[Clinical effect and safety of pegylated interferon-α-2b injection (Y shape, 40 kD) in treatment of HBeAg-positive chronic hepatitis B patients].

Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion: In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.

Effect of miR-212 targeting TCF7L2 on the proliferation and metastasis of cervical cancer.

OBJECTIVE: MicroRNAs (miRs) function as either oncogenes or tumor suppressors in the progression of various human cancers, including cervical cancer. This study aimed to explore the role of miR-212 in cervical cancer and the mechanisms underlying this role. PATIENTS AND METHODS: Quantitative real-time polymerase chain reaction (RT-PCR) and Western blot assays were used to determine the expression levels of miR-212 and TCF7L2 in the cervical cancer cells. Cell proliferation invasion was examined using BrdU assays and transwell, respectively. A bioinformatics analysis was used to predict targets, and a dual-luciferase reporter system was applied for validation. RESULTS: In our study, we demonstrated that miR-212 expression was significantly downregulated in cervical cancer tissues and cell lines. Moreover, the increased expression of miR-212 suppressed cell proliferation and invasion of cervical cancer cell lines in vitro. On the contrary, the decreased expression of miR-212 promoted cell proliferation and invasion of cervical cancer cell lines. Finally, the results of Western blot showed that overexpression of miR-212 dramatically suppressed the protein expression of TCF7L2. The knockdown of miR-212 showed the contrary effect. Luciferase reporter assay identified TCF7L2 as a novel direct target of miR-212. CONCLUSIONS: Our results revealed that miR-212 inhibited cervical cancer metastasis and progression by targeting TCF7L2 expression.

Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial.

Tenofovir disoproxil fumarate (TDF) has demonstrated long-term efficacy and a high barrier to resistance in multiple chronic hepatitis B (CHB) populations outside of China. This study aimed to evaluate the efficacy and safety of TDF compared with adefovir dipivoxil (ADV) in Chinese patients with CHB during 48 weeks of treatment (ClinicalTrial.gov number, NCT01300234). A Phase 3, multicentred, randomized, double-blind, controlled trial compared the efficacy and safety of TDF with ADV in Chinese patients with CHB. The primary endpoint was the proportion of patients with HBV DNA <400 copies/mL in each treatment group at Week 48, using an unpooled Z-test for superiority. Secondary endpoints included viral suppression, serologic response, histological improvement, normalization of alanine aminotransferase (ALT) levels and the emergence of resistance mutations. A total of 509 patients, 202 hepatitis B e antigen (HBeAg)-positive and 307 HBeAg-negative, with HBV DNA ≥10(5) copies/mL received either TDF 300 mg od or ADV 10 mg od. At Week 48, TDF demonstrated superior viral suppression compared with ADV in both HBeAg-positive (76.7% vs 18.2%, P < 0.0001) and HBeAg-negative (96.8% vs 71.2%, P < 0.0001) patients. The majority of patients in both treatment arms achieved ALT normalization (>85%). No resistance to TDF was observed. The frequency of adverse events was comparable between treatment arms (TDF 3.9% vs ADV 4.8%). In this double-blind, randomized, clinical trial, TDF demonstrated superiority over ADV with respect to viral suppression in Chinese patients with CHB at 48 weeks of treatment and without the development of resistance.

Efficacy and safety of entecavir treatment in a heterogeneous CHB population from a 'real-world' clinical practice setting in China.

