临床诊疗

CBCT对上颌前部埋伏牙的诊断应用

:103-106
 
目的 分析上颌前部埋伏牙诊断中锥形束CT(CBCT)的应用价值,以期提升疾病诊出率和定位准确率,继而提高治疗有效性。方法 分析2021年1月—2022年7月间于我院口腔门诊进行检查的150例阻生齿患者基本资料,对患者实施口腔锥形束CT检查,进行定位分型。结果 150例患者中阻生牙率100%,其中存在埋伏牙20例,占比13.33%。所有埋伏牙均经CBCT 扫描准确确定了牙体大小、埋伏牙形态、埋伏深度、萌出方向、与相邻齿的位置关系等,为临床医师提供了准确图像参考;共有上颌前部埋伏牙21颗,包括左上颌埋伏牙9颗、右上颌埋伏牙12颗。结论 CBCT检测能够极大提升埋伏牙检测定位的准确性,为医师提供准确影像学参考,以此制定针对性手术方案,在保证治疗效果的同时提升手术安全性,避免一系列并发症的发生,可在埋伏牙阻生齿诊断及治疗中进行推广使用。
临床诊疗

MRI检查FLAIR序列HVS对MCA供血区域的诊断价值

:94-97
 
目的 探讨MRI液体衰减反转恢复序列(FLAIR)高信号血管征(HVS)对大脑中动脉(MCA)供血区域的诊断价值。方法 选择2021年1月—2022年10月期间我院收治的66例MCA急性脑梗死患者,观察HVS检出情况、HVS检出率与血管狭窄之间的关系及HVS对MCA急性脑梗死患者病情程度及预后的诊断价值。结果 66例MCA急性脑梗死患者中,MRI FLAIR序列检查示有HVS(HVS阳性)40例,无HVS(HVS阴性)26例。轻度狭窄、重度狭窄和闭塞分别为26、24、16例,HVS阳性者的狭窄程度较HVS阴性者严重(P<0.05)。HVS对MCA急性脑梗死患者病情程度的诊断价值:HVS阳性者梗死面积为(86.02±10.26)cm2,大于HVS阴性者的(72.36±9.01)cm2。HVS阳性者在入院时的美国国立卫生研究院卒中量表(NIHSS)评分为(12.87±2.36)分,高于HVS阴性者的(10.28±2.07)分(P<0.05)。结论 MRI FLAIR序列示HVS对判断MCA供血区域梗死有一定价值,有助于MCA供血区急性脑梗死的诊断,对临床预后的评估也具有一定意义。
论著

血清ADPN、CA125及AMH检测在PCOS中的临床分析

Clinical diagnostic value of serum ADPN,CA125 and AMH levels in polycystic ovary syndrome

