Pharmacological Research - Modern Chinese Medicine (Jun 2023)
Efficacy and safety of Fufang Furong Effervescent Suppository for the treatment of mixed vaginitis: a randomized, multicenter, and non-inferiority study
- Ying Liu,
- Meng Li,
- Hongying Yi,
- Dianrong Song,
- Ying Lou,
- Shangrong Fan,
- Xingsheng Yang,
- Jing Lu,
- Lina Hu,
- Ping Zhou,
- Ruifang An,
- Fengjuan Han,
- Xiping Luo,
- Shan Gao,
- Weihua Song,
- Yongxiu Yang,
- Fengxia Xue,
- Zhaojun Yin,
- Wenying Wang,
- Bei Zhang,
- Ping Li,
- Yuhui Sun,
- Qiao Qiao,
- Min Hao,
- Dai Zhang,
- Zhaohui Liu,
- Hongbo Wei,
- Ting Zou,
- Jinxiang Ma,
- Shaobin Wei,
- Qinping Liao
Affiliations
- Ying Liu
- Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218
- Meng Li
- Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218; School of Clinical Medicine, Tsinghua University, Beijing 100084
- Hongying Yi
- Department of Gynecology, Sichuan Provincial Maternity and Child Health Care Hospital, Sichuan 610045
- Dianrong Song
- Department of Gynecology, Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300050
- Ying Lou
- Department of Gynecology, Qinghai Red Cross Hospital, Qinghai 810099
- Shangrong Fan
- Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Guangdong 518036
- Xingsheng Yang
- Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Shandong 250011
- Jing Lu
- Department of Gynecology, Xinjiang Uygur Autonomous Region Maternal and Child Health Hospital, The Xinjiang Uygur Autonomous Region 830001
- Lina Hu
- Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010
- Ping Zhou
- Department of Obstetrics and Gynecology, Huainan First People's Hospital, Anhui 232007
- Ruifang An
- Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an Jiaotong University, Shaanxi 710061
- Fengjuan Han
- Department of Gynecology, First Hospital of Heilongjiang University of Chinese Medicine, Heilongjiang 150040
- Xiping Luo
- Department of Gynecology, Guangdong Women's and Children's Hospital, Guangdong 511442
- Shan Gao
- Department of Obstetrics and Gynecology, Second Provincial People's Hospital of Gansu, Gansu 730099
- Weihua Song
- Department of Gynecology, Women & Children's Health Care Hospital of Linyi, Shandong 276016
- Yongxiu Yang
- Department of Obstetrics and Gynecology, The First Hospital of Lanzhou University, Gansu 730013
- Fengxia Xue
- Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin 300052
- Zhaojun Yin
- Department of Gynecology, Maternity and Child Health Care of Zaozhuang, Shandong 277102
- Wenying Wang
- Department of Gynecology, The First Affiliated Hospital of Xi'an Medical University, Shaanxi 710077
- Bei Zhang
- Department of Obstetrics and Gynecology, Xuzhou Central Hospital, Jiangsu 221009
- Ping Li
- Department of Gynecology and Endocrinology, Nanjing Maternity and Child Health Care Hospital, Jiangsu 210004
- Yuhui Sun
- Department of Gynecology, The First Affiliated Hospital of Harbin Medical University, Heilongjiang 150007
- Qiao Qiao
- Department of Gynecology, The Affiliated Hospital of Inner Mongolia Medical University, The Nei Monggol Autonomous Region 750306
- Min Hao
- Department of Obstetrics and Gynecology, Second hospital of Shanxi Medical University, Shanxi 030001
- Dai Zhang
- Department of Gynecology, Peking University First Hospital, Beijing 100034
- Zhaohui Liu
- Department of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University Beijing Maternal and Child Health Care Hospital, Beijing 100026
- Hongbo Wei
- Beijing Institute of Spacecraft System Engineering, China Academy of Space Technology, Beijing, China
- Ting Zou
- Female Reproductive and Health Medicine Research Committee of Chinese Traditional Medicine Association, Beijing 100102
- Jinxiang Ma
- Beijing Yaohai Ningkang Pharmaceutical Technology Co, Beijing 102206
- Shaobin Wei
- Department of Gynecology, Hospital of Chengdu University of TCM, Sichuan 610032; Corresponding authors at: Qinping Liao, Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University; 168 Litang Road, Changping District, Beijing 102218, China. Shaobin Wei, Department of Gynecology, Hospital of Chengdu University of TCM, 39-41 Shi Qiao Road, Jinniu District, Chengdu, Sichuan 610032 China.
- Qinping Liao
- Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218; Corresponding authors at: Qinping Liao, Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University; 168 Litang Road, Changping District, Beijing 102218, China. Shaobin Wei, Department of Gynecology, Hospital of Chengdu University of TCM, 39-41 Shi Qiao Road, Jinniu District, Chengdu, Sichuan 610032 China.
- Journal volume & issue
-
Vol. 7
p. 100225
Abstract
Objective: The aim of this study was to compare the clinical efficacy and safety of Fufang Furong Effervescent Suppository and clindamycin phosphate cream for the treatment of bacterial vaginosis (BV) combined with aerobic vaginitis (AV). Methods: This was a randomized, multicentre, active-controlled, non-inferiority clinical trial, with two parallel groups. Women diagnosed with BV + AV were randomly assigned to one of two groups and received 12-days of vaginal administration of either Fufang Furong Effervescent Suppository or clindamycin phosphate cream. The follow-up occurred during the 3–5 days (15–17 days) and 28 ± 3 days (40 ± 3 days) after drug administration, with the main assessments including the cure rate, BV, AV effective rate, recurrence rate, Lactobacillary grade (LBG) changes and adverse effects. The non-inferiority threshold of the non-inferiority test was set at 12%. Results: From among the 600 eligible participants, 559 were randomly allocated to either the Furong group (n = 285) or the Clindamycin group (n = 274). The cure rate, BV, AV effective rate and the LBG changes of Furong group were not inferior to Clindamycin group in 15–17 days. The recurrence rate of BV + AV was also non-inferior to Clindamycin group at 40±3 days. During the follow-up period, no significant difference in the incidence of side effects were found between the two groups. Conclusion: The treatment of BV + AV using Fufang Furong Effervescent Suppository was not inferior to that of clindamycin phosphate cream in terms of cure rate, LBG changes, recurrence rate and adverse effects.
