Abstract: Background　Otitis media with effusion（OME） is a kind of self-limited disease commonly found in children，which often occurs with adenoid hypertrophy，and may manifest as hearing loss，ear pain，nasal congestion，and runny nose.External use of Sun's sequential therapy （SST） is a TCM treatment including fumigating nose during preparing the decoction，and dropping nose using the distilled vapor of the decoction after cooling，which can avoid the trouble caused by oral administration of the decoction to children，contributing to good compliance in them.However，there are no studies on the efficacy of TCM syndrome-based external use of SST in OME children with different symptoms and adenoid hypertrophy.Objective　To explore the therapeutic effect of TCM syndrome-based external use of SST in OME children with different symptoms and different levels of adenoid hypertrophy.Methods　From September 2018 to December 2019，45 eligible children （64 ears） with a chief complaint of nasal or ear discomfort were selected from ENT Clinic，Guang'anmen Hospital，China Academy of Chinese Medical Sciences.The symptoms of the children at the first visit were collected，including hearing loss，earache，nasal congestion，runny nose，and so on，and all received TCM syndrome-based external treatment using SST.The overall response rates at the end of the 2nd and 16th weeks of treatment were evaluated by the number of ears with improvement in hearing loss and earache，and were evaluated by the prevalence of improvement in nasal congestion，runny nose，adenoid hypertrophy （diagnosed by nasal endoscopy），and TCM syndrome.The overall and complete response rates of affected ears at the end of the 2nd，4th，6th，8th，10th，12th，14th and 16th weeks of treatment were recorded.Results　The symptom distribution in the 45 children at the first visit：43（95.6%） with nasal congestion，35（77.8%） with runny nose，25（55.6%） with hearing loss，and 14（31.1%） with earache.Among the 64 ears，there were 38 ears with hearing loss and 26 ears without；21 ears with earache and 43 ears.There were 2 without nasal congestion，4 with mild nasal congestion，28 with moderate nasal congestion，and 11 with severe nasal congestion.35 had runny nose and 10 did not.39 had adenoid hypertrophy （including 32 diagnosed by nasal endoscopy）：4 with grade 2，15 with grade 3，and 13 with grade 4.20 had a syndrome of pathogenic wind attacking the superficies，and 25 had pathogenic toxin retention.The overall response rates were 46.9%（30/64）and 93.8%（60/64）at the end of the 2nd and 16th weeks of treatment，respectively.The overall response rate of affected ears with hearing loss and earache was lower than those without at the end of the 2nd week of treatment （P<0.05），whereas the intergroup difference became insignificant at the end of the 16th week of treatment （P>0.05）.The overall response rate did not differ significantly by the prevalence of nasal congestion，runny nose and adenoid hypertrophy at the end of the 2nd and 16th weeks of treatment （P>0.05）.Those with pathogenic wind attacking the superficies showed higher overall response rate than those with pathogenic toxin retention at the end of the 2nd week of treatment （P<0.05），but the intergroup difference became insignificant at the end of the 16th week of treatment （P>0.05）.The overall response rate of affected ears increased with the prolongation of treatment time（χ2trend=5.307，P<0.05），so did the complete response rate（χ2trend=6.583，P<0.05）.Conclusion　External treatment of OME in children using TCM syndrome-based SST has been proved to have a good therapeutic effect.Its short-term efficacy may be even more significant in those without hearing loss and earache or those with a syndrome of pathogenic wind attacking the superficies.On the whole，the therapeutic effect of this therapy may increase with time，so the long-term efficacy may also be good.So this therapy is worthy of clinical use.

Key words: Otitis media with effusion；Sun's sequential therapy；External therapies；Drugs, Chinese herbal；Pathological conditions, signs and symptoms；Treatment outcome

摘要： 背景　分泌性中耳炎（OME）作为一种自限性疾病，常见于儿童，并常与腺样体肥大伴随发生，可有听力下降、耳痛、鼻塞、流涕等症状表现。中医鼻病序贯疗法（SST）外治法采用熏鼻与点鼻的方式，可以避免口服汤药给患儿造成的困扰，但目前尚无SST外治法对不同症状表现、腺样体肥大、中医辨证分型（简称证型）的OME患儿疗效的研究。目的　探究SST外治法辨证治疗不同症状表现、腺样体肥大、证型OME患儿的疗效。方法　选取2018年9月—2019年12月于中国中医科学院广安门医院耳鼻喉科门诊就诊的以鼻部或耳部不适为主诉的符合研究标准的患儿45例（64耳）为研究对象。收集患儿初次就诊时症状，包括听力下降、耳痛、鼻塞、流涕等。患儿均采用SST外治法（包括熏鼻和点鼻）辨证治疗。以耳为单位，比较不同听力下降情况、耳痛情况患耳SST外治法辨证治疗第2、16周总有效率。以人为单位，比较不同鼻塞情况、流涕情况、腺样体肥大情况（分析经鼻内镜确诊者）、证型患儿SST外治法辨证治疗第2、16周总有效率。记录SST外治法辨证治疗第2、4、6、8、10、12、14、16周患耳总有效率及痊愈率。结果　45例患儿初次就诊时症状分布：鼻塞43例（95.6%）、流涕35例（77.8%）、听力下降25例（55.6%）、耳痛14例（31.1%）。64耳中，有听力下降38耳，无听力下降26耳；有耳痛21耳，无耳痛43耳。45例患儿中无鼻塞2例，轻度鼻塞4例，中度鼻塞28例，重度鼻塞11例；有流涕35例，无流涕10例；腺样体肥大39例（经鼻内镜确诊者32例）：2度4例，3度15例，4度13例；将患儿按证型分组，可分为风邪外袭证20例，邪毒滞留证25例。SST外治法辨证治疗第2周患耳治疗总有效率为46.9%（30/64）；治疗第16周总有效率为93.8%（60/64）。无听力下降、无耳痛患耳SST外治法辨证治疗第2周总有效率分别高于有听力下降、有耳痛患耳（P<0.05）；不同听力下降、耳痛情况患耳SST外治法辨证治疗第16周总有效率比较，差异无统计学意义（P>0.05）。不同鼻塞、流涕、腺样体肥大情况患儿SST外治法辨证治疗第2、16周总有效率比较，差异无统计学意义（P>0.05）。证型属风邪外袭证的患儿SST外治法辨证治疗第2周总有效率高于证型属邪毒滞留证的患儿（P<0.05）；不同证型患儿SST外治法辨证治疗第16周总有效率比较，差异无统计学意义（P>0.05）。患耳总有效率、痊愈率随SST外治法辨证治疗时间推移而增高（χ2趋势值分别为5.307、6.583，P<0.05）。结论　SST外治法对OME有较好的疗效，尤其对无听力下降、无耳痛及风邪外袭证型的OME短期疗效显著；且SST外治法辨证治疗OME的疗效随时间推移而增强，因此长期疗效较佳，值得临床使用。

关键词: 伴渗出液中耳炎；中医鼻病序贯疗法；外治法；中草药；病理状态, 体征和症状；治疗结果