Inqaku
Iikhepsuli neethebhulethi ze-methylene blue xa zithelekiswa namathontsi olwelo
Iikhepsuli neethebhulethi ze-methylene blue zibonelela ngeyunithi enesixa esele silinganisiwe. Amathontsi olwelo afuna ukwaziwa koxinzelelo lwento kulwelo nomthamo olinganisiweyo ukuze kumiselwe isixa. Loo mahluko wokusebenzisa ucacile. Ukuba yeyiphi indlela ehambisa i-methylene blue eninzi egazini ngumbuzo owahlukileyo ofuna ubungqina malunga nomxube othile wemveliso.
Ikhepsuli, ithebhulethi, umcu womlomo okanye ipilisi enyibilikayo emlonyeni yindlela yokuhambisa into, kungekhona inqanaba lomgangatho. Imilo ekulula ukuyisebenzisa ayinakuqinisekisa ubuni besithako, ukuchaneka kokuqulethweyo, inzuzo yezonyango okanye ukufaneleka komntu othile. Thelekisa loo mibuzo ngokwahlukeneyo ngaphambi kokukhetha indlela.
Yintoni etshintshayo xa i-methylene blue isenziwa ipilisi?
Ikhepsuli igcina umxube ngaphakathi kweqokobhe. Ithebhulethi icinezela izithako zibe yiyunithi eqinileyo, maxa wambi enoqweqwe. Izithako ezincedisayo zizithako ezingeyiyo into esebenzayo: zinokongeza ubuninzi, zibambe ithebhulethi ndawonye, ziyincede iqhekeke okanye zilawule ukukhutshwa kwento. Ubukho bazo abuthethi ngokuzenzekelayo ukuba umgangatho uphantsi. Ubuni bazo nenjongo yazo kufuneka zichazwe.
Isisombululo esithathwa ngomlomo sele siqulethe into enyibilikileyo, ngoko asifuni ukuba iqokobhe lekhepsuli okanye umbindi wethebhulethi uqhekeke. Oku kususa inyathelo elinye ekusebenzeni komxube; akubonisi iziphumo zonyango ezikhawulezayo okanye ukufunxwa okupheleleyo okukhulu ngakumbi. Lo mxube usenoxinzelelo lwento kulwelo, ezinye izithako, ukupakishwa neemfuno zokugcinwa.
Uyilo lokukhutshwa kwento nalo lunokwenziwa ngenjongo ethile. Inkcazelo ye-EMA nge-Lumeblue ichaza ithebhulethi ye-methylene blue efumaneka ngomyalelo kagqirha, esetyenziselwa ukuphucula ukubonakala ngexesha lokuhlolwa kwamathumbu amakhulu ngekhamera. Uqweqwe lwayo nokukhutshwa kwayo okucothayo kunceda ukuhambisa idayi emathunjini amakhulu. Eli liyeza elithile lokuxilonga elinenjongo ethile. Ubukho balo abuqinisekisi ukufaneleka kwethebhulethi ethengiswa ezivenkileni ngezinye iinjongo ezinganxulumananga nalo, kwaye indlela yalo yokukhutshwa kwento ayifanele ibalelwe kuyo yonke imveliso ebizwa ngokuba yithebhulethi.
Oko uphando ngokufunxwa lunokukuxelela ngokwenene
Kuphononongo lwesigaba I luka-Walter-Sack noogxa bakhe, amavolontiya ali-16 asempilweni athatha inxaxheba kuthelekiso olwabelwa ngokungakhethiyo, apho ngamnye wafumana zombini i-methylene blue efakwa emthanjeni kunye nomxube wayo osemanzini othathwa ngomlomo ngamaxesha ahlukeneyo. Abaphandi baxela umlinganiselo ophakathi wokufumaneka okupheleleyo emzimbeni we-72.3%, nokuphambuka okusemgangathweni kwe-23.9%. Ukufumaneka okupheleleyo emzimbeni kuqikelela ukuba kungakanani okufikelela kumjikelezo wegazi womzimba xa kuthelekiswa nokufakwa emthanjeni, kuthathelwa ingqalelo izixa ezinikwe umntu.
