Isihloko
I-methylene blue kwezokwelapha: ukusetshenziswa okugunyaziwe nokusetshenziswa okusaphenywa
I-methylene blue inokusetshenziswa kwezokwelapha osekwamukelekile, kodwa ukugunyazwa kuqondene nomkhiqizo othile nesimo esithile eselashwayo. Umuthi ojovwayo wokulwa nobuthi, iphilisi elenzelwe ukufaka umbala ethunjini elikhulu, nokwelashwa kokuhlola okunikezwa ngomlomo kuyizindlela zokungenelela ezihlukene, ngisho noma kuqukethe amakhemikhali ahlobene.
E-United States, imininingwane yokunquma umuthi i-ProvayBlue ibalula i-methemoglobinemia etholakala kamuva ekuphileni njengesimo esigunyazelwe ukuselwa lo muthi kubantu abadala nasezinganeni. I-European Union iphinde igunyaze umuthi owakhiwe ngendlela ehlukile, i-Lumeblue, ukuze kuthuthukiswe ukubonakala ngesikhathi se-colonoscopy. Akukho kulokhu kugunyazwa okufakazela ukuthi amaconsi e-methylene blue athengiswa ezitolo elapha isifo esingahlobene nalezi zimo.
Funda izigaba zokugunyazwa nezobufakazi ngokwehlukana
Ukusetshenziswa okugunyaziwe kusho ukuthi ukugunyazwa komkhiqizo oqanjwe ngegama kuhlanganisa isimo eselashwayo, indlela yokuwunikeza, neqembu leziguli elichaziwe. Ukusetshenziswa ngaphandle kwemibandela yelebula kusho ukuthi umuthi ogunyaziwe usetshenziswa ngaphandle kwalokho okushiwo ilebula yawo. Ukusetshenziswa okusaphenywa kusho ukuthi abacwaningi bahlola indlela yokuwusebenzisa. Indlela yokusebenzisa umuthi ingaba ngaphandle kwemibandela yelebula ekwelapheni iziguli, ibe futhi isaphenywa ezivivinyweni.
Lezi zincazelo ngokwazo azilinganiseli amandla obufakazi. Isivivinyo esincane singanikeza inkomba ewusizo ngaphandle kokufakazela inzuzo yokusetshenziswa okuvamile. Ngakolunye uhlangothi, umuthi wokulwa nobuthi osekwamukelekile esimweni esiphuthumayo esingavamile ungase usekelwe ulwazi oluqoqwe ekwelapheni nasekulandeleni amaqembu eziguli, kunokuba usekelwe izivivinyo ezinkulu eziqhathanisa nomuthi-mbumbulu ezilindelekile ezifweni ezingamahlalakhona.
Ithebula elingezansi lihlola amarekhodi emikhiqizo eqanjwe ngegama e-US, e-EU, nase-UK njengoba ayenjalo ngomhla ka-12 Septhemba 2026. Liyisiqondiso sezokwelapha, hhayi uhlu oluphelele lwayo yonke imikhiqizo yezwe ngalinye. Emigqeni yocwaningo, “ngaphandle kwemibandela yamalebula abuyekeziwe” kubhekisela emithini ye-methylene blue eqanjwe ngenhla, hhayi esitatimendeni esiphathelene nayo yonke indawo yokulawula noma ukugunyazwa kwensiza yezokwelapha.
