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1.
Journal of Gynecologic Oncology ; : e82-2021.
Article in English | WPRIM | ID: wpr-915114

ABSTRACT

Objective@#The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. @*Methods@#PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). @*Results@#Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11–1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16–2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. @*Conclusion@# @*Results@#in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer.

3.
General Medicine ; : 13-22, 2013.
Article in English | WPRIM | ID: wpr-374898

ABSTRACT

<b>Background:</b> Gingyo-gedoku-san (GGGS) is an herbal medicine approved for upper respiratory infections in Japan. We conducted an open-label, multi-center, prospective trial, comparing GGGS with oseltamivir in patients with influenza and influenza-like illness (ILI) as a pilot study.<br><b>Methods:</b> Subjects were healthy persons aged between 16 and 40, and were enrolled from January 12, 2010 to March 24, 2011. Fifteen patients were enrolled in this trial (8 and 7 for GGGS and oseltamivir, respectively). RT-PCR was positive for pandemic influenza A (H1N1) in 10 patients. The patients were provided with either GGGS or oseltamivir for 5 days. The primary outcome was mortality and/or hospitalization 7 days after the initial diagnosis. Body temperature and other clinical characteristics were also evaluated.<br><b>Results:</b> All patients recovered from illness without complication or hospitalization. The mean time to resolve symptoms for the GGGS and oseltamivir groups was 3.9 days and 3.3 days, respectively (p=0.43). The GGGS group appeared to have a smaller symptom score AUC than the oseltamivir group, (p=0.26). Time to recover activity level appeared to be shorter in the GGGS group (p=0.10), with shorter time to recover health status (p=0.02). Sub-group analysis on patients with positive PCR showed similar results between the two groups.<br><b>Conclusion:</b> GGGS was associated with symptom improvements resembling oseltamivir for both influenza and ILI. Randomized controlled trials involving larger sample sizes are needed to confirm these results.

4.
Japanese Journal of Physical Fitness and Sports Medicine ; : 31-40, 1991.
Article in Japanese | WPRIM | ID: wpr-376846

ABSTRACT

The purpose of this study was to clarify some of the characteristics of race-walking, especially the relationship between walking speed and oxygen requirement, and stride in race-walking and normal walking, and to examine whether race-walking is effective for the maintenance and promotion of health.<BR>The subjects were five male race-walkers (race-walker group) and five male college students (control group) .<BR>The results obtained were as follows:<BR>1. Under race-walk conditions, the highest speeds attained in the race-walker and control groups were 200-220 m/min and 160 m/min, respectively. Under normal walking conditions, however, the values were 140 m/min in both groups.<BR>2. A lower oxygen requirement was observed at slower speed during normal walking and at a higher speed (over 130 m/min) during race-walking.<BR>3. Oxygen requirement (ml/kg/100 m) in the race-walker group was minimal at 60-80 m/min during race-walking and at 60 m/min during normal walking. Values in the control group were minimal at 60 m/min under both walking conditions.<BR>4. The oxygen requirement in the race-walker group was less than that of the control group under both walking conditions.<BR>5. Under normal walking conditions, as the speed increased, both step-length and step frequency gradually increased, until step-length reached a limit of 80 cm. Thereafter, walking was maintained only by an increase in step frequency. However, in the race-walkes group, the subjects were capable of increasing their step-length further, and maintaining a higher speed (up to 220 m/min) .<BR>6. It was suggested that race-walking is one of the most efficient exercises for maintaining and improving health.

5.
Japanese Journal of Physical Fitness and Sports Medicine ; : 31-40, 1991.
Article in Japanese | WPRIM | ID: wpr-371515

ABSTRACT

The purpose of this study was to clarify some of the characteristics of race-walking, especially the relationship between walking speed and oxygen requirement, and stride in race-walking and normal walking, and to examine whether race-walking is effective for the maintenance and promotion of health.<BR>The subjects were five male race-walkers (race-walker group) and five male college students (control group) .<BR>The results obtained were as follows:<BR>1. Under race-walk conditions, the highest speeds attained in the race-walker and control groups were 200-220 m/min and 160 m/min, respectively. Under normal walking conditions, however, the values were 140 m/min in both groups.<BR>2. A lower oxygen requirement was observed at slower speed during normal walking and at a higher speed (over 130 m/min) during race-walking.<BR>3. Oxygen requirement (ml/kg/100 m) in the race-walker group was minimal at 60-80 m/min during race-walking and at 60 m/min during normal walking. Values in the control group were minimal at 60 m/min under both walking conditions.<BR>4. The oxygen requirement in the race-walker group was less than that of the control group under both walking conditions.<BR>5. Under normal walking conditions, as the speed increased, both step-length and step frequency gradually increased, until step-length reached a limit of 80 cm. Thereafter, walking was maintained only by an increase in step frequency. However, in the race-walkes group, the subjects were capable of increasing their step-length further, and maintaining a higher speed (up to 220 m/min) .<BR>6. It was suggested that race-walking is one of the most efficient exercises for maintaining and improving health.

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