• Title/Summary/Keyword: Monotherapy

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Effects of lamotrigine on attention-deficit hyperactivity disorder in pediatric epilepsy patients

  • Han, Seung-A;Yang, Eu Jeen;Song, Mi-Kyoung;Kim, Sun Jun
    • Clinical and Experimental Pediatrics
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    • v.60 no.6
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    • pp.189-195
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    • 2017
  • Purpose: The purpose of this study was to investigate the effects of lamotrigine for the treatment of attention-deficit hyperactivity disorder (ADHD) symptoms in children with epilepsy. Methods: Pediatric patients newly diagnosed with epilepsy (n=90 [61 boys and 29 girls]; mean age, $9.1{\pm}3.4years$) were enrolled. All patients were evaluated with the Korean ADHD rating scale (K-ARS)-IV before treatment with lamotrigine and after doses had been administered. The mean interval of ADHD testing was approximately 12.3 months. The initial dosage of lamotrigine was 1 mg/kg/day (maximum 25 mg/day for the first 2 weeks), and increased by 1 mg/kg every 2 weeks until titrated up to 7 mg/kg/day (or maximum 200 mg/day). Results: The mean ADHD test score of the 90 subjects was $17.0{\pm}1.8$ at baseline. It was slightly reduced to $15.6{\pm}1.7$ after lamotrigine monotherapy (P>0.01). Prior to treatment, a total of 31 patients (34.4%) met the diagnostic criteria for ADHD according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, Of these 31 patients, 27 (87.1%) had significantly improved ADHD scores with lamotrigine monotherapy ($28.0{\pm}1.6$ reduced to $18.1{\pm}2.6$, P<0.001). Among these 27 patients, 25 (92.6%) showed normalized electroencephalogram (EEG) and 26 (96.3%) achieved total freedom from seizures within 12 months of the initiation of lamotrigine monotherapy. Conclusion: The results from our study show that lamotrigine had a positive effect in pediatric epilepsy patients by reducing ADHD symptoms, preventing seizures, and normalizing EEG. However, further research is required to determine whether lamotrigine is efficacious against ADHD symptoms independent of its effects on epileptic seizures.

Prophylactic Therapy Response in Children with Abdominal Migraine: A Single Centre Experience in Oman

  • Al Lawati, Tawfiq Taki;Saadah, Omar I.;al Riyami, Ruwaina;al Yarubi, Zuwaina
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.25 no.2
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    • pp.121-128
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    • 2022
  • Purpose: Abdominal migraine (AM) is a very common functional gastrointestinal disorder in children. This study reports the clinical features and response of AM to prophylactic treatment in children. Methods: This retrospective study was conducted between January 2010 and December 2019 at the Royal Hospital in the Sultanate of Oman. This study included children aged ≤ 13 years with a diagnosis of AM based on the Rome IV criteria for functional diagnoses. Clinical, demographic, and treatment data were collected. Results: Seventy-four children were identified, of which 43 were eligible for inclusion in this study. The median age at the onset of symptoms was 7 years (range, 2-12 years). The most frequent symptoms were headache (81.4%), nausea (79.1%), and vomiting (72.1%). Of the total cohort, 46.5%, 23.3%, and 6.9% received riboflavin, pizotifen, and propranolol monotherapy, respectively. Combination therapy was also used; 16.3% of children received pizotifen and propranolol, 4.7% received riboflavin and pizotifen, and 2.3% received riboflavin and propranolol. Patients treated with propranolol monotherapy showed 100% clinical improvement and those treated with riboflavin or pizotifen monotherapy showed 90% clinical improvement. Response to combination therapy with pizotifen and propranolol was 71.4%, and with riboflavin and pizotifen was 100%. In addition, treatment response was significantly associated with the presence of vomiting (p=0.039). Conclusion: We found a favorable response to various modalities and combination treatments with riboflavin, pizotifen, and propranolol in children with AM. In addition, the presence of vomiting may predict treatment response.