Ithebula lokusetshenziswa kwezokwelapha
| Ukusetshenziswa | Indawo yokulawula nokugunyazwa | Indlela yokunikeza nokwakheka | Ubufakazi obutholwe kubantu nomkhawulo wabo |
|---|---|---|---|
| I-methemoglobinemia etholakala kamuva ekuphileni | US: I-ProvayBlue igunyazwe yi-FDA kubantu abadala nasezinganeni. | Ngokungena emthanjeni, uketshezi olungenamagciwane olungu-5 mg/mL. | Ukwelapha ukuguqulwa kwe-hemoglobin yi-oxidation okungavamile, okusekelwe ilebula; akufakazeli ukwelashwa kokukhathala okuvamile noma isifo samaphaphu. |
| I-methemoglobinemia ebangelwa umuthi noma ikhemikhali | EU: I-Proveblue igunyazelwe ukwelapha isimo esibukhali esinezimpawu, kuhlanganise nasezinganeni. | Ngokungena emthanjeni, umjovo ongu-5 mg/mL. | Isimo osekwamukelekile ukusebenzisa kuso umuthi wokulwa nobuthi, esinemikhawulo eqondene nomkhiqizo. Isifo umuntu azalwa naso akusona isimo esibalulwe lapha. |
| I-methemoglobinemia ebangelwa umuthi noma ikhemikhali | UK: ihlanganiswe ku-SmPC ye-Proveblue, kuhlanganise nabantu abadala nezingane. | Ngokungena emthanjeni, umjovo ongu-5 mg/mL. | Imininingwane yomkhiqizo yase-UK icacisa ukunikezwa nokuqashwa ngabasebenzi bezokwelapha; ezinye izindlela zokunikeza azikwazi ukushintshaniswa nayo. |
| Ukwenza izilonda zamathumbu amakhulu nezomgudu wokugcina wamathumbu zibonakale | EU: I-Lumeblue igunyazelwe i-colonoscopy yokuhlola noma yokuqapha abantu abadala. | Amaphilisi aphuzwa ngomlomo angu-25 mg akhipha umuthi isikhathi eside, enzelwe ukuwukhipha ethunjini elikhulu. | Ucwaningo lokuqhathanisa lwathuthukisa ukutholakala kwe-adenoma/carcinoma. Lokhu kuyinsiza yokuxilonga, hhayi ukwelashwa komdlavuza. |
| I-vasoplegia ngemva kokuhlinzwa kwenhliziyo | US/EU/UK: ngaphandle kwemibandela yamalebula emijovo abuyekeziwe; ukusetshenziswa ngochwepheshe ngaphandle kwemibandela yelebula. | I-methylene blue enikezwa emthanjeni ngokwezinqubo zesibhedlela. | ULevin nozakwabo bahlukanisa ngokungahleliwe iziguli ezingu-56 ezazine-vasoplegia ngemva kokuhlinzwa. Izivivinyo ezincane ziphathelene namaqembu akhethiwe eziguli ezihlinziwe, hhayi zonke izimbangela zomfutho wegazi ophansi. |
| Ukushaqeka okubangelwa yi-sepsis | US/EU/UK: ngaphandle kwemibandela yamalebula abuyekeziwe; ukwelashwa okwengeziwe okusaphenywa. | Uketshezi olunikezwa emthanjeni olungezwa ekunakekelweni okujwayelekile kwabagula kakhulu. | Isivivinyo esihlukanisa ngokungahleliwe iziguli ezingu-91 sanciphisa isikhathi sokwelashwa ngemithi enyusa umfutho wegazi; izinga lokufa lalifana. |
| Ukuphazamiseka kobuchopho okuhlobene ne-ifosfamide | US/EU/UK: ngaphandle kwemibandela yamalebula abuyekeziwe; ukwelapha noma ukuvimbela ngochwepheshe ngaphandle kwemibandela yelebula. | I-methylene blue enikezwa emthanjeni ekwelashweni komdlavuza okubikiwe. | UPelgrims nozakwabo babika izigameko ezingu-12, eziyisishiyagalombili zelashwa nge-methylene blue. Ukululama okubonwe ngaphandle kokwabiwa ngokungahleliwe akukwazi ukufakazela umphumela wokwelashwa. |
| Ukuhlonza izindlala ze-lymph zokuqala ezithola uketshezi oluvela endaweni ethile | US/EU/UK: ngaphandle kwemibandela yamalebula emithi yokulwa nobuthi abuyekeziwe; ukusetshenziswa enqubweni yezokwelapha kudinga umkhiqizo wakho nokuhlolwa kwendawo. | Ukujova uketshezi lukadayi wokuhlinza esicutshini sendawo; akukhona ukunikeza umuthi wokulwa nobuthi emzimbeni wonke. | Ucwaningo lwase-UK lokuqhathanisa olwalulandela iziguli ezingu-329 lwahlola ukuhlonzwa kwezindlala ngodayi kuphela noma ngodayi kanye nento yokulandela ekhipha imisebe. Ukunemba kuqondene nenqubo ethile. |
