ایمنی و اثربخشی داروی Ciclesonide در مقایسه با داروهای Fluticasone، Budesonide و Beclomethasone برای درمان بیماری آسم پایدار در ایران (مرور جامع مطالعات)

نوع مقاله : مقاله مروری

نویسندگان

1 کارشناس ارشد، گروه ارزیابی فناوری سلامت، دانشکده‌ی بهداشت، دانشگاه علوم پزشکی تهران، تهران، ایران

2 دانشیار، گروه مدیریت و اقتصاد سلامت، دانشکده‌ی بهداشت، دانشگاه علوم پزشکی تهران، تهران، ایران

3 استادیار، مرکز تحقیقات بهره‌برداری از دانش سلامت، دانشگاه علوم پزشکی تهران، تهران، ایران

4 دانشیار، سازمان غذا و دارو، وزارت بهداشت، درمان و آموزش پزشکی، تهران، ایران

5 دانشیار، گروه کودکان، بیمارستان کودکان مفید، دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران

چکیده

مقدمه: Ciclesonide یک کورتیکو استروئید غیر هالوژنه است که برای درمان آسم پایدار استفاده می‌شود. این مطالعه با هدف مقایسه‌ی ایمنی و اثربخشی این دارو در مقایسه با داروهای رایج مورد استفاده در ایران شامل Fluticasone، Budesonide و Beclometasone برای درمان آسم پایدار انجام شد.روش‌ها: مهم‌ترین بانک‌های اطلاعاتی الکترونیکی پزشکی شاملScopus، Web of science، CINHAL Cochrane، Library و Pubmed در نوامبر 2012 برای یافتن مطالعات RCT (Randomised controlled trial) و مروری منظم با کلید واژه‌های «CIC or Ciclesonide or Alvesco or Pregnenedion» و «Persistent asthma or Asthma» (Title) جستجو شد. در مواردی که نیاز به متاآنالیز بود، از نرم‌افزار Review manager استفاده شد.یافته‌ها: در ابتدا 567 مطالعه وارد گردید که در نهایت بعد از حذف موارد تکراری، 18 RCT و 5 مطالعه‌ی مروری انتخاب شد. کیفیت زندگی در نسبت دوز 1:1 بهبودی بیشتری در گروه Ciclesonide نسبت به Fluticasone دارد و عارضه‌ی جانبی کاندیازیس دهانی نیز در گروه Ciclesonide کمتر از گروه Fluticasone بود و Ciclesonide در دوز بالا، اثر کمتری بر سرکوب آدرنال داشت. Peak expiratory flow صبح در نسبت دوز 1:1 در داروی Ciclesonide بیشتر از Budesonide بود؛ اما از نظر بالینی اهمیتی نداشت. در متغیرهای حمله‌ی آسمی، رتبه‌ی کنترل آسم و روزهای بدون علامت، تفاوتی مشاهده نشد.نتیجه‌گیری: تفاوت Ciclesonide با Fluticasone در بهبود کیفیت زندگی و کاهش قارچ دهانی می‌باشد. Peak expiratory flow صبح در نسبت دوز 1:1 در داروی Ciclesonide بیشتر از Budesonide می‌باشد که از نظر بالینی اهمیتی ندارد. شواهد کافی در مورد مقایسه‌ی این دارو با Beclomethasone وجود ندارد.

کلیدواژه‌ها

عنوان مقاله [English]

The Effectiveness and Safety of Ciclesonide versus Fluticasone, Budesonide, and Beclomethasone in Treatment of Persistent Asthma: A Comprehensive Review of Literature

نویسندگان [English]

  • Zahra Zali 1
  • Ali Akbari Sari 2
  • Bahareh Yazdizadeh 3
  • Alireza Hosseini 4
  • Seyed Ahmad Tabatabaei 5
1 Department of Health Technology Assessment, School of Health, Tehran University of Medical Sciences, Tehran, Iran
2 Assistant Professor, Department of Health Management and Economics, School of Health, Tehran University of Medical Sciences, Tehran, Iran
3 Assistant Professor, Knowledge Utilization Research Center, Tehran University of Medical Science, Tehran, Iran
4 Associate Professor, Food and Drug Administration, Ministry of Health and Medical Education, Tehran, Iran
5 Associate Professor, Department of Pediatrics, Mofid Children Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
چکیده [English]

Background: Ciclesonide is a lung-activated inhaled corticosteroid that provides effective control of persistent asthma. This study aimed to evaluate the safety and effectiveness of this drug compared to commonly used drugs including fluticasone, budesonide or beclomethasone.Methods: The major medical electronic databases including Scopus, Web of Science, CINHAL, Cochrane Library and PubMed were searched in November 2012.Findings: 567 articles were found. After exclusion of duplicates and irrelevant articles, 11 randomized controlled trials (RCTs) and 5 systematic reviews were included. No significant difference was found between ciclesonide (CIC) with fluticasone propionate (FP), budesonide (BUD) and beclomethasone dipropionate (BDP) in lung function [forced expiratory volume in 1 second (FEV1) and am and pm peak expiratory flow (PEF)], asthma symptoms score, using rescue medicine and asthma exacerbation requiring use of systemic steroids. In addition, no significant difference was found in adverse events such as pharyngitis, rhinitis, upper respiratory infection, and withdrawal from the study due to adverse events or lack of efficacy. The quality of life score favored ciclesonide versus fluticasone. Candidiasis was less frequent with ciclesonide versus fluticasone. Change in the morning PEF between ciclesonide and beclomethasone dipropionate/budesonide was not clinically significant.Conclusion: Ciclesonide and budesonide and beclomethasone gave similar results in safety and effectiveness. Ciclesonide improved the quality of life and reduced the oral candidacies compared to fluticasone. There was limited evidence when comparing ciclesonide with beclometasone.

کلیدواژه‌ها [English]

  • : Safety
  • Effectiveness
  • Ciclesonide
  • Asthma
  • Systematic Review

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مجله دانشکده پزشکی اصفهان
دوره 32، شماره 278 - شماره پیاپی 278
فروردین و اردیبهشت 1393
صفحه 342-358

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  • تاریخ دریافت: 03 خرداد 1392
  • تاریخ بازنگری: 06 اردیبهشت 1403
  • تاریخ پذیرش: 17 فروردین 1401

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