Njengoba isayensi yezokwelapha iqonda kabanzi mayelana ne- fibromyalgia syndrome (i-FMS), izinkampani ezenza imithi zigijima ukuze i-FDA ivume imithi eminingi ye-fibromyalgia. Odokotela banikeze izidakamizwa ezivunyelwe kanye nohlobo olubanzi lweminye ye-label ngoba luye lwabathola ukuthi lusebenza kahle.
I-FDA-YAKHIWE IMIGOMO YEMFIBROMYALGIA
ULyrica (pregabalin) : NgoJuni 2007, uLyrica waba yizidakamizwa zokuqala ze-FDA ezigunyazwa yi-fibromyalgia.
Ekuvivinyweni kokwelashwa , abantu abane-FMS babonise ukuthuthuka okuphawulekayo ebuhlungu, ukulala, ukukhathala, kanye nekhwalithi yokuphila . Ekhiqizwa yiPfizer, uLyrica futhi uvunyelwe ukuphatha ubuhlungu besifo sikashukela nesifo sengqondo se-neuralgia . Ibuye isetshenziswe, ngokubambisana nezinye izidakamizwa, ukuvimbela ukuhlukunyezwa okuyingxenye ekukhuleni kwabantu abadala.
Kungase kuzwakale kungavamile, kepha uPfizer akaqiniseki kahle ukuthi kungani uLyrica isebenza. Yilokhu okushiwo kwiwebhusayithi ye-FDA:
Indlela yokusebenza ayifakazi, kodwa kukhona idatha ebonisa ukuthi inemiphumela ekukhululweni kwama-neurotransmitters ebuchosheni. Ama-neurotransmitter amakhemikhali ebuchosheni abathumela izimpawu kusuka kwenye i-neuron kuya kwenye.
I-Cymbalta (duloxetine) : I-Cymbalta evunyelwe i-FDA njenge-drug fibromyalgia ngoJuni 2008. I-Cymbalta ihlukaniswa njenge-SNRI, noma i-serotonin-norepinephrine reuptake inhibitor. I-Serotonin ne-norepinephrine yizo zombili izinzwa ze-neurotransmitter ezingavamile kubantu abane fibromyalgia.
I-SNRIs yenza okuningi kutholakale ebuchosheni.
I-Cymbalta ngaphambilini yayigunyaziwe i-FDA ekwelapheni ukucindezeleka nesifo sokuphefumula kwesifo sikashukela .
U-Savella (milnacipran) : Umuthi omusha emakethe yase-US, u-Savella wamukelwa ngoJanuwari 2009 njengomuthi we-fibromyalgia. Yenziwe i-Forest Laboratories, Inc. ne-Cypress Bioscience, Inc., i-Savella yinkinga yokucindezeleka efana ne-Cymbalta ngaphandle kokuthi iyisidakamizwa sokuqala ekilasini ukukhuthaza i-norepinephrine ngaphezu kwe-serotonin.
Isicelo Esisha seDrug , esenziwa ngoDisemba ka-2007, sifaka idatha kusuka kuvivinyo ezimbili lweSigaba III olubandakanya iziguli ezingaphezu kuka-2 000. Le nkampani ithi idatha yabonisa ukuthi uSapella wayesebenza kahle kune-placebo futhi wayebekezelela kahle. Kwakungekho ukufa futhi iningi lemiphumela emibi lachazwa njengobumnene ukulinganisa.
I-Milnacipran ithengiswa eYurophu ngaphansi kwegama elithi Dalcipran no-Ixel. Kuye emakethe iminyaka eyishumi futhi kuvunyelwe ukucindezeleka emazweni angaphezu kwangu-50.
UKUFUNA UKUTHUTHUKISWA NJENGOKUBA IMIBHALO YEMFIBROMYALGIA
I-JZP-6 (i-oxybate ye-sodium) : Izivivinyo zemitholampilo ye-JZP-6 (isithako esisebenzayo e-Xyrem) sibonise ukuthi ngcono kakhulu izinga lokulala nokunciphisa ubuhlungu ezigulini ze-fibromyalgia . I-JZP-6 iyinkimbinkimbi yokucindezeleka yesisindo futhi kucatshangwa ukusiza isiguli ukuba sithole isigaba esijulile sesigaba sesithathu nesigaba se-4 sokulala. Isivivinyo somtholampilo se-Phase III esihlanganisiwe ngo-Septemba 2008 kanti iJazz Pharmaceuticals ithumele isicelo esisha seDrug to the FDA ngoDisemba 2009. Imiphumela yokuqhubeka kwezilingo ze-Phase III isalindelwe, kodwa inkampani ithi ukutholakala kwesekwa kutholakale imiphumela emihle ngaphambili.
I-Xyrem i-FDA-evunyelwe ukuba i-cataplexy (ukulahlekelwa ngokungazelelwe kokulawulwa kwemisipha) nokulala ngokweqile kwamalanga ezigulini ezinezinkinga eziphuthumayo.
