KBB-Forum 2005 , Cilt 4 , Sayı 4

EFÜZYONLU OTİTİS MEDİA TEDAVİSİNDE OTOİNFLASYONUN UZUN DÖNEM ETKİSİ

İbrahim ERCAN, MD1; Burak Ömür, CAKİR, MD1; Semra KAYAOĞLU, MD2; Suat TURGUT, MD1
1Kulak Burun Boğaz- Baş Boyun Cerrahisi Kliniği, Şişli Etfal Eğitim ve Araştırma Hastanesi, İstanbul, Türkiye
2Çocuk Kliniğine Bağlı Aile Hekimliği, Şişli Etfal Eğitim ve Araştırma Hastanesi, İstanbul, Türkiye

Özet

Amaç: Bu çalışmanın amacı, efüzyonlu kronik otitis mediada (EKOM) otoinflasyonun ventilasyon tüpü takılması gerekliliğini azaltma üzerine uzun dönem etkisinin değerlendirilmesidir.

Yöntem ve gereçler: EKOM tanısı almış 60 çocuğun 93 kulağı iki gruba ayrılmıştır: Grup 1 (otoinflasyon) 6 hafta boyunca günde 3 kez otoinflasyonla (Otovent®) ve burun salin lavajı yapılarak tedavi edilmiş, grup 2 (kontrol) 6 hafta boyunca sadece burun salin lavajı yapılarak tedavi edilmiştir. EKOM tanısından önce tüm hastalar antibiotik (amoksisilin 3 hafta boyunca), antihistaminik (alerjisi olan hastalarda) ve burun salin lavajı reçetelendi. Her iki grup 9 ay boyunca ventilasyon tüpü takılması gerekliliği, efüzyonun düzelmesi ve efüzyonun tekrarlaması bakımından takip edilmiştir.

Bulgular: Dokuz aylık takip boyunca, otoinflasyon grubunda 48 kulaktan 20 kulağa (%42) ventilasyon tüpü takılması gerekti, 22 kulak (%46) tamamen iyileşti ve 6 kulak (%12) ise takipten çıktı. Kontrol grubunda ise 45 kulaktan 30 kulağa (%67) ventilasyon tüpü takılması gerekti, 8 kulak (%17.7) tamamen iyileşti, 6 kulak (%12) takipten çıktı ve tüp takılmasını kabul etmeyen hastanın 2 kulağında ise halen efüzyonlu kronik otitis media mevcuttu.

Sonuç: Otoinflasyon kısa dönemde olduğu gibi uzun dönemdede ventilasyon tüp takılması gerekliliğini azaltmaktadır. Çocuklar, hastalığın tekrarlama riskinin devam ettiği dönem boyunca takip edilmelidir.

Giriş

It is well established that impaired middle ear ventilation plays an important role in the pathogenesis of COME, where the persistent negative pressure induces metaplasia of the middle ear mucosa with goblet cell formation and subsequently effusion in the tympanic cavity [1]. It is also seen clinically that if middle ear ventilation is restored the mucosa becomes normal and the effusion clears. Most adults can easily ventilate the middle ear by performing Valsalva maneuver but for the children this maneuver is difficult to learn and it is almost impossible to control that the maneuver is made effectively. Since Politzer in 1863 [2] devised his own method for active inflation of the middle ear, several studies have been published showing beneficial effect of autoinflation in the treatment of secretory otitis media [3-9]. Hunt-Williams [4] in 1968 introduced a method for middle ear ventilation for children. The children inflate carnival-blower through the nose with or without a balloon. Stangerup et al. [7] in 1992 published a randomized controlled study of children aged 3 to 10 years suffering from Eustachian tube dysfunction or secretory otitis media. One group swas randomized to autoinflation, using a nose-piece mounted with a balloon, the other group was observed without treatment for two weeks. The nasal balloon inflation could improve or normalize the middle ear pressure in 82% of the ears with negative middle ear pressure and in 52% of the ears with effusion. In 1993 Blanshard et al. [8] evaluated the same autoinflation technique in children recruited from the waiting list for grommet insertion. Sixty-eight percent of children with high compliance autoinflation had no effusion after 2 weeks and 42% after 3 months.

