白带净胶囊联合肤芩洗剂治疗阴道毛滴虫病前瞻性随机对照多中心临床研究  

Baidaijing Capsules and Fuqin Lotion in the treatment of trichomonas vaginitis:A prospective,randomized,controlled,multi-center clinical trial

作　　者：王燚 万峰 郝松莉[2] 李丽萍[3] 王丽双[4] 徐颖 韩凤娟[2] WANG Yi;WAN Feng;HAO Song-li;LI Li-ping;WANG Li-shuang;XU Ying;HAN Feng-juan(Basic Medical School,Chengdu University of Traditional Chinese Medicine,Chengdu 610072,China)

机构地区：[1]成都中医药大学基础医学院,四川成都610072 [2]黑龙江中医药大学附属第一医院妇科,黑龙江哈尔滨150040 [3]齐齐哈尔医学院附属三院,黑龙江齐齐哈尔161099 [4]哈尔滨医科大学附属第四医院妇产科,黑龙江哈尔滨150001 [5]齐齐哈尔第一医院妇产科,黑龙江齐齐哈尔161005

出　　处：《中国实用妇科与产科杂志》2022年第1期108-112,共5页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：四川省科技成果转化示范项目(2018CC0108);四川省科学技术厅支撑项目(2021YFQ0033)。

摘　　要：目的评价白带净胶囊联合肤芩洗剂治疗阴道毛滴虫病的有效性和不良反应。方法采用前瞻性随机对照多中心临床研究方法,按照SAS 9.4生成的随机数字表,将2019年6月至2021年7月在黑龙江中医药大学附属第一医院等4个临床研究单位就诊,符合纳入排除标准的240例患者随机分为对照组、观察组Ⅰ和观察组Ⅱ,每组各80例。对照组仅给予甲硝唑;观察组Ⅰ在对照组基础上,联用白带净胶囊;观察组Ⅱ在观察组Ⅰ基础上,联合外用肤芩洗剂。最终对照组76例、观察组Ⅰ75例、观察组Ⅱ73例完成研究。比较各组治疗前后的有效率、痊愈率、中医症状评分、阴道内环境、病原学滴虫量、不良反应等。结果治疗7 d和14 d后,对照组、观察组Ⅰ、观察组Ⅱ的有效率和痊愈率两两比较,除观察组Ⅰ和观察组Ⅱ有效率差异无统计学意义外(P>0.05),其他差异均有统计学意义(P<0.05)。3组的阴道pH值两两比较,除7d观察组Ⅰ和观察组Ⅱ差异无统计学意义外(P>0.05),其他差异均有统计学意义(P<0.05)。3组的清洁度两两比较,除7d观察组Ⅰ和观察组Ⅱ清洁度正常率比较差异无统计学意义外(P>0.05),其他差异均有统计学意义(P<0.05)。3组滴虫转阴率两两比较,除7d观察组Ⅰ与观察组Ⅱ差异无统计学意义(P>0.05)外,其余差异均有统计学意义(P<0.05)。3组中医症状和带下量评分两两比较,差异均有统计学意义(P<0.05)。结论甲硝唑、白带净胶囊及肤芩洗剂3药联用治疗滴虫性阴道炎未发现严重不良反应且临床疗效显著,14 d的有效性优于7 d,且3药联用的有效性优于单用甲硝唑及甲硝唑联合白带净胶囊。Objective To observe the efficacy and the occurrence of adverse reactions of Baidaijing Capsule combined with Fuqin Lotion in the treatment of Trichomonas vaginalis.Methods In a prospective,randomized,controlled,multicenter study,240 patients in 4 clinical research units including the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine from June 2019 to July 2021 were randomly divided into control group,observation groupⅠand observation groupⅡaccording to the random number table generated by SAS 9.4,80 in each group.In the end,224 cases were enrolled,76 cases were in the control group,75 cases were in observation groupⅠ,and 73 cases were in observation group II.The control group was given metronidazole only;observation groupⅠwas given Baidaijing Capsule in addition to metronidazole;observation group II was given Fuqin Lotion besides metronidazole and Baidaijing Capsule.The effective rate,recovery rate,TCM symptom score,vaginal environment,pathogenic trichomonas and adverse reactions were compared among the groups before and after treatment.Results After 7 days and 14 days of treatment,the effective rate and recovery rate of the control group,observation groupⅠ,and observation groupⅡwere pairwise compared,except that the effective rate of observation groupⅠand observation groupⅡhad no statistical difference(P>0.05),the differences in other items were statistically significant(P<0.05).There were no significant differences in vaginal pH values between observation groupⅠand observation groupⅡat 7-day treatment(P>0.05),and other differences were statistically significant(P<0.05).There were no significant differences in the normal rate of cleanliness between observation groupⅠand observation groupⅡat 7-day treatment(P>0.05),while other differences were statistically significant(P<0.05).Pairwise comparison of trichomonas negative conversion rate among the three groups showed that there was no significant difference between observation groupⅠand observation group

关 键 词：白带净胶囊 肤芩洗剂 随机对照 阴道毛滴虫病 临床研究 

分 类 号：R711.31[医药卫生—妇产科学]