β内酰胺类抗菌药物皮肤试验指导原则(2021年版)发布

2021-04-19 国家卫健委 国家卫健委

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β 内酰胺类抗菌药物是目前临床应用最多且具有重要临床价值的一类抗菌药物。由于医务人员对该类药物诱发过敏反应存在担忧,青霉素和头孢菌素皮肤试验被广泛应用于用药前预测过敏反应。

然而,因为对药物过敏反应机制、皮试意义的认识误区,许多医务人员在临床实践中过于依赖皮试,过敏史甄别欠细致、皮试适应证偏宽泛、皮试操作不规范、结果判读不正确等现象仍普遍存在。由此可能导致过敏反应急救应对不足,浪费医疗资源,延误患者治疗,缩窄抗菌药物选择范围等后果。

基于当前存在的问题和皮试的重要影响,为澄清药物过敏反应机制和皮试的临床意义,规范 β 内酰胺类抗菌药物过敏史甄别和皮试临床实践,保障患者安全,促进抗菌药物合理应用,特制定本指导原则。

一、皮肤试验及其诊断价值

皮肤试验包括点刺试验和皮内试验,目前国内抗菌药物皮肤试验常规采用皮内试验。以下提到的皮肤试验均指皮内试验,简称皮试。

(一)药物过敏反应与皮试的预测作用。

药物过敏反应根据免疫机制的不同分为Ⅰ、Ⅱ、Ⅲ、Ⅳ四型。

Ⅰ型为 IgE 介导的速发型过敏反应,通常在给药后数分钟到 1 小时之内发生,典型临床表现为荨麻疹、血管神经性水肿、支气管痉挛、过敏性休克等。

Ⅱ型为抗体介导的溶靶细胞过程,例如药物诱发的血小板减少性紫癜。

Ⅲ型为免疫复合物介导,例如血清病、药物相关性血管炎等。

Ⅳ型为 T 细胞介导,例如药物接触性皮炎、固定性药疹、Stevens/Johnson 综合征、中毒性表皮坏死松解症等。

Ⅱ、Ⅲ、Ⅳ型为非 IgE 介导的迟发型过敏反应,通常在给药 1 小时之后直至数天发生。

β 内酰胺类抗菌药物皮试的主要目的,是通过检测患者体内是否有针对该类药物及其代谢、降解产物的特异性 IgE 抗体(specific IgE, sIgE),预测发生Ⅰ型(速发型)过敏反应的可能性,降低发生过敏性休克等严重过敏反应风险。预测Ⅱ、Ⅲ、Ⅳ型过敏反应不是皮试的目的,皮试也无法检测药品中是否含有杂质成分。

(二)青霉素皮试。

青霉素本身的分子量小,为半抗原,其代谢、降解产物与蛋白质或多肽结合形成可引发过敏反应的完全抗原。青霉素的 β 内酰胺环开环形成的青霉噻唑基,占其分解产物大多数,被称为主要抗原决定簇,其相应的批准上市皮试试剂由青霉噻唑基与多聚赖氨酸共价结合制备而成,称为青霉噻唑酰多聚赖氨酸(penicilloyl-poly-lysine,PPL)。青霉素还可形成其他降解物、重排物或降解中间体,例如青霉酸、青霉噻唑酸、脱羧青霉噻唑酸、青霉烯酸、青霉胺等。这些分解产物量少,构成次要抗原决定簇,其批准上市皮试试剂包括青霉酸、脱羧青霉噻唑酸等次要抗原决定簇混合物(minor determinant mixture,MDM)。

青霉素 G 本身亦可归为次要抗原决定簇。所谓的「主要」和「次要」是指两类分解产物量上的差异,两者免疫学及临床重要性等同。国内目前暂无已批准上市的 PPL 及 MDM 试剂。此外,半合成青霉素侧链结构也可成为抗原决定簇,诱发过敏反应。

