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

Adult ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzamides ; Gynecomastia ; chemically induced ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; Male ; Piperazines ; adverse effects ; therapeutic use ; Pyrimidines ; adverse effects ; therapeutic use

OBJECTIVETo observe the effect of electro-acupuncture (EA) for treatment of morphine sulfate caused constipation in tumor patients.

METHODSSixty-six tumor patients suffering from constipation caused by oral taking of morphine sulfate controlled-release tablet were equally randomized into the treated group treated with EA [on the bilateral Zusanli (ST36) and Tianshu (ST25) points] and the control group treated with citrate-mosapride tablet. The overall therapeutic effect and scores of constipation in both groups were estimated after treatment.

RESULTSScores of constipation in terms of frequency, time, and difficulty degree of defecation, as well as stool properties, were all improved in both groups after treatment (P<0.01, P<0.05); the total score of constipation was 5.52 +/- 1.54 and 5.70 +/- 2.49 in the two groups respectively, which in the treated group was better, and showed significant difference compared with the score in the control group (P<0.01). The overall effective rate was 97.0% in the treated group and 87.9% in the control group.

CONCLUSIONEA has a good effect in treating constipation caused by oral taking of morphine sulfate controlled-release tablet.

Adult ; Aged ; Aged, 80 and over ; Benzamides ; therapeutic use ; Constipation ; chemically induced ; therapy ; Electroacupuncture ; Female ; Humans ; Male ; Middle Aged ; Morphine ; adverse effects ; Morpholines ; therapeutic use ; Neoplasms

OBJECTIVETo evaluate the efficacy and safety of Gleevec (Imatinib) in the treatment of patients with Ph positive chronic myeloid leukemia in chronic phase (CML-CP).

METHODSA total of 54 CML-CP patients in whom previous therapy with interferon-alpha had been failed or untolerated, or relapsed after allogeneic stem cell transplantation (allo-SCT) were treated with 400 mg/d of oral Gleevec for 6 to 11 months.

RESULTFifty-three patients being able to evaluate achieved complete hematological response within 7 to 28 days. Fifty-two (98%) of them remained in this situation at last follow-up. One patient relapsed after 7 months' treatment, and progressed to accelerated phase. Gleevec induced major cytogenetic response in 37 patients (70%) and complete cytogenetic response in 27 (51%). Twenty-nine of 37 patients (78%) achieved major cytogenetic response within 3 months. Grade 3 neutropenia or thrombocytopenia occurred in about 10% of patients, which were manageable or tolerated. Grade 3 or 4 nonhematologic adverse effects were infrequent. Only 1 patient (2%) discontinued treatment because of drug-related adverse events.

CONCLUSIONSGleevec induced high rate of cytogenetic and hematologic responses in patients with CML-CP who failed in previous interferon therapy. The adverse effects were mild and manageable, or no need for treatment.

Adolescent ; Adult ; Antineoplastic Agents ; therapeutic use ; Benzamides ; Female ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; genetics ; Male ; Middle Aged ; Piperazines ; adverse effects ; therapeutic use ; Pyrimidines ; adverse effects ; therapeutic use

OBJECTIVETo compare the efficacy and safety of dasatinib and imatinib in patients with newly diagnosed chronic phase chronic myeloid leukemia (CML-CP).

METHODS37 CML-CP patients were randomized to receive dasatinib 100 mg orally daily or imatinib 400 mg orally daily. The efficacy and safety data were collected and compared.

RESULTSOf 37 CML-CP patients, 18 received dasatinib and 19 received imatinib. The both of median duration of drug therapy and follow-up were 38 months. (1) The rate of complete cytogenetic response (CCyR) at 12 months was higher in dasatinib group than in imatinib group (89% vs 68%), but there was no significantly statistic significance between two groups (P = 0.232). The cumulative CCyR rate by 36 months was 89% in both arms. The major molecular response (MMR) at 18 months was 76% in dasatinib arm, being significantly higher than that in imatinib arm (37%) (P = 0.017). The cumulative MMR rate by 36 months was 82% versus 68% in dasatinib or imatinib (P = 0.694). The median time to CCyR and MMR was significantly faster for dasatinib than for imatinib (3 months vs. 6 months, and 14 months vs. 34 months, respectively). (2) The drug-related adverse events were mostly grade 1/2 and were well-tolerated. Increase of serum glutamic pyruvic transaminase, pleural effusion and thrombocytopenia were more common in dasatinib arm, while hypophosphatemia, edema and neutropenia were more common in imatinib arm.

