Li Raymond Hang Wun, Lo Sue Seen Tsing, Gemzell-Danielsson Kristina, Fong Carol Ho Yi, Ho Pak Chung, Ng Ernest Hung Yu
Department of Obstetrics and Gynaecology, School of Clinical Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China; The Family Planning Association of Hong Kong, Hong Kong Special Administrative Region, China.
Department of Obstetrics and Gynaecology, School of Clinical Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China; The Family Planning Association of Hong Kong, Hong Kong Special Administrative Region, China.
Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16.
Levonorgestrel, a standard drug for emergency contraception (EC), is not effective if administered post-ovulation. A cyclo-oxygenase inhibitor could contribute synergistic effects. We investigated whether a single 40 mg oral dose of piroxicam as co-treatment with levonorgestrel improved emergency contraceptive efficacy.
This was a randomised double-blind placebo-controlled trial carried out in a major community sexual and reproductive health service in Hong Kong. Women who required levonorgestrel EC within 72 h of unprotected sexual intercourse were recruited and block-randomised in a 1:1 ratio to receive a single supervised dose of levonorgestrel 1·5 mg plus either piroxicam 40 mg or placebo orally. Group assignment was concealed in opaque envelopes and masked to the women, clinicians, and investigators. At follow-up 1-2 weeks after the next expected period, the pregnancy status was noted by history or pregnancy test. The primary efficacy outcome was the proportion of pregnancies prevented out of those expected based on an established model. All women randomised to receive the study drug and who completed the follow-up were analysed. The trial was registered with ClinicalTrials.gov, NCT03614494.
860 women (430 in each group) were recruited between Aug 20, 2018, and Aug 30, 2022. One (0·2%) of 418 efficacy-eligible women in the piroxicam group were pregnant, compared with seven (1·7%) of 418 in the placebo group (odds ratio 0·20 [95% CI 0·02-0·91]; p=0·036). Levonorgestrel plus piroxicam prevented 94·7% of expected pregnancies compared with 63·4% for levonorgestrel plus placebo. We noted no significant difference between the two groups in the proportion of women with advancement or delay of their next period, or in the adverse event profile.
Oral piroxicam 40 mg co-administered with levonorgestrel improved efficacy of EC in our study. Piroxicam co-administration could be considered clinically where levonorgestrel EC is the option of choice.
None.
左炔诺孕酮是紧急避孕（EC）的标准药物，但在排卵后服用无效。环氧化酶抑制剂可能具有协同作用。我们研究了单次口服40毫克吡罗昔康与左炔诺孕酮联合使用是否能提高紧急避孕效果。
这是一项在香港一家主要的社区性与生殖健康服务机构进行的随机双盲安慰剂对照试验。招募在无保护性交后72小时内需要左炔诺孕酮紧急避孕的女性，并按1:1的比例进行区组随机分组，以接受单次监督剂量的1.5毫克左炔诺孕酮加40毫克吡罗昔康或安慰剂口服。分组情况被藏于不透明信封中，对女性、临床医生和研究人员均设盲。在下一个预期月经周期后的1 - 2周进行随访时，通过病史或妊娠试验记录妊娠状态。主要疗效结局是基于既定模型预计会发生的妊娠中被预防的妊娠比例。对所有随机接受研究药物并完成随访的女性进行分析。该试验已在ClinicalTrials.gov注册，注册号为NCT03614494。
2018年8月20日至2022年8月30日期间招募了860名女性（每组430名）。吡罗昔康组418名符合疗效评估标准的女性中有1名（0.2%）怀孕，而安慰剂组418名中有7名（1.7%）怀孕（比值比0.20 [95%可信区间0.02 - 0.91]；p = 0.036）。左炔诺孕酮加吡罗昔康预防了94.7%的预期妊娠，而左炔诺孕酮加安慰剂为63.4%。我们注意到两组在下一个月经周期提前或推迟的女性比例以及不良事件方面没有显著差异。
在我们的研究中，口服40毫克吡罗昔康与左炔诺孕酮联合使用可提高紧急避孕效果。在选择左炔诺孕酮紧急避孕的临床情况下，可以考虑联合使用吡罗昔康。
无。
