机构地区:[1]北京大学第三医院药剂科,北京100083 [2]兰州大学第一医院妇产科 [3]兰州大学第一医院药剂科,兰州730000 [4]兰州大学第一医院普外科
出 处:《中国循证医学杂志》2007年第8期591-600,共10页Chinese Journal of Evidence-based Medicine
摘 要:目的评价沙丁胺醇治疗孕妇早产的疗效与安全性。方法计算机检索MEDLINE(1966~2007.1)、EMbase(1966~2007.1)、Cochrane对照试验资料库(2006年第4期)、CBMdisc(1978~2007.1)和CNKI(1979~2007.1),收集沙丁胺醇治疗早产的随机和半随机试验,对符合纳入标准的临床研究进行Meta分析。结果共纳入19篇随机和半随机试验,其中中文16篇,英文3篇。未检索到关于此题目的其他语种研究报告。16项中文研究的Jadad改良法评分均〈3分,为低质量文献,各研究均未描述具体的随机方法,未进行分配方案的隐藏,未使用盲法,未对远期效果进行评价。3篇英文研究的Jadad改良法评分〉5分,对远期效果进行了评价,为高质量文献。与基础治疗相比,沙丁胺醇组保胎超过48h的人数较高[RR(95%CI)为6.30(3.23,14.32)]、新生儿窒息率较低[RR(95%CI)为0.44(0.33,0.59)],但孕妇不良事件发生率高于基础治疗组[RR(95%CI)为4.57(1.34,15.54)]。与硫酸镁组相比,沙丁胺醇组保胎超过48h的孕妇数、新生儿窒息率OR(95%CI)分别为1.60(0.92,2.76),0.29(0.14,0.61)。与阿托西班相比,沙丁胺醇保胎超过48h的孕妇数、新生儿窒息率OR(95%CI)分别为1.18(0.42,3.37),1.13(0.30,4.31)。结论与基础治疗相比,沙丁胺醇在提高保胎成功率、降低新生儿窒息率方面优于后者,但孕妇不良事件发生率较基础治疗高;沙丁胺醇与其他常用保胎药相比,在保胎成功率方面无明显差异,在降低新生儿窒息率方面优于硫酸镁,孕妇不良事件较阿托西班高,较硫酸镁低。Objective To assess the effectiveness and safety of salbutamol in the treatment of preterm labor. Methods We searched MEDLINE (1966-Jan. 2007), EMBASE (1966-Jan. 2007), Cochrane Central Register of Controlled Trials (Issue 4, 2006), CBMdisc (1978-Jan. 2007) and CNKI (1979-Jan. 2007). Randomized controlled trials (RCTs) or quasi-randomized controlled trials (quasi-RCT) involving salbutamol for preterm labor were collected. The quality of the retrieved trials was assessed using the Jadad Scale. Meta-analyses were conducted with The Cochrane Collaboration's RevMan 4.2 software. Results A total of 19 RCTs and quasi-RCTs were included, of which 16 were published in Chinese and 3 in English. The quality of the 16 Chinese studies was low, scored less than 3 by the Jadad Scale. None of the 16 RCTs mentioned the method of randomization, allocation concealment, doubleblinding or the long-term effect. The quality of the 3 English studies was high. Compared with basic treatment, salbutamol was more effective in prolonging pregnancy over 48 hours (RR=6.30, 95%CI 3.23 to 14.32), and preventing neonatal asphyxia (RR=0.44, 95%CI 0.33 to 0.59), but the incidence of adverse events in pregnant women was higher in the salbutamol group (RR=4.57, 95%CI 1.34 to 15.54). Salbutamol was as effective as magnesium sulfate in prolonging pregnancy over 48 hours (OR=1.60, 95%CI 0.92 to 2.76), but more effective in preventing neonatal asphyxia (OR=0.29, 95%CI 0.14 to 0.61). Salbutamol was similar to atosiban in terms of prolonging pregnancy over 48 hours (OR=1.18, 95%CI 0.42 to 3.37) and preventing neonatal asphyxia (OR=1.13, 9S%CI 0.30 to 4.31). Conclusion Salbutamol is effective in prolonging pregnancy over 48 hours and preventing neonatal asphyxia, but may cause more adverse events in pregnant women. Salbutamol has similar effects to other commonly-used drugs in regard to prolonging pregnancy over 48 hours, but is better than magnesium sulfate in decreasing the incidence of neonatal a
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