Takase Z, Noda K, Hayasaki M, Iwasa S, Motomura R, Yamabe T, Ichinohe K, Kutsuzawa T, Kaneko M, Domon H, Kodama M, Shimizu T, Mizoguchi H, Yorozu Y, Maki M, Chimura T, Matsuda S, Cho N, Fukunaga K, Kunii K, Wagatsuma T, Kaku R, Hogaki M, Ikawa M, Matsumoto Y, Fukuoka H, Honma T, Sanada K, Minakuchi H, Sumiyoshi Y, Hayashi S, Nakamura H, Goto T, Ihara Y, Hagiwara K, Tsuruta S, Yabuki A, Higashide K, Hasegawa Y, Ninomiya K, Okada H, Kanao M, Yasuda J, Takashima E, Ikeuchi M, Kobayashi Y, Haruta T, Hirabayashi K, Doko F, Watanabe K
Jpn J Antibiot. 1982 Jun;35(6):1585-609.
The study group was organized to evaluate the usefulness of cefmenoxime (CMX) injection, a new synthetic cephalosporin, for the treatment of infections in the field of obstetrics and gynecology. Fundamental and clinical studies were made by the society and the following results were obtained. 1. The peak distribution of CMX's MIC for E. coli, Klebsiella sp., Enterobacter sp., Bacteroides sp. and Peptococcus sp. isolated from obstetrical and gynecological infections with relatively high frequencies area 0.1, less than or equal to 0.05, 0.2, 3.13, 1.56 micrograms/ml, respectively, with an inoculation of 10(6) cells/ml. 2. When 1 g of CMX is administered by intravenous drip infusion for 1 hour, the maximum concentrations in various tissues of female genital organs were as follows: 14.2 and 13.2 micrograms/g in ovary and oviduct, respectively, at 1.20 hours after the start of administration, and 16.9 and 26.3 micrograms/g in corpus uteri and cervix uteri, respectively, after 1 hour. As for the transfer to the exudate in the pelvic dead cavity, the peak concentration was 15.6 micrograms/ml after 2.13 hours. 3. In the clinical studies, CMX was given to 258 cases with female genital organ infections and others. As for the clinical effects, with exclusion of 3 cases in which other antibiotics are concomitantly used, responses were excellent in 76 cases, good in 162 cases and poor in 17 cases, among 255 cases in total. The efficacy rate was 93.3%. The efficacy rates by diseases were 97.1% (68/70) for intrauterine infections, 88.8% (79/89) for intrapelvic infections, 98.4% (62/63) for adnexitis, and 100% (23/23) for infections of external genital organs. As for the clinical effects on causative bacteria, the efficacy rates were 100% (19/19) for single infections due to Gram-positive bacteria, 94.8% (55/58) for single infections due to Gram-negative bacteria, and 88.2% (15/17) for single infections due to anaerobic bacteria. And its efficacy rates were 89.6% (69/77) for mixed infection cases. Side effects were observed in 2 cases (0.8%); 1 case with eruption, and 1 case with diarrhea and vomiting. As for abnormal laboratory findings, lower white blood cell count was observed in 2 cases and elevation of the values regarding hepatic functions in 9 cases. All cases were returned to the normal after the completion of the administration. Cefmenoxime showed a satisfactory clinical efficacy and a potent bacteriological effect in treatment of the infections in the field of obstetrics and gynecology, and it has been concluded that cefmenoxime will be useful addition to the antibiotics for the therapy of these infections.
成立了研究小组，以评估新型合成头孢菌素头孢甲肟（CMX）注射液在治疗妇产科感染方面的效用。该协会进行了基础研究和临床研究，并得出以下结果。1. 从妇产科感染中分离出的大肠杆菌、克雷伯菌属、肠杆菌属、拟杆菌属和消化球菌属，接种量为10(6) 个细胞/毫升时，CMX对它们的MIC峰值分布分别为0.1、≤0.05、0.2、3.13、1.56微克/毫升。2. 当静脉滴注1克CMX持续1小时时，女性生殖器官各组织中的最高浓度如下：给药开始后1.20小时，卵巢和输卵管中分别为14.2和13.2微克/克，1小时后子宫体和子宫颈中分别为16.9和26.3微克/克。至于盆腔死腔内渗出液中的转移情况，2.13小时后峰值浓度为15.6微克/毫升。3. 在临床研究中，258例女性生殖器官感染及其他病例接受了CMX治疗。在临床疗效方面，排除3例同时使用其他抗生素的病例后，255例中疗效优秀的有76例，良好的有162例，差的有17例。有效率为93.3%。按疾病分类的有效率分别为：子宫内感染97.1%（68/70），盆腔内感染88.8%（79/89），附件炎98.4%（62/63），外生殖器感染100%（23/23）。对病原菌的临床疗效方面，革兰氏阳性菌单一感染的有效率为100%（19/19），革兰氏阴性菌单一感染的有效率为94.8%（55/58），厌氧菌单一感染的有效率为88.2%（15/17）。混合感染病例的有效率为89.6%（69/77）。观察到2例（0.8%）出现副作用；1例出现皮疹，1例出现腹泻和呕吐。在实验室检查异常方面，2例白细胞计数降低，9例肝功能指标升高。所有病例在给药结束后均恢复正常。头孢甲肟在治疗妇产科感染方面显示出令人满意的临床疗效和强大的细菌学效果，得出的结论是，头孢甲肟将成为治疗这些感染的抗生素中的有用补充药物。
