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Gerilim Başagrili Depressif Hastalarda Pizotifenin Antidepresan Etkisi-Trazodon Ve Plasebo Kontrollü Bir Çalişma *

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Gerilim Başagrili Depressif Hastalarda Pizotifenin Antidepresan Etkisi-Trazodon Ve Plasebo Kontrollü Bir Çalişma * Klinik Psikofarmakoloji Bülteni 2 :3 ,1992 GERİLİM BAŞAGRILI DEPRESSİF HASTALARDA PİZOTİFENİN ANTİDEPRESAN ETKİSİ-TRAZODON VE PLASEBO KONTROLLÜ BİR ÇALIŞMA * Dr. Kemal GÖKSAN ” , Dr.İ. Tayfun UZBAY### Psk. Erengül DUMAN****, Dr. Turgay GÖNCÜ***** Dr. Muzaffer YARDIM ÖZET GİRİŞ Pizotifen benzosikloheptatiofen türevi olan trisiklik bir Gerilim başağrısı 24 saate kadar sürebilen, lokal- bileşiktir ve migrenin proflaktik tedavisinde kullanılmaktadır. ize olmayan, kişinin başın çevresinde bir bant varmış Bazı çalışmalarda, pizotifenin antidepresan eskisinin de bu­ veya başın ağırlaşmış olması gibi tanımladığı künt, bu­ lunduğu ve trisikliklerden çok tetrasiklik antidepresan profi­ lantı ve kusmanın eşlik etmediği, stres ile belirginleşen, line sahip olduğu ileri sürülmüştür. Bu çalışmada gerilim uyku veya sakinleştiricilere cevap verip ergot alka­ başağnh depressif hastalarda pizotifenin antidepresan etkisi loitleri ile düzelmeyen bir başağrısı türüdür (1). Bu ta­ araştırılmış ve trazodon kadar etkili olduğu bulunmuştur. blo 45 yaşın altındakilerde ve erkeklere göre Anahtar Kelimeler: Gerilim Başağrısı, Depre­ kadınlarda daha fazla görülmektedir. Burada esas syon, Pizotifen, Trazodon. mekanizma serotoninin strese bağlı olarak artması ve Klinik Psikofarmakoloji Bülteni, 2: 3 (47-49), 1992. temporal kaslarda vazokonstrüksiyonun yanısıra iske- miye neden olmasıdır (2). Stres ve anksiyetinin gerilim SUMMARY başağrısında önemli bir etiyololojik faktör olmasının yanısıra kronik ağrılarla birlikte depresyona da sıklıkla The Antidepressant Effect of Pizotifen in rastlanır (3). Gerilim başağrısı ve depresyon ilişkisinde Depressed Patients with Tension Headache - A hangisinin diğerine neden olduğu konusu tartışmalıdır. Bazı antidepresan ve anksiyolitikierin hem gerilim Controlled Study with Trazodone and Placebo başağnlannın hem de depresyonun tedavisinde ya­ rarlı olabileceği gösterilmiştir (2/1). Böylece hem ha­ Pizotifen, a tricyclic compound is a derivative of benzo- stanın ağrıya olan duyarlığı, hem de gerilim, depre­ cycloheptathiophene and it is used in the prophylaxis of migraine. In some studies, it has been claimed that pizoti­ syon ve anksiyete gibi ağrı eşiğini düşüren emosyonel fen has also an antidepressant effect and displays rather a boyut üzerine etkili olmak hedeflenmektedir. tetracyclic antidepressant profile than a tricyclic one. In Pizotifen (PZT) benzosikloheptatiofen türevi trisiklik this study, we evaluated the antidepressant effect of pizoti­ bir bileşiktir. Güçlü antiserotonerjik, antihistaminik, an- fen in depressed patients with tension headache and tikolinerjik ve analjezik etkileri vardır (5,6,7,8). Migren found that pizotifen is as effective as trazodone. proflaksisinde yaygın olarak kullanılmaktadır (9,10). Yapılan bazı çalışmalarda PZT’nin antidepresif etkin­ Key Words: Tension Headache, Depression, liğe de sahip olduğu ve daha çok vasküler Pizotifen,Trazodone başağrıları iie birlikte depresyonu olan veya depre­ Bull. Clin. Psychopharm. 