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1.
Article in Chinese | WPRIM | ID: wpr-880097

ABSTRACT

OBJECTIVE@#To evaluate the clinical efficacy and safety of domestic imatinib (made in China) in patients with newly diagnosed chronic myeloid leukemia chronic phase(CML-CP).@*METHODS@#Fifty-seven newly diagnosed CML-CP patients who did not receive any other anti-CML treatment were treated by domestic imatinib 400 mg once a day. The hematological, cytogenetic and molecular reactions and safety were observed and evaluated after 3, 6 and 12 months of treatment.@*RESULTS@#Fifty-six patients were treated for ≥3 and 6 months, among which 50 patients were treated for ≥12 months. After 3 months of treatment, 49 patients underwent hematological examination, 47 patients (95.9%) achieved complete hematological response (CHR), 49 patients underwent cytogenetic examination, 39 patients (79.6%) achieved major cytogenetic response (MCyR), and 12 patients (24.5%) achieved complete cytogenetic response (CCyR). 49 patients underwent the level of BCR-ABL test, including 41 patients (83.7%) with BCR-ABL@*CONCLUSION@#In the real world, Domestics imatinib mesylate is effective and safe in the treatment of newly diagnosed CML-CP patients, but long-term follow-up data are still necessary to verify its long-term efficacy.


Subject(s)
Antineoplastic Agents/therapeutic use , Benzamides/therapeutic use , China , Fusion Proteins, bcr-abl/genetics , Humans , Imatinib Mesylate/therapeutic use , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy , Piperazines , Pyrimidines/therapeutic use , Treatment Outcome
3.
Yonsei Medical Journal ; : 928-935, 2016.
Article in English | WPRIM | ID: wpr-63330

ABSTRACT

PURPOSE: Roflumilast is the only oral phosphodiesterase 4 inhibitor approved to treat chronic obstructive pulmonary disease (COPD) patients [post-bronchodilator forced expiratory volume in 1 second (FEV1) <50% predicted] with chronic bronchitis and a history of frequent exacerbations. This study evaluated the efficacy and safety of roflumilast in Korean patients with COPD and compared the efficacy based on the severity of airflow limitation. MATERIALS AND METHODS: A post-hoc subgroup analysis was performed in Korean COPD patients participating in JADE, a 12-week, double-blinded, placebo-controlled, parallel-group, phase III trial in Asia. The primary efficacy endpoint was the mean [least-squares mean adjusted for covariates (LSMean)] change in post-bronchodilator FEV1 from baseline to each post-randomization visit. Safety endpoints included adverse events (AEs) and changes in laboratory values, vital signs, and electrocardiograms. RESULTS: A total of 260 Korean COPD patients were recruited, of which 207 were randomized to roflumilast (n=102) or placebo (n=105) treatment. After 12 weeks, LSMean post-bronchodilator FEV1 increased by 43 mL for patients receiving roflumilast and decreased by 60 mL for those taking placebo. Adverse events were more common in the roflumilast group than in the placebo group; however, the types and frequency of AEs were comparable to those reported in previous studies. CONCLUSION: Roflumilast significantly improved lung function with a tolerable safety profile in Korean COPD patients irrespective of the severity of airflow limitation.


Subject(s)
Aged , Aminopyridines/therapeutic use , Asian Continental Ancestry Group , Benzamides/therapeutic use , Cyclopropanes/therapeutic use , Double-Blind Method , Female , Humans , Male , Middle Aged , Phosphodiesterase 4 Inhibitors/therapeutic use , Pulmonary Disease, Chronic Obstructive/drug therapy , Republic of Korea , Respiratory Function Tests , Treatment Outcome
4.
Article in English | IMSEAR | ID: sea-157697

