البريكابالين مقابل اميتريبتيلين في علاج فيبروميالجيا في المرضى العراقيين : دراسه مقارنه مزدوجه التعميه == Pregabalin Versus Amitriptyline in the Treatment of Fibromyalgia in Iraqi Patients (A Double Blind Comparative Study
Author name:
لمى عيسى حمودي
Supervisor name:
سامي سلمان شهاب | سامي سلمان
General topic:
Medicine
Specific topic:
Medicines and Toxins
Degree:
Master
University:
University of Baghdad - Faculty Of Medicine
Language:
English
University location:
Baghdad
First pages:
19T1589 - p.pdf
Abstract:
فيبروميالغيا (FM) هواضطراب يتميز بالام العضلات الهيكليه على نطاق واسع ،و الم عند الضغط وتصلب المفاصل لمدة اطول من ثلاثة اشهر،يرافقها التعب، واضطرابات النوم والذاكرة والمزاج. يعتبرمرض الفايبرومايلغيا تقليديا غيرالتهابيا الا ان سببه مبهم وعلاجه لا يزال في طور البحث. وقداقترحت البيانات الناشئة مؤخرا دورالاكسدة كحدث ذو صلة في التسبب في الفايبرومايلغيا وتبين علاقته مع الاعراض السريرية.الهدف : دراسه مقارنه فعالية ونسبة تحمل الاميتربتلين والبريكابالين في المرضى العراقيين اللذين يعانون من الفايبرومايلغيا, ودور حالة الاكسده على المرض واعراضه وكذلك تاثر الاميتربتلين والبريكابالين على الحاله التاكسديه.المرضى والطرق البحث : اجريت هذه الدراسه المزدوجه التعميه المسيطر عليها على 123 مريض بالفايبرومايلغيا مشخصين بطريقة وولف 1990. بحيث اعيد تقييمهم على طريقه وولف 2010. وقد تلقى هؤلاء المرضى البريكابالين 75 ملغ في اليوم الواحد (62 مريض) او الاميتربتلين 25 ملغ في اليوم الواحد (61 مريض) بصوره عشوائيه ولمدة 12 اسبوع. اما طريقه الاستبيان المنقح لتاثير الفايبرومايلجيا فقد اجريت لتقييم 54 مريض من اللذين دخلوا الدراسه (27 مريض في كل مجموعه علاج). وتم متابعة المرضى كل 4 اسابيع يتم خلالها تقييم التحسن الحاصل على الاعراض السريريه بواسطه حساب المريض لعدد النقاط المسجله في كل زياره وعلى طريقه وولف والاستبيان المنقح لتاثير الفايبرومايلغيا. لقد تم اخذ عينه من دم المرضى في بدايه الدراسه وفي نهايتها وذلك لتقدير مستوى الكلوتاثايون والمالون داي الديهايد لبيان تاثير الادويه على الحاله التاكسديه | Fibromyalgia (FM) is a disorder characterized by widespread musculoskeletal pain, tenderness and joint stiffness for longer than three months, accompanied by fatigue, sleep disturbances, memory and mood disturbances. Although FM is traditionally considered as a non - inflammatory condition, however its etiology remains elusive and its treatment remain challenging. Recently emerging data have proposed the role of oxidative stress as a relevant event in the pathogenesis of FM and suggested its correlation with clinical symptoms.Objective : To compare the efficacy and tolerability of pregabalin to that of amitriptyline in the treatment of Iraqi patients suffering from FM. The role of oxidative stress and its association with symptoms as well as the effect of treatment on this status also was examined. Patients and methods : The present double blind controlled trial was conducted on 123 patients with FM fulfilling the Wolfe 2010criteria. These patients were randomized to receive either amitriptyline in a dose of 25 mg once daily (61patients) or pregabalin in a dose of 75 mg once daily (62patients) for a period of 12 weeks. The revised fibromyalgia impact questionnaire (FIQR) criteria were also used for the assessment of 54 patients entering the study (27 patients for each treatment group). Patients were followed up at 4 weeks intervals; clinical improvement was assessed by calculating the patient's scores at each follow up visit according to Wolfe 2010 and FIQR criteria. In order to study the drug effects on the oxidative status, blood samples were taken at the beginning of the study and at the end of the 12 weeks for the estimation of malondialdehyde and glutathion levels. Results : Amitriptyline 25 mg/day and pregabalin 75 mg/day significantly improved the symptoms of fibromyalgia. Improvement in the pain score wide pain index was significantly better with pregabalin than with amitriptyline (P=0.0001) at 4 weeks of treatment, but both drugs achieved comparable improvement at 8 and 12 weeks. Both drugs (amitriptyline and pregabalin) significantly reduced the somatic symptoms severity score (SSS), but with a highly significant difference (P=0.0001) in favour of pregabalin treatment at 4, 8 and 12 weeks respectively. Comparing the effects of the two drugs on the improvement of sleep, both drugs significantly improved sleep but with a substantial improvement with pregabalin over amitriptyline (P=0.0001). Improvement on revised fibromyalgia impact questionnaire total score was also achieved with both drugs, but again significantly more with pregabalin than in amitriptyline throughout the 12 week study period. The effect of both drugs on oxidative status was shown by a significant elevation of the glutathine and reduction of the malondialdehyde levels (P=0.0001) produced by the two drugs at the end of 12 weeks. Amitriptyline was better tolerated than pregabalin and patient compliance with treatment was better. The main reported adverse effects with amitriptyline were drowsiness and sleepiness, dry mouth and palpitation, while those reported with pregabalin were sleepiness and weakness.Conclusion : Both drugs effectively improved the symptoms of fibromyalgia. Pregabalin was shown to be better than amitriptyline concerning the drug effects on the symptoms severity score and sleep disturbances, but with a comparable effect on pain for both drugs scores at the end of 12 weeks. Clinical improvement with the two treatments was associated with reduction in oxidative stress. Amitriptyline was better than pregabalin concerning patient compliance and tolerability.