2 : 3 (47-49 ), 1992. syon semptomları da olan kronik şizofrenik hastalar gibi sınırlı olgularda kullanılabileceği ileri sürülmüştür (11,12,13). Bu çalışmada gerilim başağnlı depresif hastalarda PZT'nin antidepresif etkinliğini araştırm ayı ve ilacın * Bu çalışma GATA Araştırma Merkezi tarafından desteklenmiş (Poje No : AR-72) ve XXVII. ulusal Psikiyatrik bilimler Kongresinde poster bildiri olarak sunulmuştur. ** Psikiyatri Uzmanı, Glrne Asker Hastanesi, kıbrıs *** Tıbbi Farmakoloji uzmanı, GATA T. Farmakoloji ABD, Ankara Psikolog, Askeri Hastane Psikiyatri Kliniği, Ağrı ***** Nöroloji Uzmanı, Askeri Hastane Nöroloji Kliniği, İskenderun ****** Nöroloji Profesörü. GATA Nöroloji ABD Bşk., Ankara. 47 Klinik Psikofarmakoloji Bülteni 2 :3 ,1992 olası etkisini, serotonerjik etkisi daha seçici, ağrılı b.PZT grubunda üçüncü a y sonunda Beck ve Zung semptomlarda da yararlı olabileceği bildirilmiş (2) skorlannda anlamlı ölçüde (p< 0.01) düşüşler saptandı tetrasiklik bir antideprasan olan trazodon (TRZ) ile (Şekil 1 ve 2), karşılaştırmayı amaçladık. c .TRZ grubunda üçüncü ay sonunda Beck ve Zung skorlannda yine anlamlı ölçüde (p< 0.01) düşüşler sap­ GEREÇ VE YÖNTEM tandı (Şekil 1 ve 2). a. Çalışma Grubu: II. Üçüncü ay sonundaki plasebo değerlerine göre: Çalışmamıza GATA Nöroloji ABD polikliniğine başvuran yaşlan 18-47 arasında değişen, en az altı a.PZT grubunda üçüncü ay sonunda Beck ve Zung aydır süregelen gerilim başağnsı veya depresyon skorlannda anlamlı ölçüde (sırasıyla p<0.05 ve p<0.01) dışında başkaca psikiyatrik veya nörolojik bozukluğu düşüşler saptanmıştır.(Şekil 1 ve 2), olmayan 45 hasta (28 bayan, 17 erkek) alınmıştır. Has­ b.TRZ grubunda üçüncü a y sonunda Beck ve Zung talar çalışma öncesi en az 15 gün süreyle ve çalışma skorlarında anlamlı ölçüde (sırasıyla p<0.05 ve p<0.02) boyunca başka bir psikoaktif ilacı veya çalışmada düşüşler saptanmıştır (Şekil İve 2). kullanılan ilaçlar ile bilinen klinik etkileşmesi olan ilaçlan kullanmamışlardır. III. Üçüncü ayın sonunda Beck ve Zung skorları bakımından PZT ve TRZ gruplan arasında anlamlı bir b.Yöntem ve Uygulama: fark saptanamamıştır. Çalışma öncesi üç gruba ayrılan hastalara ilaç veya plasebo vermeye başlamadan önce Beck ve Zung depresyon ölçeği uygulandı. Daha sonra birinci gruba (n=15 , 9 bayan, 6 erkek) başlangıç olarak günde iki kez 0.5 mg, daha sonra günde üç kez 0.5 mg olmak üzere PZT (Sandomigran drj, Sandoz), ikinci gruba (n=15; 8 bayan, 7 erkek) ilk hafta günde bir kez 50 m g, 1-3. h afta lar arası günde iki kez 50 mg ve üçüncü haftadan itibaren günde üç kez 50 mg TRZ (Desyrel tb, Santa Farma), üçüncü gruba (n=15; 11 bayan, 4 erkek) plasebo verildi. Hastalar ilaç veya plaseboyu üç ay süre ile kullandılar. Bu arada 15 ŞEKİL 1-Plasebo (PLS), Pizotifen (PZT) ve Trazodon günlük aralarla polikliniğe davet edilerek ilaç yan et­ (TRZ)'un BECK skoruna etkisi. kileri ve ilaca uyum yönünden kontrol edildiler. (**p<0.02, ***p<0.01 başlangıca göre anlamlı dere­ Üçüncü ayın sonunda tüm hastalara Zung ve Beck cede farklı; + p<0.05 plasebodan anlamlı dere­ depresyon ölçekleri tekrar uygulandı. cede farklı). Çalışmada etik kurallara uyulmuş ve çalışma kap­ ŞEKİL 2-Plasebo (PLS), Pizotifen (PZT) ve Trazodon samındaki tüm hastalann izinleri alınmıştır. c. Sonuçların Değerlendirilmesi: Sonuçlann istatistik değerlendirilmesinde