ABSTRACT

Prokinetics are commonly used for Functional Dyspepsia (FD) and GastroEsophageal Reflux Disease (GERD). Aims and Objectives: To evaluate the safety and efficacy of cinitapride Extended-Release (ER) tablets versus conventional cinitapride Immediate-Release (IR) tablets for the treatment of FD and GERD. Materials and Methods: Patients with FD and GERD received either cinitapride ER 3 mg tablets OD or cinitapride IR 1 mg tablets TID for 4 weeks in this randomized, multicentre study. Change in the mean intensity score of gastrointestinal (GI) symptoms (overall and individual) at the end of the study and at each weekly follow up visit as compared to baseline, patients with complete resolution of GI symptoms, patients with > 50% reduction from baseline in overall intensity score, rescue medication use and overall efficacy were recorded. The safety variables were reported adverse events (AEs), laboratory parameters, electrocardiogram, and overall tolerability. Unpaired t test, chi square test or Fisher’s exact test were used for analysis. p < 0.05 was considered significant. Results: Total 218 patients were enrolled Cinitapride ER tablets were non-inferior (non-inferiority margin -2.5) to cinitapride IR tablets for the change in the mean overall GI symptom intensity score at the end of the study as compared to the baseline (treatment difference - 0.2 (95% CI: -2.2, 1.7)); also, no significant difference was found for other efficacy variables (p > 0.05). Eight AEs of mild-to-moderate intensity were reported. There was also no difference in the overall tolerability between the study groups (p = 0.875). Conclusions : Both the study treatments were comparable in terms of safety and efficacy for the treatment of FD and GERD.


Subject(s)
Adult , Benzamides/administration & dosage , Benzamides/analogs & derivatives , Benzamides/pharmacokinetics , Benzamides/therapeutic use , Delayed-Action Preparations , Dosage Forms , Dyspepsia/drug therapy , Female , Gastroesophageal Reflux/drug therapy , Humans , Male , Middle Aged , Randomized Controlled Trials as Topic , Solubility , Tablets
5.
Clinics ; 69(11): 758-762, 11/2014. tab, graf
Article in English | LILACS | ID: lil-731105

ABSTRACT

OBJECTIVES: Despite its rising popularity, reports on the use of preoperative imatinib mesylate (IM) in patients with advanced gastrointestinal stromal tumor (GIST) are limited. This study aims to explore the clinical efficacy of preoperative IM in patients with primarily unresectable or metastatic/recurrent GIST. METHODS: Between September 2009 and February 2014, patients with primarily unresectable or metastatic/recurrent GIST treated by a single medical team were recruited and considered for preoperative IM therapy. Re-examination was conducted regularly and abdominal enhanced CT data, blood biochemistry and responses to IM were recorded. RESULTS: A total of 18 patients were enrolled, including 13 with a primary tumor (7 stomach, 3 small bowel, 2 rectal and 1 pelvic tumor) and 5 with recurrent or metastatic GIST (2 with liver metastasis, 2 with anastomotic recurrence and 1 with pelvic GIST). The median follow-up time was 9.5 months (range of 3-63). The median tumor sizes before and after initiation of IM treatment were 9.1 cm and 6.0 cm (p = 0.003) based on the CT findings, respectively. All patients showed a decrease in tumor burden and the median tumor size reduction was 35%. Sixteen of the 18 patients showed a partial response to IM and two possessed stable disease. Nine of the 18 patients (50%) underwent surgical resection of primary or metastatic/recurrent tumors, with a median of 7 months of IM therapy. One case each of multivisceral resection and tumor recurrence were noted. CONCLUSIONS: IM as a preoperative therapy is feasible and safe for unresectable or metastatic/recurrent GIST that can effectively decrease tumor size, facilitating resection. .


Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Antineoplastic Agents/therapeutic use , Benzamides/therapeutic use , Gastrointestinal Neoplasms/drug therapy , Gastrointestinal Stromal Tumors/drug therapy , Neoplasm Recurrence, Local/drug therapy , Piperazines/therapeutic use , Pyrimidines/therapeutic use , Gastrointestinal Neoplasms/pathology , Gastrointestinal Neoplasms/surgery , Gastrointestinal Stromal Tumors/pathology , Gastrointestinal Stromal Tumors/secondary , Gastrointestinal Stromal Tumors/surgery , Liver Neoplasms/secondary , Neoadjuvant Therapy , Neoplasm Metastasis/drug therapy , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/surgery , Preoperative Care , Preoperative Period , Reproducibility of Results , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , Tumor Burden
6.
Rev. méd. Chile ; 142(4): 516-520, abr. 2014. graf, tab
Article in Spanish | LILACS | ID: lil-716224

ABSTRACT

We report a 58 year-old-man without comorbid conditions, with a history of two months of weight loss, malaise and headache. His initial laboratory analysis showed leukocytosis of 16,100/mL with 65% eosinophils and an absolute eosinophil count of 10,465/mL. Both bone marrow biopsy and aspirate showed infiltration by mature appearing eosinophils. Treatment was started with hydroxyurea, associated with prednisone without satisfactory decrease in the eosinophil count. Polymerase chain reaction showed the presence of the gene fusion product FIP1L1/PDGFRA. Imatinib therapy was initiated, resulting in a rapid and progressive reduction in the absolute eosinophil count, with normalization at the second week of treatment. The incidence of the myeloproliferative variant causing hypereosinophilic syndrome is rare. However, the dramatic response to imatinib emphasizes the need to study the presence of the fusion product FIP1L1/PDGFRA in all patients with eosinophilia of unknown etiology.


