1.Improvement of Thoracic Pressure-Volume, Complincace and Histological Characteristics in Premature Newborn Rabbit after Treatment of Bovine Purified Natural Surfactant-Phospholipid.
Chong Woo BAE ; Chang Il AHN ; Haruo MAETA ; Tetsuro FUJIWARA
Journal of the Korean Pediatric Society 1994;37(2):157-166
We had previously reported the purification of bovine lung natural surfactant-phospholoipd (PNSL)and the assessment of it's surface physical properties in vitro. To observe the clinical effectiveness of PNS-L in vivo, the degree of improvement of thoracic pressure-volume, compliance and histological changes following PNS-L instilation in premature rabbits with respiratory distress syndrome(RDS)were investigated. Rabbits, delivered prematurely by cesarean section at 27 days, treated with PNS-L via tracheostomy, were enrolled the study group. Two control groups were premature RDS rabbits (no treatment with PNS-L)and mature rabbits. We compared the results of thoracic pressure-volume changes during deflation phase and lung compliance changes among PNS-L treated study group and two control groups, and compared the results of aefated lung area ratio (%) on histologic samples among PNS-L treated study group and two control groups by the methods of IBSA-2000. There were significant improvements of thoracic pressure-volume during duflation phase(p<0.001), lung compliance (p<0.01, p<0.005, p<0.001) and increased acrated area histologically (p<0.005)in PNS-L treated study group compared with premature control group. It was suspected that PNS-L had contained the effective survace physical properties as a function of pulmonary surfactant. And improvement of pulmonary ventilatory functions and histological characteristics, were observed in PNS-L treated RDS model in vivo study.
Cesarean Section
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Compliance
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Female
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Humans
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Infant, Newborn*
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Lung
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Lung Compliance
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Pregnancy
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Pulmonary Surfactants
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Rabbits
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Tracheostomy
2.Background Leading To The Development of Surfactant Replacement Therapy.
Journal of the Korean Society of Neonatology 1997;4(1):101-105
No abstract available.
3.Hemodynamic Changes Following Surfactant Therapy in Infants With Respiratory Distress Syndrome.
Senji SHIMADA ; Takeo KASAI ; Atsuki HOSHI ; Atsushi MURATA ; Shoichi CHIDA ; Tetsuro FUJIWARA
Journal of the Korean Society of Neonatology 1997;4(1):111-118
No abstract available.
Hemodynamics*
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Humans
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Infant*
4.Diagnostic Approach and Surfactant Treatment in RDS.
Shoichi CHIDA ; Tetsuro FUJIWARA ; Senji SHIMADA ; Takeo KASAI ; Atsushi MURATA ; Atsuki HOSHI
Journal of the Korean Society of Neonatology 1997;4(1):106-110
No abstract available.
5.Randomized phase III trial comparing pegylated liposomal doxorubicin (PLD) at 50 mg/m2 versus 40 mg/m2 in patients with platinum-refractory and -resistant ovarian carcinoma:the JGOG 3018 Trial
Takashi MOTOHASHI ; Akira YABUNO ; Hiroshi MICHIMAE ; Tetsuro OHISHI ; Miwa NONAKA ; Masashi TAKANO ; Shin NISHIO ; Hiroyuki FUJIWARA ; Keiichi KEIICHI ; Eiji KONDO ; Toru SUGIYAMA ; Tsutomu TABATA
Journal of Gynecologic Oncology 2021;32(1):e9-
Objective:
The standard dose for pegylated liposomal doxorubicin (PLD) is 50 mg/m2 every 4 weeks. While 40 mg/m2 has recently been used in clinical practice, evidence supporting this use remains lacking.
Methods:
This phase III randomized, non-inferiority study compared progressionfree survival (PFS) for patients with platinum-resistant ovarian carcinoma between an experimental arm (40 mg/m2 PLD) and a standard arm (50 mg/m2 PLD) until 10 courses, disease progression or unacceptable toxicity. Eligible patients had received ≤2 prior lines.Stratification was by performance status and PFS of prior chemotherapy (<3 months versus ≥3 months). The primary endpoint was PFS and secondary endpoints were overall survival (OS), toxicity profile, clinical response and tolerability. The total number of patients was 470.
Results:
The trial was prematurely closed due to slow recruitment, with 272 patients randomized to the experimental arm (n=137) and standard arm (n=135). Final analysis was performed with 234 deaths and 269 events for PFS. In the experimental arm vs. standard arm, median PFS was 4.0 months vs. 4.0 months (hazard ratio [HR]=1.065; 95% confidence interval [CI]=0.830–1.366) and median OS was 14.0 months vs. 14.0 months (HR=1.078; 95% CI=0.831–1.397). Hematologic toxicity and oral cavity mucositis (≥grade 2) were more frequent in the standard arm than in the experimental arm, but no difference was seen in ≥grade 2 hand-foot skin reaction.
Conclusion
Non-inferiority of 2 PLD dosing schedule was not confirmed because the trial was closed prematurely. However, recommendation of dose reduction of PLD should be based both on efficacy and safety.