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.
临床诊疗

一次性囊式宫颈扩张器用于治疗产后出血的临床研究

Clinical study of disposable type cervical dilator in the treatment of postpartum hemorrhage

:102-104
 
目的 探讨产后出血(PPH)应用一次性囊式宫颈扩张器治疗的临床效果。方法 选取我院2001年1月—2016年12月收治的50例PPH产妇,按就诊先后顺序进行分组,2001年1月—2015年12月就诊的25例为对照组(予以宫腔填塞纱布治疗);2016年1月—2016年12月就诊的25例为观察组(给予一次性囊式宫颈扩张器治疗),并按照分娩方式不同分为阴道分娩组(15例),剖宫产组(10例)。记录比较观察组和对照组的治疗与预后情况;阴道分娩组与剖宫产组的治疗情况。结果 与对照组比较,观察组在操作时间、填塞物留置时间及起效时间方面,均显著更优(P<0.01);两组放置后12 h出血量、显效率相比,差异无统计学意义(P>0.05);观察组子宫切除、子宫动脉结扎及产褥感染等发生率均低于对照组,但差异均无统计学意义(P>0.05);阴道分娩组的起效时间、留置时间、T2时间段阴道总流血量、显效率及产褥感染率,较剖宫产组比较,差异均无统计学意义(P>0.05),阴道分娩组T1时间段阴道总流血量显著低于剖宫产组(P<0.01)。结论 PPH产妇应用一次性囊式宫颈扩张器治疗操作简便,更有利于缩短操作时间,改善预后,效果切实,且对于阴道分娩与剖宫产产妇的疗效相当,适用于基层医院,具有较高临床推广价值。
论著

一次性包皮切割缝合器与两种传统包皮环切术的应用比较

Comparision of the effects of circumcision between using a novel disposable suture device and traditional or plastibell procedure

:73-76
 
目的 比较一次性包皮切割缝合器与传统包皮环切术和套扎环包皮环切术的临床应用效果。方法 对我院2016年7月—2016年12月内门诊收治的包皮过长和包茎患者,采用不同手术方法治疗,其手术时间、术中疼痛评分(VAS评分)、术后水肿、疼痛持续时间、以及外观满意度等方面进行对比。结果 在手术时间和外观满意度方面一次性包皮切割缝合器明显优于传统包皮环切术;在术中疼痛评分(VAS评分)、疼痛持续时间和术后水肿方面一次性包皮切割缝合器明显优于套扎环包皮环切术。结论 一次性包皮切割缝合器与两种传统常规手术比较,手术更加简单、方便且安全,术后外观满意度高,值得临床推广。
Objective To compare the effects of circumcision between using a novel disposable suture device and traditional or plastibell procedure. Methods The patients from July 2016 to December 2016 that underwent different ways of circumcision were documented. The operation time, VAS score, postoperative edema, the duration of the pain and appearance of satisfaction were collected and analyzed. Results The suture device group had shorter operation time, better appearance of satisfaction than that of traditional group (P<0.05). Besides, the suture device group had lesser VAS score, shorter duration of the pain and less postoperative edema (P<0.05). Conclusion Compared to traditional or plastibell procedure, a novel disposable suture device circumcision represents convenient, efficient and minimal invasive. It is worth promoting clinically.
论著

一次性带冲洗球囊胃管的临床应用

Study on the clinical application of disposable nasogastric tube

:36-38
 
目的 探究一次性带冲洗球囊胃管的临床应用。方法 收集来我院进行腹部外科手术的患者共200例,随机分为研究组与对照组,每组100例,其中研究组患者采用一次性带球囊胃管治疗,对照组则应用传统胃管进行治疗。观察对比2组患者进行引流的通畅情况、治愈时间、胃管滑脱及胃管相关并发症等情况。结果 研究组患者的一次置管成功率高于对照组(P<0.05),置管停顿率和自行拔管率均低于对照组(P<0.05);研究组低于对照组(P<0.05);研究组患者的不良反应发生率低于对照组(P<0.05),差异均有统计学意义。结论 一次性带冲洗球囊胃管治疗可持续冲洗胃腔及灌注药物,保证引流通畅,明显提高胃肠减压效果,促进胃黏膜的炎症水肿、糜烂出血等病症的修复愈合,并且能够提高置管效果,减少置管时间,同时避免不良反应的发生,值得临床进一步推广。
Objective To investigate the clinical value of disposable balloon catheter with irrigation. Methods In our hospital for abdominal surgery patients with a total of 200 cases were randomly divided into study group and control group, 100 cases in each group. The study group was treated by disposable balloon intubation, the control group used conventional gastric tube. Observation and comparison of two groups were taken with drainage patency, cure time, gastric tube slippage and gastric tube related complications. Results The study group of patients with a success rate of catheterization was higher than that of the control group (P<0.05), catheter pause rate and self extubation rate were lower than that of the control group (P<0.05); the study group was significantly lower than that of the control group (P<0.05); the adverse reaction of patients in the study group was significantly lower than that of the control group (P<0.05), the differences were statistically significant. Conclusion Disposable flushing balloon intubation treatment of gastric cavity perfusion and sustainable irrigation, to ensure smooth drainage, may improve the effect of gastrointestinal decompression, promote the repair of gastric mucosal inflammation and edema, erosion, bleeding and other symptoms and improve the effect of catheterization, reduce the intubation time, and avoid the occurrence of adverse reactions. It is worthy of further promotion.
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