OBJECTIVETo evaluate the effectiveness and safety of mosapride on treatment of functional dyspepsia.

METHODSRandomized controlled clinical trial was conducted and patients suffered from functional dyspepsia were included. 5 mg mosapride was given three times daily for 4 weeks in the treatment group. 10 mg domperidone was given three times daily for 4 weeks as control. Changes on symptom score, gastric empty or new occurring events were included as outcomes.

RESULTS231 patients suffered from functional dyspepsia were selected by inclusion and exclusion criteria from August 15 to Oct 22, 1999. Of these, 108 (46.8%) were males, versus 123 (53.2%) females and 118 (51.2%) in the treatment group and 113 (48.9%) as controls. 222 (96.1%) patients were followed up. Results showed that the total efficacy rates in early satiety and abdominal distension were 84.5% and 90.1% in mosapride after the 2 weeks of treatment. Mosapride seemed to be more effective in improving symptoms of belching and heartburn than that in controls (P < 0.05). In 4 weeks, the total efficacy in improving symptoms of abdominal distention and belching showed more effective in mosapride than that in controls (P < 0.05). Decrease of symptoms score was more in mosapride than that in controls (P < 0.05). Mosapride was less effective in controls in improving the gastric empty in terms of proportion (46.2% vs. 25.9%, P = 0.020) and range (46.2% vs. 24.0%, P = 0.003). Side effects would include diarrhea, constipation, headache, dizziness, insomnia, skin scare and the like. There was no significant difference between the two groups (9.6% in mosapride vs. 14.0% in controls).

CONCLUSIONMosapride was safe and effective in improving the symptoms and gastric empty of functional dyspepsia.

Adult ; Benzamides ; adverse effects ; therapeutic use ; Dyspepsia ; drug therapy ; Female ; Gastrointestinal Agents ; adverse effects ; therapeutic use ; Humans ; Male ; Middle Aged ; Morpholines ; adverse effects ; therapeutic use ; Treatment Outcome

BACKGROUND/AIMS: Infliximab has been shown to be effective and safe for treating refractory luminal and fistulizing Crohn's disease (CD). The aim of this study was to report the efficacy and adverse effect of infliximab therapy in patients with CD at our center. METHODS: Medical records of thirteen patients who were treated with infliximab for refractory luminal or fistulizing CD were reviewed. Clinical response was classified as complete response, partial response and nonresponse. RESULTS: Seven patients were treated for fistulizing CD, four patients for luminal CD, and two for both. The mean time of follow-up was 13.1 months (3.3-28.1 months). Clinical response was seen in 10/13 (77%); complete response 7/13 (54%), partial response 3/13 (23%), nonresponse 3/13 (23%). Mean time to response was 27.1 days (10-41 days). 4 of 10 responders (40%) maintained remission over 30 weeks. Those who started on immunosuppressive treatment more than 3 months before infliximab infusion achieved lower early recurrence rate (14%) compared with those less than 3 months (67%) (p=0.039). Steroid tapering was successful in 7/12 (58%). Five patients required surgical therapy; three nonresponders, one partial responder and one who recurred after initial complete response. Initial responders required less surgery than nonresponders (p=0.035). Acute infusion reactions were seen in 2/40 infusions (5%). One patient developed herpes zoster 20 weeks after infliximab infusion. During follow-up peried, no patient developed serious infection, tuberculosis or malignancy. CONCLUSIONS: Infliximab is effective and safe in clinical practice. Concurrent immunosuppressive use is associated with lower rate of early recurrence.
Adult ; Antibodies, Monoclonal/adverse effects/*therapeutic use ; Crohn Disease/*drug therapy ; Female ; Gastrointestinal Agents/adverse effects/*therapeutic use ; Humans ; Immunosuppressive Agents/therapeutic use ; Male

OBJECTIVETo evaluate rates on the adverse side effect and discontinuation of second-line drugs frequently used in the treatment of rheumatoid arthritis (RA).

METHODEight hundred and sixty-four RA patients were studied in a retrospective program.

RESULTSUpper abdominal discomfort was most commonly seen when using second-line drugs. Rash was often associated with D-penicillamine (20.6%) and Sinomenium therapy (13.7%). Methotrexate (MTX) was uniquely characterized by substantial upper GI toxicity (32.2%) and Tripterygium wilfordii Hook. f. (TWH) (14.4%) by menstrual abnormality. Sulfasalazine users reported adverse events including upper abdominal trouble (39.0%), nausea (7.3%) and anorexia (7.3%) while the risk of GI malaise was greater. Patients taking hydroxychloroquine complained of blurred vision (19.6%) but no one went blind. Toxic side effects seemed to be the most common reasons for stoppages, and the patients taking MTX had the lowest discontinuation rate. Combination of D-penicillamine and Methotrexate did not increase the incidence of adverse events.