Chronic hepatitis B infection is an important cause of liver-related mortality in China. This study assessed the efficacy and safety of entecavir in a heterogeneous patient population from a 'real-world' clinical practice setting in China. This prospective, observational cohort provides 48-week data on 2600 patients from 50 sites in China who received entecavir (0.5 or 1.0 mg) and were assessed for virologic, serologic and biochemical responses. Patients were nucleos(t)ide-na€ive or -experienced and had compensated or decompensated liver function. At Week 48, 1545/2424 (64%) patients with compensated liver disease and 30/44 (68%) patients with decompensated liver disease achieved HBV DNA<50 IU/mL. Greater proportions of nucleos(t)ide-na€ive than nucleos(t)ide-experienced (69% vs 53%), and adefovir-experienced than lamivudine/ telbivudine-experienced (62% vs 52%) patients achieved this endpoint. Most patients with HBV DNA<50 IU/mL also achieved HBV DNA<12 IU/L (60%, 45% and 61% of nucleos(t)ide-na€ive, nucleos(t)ide-experienced and decompensated patients, respectively). In patients with compensated liver disease, ALT values normalized in 1532/1792 patients (85%), and HBeAg loss and HBeAg seroconversion were observed in 17% and 15% of treatment-na€ive and 15% and 11% of treatment-experienced patients. Entecavir was generally well tolerated. Adverse event rates were comparable between treatment-na€ive and treatment-experienced patients with compensated liver disease, but were higher in decompensated than in compensated patients, consistent with previous reports in these patients with more advanced disease. Four patients discontinued treatment due to adverse events. In a 'real-world' setting, entecavir was efficacious and well tolerated throughout 48 weeks in a heterogeneous Chinese CHB population.

Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C.

UNLABELLED: As there is currently a lack of consensus on the most appropriate dose and duration of peginterferon alfa-2a (PEG-IFNα-2a) therapy in hepatitis B e antigen (HBeAg)-positive patients, the efficacy and safety of either 24 or 48 weeks' duration and 90 µg/week or 180 µg/week doses were compared. HBeAg-positive patients (n = 544; 34% genotype B, 51% genotype C) were randomized to receive PEG-IFNα-2a (2 × 2 factorial design) for 24 or 48 weeks and at 90 µg/week or 180 µg/week and included in the per-protocol population. The primary efficacy endpoint of the noninferiority study was HBeAg seroconversion 6 months posttreatment. The prespecified odds ratio (OR) noninferiority margin was 1.88 with a one-sided significance level of 0.025. The highest rates of HBeAg seroconversion 6 months posttreatment were in the 180/48 arm (36.2% versus 14.1%-25.8% in the other arms). When the dose and duration arms were pooled, the OR for noninferiority of 24 weeks versus 48 weeks was 2.17 (95% confidence interval [CI] 1.43, 3.31; P = 0.749) and for 90 µg versus 180 µg was 1.79 (95% CI 1.18, 2.72; P = 0.410). As the upper limit of the 95% CI of the ORs were >1.88, 24 weeks were inferior to 48 weeks and 90 µg/week was inferior to 180 µg/week. The highest rates of response in the 180/48 arm were achieved by patients with HBsAg <1,500 IU/mL at Week 12 (58%) or Week 24 (57%), whereas patients with HBsAg >20,000 IU/mL did not respond. Adverse events were typical of those associated with PEG-IFNα-2a. CONCLUSION: Compared with lower doses and shorter durations, the licensed PEG-IFNα-2a treatment regimen (180 µg/48 weeks) was the most efficacious and beneficial for HBeAg-positive patients predominantly infected with hepatitis B virus genotypes B or C.

Perceptual color image coding with JPEG2000.

A perceptual color image coder (PCIC) is presented for the YC(b)C(r) color space within the framework of JPEG2000. This coder employs a vision model based perceptual distortion metric (PDM) to approximate perceived error for rate-distortion (R-D) optimization in order to maximize the visual quality of coded images. The vision model employed in the PCIC is structurally based on an existing monochromatic multichannel vision model, which is extended for color image coding. Subjective tests with 30 viewers show that the PCIC provides superior picture quality at low to intermediate bitrates in comparison with a JPEG2000 compliant coder employing the mean squared error (MSE) and the visual distortion metric (Cvis) as distortion measures, respectively.

Incidence of bacterial meningitis in Asia using enhanced CSF testing: polymerase chain reaction, latex agglutination and culture.