Efficacy and Toxicity of Anti-VEGF Agents in Patients with Castration-Resistant Prostate Cancer: a Meta-analysis of Prospective Clinical Studies

  • Qi, Wei-Xiang;Fu, Shen;Zhang, Qing;Guo, Xiao-Mao
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.19
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    • pp.8177-8182
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    • 2014
  • Background: Blocking angiogenesis by targeting vascular endothelial growth factor (VEGF) signaling pathway to inhibit tumor growth has proven to be successful in treating a variety of different metastatic tumor types, including kidney, colon, ovarian, and lung cancers, but its role in castration-resistant prostate cancer (CRPC) is still unknown. We here aimed to determine the efficacy and toxicities of anti-VEGF agents in patients with CRPC. Materials and Methods: The databases of PubMed, Web of Science and abstracts presented at the American Society of Clinical Oncology up to March 31, 2014 were searched for relevant articles. Pooled estimates of the objective response rate (ORR) and prostate-specific antigen (PSA) response rate (decline ${\geq}50%$) were calculated using the Comprehensive Meta-Analysis (version 2.2.064) software. Median weighted progression-free survival (PFS) and overall survival (OS) time for anti-VEGF monotherapy and anti-VEGF-based doublets were compared by two-sided Student's t test. Results: A total of 3,841 patients from 19 prospective studies (4 randomized controlled trials and 15 prospective nonrandomized cohort studies) were included for analysis. The pooled ORR was 12.4% with a higher response rate of 26.4% (95%CI, 13.6-44.9%) for anti-VEGF-based combinations vs. 6.7% (95%CI, 3.5-12.7%) for anti-VEGF alone (p=0.004). Similarly, the pooled PSA response rate was 32.4% with a higher PSA response rate of 52.8% (95%CI: 40.2-65.1%) for anti-VEGF-based combinations vs. 7.3% (95%CI, 3.6-14.2%) for anti-VEGF alone (p<0.001). Median PFS and OS were 6.9 and 22.1 months with weighted median PFS of 5.6 vs. 6.9 months (p<0.001) and weighted median OS of 13.1 vs. 22.1 months (p<0.001) for anti-VEGF monotherapy vs. anti-VEGF-based doublets. Conclusions: With available evidence, this pooled analysis indicates that anti-VEGF monotherapy has a modest effect in patients with CRPC, and clinical benefits gained from anti-VEGF-based doublets appear greater than anti-VEGF monotherapy.

Comparison of Moxifloxacin Monotherapy versus Cephalosporin-Azithromycin Combination Therapies for the Treatment of Community Acquired Pneumonia (원외획득폐렴 환자 치료에서 Moxifloxacin 단독요법과 Cephalosporin-Azithromycin 병용요법의 비교)

  • Cheong, Eun-Jin;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.2
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    • pp.75-81
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    • 2005
  • Community acquired pneumonia (CAP) remains a prevalent and potentially life threatening illness. American Thoracic Society and Infectious Disease Society America recommend combination therapies with ${\beta}-lactam$ plus a macrolide or a fluoroquinolone monotherapy for the empirical treatment of CAP. The aim of this study was to compare moxifloxacin monotherapy with cephalosporin plus azithromycin combination therapies. From January 2004 to March 2005, 18 patients in the moxifloxacin group(MG) and 21 patients in the cefuroxime or ceftriaxone plus azithromycin group(CAG) with CAP were retrospectively reviewed with regard to clinical, laboratory and microbiological data. Each patient was stratified into mild (risk class I-II), moderate (risk class III) and severe (risk class VI, V) group according to and PSI (Pneumonia Severity Index) score. Each group was compared for microbiological eradication, clinical assessment, the length of hospital stay. As results, Total 39 patients with CAP were reviewed. The appropriateness of admission was 83.3% in MC vs. 76.2% in CAC. The mean length of the hospital day was for 8.31 days vs. 7.39 days, days switching parenteral to oral antibiotics in 5.19 days vs. 5.28 days, clinical improvement in 2.43 days vs. 2.61 days in MG vs. CAC. Radiological improvement required 3.75 days vs 3.63 days in MG vs. CAG and bacteriological eradication rate at discharge was the same in the both groups. Mortality rate was 11.1% (2 of 18) vs 14.3% (3 of 21) in MG vs. CAG (p=0.77). Drug cost of the mean 5 hospital days requiring parenteral antibiotics was the most inexpensive in moxifloxacin group for the 147,045 won, and ceftriaxone 1g-azithromycin group for the 170,285 won, cefuroxime bid-azithromycin group for the 207,800 won, ceftriaxone 2g-azithromycin group far the 220,570 won, cefuroxime tid-azithromycin group for the 251,700 won. There was no significant statistical difference in clinical, bacterial, radiological cure and hospital days, and switch to oral days. In conclusion, that i.v. moxifloxacin monotherapy was as effective as azithromycin plus cefuroxime or ceftriaxone combination therapies fur the treatment of CAP. In drug cost analysis, moxifloxacin is less expensive than CAG.

