CLINICAL STUDY OF NY-198 IN INFECTIOUS ENTERITIS
We evaluated the clinical effect and safety of a new quinoline antibacterial agent, NY-198, in patients with acute infectious enteritis (bacillary dysentery, enteropathogenic Escherichia coli enteritis, Campylobacter enteritis, Salmonella enteritis and other bacterial enteritis) and the correspondin...
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| Published in | CHEMOTHERAPY Vol. 36; no. Supplement2-Clinical; pp. 792 - 802 |
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| Main Author | |
| Format | Journal Article |
| Language | English Japanese |
| Published |
Japanese Society of Chemotherapy
1988
公益社団法人 日本化学療法学会 |
| Online Access | Get full text |
| ISSN | 0009-3165 1884-5894 |
| DOI | 10.11250/chemotherapy1953.36.Supplement2-Clinical_792 |
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| Abstract | We evaluated the clinical effect and safety of a new quinoline antibacterial agent, NY-198, in patients with acute infectious enteritis (bacillary dysentery, enteropathogenic Escherichia coli enteritis, Campylobacter enteritis, Salmonella enteritis and other bacterial enteritis) and the corresponding carriers (118 subjects in all). NY-198 was orally administered to the subjects at a daily dose of 600 mg for five days, but to patients with acute Salmonella enteritis and Salmonella-carriers for seven days. Our results are summarized as follows: 1. Clinical efficacy rate of NY-198 In 76 evaluable subjects, the overall efficacy rate of NY-198 was 90.8%, and for 31 with bacillary dysentery, the rate was 100%. In 64 subjects excreting causative organisms, the bacteriological rate was 89.1%, and for 29 of these with Shigella spp., the rate was 100%. 2. Safety of NY-198 Of 106 patients, four had side-effects (3.8%): soft stool, nausea, stomach discomfort and epigastric pain in one case each. The rate of abnomal changes in laboratory findings was 6.4%(5/78 patients). These were eosinophilia, elevation of GOT, GPT, GOT GPT and GOT, LDH, respectively. 3. Clinical value of NY-198 In 75 evaluable subjects, the overall clinical value rate was 85.3%, and for 32 with bacillary dysentery, the rate was 93.8%. The above results show that NY-198 is a useful oral antibiotic for infectious enteritis. |
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| AbstractList | We evaluated the clinical effect and safety of a new quinoline antibacterial agent, NY-198, in patients with acute infectious enteritis (bacillary dysentery, enteropathogenic Escherichia coli enteritis, Campylobacter enteritis, Salmonella enteritis and other bacterial enteritis) and the corresponding carriers (118 subjects in all). NY-198 was orally administered to the subjects at a daily dose of 600 mg for five days, but to patients with acute Salmonella enteritis and Salmonella-carriers for seven days. Our results are summarized as follows: 1. Clinical efficacy rate of NY-198 In 76 evaluable subjects, the overall efficacy rate of NY-198 was 90.8%, and for 31 with bacillary dysentery, the rate was 100%. In 64 subjects excreting causative organisms, the bacteriological rate was 89.1%, and for 29 of these with Shigella spp., the rate was 100%. 2. Safety of NY-198 Of 106 patients, four had side-effects (3.8%): soft stool, nausea, stomach discomfort and epigastric pain in one case each. The rate of abnomal changes in laboratory findings was 6.4%(5/78 patients). These were eosinophilia, elevation of GOT, GPT, GOT GPT and GOT, LDH, respectively. 