Qaphela: Ngenxa yokuthi kungenzeka ukuhlukunyezwa, i-Xyrem iyinhlangano elawulwa yiShedithini ye-Schedule III.
I-Effirma (ngomlomo flupertine) :
I-Adeona Pharmaceuticals ihlose ukuthola i-Effirma evunyelwe e-United States ngokokuqala ngqa, futhi ngo-Ephreli 2008 inkampani yamemezela ukuthi i-US FDA inikeze isicelo se-Investigational New Drug Application. Lokho kunikeza inkampani imvume yokuqhuba uhlolo lwe- Phase II olulinganiselwe, oluphindwe kabili, olulawulwa yi-placebo lwe- Phase II lwe-Effirma njengokwelashwa kwe-FMS.
I-Oral flupirtine ivunyelwe eYurophu iminyaka engaphezu kwengu-25. Lapho, isetshenziselwa ukuphatha ubuhlungu obuvela emithonjeni eminingana, kuhlanganise nokuhlinzwa , umdlavuza, ukuhlukumezeka nesifo sesibindi.
Kodwa-ke, u-Adeona uthemba ukuthi ubonisa okungaphezu nje kobuhlungu be-FMS, kodwa kuthuthukisa isimo sengqondo, ukukhathala, izinkinga zokucabanga, ukuphazamiseka kokulala nokusebenza jikelele.
EZINYE IZINDLELA ZEMFIBROMYALGIA
Ama-anti-depressants: Ama- Antidepresants aphakamisa amazinga amakhemikhali athile ebuchosheni, kuhlanganise ne- neurotransmitter serotonin kanye ne-hormone yokucindezeleka i-norepinephrine-zombili ziphansi kubantu abanokucindezeleka noma i-FMS.
- Ama-Inhibitors E-Dual Reuptake: Leli klasi lihlanganisa uCymbalta no-Savella. Ezinye izibonelo zalezi zidakamizwa ziyi: venlafaxine nefazodone.
- I-Tricyclic Antidepressants : Uma kuthathwa ebusuku, lezi zidakamizwa zingasiza abantu abane-FMS bathole ukulala okungcono kwekhwalithi. Futhi banda imiphumela ye-endorphin yokubulala ubuhlungu kanye nokusiza ukuphumula imisipha emibi . Amanye ama-anti-depressants e-tricyclic evame ukusetshenziswa ukuphatha i-FMS afaka: amitriptyline, doxepin ne-nortriptyline.
- I-Serotonin Reuptake Inhibitors (i- SSRI s) ekhethiwe : Lezi zidakamizwa zithola ubuchopho ukukhulula i-serotonin engaphezulu, okusiza ukulawula ukulala, futhi ngezinye izikhathi kusiza abantu abane-FMS bazizwe bengakhathali futhi bathole ukukhululeka kwezinye izimpawu. Nokho, bangaphazamisa ubuthongo. Izibonelo zama-SSRIs: i-fluoxetine, i-paroxetine ne-sertraline.
Yonke imithi ehlongozwe lapha inezinkinga ezingase zibe khona futhi ingabangela izinkinga ezinkulu zezokwelapha uma uyeka ukubamba ngokuzumayo. Kubalulekile ukuhlala uxhumane nodokotela wakho ukuze uxoxe ngezinkinga noma izinguquko zesilinganiso.
IZIKHOLELO / IZINDABA ZEMIBUZO YOKUTHUTHUKISWA KWEMFIBROMYALGIA
Izifundo zibonisa ukuthi ama-opiates ngokuvamile awaphumelelanga nobuhlungu be-FMS. Kodwa-ke, abantu abaningi babika ukuthi bayasiza, futhi lezi zidakamizwa zivame ukubekwa yona.
Ama-opiates / izidakamizwa zihlanganisa:
- I-Vicodin (i-hydrocodone acetaminophen)
- I-Percocet (oxycodone acetaminophen)
- I-OxyContin (oxycodone)
Ukubhekana nokwesaba kokuhlukunyezwa kwe-opiate nokulutha umlutha, i-American Pain Society ikhishwe iziqondiso odokotela.
IZINDAWO ZOKWENZA IZINDLELA NOKUPHEPHA
- Qinisekisa ukuthi udokotela wakho uyazi mayelana nazo zonke izidakamizwa nezithako zokudla okunomsoco ozithathayo . Khuluma nodokotela wakho noma umuthi mayelana nemiphumela emibi kanye nokusebenzisana okungalungile.
- Ukuze ubone uhlu lwemiphumela emibi nokusebenzisana kwezidakamizwa , kanye nolunye ulwazi oluningi, bheka i-Drugs.com noma i-RxList.com.
- Uma unomthelela omubi kumuthi, qiniseka ukuwabika ngohlelo lwe-FDA Safety Information and Adverse Reporting Programme.
Umthombo:
I-NIH Publication CHA. 04-5326.
Ukuphathwa kwe-US nokuDrug. "Ukuphila nge-Fibromyalgia"