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| 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 |
| 李彧1,2,程雯3,李森1,2,蒋继兰1,2,杨思勤1,2,孙峰1,2,齐英1,2,俞超芹3*,许泓1,2* |
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(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;
3. 海军军医大学(第二军医大学)第一附属医院中医妇科, 上海 200433
*通信作者) |
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| 摘要: |
| 目的 探究俞氏化瘀止血方联合左炔诺孕酮宫内缓释系统（LNG-IUS）治疗子宫腺肌病（AM）的疗效及安全性。方法 采用前瞻性、随机、双盲、安慰剂对照研究设计，选取2019年12月至2022年12月就诊于上海交通大学医学院附属国际和平妇幼保健院及海军军医大学（第二军医大学）第一附属医院门诊的AM患者102例，随机分为化瘀方组和安慰剂组进行双盲临床试验，化瘀方组放置LNG-IUS后1个月加用俞氏化瘀止血方治疗，安慰剂组放置LNG-IUS后1个月加用安慰剂治疗，俞氏化瘀止血方和安慰剂均服用3个月。共95例完成随访，其中化瘀方组47例、安慰剂组48例；脱落7例，脱落率为6.86%。比较两组患者的月经失血图（PBAC）评分、子宫点滴出血天数、痛经视觉模拟量表（VAS）评分、子宫体积、血清糖类抗原125（CA125）水平和中医证候量化评分，并进行安全性评价。结果 服药3个月后，与安慰剂组相比，化瘀方组患者PBAC评分、点滴出血天数、子宫体积、血清CA125水平、中医证候量化评分均降低（均P＜0.05），痛经VAS评分差异无统计学意义（P＞0.05）。随访过程中，化瘀方组患者均未接受手术治疗，安慰剂组有2例行手术治疗（其中1例行腹腔镜子宫全切术，1例行腹腔镜子宫腺肌瘤切除术），两组手术率差异无统计学意义（P＞0.05）。安慰剂组与化瘀方组均未见明显不良反应。结论 俞氏化瘀止血方可明显改善AM患者的点滴出血情况，促进子宫体积缩小，降低血清CA125水平，改善AM中医证候。建议AM患者在放置LNG-IUS后常规服用俞氏化瘀止血方制剂，以减少LNG-IUS的不良反应。 |
| 关键词: 子宫腺肌病 左炔诺孕酮宫内缓释系统 俞氏化瘀止血方 随机对照试验 |
| DOI：10.16781/j.CN31-2187/R.20240127 |
| 投稿时间：2024-02-23修订日期：2024-07-01 |
| 基金项目:上海市卫生健康委员会上海市中西医临床协作试点项目（ZXYXZ-201905），上海市徐汇区人工智能医疗院地合作项目（2021-014），上海交通大学“交大之星”计划医工交叉研究基金重点项目（YG2021ZD30），国际和平妇幼保健院“五新”项目临床研究（CR2018WX06）. |
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| Yushi Huayu Zhixue prescription combined with levonorgestrel-releasing intrauterine system in treating adenomyosis: a prospective, randomized, double-blind, placebo-controlled trial |
| LI Yu1,2,CHENG Wen3,LI Sen1,2,JIANG Jilan1,2,YANG Siqin1,2,SUN Feng1,2,QI Ying1,2,YU Chaoqin3*,XU Hong1,2* |
(1. Department of Gynecology, International Peace Maternal & Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China;
2. Shanghai Key Laboratory of Embryo Original Diseases, Shanghai 200030, China;
3. Department of Traditional Chinese Medicine (Gynecology), The First Affiliated Hospital of Naval Medical University (Second Military Medical University), Shanghai 200433, China
* Corresponding authors) |
| 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. |
| Key words: adenomyosis levonorgestrel-releasing intrauterine system Yushi Huayu Zhixue prescription randomized control trial |
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