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文章来源于华西呼吸治疗公众号
为规范iNO疗法的临床应用,由中华医学会呼吸病学分会呼吸治疗学组与中国医师协会呼吸医师分会呼吸职业发展委员会呼吸治疗师工作组组织、我院呼吸治疗科梁国鹏教授团队牵头起草了《一氧化氮吸入疗法临床应用专家共识》。
吸入一氧化氮(inhaled nitric oxide, iNO)作为一种选择性肺血管扩张剂,有舒张肺血管、增加肺血流、降低肺动脉压力以及改善氧合等作用。在发达国家,iNO已成为治疗新生儿持续性肺动脉高压(persistent pulmonary hypertension of the newborn, PPHN)的常规治疗手段。iNO治疗也被用于儿童和成人呼吸衰竭和肺动脉高压(pulmonary hypertension, PH),已被证明可以有效降低肺动脉压和改善氧合。随着iNO疗法临床应用的增加,市面上的iNO设备也逐渐增多,但设备品牌繁杂、设备间性能差异大以及连接和设置各异等问题使得iNO设备的规范使用存在困难;同时,iNO治疗过程中可能出现不良反应,如iNO可导致高铁血红蛋白(methemoglobinemia,MetHb)血症,还可与O2结合产生毒性代谢产物NO2等情况。所以,该疗法在临床的安全性和有效性可能会受到上述因素的影响。为规范iNO疗法的临床应用,中华医学会呼吸病学分会呼吸治疗学组与中国医师协会呼吸医师分会呼吸职业发展委员会呼吸治疗师工作组组织相关专家,根据最新的研究进展和临床操作经验提出了iNO疗法临床应用专家共识,以提高该治疗的安全性和有效性。
一
共识制定方法
本共识由中华医学会呼吸病学分会呼吸治疗学组和中国医师协会呼吸医师分会呼吸职业发展委员会呼吸治疗师工作组发起,启动时间为2023年4月,写作时间7个月。
为了促进共识的传播和临床应用,共识将在专业期刊上发表,发表后将以学术会议、学习班等形式在全国范围进行传播。共识制订工作组将定期进行文献检索、证据更新和评价,计划每 3~5 年对共识进行更新。
二
iNO治疗概述
iNO的主要生理学作用是舒张肺血管、降低肺动脉压力,其机制主要是通过环磷酸鸟苷途径造成细胞内钙离子浓度降低,从而引起血管扩张[11-12]。与静脉输注血管扩张剂相比,iNO可在PH患者中产生选择性肺血管扩张作用,而不会导致全身血管扩张和严重的全身性低血压。大多数临床试验都表明治疗剂量下的iNO具有相对较少的全身不良反应,并且没有明显的毒性。此外,iNO还具有改善低氧的生理学作用[3]。在低氧患者中,缺氧区域的肺血管床会收缩,从而重新分配血流朝向通气较好、肺泡内氧分压较高的肺区。有研究显示,iNO可增加这部分患者通气良好肺区的血流,从而改善通气/血流比(ventilation/perfusion ratio, V/Q),减少分流,改善氧合[4]。iNO还有下调白细胞反应、增加细胞保护、抗感染、减少血小板聚集、促进神经传递、促进组织再生、增强支气管扩张等作用[13-14]。
三
iNO疗法的适应证和禁忌证
根据目前的相关指南推荐及临床研究情况,iNO疗法在新生儿领域主要应用于多种原因导致的PPHN和低氧血症,其中足月或近足月(胎龄>34周)的PPHN是唯一批准的适应证[3, 15]。iNO在早产儿领域的应用仍存在争议,指南推荐对于明确由PPHN而非实质性肺病引起的严重低氧血症的早产儿可尝试采用iNO疗法[16-17]。iNO疗法在新生儿领域应用的禁忌证为:①严重的左心发育不良,或动脉导管依赖的先天性心脏病(congenital heart disease,CHD);②致命性的先天性缺陷和充血性心力衰竭;③先天性MetHb血症;④严重出血,如颅内出血、脑室内出血、肺出血[15]。在儿童及成人领域,iNO疗法主要应用于CHD、围手术期(心胸外科手术、体外膜氧合、移植、心室辅助等)、各种原因导致的急性低氧型呼吸衰竭或急性呼吸窘迫综合征(acute respiratory distress syndrome, ARDS)以及慢性肺疾病、心脏骤停等情况[4-5,7-8,14]。iNO也常用于急性血管反应试验[8,18],以筛选出对口服高剂量钙通道阻滞剂有效的患者;对于左心疾病相关PH患者,此项试验仅限于评估患者是否具备心脏移植的候选资格,而对于结构性心脏病伴有初始体肺分流的PH患者,可通过该试验来评估缺损闭合的可能性。关于iNO的临床适用人群参考可见表1。尽管在临床环境中iNO已得到广泛应用,且体现出了有益作用,但目前仍然缺乏高质量的研究证据。