CONCLUSIONSKnowledge on these different patterns of toxicity provided choices in the selection of second line agents for particular RA patients. However, long-term monitor are required when drugs are being used.

Adult ; Anorexia ; chemically induced ; Antirheumatic Agents ; adverse effects ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Exanthema ; chemically induced ; Female ; Gastrointestinal Diseases ; chemically induced ; Humans ; Hydroxychloroquine ; adverse effects ; therapeutic use ; Male ; Methotrexate ; adverse effects ; therapeutic use ; Middle Aged ; Nausea ; chemically induced ; Penicillamine ; adverse effects ; therapeutic use ; Phytotherapy ; Plant Preparations ; adverse effects ; therapeutic use ; Retrospective Studies ; Sinomenium ; Sulfasalazine ; adverse effects ; therapeutic use

Adult ; Aged ; Female ; Gastric Mucosa ; drug effects ; pathology ; Gastrointestinal Agents ; adverse effects ; therapeutic use ; Gastrointestinal Hemorrhage ; drug therapy ; etiology ; Humans ; Hypertension, Portal ; complications ; drug therapy ; Male ; Middle Aged ; Octreotide ; adverse effects ; therapeutic use ; Pituitary Hormones, Posterior ; adverse effects ; therapeutic use ; Treatment Outcome ; Vomiting ; chemically induced

BACKGROUND/AIMS: Our aim was to assess the long-term data regarding efficacy and safety of infliximab (IFX) treatment for refractory Crohn's disease (CD) patients in our tertiary teaching hospital. METHODS: We have retrospectively analyzed the medical records of 89 CD patients who underwent IFX treatment between March 2003 and February 2011 at Kyung Hee University Hospital (Seoul, Korea). The primary outcome measurements were the rates of initial clinical response (CR) at 10 weeks after the 1st IFX infusion and sustained CR at the end of the follow-up. Overall adverse events related to IFX treatment were also evaluated. RESULTS: The mean (SD) follow-up period of eligible 80 patients was 33.7 (21.9) months. A total of 77 patients (96%) showed initial clinical response, but 8 patients showed loss of response to IFX during the follow-up. Finally, 59 patients (59/77, 76.6%) showed sustained CR at the end of the study. Logistic regression analyses showed that an initial CR at 10 weeks was the independent predictor associated with sustained CR (OR 22.286, 95% CI 2.742-132.717, p=0.001). Overall adverse events reported in 18 patients (18/80, 23.3%), including 3 serious infection (pulmonary tuberculosis and herpes zoster). CONCLUSIONS: Treatment with IFX was efficacious and relatively safe for refractory CD patients in Korea. An initial CR at 10 weeks was significantly associated with sustained CR.
Adult ; Antibodies, Monoclonal/adverse effects/*therapeutic use ; Crohn Disease/*drug therapy ; Female ; Follow-Up Studies ; Gastrointestinal Agents/adverse effects/*therapeutic use ; Herpes Zoster/etiology ; Humans ; Logistic Models ; Male ; Odds Ratio ; Retrospective Studies ; Treatment Outcome ; Tuberculosis, Pulmonary/etiology ; Young Adult

We report a gastrointestinal stromal tumor (GIST) patient with male gynecomastia and testicular hydrocele after treatment with imatinib mesylate. A 42 yr-old male patient presented for management of hepatic masses. Two years earlier, he had undergone a small bowel resection to remove an intraabdominal mass later shown to be a GIST, followed by adjuvant radiation therapy. At presentation, CT scan revealed multiple hepatic masses, which were compatible with metastatic GIST, and he was prescribed imatinib 400 mg/day. During treatment, he experienced painful enlargement of the left breast and scrotal swelling. Three months after cessation of imatinib treatment, the tumors recurred, and, upon recommencing imatinib, he experienced painful enlargement of the right breast and scrotal swelling. He was diagnosed with male gynecomastia caused by decreased testosterone and noncommunicative testicular hydrocele. He was given androgen support and a hydrocelectomy, which improved his gynecomastia. The mechanism by which imatinib induces gynecomastia and hydrocele is thought to be associated with an inhibition of c-KIT and platelet-derive growth factor. This is the first report, to our knowledge, describing concurrent male gynecomastia and testicular hydrocele after imatinib treatment of a patient with GIST.
Adult ; Androgens/therapeutic use ; Antineoplastic Agents/adverse effects/therapeutic use ; Gastrointestinal Stromal Tumors/*drug therapy ; Gynecomastia/*chemically induced/complications/drug therapy ; Humans ; Hydrocele/*chemically induced/complications/drug therapy ; Male ; Piperazines/*adverse effects/therapeutic use ; Pyrimidines/*adverse effects/therapeutic use ; Testis/drug effects/pathology/ultrasonography