:79-83
 
目的 探讨血清脂联素(ADPN)、糖类抗原125(CA125)及抗苗勒管激素(AMH)水平检测在多囊卵巢综合征(PCOS)中的临床诊断价值。方法 选取2022年1月—2022年9月在东莞市中医院经鹿特丹诊断标准确诊的100例PCOS患者作为PCOS组;PCOS组通过测定患者体质量指数(BMI)是否大于28 kg/m2分为肥胖组和非肥胖组;测定患者的睾酮水平的高低是否大于80 ng/dL分为高雄激素组和非高雄激素组。另选身体健康、年龄与PCOS组相近的100名健康女性作为对照组。分别测定PCOS组和对照组的ADPN、CA125以及AMH,分析血清ADPN、CA125、AMH在PCOS患者中的检测价值。结果 POCS组的BMI、AMH、CA125、睾酮、ADPN与健康组比较差异均有统计学意义(P<0.05)。与对照组比较,PCOS组的BMI、AMH、CA125、睾酮水平升高、ADPN水平降低。PCOS患者的CA125与AMH水平呈正相关(P<0.05),ADPN与AMH无关(P>0.05)。结论 PCOS 患者血清CA125和AMH水平升高,ADPN水平降低。
Objective To explore the clinical diagnostic value of serum adiponectin(ADPN),carbohydrate antigen 125(CA125)and anti-Mullerian hormone(AMH)levels in polycystic ovary syndrome(PCOS).Method A total of 100 patients confirmed with PCOS in Dongguan Traditional Chinese Medicine Hospital from January 2022 to September 2022 were selected as the study subjects.All patients were diagnosed with PCOS according to the 2003 Rotterdam diagnostic criteria,and served as the PCOS group.The PCOS group was divided into obese and non obese group by measuring the patient’s body mass index(BMI)whether was greater than 28 kg/m2.A high androgen group and a non high androgen group were determined by whether the patient’s testosterone level is greater than 80 ng/dL.A hundred healthy women of similar age were selected as the healthy control group.The levels of ADPN,CA125 and AMH were measured in the experimental and control group,and their detection value were analyzed.Results BMI,AMH,CA125,testosterone and ADPN in the POCS group were statistically different compared to the healthy group(P<0.05).Compared with the PCOS group,the control group showed a significant increase in BMI,AMH,CA125 and testosterone levels,while the PCOS group showed a decrease in ADPN level.There was a positive correlation between CA125 and AMH in patients with PCOS,while there was no correlation between ADPN and AMH.Conclusions The levels of serum CA125 and AMH in PCOS patients significantly increased,while the level of ADPN decreased.The three indicators have good diagnostic value in PCOS and are worth promoting.
论著

SCCA、HPV-DNA联合阴道镜检查在宫颈鳞状细胞癌筛查中的应用价值

Application value of SCCA,HPV-DNA combined with colposcope in cervical squamous cell carcinoma screening

:75-78
 
目的 探讨鳞状上皮细胞抗原(SCCA)、人乳头瘤病毒(HPV)-DNA联合阴道镜检查在宫颈鳞状细胞癌(SCC)筛查中的应用价值。方法 选择2019年1月1日—2021年12月31日在中山市博爱医院就诊并确诊为SCC的妇女作为研究对象,共纳入100例SCC患者(SCC组),同时选择200例经活检确诊为宫颈慢性炎症的患者(宫颈慢性炎症组)作为阴性对照。采用阴道镜观察研究对象的宫颈情况,并采集研究对象的宫颈组织标本进行HPV-DNA检测。采集研究对象的静脉血,采用化学发光免疫法测定研究对象SCCA的水平。以病理检查结果为金标准,分别对HPV-DNA检测、外周血SCCA两者联用以及阴道镜、HPV-DNA检测、外周血SCCA三者联用进行筛查效果的评价。结果 SCC组研究对象的年龄≥40岁者、出血者、性生活开始年龄≤20岁者比例均高于宫颈慢性炎症患者组;而宫颈慢性炎症患者组疼痛的比例高于SCC患者组,差异均有统计学意义(P<0.01)。χ2检验结果显示,SCC组研究对象的SCCA阳性率高于宫颈慢性炎症组(P<0.001)。阴道镜结合SCCA、HPV-DNA检测筛查SCC的灵敏度和特异度均高于单独使用SCCA和HPV-DNA,并取得较好的约登系数(75%)和Kappa值(0.730)。结论 采用阴道镜结合HPV-DNA、SCCA可有效提高SCC疾病的约登系数与Kappa值,其联合诊断的效能高于单独使用阴道镜、HPV-DNA或SCCA诊断SCC。
Objective To study the application value of squamus cell carcinoma antigen(SCCA)and human papillomavirus(HPV)-DNA combined with colposcope in cervical squamous cell carcinoma(SCC)screening.Methods Women diagnosed with SCC who visited Boai Hospital of Zhongshan city from January 1,2019 to December 31,2021 were selected as research subjects,including 100 patients with SCC(SCC group)and 200 patients with chronic cervical inflammation confirmed by biopsy(chronic cervical inflammation group).The cervix of the subjects was observed by colposcope,and cervical tissue samples were collected for HPV-DNA testing.Venous blood of subjects was collected and SCCA levels were determined by chemiluminescence immunoassay.Using pathological examination results as the gold standard,the screening effect of combination HPV-DNA test and peripheral blood SCCA test,combination colposcope,HPV-DNA test and peripheral blood SCCA were evaluated respectively.Results In SCC group,the proportion of age≥40 years old,bleeding,sexual life age ≤20 years old were higher than those in chronic cervical inflammation group,but chronic cervical inflammation group had higher rate of pain than those in SCC group(P<0.01)by Chi-square test.SCCA positive rate in SCC group was higher than that in chronic cervical inflammation group(P<0.001)by Chi-square test.The sensitivity and specificity of colposcope combined with SCCA and HPV-DNA were higher than those of SCCA and HPV-DNA alone,and better Youden’s coefficient(75%)and Kappa value(0.730)were obtained.Conclusions Colposcope combined with HPV-DNA and SCCA can effectively improve the Youden’s coefficient and Kappa value of SCC disease,and its combined diagnosis efficiency was higher than that of colposcope,HPV-DNA and SCCA alone in the diagnosis of SCC,which has high clinical promotion significance.
论著