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Risperidone Monotherapy in Children and Adolescents with Autism Spectrum Disorders : A Naturalistic Study

  • Won, Eun-Kyung;Park, Jin-Park;Lee, Young-Ryul;Nam, Yoon-Young;Min, He-Ji;Kim, Yeni
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.26 no.4
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    • pp.273-278
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    • 2015
  • Objectives : We retrospectively investigated the efficacy and tolerability of risperidone monotherapy in subjects with autism spectrum disorder (ASD). In addition, we did mixed effect model analysis of the effects of risperidone in patients with ASDs naturalistically treated in a routine clinical setting to determine whether the clinical effects were maintained and the side effects were tolerable. Methods : This retrospective study assessed children and adolescents with ASD, who were on risperidone monotherapy from July 2010 to July 2011 at the Child and Adolescent ASD Clinic at Seoul National Hospital. Outcome measures included the Clinical Global Impression-Severity of Illness (CGI-S) and the CGI-Improvement (CGI-I) scales along with other clinical indices: dosage, target symptoms, and side effects. Results : The mean dose of risperidone in 47 children and adolescents with ASD (40 males, 7 females; age range 5-19 years) who were on risperidone monotherapy was $1.6{\pm}0.8mg/day$, and the mean duration of the treatment period was $20.2{\pm}17.3months$. Aggressive behavior, stereotypic behavior, irritability, and self-injurious behavior were the most frequent target symptoms of risperidone. The most common side effects were weight gain followed by somnolence and extrapyramidal symptoms. In a mixed effects model analysis of CGI-I scores, the mean CGI-I score at the 1 month follow-up was significantly different from the mean CGI-I score of the 3-month follow-up (p=.046), and the CGI-I scores were equally maintained over 3 to 48 months [F(6, 28.9)=4.393, p=.003]. Of the 47 patients, 33 patients (70.2%) were identified as the response group, showing an end point CGI-I rating of 3 or under and having continued risperidone treatment for at least 6 months. The baseline CGI-S score showed significant association with clinical response to risperidone (p=.005), the mean baseline CGI-S was higher in the response group compared to the non-response group. Conclusion : In this study, clinical improvement of risperidone stabilized around 3 months and was equally maintained up to 48 months with tolerable side effects, supporting maintenance of risperidone treatment in children and adolescents with ASDs.

Systematic Review : Comparative Safety and Efficacy of Mono- and Combination Therapy of Anti-hypertensive Agents Acting on the Renin-Angiotensin System (레닌-안지오텐신계에 작용하는 항고혈압 약제의 단독요법과 병용요법의 안전성 및 유효성에 대한 체계적 문헌고찰)

