Kansenshogaku Zasshi
Online ISSN : 1884-569X
Print ISSN : 0387-5911
ISSN-L : 0387-5911
Therapeutic Evaluation on Combination Therapy with IG-100, pH4-Treated Human Immunoglobulin Preparation for i.v. Administration, and Antibiotics Against Severe Infections
Keizo MATSUMOTO, Toru MASAOKA, Toru NAKAMURA, Kaoru SHIMADA, Ichiro URUSHIZAKI, Yutaka KOGO, Akira SAITO, Masumi TOMIZAWA, Ichiro NAKAYANA, Chikara MIKUNI, Kazuo TAKEBE, Katsuhiro OKAMOTO, Shuichiro YOSHIDA, Katsutoshi KARIYA, Yoko TOYAMA, Tomio ONUMA, Teruo NAKAMURA, Takeshi OSONOI, Shigeru OCHIAI, Morio SAGARA, Shigetoshi YANAGIYA, Osamu UEHARA, Naoyoshi MASAKI, Toyokazu TAMURA, Masao TAMURA, Takashi ITO, Yoshikatsu NEMOTO, Kiyoshi KONNO, Kotaro OIZUMI, Akira WATANABE, Shigeo KARIYONE, Tatsumi UCHIKA, Shin MATSUDA, Tadashi MAEKAWA, Shogo SHINONOME, Yasusada MIURA, Shinobu SAKAMOTO, Akihiro TSUBOYAMA, Shiro MIWA, Tadashi MIYAHARA, Jingoro SHIMADA, Hiroichi TANIMOTO, Yoshitaka NAKAMORI, Naohiko CHONABAYASHI, Hideyo KATSUNUMA, Yoshinori MIYAMOTO, Junzaburo KABE, Yasufumi MIYAMOTO, Kazuko OKABE, Keimei MASHIMO, Sumio YAMAOKA, Tetsuro UKAI, Katsunori UENO, Keiichi NAKAGAWA, Kohjin KIN, Fukuo IIJIMA, Takeshi ABE, Tadatoshi KINOSHITA, Jyuzo MATSUDA, Kazuo KAWASUGI, Toshiro OYAMA, Ichita AMAKI, Toshiteru OSHIMA, Hiroshi TAKEO, Hiroyuki KOBAYASHI, Hiroaki TAKEDA, Shin KAWAI, Hideo TERADA, Shoji HAGIWARA, Haruo NIIKURA, Kazuhiko MATSUNO, Hiraku MORI, Kunikane KIN, Yoshio TAKIZAWA, Ippei FUJIMORI, Yoshio KOBAYASHI, Akio ONAKA, Hiroshi NAKAMURA, Akira SHIBATA, Yoshiaki MORIYAMA, Hajime TAKEDA, Osamu SEKINE, Kaoru OYAMA, Michiko KANAKI, Kenichi HATTORI, Takashi YOSHIDA, Toshihiko TAKEUCHI, Masahito KATO, Toshiyuki YAMAMOTO, Kanzo SUZUKI, Hidekazu HANAKI, Motoko YAMAMOTO, Jiro YURA, Nagao SHINAGAWA, Tetsuro TAKAOKA, Akishige NAKAMURA, Yutaka HIROTA, Yoshihisa FUJIWARA, Masataka SASADA, Akemi KUBO, Tsuyoshi YONEZAWA, Yoshio KANAYAMA, Hirotoshi SHIBATA, Katsuji SAKAI, Takami UEDA, Teruo KITANI, Ichiro KONISHI, Kojiro YASUNAGA, Yuruko OKAMOTO, Keigo MAEHARA, Yoshihiro UEDA, Atsushi HORIUCHI, Hirofumi HASEGAWA, Haruto UCHINO, Hiroyoshi SAWADA, Shiro NAKAYAMA, Kenichi NAGAI, Kiyoyasu NAGAI, Akihisa KANAMURA, Soichiro YOSHIYASU, Takao HATTORI, Minoru NIIMOTO, Yukihisa MIYOSHI, Sadanori HAMAMOTO, Minoru TANADA, Hideyuki NAKANE, Rinzo SOEJIMA, Yoshito NIKI, Chikara NAKAHAMA, Toshio KANEKO, Kenji SHINOHARA, Kohei KAKU, Eiro TSUBURA, Masakazu TAMURA, Tomohiro KUSABA, Yoshiyuki NIHO, Seiichi OKAMURA, Masahide TAKII, Michio ONO, Kohei HARA, Atsushi SAITO, Keizo YAMAGUCHI, Yoji SUZUYAMA, Yoshiteru SHIGENO, Hiroshi TOMITA, Masao NAGASAWA, Michito ICHIMARU, Shuichi IKEDA, Tomoyuki HARADA, Tsuyoshi NAGATAKE, Shukuro ARAKI, Masayuki Ando, Mineharu SUGIMOTO, Moritaka SUGA
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1984 Volume 58 Issue 10 Pages 1001-1024

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Abstract

Ig-100, developed by the Swiss Red Cross, is a human immunoglobulin preparation for i. v. administration prepared by a modification of the Cohn ethanol fractionation process, incorporating mild acid treatment at pH 4. IG-100 has been evaluated clinically in Japan since 1982 in patients with severe bacterial and/or fungal infections which are resistant to antibiotic therapy.
Of 340 patients who received IG-100, 332 (97.6%) were adopted for safety evaluation and 183 (53.8%) were considered evaluable for efficacy. The adopted patients consisted of respiratory tract infections (42.2%), septicemia suspect (30.1%), septicemia (8.7%), urinary tract infections (3.0%) and others. The majority of patients had one or more underlying diseases, mainly including leukemia and/or other hematopoietic disorders (51.5%) and malignant tumor (19.9%).
Among 183 evaluable patients, clinical responses were excellent in 28, good in 74, fair in 28, poor in 43 and unknown in 10; efficacy rate being 59.0%. Causative organisms were isolated from 128 adopted patients. Among them 66 patients were evaluable for bacteriological effects which were eradicated in 36, partially eradicated in 4, decreased in 3, persisted in 18 and replaced in 5; eradication rate being 62.1%.
The analysis of the relation between clinical efficacy and leukocyte counts before and after IG-100 administration revealed that the highest efficacy rate was achieved in the patients whose leukocyte counts after IG-100 administration were in the normal range. The efficacy rate in the patients with lower leukocyte counts was much lower compared with that in the above mentioned patients. It is indicated that neutrophils and other leukocyte populations play an important role in the healing process of severe infections.
The rate of appearance of subjective and objective clinical side effects was 0.9% and none of the side effects observed was considered practically important. Abnormal laboratory findings because of IG-100 administration were not observed in 332 adopted patients.
In conclusion, combination therapy with IG-100 and antibiotics was considered to be safe and effective against severe bacterial and/or fungal infections.

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© The Japansese Association for Infectious Diseases
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