新斯的明拮抗顺阿曲库铵的时机对患者腹腔镜结直肠癌根治术后肌松残留和早期肺功能的影响

Effect of neostigmine antagonizing timing of cisatracurium on residual muscle relaxation and early lung function after laparoscopic radical resection of colorectal cancer

:70-74
 
目的 探究新斯的明拮抗顺阿曲库铵的时机对患者腹腔镜结直肠癌根治术后肌松残留和早期肺功能的影响。方法 选取于2021年2月—2022年9月在我院行结肠癌根治手术的194例患者为研究对象,以随机数字表法将患者分为空白对照组和试验组,然后结合给予新斯的明治疗时所体现的4个成串刺激(TOF)比值将试验组患者分为试验组A(TOF≤0.1)、试验组B(0.10.8)。对比组间肌松残余情况以及肺功能情况。结果 插管前,试验组A患者TOF比值低于其他组(P<0.01),空白对照组患者TOF比值高于其他组(P<0.01);空白对照组分别与试验组A~E在复苏室接受观察的时间比较,差异无统计学意义(P>0.01);试验组A患者肌松恢复指数低于其他组(P<0.01),空白对照组患者肌松恢复指数高于其他组(P<0.01)。插管前、拔管0.5 h以及拔管24 h时,组间1秒用力呼气容积(FEV1)、用力肺活量(FVC)和FEV1/FVC比较差异无统计学意义(P>0.05)。结论 结直肠癌根治术后给予新斯的明,有助于加快肌松恢复,但不会影响复苏室停留时间与肺功能水平。
Objective To investigate the effect of timing of neostigmine antagonizing cisatracurium on residual muscle relaxation and early lung function in patients underwent laparoscopic radical resection of colorectal cancer.Methods February 2021 to September 2022,194 patients who underwent radical colon cancer surgery in our hospital were selected as the research subjects.The patients were randomly divided into a blank control group and an experimental group using a random number table method.Then,combined with the train-of-four(TOF)ratios observed during neostigmine treatment,the experimental group patients were divided into experimental group A(TOF≤0.1),experimental group B(0.10.8).The residual muscle relaxation and lung function between groups were compared.Results Before intubation,the TOF ratio of patients in experimental group A was lower than that of other groups(P<0.01),while the TOF ratio of patients in the blank control group was higher than that of other groups(P<0.01).There was no significant difference in the observation time between the blank control group and the experimental group A~E in the postanesthesia care unit(P>0.01).The muscle relaxation recovery index of patients in experimental group A was lower than that of other groups(P<0.01),while the muscle relaxation recovery index of patients in the blank control group was higher than that of other groups(P<0.01).There were no significant differences in force expiratory volume in one second(FEV1),forced Vital capacity(FVC)and FEV1/FVC between groups before intubation,0.5 h after extubation and 24 h after extubation(P>0.05).Conclusions Administration of neostigmine after radical surgery for colorectal cancer can accelerate muscle relaxation recovery,but it will not affect the residence time of the postanesthesia care unit and lung function levels.
论著

