CHEMOTHERAPY DEC.1992
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1 VOL.40 NO.12
2 CHEMOTHERAPY DEC.1992
3 VOL.40 NO.12 Table 1. Findings at caesarean section of rabbit dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 1) Significantly different from control * p<0.05 ** p<0.01 Each value shows mean }SD Mean of percent 1) values per litter 2) Aborted and prematurely labored dams were excluded from pregnant dams 3) Fetuses with external malformations were excluded from the calculation
4 CHEMOTHERAPY DEC Fig. 1. Changes in body weight gain of rabbit dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 1). Fig. 2. Changes in food consumption of rabbit dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 1).
5 VOL.40 NO.12 Fig. 3. Changes in body weight gain of rabbit dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 2).
6 CHEMOTHERAPY DEC Table 2. Visceral and skeletal findings in rabbit fetuses from dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 1) %: Mean of percent values per litter
7 VOL.40 NO.12 Fig. 4. Changes in food consumption of rabbit dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 2). Table 3. Findings at caesarean section of rabbit dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 2) Each value shows mean } SD1) : Mean of percent values per litter 2): Fetuses with external malformations were excluded from the calculation
8 CHEMOTHERAPY 1404 滴 が 認 め られ,周 辺 性 脂 肪 肝 と判 断 さ れ た 4mg/kg 脈 右 優 位 の 併 発 が 各1例 投 与 群 で は異 常 所 見 は み られ な か っ た 投 与 群 と対 照 群 との 間 に 有 意 な 差 は認 め ら れ な か っ た (Table3) 2.胚 か っ た ま た,内 は,2mg/kg投 れ た1例 部 器 官 観 察 に 供 した 外 形 異 常 胎 児 で 与 群 で 左 右手 関 節 屈 曲拘 縮 が 認 め ら に 重 複 後 大 静 脈 右 優 位 が み ら れ た以 外,異 存 胎 児 数(率),性 比およ よ び4mg/kg投 め られ な か っ た(Table 頭 蓋 骨 の癒 合 が4mg/kg投 3) の 減 形 成 奇 形,右 与 群 で 複 合 奇 形(左 前 肢 の 手 関 節 屈 曲 拘 縮)お 前肢 よび 左 右 手 関 節 屈 曲 拘 縮 が 各1例(1.76%)に4mg/kg投 与 群 で 右 後 肢 の減 形 成 奇 形 が1例(0.65%)に た ま た,4mg/kg投 観 察 され 与 群 の 浸 軟 児 で 複 合 奇 形(右 与 群 で 各2例(1.96%,2,38%)に, の 片 側 性 欠 損 が2mg/kg投 も対 照 群 と 群 お よ び2mg/kg投 の 間 に有 意 差 は認 め られ な か っ た(Table 3) %),4mg/kg投 に,食 与 群 で 各1例(2.38%,1.96%) 道 の 走 行 異 常 が2mg/kg投 %)に,後 で3例(7.84%,Fig.5)に,腎 で1例(2.38%)に 観 察 さ れ た ま た,変 異 と し て重 (Fig.6)と 観 察 され た ほ か,異 与 群 で2例(1.82%) 与 群 で9例 与 常併 発が対 胸 腺 頚 部 残 留 お よ び重 複 後 大 静 脈 右 優 位 の併 発 と腎 臓 の 位 置 異 常 お よ び 重 複 後 大 静 に 観 察 され た しか し,い ず れ の 発 現 率 も対 照 群 との 間 に 有 意 な 差 は 認 め ら れ な か っ mg/kg投 照 群 で2例(4.76%) 格 観 察 に 供 し た 外 形 異 常 胎 児 で は,2 与 群 で 複 合 奇 形 が 認 め られ た1例 の 僥 骨 と尺 骨 の離 開 お よ び 指 骨 の 欠 損,右 部 関 節 の 屈 曲 拘 縮 が,4mg/kg投 形 成 奇 形 が 認 め られ た1例 (Table Fig. 5. Anomalous course of the inferior vena cava in a rabbit fetus (2 mg/kg, cefditoren に左前 肢 前 肢 の手 根 与 群 で 右後 肢 の減 に趾 骨 の 欠 損 が 認 め られ た 4) 骨 化 進 行 度 に つ い て は,い pivoxil). 