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生姜治疗妊娠剧吐的有效性和安全性。

Effectiveness and safety of ginger in the treatment of pregnancy-induced nausea and vomiting.

作者信息

Borrelli Francesca, Capasso Raffaele, Aviello Gabriella, Pittler Max H, Izzo Angelo A

机构信息

Department of Experimental Pharmacology, University of Naples Federico II, Naples, Italy.

出版信息

Obstet Gynecol. 2005 Apr;105(4):849-56. doi: 10.1097/01.AOG.0000154890.47642.23.

Abstract

OBJECTIVE

Conventional antiemetics are burdened with the potential of teratogenic effects during the critical embryogenic period of pregnancy. Thus, a safe and effective medication would be a welcome addition to the therapeutic repertoire. This systematic review was aimed at assessing the evidence for or against the efficacy and safety of ginger (Zingiber officinale) therapy for nausea and vomiting during pregnancy.

DATA SOURCES

Systematic literature searches were conducted in 3 computerized databases (MEDLINE, EMBASE, and Cochrane Library), and the reference lists of all papers located were checked for further relevant publications.

METHODS OF STUDY SELECTION

For the evaluation of efficacy, only double-blind, randomized controlled trials (RCTs) were included. All retrieved clinical data, including uncontrolled trials, case reports, observational studies, and RCTs, were included in the review of safety.

TABULATION, INTEGRATION, AND RESULTS: Six double-blind RCTs with a total of 675 participants and a prospective observational cohort study (n = 187) met all inclusion criteria. The methodological quality of 4 of 5 RCTs was high. Four of the 6 RCTs (n = 246) showed superiority of ginger over placebo; the other 2 RCTs (n = 429) indicated that ginger was as effective as the reference drug (vitamin B6) in relieving the severity of nausea and vomiting episodes. The observational study retrieved and RCTs (including follow-up periods) showed the absence of significant side effects or adverse effects on pregnancy outcomes. There were no spontaneous or case reports of adverse events during ginger treatment in pregnancy.

CONCLUSION

Ginger may be an effective treatment for nausea and vomiting in pregnancy. However, more observational studies, with a larger sample size, are needed to confirm the encouraging preliminary data on ginger safety.

LEVEL OF EVIDENCE

I.

摘要

目的

传统的止吐药在孕期关键的胚胎发育阶段有潜在致畸作用。因此,一种安全有效的药物将是治疗方法中的受欢迎补充。本系统评价旨在评估支持或反对生姜(姜科植物姜)治疗孕期恶心和呕吐有效性及安全性的证据。

数据来源

在3个计算机化数据库(MEDLINE、EMBASE和Cochrane图书馆)中进行系统文献检索,并检查所有找到论文的参考文献列表以获取更多相关出版物。

研究选择方法

为评估有效性,仅纳入双盲随机对照试验(RCT)。所有检索到的临床数据,包括非对照试验、病例报告、观察性研究和RCT,均纳入安全性评价。

制表、整合及结果:6项双盲RCT共675名参与者以及1项前瞻性观察队列研究(n = 187)符合所有纳入标准。5项RCT中有4项的方法学质量较高。6项RCT中的4项(n = 246)显示生姜优于安慰剂;另外2项RCT(n = 429)表明生姜在缓解恶心和呕吐发作严重程度方面与参比药物(维生素B6)效果相当。检索到的观察性研究和RCT(包括随访期)显示无显著副作用或对妊娠结局无不良影响。孕期生姜治疗期间无不良事件的自发报告或病例报告。

结论

生姜可能是治疗孕期恶心和呕吐的有效方法。然而,需要更多样本量更大的观察性研究来证实关于生姜安全性的令人鼓舞的初步数据。

证据级别

I级

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