To enhance the detection of bacterial meningitis in an East Asian surveillance study, we employed cerebrospinal fluid (CSF) bacterial culture, latex agglutination (LA) and polymerase chain reaction-enzyme immunoassay (PCR-EIA) testing for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae (Sp). The sensitivity and specificity of CSF PCR-EIA testing was compared to LA and culture. A meningitis case was defined by one positive result for any of the three tests. The sensitivity of H. influenzae CSF PCR-EIA, LA, and culture was 100%, 40% and 57.5% respectively; and for Sp CSF PCR-EIA, LA and culture, the sensitivity was 100%, 58.3% and 66.7%, respectively. Hib and Sp specificity was 100% by each method. CSF PCR-EIA was more sensitive than culture or LA for the detection of Hib and Sp meningitis cases increasing their incidence by 74% and 50% compared to culture respectively. CSF PCR-EIA should be included for the detection of bacterial meningitis in surveillance studies.

Comparison of forearm and conventional Bier's blocks for manipulation and reduction of distal radius fractures.

Forearm-based Bier's block has been advocated as a useful anaesthesic technique in hand surgery. However, there is limited data comparing forearm blocks with the conventional Bier's block. We conducted a randomised controlled trial (n=30) comparing the two techniques of anaesthesia for manipulation and reduction of closed distal radius fractures in an emergency room setting. Pain scores measured using the Visual Analogue Scale during the procedure were used as the primary outcome assessment. There was no significant difference in pain scores between the forearm and conventional Bier's block (mean VAS 18.4 SD 22.10 versus 33.7 SD 29.6). No major complications were observed in either group. The forearm-based Bier block is an effective alternative to the conventional block.

Association between tumour necrosis factor gene polymorphisms and the clinical types of patients with chronic hepatitis B virus infection.

A PCR restriction fragment length polymorphism assay was used to analyse single-nucleotide polymorphisms in the tumour necrosis factor (TNF)-alpha and TNF-beta genes of 56 patients with chronic severe hepatitis B virus (HBV) infection, 71 patients who either had chronic mild HBV infection or who were asymptomatic carriers, and 90 healthy controls. The serum TNF-alpha concentrations in patients with chronic severe HBV infection were compared to those of 30 healthy controls by radioimmunoassay. The frequencies of the TNF1/2 genotype and the TNF2 allele were greater in patients with chronic severe HBV infection than in healthy controls (25% vs. 11.1%, p 0.015; 12.5% vs. 5.6%, p 0.036, respectively) and patients with chronic mild HBV infection and asymptomatic carriers (25% vs. 8.8%, p 0.011; 12.5% vs. 4.2%, p 0.015, respectively). Heterozygotes carrying the TNF2 allele had higher levels of serum TNF-alpha than homozygotes for the wild-type allele among all patients with chronic severe HBV infection (p <0.01). The genotype distribution and allele frequency of TNF-beta were similar for patients with chronic severe HBV infection and healthy controls, but the frequency of the TNF-beta*2/2 genotype in patients with chronic mild HBV infection and asymptomatic controls was lower than for healthy controls (9.9% vs. 22.4%, p 0.043) or patients with chronic severe HBV infection (9.9% vs. 26.8%, p 0.043), although this was not significant after correction for multiple testing. It was concluded that TNF-alpha gene polymorphisms may play an important role as a host factor in the progression of HBV infection.

Polycolonization of Helicobacter pylori among Chinese subjects.

