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随机对照试验:N-乙酰半胱氨酸与左旋肉碱治疗枸橼酸氯米酚抵抗的多囊卵巢综合征。

Randomized controlled trial of N-acetylcysteine versus l-carnitine among women with clomiphene-citrate-resistant polycystic ovary syndrome.

机构信息

Faculty of Medicine, Zagazig University, Zagazig, Egypt.

出版信息

Int J Gynaecol Obstet. 2019 Oct;147(1):59-64. doi: 10.1002/ijgo.12902. Epub 2019 Jul 17.

Abstract

OBJECTIVE

To compare clinical and metabolic profiles between N-acetylcysteine and l-carnitine among women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS).

METHODS

A randomized trial at Zagazig University between January 2017 and March 2018. Women with CC-resistant PCOS were allocated randomly to receive CC plus N-acetylcysteine or CC plus l-carnitine. The primary outcome was clinical pregnancy rate; secondary outcomes were ovulation rate and metabolic changes.

RESULTS

Overall, 162 women completed the study (N-acetylcysteine group, n=82; l-carnitine group, n=80). After 3 months, there was no difference in pregnancy (P=0.15), ovulation (P=0.21), or spontaneous abortion (P=0.11) rates between the two groups. There was no significant decrease in BMI in either group (both P>0.05). There were improvements in menstrual pattern, follicle-stimulating hormone, luteinizing hormone, free testosterone, and insulin resistance markers in both groups (all P<0.05). An improvement in lipid profile was observed only in the l-carnitine group (P<0.001). N-Acetylcysteine treatment led to significantly greater improvement in free testosterone and insulin resistance parameters as compared with l-carnitine (all P<0.05).

CONCLUSIONS

Both N-acetylcysteine and l-carnitine were equally effective in improving pregnancy and ovulation rates among women with CC-resistant PCOS. However, N-acetylcysteine was superior in ameliorating insulin resistance and only l-carnitine improved lipid profile.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT03164421.

摘要

目的

比较 N-乙酰半胱氨酸和左旋肉碱在枸橼酸氯米酚耐药多囊卵巢综合征(PCOS)女性中的临床和代谢特征。

方法

这是 2017 年 1 月至 2018 年 3 月在 Zagazig 大学进行的一项随机试验。将枸橼酸氯米酚耐药的 PCOS 女性随机分配接受枸橼酸氯米酚加 N-乙酰半胱氨酸或枸橼酸氯米酚加左旋肉碱。主要结局为临床妊娠率;次要结局为排卵率和代谢变化。

结果

共有 162 名女性完成了研究(N-乙酰半胱氨酸组,n=82;左旋肉碱组,n=80)。治疗 3 个月后,两组的妊娠率(P=0.15)、排卵率(P=0.21)或自然流产率(P=0.11)均无差异。两组的 BMI 均无显著下降(均 P>0.05)。两组的月经模式、卵泡刺激素、黄体生成素、游离睾酮和胰岛素抵抗标志物均有改善(均 P<0.05)。仅左旋肉碱组的血脂谱得到改善(P<0.001)。与左旋肉碱相比,N-乙酰半胱氨酸治疗可显著改善游离睾酮和胰岛素抵抗参数(均 P<0.05)。

结论

N-乙酰半胱氨酸和左旋肉碱在改善枸橼酸氯米酚耐药 PCOS 女性的妊娠率和排卵率方面同样有效。然而,N-乙酰半胱氨酸在改善胰岛素抵抗方面更具优势,而只有左旋肉碱能改善血脂谱。

试验注册

ClinicalTrials.gov:NCT03164421。

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