CONCLUSIONDasatinib is an effective and safe therapy option and can be used as first-line therapy for newly diagnosed CML-CP patients.

Adult ; Aged ; Benzamides ; adverse effects ; therapeutic use ; Dasatinib ; Female ; Humans ; Imatinib Mesylate ; Leukemia, Myeloid, Chronic-Phase ; drug therapy ; Male ; Middle Aged ; Piperazines ; adverse effects ; therapeutic use ; Pyrimidines ; adverse effects ; therapeutic use ; Survival Rate ; Thiazoles ; adverse effects ; therapeutic use ; Treatment Outcome ; Young Adult

OBJECTIVETo probe the cause for triggering HBV reactivation and possible management of the chronic hepatitis B individuals received imatinib.

METHODSThis study presented two cases of transient hepatitis B virus (HBV) reactivation and hepatic dysfunction during oral imatinib for chronic myeloid leukemia (CML) and made a literatures review about the pathogenesis, possible prophylactic and therapeutic management of such chronic hepatitis B individuals receiving imatinib.

RESULTSTwo CML patients, without prior liver dysfunction but with chronic HBV infection, suffered from transient HBV reactivation occurred during oral imatinib. Both of them finally obtained good outcome following the additional oral nucleotide antiviral therapy.

CONCLUSIONIt remained unclear whether imatinib induced the reactivation of HBV in patients with a latent HBV infection. From our study, all candidates receiving oral imatinib should be screened for HBsAg and anti-HBc antibodies prior to initiation of imatinib. Prophylactic antiviral therapy should be offered to HBV-infected individuals along with a close monitoring for signs of reactivation.

Adult ; Benzamides ; adverse effects ; therapeutic use ; Hepatitis B ; virology ; Hepatitis B virus ; drug effects ; physiology ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; virology ; Male ; Piperazines ; adverse effects ; therapeutic use ; Pyrimidines ; adverse effects ; therapeutic use ; Virus Activation ; drug effects

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 safety and efficacy of imatinib in treatment of chronic myeloid leukemia (CML) patients.

METHODSFrom December 2003 to March 2007, 151 patients entered Glivec International Patient Assistance Program (GIPAP) in our center and received imatinib therapy. The overall and progression free survival, hematologic, cytogenetic and molecular response, and adverse events were evaluated. The factors associated with outcome of imatinib therapy were also analysed.

RESULTSOne hundred and forty-two patients were evaluable with a median follow-up duration of 21.5 (6 -78) months. (1) The rate of cumulative complete hematologic response (CHR), major cytogenetic response (MCyR), complete cytogenetic response (CCyR) and complete molecular response (CMoR) in chronic phase (CP) CML patients were 96.9%, 82.6%, 76.1% and 29.4%, respectively. These rates were significantly higher in patients with CP than in those with accelerated phase (AP) and blast crisis (BC) (P < 0.0001). (2) The overall survival (OS) rates at 1, 2 and 3 year were 100%, (97.3 +/- 1.9)% and (95.8 +/- 2.4)% for CP patients, they were (84.7 +/- 8.2)%, (77.0 +/- 10.4)% and (69.3 +/- 11.9)% for AP patients, and (62.9 +/- 8.9)%, (41.9 +/- 9.2)% and (28.5 +/- 9.1)% for BC patients, respectively (P < 0.0001). The progression-free survival (PFS) rates at 1, 2 and 3 year were (98.9 +/- 1.1)%, (93.9 +/- 2.7)%, (93.9 +/- 2.7)% for CP patients, (68.9 +/- 10.6)%, (61.3 +/- 11.9)%, (61.3 +/- 11.9)% for AP patients, (36.4 +/- 8.8)%, (25.4 +/- 8.1)%, (10.1 +/- 8.2)% (P < 0.0001) for BC patients respectively. (3) Among 92 CP patients, the rates of MCyR and CCyR in newly diagnosed patients were significantly higher than those in interferon therapy failure patients (P = 0.015, P = 0.010). Patients obtained CCyR at 12 months after the initiation of imatinib treatment were associated with longer PFS (P = 0.0099). According to the Sokal scoring system, the rates of MCyR and CCyR in low-risk patients were significantly higher than those in intermediate-risk and high-risk patients (P = 0.0013, P = 0.0024). Sokal score was also significantly associated with disease progression (P = 0.0467). (4) The adverse events of imatinib were moderate and tolerable.

