OBJECTIVETo validate the therapeutic efficacy of paroxetine in the treatment of premature ejaculation (PE).

METHODSEighty PE patients up to the inclusion criteria were equally randomized to an experimental and a control group. We observed all the patients for 4 weeks and recorded the baseline data on intravaginal ejaculatory latency time (IELT) and sexual satisfaction scores, followed by oral medication of paroxetine at 20 mg/d for the patients in the experimental group and placebo for the controls. Thirty days after the treatment, we again recorded IELT and sexual satisfaction scores of the patients.

RESULTSAfter the treatment, the experimental group showed significantly prolonged IELT ([5.75 +/- 1.24] min) and increased sexual satisfaction score (6.4 +/- 1.2) as compared with the baseline data ([0.89 +/- 0.21] min and [2.7 +/- 0.9]) (P < 0.01). The control group exhibited no significant differences before and after the medication either in the mean IELT or in sexual satisfaction scores ([1.06 +/- 0.28] min vs [0.97 +/- 0.18] min and 3.6 +/- 1.3 vs 3.1 +/- 1.1, P > 0.05).

CONCLUSIONOral medication of paroxetine at 20 mg/d for 30 days could improve IELT and sexual satisfaction in PE patients.

Adult ; Ejaculation ; Humans ; Male ; Paroxetine ; therapeutic use ; Serotonin Uptake Inhibitors ; therapeutic use ; Sexual Dysfunction, Physiological ; drug therapy ; Treatment Outcome ; Young Adult

Objective:To construct the recombinant DNA E.coli ghosts (EBGs) expressing Treponema pallidum adhesin Tp0751 (pcD/Tp0751-BG) and determine its immunocompetence in immunized mice,and provide a potential novel method for syphilis vaccine developing.Methods:The recombinant eukaryotic expression plasmid pcDNA3.1(+)/Tp0751 was constructed and loaded into empty EBGs to create pcD/Tp0751-BG.The loading rate was determined accordingly.Macrophages cell line RAW264.7 was transfected with pcD/Tp0751-BG,and the expression of recombinant Tp0751(rTp0751) protein was detected by Western blot(WB).For immuno-competence in mice,the female BALB/c mice were randomly divided into 6 groups,including three control groups,A (PBS),B (EBG),C (empty pcDNA),and experimental group D(naked pcD/Tp0751),E (pcD/Tp0751-BG) and F (pcD/Tp0751-BG+rTp0751).All the mice were immunized as indicated for three times by intramuscular injection at two weeks intervals.The levels of specific IgG in sera and SIgA in genital tract lavage fluid were measured by ELISA.Levels of lymphocyte proliferation and IFN-γ secretion in spleen cells were measured by CCK-8 Cell Counting Kit and ELISA as well,respectively.Results:The loading rate of pcD/Tp0751 to EBGs was 76.1%.WB showed that the target recombinant protein pcD/Tp0751 expressed in RAW264.7 cells was active with Tp-infected rabbit sera.The titers of specific IgG and SIgA in group D,E,F gradually increased to significantly higher level as compared to the control groups (P<0. 01),which reached its peak at wk 8 after last immunization(the titers of IgG and SIgA were 1 :102 400 and 1 :12 800 in group F,respectively). Higher levels of specific IgG and SIgA were observed in groups E and F as compared to group D after first boost (P<0. 01),with groups F higher than group E after last boost(P<0. 01). At wk 8 after the last boost,the stimulation index (SI) and levels of IFN-γ in group D,E,F were all significant higher than the control groups (P<0. 01), with group E and F higher than group D (P<0. 01),and group E higher than group F (P<0. 05). Conclusion: The recombinant DNA EBGs of T. pallidum adhesin Tp0751 (pcD/ Tp0751-BG) possesses the immunocompetence to induce not only strong mucosal and systemic humoral immune response but also systemic cellular immune response in BALB/ c mice. The heterologous boost can be more efficient than homologous boost during immunization process.