Oku kuxhasa ukufunxwa okukhulu kwaloo mxube osemanzini owavavanywayo phantsi kwezo meko. Akumisi ipesenti enye esebenza kuzo zonke iibhotile ezinesixhobo sokukhupha amathontsi. Uphononongo aluzange luthelekise ngokuthe ngqo iikhepsuli, iithebhulethi, imicu yomlomo neepilisi ezinyibilikayo emlonyeni ezithengiswa ezivenkileni namhlanje.
Uthelekiso phakathi kophando olunganxulumananga lunokulahlekisa xa idosi, abathathi-nxaxheba, iimeko ezinxulumene nokutya, amaxesha okuthatha iisampulu okanye indlela yohlalutyo zahlukile. Ipesenti ephezulu exelwe kwiphepha lophando elahlukileyo ayonelanga ukubeka iimveliso ezimbini zorhwebo ngokulandelelana kokugqwesa.
Isikhokelo se-ICH M13A sokulingana kokufumaneka emzimbeni sichaza ukuba kutheni uthelekiso lweemveliso luvavanya imilinganiselo yokuba umzimba ufumana kangakanani into, efana noxinzelelo oluphezulu kunye nendawo engaphantsi kwegophe loxinzelelo ngokuhamba kwexesha. Uxinzelelo oluphezulu luchaza elona nqanaba liphezulu lilinganisiweyo; indawo engaphantsi kwegophe ishwankathela ukufumaneka kwento emzimbeni ngokuhamba kwexesha. Umxube unokutshintsha ixesha lokufumaneka kwento ngaphandle kotshintsho olulinganayo kwisixa esipheleleyo esifunxwayo.
Kumthengisi othi imveliso yakhe ifunxwa ngcono, cela ukwakheka okupheleleyo kwemveliso evavanyiweyo, indlela enikwe ngayo, imveliso ethelekiswe nayo, iqela labantu abaphononongiweyo nesiphumo esilinganisiweyo. Ividiyo yokunyibilika ibonisa into isasazeka. Ayilinganisi ukufunxwa emntwini.
Uthelekiso lweendlela: iileyibhile, izithako, ubungqina nokuphathwa
Le theyibhile sisixhobo sokunceda ukuthenga, hayi uluhlu lokugqwesa kweziphumo zonyango. Okubhalwe kuyo kuchaza izinto ekufuneka zijongwe; iimveliso zokwenene ziyahluka.
| Indlela | Okufuneka kujongwe kwileyibhile yedosi | Izithako ezincedisayo ekufuneka zichongwe | Amaxwebhu ekufuneka acelwe | Umahluko ekuphathweni |
|---|---|---|---|---|
| Ikhepsuli | Iimiligram kwikhepsuli nganye nenani leekhepsuli kwisahlulo esichaziweyo | Into eyenziwe ngayo iqokobhe, izithako zomxube ongaphakathi, izinto ezisebenzayo ezongeziweyo | Uvavanyo lobungakanani bento esebenzayo kwiyunithi egqityiweyo, ukufana kokuqulethweyo, ulwazi lokukhutshwa kwento, ukuchongwa kwebhetshi | Iyunithi enesixa esimiselweyo ekulula ukuyiphatha; iimfuno zokuginya nemiyalelo yokuyivula zibalulekile |
| Ithebhulethi | Iimiligram kwithebhulethi nganye; ukukhutshwa kwangoko, okulibazisekileyo okanye okuthatha ixesha elide; nakuphi na ukwahlulwa okuqinisekisiweyo | Izibopheleli, izithako zokwandisa ubuninzi, ezinceda ukuqhekeka, izithambisi, uqweqwe | Uvavanyo lobungakanani bento esebenzayo, ukufana, ukuqhekeka okanye ukunyibilika ngokufanelekileyo; ubungqina bokwahlula ukuba kuthiwa iyahluleka | Akukho kulinganisa ulwelo; ukuyityumza okanye ukuyahlula kunokutshintsha ukuhanjiswa kwento |