  • Choi, Kyung-Eob;Kim, Hyun-Kyung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.364-375
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    • 2011
  • Given that single blockade with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) can achieve only partial and undurable suppression of the Renin Angiotensin System (RAS), it has been hypothesized that dual blockage would be more beneficial in the management of blood pressure (BP) reduction and prevention of progressive chronic kidney disease (CKD) than either agent alone. Thus, it has been suggested that the combination of an ACEI and an ARB might provide renal benefits to hypertensive patients over and above BP reduction. However, this might also expose patients to additive or synergistic side effects. We attempted to conduct a systematic review to evaluate the benefits and harms of combination therapy in hypertensive patients with or without kidney diseases. MEDLINE and KoreaMed were searched for relevant randomized clinical trials in adult hypertensive patients with or without diabetes (restricted to 1997, limited to trials published in English). Results were summarized using the random-effects model, and between-studies heterogeneity was estimated with $I^2$. A final analysis of ten trials (23,928 patients) revealed that the combination of an ACEI and an ARB reduced blood pressure (SBP/DBP) by 3.95/2.02 mmHg (95% confidence interval [CI], -4.38 to -3.53/-2.33 to -1.71) compared with ACEI monotherapy, and 2.83/2.64 mmHg (95% CI, -3.25 to -2.41/-4.95 to -0.33) compared with ARB monotherapy. Eight trials (391 patients) demonstrated a significant reduction in 24h-proteinuria (weighted mean difference, 0.16 g/day, 95% CI, -0.26-0.05), but they did not translate into an improvement in GFR. Tests for heterogeneity showed no difference in effect among the studies. The combination therapy reduced proteinuria by 30% (95% CI, 23% to 37%) and 39% (95% CI, 31% to 48%) compared with ACEI monotherapy and ARB monotherapy, respectively. However, in patients who had proteinuria more than 0.5 g/day, the combination therapy failed to show significant reduction in urinary protein excretion. The current cumulative evidence suggests that diabetic patients with proteinuria on dual RAS blockade have an increase risk of adverse events such as hyperkalemia, hypotension, and so on, compared with ACEI or ARB alone. It is, therefore, proposed that the combination therapy should not be routinely used for the treatment of hypertension with or without compelling indications.

The Comparative Efficacy of Colistin Monotherapy and Combination Therapy Based on in vitro Antimicrobial Synergy in Ventilator-associated Pneumonia Caused by Multi-drug Resistant Acinetobacter baumannii (다제내성 Acinetobacter baumannii 에 의한 인공호흡기연관 페렴에서 Colistin 단독요법과 시험관 내 상승작용에 근거한 병합요법간의 효능 비교)

  • Jang, Hang Jea;Kim, Mi-Na;Lee, Kwangha;Hong, Sang-Bum;Lim, Chae-Man;Koh, Younsuck
    • Tuberculosis and Respiratory Diseases
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    • v.67 no.3
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    • pp.212-220
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    • 2009
  • Background: Ventilator-associated pneumonia caused by multi-drug resistant Acinetobacter baumannii has been increasing and growing as a threat in intensive care units. Limited therapeutic options have forced clinicians to choose colistin with or without combination of other antibiotics. We tried to compare the effectiveness between colistin monotherapy and combination therapy based on in vitro synergistic tests. Methods: From January 2006 to December 2007 in medical ICU of a tertiary care hospital in Korea, We reviewed the medical records of patients treated with intravenous colistin due to ventilator-associated pneumonia caused by multi-drug resistant Acinetobacter baumannii. Results: A total of 41 patients were analyzed. 22 patients had been treated with colistin monotherapy and 19 patients with colistin and combination antibiotics that were found to have in vitro synergistic effects. Baseline characteristics were similar in both groups but the mean duration of colistin administration was significantly longer in the combination group (19.1${\pm}$11.2 days vs. 12.3${\pm}$6.8 days, p=0.042). There were no significant differences in outcome variables between the two groups. Conclusion: Combination treatment based on the in vitro antimicrobial synergy test did not show better outcomes compared with colistin monotherapy in VAP caused by multi-drug resistant A. baumannii.