Student's t testi kullanılmıştır. Plasebo, PZT ve TRZ gruplannda başlangıca göre üçüncü ay sonundaki değişiklikler eşlerarası farkın önemlilik testi ile, TRZ ve PZT gru­ plarının çalışma başlangıcı ve üçüncü ay sonunda plasebo grubundan farkı ise gruplar arası farkın önemlilik testi ile değerlendirildi. Sonuçlar ortalama ± Standart Mata şeklinde verilmiştir. (TRZ)'un ZUNG skoruna etkisi. (***p<0.01, ** p<0.02 başlangıça göre anlamlı der­ BULGULAR ecede farklı; ++ p<0.02, +++p<0.01 plasebodan an­ lamlı derecede farklı).. I. Başlangıç değerlerine göre: a. Plasebo grubunda üçüncü ay sonunda Beck ve Zung skorlarında anlamlı bir değişiklik olmadı (Şekil 1 ve 2), 48 Gerilim Başağrılı Depresif Hastalarda Pizotifenin/GÖKSAN ve ark. TARTIŞMA başağrısında mianserin. XXII. Ulusal Psikiyatri ve Nörolojik Bi­ limler Kongresi, Bilimsel Çalışmalar Kitabı, Marmaris, 1986, s. Çalşı mamızda plasebo grubu dışında kalan PZT ve 527-533 5-Przegalinski E., Baran L., Palider W., Siwanowicz J.: The TRZ gruplarında Beck ve Zung skorlarında başlangıç central action of pizotifen. Psychopharmacology, 1979 değerlerine göre anlamlı düşüşler kaydedilmiştir. PZT 62.295-300 ve TRZ gruplarında üçüncü ay sonunda gözlenen 6-Dixon AK., Hill RC., Roemer D., Scholtysik G.: Phar­ düşüşler plasebodan da anlamlı düzeyde farklıdır. m acological properties of pizotifen. Arzneim. Forsch.. 1977 Başka bir deyişle, bu ilaçlar ile orta derecede de­ 27:1968-1979. presif olan hastalarda anlamlı düzeyde düzelmeler 7-Çelik S., Saygı Ş., Uzbay İT.: Pizotifenin analjezik etkin­ görülmüştür. Standal (12) günde 4-10 mg dozunda PZT liği. Türk Farmakoloji ve Klinik Araştırma Dergisi, 1988 1:42-43. ile Zung skorlarında anlam lı düşüşler gözlemiştir. Krum- 8-Deniz G.. Saygı Ş.. Uzbay İT., Çelik S.: Sıçanlarda pizotif­ hoitz ve diğ. (13) ise 1-9 mg /gün dozunda PZT ile kro­ enin analjezik etkinliğinin Tail-Flick yöntemi ile araştırılması. nik şizofrenik hastalarda depresyon belirtilerinin Pharmada, 1991 32:24-27. düzenlediği ileri sürmüşlerdir. Bu çalışm alarda PZT'nin 9-Mylecharane EJ.: 5-HT2 receptor antagonists and mi­ graine therapy. J. Neurol., 1991 238 (Suppl. 1): S45-S52 antidepresan etkisi başka antidepresanlarla 10-Andersson KE.. Vinge E.: Beta - adrenoceptor blockers karşılaştınlmamıştır. Biz bu araştırıcılardan farklı olarak and calcium antagonists in the prophylaxis and treatment daha dü; ük dozda (1.5 mg /gün) PZT ile antidepresan of migraine Drugs, 1990 39:355-373. etkinlik saptadık ve bunu plasebonun yanısıra TRZ gibi 11-Çelik S., Kabasakal L.. Çetin T.. Uzbay İT.: Pizotifenin serotonerjik etkisi daha seçici olan bir antidepressif antidepresan etkinliği. GATA Bülteni, 1989 31:679-686. ilaç ile de karşılaştırdık. TRZ’yi tercih edişimizin bir ne­ 12-Standal JE.: Pizotifen as an antidepressant. A cta Psy- deni de ilacın tetrasiklik yapıda olmasıdır. Daha önce chiat. Scand., 1977 56: 276-279. yapılan bazı çalışmalarda (5,11) PZT'nin trisiklik bir 13-Krumholz WV., Yaryuva - Tobias JA.. White L.: The a c ­ ajan olmasına karşın farmakolojik profilinin trisiklik- tion of BC - 105 in chronic schizopherincis with depression. lerden çok tetrasiklik antidepresanlara benzediği ile­ Curr. Ther. Res., 1968 10:342-344. ri sürülmüştür. Çalışmamızda PZT ve TRZ'nin antidepres-
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