To investigate transcription factor PAX5 expression characteristics in childhood acute leukemic cells, expression levels of PAX5 and CD19 mRNA in 6 hematological tumor cell lines and bone marrow cells of 6 normal children, 58 de novo patients and 4 relapse acute leukemic children, including 39 cases of B-ALL, 10 cases of T-ALL and 13 cases of AML, were detected by a real-time RT-PCR. The results showed that PAX5 and CD19 mRNA expression levels were 2.35% and 2.52% in Namalwa (B-cell lines) respectively, but almost not detectable in other T- and myeloid cell lines. Among clinical samples, expression of PAX5 mRNA in B-ALL was significantly higher than that in T-ALL and AML (P = 0.029 and P = 0.013 respectively). PAX5 expression was significantly lower in T-ALL and AML than that in normal controls. The difference of PAX5 mRNA expression levels between T-ALL and AML was not significant. Individual difference of PAX5 mRNA expression levels in children with B-ALL was great. Moreover, PAX5 mRNA expressions in de novo and relapse patients with B-ALL were significantly higher than those in remission (P = 0.011 and P = 0.006 respectively). As binding sites for B-cell specific activator protein have been identified in the promoter regions of CD19, the study found that in B-ALL, there was clear correlation between the expression levels of PAX5 and CD19, which was also studied by real-time RT-PCR. It is concluded that PAX5 transcripts are readily detectable and quantifiable in clinical materials with B-ALL by real-time RT-PCR. The strong PAX5 mRNA expression in some B-ALL can be considered to be particularly interesting for further analysis.
Adolescent ; Antigens, CD19 ; biosynthesis ; genetics ; Cell Line, Tumor ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Male ; PAX5 Transcription Factor ; biosynthesis ; genetics ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; metabolism ; pathology ; RNA, Messenger ; biosynthesis ; genetics ; Transcription Factors ; biosynthesis ; genetics

OBJECTIVETo study the effect of Notoginsenoside Rgl on p38 mitogen activated protein kinase (p38MAPK) expression in pulmonary artery smooth muscle cells (PASMCs) cultured in hypoxia hypercapnia.

METHODSSD rat PASMCs was primary cultured, the cells of passage 2- 5 were divided into six groups: normoxic group (N group), hypoxia hypercapnia group (H group), dimethyl sulfoxide (DMSO) control group (HD group), Rg1 treated group (Rg low dose, Rg middle dose and Rg high dose group). Western blot was used to detect the expression of p-p38MAPK protein, and RT-PCR to determine the expression of p38MAPK mRNA.

RESULTSWestern blot and RT-PCR analysis indicated that the expression of p-p38MAPK protein and p-p38MAPK mRNA were significantly higher in HD group than those in N group (P < 0.01). Whereas, in Rg1 treated groups, the level of p-p38MAPK markedly decreased (P < 0.01) in dose-dependent manner.

CONCLUSIONNotoginsenoside Rg1 has protective effects on PASMCs under hypoxia hypercapnia condition, which may be related to inhibiting expression of p38MAPK.

Animals ; Cell Hypoxia ; Cells, Cultured ; Ginsenosides ; pharmacology ; Hypercapnia ; metabolism ; Male ; Muscle, Smooth, Vascular ; cytology ; drug effects ; Myocytes, Smooth Muscle ; drug effects ; Pulmonary Artery ; cytology ; RNA, Messenger ; genetics ; Rats ; Rats, Sprague-Dawley ; p38 Mitogen-Activated Protein Kinases ; metabolism

OBJECTIVEMinimal residual disease (MRD) is one of the most important prognostic factors in childhood acute lymphoblastic leukemia (ALL). Flow cytometry and PCR are two common techniques for examining MRD in ALL. This study aimed to identify MRD targets by tandem application of both techniques in children with ALL.

METHODSFrom September 2001 to October 2003, 126 children with newly diagnosed ALL were enrolled on the treatment protocol ALL-XH-99. Tandem application of flow cytometry and PCR was performed to identify MRD targets in these patients.

RESULTS1. Using sets of combined antibodies, immunophenotypic expression of leukemia cells was observed in 95 of 106 B-lineage ALL cases (89.6%). Only one aberrant immunophenotype was observed in 11 cases (11.6%) and most patients with B-lineage ALL (88.4%) expressed at least two suitable targets. 2. Using PCR technique, T-cell receptor (TCR) or immunoglobulin gene rearrangements were identified in 26 of 27 patients (96.3%). Two or more monoclonal/ bi-allelic gene rearrangements were identified in 17 cases (65.4%). The majority (70%) of T-lineage ALL cases contained TCRVgammaI-Jgamma1.3/2.3. Cross-lineage TCR rearrangements were found in 57.1% of cases with B-lineage ALL. 3. Suitable MRD targets of immunophenotypic abnormalities or antigen receptor gene rearrangements were detected in 121 patients (96.0%).

CONCLUSIONSMRD targets were identified using tandem application of flow cytometry and PCR in almost of children with ALL. Cross-lineage TCR rearrangements and bi-allelic gene rearrangements were observed in many patients.

Child ; Flow Cytometry ; methods ; Gene Rearrangement, T-Lymphocyte ; Humans ; Immunophenotyping ; Neoplasm, Residual ; Polymerase Chain Reaction ; methods ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; genetics ; immunology

OBJECTIVEThe prognostic significance of immunophenotyping in acute myeloid leukemia (AML) has been controversial. This study investigated the relationship of immunophenotypes with French-American-British (FAB) subtypes and chromosomal abnormalities and assessed the prognostic value of immunophenotyping in children with AML.