OBJECTIVE: To investigate the situation among Chinese patients with regard to infection with multiple strains of Helicobacter pylori. METHODS: Biopsy specimens for culture of H. pylori were obtained from gastric antrum, body and fundus of 20 patients during endoscopic investigation of upper gastrointestinal symptoms. H. pylori was identified by culture from one site in 16 and two or more sites in 10 of the 16 patients. Five isolated colonies of six strains of H. pylori from gastric antrum were subcultured and used for further analysis. Antibiotic susceptibility to metronidazole and clarithromycin was determined by disk diffusion test. Protein profiles of isolates were compared by sodium dodecylsulfate-polyacrylamide gel electrophoresis (SDS-PAGE). DNA diversity of the isolates was determined by arbitrarily primed polymerase chain reaction (AP-PCR) fingerprinting. RESULTS: Of the 10 patients with multiple isolates, 70% (7/10) exhibited variation in susceptibility to metronidazole and 20% (2/10) to clarithromycin between different sites. In 83% of (5/6) single colonies, no variability was seen in metronidazole and clarithromycin susceptibility; they were either susceptible or resistant. Protein profiles of all isolates by SDS-PAGE were similar. Isolates from different patients produced clearly different AP-PCR fingerprints. In 50% of H. pylori strains isolated from different sites of the stomach, genetic diversity was demonstrated by different AP-PCR fingerprints. In 67% (4/6) strains, five single-colony fingerprints were similar. CONCLUSIONS: Genetic variability has been found in H. pylori strains. Individual patients are infected with a single predominant genotype at a single site but can be colonized by multiple strains, and they may show different antibiotic susceptibilities. Individual colonies of the H. pylori population from a single site may not always yield identical DNA fingerprints and antibiotic sensitivities.

[Inhibitory effect of the combination of DHPAs and hyperbaric oxygen on Japanese B encephalitis virus infection in mice].

OBJECTIVE: To investigate the inhibitory effect of the combination of 2,3-dihydroxypropyl-adenine (DHPAs) and hyperbaric oxygen (HBO) on Japanese B encephalitis virus infection in mice. METHODS: Mice infected P3-55 and P3-53 virus were used in the experiments. Virus was inoculated intraperitoneally to Kumming strain mice (8.5-9.5 g). Mice were divided into groups and treated in the incubation period of the infection. The duration of treatment was 5 days, and the experiments were terminated at the end of 2 weeks after treatment. The living and the dead were then counted finally. RESULTS: The intergroup comparison showed marked difference between the control group and combination of DHPAs and hyperbaric oxygen group (P < 0.025 and P < 0.01), but there was no statistical difference between other groups and the control group (P > 0.05). CONCLUSION: The combined treatment of (S) DHPA and/or (RS)-DHPA and HBO has inhibitory effect on Japanese encephalitis virus infection in experimental mice.

[Effect of artificial liver support system on the patients with severe hepatitis].

OBJECTIVE: To study the effective treatment for severe hepatitis. METHODS: The severe hepatitis patients were treated by artificial liver support system on basis of the generalized treatment. RESULTS: After treatment the level of serum total bilirubin was significant decreased (P < 0.01); the level of aminotransferase were significant decreased (P < 0.01); the prothrombin time was significantly shortened(P < 0.05). The survival rate of severe hepatitis was significantly increased(72%, 31/43)(P < 0.05). CONCLUSION: The artificial liver support system can elevate the survival rate of severe hepatitis.

Diversity of Helicobacter pylori among Chinese persons with H. pylori infection.

To determine whether there is diversity among clinical isolates of Helicobacter pylori in Chinese patients with peptic ulcer disease, 40 strains of H. pylori were isolated from antral biopsy specimens obtained at the gastroenterology clinic of Xiangya Hospital from January 1996 to June 1998. Total protein profile by sodium dodecyl sulphate-polyacrylamide gel electrophoresis (SDS-PAGE) and DNA diversity by polymerase chain reaction-random amplified polymorphic DNA (PCR-RAPD) fingerprinting were performed with these isolates. All the isolates from peptic ulcer disease were relatively homogeneous in protein profiles, but they showed a great DNA sequence diversity by PCR-RAPD fingerprinting. In Chinese patients H. pylori demonstrated an enormous diversity. The diversity among clinical isolates of H. pylori could be distinctly demonstrated and this observation will be helpful in the management of intrafamilial and recurrent H. pylori infection. PCR-RAPD fingerprinting is an efficient method of distinguishing between clinical isolates of H. pylori.

