羧甲基壳聚糖阴道温敏性原位凝胶在家兔细菌性及霉菌性阴道炎中的疗效考察  

Efficacy of Carboxymethyl Chitosan Temperature-sensitive In-situ Gel for Vaginal Use in Rabbits with Bacterial Vaginitis or Mycotic Vaginitis

作　　者：胡拥军[1] 宋玲[1] Hu Yongjun;Song Ling(Department of Pharmacy,Maternal and Child Health Hospital,Wuhan 430070,China)

机构地区：[1]湖北省妇幼保健院药剂科,武汉430070

出　　处：《中国药师》2021年第8期500-504,共5页China Pharmacist

摘　　要：目的:考察羧甲基壳聚糖(CCS)阴道温敏原位凝胶治疗家兔细菌性及霉菌性阴道炎的疗效,并观察其对阴道的刺激性。方法:选取健康雌性家兔分别制造细菌性及霉菌性阴道炎模型,并各随机分为5组:模型组、阳性对照组(碘伏组或保妇康栓组)、CCS原位凝胶低、中、高剂量组,每组10只,另分别取10只健康雌性家兔作为空白对照组;模型组及空白对照组给予无菌生理盐水,碘伏组给予2 ml市售碘伏消毒液,保妇康栓组给予0.08 g·kg^(-1)栓剂,CCS原位凝胶组分别给予0.06,0.12,0.24 g·kg^(-1)CCS原位凝胶;各组家兔每天给药1次,连续7 d。每日观察家兔一般行为,并于末次给药12 h后观察外阴、阴道红肿及分泌物情况,临床微生物检验阴道及宫颈分泌物含染病病源菌。另取36只雌性家兔随机分为阴性对照组、碘伏组、保妇康栓组、CCS低、中、高剂量组,连续给药7 d后处死家兔,取出完整阴道纵向切开,肉眼观察,并选取阴道组织HE染色后,显微镜下观察,按阴道黏膜刺激反应评分标准评分,并按阴道黏膜刺激强度分级标准确定刺激性强度。结果:各药物治疗组在治疗7 d后均取得显著疗效,与模型组相比,阴道红肿率及病原菌阳性率均显著下降(P<0.05)。与阳性对照组相比,CCS低剂量组疗效较差,高剂量组疗效更好,差异有统计学意义(P<0.05),中剂量组效果相当(P>0.05);刺激性实验表明,阳性对照药品及CCS高浓度组对家兔阴道有极轻微刺激,CCS低、中浓度均对阴道无刺激。结论:CCS温敏性原位凝胶对家兔细菌性和霉菌阴道炎有较好的治疗作用,且无明显阴道刺激性。Objective:To observe the efficacy of carboxymethyl chitosan(CCS)thermal sensitive in-situ gel for vaginal use in rabbits with bacterial vaginitis or mycotic vaginitis,and to explore the vaginal irritation.Methods:Healthy female New Zealand rabbits were used to make bacterial vaginitis or mycotic vaginitis model,and then randomly divided into 5 groups:model group,iodophor group(Baofukang suppository group),and CCS low,medium and high dose groups with 10 ones in each group.Another 10 rabbits were used as blank control group.The model group and blank group were given sterile saline,iodophor group was treated with 2 ml marketed iodophor disinfectant,Baofukang suppository group was treated with 0.08 g·kg^(-1)suppository,and CCS low,medium and high dose groups were given 0.06,0.12 and 0.24 g·kg^(-1)CCS in-situ gel,once a day for 7 consecutive days.The general behavior of rabbits was observed every day,and at 12 h after the last administration,the vulva,vaginal redness and swelling and vaginal fluid were observed as well.Pathogenic bacteria in vaginal fluid and cervical secretion were detected by clinical microbiological examination.Totally 36 healthy female rabbits were divided into blank control group,iodophor group,Baofukang suppository group,and CCS low,medium and high dose groups.After 7-day treatment,the rabbits were sacrificed to withdraw the whole vaginal tissue,and the vaginal irritation was observed by naked eyes.After HE staining,the morphology of vaginal mucosa was observed under a microscope,and the irritation was evaluated by Scoring Criteria for Vaginal Mucosal Irritation,while the irritation intensity was assessed by Grading Standard for Intensity of Vaginal Mucosal Stimulation.Results:After the 7-day treatment,compared with the model group,all the drug treatment groups showed significant efficacy with decreased vaginal redness and swelling rate and positive rate of pathogenic bacteria(P<0.05).Compared to the positive drug for the therapy of bacterial vaginitis or mycotic vaginitis,CCS at low dose had

关 键 词：羧甲基壳聚糖 温敏性原位凝胶 细菌性阴道炎 霉菌性阴道炎 阴道刺激性 

分 类 号：R965.1[医药卫生—药理学]