[Translation] A randomized, blinded, active drug/placebo parallel-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of Baofukang suppository in the treatment of bacterial vaginosis

评价保妇康栓治疗细菌性阴道病（BV）的有效性和安全性

[Translation]

To evaluate the effectiveness and safety of Baofukang suppository in the treatment of bacterial vaginosis (BV)

Start Date10 Apr 2024

Sponsor / Collaborator

Hainan Bikai Pharmaceutical Co. Ltd.

ChiCTR2400082587 / RecruitingPhase 2IIT

A randomized, blinded, positive drug/placebo parallel-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of Baofukang suppositories in the treatment of bacterial vaginosis

Start Date01 Apr 2024

Sponsor / Collaborator

Peking University Shenzhen Hospital

CTR20210287 / RecruitingPhase 2

保妇康栓治疗宫颈高危型人乳头瘤病毒 16/18（HR-HPV16/18）感染合并低级别鳞状上皮内病变（CINI/P16 阴性的 CINII）有效性和安全性的随机、双盲、安慰剂平行对照、多中心 II 期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of Baofukang suppositories in the treatment of cervical high-risk human papillomavirus 16/18 (HR-HPV16/18) infection combined with low-grade squamous intraepithelial lesions (CINI/P16 negative CINII)

（1）探索保妇康栓治疗宫颈 HR-HPV16/18 感染合并 LSIL（CINI/P16 阴性的 CINII）的最佳给药方案。（2）初步评价保妇康栓治疗 HR-HPV16/18 感染合并 LSIL（CINI/P16 阴性的 CINII）的有效性和安全性。（3）初步评价保妇康栓治疗宫颈 HR-HPV16/18 感染的有效性和安全性。

[Translation]

(1) To explore the optimal dosing regimen of Baofukang suppository for the treatment of cervical HR-HPV16/18 infection combined with LSIL (CINI/P16 negative CINII). (2) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of HR-HPV16/18 infection combined with LSIL (CINI/P16 negative CINII). (3) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of cervical HR-HPV16/18 infection.

Start Date12 Mar 2021

Sponsor / Collaborator

Hainan Bikai Pharmaceutical Co. Ltd.

100 Clinical Results associated with Baofukang Suppository

100 Translational Medicine associated with Baofukang Suppository

100 Patents (Medical) associated with Baofukang Suppository

Literatures (Medical) associated with Baofukang Suppository

20 Mar 2023·Virology journal

Evaluation of the clinical efficacy of vaginal treatment options for persistent high-risk human papillomavirus infection after excisional treatment of cervical high-grade squamous intraepithelial lesions: a systematic review and Bayesian network meta-analysis.

Review

Author: Xu, Cai ; Tang, Yiqian ; Tong, Qing ; Dai, Ning

BACKGROUNDTo evaluate the clinical efficacy of different vaginal administration on cervical persistent high-risk human papillomavirus (HR-HPV) infection after excisional treatment for high-grade squamous intraepithelial lesions (HSIL).METHODSSix databases (PubMed, EmBase, Cochrane Central, China Knowledge Network database, China Biomedical Literature Service, and WanFang database) were searched to collect randomized controlled trials (RCTs) of various types of vaginal administration compared to no treatment on persistent HR-HPV infection after HSIL excisional treatment, and comprehensive analysis of the clearance of different drugs on HR-HPV was performed using Bayesian reticulation meta-analysis.RESULTSThe study analyzed the efficacy of eight interventions, including Interferon, Baofukang, Paiteling, Bletilla striata Sanhuang Powder, Lactobacilli vaginal capsules, Fuanning + Interferon, Interferon + Lactobacilli vaginal capsules, and Interferon + Baofukang, on the clearance of HR-HPV after excisional treatment through pooling and analyzing data from 52 RCTs. The results of the study demonstrated that Interferon + Lactobacilli vaginal capsules [OR 16.0 (95% CIs 8.1-32.0)], Interferon + Fuanning [OR 16.0 (95% CIs 1.1-52.0)], and Interferon + Baofukang [OR 14.0 (95% CIs 6.8-28.0)] were all found to significantly improve postoperative HR-HPV clearance rates when compared to no treatment. Furthermore, when studies with high-risk bias were excluded, Interferon + Lactobacilli vaginal capsules [OR 8.6 (95% CIs 4.7-19.0)] and Interferon + Baofukang [OR 22.0 (95% CIs 8.7-59.0)] were still found to be positively associated with increased postoperative HR-HPV clearance rate. Additionally, the study´s results also indicate that Interferon + Baofukang was effective in enhancing the postoperative HR-HPV clearance rates, mainly when the studies were restricted to a follow-up period of at least 12 months [OR 9.6 (95% CIs 2.9-34.0)]. However, it is important to note that the majority of the trials (29 out of 52, 51.6%) were rated as moderate to high risk of bias, and the certainty of the evidence was moderate to very low.CONCLUSIONThe application of various forms of vaginal administration, except for individual use of Lactobacilli vaginal capsules, is more efficacious than no treatment in patients with cervical persistent HR-HPV infection after excisional treatment. However, all of the estimates of the effect size for change in the efficiency of HR-HPV clearance are uncertain. Our confidence in effect estimates and ranking of treatments is low, which needs larger, more rigorous, and longer follow-up RCTs to resolve.