All studies examined the short term effect of the autoinflation. The aim of the study was to evaluate the long-term effect of autoinflation on reducing the need for insertion of ventilation tube in COME.

Yöntem ve Gereçler

During the two years period (between January 2002 and April 2004), 60 patients (93 ears) who were diagnosed as COME were included in the study. Thirty-two were male and 28 were female. The mean age was 6.2 years (range 4 to 10 years).

Patients who were admitted to our clinic with middle ear effusion (MEE) and free of sign of otitis media at least 4 weeks period (earach, ear discharge etc) were selected as pre-study group. Children were excluded from entry when they had any of the following conditions: hypersensitivity or significant adverse reactions to penicillins; previous tonsillectomy and/or adenoidectomy; previous ear surgery other than tympanocentesis or myringotomy with or without tube insertion; history of seizure disorder, diabetes mellitus, asthma requiring daily medication, or any health condition that could make entry potentially dangerous; medical conditions with a predisposition for MEE, such as cleft palate, Down syndrome, congenital malformations of the ear, cholesteatoma, or chronic mastoiditis; severe retraction pockets; acute or chronic diffuse external otitis; perforation of the tympanic membrane; intracranial or intratemporal complications of MEE; upper respiratory obstruction attributable to tonsil or adenoid enlargement or both with cor pulmonale, sleep apnea, or severe dysphagia; history of varicella exposure within the previous 30 days (if never had clinical varicella or varicella vaccine) or clinical varicella in the previous 3 weeks; history of measles exposure in the previous 30 days; or immunization in the previous 30 days. This group was followed 3 months and the patients who had new otitis media attack in this period were excluded from the study group. In this 3 months period all the patients were medicated with antibiotic (amoxicillin for 3 weeks), antihistamines (in case with allergy), and nasal saline irrigation.

Diagnosis of COME was established by the typical appearance (fluid level or air bubles in middle ear, white opacification in the tympanic membrane, vascularization of the tympanic membrane without erythema, lack of mobility of the tympanic membrane in ventilation of the external ear canal, etc) of the tympanic membrane at the pneumatic otoscopic examination and type B tympanogram at the end of the 3 months follow-up. The details of the study were described to the child’s parent(s) and informed consent for the child to participate in the study was obtained.

The patients were randomly divided into two groups: Group 1 (autoinflation); treated with autoinflation three times a day for 6 weeks (Otovent®), with nasal saline irrigation 3 times a day for 6 weeks, and group 2 (control); treated with only nasal saline irrigation 3 times a day for 6 weeks.

The autoinflation group consisted of 30 patients (48 ears, 12 unilateral and 18 bilateral) who could inflate the nasal balloon. The children were instructed to perform autoinflation three times a day for 6 weeks. In case of upper respiratory tract infection the patient was advised not to autoinflate.

The control group consisted of 30 patients (45 ears, 15 unilateral and 15 bilateral). The children were treated with only nasal saline irrigation for 6 weeks.

The patients in both groups were examined with pneumatic otoscopy and tympanogram once every two weeks for the first two months and then once a month for 7 months. Examinations were recorded at 6th week, 3rd, 6th, and 9th month. Distributions of age and sex of these groups were similar. Chi-square test was used for the statistical analysis.

Technique of otovent use:
1. The balloon is attached to the nose-piece.
2. The ball-shaped end of the tube is held airtight to one nostril, the opposite nostril is compressed with a finger and with the mouth closed the balloon is inflated through the nose to the size of an orange (Figure 1).


Büyütmek İçin Tıklayın
Figure 1: Application of otovent® to the nose.

Bulgular

Follow-up of the progress of the autoinflation and of the control group over the period of 6 weeks, 3 months, 6 months and 9 months were shown in table 1 and 2. Tympanic membrane perforation due to autoinflation was not observed. The compliance of the children to the autoinflation was satisfactory and the autoinflation was somehow amusing for the children.

Eleven children who had upper respiratory tract infection ceased the autoinflation for 5 days but autoinflation treatment was completed to 6 weeks. In this period patients did not have acute otitis media.

