Isihloko
Imiphumela emibi ye-methylene blue, izimo ezingavumeli ukusetshenziswa kwayo, nokuphepha
I-methylene blue ayiphephile kuwo wonke umuntu. Izingozi zayo zincike emkhiqizweni, endleleni yokuyisebenzisa, enanini, kweminye imithi esetshenziswa nayo, nasempilweni yomuntu. Ukwelashwa esibhedlela kwesifo segazi esichaziwe akuqinisekisi ukuphepha kokuyisebenzisa ngokuphindaphindiwe ngaphandle kokuqondiswa ukuze kutholakale amandla noma kugxilwe.
Ngemva kokuchayeka, shayela abezimo eziphuthumayo uma kuba nobunzima bokuphefumula, ukuwa, ukuquleka okunesithuthwane, noma ukudideka okukhulu. Ukuyaluza okuhambisana nomkhuhlane, ukujuluka kakhulu, nokuqina noma ukudlikizela kwemisipha kungabonisa ukusabela okubi kakhulu. Ulwazi lwase-US lokunquma lo muthi luchaza i-serotonin syndrome engase ibulale kanye nokusabela okukhulu kokungezwani nawo. Ungalindi incazelo eku-inthanethi lapho izimpawu zinzima. Uma kusolwa ukuchayeka okweqile noma okungaqinisekile, xhumana ngokushesha nesevisi yolwazi ngobuthi; umhlahlandlela wethu wobuthi nokusebenzisa inani eleqile uchaza umongo wezokwelapha.
Qala ngendlela yokuyisebenzisa nokwakheka kwayo
I-European Medicines Agency ichaza i-Proveblue njengekhambi lobuthi elifakwa emthanjeni le-methemoglobinemia ebangelwa umuthi noma ikhemikhali. Kuleso sifo, uhlobo olungajwayelekile lwe-hemoglobin alukwazi ukuthwala umoya-mpilo ngendlela efanele. Umkhiqizo unikezwa uchwepheshe wezempilo.
Lobo bufakazi bunemingcele. Ukugwinya isixazululo, ukujovwa, nokugcoba umkhiqizo endaweni ethile yomzimba kuyizinhlobo ezahlukene zokuchayeka. Iphesenti lesixazululo alizivezi zonke izithako zaso, indlela okuhloswe ukuthi sisetshenziswe ngayo, noma ukufaneleka kwaso kumuntu. Igama lekhemikhali elijwayelekile noma isimangalo sokuhlanzeka akuqinisekisi ukuthi umkhiqizo owenziwe elabhorethri noma wokusetshenziswa ethangini lezinhlanzi uwumuthi.
Ngakho umbuzo wokuphepha owusizo kufanele ucacise: “Yini eyaziwayo ngalokhu kwakheka, ngale ndlela yokusetshenziswa, ngale njongo, kumuntu osebenzisa le mithi?” Umbiko ophathelene nomkhiqizo owodwa awukwazi ukuwuphendula ngokuzenzakalelayo lowo mbuzo ngomunye umkhiqizo. Umhlahlandlela wokumuncwa nokusabalala emzimbeni uqhathanisa ubufakazi obuphathelene nendlela ngayinye yokusetshenziswa.
Yimiphi imiphumela emibi eqinisekisiwe?
Ulwazi lomkhiqizo we-Proveblue lwase-UK lubala isiyezi, ukuzwa ukuntininiza, ukushintsha kokunambitha, isicanucanu, ukujuluka, ubuhlungu endaweni yomjovo, nokushintsha kombala wesikhumba noma womchamo. Umchamo oluhlaza okwesibhakabhaka oxube nokuluhlaza okotshani ungase ubonise udayi. Ukuba khona kwawo akukali inzuzo, akuqinisekisi ukuthi ukuchayeka bekufanele, futhi akususi amathuba enye inkinga.
Izimangalo zokuthi imiphumela ivela kaningi kangakanani zidinga umongo. Iqoqo lemininingwane yokuphepha kubantu abadala eliselebula lase-US lalihlanganisa iziguli ezingu-31 kuphela ezazine-methemoglobinemia etholakele; izehlakalo ezabikwa zazihlanganisa ikhanda elibuhlungu, isicanucanu, isifo sohudo, ukuphazamiseka kwamazinga ama-electrolyte, ukudlikizela kwemisipha, nesenzakalo esifana nokuquleka okunesithuthwane. Leyo mininingwane ayinikezi izilinganiso ezinokwethenjelwa zokuthi imiphumela ivela kaningi kangakanani ekusetshenzisweni kwansuku zonke nokwesikhathi eside kubantu abaphilile.
Lelo lebula liphinde lichaze ukuwohloka kwamaseli abomvu egazi okwenzeka kamuva kanye nokuphazamiseka kokufundwa kwe-pulse oximeter nokuhlolwa komchamo. Tshela ithimba lezokwelapha ngokuchayeka kwakamuva ngaphambi kokuba lihumushe imiphumela.