METHODSFrom January 1998 to May 2003, 75 children with newly diagnosed AML were enrolled on protocol AML-XH-99. Immunophenotypes were measured with the flow cytometry. According to the McAbs used, the patients were classified into five groups: panmyeloid antigens (CD13, CD33, and MPO), myeloid-lineage associated antigens (CD14, CD15), lineage-specific antigens (CD41, GlyA), progenitor-associated antigens (CD34, HLA-DR) and lymphoid-associated antigens (CD19, CD7). The probability of event-free survival (EFS) was estimated by Kaplan-Meier analysis. The distributions of EFS were compared using the log-rank test. Chi-square analysis or Fisher exact test was used to compare the differences in the distribution of biologic presenting features. A Cox proportional hazards model was used to identify independent prognostic factors.

RESULTSAt least one of panmyeloid antigens CD13, CD33 and MPO was expressed in 72 patents (97.3%). Two or more panmyeloid antigens were expressed in 45 patients (60.8%). The proportion of children with AML expressing one or more of the lymphoid-associated antigens was 24.3%. Lymphoid-associated antigen CD19 was expressed by blast cells in most of FAB M2 patients. The patients with acute promyelocytic leukemia were characterized by the absence of HLA-DR and lymphoid-associated antigens CD19 and CD7. Monovariate analysis showed immunophenotypes were not related to the complete remission rate after the first induction course and the 5-year-EFS. Multivariate analysis suggested immunophenotyping had no independent prognostic value in AML.

CONCLUSIONSImmunophenotyping can not be used independently in the evaluation of risk classification in children with AML. However, it is useful in the reorganization of special types of AML.

Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Immunophenotyping ; Infant ; Leukemia, Myeloid, Acute ; drug therapy ; immunology ; mortality ; Male ; Prognosis ; Proportional Hazards Models ; Sensitivity and Specificity

OBJECTIVETo analyze the relationship between karyotypic characteristics and treatment outcome of childhood acute lymphoblastic leukemia (ALL) and compare the difference in karyotypic aberration between ALL patients in China and in western countries.

METHODSFrom January 1998 to May 2003, 193 patients with newly diagnosed ALL were enrolled on protocol ALL-XH-99. The patients were classified into 4 groups according to the karyotype of the leukemia cells: normal karyotype, hypodiploid, hyperdiploid and pseudodiploid. Event-free survival (EFS) was estimated by Kaplan-Meier analysis and the distributions of EFS were compared using the log-rank test. A Cox proportional hazards model was used to identify independent prognostic factors.

RESULTS(1) Of 193 ALL patients, 115 had cytogenetic data. There were 53 (46.09%) with normal karyotype, 29 (25.22%) hyperdiploid, 9 (7.83%) hypodiploid, 4 coexpression of hypodiploid/hyperdiploid and 20 (17.39%) pseudodiploid. The probability of 5-year EFS for the four subgroups were (78.28 +/- 6.34)%, (86.07 +/- 6.47)%, (53.85 +/- 13.83)% and (40.10 +/- 12.17)%, respectively (P = 0.0041). (2) The clinical presentation and early response to treatment had no difference among the four groups, but the events are significantly different. (3) The probability of 5-year EFS for the combined hypodiploid group and the non-hypodiploid group was (53.85 +/- 13.83)% and (69.98 +/- 5.94)%, respectively (P = 0.1281). (4) The probability of 4-year EFS was significantly worse for patients with Philadelphia chromosome than for no Philadelphia chromosome patients [(28.57 +/- 17.07)% vs (70.85 +/- 5.60)%, P = 0.0009]. (5) Multivariate analysis suggested that the karyotypic characteristics, Philadelphia chromosome, age < 1-year or > 12-year, and white blood cell counts were independent prognostic factors.

CONCLUSIONSThe cytogenetic pattern of Chinese childhood ALL patients was similar to that of western countries. Cytogenetic findings especially Philadelphia chromosome had important prognostic significance.

Adolescent ; Child ; Child, Preschool ; Chromosome Aberrations ; statistics & numerical data ; Diploidy ; Female ; Humans ; Infant ; Kaplan-Meier Estimate ; Karyotyping ; Male ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; classification ; genetics ; pathology ; Prognosis ; Proportional Hazards Models

OBJECTIVETo assess the prognostic value of minimal residual disease (MRD) in childhood B-cell acute lymphoblastic leukemia (ALL) after induction chemotherapy.

METHODSFrom September 2001 to October 2004, 102 patients with newly diagnosed B-ALL were enrolled in protocol ALL-XH-99. MRD after induction therapy, before high-dose methotrexate and early intensification as well as at 1 year and 2 year maintenance therapy was detected by multiparameter-flow-cytometry (MP-FCM).

