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生姜与维生素B6治疗妊娠恶心和呕吐的随机对照比较。

A randomized comparison of ginger and vitamin B6 in the treatment of nausea and vomiting of pregnancy.

作者信息

Sripramote Manit, Lekhyananda Nol

机构信息

Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College, Vajira Hospital, Thailand.

出版信息

J Med Assoc Thai. 2003 Sep;86(9):846-53.

PMID:14649969
Abstract

OBJECTIVE

To compare the efficacy of ginger to vitamin B6 in the treatment of nausea and vomiting of pregnancy.

STUDY DESIGN

A randomized double-blind controlled trial.

SETTING

The Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Vajira Hospital.

SUBJECTS

Women with nausea and vomiting of pregnancy at or before 16 weeks of gestation, who attended the antenatal care clinic. The subjects requested anti-emetics, had no medical complications, non-hospitalized and were able to attend a one week follow-up visit. From November, 1999 to November 2000, 138 women participated and gave consent for the study.

METHOD

The subjects were randomly allocated into two groups to take either 500 mg of ginger orally or an identical 10 mg of vitamin B6 one capsule three times daily for three days. Subjects graded the severity of their nausea using visual analogue scales before treatment and recorded the number of vomiting episodes in the previous 24 hours and again during three consecutive days of treatment.

MAIN OUTCOME MEASURES

The change of nausea scores and the number of vomiting episodes during three days of treatment.

RESULTS

The 64 subjects in each group remained in the study. The demographic data were comparable in both groups. The ginger and vitamin B6 significantly reduced the nausea scores from 5.0 (SD, 1.99) to 3.6 (SD, 2.48) and 5.3 (SD, 2.08) to 3.3 (SD, 2.07) respectively, with p < 0.001. The mean score change after treatment with ginger was 1.4 (2.21), less than with vitamin B6, which was 2.0 (2.19) but with no statistically significant difference (95% CI -1.4 to 0.2, p = 0.136). The ginger and vitamin B6 also significantly reduced the number of vomiting episodes from 1.9 (2.06) to 1.2 (1.75) and 1.7 (1.81) to 1.2 (1.50) respectively, with p < 0.01. The mean number change after treatment with ginger was 0.7 (2.18), more than with vitamin B6, which was 0.5 (1.44) but with no statistically significant difference, (p = 0.498). There were some minor side effects in both groups such as sedation (26.6% vs 32.8%, p = 0.439), and heartburn (9.4% vs 6.3%, p = 0.510), a non-significant difference.

CONCLUSION

The nausea score and the number of vomiting episodes were significantly reduced following ginger and vitamin B6 therapy. Comparing the efficacy, there was no significant difference between ginger and vitamin B6 for the treatment of nausea and vomiting during pregnancy.

摘要

目的

比较生姜与维生素B6治疗妊娠恶心呕吐的疗效。

研究设计

随机双盲对照试验。

研究地点

曼谷都市管理医学院及瓦吉拉医院妇产科。

研究对象

妊娠16周及以前出现恶心呕吐、前来产前护理门诊就诊的孕妇。这些孕妇要求使用止吐药,无医学并发症,未住院且能够参加为期一周的随访。1999年11月至2000年11月,138名孕妇参与并同意参加本研究。

方法

将研究对象随机分为两组,一组口服500毫克生姜,另一组口服相同剂量的10毫克维生素B6,均为每日三次、每次一粒胶囊,持续服用三天。研究对象在治疗前使用视觉模拟量表对恶心严重程度进行评分,并记录前24小时内的呕吐次数,以及治疗连续三天期间的呕吐次数。

主要观察指标

治疗三天期间恶心评分及呕吐次数的变化。

结果

每组各64名研究对象完成研究。两组的人口统计学数据具有可比性。生姜组和维生素B6组均使恶心评分显著降低,分别从5.0(标准差1.99)降至3.6(标准差2.48)以及从5.3(标准差2.08)降至3.3(标准差2.07),p < 0.001。生姜治疗后的平均评分变化为1.4(2.21),低于维生素B6组的2.0(2.19),但差异无统计学意义(95%可信区间为 -1.4至0.2,p = 0.136)。生姜组和维生素B6组也均使呕吐次数显著减少,分别从1.9(2.06)降至1.2(1.75)以及从1.7(1.81)降至1.2(1.50),p < 0.01。生姜治疗后的平均次数变化为0.7(2.18),高于维生素B6组的0.5(1.44),但差异无统计学意义(p = 0.498)。两组均有一些轻微副作用,如镇静(26.6%对32.8%,p = 0.439)和烧心(9.4%对6.3%,p = 0.510),差异无统计学意义。

结论

生姜和维生素B6治疗后,恶心评分和呕吐次数均显著降低。比较疗效发现,生姜与维生素B6在治疗妊娠恶心呕吐方面无显著差异。

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