| Imikhiqizo ehlanganisa izithako yezimpawu zomgudu womchamo | US: irekhodi le-Uribel Tabs elihloliwe libala umuthi ongagunyaziwe, naphezu kwelebula elibonisa ukuthi udinga incwadi kadokotela. | Amaphilisi aphuzwa ngomlomo anezithako eziningi, aqukethe i-methylene blue nezinye izithako ezisebenzayo. | Ilebula elisohlwini alisho ukugunyazwa yi-FDA. Izimangalo zemikhiqizo ehlanganisa izithako azikwazi ukufakazela ukuthi i-methylene blue iyodwa yelapha ukutheleleka. |
| Ucwaningo ngenkumbulo nangesimiso sezinzwa | US/EU/UK: ngaphandle kwemibandela yamalebula e-methylene blue abuyekeziwe; kusaphenywa. | I-methylene blue ephuzwa ngomlomo ezivivinyweni ezimfushane; izinhlobo ezihlukile zokwakheka kwe-methylthioninium ezivivinyweni zokuwohloka komqondo. | Isivivinyo esinamavolontiya aphilile angu-26 salinganisa izinguquko zesikhashana ekwenzeni imisebenzi nasezithombeni zokuhlola umzimba. Asizange sihlole ukwelashwa kokuwohloka komqondo noma inzuzo ehlala isikhathi eside ekuphileni kwansuku zonke. |
| Ukunciphisa ukudluliselwa kukamalaleveva | Isivivinyo eMali; akusona isimo esigunyaziwe kumalebula ase-US/EU/UK abuyekeziwe. | I-methylene blue ephuzwa ngomlomo engezwa enhlanganisweni ethile yemithi kamalaleveva. | Isivivinyo sesigaba 2 esinabahlanganyeli abangu-80 sacwaninga amathuba okuthelela omiyane kwabesilisa abanezinga elijwayelekile le-G6PD nababenokutheleleka okungenazimpawu. Okutholakele akufakazeli ukwelashwa kukamalaleveva onzima nge-methylene blue kuphela. |
| Ukwelashwa kwe-photodynamic kwezicubu ezizungeze amazinyo | Isivivinyo e-Iraq; akusona isimo esigunyaziwe kumalebula abuyekeziwe emithi esebenza emzimbeni wonke. Isimo sokugunyazwa kwensiza noma kokwakheka komkhiqizo endaweni sidinga ukuqinisekiswa ngokwehlukana. | I-methylene blue esetshenziswa endaweni ethile ngokukhanya okuyenza isebenze, kanye nokwelashwa ngokuhlanza ngezinsiza. | Isivivinyo seziguli ezingu-18 esasisebenzisa ukwelashwa okuhlukene ezinhlangothini zomlomo sabika ukuthuthuka kwezicubu ezizungeze amazinyo. Izindawo ezingu-332 ezalinganiswa kwakungezona iziguli ezingu-332 ezizimele. |
Kungani indlela yokunikeza ishintsha umbuzo wezokwelapha
Ku-methemoglobinemia, i-iron ye-hemoglobin isuke iguqulwe yi-oxidation isuka esimweni sayo esisebenzayo se-ferrous, Fe²⁺, iye ku-ferric iron, Fe³⁺. I-methylene blue ibamba iqhaza endleleni ye-reduction esiza ukubuyisela i-hemoglobin esebenzayo. Incazelo yesayensi yokusebenza kwe-Proveblue ichaza lokhu kuguqulwa. Ukwelashwa kuqondiswe ekuphazamisekeni okuthile kwegazi, hhayi ekuntulekeni kwamandla okuvamile. Incazelo yethu yokwelashwa kwe-methemoglobinemia esibhedlela ilandela lowo mehluko ngokuningiliziwe.
I-Lumeblue isebenzisa isici esihlukile: ukufaka umbala. Ungqimba lwayo lwangaphandle lubambezela ukukhishwa ukuze udayi ukwazi ukufaka umbala olwelwesini lwamathumbu ngesikhathi kulungiselelwa ukuhlolwa. Isifinyezo sokuhlola se-EMA sibika ukutholakala ku-56% uma kuqhathaniswa no-48% wabahlanganyeli ekuqhathaniseni okuyinhloko. Inzuzo eyalinganiswa kwakuwukuthola izilonda, okuqinisekiswe ukuhlolwa kwezicubu. Kwakungekhona ukuncipha kwesimila noma ukuncipha okubonwe ekufeni ngenxa yomdlavuza.
Lowo mehluko uchaza nokuthi kungani umjovo kadayi wokuhlinza endaweni ethile, uketshezi oluphuzwa ngomlomo, nomuthi onikezwa emthanjeni kungakwazi ukushintshaniswa ngokumane kulinganiswe isisindo sikadayi. Indawo umkhiqizo ofinyelela kuyo, ukungabi namagciwane, izici zokukhishwa, nenqubo kunquma lokho umkhiqizo okwenzayo. Imininingwane itholakala ezihlokweni ezimayelana nemijovo nemithi eyakhelwe ukunikezwa emthanjeni kanye nokusetshenziswa ekuhlinzeni nasekuxilongeni.