01 Jan 2023·Journal of Cancer

Comparative Efficacy and Safety of Chinese Patent Medicines for Cervical High-risk Human Papillomavirus Infection: A Bayesian Network Meta-analysis.

Review

Author: Wei, Shaobin ; Mo, Jing ; Li, Maoya ; Bin, Chengli ; Zhong, Hanzhi ; Wang, Zhenyi

Background: Many Chinese patent medicines have been reported to show anti-tumor cell effects on cervical cancer. To estimate the comparative effectiveness and safety of Chinese patent medicines for cervical high-risk human papillomavirus (HR-HPV) infection. Methods: Randomized controlled trials (RCTs) of Chinese patent medicines for HR-HPV infection were searched in eight databases until 31 August 2022, and two review authors independently extracted data and assessed the risk of bias. Outcomes concerning efficacy were evaluated as odds ratio (OR) and 95% credible intervals (CrI) utilizing R 4.1.2 and Stata 16.1. The protocol was registered on the International Prospective Register of Systematic Reviews (CRD42022351120). Results: We ultimately identified 60 RCTs that involved 5,951 participants and 8 interventions. Chinese patent medicines combined with recombinant human interferon (rhIFN) have better treatment effects than rhIFN alone. The results showed that Baofukang suppository (BFK) combined with rhIFN is greater for the rate of HR-HPV clearance follow-up at 6 months (SUCRA = 78.16%). Kushen gel (KS) combined with rhIFN ranked first for the rate of HR-HPV clearance after treatment (SUCRA = 90.77%). Furthermore, KS + rhIFN is most likely to be the best intervention for improving the clinical effectiveness rate (SUCRA = 87.39%). Adverse reactions were not statistically significant in BFK + rhIFN versus BFK, BFK + rhIFN versus rhIFN, and BFK versus rhIFN. Conclusion: The combination of Chinese patent medicines with rhIFN may demonstrate a higher efficacy than rhIFN alone in clearing the virus and improving cervical symptoms. Weighing with the clinical comprehensive efficacy, BFK + rhIFN and KS + rhIFN maybe the optimal treatments for cervical HR-HPV infection. However, more high-quality randomized controlled trials are needed in the future to further confirm the efficacy and safety of proprietary Chinese medicines for cervical HR-HPV infection.

01 Jan 2022·American journal of translational research

Meta-analysis of the effect and safety of recombinant human interferon α-2b combined with Baofukang suppository in the treatment of HPV infection.

Review

Author: Song, Chunyan ; Ma, Wenyan ; Sun, Shuhua ; He, Changfu ; Li, Min

Persistent infection of human papilloma virus (HPV) increases the risk of cervical precancerous lesions turning into cervical cancer, which seriously affects women's reproductive health and quality of life. This meta-analysis analyzed the effect and safety of recombinant human interferon α-2b (rhIFNα-2b) combined with Baofukang suppository in the treatment of HPV infection. Online databases were used to search for randomized clinical trials (RCTs) on the treatment of HPV infection with the deadline of January 2022 and the effects of treatment were analyzed by the odds ratio (OR) of treatment outcomes (total effective rate, HPV clearance rate and adverse reaction rate). The interval estimation was expressed by 95% confidence interval (CI). The searching results showed that there were 15 RCTs, including 1786 HPV-infected cases meeting the criteria for meta-analysis, of which 893 received combination therapy. In terms of total effective rate, combination therapy was superior to monotherapy (OR = 4.82, 95% CI 3.43-6.75, P < 0.001). In terms of increasing the HPV clearance rate and reducing the adverse reaction rate, combination therapy also showed obvious advantages over monotherapy (OR = 4.51, 95% CI 3.18-6.39, P < 0.001; OR = 0.60, 95% CI 0.40-0.91, P < 0.02). Our findings suggested that rhIFNα-2b combined with Baofukang suppository is safe and effective in the treatment of cervical HPV infection. Due to the limited quality of the included studies, the results need to be further studied and validated by more high quality RCTs.

100 Deals associated with Baofukang Suppository

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Leukorrhea	CN	Hainan Bikai Pharmaceutical Co. Ltd.	08 May 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Vaginosis	Phase 2	CN	Hainan Bikai Pharmaceutical Co. Ltd.	10 Apr 2024
Human Papillomavirus Infection	Phase 2	CN	Hainan Bikai Pharmaceutical Co. Ltd.	12 Mar 2021
Squamous Intraepithelial Lesions	Phase 2	CN	Hainan Bikai Pharmaceutical Co. Ltd.	12 Mar 2021
Squamous Intraepithelial Lesions of the Cervix	Phase 2	CN	Hainan Bikai Pharmaceutical Co. Ltd.	09 Mar 2021
Postmenopausal atrophic vaginitis	Phase 1	CN	Hainan Bikai Pharmaceutical Co. Ltd.	26 Sep 2014
Candidiasis, Vulvovaginal	Phase 1	CN	Hainan Bikai Pharmaceutical Co. Ltd.	25 Sep 2014
Uterine Cervicitis	Phase 1	CN	Hainan Bikai Pharmaceutical Co. Ltd.	03 Sep 2014

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