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与氨甲环酸相比,波斯戈尔纳尔对子宫异常出血女性月经过多的疗效:一项三盲随机等效性试验。

Effectiveness of Persian Golnar on Excessive Menstrual Bleeding in Women with Abnormal Uterine Bleeding, Compared to Tranexamic Acid: A Triple-Blind, Randomized Equivalence Trial.

作者信息

Es-Haghee Ashteany Somayeh, Vahid Dastjerdi Marzieh, Tabarrai Malihe, Nejatbakhsh Fatemeh, Sadati Lamardi Seyede Nargess, Rahmani Azam, Azizkhani Mohammad, Tavoli Zahra

机构信息

Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences (TUMS), Tehran, Iran.

Department of Obstetrics and Gynecology, Tehran University of Medical Science, Tehran, Iran.

出版信息

Evid Based Complement Alternat Med. 2023 Jul 20;2023:5355993. doi: 10.1155/2023/5355993. eCollection 2023.

Abstract

INTRODUCTION

Abnormal uterine bleeding (AUB) is a major healthcare problem in females of reproductive age and impacts women's health and quality of life (QoL). This study aimed to test the equivalence of Persian Golnar (PG) and tranexamic acid (TA) for the treatment of excessive menstrual bleeding.

METHOD

A triple-blind randomized equivalence trial with parallel design and block randomization technique was performed. A total of 80 patients with AUB were randomly allocated to receive either PG or TA for three consecutive menstrual cycles. Blood loss was measured by the Pictorial Blood Loss Assessment Chart (PBAC). Hematological evaluations were done before the intervention and after treatment. QoL and premenstrual dysphoric disorder (PMDD) as secondary outcomes were assessed using the menorrhagia questionnaire (MQ) and Premenstrual Symptoms Screening Tool (PSST). Statistical analysis was performed using an independent -test, paired -test, 2 test, Mann-Whitney test, and Wilcoxon signed-rank test.

RESULTS

Seventy-six women completed the 12-week follow-up. Both PG and TA groups experienced a significant reduction in blood loss. Furthermore, the serum level of hemoglobin in the PG group enhanced significantly ( < 0.001). QoL and PMDD scores were significantly improved in both groups (< 0.001).

CONCLUSION

The findings of the current trial supposed that the Golnar product is as effective as tranexamic acid in controlling bleeding and enhancing the quality of life and premenstrual symptoms.

摘要

引言

异常子宫出血(AUB)是育龄女性面临的一个主要医疗问题,会影响女性的健康和生活质量(QoL)。本研究旨在检验波斯戈尔纳尔(PG)和氨甲环酸(TA)治疗月经过多的等效性。

方法

采用平行设计和区组随机化技术进行三盲随机等效性试验。总共80例AUB患者被随机分配,连续三个月经周期接受PG或TA治疗。采用图片式失血评估图(PBAC)测量失血量。在干预前和治疗后进行血液学评估。使用月经过多问卷(MQ)和经前症状筛查工具(PSST)评估生活质量和经前烦躁障碍(PMDD)作为次要结局。采用独立样本t检验、配对样本t检验、卡方检验、曼-惠特尼检验和威尔科克森符号秩检验进行统计分析。

结果

76名女性完成了12周的随访。PG组和TA组的失血量均显著减少。此外,PG组的血红蛋白血清水平显著提高(P<0.001)。两组的生活质量和PMDD评分均显著改善(P<0.001)。

结论

当前试验的结果表明,戈尔纳尔产品在控制出血、提高生活质量和改善经前症状方面与氨甲环酸同样有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a64/10374373/31cd04bcd49b/ECAM2023-5355993.001.jpg

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