Recovery rates of effusions in both groups in the 6th week, 3rd month, 6th month, and 9th month follow-up were shown in table 3. Except for the 3rd month autoinflation group has statistically significant (p<0.05) better recovery rates than the control group. In the 3rd month there was no statistically significant difference (p>0.05). Insertion of ventilation tube in both groups in the 3rd month, 6th month, and 9th month follow-up was shown in Table 4. In control group there was a statistically significant need for insertion of ventilation tube according to autoinflation group (p<0.05).

Autoinflation group:
In the 6th week of treatment, effusion had cleared in 27 out of 48 ears (56%). At the last control (in the 9th month) 4 ears were lost at follow-up and 22 out of 42 ears (52%) were effusion free. A total of 20 (in 18 ears after 3 months and in 2 ears after 6 months) out of 48 ears (42%) required ventilation tubes due to lack of improvement (Table 1 and 3).

Table 1: Progress of effusion in autoinflation group at the 6th week, 3rd month, 6th month, and 9th month.

Table 2: Progress of effusion in patients in control group at the 6th week, 3rd month, 6th month, and 9th month.

Table 3: Recovery rates of effusion in both groups in the 6th week, 3rd month, 6th month, and 9th month follow-up.

Table 4: Required ventilation tube in both groups in the 3rd month, 6th month, and 9th month. Control group:
In the 6th week of treatment, effusion had cleared in 14 out of 45 ears (31%). At the last control (in the 9th month); 3 ears were lost at follow-up, 8 of 40 ears (20%) were effusion free, and 2 ears of 1 patient who regretted the insertion of ventilation tube had still COME. A total of 30 (in 28 ears after 3 months and in 2 ears after 9 months) out of 45 ears (67%) required ventilation tubes due to lack of improvement (Table 2 and 3).

Tartışma

COME is one of the most common medical problems during childhood [10]. It is reported that more than 3.5 Billion dollars are spent annually for treatment of COME in the U.S.A [11]. Untreated, it may predispose acute otitis media [12], chronic otitis media and cholesteatoma [10]. Although the mechanical obstruction of the Eustachian tube is suggested to play a role in the etiology of COME, Bluestone and Beery [13] reported that the functional dysfunction of Eustachian tube as being the most common cause of Eustachian tube dysfunction in children. The inability of opening of the Eustachian tube results in negative middle ear pressure. Persistent tubal obstruction causes middle ear effusion in some children. According to suction-insufflation theory, positive nasopharynx pressure, which acts synergistically to negative middle ear pressure, provides an opening of the Eustachian tube to balance the changes of negative pressure in the middle ear [11]. Increasing positive pressure in the nasopharynx, which is obtained when inflating Otovent, may help a passive opening of the Eustachian tube. Schwartz et al. [6] reported that COME could be treated, and middle ear pressure could return to normal, with home politzerization. Stangerup et al. [7] showed the efficacy of autoinflation treatment of COME, where 52% was cleared of the effusion after two weeks of autoinflation.

In our study, with respect to the need for ventilation tubes during the follow up for 3, 6, and 9 months, it is apparent that the autoinflation group required significantly (p< 0.05) fewer ventilation tubes than the control group (Table 4).

There are 3 studies in the literature [14-16] indicating the bad effect or the lack of effect of autoinflation. Reidpath et al. [17] analyzed the studies on autoinflation and reported that the major drawback was the short term follow-up period. They also commented that although the use of autoinflation in the case of glue ear is conflicting, some benefits may be acknowledged. However, they also reported that larger and long term trials are needed for autoinflation to be considered for clinical practise.

There is also an argument that COME recurs even after a successful autoinflation treatment [7,13]. However in our study the long term follow-up of spontaneous recoveries and spontaneous deteriorations were observed to be similar in both groups. In 9 months follow-up 7 ears (26%) which are healed after 6 weeks autoinflation treatment deteriorated to COME whereas 7 ears (33.3%) with no improvement at the end of the 6 weeks autoinflation treatment spontaneously healed in group 1. On the other hand, in group 2, in 9 months follow-up 7 ears (50%) which are spontaneously healed after 6 weeks nasal saline irrigation deteriorated to COME whereas 6 ears (19.3%) with no improvement at the end of the 6 weeks spontaneously healed. Thus, we concluded that in long term follow-up there is no increased recurrence risk of COME after the autoinflation treatment. The risk involved is as much as it is found to be in the control group.

