Witter F R, Mercer B M
Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
J Matern Fetal Med. 1996 Mar-Apr;5(2):64-9. doi: 10.1002/(SICI)1520-6661(199603/04)5:2<64::AID-MFM3>3.0.CO;2-O.
The purpose of this study was to determine if prostaglandin E2 (PGE2) in a controlled-release vaginal insert with retrieval system can produce cervical ripening at term. This was a multicenter, double blind, randomized, placebo-controlled study involving 206 patients with 102 receiving active agent. A successful outcome was defined as a change in Bishop score of > or = 3, or a Bishop score of > or = 6 at 12 h or delivery within 12 h of the insert placement. Analysis was by Fisher's exact test, Wilcoxon's two-sample rank-sum test, and Student's t-test where appropriate. One hundred ninety-three women completed the protocol. Initial Bishop scores were 2.6 +/- 1.2 and 2.5 +/- 1.4 in the PGE2 and placebo groups, respectively. The incidence of cesarean delivery was identical in the two groups. Uterine hyperstimulation lasted 2-13 min in 5 PGE2 patients (4.9%) with 1 patient requiring tocolysis. More patients in the PGE2 group had a change in Bishop score of > or = 3 (62% vs. 40%; P = 0.002), a Bishop score > or = 6 after 12 h (46% vs. 34%; P = 0.11), and vaginal delivery within 12 h (6.5% vs. 1%; P = 0.055). Sixty-five percent of PGE2 group patients had a successful outcome vs. 44% of control patients (P = 0.001). In conclusion, when administered in a controlled-release vaginal insert with a retrieval system, PGE2 is effective in promoting cervical ripening at term.
本研究的目的是确定带有取出系统的控释阴道栓剂中的前列腺素E2（PGE2）能否在足月时促宫颈成熟。这是一项多中心、双盲、随机、安慰剂对照研究，涉及206例患者，其中102例接受活性药物治疗。成功结局定义为Bishop评分变化≥3分，或在放置栓剂后12小时时Bishop评分≥6分，或在放置栓剂后12小时内分娩。在适当情况下采用Fisher精确检验、Wilcoxon两样本秩和检验及Student t检验进行分析。193名女性完成了方案。PGE2组和安慰剂组的初始Bishop评分分别为2.6±1.2和2.5±1.4。两组剖宫产率相同。5例PGE2组患者（4.9%）出现子宫过度刺激，持续2 - 13分钟，其中1例需要进行宫缩抑制治疗。PGE2组更多患者的Bishop评分变化≥3分（62%对40%；P = 0.002），12小时后Bishop评分≥6分（46%对34%；P = 0.11），以及在12小时内阴道分娩（6.5%对1%；P = 0.055）。PGE2组65%的患者有成功结局，而对照组为44%（P = 0.001）。总之，当通过带有取出系统的控释阴道栓剂给药时，PGE2在足月时促宫颈成熟有效。