专家共识1:iNO疗法唯一批准的适应证为PPHN,但临床上已广泛应用于多种原因导致的PH或低氧血症患者,建议对这些患者充分评估其是否存在相关禁忌证后谨慎使用。
四
iNO相关治疗设备和连接
专家共识3:建议iNO设备连接时,将输入端放于吸气肢远离患者处,监测采样端放于吸气肢靠近患者处。采样端需与输入端和呼吸机回路Y型端或呼气阀(若有)保持一定距离(>15 cm),以免监测值受到干扰。
五
iNO剂量选择和疗效评估
专家共识5:iNO 起效迅速,建议在治疗开始后 30~60 min应进行疗效评估,对 iNO疗法无反应者应及时调整治疗方案,对调整后仍然表现为无反应甚至出现负反应的患者,应立即停用 iNO。
六
iNO治疗时的不良反应
专家共识6:在iNO治疗过程中建议对患者进行安全性监测,如果在治疗量下出现MetHb血症、反跳性PH和反跳性低氧血症等不良反应,应立即调整iNO治疗方案或停止iNO治疗。
七
职业防护
专家共识7:iNO设备在使用过程中,可能因气体泄漏导致相关医务人员出现职业暴露,危害身体健康,建议iNO使用过程中常规监测环境中的NO和NO2浓度。
八
iNO患者转运
专家共识8:iNO患者转运途中,建议保证iNO治疗连续性并持续对管路和环境中NO、NO2浓度进行监测,避免气体泄漏等重大危险事件的发生,同时,临床应制订规范化转运流程和紧急情况处理预案,并于日常工作中加强相关流程演练,以保证患者和医务人员安全。
九
iNO的撤离
专家共识9:撤离iNO时,建议严格按照撤离流程逐步降低iNO浓度,并密切监测患者呼吸和循环状态,做好反跳性PH和反跳性低氧血症的预防和处理。
十
清洁消毒和维护保养
专家共识10:建议对iNO设备和耗材进行日常清洁消毒和定期维护保养,保证监测准确、运行状态良好,以防止意外情况发生、避免交叉感染、延长设备使用寿命。
十一
iNO应用流程和记录
共识审校专家组(以姓氏汉语拼音排序):鲍彰(浙江大学医学院附属第一医院呼吸与危重症医学科);陈成(苏州大学附属第一医院呼吸与危重症医学科);董霄松(北京大学人民医院呼吸与危重症医学科);傅立军(上海交通大学医学院附属上海儿童医学中心心内科);韩锋锋(上海交通大学医学院附属新华医院呼吸与危重症医学科);黄蓉(北京协和医院呼吸与危重症医学科);黄絮(中日友好医院呼吸与危重症医学科);蒋进军(复旦大学附属中山医院呼吸与危重症医学科);姜蓉(上海市肺科医院肺循环科);居旻杰(复旦大学附属中山医院重症医学科);李惠萍(深圳市人民医院呼吸与危重症医学科);罗凤鸣(四川大学华西医院);梁国鹏(四川大学华西医院呼吸治疗科);刘嘉琳(上海交通大学医学院附属瑞金医院老年科);黎毅敏(广州医科大学附属第一医院);刘玉琪(福建医科大学附属第二医院重症医学科);马江伟(中国医科大学附属第一医院呼吸与危重症医学科);宋立强(第四军医大学西京医院呼吸与危重症医学科);屠国伟(复旦大学附属中山医院心脏重症监护中心);王胜昱(西安医学院第一附属医院);王伟(武汉大学中南医院呼吸与危重症医学科);解立新(解放军总医院第八医学中心呼吸与危重症医学部);夏金根(中日友好医院呼吸与危重症医学科);肖坤(解放军总医院第八医学中心呼吸与危重症医学部);赵卉(山西医科大学第二医院呼吸与危重症医学科);赵建平(华中科技大学同济医学院附属同济医院呼吸与危重症医学科);郑春燕(山东大学齐鲁医院全科医学科)
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