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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.
目的 探讨B超与MRI、宫腔镜联合诊断对宫腔占位性病变的临床意义。方法 选择2017年1月1日— 12月31日我院收治的108例疑似宫腔占位性病变患者为研究对象。所有患者均于宫腔操作前行阴道彩色多普勒超声(以下简称B超)检查、MRI检查及宫腔镜检查。与病理检查结果对比,分别分析其灵敏度、特异度。结果 108例患者中宫腔无病理变化者27例,子宫内膜息肉39例,子宫内膜增生27例,子宫黏膜下肌瘤10例,子宫内膜癌5例。B超、MRI、宫腔镜诊断灵敏度分别为72.84%、71.60%、75.31%,特异度分别为62.96%、85.19%、66.67%。B超+MRI诊断子宫黏膜下肌瘤和子宫内膜癌灵敏度100%,特异度分别为87.76%和99.03%。B超+MRI+宫腔镜诊断子宫内膜增生、子宫黏膜下肌瘤、子宫内膜癌灵敏度均为100%。结论 宫腔占位病变以良性病变居多,B超联合宫腔镜和MRI检查可提高诊断率。对子宫内膜癌高危人群应进行B超与MRI联合检查,宫腔镜定位活检仅在必要时实施。
Objective To explore the clinical significance of B-ultrasound, MRI and hysteroscopy in the diagnosis of uterine space occupying lesions. Methods 108 patients with suspected uterine space occupying lesions admitted to our hospital from January 1 to December 31 2017 were selected as the study objects. All patients were examined by vaginal color Doppler ultrasound, MRI and hysteroscopy before uterine operation. Compared with the results of pathological examination, the sensitivity and specificity were analyzed. Results Among the 108 patients, 27 had no pathological changes in uterine cavity, 39 had endometrial polyps, 27 had endometrial hyperplasia, 10 had submucous myoma, and 5 had endometrial cancer. The sensitivity of B-ultrasound, MRI and hysteroscopy were 72.84%, 71.60% and 75.31% respectively, and the specificity were 62.96%, 85.19% and 66.67% respectively. The sensitivity of B-ultrasound+MRI in the diagnosis of submucous myoma and endometrial carcinoma was 100% and the specificity was 87.76% and 99.03%, respectively. The sensitivity of B-ultrasound+MRI+hysteroscopy in the diagnosis of endometrial hyperplasia, submucous myoma and endometrial carcinoma was 100%. Conclusion Most of the uterine space occupying lesions are benign. B-ultrasound combined with hysteroscopy and MRI may improve the diagnosis rate. The high-risk group of endometrial cancer should be examined by B-ultrasound and MRI, and hysteroscopic biopsy would be performed only when necessary.
目的 研究宫腔镜治疗子宫粘连性所致不孕症的临床疗效,为临床相关治疗提供参考。方法 选取我院于2016年11月—2017年11月收治的180例子宫粘连性所致不孕症患者作为观察对象,按照随机数表法平均分成两组。其中观察组90例采用宫腔镜治疗,对照组90例采用传统输卵管通液治疗。对比两组患者治疗前后性激素水平、临床指标及妊娠结局变化。结果 两组间相比,治疗前后 LH、FSH、E2、P等性激素水平无变化,且治疗后观察组与对照组相比,差异均无统计学意义(P>0. 05);两组间相比,治疗后观察组患者的术中出血量、手术时间、住院天数均少于对照组,差异有统计学意义(P<0. 05);两组间相比,治疗后观察组患者的足月分娩率高于对照组,早产率低于对照组,差异有统计学意义(P<0. 05)。结论 宫腔镜治疗子宫粘连性所致不孕症,与传统输卵管通液治疗相比,对性激素水平无影响,但可显著降低患者住院时间及术中出血量,有效提高足月分娩率,值得在临床上推广。
目的 观察喉罩通气下全凭七氟醚吸入麻醉在妇科宫腔镜手术中的应用价值。方法 60例拟行妇科宫腔镜手术的患者随机分为七氟醚和丙泊酚组,每组30例,记录不同时间点两组患者的平均动脉压(MAP),脉搏血氧饱和度(SpO2)、苏醒时间以及术后恶心,呕吐、躁动的发生率。结果 A组患者血流动力学指标波动较少,苏醒时间A组明显短于B组,差异有显著性(P<0.05)。两组患者诱导后MAP,HR均较诱导前显著下降(P<0.05)。B组患者术中MAP,HR值显著低于A组(P<0.05),拔除喉罩即刻两组MAP,HR差异无显著性(P>0.05)。结论 喉罩下全凭七氟醚吸入麻醉对患者的血流动力学的影响较小,适用于妇科宫腔镜手术。
Objective To observe the effect of laryngeal mask airway(LMA) combined with sevoflurane inhalation anaesthesia in gynecological hysteroscopy operation. Methods Sixty patients, classified from ASAⅠtoⅡscheduled for hysteroscopic operation were randomly divided into sevoflurane inhalation anesthesia group (group A) and propofol intravenous anesthesia group(group B).The mean arterial pressure (MAP), pulse oxygen saturation (SpO2), recovery time and the incidence of nausea, vomiting and recovery time were recorded at different time points of the two groups. Results The hemodynamic index of the patient in the group A fluctuated seldom,and the recovery time was significantly shorter than that in the B group, and the differences were significant (P<0.05).The MAP and the HR were all decreased after anesthesia induction compared with those of before in both groups (P<0.05).The MAP and the HR in the group B was significantly lower than that in the group A (P<0.05), there were no significant differences in MAP and HR between the two groups of patients with laryngeal mask airway removal. Conclusion Small hemodynamic influence is taken with the technique of laryngeal mask airway(LMA) combined with sevoflurane inhalation anesthesia. It is suitable for gynecological hysteroscopic operation.