右第一 肋 第一 肋軟 骨 の 分岐 お よ び第 一胸 骨 核 の分 た ま た,骨 群 で2例(4,90%)に 観 察 され た 第 一 肋 骨 の位 置 異 常 お よ び 第 一 胸 骨 核 離 の併 発 が 各1例 kg投 複 後 大 静 脈 左 優 位 が2mg/kg投 与 群 で4例(5.26%)に ほ か,異 常 併 発 が 対 照 群 で1例(2.22%) 複 後 大 静 脈 右 優 位 が 対 照 群 で6例(15,48%),2mg/ (30.95%)に,重 椎が対照 与 群 で 各1例(0.95%,0.98 左右 前頭 骨 の癒 合 お よ び剣状 突起 の形 成 不全 の併 発 与群 静 脈 の分岐 が対 照群 与 群 で7例(16.66%),4mg/kg投 椎 体 の 骨 化 遅延 が の 分 離 の 併 発,2mg/kg投 大 静 脈 走 行 異 常 が 対 照 群 お よ び4mg/kg 投 与 群 で 各2例(5.95%,4.76%),2mg/kg投 与 群 で 各1例 与 群 で1例(1.02%)に,8腰 軟 骨 の 分 岐,左 与 群 で1例(2.94 異 と し て頭 蓋 骨 の 骨 化 よ び4mg/kg投 (1 11%,0.98%,1 02%)&こ,胸 られ た しか し,い ず れ の 発 現 数(率)と 尾椎体 与 群 で1例(0.98%)}こ そ れ ぞ れ 観 察 さ れ た ま た,変 遅 延 が 対 照 群,2お 4mg/kg投 群 お よ び2mg/kg投 与 群 で1例(1.19%)に, 胸 骨 格 の癒 合 が 対 照 群 で1例(1.11%)に,仙 後 肢 の 内 反 足 お よ び減 形 成 奇 形)が1例(1.02%)み 内 部 器 官 観 察 で は,異 常 と し て胸 腺 頚 部 残 留 が 対 照 常 4) 骨 格 観 察 で は,異 常 と し て頭 蓋 骨 の 形 成 不 全 が2お び胎 児 体 重 で は 投 与 群 と対 照 群 との 間 に 有 意 な 差 は 認 外 形 異 常 で は2mg/kg投 に観 察 され た しか し,い は 観 察 され な か っ た(Table 胎 児 に お よぼ す 影 饗 死 亡 吸 収 胚 数(率),生 1992 ず れ の 発 現 率 も対 照 群 との 間 に 有 意 な 差 は認 め ら れ な 帝 王 切 開 時 の 所 見 で は,平 均 貴 体 数 お よ び 平 均 着 床 数(率)は DEC. ず れ の 投 与 群 と も対 照 群 Fig. 6. Hypoplasia of processus xiphoideus in a rabbit fetus (2 mg/kg, cefditoren pivoxil).
9 VOL.40 NO.12 Table 4. Visceral and skeletal findings in rabbit fetuses from dams treated orally with cefditoren pivoxil from day 6 to day 18 of pregnancy (Experiment 2) %: Mean of percent values per litter
10 CHEMOTHERAPY DEC. 1992
11 VOL.40 NO.12 3) Barrow M V, Taylor W J: A rapid method for detecting malformations in rat fetuses. J. Morph. 127: , ) Matsuzawa T, Nakata M, Goto I, Tsushima M: Dietary deprivation induces fetal loss and abortion in rabbits. Toxicology 22: , 1981
12 CHEMOTHERAPY DEC Toxicity studies of cefditoren pivoxil, a new oral cephem antibiotic VIII. Reproductive and developmental toxicity study of cefditoren pivoxil in rabbits by oral administration during the period of organogenesis Minako Ito, Keiko Hasunuma, Kazuo Okano, Masanori Izawa, Chieko Fujii, Isao Kosugi and Masataka Fujita Pharmaceutical Research Center, Meiji Seika Kaisha, LTD., 760 Morooka-cho, Kouhoku-ku, Yokohama, Kanagawa Prefecture 222, Japan Effects of cefditoren pivoxil (CDTR-PI) on dams and their fetuses were evaluated in Kbl-JW rabbits. CDTR-PI was administered orally to pregnant rabbits during the period of fetal organogenesis at doses of 2, 4, 7.5, 15 and 30 mg/kg. One abortion each was observed in the 7.5 and 15 mg/kg groups, and one premature birth and seven abortions were observed in the 30 mg/kg group. Food consumption of dams decreased at 4 mg/kg and higher. The suppression of body weight gain of dams, as the result of a dose-related decrease of food and water consumption, was observed at 7.5 mg/kg and higher. The number of fetuses decreased at 7.5 mg/kg and higher, and fetal body weight decreased in the 30 mg/kg group. However, external, visceral and skeletal observations showed no anomalies and variations attributable to the administration of CDTR-PI. From these results, CDTR-PI may have no teratogenic effect in rabbits, and the no effect dose level of CDTR -PI for dams' reproductive performance and their fetuses is estimated to be 4 mg/kg.
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