经鼻高流量氧疗治疗AECOPD伴Ⅱ型呼吸衰竭的疗效

Efficacy of nasal high-flow oxygen therapy in the treatment of AECOPD with type Ⅱ respiratory failure

:58-63
 
目的 观察经鼻高流量氧疗治疗慢性阻塞性肺疾病急性加重期(AECOPD)伴Ⅱ型呼吸衰竭对患者肺功能、血气分析指标的影响。方法 收集2020年3月—2022年3月我院收治的AECOPD伴Ⅱ型呼吸衰竭患者92例,随机分为常规通气组(46例,无创正压通气)、经鼻氧疗组(46例,经鼻高流量氧疗),测量记录治疗前及治疗后2组患者心率及呼吸频率、血气分析指标、肺功能指标,评估患者舒适度及呼吸困难情况,记录治疗期间并发症。结果 治疗后经鼻氧疗组心率、呼吸频率低于常规通气组(P<0.05);治疗后经鼻氧疗组二氧化碳分压(PaCO2)低于常规通气组,动脉血氧分压(PaO2)高于常规通气组(P<0.05);治疗后经鼻氧疗组第1秒用力呼出气容积(FEV1)、用力呼气容积(FVC)高于常规通气组(P<0.05);治疗后经鼻氧疗组Borg评分低于常规通气组,舒适率高于常规通气组(P<0.05);经鼻氧疗组并发症发生率低于常规通气组(P<0.05)。结论 给予AECOPD伴Ⅱ型呼吸衰竭患者经鼻高流量氧疗可改善患者肺功能、血气分析指标,促进呼吸困难症状缓解,且可提高患者舒适度,降低并发症发生率。
Objective To observe the effect of nasal high-flow oxygen therapy on pulmonary function and blood gas analysis indexes in patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD)with type Ⅱ respiratory failure.Methods From March 2020 to March 2022,92 patients with AECOPD complicated with type Ⅱ respiratory failure who were treated in our hospital were enrolled and randomly divided into conventional ventilation group(46 cases,non-invasive positive pressure ventilation)and nasal oxygen therapy group(46 cases,nasal high-flow oxygen therapy).The heart rate and respiratory rate,blood gas analysis indexes,pulmonary function indexes of the two groups of patients before and after treatment were measured and recorded,the comfort level and dyspnea situation of the patients were evaluated,and the complications during the treatment were recorded.Results After treatment,the heart rate and respiratory rate in the nasal oxygen therapy group were significantly lower than those in the conventional ventilation group(P<0.05).The partial pressure of carbon dioxide(PaCO2)in the nasal oxygen therapy group was significantly lower than that in the conventional ventilation group,partial pressure of oxygen(PaO2)was significantly higher than the conventional ventilation group(P<0.05).The nasal oxygen therapy group forced expiratory volume in one second,(FEV1),forced vital capacity(FVC)were significantly higher than the conventional ventilation group(P<0.05).The Borg score of nasal oxygen therapy group was significantly lower than the conventional ventilation group,the comfort level was significantly higher than the conventional ventilation group(P<0.05).The incidence of complications in the nasal oxygen therapy group was significantly lower than that in the conventional ventilation group(P<0.05).Conclusions Nasal high-flow oxygen therapy for AECOPD patients with type Ⅱ respiratory failure can significantly improve the pulmonary function and blood gas analysis indicators,promote the relief of dyspnea symptoms,improve the comfort level of patients,and reduce the incidence of complications.
论著

改良颈肩体热塑膜固定下颈胸段食管癌放射治疗中的摆位误差分析

Analysis of set-up errors in radiotherapy of cervical thoracic esophageal cancer under modified neck shoulder body thermoplastic film fixation