青霉素皮试是目前预测青霉素速发型过敏反应最快速、灵敏、有效的检测方法。完整的青霉素皮试,其检测试剂应包含青霉素 G、MDM、PPL、半合成青霉素,并做阴性对照(生理盐水)及阳性对照(组胺)。研究表明,通过完整、规范的皮试诊断方法,青霉素皮试的阳性预测值为 50%,阴性预测值为 70%~97%。

(三)头孢菌素皮试。

头孢菌素分解产物尚未完全明确,但现有的证据表明头孢菌素类的抗原决定簇主要由其侧链结构所构成。头孢菌素之间的交叉过敏性可能主要是由于具有相同或相似的 C7 位的 R1 侧链(见附表)。迄今尚无批准上市的头孢菌素皮试试剂,且皮试的灵敏度、特异度、阳性预测值及阴性预测值亦未确定。

(四)青霉素与头孢菌素的交叉过敏反应。

青霉素与第一代头孢菌素之间的交叉过敏性较多见,可达 10%。但第二代头孢菌素与青霉素之间的交叉过敏反应率仅为 2%~3%,第三、四代头孢菌素与青霉素之间的交叉过敏反应率更低至 0.17%~0.7%。目前研究认为头孢菌素 C7 位的 R1 侧链与青霉素 C6 位的侧链结构相同或相似是导致交叉过敏反应的主要因素(见附表)。

二、皮试适应证

使用 β 内酰胺类抗菌药物前是否需要进行皮试,由医师基于以下适应证判定。需进行皮试者,应由医师开具皮试医嘱后进行。

(一)青霉素类。

目前我国青霉素类抗菌药物说明书、《抗菌药物临床应用指导原则》和《中华人民共和国药典临床用药须知》均要求在使用青霉素类抗菌药物之前需常规做青霉素皮试。

(二)头孢菌素类。

头孢菌素给药前常规皮试对过敏反应的临床预测价值无充分循证医学证据支持,大多数头孢菌素类抗菌药物的说明书、《抗菌药物临床应用指导原则》和《中华人民共和国药典临床用药须知》均未要求头孢菌素用药前常规进行皮试。

不推荐在使用头孢菌素前常规进行皮试,仅以下情况需要皮试:

①既往有明确的青霉素或头孢菌素Ⅰ型(速发型)过敏史患者。此类患者如临床确有必要使用头孢菌素,并具有专业人员、急救条件,在获得患者知情同意后,选用与过敏药物侧链不同的头孢菌素(见附表)进行皮试,其结果具有一定的参考价值;

②药品说明书中规定需进行皮试的。应当向药品提供者进一步了解药品引发过敏反应的机理,皮试的灵敏度、特异度、阳性预测值和阴性预测值,并要求提供相应皮试试剂。

有过敏性疾病病史,如过敏性鼻炎、过敏性哮喘、特应性皮炎、食物过敏和其他药物(非 β 内酰胺类抗菌药物)过敏,发生头孢菌素过敏的几率并不高于普通人群,应用头孢菌素前也无需常规进行皮试。但上述患者用药后一旦出现过敏反应,症状可能会更重,应加强用药后观察。

(三)其他 β 内酰胺类。

青霉素类、头孢菌素类的 β 内酰胺酶抑制剂复方制剂,皮试适应证和方法可分别参照青霉素类、头孢菌素类药物。

单环类、头霉素类、氧头孢烯类、碳青霉烯类、青霉烯类等其他 β 内酰胺类抗菌药物均无循证医学证据支持皮试预测作用,给药前无需常规进行皮试。若这些类别药物的说明书要求使用前皮试,参照头孢菌素类处理。

氨曲南侧链结构与头孢他啶 C7 位侧链结构相同,研究报道二者之间存在交叉过敏,有明确头孢他啶过敏史患者应避免使用氨曲南。

三、皮试操作基本原则与结果判读 

(一)皮试液配制。

青霉素皮试液配制:根据《中华人民共和国药典临床用药须知》规定,以注射用青霉素 G 或青霉素 G 皮试制剂稀释为 500U/ml 的皮试液。前者需多步稀释;后者仅一步稀释,可节约操作时间和人力,并减少误差及污染。

