مروری بر درمان ترکیبی با دوز ثابت برای پیشگیری ثانویه از حوادث نامطلوب قلبی- عروقی و نتایج اولیه‌ی کارآزمایی بالینی تصادفی شده‌ی PersianPolypill

نوع مقاله : مقاله مروری

نویسندگان

1 استاد، مرکز تحقیقات بازتوانی قلب، پژوهشکده‌ی قلب و عروق، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

2 پزشک متخصص، مرکز تحقیقات بازتوانی قلب، پژوهشکده‌ی قلب و عروق، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

3 داروساز، پژوهشکده‌ی بیماری‌های گوارشی، دانشگاه علوم پزشکی تهران، تهران، ایران

4 استاد، مرکز تحقیقات قلب و عروق اصفهان، پژوهشکده‌ی قلب و عروق، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

5 استاد، مرکز تحقیقات مدیریت و اقتصاد سلامت، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

6 دانشیار، مرکز تحقیقات نارسایی قلبی، پژوهشکده‌ی قلب و عروق، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

7 پزشک، مرکز تحقیقات بازتوانی قلب، پژوهشکده‌ی قلب و عروق، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

8 استادیار، گروه طب فیزیکی و توانبخشی، دانشکده‌ی پزشکی و مرکز تحقیقات بازتوانی قلب، پژوهشکده‌ی قلب و عروق، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران

چکیده

مقاله مروری




مقدمه: این مقاله به روزرسانی مرور قبلی ما بر مطالعات بالینی درمورد نقش polypill (درمان ترکیبی با دوز ثابت) در پیشگیری ثانویه از بیماری‌های قلبی- عروقی (Cardiovascular diseases) CVD و همچنین ارائه‌ی نتایج اولیه‌ی مطالعه‌ی PersianPolypill می‌باشد.
روش‌ها: PersianPolypill یک کارآزمایی بالینی با دو بازوی موازی بر روی بیماران بستری در بیمارستان به دلیل انفارکتوس حاد میوکارد (Acute myocardial infarction) AMI می‌باشد. برنامه‌ریزی شده است که 1100 بیمار به صورت تصادفی در یکی از دو بازو وارد شده و با دریافت polypill یا مراقبت‌های معمول، به مدت 34 ماه پیگیری شوند. پیامد اولیه، یک نتیجه‌ی بالینی ترکیبی از حوادث نامطلوب قلبی- عروقی (Major adverse cardiovascular events) MACE و پیامد ثانویه، هزینه- اثربخشی درمان با polypill خواهد بود.
یافته‌ها: ما 10 مطالعه‌ی تکمیل ‌شده و دو مطالعه‌ی بالینی در حال انجام را شناسایی کردیم که حداقل 10 درصد از شرکت‌کنندگان آن‌ها مبتلا به CVD بودند. ارزیابی این مطالعات، فقدان تحقیقات در کشورهای با درآمد کم و متوسط در مورد نقش polypill در پیشگیری ثانویه CVD و اطلاعات محدود درمورد هزینه- اثربخشی منتج از کارآزمایی‌های بالینی را نشان داد. در کارآزمایی PersianPolypill تاکنون 624 بیمار بستری در سه بیمارستان بدلیل AMI وارد مطالعه شده‌اند. میانگین سنی بیماران
8/7 ± 60/9 و 506 نفر مرد (81/1 درصد) هستند. در مجموع 94/4 درصد از بیماران در بیمارستان تحت مداخله اولیه عروق کرونر از راه پوست قرار گرفتند و 26/3 درصد دچار عوارض بیمارستانی شدند.
نتیجه‌گیری: نتایج نهایی این مطالعه می‌تواند خلاء موجود در مطالعات انجام شده را پوشش دهد و تأییدی بر نقش polypill در مدیریت ابتدایی AMI و پیشگیری ثانویه درازمدت در این بیماران باشد.

تازه های تحقیق

معصومه صادقی: Google Scholar

شروین غفاری حسینی: Google Scholar

کلیدواژه‌ها

موضوعات

عنوان مقاله [English]

A Review of Fixed-Dose Combination Therapy for Secondary Prevention of Adverse Cardiovascular Events and the Preliminary Results of the Persianpolypill Randomized Clinical Trial

نویسندگان [English]

  • Masoumeh Sadeghi 1
  • Hamidreza Roohafza 2
  • Alireza Nateghi 3
  • Nizal Sarrafzadegan 4
  • Marjan Mansourian 5
  • Jamshid Najafian 6
  • Fatemeh Bostan 7
  • Shervin Ghaffari Hoseini 8
1 Professor, Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
2 MD, Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
3 Pharmacist, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
4 Professor, Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
5 Professor, Health Management and Economics Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
6 Associate Professor, Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
7 MD, Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
8 Assistant Professor, Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
چکیده [English]

Background: This article is an update on our previous review of clinical studies on the role of polypills in the secondary prevention of cardiovascular diseases (CVD). We also present the preliminary results of the Persian Polypill study.
Methods: Persian Polypill is a randomized clinical trial with two parallel arms on hospitalized patients due to acute myocardial infarction (AMI). It is planned that 1100 patients will be randomly assigned to one of the two arms of Polypill or usual care and will be followed up for 34 months. The primary outcome will be a composite clinical outcome of major adverse cardiovascular events (MACE), and the secondary outcome will be the cost-effectiveness of polypill treatment.
Findings: We identified ten completed studies and two ongoing trials in which at least 10% of participants had CVD. The evaluation of these studies showed the lack of research in low- and middle-income countries about the role of polypill in secondary prevention of CVD and limited information about cost-effectiveness resulting from clinical trials. In Persian Polypill, so far, 624 patients admitted to three hospitals due to AMI have been included in the study. The average age of patients is 60.9 ± 8.7 and 506 are male (81.1%). Overall, 94.4% of the patients underwent percutaneous coronary intervention in the hospital, and 26.3% had hospital complications.
Conclusion: The final results of this study can compensate for the gap in the past studies. They may confirm the role of polypill in the initial management of AMI and long-term secondary prevention in these patients.

کلیدواژه‌ها [English]

  • Myocardial infarction
  • Cardiovascular diseases
  • Drug combinations
  • Cost-Effectiveness analysis
  • Secondary prevention

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مجله دانشکده پزشکی اصفهان
دوره 42، شماره 771
هفته 3 مرداد
مرداد و شهریور 1403
صفحه 497-510

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سابقه مقاله

  • تاریخ دریافت: 16 خرداد 1403
  • تاریخ پذیرش: 17 شهریور 1403

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