二氧化碳结肠镜检查的动物实验和临床研究
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摘要
目的目前,结肠镜检查中注入空气在全世界绝大多数地方是使用的标准方法。然而,采用空气作为注入媒介的结肠镜检查存在一系列的并发症:检查后腹痛腹胀、空气栓塞、甚至爆炸等等。二氧化碳因其具有快速可吸收性、不可燃、不易形成气栓、易于代谢调节等特性,一种改良的使用二氧化碳作为注入媒介的结肠镜检查方法正现逐渐被临床接受。本研究的目的是制作一个简便的二氧化碳注气机,通过动物实验及临床随机对照试验评估二氧化碳结肠镜检查在临床应用中的有效性及安全性。
     方法(1)采用二氧化碳减压器和流量计制作一个注气机,通过动物实验验证该设备注入二氧化碳在结肠镜应用中的有效性安全性,20条平均体重约12.5Kg的杂种犬随机分配到二氧化碳组和空气组进行结肠镜检查,评估检查前后的血气分析情况,通过腹平片检查对比其肠扩张情况。(2)收集本院门诊结肠镜检查的360例患者,随机分配到二氧化碳组(n=177)或空气组(n=183),采用自制的注气机操作。合并急性消化道出血或是严重心肺疾病的患者被排除在外。通过直观模拟评分(VAS)调查表分别于检查结束时及检查后1、3、6、24小时记录患者腹痛腹胀程度评分,以及腹胀的缓解时间;同时于结肠镜检查前、到达回盲部、回到直肠时、检查后四个时段记录患者呼气末二氧化碳分压。检查1小时后通过腹平片评估肠道气体残留情况。
     结果(1)自制内镜二氧化碳注气设备输出气体压力为0.05Mpa,流量为2.8L/min,与结肠镜主机气泵注气效果相当。(2)动物实验中通过腹平片评估其肠扩张程度,比较在检查结束时(P<0.01),检查后5分钟(P<0.01),检查后30分钟(P<0.01),检查后1小时(P<0.01),二氧化碳组均明显优于空气组;而动脉血二氧化碳分压两组前后对比无明显差异,空气组前后对比(P=0.414),二氧化碳组前后(P=0.868)。(3)临床随机对照试验中一共353例患者完成调查,结果发现空气组在检查后1、3、6、24小时有腹痛的比例明显高于二氧化碳组(78%vs 10%,46%vs 2%,39%vs 0.5%,23%vs 0.5%,6%vs 0.5%,均P<0.01);且检查后Air组有83%有不同程度腹胀,CO2组仅7%,P值<0.01;腹胀缓解时间CO2组为0.82±0.51小时,而Air组为3.89±5.96小时,P值<0.01;呼气末二氧化碳分压两组前后对比无明显差异,空气组前后对比(P=0.881),二氧化碳组前后(P=0.289)。患者检查后腹平片检查肠道气体残留二氧化碳组明显少于空气组,空气组有93%有明显肠扩张,而二氧化碳组为34%(P<0.01)。
     结论(1)自制二氧化碳注气机应用安全可靠,能够达到结肠镜主机气泵相同效果,在缺少专用内镜二氧化碳注气机的情况下,可望成为其的替代产品。(2)二氧化碳是一种有效而且安全的结肠镜注入气体媒介,在减少结肠镜检查后患者的腹痛腹胀方面明显优于空气,且对患者血PCO2值无明显影响。
Aims At present,air insufflation in colonoscopy has remained the standard method in most centres around the world.However,there is a series of complication in conventional colonoscopy in which air is used as an insufflating agent,such as abdominal pain or bloating after colonoscopy,air embolism,even explosion et al.Recently,a modified technique of colonoscopy using carbon dioxide(CO2)as an insufflating agent has gained gradually clinical acceptance,because CO2 have some good feature,such as high absorbability,non-conbustible,difficult to form gas embolism,easy to regulate metabolism.The objective of this study were to make a simple carbon dioxide insufflator,to evaluate CO2 insufflation in colonoscopy performance and safety for animal experiment and a randomized controlled clinical trial.
     Methods(1)The insufflator is made of a CO2 regulator and a flow instrument.The performance and safety of CO2 insufflation in colonoscopy have been evaluated with animal experiment.Twenty hybrid dogs with an average weight of 12.5 kg were randomized to CO2 group or to air group for colonoscopy.To evluate the situation before and after the blood gas analysis,and contrast bowel distention by abdominal plain film examination.(2)Three hundred sixty patients collected from our hospital were randomized to undergo colonoscopy with insufflation of air (n=183)or CO2(n=177)by means of a the new homemade regulator. Patients with active GI bleeding and severe cardiopulmonary disease were excluded.Abdominal pain or bloating scores were recorded immediately after colonoscopy and at 1,3,6 and 24 hours by VAS,and Abdominal distention mitigation time.Meanwhile,ETCO2 were observed in four period:before exam,arrived caecum,back rectum,after exam.Residual colonic gas was evaluated on abdominal radiographs at 1hours.
     Results(1)The output gas pressure of homemade endoscopic CO2 regulator can reached 0.05Mpa,the flow 2.8L/min,the effect of insufflation were equal to new insufflator with air pump in endoscopic master station.(2)To assess the degree of bowl distention was slightly in the CO2 group compared with the air group at 0 minute(P<0.01),at 5 minutes(P<0.01),at 30 minutes(P<0.01),at 1 hours(P<0.01)after the procedure.There were no differences in P CO2 values in artery between the two groups before and after procedure,at the air group (P=0.414),at the CO2 group(P=0.868).(3)Three hundred fifty three patients completed the randomized controlled clinical trial. Postprocedural pain at 1,3,6 and 24 hours were significantly less in the CO2 group.93%of patients insufflated with air had colonic severe distension versus 34%for those in the CO2 group(P<0.01).The rate of patients insufflated with air had pain at,respectively,the end,1 hours,3hours,6 hours and 24 hours(78%vs 10%,46%vs 2%,39%vs 0.5%,23%vs 0.5%,6%vs 0.5%,respectively P<0.01)higher than the CO2 group.Abdominal distention scores in VAS were indicate that 83% patients have Varying degrees in Air group,but only 7%in CO2 group, P<0.01.The distention mitigation time in CO2 group was Significantly less than Air group(0.82±0.51 vs 3.89±5.96hours,P<0.01).There were no differences in ETCO2 values between the two groups before and after procedure,at the air group(P=0.881),at the CO2 group(P=0.289). Residual colonic gas in CO2 group was less than Air group by abdominal plain film examination(34%vs 93%,P<0.01).
     Conclusions(1)The homemade CO2 regulator was safe and reliable,can achieved the same effect for colonoscopy gas pump,is ecpected to become a substitute product as the absence of dedicated endoscopic carbon dioxide regulator.(2)CO2 is an effective and safe gas media insufflate colonoscopy,is superior to the Air in the aspects for reducing the abdominal pain and distention after colonoscopy,and no significant impact on the arterial blood PCO2 value in the patients after colonoscopy.
引文
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