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1.
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.
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.

5.
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.

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