven eyes with peripapillary choroidal neovascularization) were enrolled. three of the seven eyes had choroidal neovascularization associated with angioid streaks, two had idiopathic neovascularization, and the last eye had peripapillary neovascular membrane associated with age-related macular degeneration. The median follow-up was 12 months (+/-3 months). At 1 year, the best-corrected visual acuity improved from +0.74 log Mar to +0.45 log Mar (p=0.0431), with resolution of intraretinal fluid. On average, four intravitreal injections of ranibizumab (0.5mg) were required during this year. Laser photocoagulation treatment, photodynamic therapy, or subretinal surgery are limited by the high recurrence rate, the difficulty in assessing the true extent of the lesion, and the difficulty in improving visual function. Intravitreal ranibizumab injections appeared to be a good therapeutic option for patients with peripapillary CNV in the short term. Long-term follow-up of these patients will aid in assessing the sustained effect of the drug.

게르마늄 처리 토양에서 미나리 생육 특성과 게르마늄 흡수

In order to obtain the basic information for agricultural utilization of Germanium(Ge), the growth characteristics and the germanium uptake by water celery were investigated at different concentration of germanium in soil. This experiment was carried out in the Wagner pot(1 ). Germanium concentrations in soil for water celery cultivation were maintained at 0.26, 25.0, 62.5, and 125.0 mg , respectively. The treatment of over Ge 25.0 mg in the soil led to germanium phytotoxicity such as reduction of plant height and fresh weight. The contents of germanium in water celery were increased with the increase of germanium concentration in the soil. When water celery was cultivated from soil maintained with Ge 25.0 and 62.5 mg , its germanium contents in plant were 89.9 and 371.6 mg , respectively. Then, the efficiency of germanium uptake of water celery in Ge 25.0 and 62.5 mg maintained plots was 1.7 and 2.4%, respectively. When water celery was cultivated from soil maintained with Ge 25.0, 62.5 and 125.0 mg , its content of amino acid was found to be 89.8, 198.4, and 318.2 mg , respectively. To investigate the effect of N fertilizer application in uptake of germanium by water celery, these were treated with nontreatment, 1.0, 1.5 and 2.0 times of N application based on soil testing for cultivation of water celery. However, the amount of the N fertilizer application did not affect the contents of germanium in the water celery. When water celery was cultivated from soil maintained with two kinds of inorganic and organic germanium 50 mg , respectively, the content of germanium were 24.2 mg in the Ge-132 treatment and 11.8 mg in the treatment.

Efficacy and Safety of Propiverine Hydrochloride 40mg in Treatment of Overactive Bladder : Prospective, Multicenter, Observational study

Efficacy and Safety of Propiverine Hydrochloride 40mg in Treatment of Overactive Bladder : Prospective, Multicenter, Observational study

Eszopiclone in Patients With Insomnia During Perimenopause and Early Postmenopause

To evaluate eszopiclone 3 mg for treatment of insomnia in perimenopausal and early postmenopausal women, as well as the impact of insomnia treatment on mood, menopause-related symptoms, and quality of life. This was a double-blind, placebo-controlled study with 410 women (aged 40-60; perimenopausal or early postmenopausal) who reported insomnia defined as sleep latency of at least 45 minutes and total sleep time less than or equal to 6 hours per night for at least 3 nights per week over the previous month. Patients were randomly assigned to eszopiclone 3 mg or placebo nightly for 4 weeks. Sleep data were collected once a day. Physician global assessments of menopause, menopause-specific questionnaire, Greene Climacteric Scale, the Montgomery Asberg Depression Rating Scale, and the Sheehan Disability Scale were collected at baseline and end of treatment. Patients receiving eszopiclone reported improvements in sleep induction, sleep maintenance, sleep duration, sleep quality, and next-day functioning relative to placebo (P<.05). Patients receiving eszopiclone reported fewer total awakenings and awakenings due to hot flushes (P<.05). Eszopiclone use led to greater improvement in Montgomery Asberg Depression Rating Scale scores (P<.05) and physician global assessments of menopause scores (P<.001); total Greene Climacteric Scale score and the vasomotor and psychological sub-scores (P<.05); vasomotor and physical domains of the menopause-specific questionnaire (P<.05); and family life/home domain of the Sheehan Disability Scale (P<.05). In this study, eszopiclone provided significant improvements in sleep and positively impacted mood, quality of life, and menopause-related symptoms in perimenopausal and early postmenopausal women with insomnia. ClinicalTrials.gov www.clinicaltrials.gov NCT00366093 I.