Korean Medication Algorithm Project for Bipolar Disorder 2018 (KMAP-BP 2018): Fourth Revision

  • Woo, Young Sup;Bahk, Won-Myong;Lee, Jung Goo;Jeong, Jong-Hyun;Kim, Moon-Doo;Sohn, InKi;Shim, Se-Hoon;Jon, Duk-In;Seo, Jeong Seok;Min, Kyung Joon;Kim, Won;Song, Hoo-Rim;Yoon, Bo-Hyun
    • Clinical Psychopharmacology and Neuroscience
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    • v.16 no.4
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    • pp.434-448
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    • 2018
  • Objective: The Korean Medication Algorithm Project for Bipolar Disorder (KMAP-BP) was first published in 2002 through an expert consensus of opinion, and updated in 2006, 2010, and 2014. This study constitutes the fourth revision of the KMAP-BP. Methods: A 50-item questionnaire was used to obtain the consensus of experts regarding pharmacological treatment strategies for various phases of adult bipolar disorder and six items for pediatric bipolar disorder. The review committee included 84 Korean psychiatrists and 43 child and adolescent psychiatry experts. Results: The preferred first-step strategies for acute mania were the combination of a mood stabilizer (MS) and an atypical antipsychotic (AAP), MS monotherapy, and AAP monotherapy. A combination of a MS and an AAP, and AAP monotherapy were preferred for psychotic mania. The first-step strategies for mild to moderate bipolar depression were monotherapy with MS, AAP, or lamotrigine (LMT), and the combination of a MS and an AAP or LMT, or a combination of an AAP and LMT. The combination of two among a MS, AAP, and LMT were preferred for non-psychotic severe depression. A combination of a MS and an AAP or the combination of an AAP with an antidepressant or LMT were the first-line options for psychotic severe depression. Conclusion: The recommendations of the KMAP-BP 2018 have changed from the previous version by reflecting recent developments in pharmacotherapy for bipolar disorder. KMAP-BP 2018 provides clinicians with a wealth of information regarding appropriate strategies for treating patients with bipolar disorder.

A case of Advanced Gastric cancer patient treated by Korean Medicine monotherapy

  • Kim, Sulki;Son, Changgue;Choi, Inwoo;Park, Sojung
    • The Journal of Korean Medicine
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    • v.40 no.4
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    • pp.91-100
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    • 2019
  • Objectives: The present study reports case of an advanced gastric cancer patient who did not receive resection and was treated with Korean Medicine (KM) monotherapy. Methods: A 59-year-old female patient diagnosed with advanced gastric cancer visited the Dunsan Korean medicine Hospital of Daejeon University on April 15, 2018 for the Korean medicine treatment. The patient was treated with KM for approximately 1 year, from May, 2018 to May, 2019. Computed tomography (CT) was used to follow-up of the tumor site. Laboratory analysis and National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 5.0 were used to evaluate the safety of our treatment. Results: The patient's quality of life (QOL) and related symptoms improved during the treatment. Conclusion: This study suggests that KM may help to improve QOL of advanced gastric cancer patients. This is a valuable report that shows the natural history of Korean gastric cancer invasion to deeper layers over time.

Economic Evaluation of Ramosetron in Male Patients with Diarrhea-predominant Irritable Bowel Syndrome in Korea (설사형 과민성 장 증후군 남성 환자에게 사용되는 ramosetron 의 경제성 평가)

  • Sohn, Hyun-Soon;Lee, Tae-Jin;Kim, Sun
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.268-277
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    • 2010
  • This study was conducted to analyze the cost-utility of ramosetron monotherapy, trimebutine monotherapy and trimebutine+loperamide combination therapy in male diarrhea-predominant patients with irritable bowel syndrome (IBS) in Korean healthcare setting. We constructed a decision-analytical model to estimate both total costs for each state of health and outcomes such as IBS-symptoms improvement for 3 and 6 months time horizon. Base analysis found that for ramosetron treatment with the price of KW910 for 5 ${\mu}g$ tablet, incremental cost effectiveness ratios (ICERs, cost per quality-adjusted life day) were KW85,000 and KW62,000 for 3 months and 6 months, respectively, compared with trimebutine. But ramosetron was a dominant strategy when compared with trimebutine+loperamide for both 3 months and 6 months. Sensitivity analyses showed robust results for drug acquisition costs till ramosetron price of KW950/tablet. In conclusion, ramosetron was a cost-effective regimen compared with trimebutine or trimebutine+loperamide from the societal perspective.