头孢菌素皮试液配制:头孢菌素皮试不引发皮肤非特异性刺激反应的推荐浓度为 2 mg/ml。若确需进行皮试,需将拟使用的头孢菌素加生理盐水稀释至 2 mg/ml 浓度配制成皮试液。

设立阴性对照(生理盐水)及阳性对照(0.01 mg/ml 磷酸组胺),有助于排除假阳性反应及假阴性反应。

(二)皮试操作方法。

用 75% 乙醇消毒前臂掌侧下段皮肤,对乙醇敏感的患者可使用生理盐水清洁。使用 1 ml 一次性注射器抽取皮试液,先排净针管内空气。用一手绷紧患者皮肤,另一手持针,针头斜面向上,与皮肤呈 5~15°进针,皮内注射皮试液 0.02~0.03 ml,形成直径 3 mm 的皮丘。

(三)皮试结果的判断与解读

进行皮试后 15~20 分钟后判断皮试结果,如皮丘较之前注射形成的皮丘直径扩大 ≥ 3 mm 应判断为皮试阳性,伴有红晕或痒感更支持呈阳性反应。

在排除假阳性反应的前提下,皮试阳性有临床意义,提示患者有发生 IgE 介导的速发型过敏反应的可能。皮试阳性(除非皮试诱发严重过敏反应)不应记录为「过敏」,而应记录为「皮试阳性」。既往仅皮试阳性的患者,并非皮试的禁忌证,可在密切观察基础上重复皮试。

皮试阴性不能完全排除过敏反应的可能,原因在于:①皮试仅对 IgE 介导的速发型过敏反应有预测价值,对非 IgE 介导的迟发型过敏反应无预测价值;②我国青霉素皮试检测试剂仅含青霉素 G,部分医院加入了半合成青霉素,但未包含 PPL、MDM,皮试的灵敏度有限;③未常规采用阳性对照,不能排除假阴性结果。因此即使皮试为阴性,在药物使用过程中仍需注意密切观察,并做好过敏反应抢救准备。

(四)皮试注意事项。

1. 皮试有诱发严重过敏反应甚至过敏性休克的可能,皮试区应常规备有相关抢救设备及药品,且相关人员应接受过严重过敏反应抢救的正规培训;4~6 周内发生过 β 内酰胺类药物严重过敏反应的患者进行皮试,由于 sIgE 在严重过敏反应发生时已被大量消耗,皮试可能出现假阴性结果。如需进行皮试,建议在反应发生 4~6 周后进行。

2. 有些药物可抑制皮肤反应,导致假阴性结果,故皮试前应询问近期用药史,并在病情允许时停用可能干扰皮试结果的药物。全身应用一代抗组胺药物停药至少 2~3 天,二代抗组胺药物停药至少 3~7 天,全身较长时间应用糖皮质激素停药至少 7 天,丙咪嗪类抗抑郁药、吩噻嗪类抗精神病药停药至少 7 天,对皮试的影响才能消除。如用药史不明,或因客观原因无法停药或停足够长时间,应以磷酸组胺作为阳性对照,明确皮肤反应性是否受抑制而导致假阴性。

3. 哮喘控制不佳或哮喘急性发作期患者进行皮试,一旦出现严重过敏反应,症状会更重,因此皮试最好在哮喘控制期进行;若必须在非控制期进行皮试,需加强监测。

4.β 受体阻滞剂及血管紧张素转化酶抑制剂可影响对严重过敏反应的救治。有严重过敏反应高危因素的患者,皮试前应至少停此类药物 24 小时。

5. 皮试液浓度过高会引起皮肤非特异性刺激,操作者手法较重、注射量大及注入气泡等均可导致假阳性反应。

6. 皮肤反应性增高(如部分荨麻疹、皮肤肥大细胞增多症)的患者可出现假阳性反应,影响结果判读,应以生理盐水作为阴性对照。

7. 婴幼儿及老年患者皮肤反应性差,可能出现假阴性结果。

8. 皮试液抗原性低或失效可导致假阴性反应,因此皮试液应尽量现配现用,如需保存应 4℃ 冷藏,且保存时间不应超过 24 小时。

四、过敏史的甄别与严重过敏反应的救治

皮试仅为预防过敏反应的措施之一,其预测作用仅限于少数药物引发的 IgE 介导的速发型过敏反应。预防和降低过敏反应风险应更多依靠:①详细询问和甄别过敏史;②用药期间的密切观察;③配备过敏反应抢救药品和设备;④医务人员熟悉严重过敏反应救治措施。