Subject(s)
Humans , Male , Middle Aged , Antineoplastic Agents/therapeutic use , Benzamides/therapeutic use , Hypereosinophilic Syndrome/drug therapy , Piperazines/therapeutic use , Pyrimidines/therapeutic use , Treatment Outcome
7.
Indian J Cancer ; 2014 Jan-Mar; 51(1): 5-9
Article in English | IMSEAR | ID: sea-154271

ABSTRACT

INTRODUCTION: Imatinib is a bcr‑abl tyrosine kinase inhibitor which has revolutionized the treatment for chronic myeloid leukemia (CML). Even though there is much data on CML chronic phase, there is limited data on imatinib‑naïve advanced phase CML. MATERIALS AND METHODS: We retrospectively analysed 90 patients with advanced phase CML (accelerated phase [AP]: 51 and blast crisis [BC]: 39), patients who received imatinib as frontline therapy. RESULTS: The median age of presentation in CML‑AP and CML‑BC were 32 years (12‑61) and 39 years (8‑59), respectively. Imatinib at 600 mg/day was initiated within 2 weeks of diagnosis. Median time to complete hematological response in both CML‑AP and CML‑BC was 3 months (CML‑AP: 1‑9 months and CML‑BC: 1‑14 months). At 6 months 30 (59%) CML‑AP and 15 (38%) CML‑BC patients achieved major cytogenetic response (MCyR), of them 24 (47%) and 10 (25.6%) being the complete cytogenetic response, respectively. At a median follow‑up of 41 months, the median overall survival in CML‑AP was 61 months, but in CML‑BC it was 14 months. The median progression‑free survival and event‑free survival were 30 months and 23 months in CML‑AP and 14 and 12 months in CML‑BC, respectively. On univariate analysis, performance status (PS), spleen size, and MCyR predicted survival in AP, whereas in BC, platelet count, PS, and early MCyR were predictive. Non‑hematologic and hematologic adverse events were observed in 80% and 60% of patients, respectively. Dose was reduced in 10% of patients for grade IV toxicity and interrupted in 30% for grade III toxicity. CONCLUSION: Front‑line imatinib is an option in advanced phases of CML especially in CML‑AP in low‑resource countries, where stem cell transplantation and alternate TKIs are not available.


Subject(s)
Adolescent , Adult , Antineoplastic Agents/therapeutic use , Benzamides/therapeutic use , Blast Crisis/drug therapy , Blast Crisis/mortality , Blast Crisis/pathology , Child , Drug Resistance, Neoplasm/drug effects , Female , Follow-Up Studies , Humans , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/mortality , Leukemia, Myelogenous, Chronic, BCR-ABL Positive/pathology , Male , Middle Aged , Neoplasm Staging , Piperazines/therapeutic use , Prognosis , Pyrimidines/therapeutic use , Remission Induction , Retrospective Studies , Survival Rate , Young Adult
11.
Indian J Cancer ; 2013 Jan-Mar; 50(1): 31-40
Article in English | IMSEAR | ID: sea-147317

ABSTRACT

The availability of imatinib followed by other tyrosine kinase inhibitors (TKIs) has dramatically altered the outcome of gastrointestinal stromal tumor (GIST). Patients with advanced or poor risk disease can now expect survival measured in years instead of months. An experienced multi disciplinary team (MDT) will be able to personalize therapy to ensure maximum benefit. This review will provide the updated information and finer points regarding state of the art management of GIST with the use of imatinib and other TKIs.


