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甲氨蝶呤单剂量与多剂量给药用于异位妊娠药物治疗的成功率比较:一项前瞻性随机临床试验

Comparison of success rates in the medical management of ectopic pregnancy with single-dose and multiple-dose administration of methotrexate: a prospective, randomized clinical trial.

作者信息

Alleyassin Ashraf, Khademi Afsaneh, Aghahosseini Marzieh, Safdarian Leili, Badenoosh Bita, Hamed Ehsan Akbari

机构信息

Department of Obstetrics and Gynecology, Vali-e-asr Reproductive Health Research Center, Dr. Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.

出版信息

Fertil Steril. 2006 Jun;85(6):1661-6. doi: 10.1016/j.fertnstert.2005.11.055. Epub 2006 May 2.

Abstract

OBJECTIVE

To assess whether success rate differs in single-dose versus multiple-dose administration of methotrexate (MTX) in medical management of unruptured ectopic pregnancies.

DESIGN

Prospective randomized clinical trial.

SETTING

Tertiary university hospital.

PATIENT(S): The study population included 108 patients presenting with unruptured ectopic pregnancies who fulfilled the criteria for medical management.

INTERVENTION(S): A single dose (study group) or multiple doses (control group) of MTX were administered IM.

MAIN OUTCOME MEASURE(S): Success rate of medical management in each group.

RESULT(S): Of the 54 patients on the single-dose protocol, treatment was considered successful in 48 patients (88.9%). Of the 54 patients on the multiple-dose protocol, 50 participants responded to the treatment (92.6%). The difference between success rates in the two groups was not statistically significant (P=.7; odds ratio 0.64; 95% confidence interval 0.17-2.4). In the single-dose and multiple-dose groups, 15 (27.8%) and 20 (37%) patients, respectively, had complications (P=.3).

CONCLUSION(S): The results of our study showed that single-dose treatment with MTX could be as successful as multiple doses. The incidence of complications did not differ between the two groups. It appears that single-dose treatment could be the first line of treatment in selected patients.

摘要

目的

评估甲氨蝶呤(MTX)单剂量与多剂量给药在未破裂异位妊娠药物治疗中的成功率是否存在差异。

设计

前瞻性随机临床试验。

地点

三级大学医院。

患者

研究人群包括108例符合药物治疗标准的未破裂异位妊娠患者。

干预措施

肌肉注射单剂量(研究组)或多剂量(对照组)MTX。

主要观察指标

每组药物治疗的成功率。

结果

在单剂量方案组的54例患者中,48例(88.9%)治疗成功。在多剂量方案组的54例患者中,50例对治疗有反应(92.6%)。两组成功率的差异无统计学意义(P = 0.7;优势比0.64;95%置信区间0.17 - 2.4)。在单剂量组和多剂量组中,分别有15例(27.8%)和20例(37%)患者出现并发症(P = 0.3)。

结论

我们的研究结果表明,MTX单剂量治疗与多剂量治疗同样成功。两组并发症的发生率无差异。看来单剂量治疗可能是部分患者的一线治疗方法。

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