LAPORAN EVIDANCE BASED MEDICINE

(TERAPI)

COMPARISON OF TERBUTALINE AND SALBUTAMOL INHALATION IN CHILDREN

WITH MILD OR MODARETE ACUT EXACERBATION OF ASTHMA

Disusun oleh :

Annisa Eka Nova Wulandari

NPM : 1102011032

Pembimbing : Dr. Saskia Nassa M. SpM

FAKULTAS KEDOKTERAN UNIVERSITAS YARSI

JAKARTA

TAHUN AJARAN 2013-2014TUGAS EVIDANCE BASED MEDICINE

SKENARIO

Ny. S datang ke klinik bersama anak laki-laki bernama AZ yang berusia 8 tahun dengan keluhan sesak napas. Keluhan ini dirasakan ananknya sejak kemarin siang setelah pulang sekolah, sebelum nya anak tersebut sedang mengikuti pelajaran olahraga dilapangan.

Saat anamnesis ibu pasien menyatakan pasien memiliki penyakit asma sejak kecil. Setelah di lakukan pemeriksaan fisik pada anak didapatkan napas 30x/menit, HR 115x/menit, keadaan anak lemas dan saat auskultasi mengik terdengar saat ekspirasi.

Dokter mendiagnosis pasien mengalami kekambuhan asma dan akan memberikan obat terbutaline inhalasi. Tapi ibu pasien mengatakan dokter sebelum nya sering memberikan obat salbutamol dan setelah memakai obat tersebut anak nya sering mengeluh tangan dan kaki nya gemetar. Ibu pasien menanyakan apakah obat terbutaline tidak memberikan efek samping gemetar juga?

FOREGROUND QUESTIONApakah obat terbutaline inhalasi memberikan kemungkinan efek samping tremor yang lebih kecil dibandingkan salbutamol inhalasi?

PICO

Population : Anak laki-laki 8 tahun dengan serangan asma akutIntervention : TerbutalineComparison : SalbutamolOutcome : Membandingkan efek samping tremor pada salbutamol dan terbutalin

HASIL BUKTI PENCARIAN

Website : http://web.b.ebscohost.com/ehost/search

Keyword :Asthma AND children AND terbutalin AND salbutamol

Hasil : 6

Judul yang ambil :“Comparison Terbutaline and Salbutamol Inhalation in Children with Mild or Moderate Acute Exacerbation of Asthma”

REVIEW JOURNAL

Introduction

Beta-agonist such as salbutamol and terbutaline are widely used in treatment of asthma, particularly in acute exacerbations. In clinical practice, salbutamol is prescribe more frequently than terbutaline. Studies comparing the clinical efficacy and side effect of the two b2-agonist in acute exacerbations are limited and those present give conflicting views.

Methods

The study was conducted in the pediatric chest clinic of a tertiary care hospital in north India. The study subjects were children in the age group of 5-15 years old who presented with a mild or moderate acute exacerbation of asthma. Mild exacerbation was defined by presence of cough and wheezing without any forn of distress, cyanosis, increased respiratory rate , or impairment of activity, ability to speak in between breaths.

Baseline clinical assessment of the child was done by one of the authors after obtaining consent from the parents. This author was unaware of the drug that is going to be administered. The children were then randomized by using a random number table to receive salbutamol or terbutaline.

Result

After drug administration, all the studied variable showed significant improvement within each group. However, there were no statistically significant difference when the two groups were compared with each other (table 2). Percentage PEFR increased by about 13.2% in terbutaline group and 17.03% in salbutamol group ; however this difference was not statistically significant.

Discussion

The authors reported equal efficacy in treatment of acute bronchospasm. The authors also reported similar onset of action for all the drug. Unlike the present study, they used nebulization for administration of the drug. It has been demonstrated that the delivery of the drug by metered dose inhaler with spacer is as effective as that achieved by nebulization.

The other concern has been the side effects. Salbutamol may have a lesser risk of side effects compared with terbutaline because of its greater affinity for B2-receptors than for B1-receptors. However the present study and the other studies did not demonstrated any significant difference between two groups.

We conclude that terbutaline and salbutamol, when administered by MDI with spacer, are equally efficacious in children with mild or moderate acute exacerbation of asthma.

VALIDITY

1. A.) Was the assignment of patient to treatments randomized ?Ya, pada penelitian ini dilakukan randomisasi

B.) Were the group similar at the start of the trial?Ya, kedua group memiliki karakteristik yang sama. Bisa dilihat pada table 1 karakteristik anak yang di obati pada kedua group, seluruh karakteristik nya nilai P value nya tidak ada yang lebih kecil dari 0.05 yang berarti tidak ada prbedaan bermakna

2. A.) Aside from the allocated treatments, were the group treated equally?Tidak ada keterangan mengenai perlakuan diluar treatment yang di berikan.

B.) Were all patients who entered the trial accounted for? – and were they analysed in the groups to which they were randomized?

Ya, semua pasien yang megikuti penelitian ini di perhitungkan karena jumlah yang mengikuti pada awal penelitian dan total jumlah pasien pada tabel outcome (tabel 2) sama

3. Were measures objective or were the patients and clinicians kept “blind” to which treatment was being received?

Ya, dilakukan dengan cara double blind karena pasien tidak mengetahui obat apa yang di dapatkan dan peneliti juga tidak mengetahui jenis obat mana yang di dapat pada masing masing group.

RESULT

1. Berapakah besar efek terapi (CER,EER,ARR,ARI,NNT) ?

Komplikasi Tremor TotalYes NoTerapi Inhalasi Terbutaline (experimental)

3 (a) 28 (b) 31 (a+b)

Terapi Inhalasi Salbutamol (Control)

4 (c) 25 (d) 29 (c+d)

Total 7 53 60

Experimental event rate (EER) = a/ (a+b) = 3/31 = 0.09

Control event rate (CER) = c/ (c+d) = 4/29 = 0.13

Relative Risk (RR) = EER / CER = 0.09/0.13 = 0.69

OR =ad/bc = 75/112 = 0.66

Relative risk reduction (RRR) = CER−EER

CER or 1-RR = 0.31

Absolute risk reduction (ARR) = CER−EER = 0.13 – 0.09 = 0.04

Number needed to treat (NNT) = 1

ARR = 25

2. Berapakah presisi estimasi efek terapi ?

Confidence interval (CI) pada table 2 atau table outcome tertulis 95%

3. Apakah ada kemungkinan penerapan pada pasien (spektrum pasien dan setting) ?

Penerapan pada pasien anak AZ jika dilihat dari usia nya sesuai karena pada penelitian sampel nya berusia 5-15 tahun dan pasien ini berusia 8 tahun

Terapi terbutalin juga tersedia di Indonesia Tetapi dari segi harga terdapat cukup perbedaan yang significant antara

Salbutamol Inhalasi dan Terbutaline Inhalasio Salbutamol Inhaler (Ventholin Inhaler) : Rp. 92.000o Terbutaline Inhaler (Bricasma Inhaler) : Rp. 191.000

4. Apa potensi keuntungan dan kerugian bagi pasien

Bagi pasien ada kemungkinan timbul nya efek samping yang lebih sedikit

Tetapi dari segi biaya yang dikeluarkan lebih besar