CONCLUSIONSTreatment of CML patients in CP with imatinib can induce high hematologic, cytogenetic and molecular response and overall survival, but can not do satisfactorily for patients in AP and BC.

Adolescent ; Adult ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzamides ; Child ; Child, Preschool ; Female ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; Male ; Middle Aged ; Piperazines ; adverse effects ; therapeutic use ; Pyrimidines ; adverse effects ; therapeutic use ; Treatment Outcome ; Young Adult

Imatinib mesylate has been commonly used in the treatment of patients with chronic myeloid leukemia (CML). However, a significant number of CML patients treated with imatinib developed thrombocytopenia. Platelet-derived growth factor (PDGF)/platelet-derived growth factor receptor (PDGFR) plays a significant role in the regulation of thrombopoiesis. It is suggested that imatinib may block the PDGF/PDGFR and PI3-K/Akt pathway, then inducing the apoptosis of megakaryocytes and developing thrombocytopenia in these patients. In this review, the potential molecular mechanism of imatinib-induced thrombocytopenia in the treatment of CML patients is discussed, including imatinib and thrombocytopenia, PDGF/PDGFR and thrombopoiesis, potential mechanism of imatinib-induced thrombocytopenia in treatment of patients with CML and so on.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Benzamides ; Caspase 3 ; metabolism ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; genetics ; metabolism ; Piperazines ; adverse effects ; therapeutic use ; Platelet-Derived Growth Factor ; metabolism ; Proto-Oncogene Proteins c-akt ; metabolism ; Pyrimidines ; adverse effects ; therapeutic use ; Signal Transduction ; Thrombocytopenia ; chemically induced ; Thrombopoiesis

OBJECTIVETo evaluate the efficiency and safety of dasatinib in Chinese patients (pts) with chronic myelogenous leukemia (CML) in chronic phase (CP), accelerated-phase (AP) or blast-phase (BP) who are resistant or intolerant to imatinib (IM).

METHODS119 CML pts received dasatinib 100 mg once daily for pts in CP or 70 mg twice daily for pts in AP/BP. The hematologic/cytogenetic response, progression-free-survival (PFS), overall survival (OS) and adverse effects (AE) of the pts were assessed.

RESULTS59 pts in CP, 25 in AP and 35 in BP received dasatinib treatment. The median duration of dasatinib treatment were 19.32, 20.99 and 3.22 months respectively. Complete hematologic response (CHR), major cytogenetic response (MCyR) and complete cytogenetic response (CCyR) were achieved by 91.5%, 50.8% and 42.4% of pts in CP respectively. The median times to achieving MCyR was 12.1 weeks. None of the pts in CP achieved MCyR progressed or died till to last follow-up. CHR and major hematologic response (MaHR) were achieved by 52.0% and 84.0% of pts in AP, respectively. The median time to CHR and MaHR were 16.0 and 12.1 weeks, respectively. 10 pts in AP achieved MCyR and 9 of them were CCyR. The median duration of PFS was 25.7 months for pts in AP. For 35 pts in BP, the rates of CHR and MaHR were 17.1% and 31.4% respectively. Both of the median time to CHR and MaHR were 12.1 weeks and median time of duration of MaHR was 11.2 months. 8 pts in BP achieved MCyR and the median time of duration of MCyR was 13.2 months. The median duration of PFS and OS for the pts in BP were 4.3 and 16.7 months respectively. Grade 3-4 of hematologic AEs related to dasatinib were frequent but manageable by dose interruption/reduction or supportive care. 52.5% and 61.0% of pts in CP experienced grade 3-4 of neutropenia and thrombocytopenia. More than 80% pts in AP/BP occurred grade 3-4 cytopenia. The common non-hematologic AEs related to dasatinib were including grade 1-2 pleural effusion, headache, pneumonia and diarrhea. The frequency of non-hematologic AE was higher in pts with AP/BP than in pts with CP.

CONCLUSIONChinese pts with CML resistant or intolerant to IM treated by dasatinib can achieve relatively sustained hematologic and even cytogenetic remission and are well tolerated.

Adolescent ; Adult ; Aged ; Benzamides ; adverse effects ; pharmacology ; Dasatinib ; Drug Resistance, Neoplasm ; Female ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; drug therapy ; Male ; Middle Aged ; Piperazines ; adverse effects ; pharmacology ; Pyrimidines ; adverse effects ; pharmacology ; therapeutic use ; Thiazoles ; adverse effects ; therapeutic use ; Treatment Outcome ; Young Adult