| Amathontsi olwelo | Iimiligram kwimililitha nganye, isiseko esichaziweyo soxinzelelo lwento kulwelo, umthamo olinganisiweyo wesahlulo | Isinyibilikisi, izigcinakalisi, iziqholo zencasa, ezinye izinto ezisebenzayo | Uxinzelelo lwento kwisisombululo esigqityiweyo, uvavanyo olufanelekileyo lokungcola neentsholongwane, ulwazi lokupakishwa nokuzinza | Afuna ukulinganiswa; ukuchitheka namabala abangelwa kukuchukumisa zizinto ekufuneka ziqwalaselwe ekusetyenzisweni |
| Umcu womlomo | Iimiligram kumcu opheleleyo ngamnye nenani lemicu kwisahlulo ngasinye | Izithako ezenza ifilimu, izithako ezithambisa ifilimu, izimuncumuncu, iziqholo zencasa | Ukufana kokuqulethwe yiyunithi nganye, ukuzinza, ukuqhekeka; idatha yabantu ngalo naliphi na ibango lokufunxwa | Iyunithi encinci; ukupakishwa nemiyalelo enxulumene nokufuma zibalulekile; musa ukucinga ukuba ukusika kugcina ukuchaneka kwedosi |
| Ipilisi enyibilikayo emlonyeni | Iimiligram kwipilisi nganye enyibilikayo emlonyeni, ubungakanani besahlulo, indlela ecetyelwe ukuthathwa ngayo | Isiseko esineswekile okanye esingenaswekile, izibopheleli, iziqholo zencasa, izinto ezisebenzayo ezongeziweyo | Ukufana kokuqulethwe yiyunithi nganye, indlela yokukhutshwa kwento, ubungqina obuvela ebantwini obungqale kwindlela yokuthathwa kwayo | Iyanyibilika emlonyeni; ixesha lokuchukumisa izicubu nendlela yokuginya zahlukile kwezekhepsuli engavulwanga |
Unako ukukhuphela iphepha lomsebenzi lothelekiso nomthengisi ukuze ubhale ubungqina beemveliso ezimbini oziqwalaselayo.
Funda iyunithi ngaphambi kokuthelekisa inani
“Iimiligram kwisahlulo ngasinye” zinokubhekisa kwiikhepsuli okanye kwimicu emininzi. “Iimiligram kwibhotile nganye” zibhekisa kuso sonke isikhongozeli. Akukho nanye echaza ngokuzenzekelayo iyunithi enye. Kulwelo, isixa kwisahlulo esilinganisiweyo sifunyanwa ngokuphinda-phinda uxinzelelo lwento kulwelo ngomthamo; ukubala amathontsi kufuna ubudlelwane obuqinisekisiweyo phakathi kwenani lamathontsi nomthamo kwisixhobo sokuwakhupha esibonelelweyo.
Ileyibhile yomzekelo ethi “12 mg kwisahlulo ngasinye; ubungakanani besahlulo ziikhepsuli ezi-3” ichaza i-4 mg kwikhepsuli nganye, ukuba okuqulethweyo kuhambelana neleyibhile. Ayichazi i-12 mg kwikhepsuli nganye. Olu lubalo lweleyibhile, hayi isixa esicetyiswayo ukuba sithathwe.
Buza ukuba iimiligram ezichaziweyo zisekelwe koluphi uhlobo lwento xa iileyibhile okanye izatifikethi zichaza iintlobo ezahlukeneyo zekhemikhali okanye iindlela ezahlukeneyo zokuxela iziphumo zovavanyo lobungakanani bayo. Ukuthelekisa amaxabiso eebhotile ngaphambi kokucacisa iyunithi nobuni bekhemikhali kunokukhokelela kuthelekiso lwexabiso olungenantsingiselo.
Iiyunithi ezinezixa esele zilinganisiwe nazo zixhomekeke ekuhambelaneni kwemveliso ngexesha lokwenziwa. Uvavanyo lwento edityaniswe kwiiyunithi ezininzi lunokuchaza umlinganiselo ophakathi kodwa lushiye umahluko phakathi kweeyunithi ungaphendulwanga. Umbuzo kukuba ingaba iyunithi nganye egqityiweyo ihlala ihlangabezana neemfuno ezichaziweyo, kungekhona nje ukuba isithako esingekalungiswa siyaluphumelela uvavanyo lokucoceka.