OBJECTIVE: We aimed to describe radiologic signs and time-course of imatinib-associated fluid retention (FR) in patients with gastrointestinal stromal tumor (GIST), and its implications for management. MATERIALS AND METHODS: In this Institutional Review Board-approved, retrospective study of 403 patients with GIST treated with imatinib, 15 patients with imaging findings of FR were identified by screening radiology reports, followed by manual confirmation. Subcutaneous edema, ascites, pleural effusion, and pericardial effusion were graded on a four-point scale on CT scans; total score was the sum of these four scores. RESULTS: The most common radiologic sign of FR was subcutaneous edema (15/15, 100%), followed by ascites (12/15, 80%), pleural effusion (11/15, 73%), and pericardial effusion (6/15, 40%) at the time of maximum FR. Two distinct types of FR were observed: 1) acute/progressive FR, characterized by acute aggravation of FR and rapid improvement after management, 2) intermittent/steady FR, characterized by occasional or persistent mild FR. Acute/progressive FR always occurred early after drug initiation/dose escalation (median 1.9 month, range 0.3-4.0 months), while intermittent/steady FR occurred at any time. Compared to intermittent/steady FR, acute/progressive FR was severe (median score, 5 vs. 2.5, p = 0.002), and often required drug-cessation/dose-reduction. CONCLUSION: Two distinct types (acute/progressive and intermittent/steady FR) of imatinib-associated FR are observed and each type requires different management.
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/*adverse effects/therapeutic use ; Ascites/pathology/radiography ; Benzamides/*adverse effects/therapeutic use ; Echocardiography/methods ; Edema/pathology/radiography ; Female ; Gastrointestinal Stromal Tumors/drug therapy/pathology/*radiography ; Gastrointestinal Tract/pathology/*radiography ; Heart Failure/radiography ; Humans ; Male ; Middle Aged ; Molecular Targeted Therapy/*adverse effects ; Pericardial Effusion/pathology/radiography ; Peritoneal Neoplasms/diagnosis/radiography/secondary ; Piperazines/*adverse effects/therapeutic use ; Pleural Effusion/pathology/radiography ; Pyrimidines/*adverse effects/therapeutic use ; Radiology ; Retrospective Studies ; Tomography, X-Ray Computed

OBJECTIVETo evaluate the roles of folic acid and beta-carotene in the chemoprevention of gastric and other gastrointestinal (GI) cancers.

METHODSIn a randomized, double-blind, placebo-controlled trial, a total of 216 patients with atrophic gastritis were randomly assigned to one of the four groups: (1) folate (FA, 20 mg per day plus vitamin B(12) 1 mg, intramuscularly, per month for one year, then 20 mg two times a week plus 1 mg per three months for the next year); (2) natural beta-carotene (N-betaC, 30 mg per day for first year, then 30 mg two times a week for the next); (3) synthetic beta-carotene (S-betaC, administered as in N-betaC); and (4) placebo. Follow-ups continued from 1994 to 2001.

RESULTSA total of 7 new cases of gastrointestinal cancers were diagnosed with 3 stomach, 1 colon and 1 esophageal cancers occurring in the placebo group; 1 stomach cancer in both of the N-betaC and S-betaC groups, and no cancer occurring in FA group. In terms of GI cancers, there was a significant reduction in the FA group, compared with the placebo group (P = 0.04). A similar trend was observed in both N-betaC and S-betaC groups (P = 0.07 - 0.08). Taken together, the three intervention groups displayed a highly significant decrease in occurrence (P = 0.004, vs placebo), and a lower risk for GI cancers (OR = 0.12; 95% confidence interval, 0.03 - 0.51). For development of gastric cancer, any one of the three active-treated groups did not reach statistically significant reduction. The FA group showed obvious improvement of the gastric mucosal lesions with more patients displaying lesions reversed or stable atrophy and inflammation (P = 0.04), reversed intestinal metaplasia (P = 0.06) at the end of follow-up, and reversed displasia (P = 0.017) at 12 months. Two cases of false jaundice were found in beta-carotene groups with no influence on administration, and no side-effects were reported in FA group.