:52-57
 
目的 应用锥形束CT比较改良颈肩体热塑膜和传统颈肩体热塑膜体位固定装置在颈胸段食管癌患者放射治疗中的摆位差异,分析两种固定方式对锁骨上下区摆位误差的影响。方法 分析2021年6月—2022年10月在南京医科大学第一附属医院行放射治疗的29例食管癌患者的临床资料。将患者分为改良颈肩体热塑膜组(改良组)和光板颈肩体热塑膜组(对照组),对比分析2组病例不同配准区域的摆位误差。结果 改良组在X(左右)方向的平移误差及Rz(冠状面)方向的旋转误差小于对照组,差异有统计学意义(P<0.05)。改良组锁骨上下区在X(左右)方向的平移误差以及Rx(矢状面)方向的旋转误差小于对照组,差异有统计学意义(P<0.05)。改良组的整体靶区外放范围在X、Y方向上均小于颈肩体组,改良组在锁骨上下区的X方向靶区外放范围也更小。结论 对于颈胸段食管癌需行锁骨上下区放疗的患者,应用改良颈肩体热塑膜可减少平移误差,控制旋转角度,减少靶区外放范围。
Objective To compare the set-up errors between the modified neck-shoulder body thermoplastic film and the traditional neck-shoulder body thermoplastic film fixation device in the radiotherapy of patients with cervical and thoracic esophageal cancer by cone beam CT,and to analyze the influence of the two fixation methods on the positioning error of the upper and lower clavicular region.Methods The clinical data of 29 patients with esophageal cancer who underwent radiotherapy in the First Affiliated Hospital of Nanjing Medical University from June 2021 to October 2022 were analyzed.The patients were divided into two groups:the modified neck-shoulder body thermoplastic film group(the modified group)and the smooth neck-shoulder body thermoplastic film group(the control group),the positioning errors in different regions of the two groups were compared and analyzed.Results The translation error in the X(left and right)direction and the rotation error in the Rz(coronal plane)direction of the modified group were smaller than those of the control group,and the differences were statistically significant(P<0.05).The translation error in the X(left and right)direction and the rotation error in the Rx(sagittal plane)direction of the superior and inferior clavicular region in the modified group were smaller than those in the control group,and the differencs were statistically significant(P<0.05).The overall target area of the modified group was smaller in X and Y directions than that of the neck-shoulder body group,and the target area of the improved group in X direction was also smaller in the upper and lower clavicle area.Conclusions For patients with cervical and thoracic esophageal cancer who need radiotherapy in the upper and lower clavicular region,the application of modified neck shoulder body thermoplastic film can reduce the translation error,control the rotation angle and reduce the external radiation range of the target region.
论著

小于4 cm胃神经鞘瘤CT误诊与漏诊分析

Gastric schwannomas less than 4 cm:analysis of CT misdiagnosis and missed diagnosis

:46-51
 
目的 探讨小于4 cm的胃神经鞘瘤(GS)的CT误诊与漏诊原因,从而加深影像科医师对GS的认识,提高其CT检出率及诊断准确率。方法 回顾性分析2019年3月—2022年10月经手术切除及病理证实的10例小于4 cm的GS患者的临床、CT及病理资料。在CT图像上评估肿瘤的位置、大小、形态、密度、强化特点及周围淋巴结等情况。结果 术前CT误诊7例,漏诊2例,仅1例正确诊断;10例病灶均起源于胃黏膜下;9例为圆形或类圆形;7例发生于胃体;平扫密度均低于肌肉组织,均呈渐进性强化。结论 小于4 cm的GS术前误诊率很高,且可发生漏诊。当CT检查提示胃体部黏膜下圆形或类圆形占位病变,平扫呈均匀稍低密度,增强呈渐进性强化时应考虑GS的可能,最终确诊需病理及免疫组化检查。
Objective To investigate the causes of CT misdiagnosis and missed diagnosis of gastric schwannomas(GS)smaller than 4 cm in size,and to improve radiologists’ awareness of GS and increase the detection rate and diagnostic accuracy.Methods Clinical,pathological and CT data of ten surgically and pathologically confirmed GS patients were retrospectively reviewed between March 2019 and October 2022.The location,size,shape,attenuation,enhancement features and surrounding lymph nodes of each tumor on CT were analyzed.Results Of the 10 patients,7 cases were misdiagnosed in preoperative CT examination,two cases were missed diagnosed and only one case was correctly diagnosed.All tumors originated from the submucosa in ten cases,and nine cases showed a round or oval shape.Seven lesions were located in the gastric body,and all tumors had homogeneous low attenuation compared to muscle on plain CT images.All cases displayed mild-moderate to obvious enhancement.Conclusions GS smaller than 4 cm have a high rate of misdiagnosis and missed diagnosis preoperatively.When CT examination indicates a submucosa tumor with a round-like shape in the gastric body and homogeneous mild hypoattenuation on plain CT,the possibility of GS should be raised.Pathological and immunohistochemical examinations are necessary to confirm the final diagnosis.
论著

