低剂量阿司匹林预防早产效果是否受依从性影响：多中心试验事后分析
通过每2周药片计数评估依从性，分析治疗开始孕周和依从性对低剂量阿司匹林预防早产效果的影响。结果显示早产、34周前早产和围产期死亡的结果均不依赖于治疗开始时间或依从性。
要点
- 低剂量阿司匹林预防早产的效果不随治疗开始孕周（6-13周）改变。
- 依从性每增加5%，早产及围产期死亡风险比无明显变化。
- 不同地区之间未观察到效果修饰作用。
核心结论
- 早产、34周前早产和围产期死亡的结果不依赖于低剂量阿司匹林治疗开始时间或依从性。
研究设计与样本
- 研究设计为随机对照试验的事后分析。
- 孕妇每2周领取预包装药物，通过每2周药片计数评估依从性。
主要发现
- 治疗开始中位孕周为10.1周（IQR 8.6，12.0），85.5%的孕妇依从性超过90%。
- 治疗开始孕周每增加1周，早产风险比为0.97（95%CI 0.93-1.02），34周前早产风险比小于0.98（95%CI 0.89-1.07），围产期死亡风险比为1.04（95%CI 0.96-1.12），均无证据显示效果修饰。
- 依从性每增加5%，早产风险比为1.01（95%CI 0.99-1.04），34周前早产风险比小于0.99（95%CI 0.95-1.03），围产期死亡风险比为1.02（95%CI 0.98-1.06），无有意义的交互作用。
- 不同地区之间未观察到效果修饰。
关键数值与推荐
- 对每个结局拟合Poisson模型，调整地点、治疗组和治疗开始孕周。
- 主要结局为早产，次要结局包括34周前早产和围产期死亡，并按地区进行分析。
- 临床试验注册号：NCT02409680。
临床怎么用
- 在孕6-13周内启动低剂量阿司匹林预防早产时，治疗开始孕周和依从性不是影响效果的关键因素。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
OBJECTIVE: To evaluate if the effect of low-dose aspirin (LDA) commenced between 6 and 13 weeks of gestational age (GA) on preterm delivery (PTD) is modified by total exposure. DESIGN: Post hoc analysis of a randomized controlled trial. SETTING: Hospitals in low-resource settings in Africa, Asia and Latin America. POPULATION: Outcomes were obtained for 11 908/11943 women at 6 0/7 to 13 6/7 weeks' GA randomized. METHODS: Women received prepackaged two-week medication allotments. Adherence was assessed by pill counts every 2 weeks. Estimated relative risk and 95% confidence interval data for each outcome at each GA of treatment initiation weeks were obtained by fitting a Poisson model to each outcome, adjusting for site, treatment arm and GA at treatment initiation. MAIN OUTCOMES MEASURES: The primary outcome was PTD. Secondary outcomes included PTD < 34 weeks and perinatal mortality including analysis by region. RESULTS: The median gestational age at treatment initiation was 10.1 weeks (IQR 8.6, 12.0). 85.5% of the mothers had over 90% adherence to treatment. For each 1 week increase of GA at treatment initiation, the treatment risk ratio did not change for PTD [RR 0.97 (95% CI, 0.93, 1.02)], PTD < 34 weeks [< 0.98 (0.89, 1.07)] or perinatal mortality [1.04 (0.96, 1.12)], with no evidence of effect modification. For each 5% increase in adherence, the treatment risk ratio did not change for PTD [1.01 (0.99, 1.04)], PTD < 34 weeks [< 0.99 (0.95, 1.03)] or perinatal mortality [1.02 (0.98, 1.06)], indicating no meaningful interaction with adherence. There was no effect modification by region. CONCLUSIONS: This analysis shows that the results of PTD, PTD < 34 weeks and perinatal mortality were not dependent on the timing of the initiation or adherence to treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02409680.
引用
- Mwenechanya, Tembo, Chomba, et al. Does Adherence Modify Low-Dose Aspirin Effects in Pregnancy? Post Hoc Analysis From a Multi-Centre Trial. BJOG. 2026. PMID: 42002305. doi:10.1111/1471-0528.70244
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。