Etelcalcetide

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Etelcalcetide bụ peptide calcimimetic sịntetik ejiri maka ọgwụgwọ hyperparathyroidism nke abụọ (SHPT) na ndị ọrịa nwere ọrịa akụrụ na-adịghị ala ala (CKD) na hemodialysis. Ọ na-arụ ọrụ site na ịgbalite calcium-sensing receptor (CaSR) na mkpụrụ ndụ parathyroid, si otú ahụ na-ebelata ọkwa hormone parathyroid (PTH) ma na-emeziwanye metabolism nke ịnweta. Emepụtara API Etelcalcetide dị ọcha anyị site na njikọ peptide siri ike (SPPS) n'okpuru ọnọdụ GMP, dabara adaba maka usoro injectable.

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Etelcalcetide API

Etelcalcetidebụ akwụkwọ akụkọ, sịntetikpeptide calcimimetickwadoro maka ọgwụgwọ nkehyperparathyroidism nke abụọ (SHPT)na okenye ọrịa naọrịa akụrụ na-adịghị ala ala (CKD)ịnatahemodialysis. SHPT bụ ihe mgbagwoju anya na nke siri ike nke ọrịa gbasara akụrụ na njedebe nke njedebe, nke kpatara nkwụsị na calcium, phosphorus, na vitamin D metabolism. Na-adịgide adịgide elu nkehomonụ parathyroid (PTH)nwere ike idugaakụrụ osteodystrophy, vascular calcification, ọrịa obi, na ụba ọnwụ.

Etelcalcetide na-enye aezubere iche, nhọrọ na-abụghị nke ịwa ahụiji chịkwaa ọkwa PTH na ndị ọrịa dialysis, na-anọchite anya calcimimetic ọgbọ nke abụọ nwereuru dị iche ichen'elu usoro ọgwụgwọ ọnụ dị ka cinacalcet.

Usoro nke Omume

Etelcalcetide bụ asynthetic peptide agonistnkeonye na-anabata calcium-sensing (CaSR), nke dị n'elu sel parathyroid gland. Ọ na-eṅomi omume nke calcium extracellular site na-arụ ọrụ CaSR n'ụzọ nkịtị, si otú ahụ:

Na-ebelata mmepụta nke homonụ parathyroid (PTH).
Na-ebelata mkpokọta calcium na phosphorus nke serum
Ịkwalite calcium-phosphate homeostasis
Na-ebelata ihe ize ndụ nke mgbanwe mgbanwe ọkpụkpụ na ọkpụkpụ vaskụla

N'adịghị ka calcimimetics ọnụ, a na-enye Etelcalcetideintravenouslymgbe hemodialysis gasịrị, nke na-eme ka nrube isi ọgwụgwọ dịkwuo mma ma na-ebelata mmetụta nke eriri afọ.

Nnyocha ụlọ ọgwụ na arụmọrụ

Atụlela Etelcalcetide n'ọtụtụ ule ụlọọgwụ nke 3, gụnyereọmụmụ ihe abụọ dị mkpa na-achịkwa randomizedbipụtara naLancetnaAkwụkwọ akụkọ Ọgwụ nke New England. Ọmụmụ ihe ndị a metụtara ndị ọrịa hemodialysis karịrị 1000 nwere SHPT na-achịkwaghị achịkwa.

Isi nsonaazụ ụlọ ọgwụ gụnyere:

Mbelata dị ịrịba ama na ọkwa PTH(> 30% n'ọtụtụ ndị ọrịa)
Elu njikwa nkeSerum phosphorus na calcium-phosphate ngwaahịa (Ca × P)
Ọnụ ọgụgụ nzaghachi biochemical ka ukwuutụnyere cincalcet
Mma ndidi nrubeisin'ihi nchịkwa nchịkwa IV mgbe dialysis gasịrị ugboro atọ
Mbelata akara ngbanwe ọkpụkpụ(dịka ọmụmaatụ, alkaline phosphatase ọkpụkpụ kpọmkwem)

Uru ndị a na-akwado Etelcalcetide dị ka aCalcimimetic injectable nke mbụmaka ijikwa SHPT na ndị ọrịa dialysis.

API nrụpụta na Ogo

AnyịEtelcalcetide APIna-arụpụtara siteNgwakọta peptide siri ike (SPPS), na-eme ka mkpụrụ dị elu, ịdị ọcha, na nkwụsi ike molekụla. API:

Dabara na stringentỤkpụrụ GMP na ICH Q7
Kwesịrị ekwesị maka iji nangwaahịa ọgwụ injectable
Na-enweta ule nyocha zuru oke, gụnyere HPLC, ihe mgbaze, ọla dị arọ, na ọkwa endotoxin.
Dị napilot na azụmahịa mmepụta akpịrịkpa

Enwere ike ịgwọ ọrịa na uru

Ọgwụgwọ na-abụghị nke homonụmaka SHPT na ndị ọrịa CKD na dialysis
Ụzọ IV na-eme ka nrubeisi, karịsịa na ndị ọrịa nwere ibu pill ma ọ bụ enweghị GI
Nwere ike inye aka belatansogbu ogologo ogensogbu nke ịnweta na ọkpụkpụ (CKD-MBD)
Dakọtara na phosphate binders, vitamin D analogs na nlekọta dialysis ọkọlọtọ