Subject(s)
Antineoplastic Agents/therapeutic use , Benzamides/therapeutic use , Female , Gastrointestinal Neoplasms/drug therapy , Gastrointestinal Stromal Tumors/drug therapy , Humans , Precision Medicine , Male , Molecular Targeted Therapy , Patient Care Team , Piperazines/therapeutic use , Practice Guidelines as Topic , Protein Kinase Inhibitors/therapeutic use , Pyrimidines/therapeutic use , Treatment Outcome
13.
Arq. bras. cardiol ; 99(6): 1082-1091, dez. 2012. ilus, graf, tab
Article in Portuguese | LILACS | ID: lil-662371

ABSTRACT

FUNDAMENTO: O Imatinib é um inibidor do receptor tirosina-quinase que foi confirmada como exercendo um efeito inibidor sobre a atividade do receptor do PDGF, fator de crescimento plaquetário (PDGFRα e PDGFRβ). OBJETIVO: Investigar o efeito protetor do Imatinib na fibrose miocárdica em acetato de deoxicorticosterona (DOCA)/ratos com hipertensão induzida por sal. MÉTODOS: Sessenta ratos Sprague-Dawley machos, uninefrectomizados foram distribuídos em três grupos: ratos controles (grupo CON): grupo deoxicorticosterona (grupo DOCA); grupo deoxicorticosterona e Imatinib (grupo DOCA IMA). A Pressão Arterial Sistólica (PAS) foi medida quinzenalmente. Foi estudada a porção apical do ventrículo esquerdo. Foram empregados: coloração vermelho sirius, coloração de hematoxilina-eosina, imuno-histoquímica e ensaio de western blot. RESULTADOS: A PAS nos grupos DOCA e IMA+DOCA foi maior que no grupo CON nos dias 14 e 28. Os animais do grupo DOCA apresentaram fibrose intersticial e perivascular grave no dia 28, e as expressões de PI, PIII, tenascina-C e fibronectina foram significativamente maiores que nos grupos DOCA+IMA e CON. Quando comparados com o grupo CON, os grupos DOCA e DOCA+IMA apresentaram resposta inflamatória de tecido miocárdico e infiltração de monócitos/macrófagos de diferentes graus. As expressões proteicas do PDGF-A, PDGF-C e PDGFRα foram significativamente maiores nos grupos DOCA e DOCA+IMA que no grupo CON, mas a expressão proteica do p-PDGFRα no grupo DOCA+IMA foi menor que no DOCA. CONCLUSÃO: O Imatinib pode exercer efeitos inibitórios sobre a fibrose miocárdica em ratos com hipertensão induzida por DOCA/sal, os quais podem ser atribuídos à inibição da atividade do PDGFR-α.


BACKGROUND: Imatinib is a tyrosine kinase receptor inhibitor that has been confirmed to exert inhibitory effect on the platelet derived growth factor PDGF receptor (PDGFRα and PDGFRβ) activity. OBJECTIVE: To investigate the protective effect of imatinib on the myocardial fibrosis in deoxycorticosterone-acetate (DOCA)/salt induced hypertensive rats. METHODS: Sixty male uninephrectomized Sprague-Dawley rats were assigned to three groups: control rats (CON group); deoxycorticosterone group (DOCA group); deoxycorticosterone and imatinib group (DOCA+IMA group). Systolic blood pressure (SBP) was measured biweekly. The apical portion of the left ventricle was studied. Sirius-Red staining, Hematoxylin-Eosin staining, immunohistochemistry and Western blot assay were employed. RESULTS: SBP in the DOCA group and DOCA+IMA group was higher than that in the CON group on day 14 and 28. Animals in the DOCA group showed severe interstitial and perivascular fibrosis on day 28, and the expressions of PI, PIII, tenascin-C and fibronectin were significantly higher than those in the DOCA+IMA group and CON group. When compared with the CON group, myocardial tissue inflammatory response and monocyte/macrophage infiltration of different degrees were observed in the DOCA group and DOCA+IMA group. Protein expressions of PDGF-A, PDGF-C and PDGFRα were signiflcantly higher in the DOCA and DOCA+IMA groups than those in the CON group, but the p-PDGFRα protein expression in the DOCA+IMA group was lower than that in the DOCA group. CONCLUSION: Imatinib can exert inhibitory effects on myocardial fibrosis in DOCA/salt induced hypertensive rats, which may be attributed to the inhibition of PDGFR-α activity.