[A study of the autoimmune pathogenesis of chronic HCV infection].

To explore the autoimmune pathogenesis of chronic hepatitis C virus(HCV) infection. Anti-GOR, antinuclear antibodies(ANA), thyroglobulin antibody(TGA), thyroid microsome antibody(TMA), serum levels of soluble Fas(sFas), and peripheral blood lymphocyte(PBMC) subsets and their apoptosis were measured in chronic HCV infection by using immunity assay and flow cytometry, respectively. The results showed that the positive rates of anti-GOR, ANA and TMA/TGA were significantly higher in chronic HCV-infected patients than those in normal controls(P < 0.01, respectively). In comparison with chronic HBV infected patients, anti-GOR and ANA were also significantly increased in chronic HCV infected patients(P < 0.01, P < 0.05, respectively). The serum levels of sFas were significantly higher in chronic HCV infection than those in healthy donors(P < 0.01). The apoptosis percentage of PBMCs and CD3+ cell was all increased in chronic HCV infection (vs normal controls P < 0.05). However, the apoptosis percentages of CD4+ T and CD19+ B cells in PBMCs were significantly decreased in patients with anti-GOR positive as compared with anti-GOR negative(P < 0.01, P < 0.05). The results indicate that autoimmune reactions and the imbalance of lymphocyte apoptosis exist during chronic HCV infection. Decreasing of the apoptosis of CD4+ T and CD19+ B lymphocytes may be the important reasons for the mechanism of autoimmune pathogenesis of chronic HCV infection. Increased serum levels of sFas may be responsible for the decrease of the apoptosis in a part of lymphocytes in chronic HCV infection.

Circulating Th1 and Th2 cytokines in patients with hepatitis C virus infection.

The imbalance of T-helper (Th) lymphocyte cytokine production may play an important role in immunopathogenesis of persistent hepatitis C virus (HCV) infection. To know whether an imbalance between Th1 and Th2 cytokines is present in chronic HCV infection, serum levels of Th1 cytokines, interferon gamma (IFN-gamma) and interleukin (IL)-2, and Th2 cytokines, IL-4 and IL-10, were measured using enzyme-linked immunosorbent assay in this study. Eighteen individuals with chronic HCV infection, 11 healthy subjects as normal controls and 10 chronic HBV infected patients as disease controls were observed. The results showed that the levels of Th2 cytokines (IL-4 and IL-10) were significantly increased in chronic HCV infected patients compared with normal controls (IL-4: 30.49+/-17.55 vs. 14.94+/-13.73, pg/ml, P<0.025; IL-10: 50.30+/-19.59 vs. 17.87+/-9.49, pg/ml, P<0.001). Similarly, the levels of Th1 cytokine, IL-2, was also elevated in individuals with chronic HCV infection when compared with normal controls (IL-2: 118.53+/-95.23 vs. 61.57+/-28.70, pg/ml, P<0.05). However, Th1 cytokine IFN-gamma level was not significantly changed during HCV infection (IFN-gamma: 28.09+/-15.65 vs. 24.10+/-15.61, pg/ml, P>0.05). Furthermore, the elevated levels of Th2 cytokines are greater than Th1 cytokines in HCV infection. Thus, the study indicates that an enhanced Th2 responses are present during chronic HCV infection, which may partly be responsible for the persistence of HCV infection.

Molecular cloning, sequencing and expression of core and NS3 fragments of HCV from patients with HCV infection.

