自交联透明质酸钠凝胶预防中重度宫腔粘连分离手术后再粘连的前瞻性、随机、阴性对照临床研究  

Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel： a prospective,randomized, controlled clinical study

作　　者：肖松舒[1] 万亚军[1] 邹放军[2] 叶明珠[1] 邓赫男[3] 马洁稚[1] 魏颖颖[2] 谭琛[3] 薛敏[1] 

机构地区：[1]中南大学湘雅三医院妇产科,长沙410013 [2]湖南省人民医院妇产科 [3]湖南省郴州市第一人民医院妇产科

出　　处：《中华妇产科杂志》2015年第1期32-36,共5页Chinese Journal of Obstetrics and Gynecology

摘　　要：目的 评价自交联透明质酸钠凝胶预防中重度宫腔粘连分离手术后再粘连的有效性和安全性.方法 前瞻性、多中心、随机、阴性对照临床研究;对2011年11月至2012年11月中南大学湘雅三医院等医院符合入组标准的宫腔粘连患者,根据美国生育学会（AFS）宫腔粘连评分分级标准进行宫腔镜下的术前诊断分级,中重度宫腔粘连患者纳入本研究.随机入组120例患者（试验组和对照组各60例）,对试验组患者在宫腔镜粘连分离术后应用Foley球囊导尿管结合自交联透明质酸钠凝胶防止术后再粘连;对照组患者在宫腔镜粘连分离术后只用Foley球囊导尿管防止术后再粘连.在术后3个月时进行第2次宫腔镜检查,再次对宫腔粘连进行分级.主要评价指标：术后3个月时防止宫腔粘连的有效率.次要评价指标：对宫腔粘连累及范围、粘连类型、月经模式的得分进行手术前后和组间比较.结果 完成本研究的患者共111例,其中试验组55例、对照组56例.试验组自交联透明质酸钠凝胶防止术后宫腔粘连的有效率（76％,42/55）明显高于对照组（48％,27/56）,两组比较,差异有统计学意义（P=0.000 9）.试验组应用自交联透明质酸钠凝胶显著减少了AFS总分,试验组为（2.1±1.1）分,对照组为（3.7±2.5）分,两组比较,差异有统计学意义（P=0.000 8）;并对宫腔粘连累及范围得分[试验组（1.3±0.5）分,对照组（1.7±0.8）分]和月经模式得分[试验组（0.8±1.1）分,对照组（1.4±1.1）分]均有明显改善（P=0.037 8、0.0004）.试验组应用自交联透明质酸钠凝胶减少了术后再粘连（中度和重度）的发生率,试验组术后3个月时中重度宫腔粘连的发生率为13％（7/55）,而对照组为38％（21/56）,两组比较,差异有统计学意义（P=0.000 6）.未发生与材料相关的不良事件和并发症.结论 自交联透明质酸钠凝胶能够有效减少中重度宫腔粘连分离�Objective To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid （HA） gel for preventing intrauterine adhesion （IUA） after hysteroscopic adhesiolysis.Methods A prospective,randomized,double blinded and controlled clinical trial （level Ⅰ） was performed.According to American Fertility Society （AFS） scoring system,120 patients （treatment group：60 cases,control group：60 cases） with moderate to severe IUA were enrolled.Upon completion of adhesiolysis,a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group,however,only received Foley balloon catheter.Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA.Primary endpoint was the reduction rate of IUA at 3 months after surgery.The secondary endpoints include total AFS score,score of each individual AFS category.Results At 3 months after surgery,auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion,the effective rate were 76% （42/55） and 48% （27/56） respectively （P=0.000 9）; the total AFS score of treatment group was 2.1 ± 1.1,and significantly lower than that of control group （3.7 ± 2.5,P=0.000 8）.Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern （P=0.037 8,P=0.000 4）.The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% （7/55） versus 38% （21/56）,P=0.000 6].No adverse events and complications were observed.Conclusions Auto-crosslinked HA gel coule be able to reduce IUA,decrease adhesion severity,and improve menopause postoperatively.This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

关 键 词：子宫内膜 组织粘连 透明质酸 凝胶类 宫腔镜检查 临床对照试验 

分 类 号：R713.4[医药卫生—妇产科学]