Non inferiority study of effects of Chinese herbal medicine of invigorating spleen and softening liver on pregnancy outcome in patients of recurrent spontaneous abortion with hyperprolactinemia

LI Ji; CAI Shi-ying; DAI Yu-ting; NI Kun-yan; ZHUANG Jia-yi; XIE Shi-yun

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Non inferiority study of effects of Chinese herbal medicine of invigorating spleen and softening liver on pregnancy outcome in patients of recurrent spontaneous abortion with hyperprolactinemia

更新时间：2022-08-31

- Non inferiority study of effects of Chinese herbal medicine of invigorating spleen and softening liver on pregnancy outcome in patients of recurrent spontaneous abortion with hyperprolactinemia
- Shanghai Journal of Traditional Chinese Medicine Vol. 51, Issue 9, Pages: 60-63(2017)
- 作者机构：
  
  1. 上海中医药大学附属龙华医院妇科,上海,200032
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LI Ji, CAI Shi-ying, DAI Yu-ting, et al. Non inferiority study of effects of Chinese herbal medicine of invigorating spleen and softening liver on pregnancy outcome in patients of recurrent spontaneous abortion with hyperprolactinemia. [J]. Shanghai Journal of Traditional Chinese Medicine 51(9):60-63(2017)
DOI：

LI Ji, CAI Shi-ying, DAI Yu-ting, et al. Non inferiority study of effects of Chinese herbal medicine of invigorating spleen and softening liver on pregnancy outcome in patients of recurrent spontaneous abortion with hyperprolactinemia. [J]. Shanghai Journal of Traditional Chinese Medicine 51(9):60-63(2017) DOI：

摘要

目的：在补肾活血安胎方的基础上,观察加用健脾柔肝中药与加用西药溴隐亭对伴有高泌乳素血症(HPRL)的复发性流产患者妊娠结局的影响。方法：将326例伴HPRL的复发性流产患者随机分为治疗组和对照组,每组163例。两组均予补肾活血安胎方,治疗组加用健脾柔肝中药(生麦芽、生谷芽、白芍、生甘草),对照组加用溴隐亭。两组总疗程均为12周,观察比较妊娠12周通过率及妊娠结局。结果：①最终完成试验者319例,治疗组161例,对照组158例。②治疗组、对照组妊娠12周通过率分别为86.3%、85.3%,组间通过率比较差异无统计学意义(P>0.05),经两样本率非劣效性检验合格(P<0.01)。③治疗组、对照组分娩成功率分别为83.2%、81.5%,组间分娩成功率比较差异无统计学意义(P>0.05),经两样本率非劣效性检验合格(P<0.01)。结论：确认妊娠后在补肾活血安胎方的基础上,加用健脾柔肝中药与加用西药溴隐亭的保胎作用相当,但与溴隐亭相比,健脾柔肝中药具有副反应少、患者更易接受的优势。

Abstract

Objective:To observe the effects of Chinese herbal medicine of invigorating spleen and softening liver or bromocriptine combined with Bushen Huoxue Antai Recipe on pregnancy outcome in patients of recurrent spontaneous abortion(RSA)with hyperprolactinemia(HPRL). Methods326 RSA patients with HPRL were randomly divided into the treatment group and control group,163 cases in each group. Both groups were treated with Bushen Huoxue Antai Recipe. The treatment group was treated with Chinese herbal medicine of invigorating spleen and softening liver(unprocessed Fructus Hordei Germinatus,unprocessed Fructus Setariae Germinatus,Radix Paeoniae Alba,unprocessed Radix Glycyrrhizae)and the control group was treated with bromocriptine additionally. The total treatment course in both groups was 12 weeks. The normal rate of 12-week pregnancy and pregnancy outcome were observed and compared. Results:①Finally 319 patients completed the trial,among 161 cases in the treatment group and 158 case in the control group. ②The normal rate of 12-week pregnancy was 86.3%in the treatment group and 85.3%in the control group. There was no statistically significant difference on the normal rate between the two groups(P>0.05).The non inferiority test for two sample rate was up to standard(P<0.01). ③The successful parturition rate was 83.2% in the treatment group and 81.5%in the control group. There was no statistically significant difference on the successful parturition rate between the two groups(P>0.05). The non inferiority test for two sample rate was up to standard(P<0.01). Conclusion:After pregnancy confirmation,the tocolysis effects of Bushen Huoxue Antai Recipe combined with Chinese herbal medicine of invigorating spleen and softening liver are equivalent to the effects of Bushen Huoxue Antai Recipe combined with bromocriptine. Compared with bromocriptine,the side reactions of Chinese herbal medicine of invigorating spleen and softening liver are less,which accepted more easily by patients.

关键词

高泌乳素血症复发性流产补肾活血健脾柔肝溴隐亭副作用

Keywords

hyperprolactinemiarecurrent spontaneous abortiontonifying kidney and promoting blood circulationinvigorating spleen and softening liverbromocriptineside reaction

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