Lokho okufakazelwa ngempela yimiphumela yezivivinyo ethembisayo
Isivivinyo sokushaqeka okubangelwa yi-sepsis sinikeza isibonelo esiwusizo sokufunda udlulele ngale kwesihloko esibonakala sithembisa. Kwakuwucwaningo olwenziwa esikhungweni esisodwa, olwalunokuqhathaniswa nomuthi-mbumbulu, lapho i-methylene blue yengezwa kusenesikhathi ekwelashweni okwakukhona. Isikhathi esimaphakathi kuze kube yilapho imithi enyusa umfutho wegazi ingamiswa sasingamahora angu-69 nge-methylene blue uma kuqhathaniswa namahora angu-94 ngomuthi-mbumbulu. Izinga lokufa nobude besikhathi sokusebenzisa umshini wokusiza ukuphefumula kwakufana. Lokhu kusekela ukuqhubeka nokuphenya umphumela wokunciphisa isidingo semithi enyusa umfutho wegazi; akubonisi inzuzo yokusinda. Izivivinyo ze-vasoplegia nezokushaqeka okubangelwa yi-sepsis zidinga ukuhunyushwa ngokwehlukana ngoba iziguli zazo nezimbangela zokwehluleka kokujikeleza kwegazi ziyahluka.
Ucwaningo ngesimiso sezinzwa lwengeza inkinga yokwakheka komuthi. Isivivinyo se-LMTM sesigaba 3 esinabahlanganyeli abangu-891 sacwaninga i-leuco-methylthioninium bis(hydroxymethanesulfonate), uhlobo lwe-methylthioninium olusesimweni se-reduction, phakathi nezinyanga ezingu-15 kubantu abanesifo i-Alzheimer esisezingeni eliphakathi kokuncane nokulingene. Ukuhlaziywa kwaso okuyinhloko okwakunqunywe kusengaphambili akutholanga nzuzo ekucabangeni noma emisebenzini yokuphila kwansuku zonke ngemithamo ephakeme eyahlolwa uma kuqhathaniswa neqembu lokuqhathanisa elalithola umthamo ophansi. Ukuhunyushwa kwemiphumela yamaqembu amancane akuthathi indawo yalowo mphumela oyinhloko, futhi lokhu kwakheka komuthi akulona ibhodlela elivamile le-methylene blue.
Lesi isivivinyo esisodwa ohlelweni locwaningo oluqhubekayo, hhayi isinqumo mayelana nayo yonke inhlanganisela yamakhemikhali noma ucwaningo oluzolandela. Funda ukuhlaziywa kwesivivinyo se-Alzheimer ukuze uthole ubufakazi obuqhubeka buthuthuka. Ukuhlolisisa okufanayo kuyasebenza ocwaningweni lomdlavuza: ukubulala amaseli akhuliswe elabhorethri, ukuthuthukisa umphumela olinganiswa ngezithombe zokuhlola umzimba, nokusiza iziguli ziphile isikhathi eside kuyimiphumela ehlukene.
Ukuphepha kuyingxenye yokwakheka komuthi, akusona isigaba esihlukile sokumaka nje
Ilebula yomjovo yase-US ixwayisa nge-serotonin syndrome eyingozi uma usetshenziswa nemithi esebenza ku-serotonin nama-opioid, iyakwenqabela ukusetshenziswa lapho kukhona ukuntuleka kwe-G6PD, futhi ichaza ukuphazamiseka kokufundwa kwe-pulse oximeter. Lezi yizizathu ezisebenzayo zokuthi abelaphi bahlole uhlu lwangempela lwemithi kanye nemininingwane yokuhlolwa kwaselabhorethri. Ukufundwa komoya-mpilo okubonakala kuphansi ngemva kokuthola lo muthi akufakazeli ngokwakho ukuthi ukufinyelela komoya-mpilo ezicutshini sekubi kakhulu.
I-SmPC yase-UK iphinde icacise izimo lapho kungafanele usetshenziswe khona, njengobuthi be-chlorate nezimo ezithile ezihlobene ne-nitrite. Ngakho “umuthi wokulwa nobuthi” akusho ukuthi ufanele bonke ubuthi. Ukuphefumula kanzima kakhulu, ukuwa, noma ukudideka okuzumayo kudinga ukuhlolwa okuphuthumayo, hhayi ukuzama udayi oluhlaza okwesibhakabhaka ekhaya.
Uma kuhlongozwa ukwelashwa, qala ngokuhlonza umkhiqizo oqondile, indlela yokuwunikeza, ukuxilongwa, nomphumela. Letha leyo mininingwane ohlwini lokuhlola lwengxoxo nomelaphi futhi ufunde umhlahlandlela wemiphumela engemihle nezimo lapho kungafanele usetshenziswe khona. Umbuzo owusizo uwukuthi ubufakazi buyakusekela yini lokho kungenelela okuqondile kuleso simo esiqondile.