Isifinyezo sokuphepha esinezinsuku zemithombo
Leli thebula lihlukanisa izinhlobo ezahlukene zobufakazi nombuzo okufanele uhlobo ngalunye luwuphakamise. Imithombo yahlolwa ngomhlaka-12 Septhemba 2026. Usuku umthombo owashicilelwa noma owabuyekezwa ngalo luhlukile osukwini owafinyelelwa ngalo.
| Udaba lokuphepha | Lokho umthombo okuqinisekisayo | Okushiwo yilokhu ekwenzeni kanye nomthombo onosuku |
|---|---|---|
| Ukuntuleka kwe-G6PD noma ukungezwani nodayi we-thiazine | Lezi yizimo ezingavumeli ukusetshenziswa; ukuntuleka kwe-G6PD kwandisa ingozi yokubhujiswa kwamaseli abomvu egazi. | Thola ukuthi kukhona yini ukuntuleka okwaziwayo noma ukusabela okukhulu kwangaphambilini kudayi ngaphambi kokuchayeka. Isifinyezo se-EMA, esabuyekezwa ngomhlaka-7 Meyi 2018, siphinde sibale izimo ezithile ezihlobene nobuthi ezingavumeli ukusetshenziswa. |
| Imithi ethinta i-serotonin nama-opioid | Isexwayiso esisebhokisini sase-US siveza i-serotonin syndrome enzima, ngezinye izikhathi ebulalayo. | Thola ukuhlolwa okuphelele kokusebenzisana kwemithi. Ilebula lase-US labuyekezwa ngoFebhuwari 2024; i-DailyMed yabuyekeza irekhodi layo ngomhlaka-28 Meyi 2025. |
| Ukukhulelwa, ukuncelisa, nezinsana ezincane | Imininingwane yokukhulelwa kubantu ayanele; ubuthi obuthinta ukuzala ezilwaneni nokuba sengozini kwezinsana kudinga ukuhlolwa okuqondile. | Ungasebenzisi okwenzeka kubantu abadala ukuze uphethe ngalawa maqembu. Ulwazi lomkhiqizo lwase-UK, olwabuyekezwa ngomhlaka-1 Julayi 2024, luvumela ukusetshenziswa ngesikhathi sokukhulelwa kuphela lapho kunesidingo esicacile futhi lunikeza izinyathelo zokuqapha ngesikhathi sokuncelisa. |
| Ukungasebenzi kahle kwezinso noma kwesibindi | Ukungasebenzi kahle kwezinso kungandisa ukuchayeka; ulwazi lokusetshenziswa lapho isibindi singasebenzi kahle kakhulu lulinganiselwe. | Letha imininingwane yokuxilongwa kwakamuva nemiphumela yokuhlolwa etholakalayo. Uhlelo lwe-EMA lokulawula izingozi, inguqulo 3.4, Mashi 2025, luveza la maqembu ngokucacile. |
| Ukukhala ezindlebeni noma ukuzizwa uvuseleleke ngokweqile ngemva kokusetshenziswa | Ukulandisa komuntu kuqinisekisa lokho abike ukuthi kwenzekile kuye, hhayi imbangela yakho noma ukuthi kwenzeka kaningi kangakanani. | Bhala isikhathi okwenzeke ngaso nazo zonke izithako. Ingxoxo esithangamini yangomhla ka-15 Meyi 2023 iqukethe imibiko enjalo nezincazelo eziphikisanayo. |
Ukuhlola ukusebenzisana kudinga umlando wemithi
Ukuhlola kuka-Ramsay nozakwabo ngo-2007 ngama-enzyme abantu ahlanziwe kwabonisa ukuvinjelwa okunamandla, okubuyiseleka emuva, kwe-monoamine oxidase A. Lokhu kusekela indlela engachaza ukusebenzisana nemithi ethinta i-serotonin. Kwakuwucwaningo lwama-enzyme, hhayi ukuhlolwa okuqinisekisa uhlelo oluphephile lokusetshenziswa ekhaya.
Ulwazi lomkhiqizo lwaseYurophu lubala imithi yokucindezeleka kwengqondo, amanye ama-opioid, ne-dextromethorphan phakathi kwemithi ebalulekile lapho kuhlolwa ukuhlanganiswa. Faka imithi yokukhwehlela nemikhiqizo etholakala ngaphandle kwencwadi kadokotela ekuhlolweni kokusebenzisana. Ungayeki umuthi owunqunyelwe noma uhlele ngokwakho isikhathi sokuwukhipha emzimbeni ukuze ukwazi ukusebenzisa i-methylene blue. Umhlahlandlela wokusebenzisana kwemithi uhlukanisa izingozi ezibhaliwe kulokho okusolwayo ngenxa yendlela izinto ezisebenza ngayo kanye nokuhlanganiswa okungakacwaningwa.