The role of elasticity of the tympanic membrane and gas exchange on the balance of middle ear pressure is known [18]. It is apparent that the mechanical opening of the Eustachian tube with Otovent cannot solve the problem in all patients with COME. If the Eustachian tube pathology is the major problem, autoinflation seems beneficial. It is suggested that a middle ear pressure of -200 mm H2O can not remain for a long time without development of transudation. Chronic Eustachian tube dysfunction, without the development of COME, causing a long lasting negative middle ear pressure, can cause loss of elastic fibers of the tympanic membrane, and as a result, can lead to the development of retraction, atelectasis and cholesteatoma.

Otovent® makes home politzerization fun for the child and contributes to the therapy. With more common use of Otovent on patients with COME and Eustachian tube dysfunction, we will have more information about the optimal number and duration of applications during the disease period. To our best of the knowledge this is the first study evaluating the long term effect of autoinflation. We conclude that autoinflation could be added to medical treatment of secretory otitis media and reduce the need for insertion of ventilation tube not only in short term but also in long term as well. The children should be followed as long as they are at risk of recurrence.

Kaynaklar

1) Sade J. Pathology and pathogenesis of serous otitis media. Arch Otolaryngol 1966; 84:297-305 [ Özet ].

2) Politzer A. Disease of ear the ear. Fifth edition, Translated by MJ Ballin & CL Hellerpp. Lea & Fibirger, Philadelphia; 1869. P.145-155, p. 282-302.

3) Gottschalk GH. Serous otitis: Treatment by controlled middle ear inflation. Laryngoscope 1962;90:1372-1379 [ Özet ].

4) Hunt-Williams R. A method for maintaining middle ear ventilation in children. J Laryngol Otol 1968;82:921-926 [ Özet ].

5) Shea JJ. Autoinflation treatment of serous otitis media in children. J Laryngol Otol 1971;85:1254-1258 [ Özet ].

6) Schwartz DM, Schwartz RH, Redfield NP. Treatment of negative middle ear pressure and serous otitis media with Politzer’s technique. An old procedure revisited. Arch Otolaryngol 1978;104:487-490 [ Özet ].

7) Stangerup SE, Sederberg-Olsen J, Balle V. Autoinflation as a treatment of secretory otitis media. Arch Otolaryngol Head Neck Surg 1992;118: 149-152 [ Özet ].

8) Blanshard JD, Maw AR; Bawden R. Conservative treatment of otitis media with effusion by autoinflation of the middle ear. Clin Otolaryngol 1993;18:188-192 [ Özet ].

9) Stangerup SE. Autoinflation: historical highlights and clinical implications. Ear Nose Throat J 1998;77:737-742 [ Özet ].

10) Tos M. Epidemiology and natural history of secretory otitis media. Am J Otol 1984;5:459-62 [ Özet ].

11) Wayoff M, Haracon R, Roulleau G, et al. Surgical treatment of middle ear cholesteatoma. In Pfaltz CR (eds): Advances in Oto-Rhino-Laryngology. Karger Basel. 1987; p.86-9.

12) Stangerup SE, Tos M. The etiological role of acute suppurative otitis media in chronic secretory otitis. Am J Otol 1985;6:126-131 [ Özet ].

13) Bluestone CD, Beery QC. Concept on the pathogenesis of middle ear effusion. Ann Otol Rhinol Laryngol 1976;85: 182-186 [ Özet ].

14) Brooker DS, McNeice A. Autoinflation in the treatment of glue ear in children. Clin Otolaryngol. 1992;17:289-90 [ Özet ].

15) Chan KH, Bluestone CD. Lack of efficacy of middle-ear inflation: treatment of otitis media with effusion in children. Otolaryngol Head Neck Surg. 1989;100:317-23 [ Özet ].

16) Kubba H. Autoinflation for treatment of glue ear. Autoinflation does not produce worthwhile benefit. BMJ. 1999 Aug 7;319(7206):383. [ Özet ].

17) Reidpath D, Glasziou P, Del Mar C. Systematic review of autoinflation for treatment of glue ear in children. BMJ 1999;318:1177-8. [ Özet ].

18) Magnusson B. Retraction type middle ear disease. In Tos M (Eds): Cholesteatoma and Mastoid surgery. Kugler Amsterdam. 1982; p. 454-480.