Subject(s)
Animals , Male , Rats , Benzamides/pharmacology , Endomyocardial Fibrosis/drug therapy , Piperazines/pharmacology , Protein Kinase Inhibitors/pharmacology , Pyrimidines/pharmacology , Receptor, Platelet-Derived Growth Factor alpha/antagonists & inhibitors , Blotting, Western , Benzamides/therapeutic use , Blood Pressure/drug effects , Desoxycorticosterone , Disease Models, Animal , Endomyocardial Fibrosis/pathology , Fibronectins/analysis , Fibronectins/metabolism , Fibrosis/drug therapy , Fibrosis/pathology , Hypertension/chemically induced , Hypertension/physiopathology , Nephrectomy/methods , Piperazines/therapeutic use , Protein Kinase Inhibitors/therapeutic use , Pyrimidines/therapeutic use , Rats, Sprague-Dawley , Receptor, Platelet-Derived Growth Factor alpha/metabolism , Receptor, Platelet-Derived Growth Factor beta/antagonists & inhibitors , Receptor, Platelet-Derived Growth Factor beta/metabolism , Treatment Outcome , Tenascin/analysis , Tenascin/metabolism
14.
Rev. gastroenterol. Perú ; 32(4): 394-399, oct.-dic. 2012. ilus, tab
Article in Spanish | LIPECS, LILACS, LIPECS | ID: lil-692408

ABSTRACT

Los tumores estromales gastrointestinales (GIST) son neoplasias mesenquimales que típicamente surgen a nivel del estómago, intestino delgado, colon, y otros sitios en la cavidad abdominal y su identificación se ha incrementado por mejoras en los criterios de detección. La mayor parte de los tumores GIST son causados por mutaciones activadoras en los genes de receptores transmembranares tirosina quinasa c-KIT y receptor alpha del factor de crecimiento derivado de plaquetas (PDGFRA). Las mutaciones causales de GIST se restringen solo a ciertas regiones del gen que corresponden a importantes zonas funcionales de c-KIT o PDGFRA. Se reporta que hasta 70% de casos de GIST se debe a mutaciones en el exón 11 del gen c-Kit que corresponde a la región yuxtamembrana del receptor. La región y el tipo de mutación determinan diferencialmente cómo se desarrolla la neoplasia, el pronóstico y su respuesta a inhibidores de las tirosina quinasas como el Imanatib. Por tal motivo, el genotipado de KIT y PDGFRA es importante para el diagnóstico y establecimiento de la sensibilidad a los inhibidores tirosina quinasa.


Gastrointestinal stromal tumors (GISTs) are mesenchymal neoplasms typically arising in the stomach, small intestine, colon, and other sites in the abdominal cavity and its identification has improved dramatically mainly due to better criteria in its detection. Most GISTs tumors harbor activating mutations in the tyrosine kinase receptor c-KIT or platelet derived growth factor receptor-alpha (PDGFRA). Those mutations are restricted to a few regions corresponding to important functional domains of c-KIT or PDGFRA. Upto 70% of cases are due to mutations in exon 11 of c-KIT corresponding to its juxtamembrane region of the receptor. The location and type of mutation will differentially determine the development of the disease, its prognosis and the response to inhibitors of tyrosine kinases as Imanatib. For this reason, genotyping c-KIT and PDGFRA is important for GIST diagnosis and assessment of sensitivity to tyrosine kinase inhibitors.


Subject(s)
Humans , Gastrointestinal Neoplasms/metabolism , Gastrointestinal Stromal Tumors/metabolism , Proto-Oncogene Proteins c-kit/metabolism , Receptor, Platelet-Derived Growth Factor alpha/metabolism , Biomarkers, Tumor/metabolism , Antineoplastic Agents/therapeutic use , Benzamides/therapeutic use , Drug Resistance, Neoplasm , Gastrointestinal Neoplasms/drug therapy , Gastrointestinal Neoplasms/genetics , Gastrointestinal Stromal Tumors/drug therapy , Gastrointestinal Stromal Tumors/genetics , Mutation , Piperazines/therapeutic use , Proto-Oncogene Proteins c-kit/genetics , Pyrimidines/therapeutic use , Receptor, Platelet-Derived Growth Factor alpha/genetics , Treatment Outcome , Biomarkers, Tumor/genetics
16.
Mem. Inst. Oswaldo Cruz ; 104(8): 1083-1090, Dec. 2009. ilus, tab
Article in English | LILACS | ID: lil-538167

