目的 比较采用一次性使用电子宫腔镜与可重复使用宫腔镜用于门诊宫腔镜检查的有效性与安全性。方法 采用平行随机对照的方法,在3间临床试验研究机构同时进行,一次性使用电子宫腔镜用于宫腔镜检查者82例为试验组,Storz Bettochi检查镜进行检查者82例为对照组。记录2组患者宫腔影像的临床诊断符合率、操作性能评分、不良事件发生率。结果 试验组临床诊断要求符合率98.8%（80/82）,对照组临床诊断要求符合率100%（82/82）;试验组与对照组宫腔影像的临床诊断要求符合率的差值为-1.22%,试验组和对照组符合率差值的95%可信区间下限为-3.60%,大于非劣效界值-10.00%。试验组与对照组之间的操作性能评分比较差异无统计学意义（P>0.05）。试验组不良事件发生率11.0%（9例,9件）,严重不良事件发生率1.2%（1例,1件）;对照组中不良事件发生率9.8%（8例,9件）,严重不良事件发生率0%（0例,0件）;不良事件发生率和严重不良事件发生率的组间比较差异均无统计学意义（P>0.05）。结论 一次性使用电子宫腔镜用于提供患者子宫内图像,整体性能与可重复使用的电子宫腔镜相当,并且安全性好。试验用一次性使用电子宫腔镜的使用性能可满足临床宫腔镜手术的需求,可作为宫腔镜技术的补充手段。

Objective To compare the efficacy and safety of single-use digital hysteroscope and reusable hysteroscope for outpatient hysteroscopy．Methods A parallel randomized control method was used in three clinical trials institutions．Eighty-two cases of outpatient patients who used single-use digital hysteroscope for hysteroscopy were included in experimental group,and 82 cases who underwent hysteroscopy by reusable hysteroscope（Storz Bettochi）were included in control group．The clinical diagnosis coincidence rate,performance score and incidence of adverse events of uterine imaging were recorded in the two groups．Results The coincidence rate of clinical diagnosis in the experimental group was 98.8%（80/82）,1.22% lower than the 100%（82/82）in control group．And the difference of lower limit of 95% confidence interval between the experimental group and the control group was-3.60%,which was greater than the non-inferiority margin-10.00%．There was no significant difference in performance scores between the experimental group and the control group（P>0.05）．The incidence of adverse events in the experimental group was 11.0%（9 cases,9 events）,and serious adverse events incidence was 1.2%（1 case,1 event）．In the control group,the incidence of adverse events was 9.8%（8 cases,9 events）,and no serious adverse events occurred（0 cases,0 events）．There was no significant difference in the incidence of adverse events or serious adverse events between two groups．Conclusions The overall performance of single-use digital hysteroscope for providing intrauterine images,observation and diagnosis is comparable to that of reusable hysteroscope,and the safety is also comparable．The performance of the single-use digital hysteroscope can meet the needs of outpatient hysteroscopy,and it can be an effective supplementary hysteroscopy technology．