复方芙蓉泡腾栓治疗细菌性阴道病合并需氧菌性阴道炎的随机、阳性药平行对照、多中心临床非劣效研究  

A multicenter,randomized and positive parallel controlled clinical non-inferiority study of Compound Furong Effervescent Suppository in the treatment of bacterial vaginosis complicated with aerobic vaginitis

作　　者：刘瑛[1] 张琼琼 李萌[1,2] 易红英[3] 宋殿荣[4] 娄英[5] 樊尚荣[6] 杨兴升[7] 路静 胡丽娜[9] 周萍[10] 安瑞芳[11] 韩凤娟[12] 罗喜平[13] 高珊 宋维花 薛凤霞[16] 杨永秀[17] 殷昭君 王稳莹 张蓓[20] 李萍[21] 孙宇辉[22] 乔峤[23] 郝敏[24] 张岱[25] 刘朝晖 吕涛[1] 张蕾[1] 魏绍斌[27] 廖秦平[1] LIU Ying;ZHANG Qiong-qiong;LI Meng;YI Hong-ying;SONG Dian-rong;LOU Ying;FAN Shang-rong;YANG Xing-sheng;LU Jing;HU Li-na;ZHOU Ping;AN Rui-fang;HAN Feng-juan;LUO Xi-ping;GAO Shan;SONG Wei-hua;XUE Feng-xia;YANG Yong-xiu;YIN Zhao-jun;WANG Wen-ying;ZHANG Bei;LI Ping;SUN Yu-hui;QIAO Qiao;HAO Min;ZHANG Dai;LIU Zhao-hui;LYU Tao;ZHANG Lei;WEI Shao-bin;LIAO Qin-ping(Department of Obstetrics and Gynecology,Beijing Tsinghua Changgung Hospital,Beijing 102218,China;不详)

机构地区：[1]清华大学附属北京清华长庚医院妇产科,北京102218 [2]清华大学临床医学院,北京100084 [3]四川省妇幼保健院妇科,四川成都610045 [4]天津中医药大学第二附属医院妇科,天津300050 [5]青海红十字医院妇科,青海西宁810099 [6]北京大学深圳医院妇产科,广东深圳518036 [7]山东大学齐鲁医院妇产科,山东济南250011 [8]新疆维吾尔自治区妇幼保健院妇科,新疆乌鲁木齐830001 [9]重庆医科大学附属第二医院妇产科,重庆400010 [10]淮南市第一人民医院妇产科,安徽淮南232007 [11]西安交通大学第一附属医院妇产科,陕西西安710061 [12]黑龙江中医药大学附属第一医院妇科,黑龙江哈尔滨150040 [13]广东省妇幼保健院妇科,广东广州511442 [14]甘肃省第二人民医院妇产科,甘肃兰州730099 [15]临沂市妇幼保健院妇科,山东临沂276016 [16]天津医科大学总医院妇产科,天津300052 [17]兰州大学第一医院妇产科,甘肃兰州730013 [18]枣庄市妇幼保健院妇科,山东枣庄277102 [19]西安医学院第一附属医院妇科,陕西西安710077 [20]徐州市中心医院妇产科,江苏徐州221009 [21]南京市妇幼保健院妇科内分泌科,江苏南京210004 [22]哈尔滨医科大学附属第一医院妇科,黑龙江哈尔滨150007 [23]内蒙古医科大学附属医院妇科,内蒙古呼和浩特750306 [24]山西医科大学第二医院妇产科,山西太原030001 [25]北京大学第一医院妇科,北京100034 [26]首都医科大学附属北京妇产医院/北京妇幼保健院妇产科,北京100026 [27]成都中医药大学附属医院妇科,四川成都610032

出　　处：《中国实用妇科与产科杂志》2023年第10期1017-1023,共7页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：国家重点研发计划(2018YFC1707404);北京市自然科学基金(7202239);清华大学精准医学院优先项目(10001020109);清华大学精准医学院重点实验室(20219990012)。

