妇宁膨胀栓联合抗HPV生物蛋白敷料治疗宫颈高危型人乳头瘤病毒持续感染的Ⅳ期临床试验  

Phase IV clinical trial of funing dilatant suppository combined with anti hpv bioprotein dressing for the treatment of high risk human papillomavirus persistent infection in the cervix

作　　者：邹凡睦 刘雪 何森 Zou Fanmu;Liu Xue;He Sen(Department of Gynecology,Yinchuan Central Hospital,Yinchuan 750002,China;Department of Gynecology,Xining Women and Children's Hospital,Xining 810099,China;Department of Gynecology,Guyuan People's Hospital,Guyuan 756099,China)

机构地区：[1]银川市中心医院妇科,宁夏银川750002 [2]西宁市妇幼医院妇科,青海西宁810099 [3]固原市人民医院妇科,宁夏固原756099

出　　处：《实用妇科内分泌电子杂志》2023年第17期74-76,共3页Electronic Journal of Practical Gynecological Endocrinology

摘　　要：目的 利用Ⅳ期开放性临床试验方法,评估妇宁膨胀栓联合抗HPV生物蛋白敷料治疗宫颈高危型人乳头瘤病毒(HR-HPV)持续感染的疗效与安全性。方法 选取242例宫颈HR-HPV持续感染患者为研究对象,分为对照组120例、联合组122例。对照组给予抗HPV生物蛋白敷料治疗,联合组给予妇宁膨胀栓联合抗HPV生物蛋白敷料治疗,比较两组的HR-HPV转阴率、病毒平均载量及不良反应发生情况。结果 联合组HR-HPV转阴率为86.1%,显著高于对照组的61.7%,差异有统计学意义(P<0.05);治疗1、2、3个月,联合组的HR-HPV病毒平均载量低于对照组,差异有统计学意义(P<0.05);两组均未发生不良反应。结论 妇宁膨胀栓联合抗HPV生物蛋白敷料治疗宫颈HR-HPV持续感染,能显著提升HR-HPV转阴率,降低病毒平均载量,且不增加不良反应,安全性高。Objective To using the phase IV open clinical trial method,evaluate the efficacy and safety of funing dilatant suppository combined with anti HPV bioprotein dressing in the treatment of high-risk human papillomavirus(HR-HPV)persistent infection in the cervix.Methods 242 patients with persistent cervical HR-HPV infection were selected as the study subjects,divided into a control group of 120 cases and a combination group of 122 cases.The control group was treated with anti HPV bioprotein dressing,while the combination group was treated with funing dilatant suppository combined with anti HPV bioprotein dressing.The HR-HPV conversion rate,average viral load,and incidence of adverse reactions were compared between the two groups.Results The negative conversion rate of HR-HPV in the combination group was 86.1%,significantly higher than 61.7%in the control group,with a statistically significant difference(P<0.05);After treatment for 1,2,and 3 months,the average load of HR-HPV virus in the combination group was lower than that in the control group,with a statistically significant difference(P<0.05);No adverse reactions occurred in both groups.Conclusion The combination of funing dilatant suppository and anti HPV bioprotein dressing can significantly improve the negative conversion rate of HR-HPV,reduce the average viral load,and do not increase adverse reactions in the treatment of persistent cervical HR-HPV infection.It has high safety.

关 键 词：妇宁膨胀栓 抗HPV生物蛋白敷料 人乳头瘤病毒 

分 类 号：R711.32[医药卫生—妇产科学]