ABSTRACT

Gap junction connexin-43 (Cx43) molecules are responsible for electrical impulse conduction in the heart and are affected by transforming growth factor-â (TGF-â). This cytokine increases during Trypanosoma cruzi infection, modulating fibrosis and the parasite cell cycle. We studied Cx43 expression in cardiomyocytes exposed or not to TGF-â T. cruzi, or SB-431542, an inhibitor of TGF-â receptor type I (ALK-5). Cx43 expression was also examined in hearts with dilated cardiopathy from chronic Chagas disease patients, in which TGF-â signalling had been shown previously to be highly activated. We demonstrated that TGF-â treatment induced disorganised gap junctions in non-infected cardiomyocytes, leading to a punctate, diffuse and non-uniform Cx43 staining. A similar pattern was detected in T. cruzi-infected cardiomyocytes concomitant with high TGF-â secretion. Both results were reversed if the cells were incubated with SB-431542. Similar tests were performed using human chronic chagasic patients and we confirmed a down-regulation of Cx43 expression, an altered distribution of plaques in the heart and a significant reduction in the number and length of Cx43 plaques, which correlated negatively with cardiomegaly. We conclude that elevated TGF-â levels during T. cruzi infection promote heart fibrosis and disorganise gap junctions, possibly contributing to abnormal impulse conduction and arrhythmia that characterise severe cardiopathy in Chagas disease.


Subject(s)
Adult , Animals , Female , Humans , Male , Mice , Middle Aged , Benzamides/therapeutic use , Chagas Disease/metabolism , /metabolism , Dioxoles/therapeutic use , Gap Junctions/metabolism , Myocytes, Cardiac/chemistry , Receptors, Transforming Growth Factor beta/antagonists & inhibitors , Transforming Growth Factor beta/therapeutic use , Chagas Disease/drug therapy , Fluorescent Antibody Technique , Gap Junctions/drug effects , Immunohistochemistry , Microscopy, Confocal , Myocytes, Cardiac/drug effects , Myocytes, Cardiac/metabolism
17.
J Indian Med Assoc ; 2008 Dec; 106(12): 814-5
Article in English | IMSEAR | ID: sea-96333

ABSTRACT

The most common cause of gastroparesis is diabetes mellitus. The present study was carried out to asses the combination of itopride and pantoprazole in the treatment of diabetic gastroparesis. The study was an open label, multicentre, conducted in 743 patients with diabetic gastroparesis for a period of 3 weeks. The efficacy parameters included nausea, vomiting, early satiety, bloating, postprandial fullness, epigastric pain and regurgitation. The patients were evaluated based on the frequency and severity of symptoms and compared with the baseline scores. There were significant improvement in severity as well as the frequency of all the symptom parameters of the disease (p<0.001). The physicians' evaluation to the therapy was rated either excellent or good.


Subject(s)
2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use , Adolescent , Adult , Aged , Benzamides/therapeutic use , Benzyl Compounds/therapeutic use , Diabetes Complications/complications , Drug Therapy, Combination , Gastrointestinal Agents/therapeutic use , Gastroparesis/diagnosis , Humans , Middle Aged , Proton Pump Inhibitors/therapeutic use , Severity of Illness Index , Treatment Outcome , Young Adult
18.
J Indian Med Assoc ; 2008 Nov; 106(11): 752-4
Article in English | IMSEAR | ID: sea-100281

ABSTRACT

The aim of the study was to evaluate and document the efficacy and tolerability of rabeto plus (FDC of rabeprazole and itopride) in management of functional dyspepsia. It was an open, prospective, non-comparative, multidose study. The patients with functional dyspepsia (NERD or non-erosive reflux disease) attending OPD of a leading, tertiary care, teaching hospital in West Bengal (BS Medical College, Bankura) were inducted in the study. A total of 46 adult patients of either sex with functional dyspepsia and a clinical diagnosis of NERD were given 1 capsule of rabeto plus before breakfast, for up to 4 weeks. Primary efficacy variables were relief from symptoms of heartburn, nausea, vomiting, waterbrash and fullness. Secondary efficacy variables were global assessment of efficacy and toleration by patients and treating physicians. The tolerability was assessed on the basis of record of spontaneously reported adverse events with their nature, intensity and outcome. Out of 55 patients enrolled in the study, 46 completed the study as planned, while 9 patients were lost to follow-up (dropped). Most patients reported near total symptom relief by the end of study. Total symptom score showed remarkable and significant improvement from baseline to end of the study. Importantly, none of the patients reported any side-effect. All participants tolerated the drug well. Moreover, response to study drug was rated as excellent or good by over 93% patients and their treating physicians. This means that 9 out 10 patients receiving rabeto plus reported desired symptom relief from dyspepsia. Thus it was concluded that rabeto plus is a valuable drug for treatment of functional dyspepsia or NERD.