Fragments of core and NS3 of hepatitis C virus-Hunan (HCV-Hun) were cloned by RT-PCR and gene recombinant techniques from blood samples collected in Hunan Province, China. In comparison with sequences of our samples with those of HCV-US and HCV-J, the homologies of nucleotides and amino acids were about 90%, indicating that fragments of core and NS3 of HCV-Hun were in a relative conserved region of HCV. Two fusion proteins containing the peptides coded by HCV core (MBP-HCV core) and HCV. NS3 (MBP-HCV. NS3-Gal) were expressed by Escherichia Coli with recombinant plasmids. The specific HCV antigenicity of the two fusion proteins were identified by western blotting. Therefore, MBP-HCV. core and MBP-HCV.NS3-Gal were found useful for anti-HCV assay.

[Molecular cloning and sequencing of hepatitis C virus gene from human blood].

To clone and characterize hepatitis C virus strain in China, we extracted RNA from the pooled plasma of persons with HCV infection in Hunan, China. HCV gene was amplified and cloned by RT-PCR and gene recombinant techniques. A total of 2,307 nucleotides of the complementary DNA clones of HCV (HCV-Hun), including the clone of 5' noncoding region (311bp), core region (340bp), envelope region (397bp), NS1 region (634bp), NS3 region (245bp), and NS5 region (380bp) were isolated and identified. The homologies in nucleotide sequence between HCV-Hun and HCV-US or HCV-J were 98.1% and 98.7% respectively in 5' noncoding region; 92.6% and 97.4% in core region; 74.3% and 88.7% in envelope region; 83.5% and 91.0% in NS1 region; 82.9% and 94.7% in NS3 region; and 74.8% and 90.1% in NS5 region. The similar results were seen in deduced amino acid sequence homologies between above HCV stains. These findings indicate that HCV-Hun were more mimic to HCV-J than HCV-US, and there were considerable heterogeneity in hepatitis C virus genomes isolated from different areas of the world.

[Detection of serum antibody against hepatitis C virus in patients with hepatitis and liver diseases].

Antibody against hepatitis C virus (anti-HCV) was tested in 658 cases of hepatitis and liver diseases with ELISA, ninety of these cases were positive, with a total infection rate of 13.68% (90/658). The positive rate of anti-HCV was highest in patients with chronic severe hepatitis (33.78%) and CAH accompanied by cirrhosis of liver(31.58%). The infection rate in other types of hepatic diseases in order of frequency was as follows: fulminant hepatitis (18.18%), CAH without cirrhosis (15.13%), subacute severe hepatitis (13.43%), CPH (5.88%), primary hepatocellular carcinoma (3.85%), and acute hepatitis (2.42%). Serological markers of HBV infection were detectable concomitantly in 77 of the 90 cases who were anti-HCV positive, but there was no evidence of mutual inhibition of viral replication. There was neither appreciable difference in the level of hyperbilirubinemia in cases of hepatitis with or without anti-HCV, nor significant diversity in the number of death between cases of severe hepatitis with and without anti-HCV.

Effects of a minimally supervised exercise program for mentally retarded adults.

Previous exercise studies that attempted to improve the cardiovascular fitness (CVF) of mentally retarded (MR) adults were flawed with methodological shortcomings that prevented conclusive results. At issue in these training studies were fitness test validity and reliability, exactness of duration and intensity of training, and an inordinate amount of supervision. Therefore, we sought to determine whether moderately MR adults (seven males, five females; IQ = 61 +/- 3, age = 25 +/- 3 yr) could improve their CVF through a minimally supervised 16-wk training program. Each subject repeated exercise tests twice on two different modes of exercise, the treadmill (TM) and Schwinn Air-Dyne ergometer (SAE), before training to ensure validity and reliability of initial CVF levels. Intensity and frequency of exercise were closely monitored. An observer was present during the training bouts, but, following initial instructions, no additional encouragement or instructions were given. Although the training program significantly increased peak VO2 (29.2 +/- 8 to 33.5 +/- 9 ml.kg-1.min-1) and peak ventilation (73 +/- 26 to 81 +/- 231.min-1) when assessed on the TM, significant changes in these same parameters were not seen when assessed on the SAE. The importance of these results was discussed.