Daya guna klinis membran amnion sebagai bahan Bridge pada penutupan perforasi membran timpani permanen secara konservatif
HARTANTO, Dony, dr. Soepomo Soekardono, Sp.THT
2004 | Tesis | PPDS I Ilmu Penyakit Telinga Hidung TenggorokLatar belakang: Perforasi membran timpani permanen adalah suatu lubang pada membran timpani yang tidak dapat menutup secara spontan dalam waktu 3 bulan setelah perforasi. Upaya penutupan perforasi membran timpani permanen secara konservatif masih diperlukan oleh karena terapi secara operatif memerlukan peralatan yang tidak selalu tersedia di rumah sakit kabupaten atau kota dan memerlukan biaya yang tidak sedikit. Keberhasilan metode konservatif penutupan perforasi membran timpani permanen dengan aplikasi asam hialuronat 1% dan kertas rokok sebagai bahan bridge masih rendah (59,3%). Oleh karena itu diperlukan penyempurnaan metode untuk mendapatkan hasil yang lebih baik. Membran amnion dipilih sebagai bahan bridge, karena merupakan bahan biologis yang mengandung matriks ekstraseluler dan faktor pertumbuhan yang diperlukan pada proses penyembuhan luka Tujuan penelitian: Menentukan daya guna klinis myringo-bridge membran amnion ditambah asam hialuronat 1% dibandingkan dengan metode myringo-bridge kertas rokok ditambah asam hialuronat 1% pada penutupan perforasi membran timpani permanen akibat otitis media supuratif kronik benigna secara konservatif. Manfaat penelitian: sebagai bahan asupan untuk upaya penutupan perforasi membran timpani permanen secara konservatif. Metode penelitian: Uji klinis acak buta ganda terkendali. Tempat dan waktu: Poliklinik THT RS. Dr. Sardjito, Yogyakarta pada kurun waktu Juni 2003 – September 2004. Bahan dan cara: Subyek yang memenuhi kriteria inklusi dan eksklusi 76 orang, secara acak terbagi menjadi dua kelompok dengan tiap kelompok terdiri dari 38 orang, yaitu kelompok myringo-bridge membran amnion dan kelompok myringo-bridge kertas rokok. Randomisasi dikerjakan dengan menggunakan sistem blok. Setelah dilakukan pembuatan luka baru tepi perforasi dan aplikasi asam hialuronat 1%, perforasi ditutup dengan bahan bridge. Evaluasi dilakukan satu kali seminggu sampai dua bulan. Luaran utama yang diukur ialah hasil terapi, yaitu perforasi membran timpani menutup atau tidak, sedangkan luaran sekunder berupa perbaikan ambang pendengaran, efek samping dan cost efficacy pada akhir penelitian. Analisis statistik: Menggunakan X², X² Mantel- Haenszel, uji pasti Fisher, regresi logistik dan marginal cost efficacy. Hasil: Dari 76 subyek yang terbagi atas dua kelompok, masing-masing terdiri dari 38 subyek dengan kasus drop out dua subyek pada tiap kelompok sehingga didapatkan 36 subyek pada tiap kelompok. Keberha silan penutupan perforasi membran timpani pada kelompok membran amnion sebanyak 27 subyek (75%) dan pada kelompok kertas rokok sebanyak 18 subyek (50%). Perbedaan ini secara statistik bermakna dengan nilai p=0,028; RR: 3,0; IK 95%: 1,106-8,138. Kesimpulan: Myringo-bridge membran amnion ditambah asam hialuronat 1% lebih berdaya guna dibandingkan myringo-bridge kertas rokok ditambah asam hialuronat 1%.
Background: Chronic or permanent tympanic membrane (TM) perforations are a common problem in otology. Perforation most commonly arises as a result of either otitis media or trauma, usually presenting clinically with conductive hearing lost and chronic infection. Permanent or chronic perforation of TM is a hole or defect in TM that cannot closed spontaneously in three months after perforation. The current repair techniques (tympanoplasty) are highly successful, but require a large capital investment and highly specialized training. There is an obvious interest in developing noninvasive (conservative), less expensive methods of addressing this problem. The efficacy from the previous study with 1% hyaluronic acid and cigarettes paper as a bridge was still low (59,3%). Amniotic membrane was selected as a bridge on conservative method, because this biological material contains of extracellular matrix component and growth factor which needed in wound healing. Objectives: This study was done to determine the clinical efficacy of amniotic membrane with 1% hyaluronic acid as a conservative method on closing the permanent perforation of TM caused by benign type chronic supurative middle ear otitis. Advantage: It can be used as conservative method on closing TM perforation. Study design: Randomized double blind controlled trial (RCT). Setting: ENT Department of Dr. Sardjito Hospital Yogya in June 2003 – September 2004. Material and methods: The subjects, who fulfilled eligible criteria, divided into two groups and each groups contains 38 patients. The first group used amniotic membrane as a bridge and the second group used cigarette paper as a bridge. Randomization was performed in block design. After making a new wound in the edge of the perforation and applicating 1% hyaluronic acid, the perforation close by bridge material. The evaluation was done once a week until two months. The main outcome was the result on closing TM, analysed with Chi-square test. The secondary outcome was the hearing improvement and duration on closing TM, analysed with t-test. Adverse reaction analysed with Chi-square test. Several factors which could influence the results analysed with X² Mantel-Haenszel and logistic regression. Marginal costefficacy was also used in this study. Result: All of 76 samples were randomly allocated into two groups and each group contain 38 samples. From all samples two from each groups or 4 samples (6,6%) were drop out. There were 75% success rate (27 samples) on closure of TM using amniotic membrane as a bridge and the control group using cigarette paper as a bridge were 50% success rate (18 samples). This difference was statistically significant (p value: 0,028; RR: 3,0 with 95% CI: 1,106-8,138). Conclusion: Myringo-bridge with amniotic membrane and 1% hyaluronic acid were more efficacy than myringo-bridge with cigarette paper and 1% hyaluronic acid.
Kata Kunci : Perforasi Membran Timpani Permanen,Terapi Konservatif,Membran Amnion, Efficacy, conservative therapy, permanent perforation of tympanic membrane, dry amniotic membrane