Subject(s)
2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use , Adolescent , Adult , Aged , Benzamides/therapeutic use , Benzyl Compounds/therapeutic use , Drug Therapy, Combination , Dyspepsia/complications , Female , Gastroesophageal Reflux/complications , Gastrointestinal Agents/therapeutic use , Humans , Male , Middle Aged , Prospective Studies , Proton Pump Inhibitors/therapeutic use , Treatment Outcome , Young Adult
19.
Article in Korean | WPRIM | ID: wpr-34265

ABSTRACT

BACKGROUND/AIMS: It is unknown whether the prokinetics improve the quality of life in patients with functional dyspepsia. Thus, we evaluate the effect of the mosapride, selective 5-HT4 agonist, on the symptom and life quality of patients with functional dyspepsia using the Nepean dyspepsia index-Korean version (NDI-K), a reliable and validated disease-specific quality of life questionnaire. METHODS: A single, open trial was performed in 129 patients with functional dyspepsia. Patients were received mosapride 5 mg t.i.d before each meal for 4 weeks. The symptoms and quality of life were measured with the NDI-K at baseline and 4 weeks. The responsiveness of the NDI-K was evaluated by correlation with symptom scores. RESULTS: All the 15 symptom scores and the dyspepsia score decreased after treatment (p<0.05). The total symptom score decreased from 60.9 +/- 25.8 to 24.7 +/- 20.4 (p=0.001). Correlations were observed between the total symptom score and the NDI-K score (r=0.47, p=0.001), and between the total symptom score and each score in 5 subscales (r=0.25-0.44, p=0.001). The NDI-K score was significantly increased in the effective group whose dyspepsia score decreased more than 50% of the score at baseline, compared with that of ineffective group. Any significant adverse effect and prolongation of QT interval were not occurred in all patients. CONCLUSIONS: A prokinetic drug, mosapride improves the symptoms and the quality of life in patients with functional dyspepsia.


Subject(s)
Adult , Aged , Benzamides/therapeutic use , Dopamine Antagonists/therapeutic use , Dyspepsia/diagnosis , English Abstract , Female , Gastrointestinal Agents/therapeutic use , Humans , Male , Middle Aged , Morpholines/therapeutic use , Quality of Life , Surveys and Questionnaires
20.
J. bras. psiquiatr ; 46(2): 103-8, fev. 1997. tab
Article in English | LILACS | ID: lil-189080

ABSTRACT

Fundamento - A farmacoterapia da fobia social ainda näo está bem estudada. Mais ensaios clínicos com o clonazepam, dentre outros medicamentos, säo necessários. Método - Quarenta pacientes sofrendo de fobia social (DSM-III-R) foram tratados com clonazepam durante 16 semanas. As avaliaçöes compreenderam: Impressöes Clínicas Globais, Escala de Liebowitz para Fobia social, Escala de Hamilton para Ansiedade, Escala de Hamilton para Depressäo, Escalas de Sheehan para Incapacitaçäo, Inventário de Personalidade de Willoughby, Escala de Evitaçäo Social e o SCL-90. Resultados - A dose diária média foi de 4,8 mg. Em todos os instrumentos de avaliaçäo diferenças estatisticamentes significativas demostraram melhora acentuada em 86, 8 por cento dos casos. Efeitos indesejáveis foram frequentes, principalmente transtornos cognitivos e sexuais. Somente dois droupouts ocorreram devido a efeitos colaterais sexuais. Na fase de retirada do medicamento (semanas 17 a 24) manifestaçöes de abstinência/rebote foram frequentes. Conclusöes - O clonazepam é muito eficaz no tratamento da fobia social. Em um caso particular o clínico deve avaliar a relaçäo risco-benefício. Outras opçöes, como a moclobemida, devem também, ser consideradas


Subject(s)
Benzamides/therapeutic use , Clonazepam/adverse effects , Clonazepam/pharmacology , Clonazepam/therapeutic use , Phobic Disorders/drug therapy
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