CONCLUSIONSThis trial revealed the interventional effect of folic acid on the development of GI cancers, a similar effect of beta-carotene was also detected. Also, folic acid may be of use to treat atrophic gastritis by preventing or reversing the precancerous lesions.

Adult ; Aged ; Anticarcinogenic Agents ; therapeutic use ; Double-Blind Method ; Female ; Folic Acid ; adverse effects ; therapeutic use ; Gastric Mucosa ; pathology ; Gastrointestinal Neoplasms ; prevention & control ; Humans ; Male ; Middle Aged ; Patient Compliance ; Stomach Neoplasms ; prevention & control ; beta Carotene ; therapeutic use

OBJECTIVETo make an open label prospective trial for comparing the therapeutic effects of mycophenolate mofetil (MMF) vs cyclophosphamide (CYC) pulse therapy on patients with diffuse proliferative lupus nephritis (DPLN).

METHODSForty-six patients with biopsy proven active DPLN were enrolled in this study. Twenty-three patients were given MMF orally at a dosage of 1.0 - 1.5 g/d (MMF Group). Another 23 cases received conventional intermittent CYC pulse therapy (CYC Group). Supplemental steroid treatment was offered in the same manner to both groups. The age, sex distribution and severity of renal damage were matched in two groups. Therapeutic effects were evaluated at the end of six-month treatment. Fifteen patients in the MMF Group and 12 patients in the CYC Group had repeated renal biopsy at that time.

RESULTSMMF therapy was more effective in reducing proteinuria and hematuria. A 50% reduction of urinary protein and urinary red blood cell excretion from baseline value in 69.6% and 91.3% patients in the MMF Group, while only 47.8% and 65.2% in the CYC Group. MMF was more effective in inhibiting autoantibody production (especially anti-dsDNA antibody) and in decreasing serum cryoglobulin levels. Pathologically, the MMF group showed more markedly reduction in glomerular immune deposits with less glomerular necrosis, and less microthrombi, less crescent formation and vascular changes in the repeated renal biopsy as compared with the CYC group. Adverse reactions related to the treatment included gastrointestinal symptoms 26.1% and 43.5% in the MMF and CYC Groups respectively, infection 17.4% in the MMF group and 30.4% in the CYC group.

CONCLUSIONMMF was more effective in controlling the clinical activity of DPLN and renal vascular lesions as compared with CYC pulse therapy in a 6 month follow-up study.

Adult ; Cyclophosphamide ; adverse effects ; therapeutic use ; Female ; Gastrointestinal Diseases ; chemically induced ; Humans ; Immunosuppressive Agents ; adverse effects ; therapeutic use ; Infection ; chemically induced ; Kidney ; drug effects ; pathology ; Lupus Nephritis ; drug therapy ; Male ; Mycophenolic Acid ; adverse effects ; analogs & derivatives ; therapeutic use ; Pneumonia ; chemically induced ; Prospective Studies ; Treatment Outcome

OBJECTIVETo investigate the efficacy of dietary therapy of qi-yin-reinforcing porridge for the alleviation of clinical symptoms during FOLFOX chemotherapy.

METHODSA single-case randomized controlled study was carried out. Fourteen patients with gastrointestinal tumors accepting FOLFOX chemotherapy were enrolled using self-crossover control design. On days 1-7 of chemotherapy, the dietary therapy experimental group and the placebo control group were given dietary therapy of qi-yin-reinforcing porridge and dextrin-prepared porridge which had the same appearance, smell, color and taste as the qi-yin-reinforcing porridge, respectively. Fourteen clinical symptoms, including debility, vomiting and nausea, etc. were observed.

RESULTSTen patients completed the study and were estimable. The qi-yin-reinforcing porridge demonstrated certain efficacy in alleviating clinical symptoms of patients with gastrointestinal tumors during the period of chemotherapy. Better effect of alleviating debility was found in the dietary therapy experimental group than in the placebo control group, and the difference was statistically significant (Z=2.27, P=0.02). No statistically significant difference was found between the experimental group and the control group with respect to the effect of alleviating the other 13 clinical symptoms including anorexia, nausea, vomiting, dry stool, loose stool, etc. and body weight (P>0.05).

CONCLUSIONDietary therapy of qi-yin-reinforcing porridge shows an additional benefit in alleviating debility of patients during chemotherapy and deserves clinical use and popularization.

Aged ; Antineoplastic Agents ; adverse effects ; pharmacology ; therapeutic use ; Body Weight ; drug effects ; Coix ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Female ; Gastrointestinal Neoplasms ; diet therapy ; drug therapy ; Humans ; Male ; Middle Aged ; Oryza