Imicu neepilisi ezinyibilikayo emlonyeni: ukunyibilika akusosiphumo sokufunxwa
“Ngomlomo,” “phantsi kolwimi” kunye “naphakathi kwesidlele” azizonkcazelo ezinokusetyenziswa endaweni yenye. Ukuthathwa phantsi kolwimi kuthetha ukubekwa ngaphantsi kolwimi; ukuthathwa ngaphakathi kwesidlele kubhekisa ekubekweni ecaleni lesidlele ngaphakathi emlonyeni. Imveliso enyibilika ematheni inokuginywa emva koko. Ukunyamalala kwayo emlonyeni akubonisi ukuba kungakanani okuwele kwinwebu yangaphakathi yomlomo.
Isikhokelo se-FDA ngeethebhulethi eziqhekeka emlonyeni siphatha ukuqhekeka njengophawu lwendlela elungiswe ngayo idosi. Asisosiqinisekiso sokufumaneka okungcono emzimbeni. Kwimicu okanye kwiipilisi ezinyibilikayo emlonyeni ze-methylene blue, cela ubungqina obuvela ebantwini ngendlela into efunxwa, isasazwa, iguqulwa nekhutshwa ngayo emzimbeni, kusetyenziswa umxube wemveliso wokwenene nendlela ecetyelwe ukuthathwa ngayo. Imithombo efunyenwe kolu thelekiso ayizange iqinisekise ukuba imicu okanye iipilisi ezinyibilikayo emlonyeni ezithengiswayo zigqwesa iikhepsuli okanye ulwelo.
Jonga zonke izithako endaweni yokuthatha ibango elithi “ayinayo iswekile” okanye “inyibilika ngokukhawuleza” njengenkcazelo epheleleyo yomxube. Iilekese ezithambileyo ze-methylene blue zinemibuzo yazo yezithako novavanyo.
Khetha ukufaneleka okungqinwe ngamaxwebhu, wandule ukujonga lula kokusebenzisa
Musa ukuzenzela izahlulo zeeyunithi ngokuvula iikhepsuli okanye ukusika imicu. Kwiithebhulethi, ingcebiso ye-FDA ngokwahlula iithebhulethi ichaza ukuba imveliso engenamiyalelo yokwahlulwa evavanyiweyo ayibonisanga ngokuqinisekileyo ukuba iziqingatha zayo ziqulethe isixa esilinganayo seyeza okanye ziziphatha ngendlela efanayo. Uyilo lokukhutshwa kwento okulungisiweyo lufuna inkathalo ekhethekileyo.
Ukutshintsha indlela yemveliso nako akuyisusi indlela i-methylene blue esebenza ngayo emzimbeni. Ukuhambelana namayeza kusabalulekile; sebenzisa isikhokelo sokusebenzisana kwe-methylene blue namayeza xa ulungiselela imibuzo yogqirha okanye usokhemesti. Imveliso ye-EMA yokuxilonga ethathwa ngomlomo nayo ineemeko ezingavumeli ukusetyenziswa kwayo, kuquka ukunqongophala kwe-G6PD nokukhulelwa, nto leyo ebonisa ukuba “ngomlomo” akuthethi ukufaneleka okungenamida.
Kwisigqibo sokuthenga, qala uqinisekise injongo yokusetyenziswa, ubume bemveliso ngokomthetho, iileyibhile ezicacileyo nobungqina bemveliso egqityiweyo obunxulunyaniswe nebhetshi. Emva koko thelekisa ukuginya, ukulinganisa, lula kokuyiphatha, izithako nokupakishwa ngokwemfuno yokwenene. Uluhlu lokuhlola lothelekiso lomthengi lubonelela ngesakhelo esibanzi somgangatho. Ikhepsuli inokuyisombulula ingxaki yokuphatha; ulwelo lunokuhlangabezana nemfuno yokulinganisa. Akukho nasinye kwezo zigqibo esiqinisekisa ukulingana kokufunxwa okanye inzuzo yezonyango.