Efficacy and safety of morinidazole in pelvic inflammatory disease: results of a multicenter, double-blind, randomized trial
Efficacy and safety of morinidazole in pelvic inflammatory disease: results of a multicenter, double-blind, randomized trial
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DOI：
10.1007/s10096-017-2913-z
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发表时间：
2017-07-01
影响因子：
4.5
通讯作者：
Wang, S.
中科院分区：
文献类型：
--
作者：
Cao, C.;Luo, A.;Wang, S.
这项多中心、双盲、随机、平行组、非劣效性研究比较了莫硝唑与奥硝唑治疗盆腔炎的疗效和安全性。来自中国18家医院的妇女接受了14天疗程的静脉注射莫立硝唑，500 mg，每日两次（n = 168），或静脉注射奥硝唑，500 mg，每日两次（n = 170）。全分析集（FAS）的338例患者中共有312例（92.3%）被纳入符合方案集（PPS）分析，其中61例（19.6%）被纳入微生物学有效（MBV）人群。PPS人群在治愈检验（TOC，主要疗效终点，治疗后7-30天）访视时的临床消退率为：莫硝唑96.86%（154/159），奥硝唑96.73%（148/153）（95% CI：-3.79%至4.03%）。TOC访视时MBV人群的细菌学成功率为：莫立硝唑100%（32/32），奥硝唑89.66%（26/29）（95% CI：-16.15%至11.21%）。药物相关不良反应发生率，莫立硝唑组为32.74%（55/168），奥硝唑组为47.06%（80/170），两组比较差异有显著性（P < 0.01）。对于患有盆腔炎的女性，每日两次服用莫硝唑14天在临床和细菌学上与每日两次服用奥硝唑14天一样有效，而前者与药物相关的不良事件比后者少。
This multicenter, double-blind, randomized, parallel-group, non-inferiority study compared the efficacy and safety of morinidazole with those of ornidazole in women with pelvic inflammatory disease. Women from 18 hospitals in China received a 14-day course of either intravenous morinidazole, 500 mg twice daily (n = 168), or intravenous ornidazole, 500 mg twice daily (n = 170). A total of 312 of 338 patients in the full analysis set (FAS) (92.3%) were included in the per protocol set (PPS) analyses, 61 (19.6%) of whom were included in the microbiologically valid (MBV) population. The clinical resolution rates in the PPS population at the test of cure (TOC, primary efficacy end point, 7-30 days post-therapy) visit were 96.86% (154/159) for morinidazole and 96.73% (148/153) for ornidazole (95% CI: -3.79% to 4.03%). The bacteriological success rates in the MBV population at the TOC visit were 100% (32/32) for morinidazole and 89.66% (26/29) for ornidazole (95% CI: -16.15% to 11.21%). Drug-related adverse events occurred less frequently with morinidazole (32.74%, 55/168) than with ornidazole (47.06%, 80/170) (p < 0.01). For women with pelvic inflammatory disease, twice-daily morinidazole for 14 days was clinically and bacteriologically as efficacious as twice-daily ornidazole for 14 days, while the former was associated with fewer drug-related adverse events than the latter.