- 著者
- Wataru Takahashi Toshiko Mizuno Kaori Hara Yoshiaki Ara Rikiya Hurutani Toshihiko Agatsuma Minoru Fujimori
- 出版者
- The Japanese Society of Internal Medicine
- 雑誌
- Internal Medicine (ISSN:09182918)
- 巻号頁・発行日
- pp.9699-22, (Released:2022-08-20)
- 参考文献数
- 14
- 被引用文献数
- 2
Objectives The influential factors for anti-severe acute respiratory syndrome coronavirus 2 spike protein antibody (S-ab) levels were assessed after the administration of BNT162b2 mRNA coronavirus disease-2019 (COVID-19) vaccine at short and medium terms. Methods A total of 470 healthcare workers (118 males, mean age 41.0±11.9 years) underwent serum S-ab level measurement at 3 and 8 months after two inoculations of BNT162b2 vaccine given 3 weeks apart, who had no history of COVID-19 were enrolled in this study. The changes and differences after vaccination due to gender and adverse reactions of S-ab were analyzed. Results Systemic adverse reactions incidence (48%) was significantly higher after the second dose than after the first dose (8%). S-ab levels decreased as the age increased (from the 20s to 60s) in both measurements. S-ab level 8 months after the second inoculation (median 476.3 [interquartile range {IQR} 322.4-750.6] U/mL) was significantly lower than that after 3 months (977.5 [637.2-1409.0] U/mL; P <0.001). The median decrease rate of S-ab levels in 5 months was 50.3 (IQR 40.3-62.6) % and those differences were not observed among all generations. Gender-associated differences in S-ab levels were not observed; however, a significant relationship between higher S-ab levels and the systemic adverse reactions was observed at both measurements. Conclusions The systemic adverse reaction is an independent factor for higher S-ab levels at short and medium terms after BNT162b2 vaccination as demonstrated in our data.
- 著者
- Naoki Sato Wataru Takahashi Atsushi Hirayama Masayoshi Ajioka Naoto Takahashi Kaoru Okishige XingLi Wang Akio Maki Hideki Maruyama Ursula Ebinger Masayuki Yamaguchi Yinuo Pang Hiroki Matsumoto Masatoshi Kawana
- 出版者
- 日本循環器学会
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-15-0227, (Released:2015-04-24)
- 参考文献数
- 27
- 被引用文献数
- 4 16
Background:Serelaxin, a recombinant form of human relaxin-2, is in development for treating acute heart failure (AHF) and a Phase II study in Japanese AHF patients was conducted.Methods and Results:A randomized, double-blind, placebo-controlled study of serelaxin at 10 and 30 µg·kg–1·day–1continuous intravenous infusion for up to 48 h, added to standard care for Japanese AHF patients. Primary endpoints were adverse events (AEs) through Day 5, serious AEs (SAEs) through Day 14, and serelaxin pharmacokinetics. Secondary endpoints included changes in systolic blood pressure (SBP) and cardiorenal biomarkers. A total of 46 patients received the study drug and were followed for 60 days. The observed AE profile was comparable between the groups, with no AEs of concern. Dose-dependent increase in the serum concentration of serelaxin was observed across the 2 dose rates of serelaxin. A greater reduction in SBP was observed with serelaxin 30 µg·kg–1·day–1vs. placebo (–7.7 [–16.4, 1.0] mmHg). A greater reduction in NT-proBNP was noted with serelaxin (–50.8% and –54.9% for 10 and 30 µg·kg–1·day–1, respectively at Day 2).Conclusions:Serelaxin was well tolerated in this study with Japanese AHF patients, with no AEs of concern and favorable beneficial trends on efficacy. These findings support further evaluation of serelaxin 30 µg·kg–1·day–1in this patient population.