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用牡荆属植物(BNO 1095)治疗中国妇女中重度经前期综合征。

Treatment of moderate to severe premenstrual syndrome with Vitex agnus castus (BNO 1095) in Chinese women.

机构信息

Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, People's Republic of China.

出版信息

Gynecol Endocrinol. 2010 Aug;26(8):612-6. doi: 10.3109/09513591003632126.

DOI:10.3109/09513591003632126
PMID:20334585
Abstract

OBJECTIVES

To assess efficacy of the extract of Vitex agnus castus (VAC, BNO 1095) in the treatment of Chinese women suffering from moderate to severe premenstrual syndrome (PMS).

METHODS

It was a prospective randomised double-blind placebo-controlled study conducted in Chinese women. Eligible patients were randomly assigned into VAC or placebo group. Symptoms were documented with a daily rating scale with four symptom factors (negative affect, water retention, food cravings and pain).

RESULTS

Sixty-seven patients were enrolled and randomly assigned to receive one tablet of VAC or placebo once a day. The premenstrual syndrome diary (PMSD) sum score decreased from 29.38 +/- 7.63 score points at baseline to 4.28 +/- 5.76 at the 3rd cycle in the treatment group, while it decreased from 28.76 +/- 8.23 to 11.79 +/- 11.78 in the placebo group. All the four symptom factor scores were significantly reduced by the 3rd treatment cycle. There was significant difference in PMSD sum score, score of negative affect and water retention between two groups at cycle 3 (P < 0.05). PMSD sum scores decreased 60% was defined as efficacy, and the efficacy rate in treatment group was significantly higher than that in placebo group at the 3rd treatment cycle.

CONCLUSION

Vitex agnus castus extract BNO 1095 shows effective in treating moderate to severe PMS in Chinese women, especially in symptoms of negative affect and water retention.

摘要

目的

评估马鞭草提取物(VAC,BNO 1095)治疗中国中重度经前期综合征(PMS)女性患者的疗效。

方法

这是一项在中国女性中进行的前瞻性随机双盲安慰剂对照研究。合格患者被随机分配到 VAC 或安慰剂组。症状采用每日评分量表和四个症状因子(负性情绪、水潴留、食欲和疼痛)进行记录。

结果

67 名患者入组并随机接受每天一次 VAC 或安慰剂片剂。治疗组经前期综合征日记(PMSD)总分从基线时的 29.38 +/- 7.63 分降至第 3 个周期的 4.28 +/- 5.76 分,而安慰剂组从 28.76 +/- 8.23 分降至 11.79 +/- 11.78 分。所有四个症状因子评分在第 3 个治疗周期均显著降低。第 3 个治疗周期时,两组 PMSD 总分、负性情绪和水潴留评分均有显著差异(P < 0.05)。PMSD 总分下降 60%定义为有效,治疗组在第 3 个治疗周期的有效率明显高于安慰剂组。

结论

马鞭草提取物 BNO 1095 对治疗中国中重度 PMS 有效,尤其是对负性情绪和水潴留症状。

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