Laga M, Naamara W, Brunham R C, D'Costa L J, Nsanze H, Piot P, Kunimoto D, Ndinya-Achola J O, Slaney L, Ronald A R
N Engl J Med. 1986 Nov 27;315(22):1382-5. doi: 10.1056/NEJM198611273152203.
We conducted a randomized clinical trial comparing a single intramuscular dose of 125 mg of ceftriaxone with a single intramuscular dose of 75 mg of kanamycin followed by topical gentamicin for seven days, and with a single intramuscular dose of 75 mg of kanamycin followed by topical tetracycline for seven days, in the treatment of gonococcal ophthalmia neonatorum in Nairobi, Kenya. Of 122 newborns with culture-proved gonococcal ophthalmia neonatorum, 105 returned for follow-up. Sixty-one infants (54 percent) received ceftriaxone, 32 received kanamycin plus topical gentamicin, and 29 received kanamycin plus topical tetracycline. Sixty-six (54 percent) of the Neisseria gonorrhoeae isolates were penicillinase producing. All 55 newborns who received ceftriaxone and returned for follow-up were clinically and microbiologically cured. One of 26 returning newborns who received kanamycin plus tetracycline and 2 of 24 returning newborns who received kanamycin plus gentamicin had persistent or recurrent gonococcal conjunctivitis. Ceftriaxone also eradicated oropharyngeal gonococcal infection in 18 newborns, whereas oropharyngeal infection persisted in 2 of 8 newborns who had received kanamycin (P not significant). We conclude that 125 mg of ceftriaxone as a single intramuscular dose is very effective therapy for gonococcal ophthalmia neonatorum, with marked efficacy against extraocular infection and without the need for concomitant topical antimicrobial therapy.
我们在肯尼亚内罗毕进行了一项随机临床试验，比较单次肌内注射125mg头孢曲松、单次肌内注射75mg卡那霉素后外用庆大霉素7天以及单次肌内注射75mg卡那霉素后外用四环素7天，用于治疗新生儿淋菌性眼炎。在122例经培养证实为新生儿淋菌性眼炎的新生儿中，105例返回接受随访。61例婴儿（54%）接受了头孢曲松治疗，32例接受了卡那霉素加外用庆大霉素治疗，29例接受了卡那霉素加外用四环素治疗。66株（54%）淋病奈瑟菌分离株产青霉素酶。所有55例接受头孢曲松治疗并返回接受随访的新生儿在临床和微生物学上均治愈。接受卡那霉素加四环素治疗的26例返回新生儿中有1例、接受卡那霉素加庆大霉素治疗的24例返回新生儿中有2例患有持续性或复发性淋菌性结膜炎。头孢曲松还根除了18例新生儿的口咽淋菌感染，而接受卡那霉素治疗的8例新生儿中有2例口咽感染持续存在（P值无统计学意义）。我们得出结论，单次肌内注射125mg头孢曲松是治疗新生儿淋菌性眼炎的非常有效的疗法，对眼外感染有显著疗效，且无需同时进行外用抗菌治疗。
