학술논문
Therapeutic Evaluation of Combination Therapy using C-425 and Antibiotics in Severe Bacterial Infections A Double Blind Group Comparative Study / 重症細菌感染症に対する静注用人免疫グロブリン (C-425) と抗生剤との併用療法についての臨床評価
Document Type
Journal Article
Author
Akihiro TAKESHITA; Akira SAKUMA; Fumio MARUYAMA; Harumitsu MIZUNO; Hideo TAKEYAMA; Hironori YAMADA; Hiroshi NISHIWAKI; Kanji OHARA; Kazumasa YAMADA; Kazuyuki NAITO; Kenjiro KITAORE; Koichiro NAGATA; Kunio YANO; Masahide KOBAYASHI; Masami HIRANO; Masao OKUMURA; Masatomo ICHIHARA; Naoyuki KATAYAMA; Noriyuki HIRABAYASHI; Ryuzo OHNO; Saburo MINAMI; Shigeru SHIRAKAWA; Shinichi KAGEYAMA; Shozo YOKOMAKU; Takashi WATANABE; Yasushi IKEDA; Yoshiki AKATSUKA; Yoshinao KODERA; Yoshitaka ONO; Yukio KATO; 丸山 文夫; 佐久間 昭; 内藤 和行; 加藤 幸男; 北折 健次郎; 南 三郎; 大野 竜三; 奥村 雅男; 小原 寛治; 小寺 良尚; 小林 政英; 小野 芳孝; 山田 一正; 山田 博豊; 市原 正智; 平林 憲之; 平野 正美; 影山 慎一; 横幕 省三; 水野 晴光; 永田 紘一郎; 池田 靖; 渡辺 隆; 片山 直之; 白川 茂; 矢野 邦夫; 竹下 明裕; 竹山 英夫; 西脇 洋; 赤塚 美樹
Source
感染症学雑誌 / Kansenshogaku Zasshi. 1990, 64(2):149
Subject
Language
Japanese
ISSN
0387-5911
1884-569X
1884-569X
Abstract
Clinical usefulness of C-425, a native human immunoglobulin liquid preparation for intravenous injection, was studied in combination with antibiotics in severe bacterial infections in a double blind group comparison using an alkylated human immunoglobulin liquid preparation (Polyglobin®, A·γG) as a reference drug.The following results were obtained:1. C-425 or A·γG was administered to a total of 117 patients, of whom 89 patients, 45 in C-425 group and 44 in A·γG group, were included in the present analysis of efficacy and usefulness. Analysis of safety of the drugs included a total of 113 patients, 58 in C-425 group and 55 in A·γG group.2. Efficacy and usefulness were graded according to a visual analog scale (VAS).3. Mean efficacy values with standard deviations of VAS value were calculated at 52.0±34.9 for the C-425 group, and 47.2±34.8 for the A·γG group. The respective medians were 59.0 and 61.0. The Mann-Whitney U-test revealed no significant differences between the two groups. When those with VAS values of 50 or above were regarded as cases of effective treatment, the efficacy rates of the two groups were also practically comparable.4. Side effects were not observed in either drug group.5. Mean usefulness values with standard deviations were 52.3±34.9 for the C-425 group, and 47.9±35.0 for the A·γG group. The respective medians were 60.0 and 61.0. The Mann-Whitney U-test revealed no significant differences between the two groups. When the cases with VAS values of 50 or above were regarded as cases of useful treatment, there were no significant differences in the utility rates between the two groups.From these results, C-425 was considered to be useful for treating severe bacterial infections when used combinedly with antibiotics.