腹主动脉瘤腔内修复术后瘤体直径及体积变化的随访研究

Changes in aneurysm diameter and volume after endovascular aneurysm repair of abdominal aortic aneurysm

:34-39
 
目的 探讨腹主动脉瘤腔内修复术后瘤体直径和瘤体体积的转归以及与术后内漏的关系。方法 回顾性分析2015年—2020年在我院行腹主动脉瘤腔内修复术的83例患者的临床及影像学资料。测量术前和术后各随访时间点瘤体最大直径及体积。CT评价术后内漏发生情况。定义瘤体(直径/体积)扩张/回缩及瘤体(直径/体积)稳定。以术前瘤体最大直径大小和术后内漏发生情况将患者分组,比较组间各随访时点的瘤体直径和体积转归情况。结果 患者术后平均随访时间24(10~62)个月。以瘤体直径<50 mm及≥50 mm分组,术后各随访时间点2组间瘤体体积及瘤体直径比较均无统计学差异。以术后有无内漏分组,术后各随访时间点组间比较瘤体体积变化比较差异均有统计学意义(P<0.05),但瘤体直径变化组间比较差异均无统计学意义。结论 主动脉瘤瘤体体积与直径变化并不存在一致性,监测瘤体体积可以发现那些直径变化不明显的瘤体变化;腹主动脉瘤腔内修复术后内漏可能是导致瘤体增大的因素之一。
Objective To evaluate the outcome of aneurysm diameter and volume,and the role of endoleak after endovascular aneurysm repair of abdominal aortic aneurysm.Methods The clinical and imaging data from 83 patients who underwent endovascular repair of abdominal aortic aneurysm in our hospital from 2015 to 2020 were retrospectively analyzed.The maximum aneurysm diameter and volume were measured at the preoperative and postoperative follow-up time points.CT was used to evaluate the incidence of postoperative leakage.The aneurysm(diameter/volume)expansion/shrinkage and aneurysm(diameter/volume)stability were defined.Patients were divided into different groups according to the maximum preoperative aneurysm diameter and the incidence of postoperative endoleak,and the outcomes of aneurysm diameter and volume were compared at established follow-up points.Results The mean follow-up time was 24(10-62)months.There were no statistically significant differences in postoperative aneurysm volume and diameter at follow-up points between the patients with aneurysm diameter <50 mm and patients with aneurysm≥50 mm.There were statistically significant differences in postoperative aneurysm volume between the patients with postoperative endoleak and patients without postoperative endoleak(P<0.05).However,there were no statistically significant differences in postoperative diameter between the two groups.Conclusions The changes of aneurysm volume and diameter were not closely related,and the detection of aneurysm volume can help to find the aneurysm changes with no obvious diameter changes.The postoperative endoleak after endovascular aneurysm repair may be one of the factors leading to aneurysm enlargement.
论著

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多中心随机对照研究

A multicenter randomized controlled study of single-use digital hysteroscope versus reusable hysteroscope for outpatient hysteroscopy

:16-22
 
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.
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