Kuthiwani ngokukhala ezindlebeni nokuvuseleleka ngokweqile?
Umbiko wesithangami oxhunywe ngenhla uchaza ukukhala ezindlebeni nemiphumela enamandla kakhulu lapho kusetshenziswa ikhofi. Abanye ababambiqhaza baqagela ngezithako ezengeziwe zomkhiqizo. Lokhu kuyisizathu sokuphenya konke ukuchayeka, hhayi isisekelo sokuxilonga “i-dopamine ephezulu,” ama-catecholamine eqile, noma izinga elithile le-serotonin. Izimpawu umuntu azizwayo azikwazi ukunikeza lezo zilinganiso.
I-NIDCD ichaza ukuthi ukukhala ezindlebeni kungahlotshaniswa nezinto eziningana, okuhlanganisa ukulahlekelwa ukuzwa, ukuchayeka emsindweni, izinkinga zezindlebe, nemithi ethile. Uphawu oluvela ngemva kokusetshenziswa komkhiqizo lungase luhlobane nawo, luvele ngokuqondana nje, noma luthonywe okunye ukuchayeka. Isikhathi lubalulekile, kodwa isikhathi sodwa asiqinisekisi imbangela.
Ukukhala ezindlebeni okusha noma okuqhubekayo kudinga ukuhlolwa kwezokwelapha. Uma kuhambisana nokuncipha kokuzwa okungazelelwe, funa ukuhlolwa ngokushesha: i-NIDCD ibheka ukulahlekelwa ukuzwa okungazelelwe njengesimo esiphuthumayo sezokwelapha. Ungacabangi ukuthi ukushintsha kokuzwa kuzophela lapho udayi usuphuma emzimbeni.
Letha irekhodi lokuchayeka, hhayi igama lophawu kuphela
Sebenzisa leli rekhodi elifushane lapho uxhumana nochwepheshe wezokwelapha noma nesevisi yolwazi ngobuthi:
- Umkhiqizo: thwebula isithombe selebula; bhala umkhiqizi, izithako, ukugxila, inombolo yeqoqo, nokuthi utholwephi.
- Ukuchayeka: bhala indlela yokusetshenziswa, inani elisetshenziswe ngempela, indlela yokulinganisa, usuku, isikhathi, nokuchayeka okuphindaphindiwe. Phawula amanani angaqinisekile njengangaqinisekile.
- Ezinye izinto: bhala imithi enqunyiwe, imithi etholakala ngaphandle kwencwadi kadokotela, izithasiselo, i-caffeine, nezinguquko zakamuva.
- Izimpawu: chaza ukuqala kwazo, ukulandelana, ubunzima, ubude besikhathi, nanoma yiziphi izilinganiso ezitholakalayo. Faka nokwenzeke ngaphambi kokuchayeka.
- Umongo wezempilo: faka ukuntuleka kwe-G6PD okwaziwayo, ukungezwani nezinto ezithile, isifo sezinso noma sesibindi, ukukhulelwa noma ukuncelisa, nezehlakalo ezifanayo zangaphambilini.
Uma uhlela ingxoxo, imibuzo ongayibuza uchwepheshe wezokwelapha isiza ukwenza lolu lwazi lube yingxenye yokubonana okugxile ezindabeni ezithile. Ngengane, sebenzisa umhlahlandlela wobufakazi obuphathelene nezingane ukuze uhlukanise ukusetshenziswa kwezokwelapha kulokho okucatshangwa ngokususelwa kubantu abadala. Abasubathi kufanele bahlole futhi izimfuneko zemidlalo yokuncintisana; ukufaneleka ukubamba iqhaza kwezemidlalo nokuphepha kwezokwelapha kuyimibuzo ehlukene.
Bika ukusabela okusolwayo
Awudingi ukufakazela imbangela ukuze ubike ukusola. E-US, i-FDA ichaza ukuthi abathengi bangazibika kanjani izinkinga zemithi nge-MedWatch. Isiqondiso sayo siqondisa izehlakalo eziphathelene nezithasiselo zokudla ku-Safety Reporting Portal futhi sinikeza i-SmartHub yokuthola indlela efanele. Ngaphandle kwe-US, sebenzisa uhlelo lokubika lomlawuli wemithi kazwelonke.
Faka irekhodi lokuchayeka nokutholwe ekuhlolweni kwezokwelapha okuphathelene nakho lapho kutholakala. Ukubika kusiza abalawuli ukubona amaphethini; akunikezi ukuhlolwa kwezokwelapha okuphuthumayo futhi akuqinisekisi ukuthi umkhiqizo ubangele leso senzakalo.