抗妇炎胶囊治疗盆腔炎性疾病-慢性盆腔痛的有效性及安全性：一项随机、双盲、平行对照、多中心临床试验

Zhao-hui LIU; Zhe JIN; Hong ZHAO; Yao LU; Hui ZHEN; Ting ZOU

doi:10.1007/s11655-021-3490-7

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抗妇炎胶囊治疗盆腔炎性疾病-慢性盆腔痛的有效性及安全性：一项随机、双盲、平行对照、多中心临床试验

Original Article | Updated：2021-11-29

- 抗妇炎胶囊治疗盆腔炎性疾病-慢性盆腔痛的有效性及安全性：一项随机、双盲、平行对照、多中心临床试验
- Effect and Safety of Kangfuyan Capsules (抗妇炎胶囊) for Relieving Chronic Pelvic Pain: A Multicenter, Randomized,Controlled, Double-Blind, Parallel-Group Clinical Trial
- Chinese Journal of Integrative Medicine 2021年27卷第12期页码：883-890
- Affiliations：
  
  1.Department of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing (100026), China
  2.China Association of Traditional Chinese Medicine, Beijing(100101), China
  3.Department of Gynecology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine,Beijing (100078), China
  4.Department of Gynecology, China-Japan Friendship Hospital, Beijing (100029), China
- Author bio：
  
  Prof. LIU Zhao-hui, E-mail: 17301255426@163.com;
  Prof. JIN Zhe, E-mail: jzhe0105@126.com
- Funds：
- DOI：10.1007/s11655-021-3490-7
  中图分类号：
- 纸质出版日期：2021-11-15，
  
  网络出版日期：2021-08-25，
  
  录用日期：2020-04-24
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Zhao-hui LIU, Zhe JIN, Hong ZHAO, 等. 抗妇炎胶囊治疗盆腔炎性疾病-慢性盆腔痛的有效性及安全性：一项随机、双盲、平行对照、多中心临床试验[J]. Chinese Journal of Integrative Medicine, 2021,27(12):883-890.

Zhao-hui LIU, Zhe JIN, Hong ZHAO, et al. Effect and Safety of Kangfuyan Capsules (抗妇炎胶囊) for Relieving Chronic Pelvic Pain: A Multicenter, Randomized,Controlled, Double-Blind, Parallel-Group Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(12):883-890.
Zhao-hui LIU, Zhe JIN, Hong ZHAO, 等. 抗妇炎胶囊治疗盆腔炎性疾病-慢性盆腔痛的有效性及安全性：一项随机、双盲、平行对照、多中心临床试验[J]. Chinese Journal of Integrative Medicine, 2021,27(12):883-890. DOI： 10.1007/s11655-021-3490-7.

Zhao-hui LIU, Zhe JIN, Hong ZHAO, et al. Effect and Safety of Kangfuyan Capsules (抗妇炎胶囊) for Relieving Chronic Pelvic Pain: A Multicenter, Randomized,Controlled, Double-Blind, Parallel-Group Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2021,27(12):883-890. DOI： 10.1007/s11655-021-3490-7.

摘要

目的

一项随机、双盲、平行对照、多中心临床试验

评价抗妇炎胶囊治疗盆腔炎性疾病-慢性盆腔痛的有效性、安全性.

方法

于2014年9月-2015年10月

在中国10家医院共纳入盆腔炎性疾病-慢性盆腔痛的患者240例

采用计算机生成随机数按照1:1比例随机分为2组

分别接受抗妇炎胶囊或宫炎平胶囊治疗

两组治疗方案均为4粒/次

3次/日

疗程12周

随访4周. 分别于基线、治疗1、2、3个月后评价视觉模拟量表(VAS) 评分、疾病疗效、各单项症状/体征愈显率和生活质量评分

同时观察不良事件.

结果

治疗3个月后

相对于对照组

抗妇炎组VAS评分下降更明显(

0.05); 而疾病疗效、下腹痛、子宫压痛、附件包块、附件压痛的愈显率以及健康生活质量(EQ-5D) 评分均高于对照组(

0.05). 不良事件主要包括肝酶升高、血红蛋白降低和血小板计数升高

所有不良事件程度为轻、中度.

结论

相较于宫炎平胶囊

抗妇炎胶囊治疗盆腔炎性疾病-慢性盆腔痛镇痛效果更显著

长期疗效更好

安全性良好. (注册登记号ChiCTR190022732)

Abstract

Objective:

To evaluate the effect and safety of Kangfuyan Capsules (抗妇炎胶囊) for treating pelvic inflammatory disease (PID) in patients with chronic pelvic pain (CPP) in a multicenter

randomized

controlled

double-blind

parallel-group clinical trial.

Methods:

Totally

240 PID patients with CPP were randomized into 2 groups using a computer generated random number at a 1:1 ratio from 10 hospitals in China between September 2014 and November 2015. Patients received either oral Kangfuyan Capsules or Gongyanping Capsules (宫炎平胶囊

control); the regimen for both groups comprised 4 capsules (3 times daily) for 12 weeks

with follow-up visit 4 weeks after treatment. The visual analogue scale (VAS) scores

clinical responses

remarkable cure rates for each symptom

and quality of life scores were assessed at baseline

and after 1

and 3 months. Adverse events were also recorded.

Results:

The VAS scores were significantly lower (

0.05)

whereas the clinical responses

remarkable cure rates for lower abdominal pain

uterine tenderness

adnexal mass

and adnexal tenderness

and health-related quality of life (EQ-5D) scores were higher in the Kangfuyan group than in the control group at 3 months (

0.05). Common treatment-related adverse events included high hepatic enzyme levels

reduced hemoglobin levels

and elevated platelet counts

although all the adverse events were either mild or moderate in severity.

Conclusion:

Compared with Gongyanping therapy

Kangfuyan therapy yielded markedly better analgesia effects for CPP caused by PID

with obvious long-term efficacy and good safety. (Registration No. ChiCTR190022732)

关键词

Keywords

pelvic inflammatory diseasechronic pelvic painKangfuyan Capsulerandomized controlleddouble-blind trialChinese medicine

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