采集和甄别过敏史,应认真询问并详细记录:①可疑药物品种;②给药途径;③给药与出现疑似过敏反应的时间间隔;④临床表现;⑤处置与转归;⑥经治医师所做诊断。

应注意鉴别患者所诉的「过敏反应」是否为非过敏性的药物不良反应。如考虑过敏反应,还应尽量区分为速发型还是迟发型。记录过敏史时,尽量具体到药物品种而非笼统表述为某类药物过敏;既往仅皮试阳性患者,应为「既往皮试阳性」,而不应表述为「过敏」。

严重过敏反应的抢救必须争分夺秒,救治的首要目的是维持有效通气及循环。抢救的首选用药是肾上腺素。糖皮质激素及抗组胺药物并不是严重过敏反应的抢救首选用药。糖皮质激素起效慢,对于严重过敏反应急性期无效,仅适用于预防严重过敏反应迟发相反应(少数患者严重过敏反应可为双相,即速发相反应消失 4~8 小时后症状再次出现,称为迟发相反应)。

严重过敏反应的救治措施包括:

①立即停用导致过敏药物,静脉给药者更换输液瓶及输液器,救治过程严密监控心率、血压、呼吸及血氧饱和度;

②肾上腺素(1:1000):14 岁及以上患者单次 0.3~0.5 ml 深部肌内注射,14 岁以下患者 0.01 ml/kg 体重深部肌内注射(单次最大剂量 0.3 ml),5~15 分钟后效果不理想者可重复注射,注射最佳部位为大腿中部外侧;

③保持气道通畅,吸氧,必要时气管插管或气管切开,如暂无条件建立人工气道,紧急情况下可先行环甲膜穿刺;

④建立静脉通道(两条或两条以上),静滴晶体液维持血压(液体用量 20 ml/kg,根据患者情况调整剂量),必要时静脉点滴多巴胺维持血压;

⑤若有支气管痉挛,可吸入 β2 受体激动剂;

⑥抗组胺药:如苯海拉明 1.25 mg/kg,最大量 50 mg,肌内注射;

⑦糖皮质激素:静脉甲泼尼龙 40 mg/100 ml 生理盐水,或氢化可的松琥珀酸钠 100 mg~200 mg;

⑧任一环节中如出现心跳呼吸骤停,立即就地进行规范心肺复苏术。患者经救治脱离危险后,应留院观察至少 12 小时。

五、改进皮试实践的策略和措施

各级卫生健康行政部门、医疗机构和相关学术组织应充分认识规范 β 内酰胺类抗菌药物皮试对于抗菌药物合理应用的重大意义,基于当前实际,循序渐进地改进 β 内酰胺类抗菌药物皮试。

(一)积极组织医务人员进行有关 β 内酰胺类抗菌药物皮试适应证、意义、结果解读和过敏反应预防、救治的培训,纠正将预防过敏反应全部寄托于皮试、皮试适应证过泛的错误观念和做法。对从事皮试操作的护士进行过敏反应相关理论和皮试操作实践的重点培训。在有条件的医疗机构建立变态反应科,以提高皮试和过敏反应防控水平。

(二)各级卫生健康行政部门、医疗机构、相关学术组织等,应根据循证证据和本指导原则精神,修正相关规章、制度、指南、共识、专业著作中关于皮试的内容。鼓励通过积极反馈,促进修改 β 内酰胺类抗菌药物说明书中关于皮试的内容。