RESULTS(1) The probability of 39-month event-free survival (EFS) for patients with a level of MRD < 10(-4), was significantly higher than for those with a higher MRD [(83.00 +/- 9.90)% vs 0.00%, P < 0.01]. (2) Univariate analysis indicated that the MRD level at achieving complete remission (CR) had no relationship with the biologic features at presentation (gender, age, white blood cells and cytogenetic abnormalities), but did with Philadelphia chromosome, the time reaching CR, ALL-XH-99 risk group and lymphoblasts in bone marrow on day 19 after induction therapy (P < 0.05). (3) Multivariate analysis suggested that MRD level after the first induction course was an independent prognostic factor (hazard ratio, 5.381; 95% CI 0.004 to 0.624; P < 0.05).

CONCLUSIONThe MRD level at achieving CR is one of important prognostic factor in the treatment of childhood B-cell ALL, and might be used to assess the early treatment response.

Adolescent ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Leukemia, B-Cell ; drug therapy ; Male ; Neoplasm, Residual ; diagnosis ; Prognosis ; Remission Induction

OBJECTIVETo assess the prognostic value of the biological features and therapy-related factors in childhood acute myeloid leukemia (AML).

METHODSFrom January 1998 to May 2003, 75 patients with newly diagnosed AML were enrolled on the protocol AML-XH-99. Biological features at presentation [gender, age, white blood cells, platelet count, French-American-British (FAB) subtypes, cytogenetic abnormalities] and therapy-related factors [bone marrow (BM) blast cell counts at 48 h after the first induction course, complete remission (CR) rate after the first course of induction therapy] were analyzed. The probability of event-free survival (pEFS) was estimated by Kaplan-Meier analysis and the distributions of pEFS were compared using log-rank test. Chi-square analysis or Fisher exact test was used to compare differences in the distribution of presenting biological features. A Cox proportional hazards model was used to identify independent prognostic factors.

RESULTS(1) Univariate analysis of the proportion of patients attaining CR after induction indicate that FAB M(5), BM blasts >or= 0.150 at 48 h after the first induction course and no response to the first induction course were associated with lower CR rates (P = 0.001, 0.011, 0.000 respectively). Univariate analysis also demonstrated that the 5-year pEFS for patients with age < 1 year or > 10 years, platelet count < 20 x 10(9)/L, FAB M(5), hepatomegaly, BM blasts >or= 0.150 at 48 h after the first induction course and no response to the first induction course, central nervous system (CNS) leukemia was unfavorable, while the outcome of patients with cytogenetic abnormalities of t (8; 21) or t (15; 17) were better. (2) Multivariate analysis suggested that cytogenetic abnormality of t (15; 17), achieved CR after the first induction course and no CNS leukemia were independent favorable prognostic factors.

CONCLUSIONSCombined analysis of cytogenetic abnormalities with early treatment response has an important prognostic significance, and can predict outcomes.

Adolescent ; Child ; Child, Preschool ; Chromosome Aberrations ; Disease-Free Survival ; Female ; Humans ; Infant ; Karyotyping ; Leukemia, Myeloid, Acute ; diagnosis ; drug therapy ; therapy ; Male ; Prognosis ; Treatment Outcome

OBJECTIVEEarly response to therapy is one of the most important prognostic factors in childhood acute lymphoblastic leukemia (ALL). This study aimed to assess the prognostic value of morphological assessment of bone marrow blasts during remission induction and determination of minimal residual disease (MRD) after remission induction.

METHODSFrom January 1998 to May 2003, 193 children with newly diagnosed ALL were enrolled on the ALL-XH-99 protocol. Blast cell count in the bone marrow was examined on day 19 of remission induction and by the completion of remission induction. MRD was measured with the flow cytometry. Event-free survival (EFS) was estimated by Kaplan-Meier analysis and the distributions of EFS were compared using the log-rank test. A Cox proportional hazards model was used to identify independent prognostic factors.

RESULTSThe 4-year EFS was significantly worse in patients with > or = 5% lymphoblasts in the bone marrow on day 19 as compared to those with <5% lymphoblasts on that date (42.59%+/- 14.28% vs 74.24%+/- 6.67%; p< 0.01). The 4-year EFS was significantly worse in patients with any amount of lymphoblasts in the bone marrow on the remission date as compared to that of other patients with no morphologically identifiable blasts (63.47%+/-9.23% vs 76.41%+/- 6.09%; p<0.05). The patients with MRD <0.01 had significantly better outcome than those with a level > or = 0.01% (15-month EFS:94.44%+/-5.40% vs 23.81%+/- 20.26%; p<0.01).

CONCLUSIONSEarly treatment response as assessed by morphological examination or minimal residual leukemia determination by flow cytometry has important prognostic significance, and can be performed in a resource-poor patient population.

Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Male ; Neoplasm, Residual ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; drug therapy ; mortality ; pathology ; Prognosis ; Proportional Hazards Models ; Treatment Outcome