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首页> 外文期刊>Journal of infection and chemotherapy: official journal of the Japan Society of Chemotherapy >Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women
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Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women

机译：静脉用阿奇霉素联合口服阿奇霉素治疗日本女性急性盆腔炎和肝周炎的疗效和安全性

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Pelvic inflammatory disease (PID) is mainly caused by ascending infection from the vaginal flora including the sexually transmitted organisms, Neisseria gonorrhoeae and Chlamydia trachomatis, and lower genital tract endogenous anaerobes, leading to serious consequences including infertility and ectopic pregnancy. To evaluate the efficacy and safety of azithromycin in the treatment of PID that requires initial intravenous therapy, we conducted a multicenter, unblinded, non-comparative phase 3 trial. Intravenous azithromycin (500 mg, once daily) for 1 or 2 days followed by oral azithromycin (250 mg once daily) to complete a total of 7 days treatment was administered to 60 Japanese women with acute PID. The clinical and bacteriological responses were assessed at the end of treatment, and on Days 15 and 29. The most commonly detected baseline causative pathogens were C. trachomatis (12 strains), Prevotella bivia (10 strains), Streptococcus agalactiae (7 strains), N. gonorrhoeae and Peptostreptococcus anaerobius (6 strains each). The clinical success rate on Day 15 was 94.1% (48/51 subjects including perihepatitis). The clinical efficacy and bacterial eradication rates against C. trachomatis and N. gonorrhoeae (including 2 quinolone-resistant strains) were both 100%. Common treatment-related adverse events were diarrhoea, injection site pain, and nausea. All adverse events were mild or moderate in severity. Azithromycin intravenous-to-oral switch therapy demonstrated excellent clinical and bacteriological effects for PID caused by various etiologic agents including quinolone-resistant strains and strains with low susceptibility to azithromycin at in vitro testing. The therapy was well tolerated in the treatment of PID in Japanese women.
机译：盆腔炎（PID）主要是由阴道菌群（包括性传播生物，淋病奈瑟氏球菌和沙眼衣原体）以及下生殖道内源厌氧菌的不断上升的感染引起的，从而导致严重后果，包括不孕症和异位妊娠。为了评估阿奇霉素治疗需要初始静脉治疗的PID的疗效和安全性，我们进行了一项多中心，无盲，非对照的3期临床试验。对60例急性PID的日本女性给予静脉阿奇霉素（500 mg，每天一次）治疗1或2天，然后口服阿奇霉素（250 mg，每天一次）以完成总共7天的治疗。在治疗结束时以及第15天和第29天评估了临床和细菌学反应。最常见的基线致病菌是沙眼衣原体（12株），双歧杆菌（10株），无乳链球菌（7株），淋病奈瑟氏球菌和厌氧消化链球菌（各6个菌株）。第15天的临床成功率为94.1％（48/51名受试者，包括肝炎）。沙眼衣原体和淋病奈瑟氏球菌（包括2株喹诺酮耐药菌株）的临床疗效和细菌清除率均为100％。常见的与治疗相关的不良事件为腹泻，注射部位疼痛和恶心。所有不良事件的严重程度均为轻度或中度。阿奇霉素静脉-口服转换疗法对由多种病因引起的PID表现出优异的临床和细菌学作用，包括喹诺酮耐药菌株和对阿奇霉素敏感性低的菌株。在日本女性中，PID的治疗耐受性良好。

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