- 著者
- Kentaro Iwata Asako Doi Goh Ohji Hideaki Oka Yuichiro Oba Kohei Takimoto Wataru Igarashi David H. Gremillion Toshihiko Shimada
- 出版者
- The Japanese Society of Internal Medicine
- 雑誌
- Internal Medicine (ISSN:09182918)
- 巻号頁・発行日
- vol.49, no.22, pp.2423-2432, 2010 (Released:2010-11-15)
- 参考文献数
- 27
- 被引用文献数
- 43 132
Introduction Sivelestat is neutrophil elastase inhibitor, which is widely used in Japan for the treatment of acute lung injury. However, the clinical efficacy of the medication has not been convincingly demonstrated. Methods We conducted a systematic review and meta-analysis of randomized controlled trials on sivelestat for the treatment of acute lung injury and acute respiratory distress syndrome. Studies were identified using MEDLINE, EMBASE, Cochrane library, conference proceedings, and references of included studies. Authors were contacted if necessary. ICHUSHI, the Japanese database for medical literature and conference proceedings was also used for the search, since many studies on sivelestat were published in Japanese language and not registered in major databases such as MEDLINE. The primary outcome was mortality within 28-30 days after randomization. Relative risks were pooled with the random effect model. Results 8 trials were included in the analysis. There was no difference in mortality within 28-30 days after randomization (relative risk 0.95, 95% confidence interval 0.72 to 1.26). Subgroup analysis conducted only on studies conducted in Japan showed the same result (0.59, 0.28 to 1.28). There was no difference in mechanical ventilation days (standardized mean difference -0.43, -1.12 to 0.27), but sivelestat was associated with a better short term PaO2/FiO2 ratio (0.30, 0.05 to 0.56). Heterogeneity was not significant for the main analysis and funnel plot did not suggest publication bias. Conclusion Sivelestat was not associated with decreased mortality, even when including studies published in Japanese language.
- 著者
- Kentaro Iwata Wataru Igarashi Midori Honjo Takashi Nishimoto Kyoko Shinya Akiko Makino Kazuo Mitani Yoshiko Tatsumi Hiroyuki Ninomiya Kumi Higasa Seiichiro Usuki Hiroki Kagawa Daisuke Uchida Kohei Takimoto Rei Suganaga Hiroo Matsuo Yuichiro Oba Mami Horigome Hideaki Oka Goh Ohji Yasuhisa Abe Hiroyuki Yoshida Shohiro Kinoshita Midori Hirai
- 出版者
- 日本プライマリ・ケア連合学会
- 雑誌
- General Medicine (ISSN:13460072)
- 巻号頁・発行日
- vol.14, no.1, pp.13-22, 2013 (Released:2013-07-05)
- 参考文献数
- 34
- 被引用文献数
- 3
Background: 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.Methods: 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.Results: 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.Conclusion: 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.