JOURNAL READING

Khasiat Klinis dari Mikrobioma Bakteri Asam La

ktat Topikal
Rhinosinusitis Kronis: randomised control trial

Pembimbing :
dr. Ardhian Noor Wicaksono Sp. THT-KL

Disusun oleh :
Erna Wati
406181037
 Journal Identity
Title Clinical Efficacy of a Topical Lactic Acid Bacterial Microbiome
in
Chronic Rhinosinusitis: A Randomized Controlled Trial
Written By Anders Ma°rtensson, MD ; Milad Abolhalaj, MSc; Malin Lindst
edt, PhD; Anette Ma°rtensson, MSc;
Tobias C. Olofsson, PhD; Alejandra Vasquez, PhD; Lennart G
reiff, MD, PhD; Anders Cervin, MD, PhD
Published By Wiley Periodicals, Inc. on behalf of The Triological Society
Introduction
•Rinosinusitis kronis\berulang (CRS)  penyakit terkait gangguan kualitas hidup.
•Kadang-kadang dikaitkan  asma, alergi, atau poliposis hidung, banyak kasus
penyebab tidak jelas.

•Studi terbaru, bakteri komensal mengkolonisasi rongga hidung dan paranasal

individu sehat  ketika kerusakan mikroba komersal, oleh patogen atau
antibiotik  ketidakseimbangan & CRS
• menghilangkan patogen tanpa merusak microbiome komensal  probiotik
bakteri asam laktat (BAL)
Introduction
•BAL, mikroba dari madu Apis mellifera
•Dosis tunggal ditoleransi dengan baik dan tidak mempengaruhi bakteri komensal
atau menghasilkan respon peradangan
•sitokin tipe-1 dalam lavage hidung interleukin-1ß (IL-1ß), interferon-a (IFN-a),
interleukin-6 (IL-6), inflamasi makrofag protein (MIP-1a), interferon-c (IFN-c), dan
faktor nekrosis tumor-a (TNF-a).

•LAB honeybee  antimikroba kuat terhadap bakteri yang terkait dengan CRS
• Dalam penelitian ini, pemberian berulang honeybee BAL ke rongga hidung
selama 2 minggu  memengaruhi gejala
dari kondisi  dinilai oleh kuesioner (SNOT-22).
•hidung lavage\analisis sitokin / mediator pilihan.
 Materials and Methods
Patients
21 ps yang menderita CRSsNP usi
a 21-80 thn (rata-rata 58) direkrut (
10 wanita dan 11 pria).
Kriteria inklusi
1. 2 gejala hidung > 12 mgg, sala
h satunya : sumbatan hidung\di
scharge tidak berwarna,
2. verifikasi penyakit  endoskopi
atau CT sesuai definisi yang dit
entukan dalam pedoman EPOS
2012
Desain Study
randomised clinical controlled tri
al, double-blind, cross over, sh
am-controlled
campuran 9 lactobacilli
& 4 bifidobacteria (LAB) pengobatan topik
al (semprotan hidung) 2 minggu untuk fok
us CRSsNP
Kriteria Ekslusi
1. polip hidung
2. pengobatan antibiotik jangka
waktu 14 hari sebelumnya.
3. Asma dan alergi
01 Kunjungan 1
1. Subjek menyelesaikan Sino-Nasal test (SNOT-22)
2. bedah THT (AM) melakukan pemeriksaan & mengambil sa
mpel dari meatus tengah menggunakan E-Swab (Copan, M
urrieta, CA)  mikrobiologis.
3. Endoskopi serat optik (Storz, Tuttlingen, Jerman)
4. Bilas hidung dilakukan.
5. Diberi 2 botol nasal spray  (ditandai 1 & 2) yang berisi bai
k LAB \sharm solution
6. Diberikan buku harian  catat gejala saluran pernafasan
atas dan bawah,saluran pencernaan, dan gejala lainnya sel
ama 2 mgg

02 Kunjungan 2
1. 14 hari setelah perawatan, buku harian dikumpulkan
2. AM mengulangi pemeriksaan, endoskopi hidung, dan
pengambilan sampel seperti pada kunjungan 1. Bilas
hidung dilakukan.
3. Setelah periode pencucian s4 minggu, pasien
kembali ke klinik
4. Pemeriksaan diulang urutan yang sama  Kunjungan
3
5. Nasal-spray ditukar
 Materials and Methods
Formulasi honeybee BAL
• Terdiri dari 13 spesies: Lactobacillus apinor
um Fhon13N, Lactobacillus mellifer Bin4N,
Lactobacillus mellis Hon2N, Lactobacillus k
imbladii Hma2N, Lactobacillus
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 Materials and Methods
• Intervensi 1:
- Obat oral  suspensi kotrimoksazol (atau tablet untuk anak-anak lebih dari 12 tahun). S
uspensi kotrimoksazol diberikan sebagai 4 mg / kg per dosis (komponen trimethoprim) d
ua kali sehari secara oral selama 16 minggu.
- Plasebo diberikan dengan cara yang identik.

• Intervensi 2:
- Perawatan topikal  aqueous povidone- yodium 10%, diencerkan dalam suhu kamar ya
ng bersih air (1:20). Setiap telinga yang keluar disuntik dua kali menggunakan jarum sun
tik 20ml hingga 16 minggu atau sampai telinga kering selama 14 hari
- (dikonfirmasi pada dua pemeriksaan klinis 1 minggu terpisah oleh staf studi atau klinik).
 Result
Ukuran hasil utama  proporsi anak-anak dengan kegagalan klinis setelah 16 minggu (4 bul
n) pengobatan.
• Kegagalan klinis ditentukan secara klinis pemeriksaan untuk mengetahui adanya kotora
n telinga.
 Results
Ukuran hasil sekunder tambahan pada 4 bulan dan 12 bulan termasuk:
i) tingkat pendengaran, ditentukan oleh audiometri (dilakukan oleh audiolog terlatih) dan di
ringkas sebagai nada murni 4 frekuensi rata-rata tingkat pendengaran pada 500, 1000, 2
000 dan 4000 Hz di telinga pendengaran lebih baik dan lebih buruk;
ii) ikegagalan untuk meningkatkan (ditentukan oleh ukuran perforasi dan jumlah debit);
iii) perubahan ukuran dan jumlah perforasi debit (ditentukan oleh perbandingan standar pen
ilaian pada awal dengan akhir studi)
iv) waktu untuk penghentian pemecatan (ditentukan oleh ulasan kesehatan catatan)
v) kepatuhan terhadap manajemen yang direkomendasikan termasuk kehadiran untuk tinja
uan spesialis (ditentukan dengan meninjau catatan kesehatan)
vi) kehadiran yang diakui bakteri patogen dalam pengeluaran hidung dan telinga
(ditentukan oleh budaya mikrobiologis standar dan metode sensitivitas antimikroba);
vii) komplikasi (Didefinisikan sebagai pengembangan penyakit terkait yang membutuhkan
perawatan medis tambahan)
viii) efek samping (didefinisikan sebagai perkembangan penyakit yang membutuhkan pengh
entian perawatan yang ditentukan).
 Discussion
• Uji coba ini akan mengevaluasi efektivitas keduanya
perawatan tambahan selain perawatan standar
dan melaporkan klinis, mikrobiologis, dan hasil pendengaran.
• Hasil uji coba ini akan menjadi bukti terbaik untuk perawatan medis anak-an
ak Pribumi dengan OMSK.
• Hasil dari penelitian ini akan disebarluaskan kepada peserta, komunitas mer
eka dan semua kepentingan secara langsung (jika memungkinkan) dan den
gan publikasi.
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