3. Clinical value of NY-198 In 75 evaluable subjects, the overall clinical value rate was 85.3%, and for 32 with bacillary dysentery, the rate was 93.8%. The above results show that NY-198 is a useful oral antibiotic for infectious enteritis. We evaluated the clinical effect and safety of a new quinoline antibacterial agent, NY-198, in patients with acute infectious enteritis (bacillary dysentery, enteropathogenic Escherichia coli enteritis, Campylobacter enteritis, Salmonella enteritis and other bacterial enteritis) and the corresponding carriers (118 subjects in all).NY-198 was orally administered to the subjects at a daily dose of 600 mg for five days, but to patients with acute Salmonella enteritis and Salmonella-carriers for seven days. Our results are summarized as follows:1. Clinical efficacy rate of NY-198In 76 evaluable subjects, the overall efficacy rate of NY-198 was 90.8%, and for 31 with bacillary dysentery, the rate was 100%. In 64 subjects excreting causative organisms, the bacteriological rate was 89.1%, and for 29 of these with Shigella spp., the rate was 100%.2. Safety of NY-198Of 106 patients, four had side-effects (3.8%): soft stool, nausea, stomach discomfort and epigastric pain in one case each. The rate of abnomal changes in laboratory findings was 6.4%(5/78 patients). These were eosinophilia, elevation of GOT, GPT, GOT GPT and GOT, LDH, respectively.3. Clinical value of NY-198In 75 evaluable subjects, the overall clinical value rate was 85.3%, and for 32 with bacillary dysentery, the rate was 93.8%.The above results show that NY-198 is a useful oral antibiotic for infectious enteritis. 感染性腸炎 (細菌性赤痢, 病原大腸菌腸炎, カンピロバクター腸炎, サルモネラ腸炎など) に対する新キノロン系抗菌剤NY-198の有効性, 安全性および有用性を評価する目的で, 感染性腸炎患者および保菌者計118例 (入院56例, 外来62例) に本剤を投与し臨床的検討を行なった。あわせて, 臨床分離株に対する本剤の抗菌力を測定した。これについては後藤ら1) により別途原著として発表した。投与方法は1回200mg 1日3回 (計600mg) を5日間 (サルモネラ腸炎患者および保菌者は7日間) 経口投与とした。1. 有効性感染性腸炎118例中, 有効性検討可能症例は76例 (細菌性赤痢では31例) であった。そのうち有症状例36例 (細菌性赤痢では10例) の臨床効果は全例が著効あるいは有効であり, 有効率100%であったが, 投与開始日に排菌のあった64例 (細菌性赤痢では29例) の細菌学的効果は有効 (投与終了以後の排菌は陰性) 以上が57例 (細菌性赤痢では29例) であり, 有効率89.1%(細菌性赤痢では100%) であった。これらの臨床効果および細菌学的効果を勘案して評価した76例の総合効果は (細菌性赤痢では31例) 著効36例, 有効33例であり, 有効率90.8%(細菌性赤痢では100%) であった。2. 安全性118例中, 副作用検討可能症例は106例であり, 消化器症状が4例 (3.8%) に認められた。いずれも軽度であり本剤は継続投与されたが, 発現6日後までに全例が治癒した。臨床検査値異常は78例中, 好酸球増多, GOT上昇, GPT上昇, GOTおよびGPT上昇ならびにGOTおよびLDH上昇がそれぞれ1例の計5例 (6.4%) に認められたが, いずれも軽度であった。3. 有用性118例中, 有用性検討可能症例は75例であり「満足」以上は64例 (85.3%), そのうち細菌性赤痢では32例中30例 (93.8%) が「満足」以上であった。 |
| Author | AOKI, TAKAKAZU |
| Author_FL | 青木 隆一他 |
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| References | 5) 橋本博, 他 (9施設): 腸管感染症に対するAT-2266の基礎的・臨床的研究. Chemotherapy 32 (S-3): 616-631, 1984 3) 斎藤誠, 他 (9施設): 感染性下痢症に対するDL-8280の基礎的・臨床的研究. Chemotherapy 32 (S-1): 294-331, 1984 8) 斎藤誠, 他 (8施設): 感染性腸炎に対するBAYo9867の基礎的・臨床的研究. Chemotherapy 33 (S-7): 341-366, 1985 7) 青木隆一, 他 (16施設): 感染性腸炎に対するAM-715の臨床的研究. 感染症学雑誌60 (5): 495-509, 昭61 2) 第35回日本化学療法学会総会, 新薬シンポジウム (3), NY-198. 盛岡, 1987 6) 橋本博, 他 (18施設): 感染性下痢症に対するEnoxacin (ENX, AT-2266) とPipemidic acid (PPA) の二重盲検法による有用性の比較検討. 感染症学雑誌58 (10): 1114-1134, 昭59 4) 斎藤誠, 他 (18施設): 感染性下痢症に対するオフロキサシン (OFLX: DL-8280) とピペミド酸 (PPA) の二重盲検法による治療効果の検討. 感染症学雑誌58 (10): 965-981, 昭59 9) 斎藤誠, 他 (14施設): 細菌性赤痢に対するピペミド酸 (PPA) とカナマイシン (KM) の二重盲検法による治療効果の検討. 感染症学雑誌57 (4): 303-317, 昭和58 1) 後藤延一, 堀内三吉, 稲垣好雄, チャルアイエカタクシン, 桧垣恵, 高野秀子, 中谷林太郎: ニューキノロン剤NY-198の腸炎起因菌新鮮臨床分離株に対する試験管内抗菌力. Chemotherapy 36 (S-2): 93-98, 1988 |
| References_xml | – reference: 5) 橋本博, 他 (9施設): 腸管感染症に対するAT-2266の基礎的・臨床的研究. Chemotherapy 32 (S-3): 616-631, 1984 – reference: 8) 斎藤誠, 他 (8施設): 感染性腸炎に対するBAYo9867の基礎的・臨床的研究. Chemotherapy 33 (S-7): 341-366, 1985 – reference: 6) 橋本博, 他 (18施設): 感染性下痢症に対するEnoxacin (ENX, AT-2266) とPipemidic acid (PPA) の二重盲検法による有用性の比較検討. 感染症学雑誌58 (10): 1114-1134, 昭59 – reference: 3) 斎藤誠, 他 (9施設): 感染性下痢症に対するDL-8280の基礎的・臨床的研究. Chemotherapy 32 (S-1): 294-331, 1984 – reference: 9) 斎藤誠, 他 (14施設): 細菌性赤痢に対するピペミド酸 (PPA) とカナマイシン (KM) の二重盲検法による治療効果の検討. 感染症学雑誌57 (4): 303-317, 昭和58 – reference: 1) 後藤延一, 堀内三吉, 稲垣好雄, チャルアイエカタクシン, 桧垣恵, 高野秀子, 中谷林太郎: ニューキノロン剤NY-198の腸炎起因菌新鮮臨床分離株に対する試験管内抗菌力. Chemotherapy 36 (S-2): 93-98, 1988 – reference: 2) 第35回日本化学療法学会総会, 新薬シンポジウム (3), NY-198. 盛岡, 1987 – reference: 4) 斎藤誠, 他 (18施設): 感染性下痢症に対するオフロキサシン (OFLX: DL-8280) とピペミド酸 (PPA) の二重盲検法による治療効果の検討. 感染症学雑誌58 (10): 965-981, 昭59 – reference: 7) 青木隆一, 他 (16施設): 感染性腸炎に対するAM-715の臨床的研究. 感染症学雑誌60 (5): 495-509, 昭61 |
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