(三)使用头孢菌素类抗菌药物前,除上述「二、皮试适应证」一节规定的两种需进行皮试的特定情况外,不需皮试。

(四)鼓励医疗机构、相关学术组织等对我国青霉素、头孢菌素过敏反应发生率进行调查,为我国青霉素皮试试剂的最佳组合提供循证医学证据。协调促进研制或引进 PPL、MDM,为青霉素皮试提供更完备的试剂种类。

(五)根据世界卫生组织对青霉素皮试的推荐意见,在充分研究,推进修订药品说明书、相关文件、权威著作的基础上:①精准定位青霉素皮试适应证,并从口服青霉素类药物做起,逐步取消常规青霉素皮试筛查;②完善青霉素皮试方法。

(六)医疗机构、相关学术组织和医务人员积极开展面向公众的 β 内酰胺类抗菌药物皮试知识普及工作,并与相关管理部门充分沟通,为规范 β 内酰胺类抗菌药物皮试创造良好环境。

β 内酰胺类药物侧链相似性比较

图片

备注:同一列内药物具有相同或相似的侧链结构

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  1. 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  2. 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    2021-07-09 413424595

    学习

    0

  3. 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    2021-06-28 1581f80970m

    学习了

    0

  4. 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  5. 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createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Apr 19 21:07:22 CST 2021, time=2021-04-19, status=1, ipAttribution=)]
    2021-04-21 lhlxtx
  6. 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    2021-04-20 随风1991

    学习了

    0

  7. 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createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Apr 19 21:07:22 CST 2021, time=2021-04-19, status=1, ipAttribution=)]
    2021-04-20 ZJYYY7

    最近指南都在更新啊

    0

  8. 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createdName=随风1991, createdTime=Tue Apr 20 21:33:36 CST 2021, time=2021-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=958584, encodeId=116c9585847f, content=最近指南都在更新啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201214/b3170121d995432ea306ae3a7809cc05/2cfb236f361b4d3c80ef8fdef4301832.jpg, createdBy=8ad35400531, createdName=ZJYYY7, createdTime=Tue Apr 20 00:36:05 CST 2021, time=2021-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=958583, encodeId=f883958583df, content=学习学习 , beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201214/b3170121d995432ea306ae3a7809cc05/2cfb236f361b4d3c80ef8fdef4301832.jpg, createdBy=8ad35400531, createdName=ZJYYY7, createdTime=Tue Apr 20 00:35:54 CST 2021, time=2021-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=958540, encodeId=aac0958540ff, content=越学越觉得所学的不够用, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3845482238, createdName=泡泡糖111, createdTime=Mon Apr 19 23:28:44 CST 2021, time=2021-04-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=958501, encodeId=2f7a958501f0, content=了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Apr 19 21:07:22 CST 2021, time=2021-04-19, status=1, ipAttribution=)]
    2021-04-20 ZJYYY7

    学习学习

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1988489, encodeId=46f01988489a1, content=<a href='/topic/show?id=f437e2116d6' target=_blank style='color:#2F92EE;'>#皮肤试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72116, encryptionId=f437e2116d6, topicName=皮肤试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c22f171, createdName=kord1982, createdTime=Wed Jun 23 10:19:50 CST 2021, time=2021-06-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=998083, encodeId=93919980833a, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e301523945, createdName=413424595, createdTime=Fri Jul 09 22:31:35 CST 2021, time=2021-07-09, status=1, ipAttribution=), 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createdName=随风1991, createdTime=Tue Apr 20 21:33:36 CST 2021, time=2021-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=958584, encodeId=116c9585847f, content=最近指南都在更新啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201214/b3170121d995432ea306ae3a7809cc05/2cfb236f361b4d3c80ef8fdef4301832.jpg, createdBy=8ad35400531, createdName=ZJYYY7, createdTime=Tue Apr 20 00:36:05 CST 2021, time=2021-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=958583, encodeId=f883958583df, content=学习学习 , beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Mon Apr 19 21:07:22 CST 2021, time=2021-04-19, status=1, ipAttribution=)]
    2021-04-19 泡泡糖111

    越学越觉得所学的不够用

    0

  10. 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    2021-04-19 wxl882001

    了解

    0

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