Yushi Huayu Zhixue prescription combined with levonorgestrel-releasing intrauterine system in treating adenomyosis:a prospective,randomized,double-blind,placebo-controlled trial
10.16781/j.CN31-2187/R.20240127
- VernacularTitle:俞氏化瘀止血方联合左炔诺孕酮宫内缓释系统治疗子宫腺肌病的前瞻性、随机、双盲、安慰剂对照研究
- Author:
Yu LI
1
,
2
;
Wen CHENG
;
Sen LI
;
Jilan JIANG
;
Siqin YANG
;
Feng SUN
;
Ying QI
;
Chaoqin YU
;
Hong XU
Author Information
1. 上海交通大学医学院附属国际和平妇幼保健院妇科,上海 200030
2. 上海市胚胎源性疾病重点实验室,上海 200030
- Keywords:
adenomyosis;
levonorgestrel-releasing intrauterine system;
Yushi Huayu Zhixue prescription;
randomized control trial
- From:
Academic Journal of Naval Medical University
2024;45(9):1069-1076
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the efficacy and safety of Yushi Huayu Zhixue prescription (Huayu prescription) combined with levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of adenomyosis (AM). Methods A prospective,randomized,double-blind,placebo-controlled trial was designed and 102 patients with AM admitted to the outpatient department of International Peace Maternal & Child Health Hospital and The First Affiliated Hospital of Naval Medical University (Second Military Medical University) from Dec. 2019 to Dec. 2022 were enrolled. The patients were randomly divided into Huayu prescription group and placebo group for double-blind clinical trial. The Huayu prescription group was treated with Huayu prescription 1 month after LNG-IUS placement,while the placebo group was treated with placebo 1 month after LNG-IUS placement,and both Huayu prescription and placebo were taken for 3 months. A total of 95 patients completed the follow-up,including 47 in the Huayu prescription group and 48 in the placebo group;and 7 were shed,with a shedding rate of 6.86％. The pictorial blood loss assessment chart (PBAC) score,uterine spotting days,visual analogue scale (VAS) score,uterine volume,serum carbohydrate antigen 125 (CA125) level and traditional Chinese medicine (TCM) syndrome quantitative score were compared between the 2 groups,and the safety was evaluated. Results After 3 months of treatment,compared with the placebo group,the PBAC score,spotting days,uterine volume,serum CA125 level and TCM syndrome quantitative score of patients in the Huayu prescription group were all decreased (all P<0.05),but there was no significant difference in the VAS score of dysmenorrhea (P>0.05). During the follow-up,no patients in the Huayu prescription group but 2 patients in the placebo group received surgical treatment (including 1 case of laparoscopic hysterectomy and 1 case of laparoscopic adenomyomectomy),and there was no significant difference in the surgical rate between the 2 groups (P>0.05). Meanwhile,no obvious adverse reactions were found in both groups. Conclusion Huayu prescription can significantly improve the spotting of patients with AM,promote uterine volume reduction,reduce serum CA125 level,and significantly improve the TCM syndrome of AM. It is suggest that AM patients should take Huayu prescription after placing LNG-IUS,so as to reduce the adverse reactions of LNG-IUS.