摘　　要：目的 以克林霉素磷酸酯阴道用乳膏为阳性对照,通过随机、阳性药平行对照、多中心的临床研究,评价复方芙蓉泡腾栓治疗细菌性阴道病(bacterial vaginosis,BV)合并需氧菌性阴道炎(aerobic vaginitis,AV)的临床有效性及安全性。方法 于2019年12月至2021年7月,在全国26家三甲医院纳入600例经阴道微生态检查和中医临床证候评分,确诊为BV合并AV的患者,按随机数字表法1∶1比例分为研究组(复方芙蓉泡腾栓2.2 g组)和对照组(2%克林霉素磷酸酯阴道用乳膏5 g组),两组患者均每晚阴道上药1次,连续12 d。记录停药后3~5 d和停药后(28±3)d药物的治疗效果(治愈率、BV有效率、AV有效率、疾病复发率、乳杆菌分级变化等)及不良反应发生情况,用中医临床证候评分的差值评价临床症状改善情况。非劣效检验的非劣效界值设为12%。结果 最终符合方案集的患者共559例(研究组285例,对照组274例)。在停药后3~5 d随访时,研究组和对照组BV合并AV的治愈率分别为63.5%(181/285)和67.2%(184/274),BV有效率分别为79.3%(226/285)和84.7%(232/274),AV有效率分别为71.2%(203/285)和74.1%(203/274),三者率差的95%置信区间的置信下限均大于-12%,表明研究组的治愈率、BV有效率和AV有效率均不劣于对照组。研究组中医证候总有效率、中医单项症状消失率(带下量多、色黄有味、阴部瘙痒、阴中灼热、脘闷纳呆、口苦口腻、大便黏滞)、乳杆菌分级变化均不劣于对照组。停药后(28±3)d随访时,研究组和对照组AV合并BV的复发率分别为13.8%(25/181)和8.7%(16/184),该率差的95%置信区间的置信上限小于12%,表明研究组非劣于对照组。随访期间两组不良反应发生率[主要包括继发外阴阴道假丝酵母菌病(VVC)、瘙痒、灼热感和疼痛等]差异无统计学意义(P>0.05)。结论在BV合并AV的治疗上,复方芙蓉泡腾栓在治愈率、乳杆菌分级变化、临床症状改善以及不良反�Objective To evaluate the efficacy and safety of Compound Furong Effervescent Suppository in the treatment of bacterial vaginosis(BV)combined with aerobic vaginitis(AV)with clindamycin phosphate vaginal cream as a positive control by a multicenter,randomized and positive parallel controlled study.Methods This study was carried out in 26 hospitals from December 2019 to July 2021.The patients with bacterial vaginosis and aerobic vaginitis diagnosed by vaginal secretion microecological examination and Traditional Chinese Medicine clinical symptom score were observed.A randomized,controlled,positive drug parallel control multicenter non-inferiority clinical study design was used to include 600 patients.They were randomly assigned to the trial group(2.2g Compound Furong Effervescent Suppository group)and the control group(2%clindamycin phosphate vaginal cream 5g group)as 1:1 ratio.Both groups received 12 consecutive days of treatment,once a day.The therapeutic effects of the drug[cure rate,BV effective rate,AV effective rate,disease recurrence rate,changes in Lactobacillus grade(LBG),etc.] and the occurrence of adverse reactions were recorded 3-5 days and 28±3 days after drug withdrawal.The difference in Traditional Chinese Medicine(TCM)clinical symptom score was used to evaluate the improvement of clinical symptoms.The noninferiority margin for the noninferiority test was set at 12%.Results A total of 559 patients in this study finally met the regimen set(trial group:285 cases;control group:274 cases).During the follow-up at 3-5 days after drug withdrawal,the cure rates of BV combined with AV in trial group and control group were 63.5%(181/285)and 67.2%(184/274),respectively,the BV effective rates were 79.3%(226/285)and 84.7%(232/274),and the AV effective rates were 71.2%(203/285)and 74.1%(203/274),respectively.The lower confidence limits of the 95%confidence interval of the three were all greater than 12%,indicating that the cure rate,BV effective rate and AV effective rate of the trial group were not inferior to t

关 键 词：复方芙蓉泡腾栓 克林霉素磷酸酯阴道用乳膏 细菌性阴道病 需氧菌性阴道炎 非劣效研究 

分 类 号：R711.31[医药卫生—妇产科学]