The 41 references with contexts in paper G. Gorodetskaya I., E. Sokova A., O. Muslimova V., T. Aleksandrova V., I. Mazerkina A., S. Rudnev G., Г. Городецкая И., Е. Сокова А., О. Муслимова В., Т. Александрова В., И. Мазеркина А., С. Руднев Г. (2018) “Взаимозаменяемость препаратов левотироксина // Interchangeability of levothyroxine sodium tablets” / spz:neicon:vedomostincesmp:y:2017:i:1:p:33-40

1
Eskandari S, Loo DD, Dai G, Levy O, Wright EM, Carrasco N. Thyroid Na+/I–symporter. Mechanism, stoichiometry, and specificity. J Biol Chem.1997; 272: 27230–8.
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    Îáû÷íî êîíöåíòðàöèÿ éîäèäà â êðîâè î÷åíü ìàëà (15–30 íìîëü/ë), íî ùèòîâèäíàÿ æåëåçà àêòèâíî çàõâàòûâàåò åãî ñ ïîìîùüþ ñïåöèôè÷åñêîãî ìåìáðàííîãî áåëêà ïåðåíîñ÷èêà Na+/I–, áëàãîäàðÿ ÷åìó êîíöåíòðàöèÿ éîäèäà â òèðîöèòàõ â äåñÿòêè ðàç áîëüøå, ÷åì â ïëàçìå
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    . Êîòðàíñïîðò Na+/I–õàðàêòåðåí äëÿ ñëþííûõ æåëåç, ñëèçèñòîé æåëóäêà, ñðåäíåé ÷àñòè òîíêîé êèøêè, ñîñóäèñòûõ ñïëåòåíèé æåëóäî÷êîâ ìîçãà, ìîëî÷íûõ æåëåç, êîæè, ïëàöåíòû, ÷òî ïðèâîäèò ê íàêîïëåíèþ èîäèäà â ýòèõ òêàíÿõ [2].

2
De la Vieja A, Dohan O, Levy O, Carrasco N. Molecular analysis of the sodium/iodide symporter: impact on thyroid and extrathyroid pathophysiology. Physiological Reviews 2000; 80(3): 1083–105.
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    Êîòðàíñïîðò Na+/I–õàðàêòåðåí äëÿ ñëþííûõ æåëåç, ñëèçèñòîé æåëóäêà, ñðåäíåé ÷àñòè òîíêîé êèøêè, ñîñóäèñòûõ ñïëåòåíèé æåëóäî÷êîâ ìîçãà, ìîëî÷íûõ æåëåç, êîæè, ïëàöåíòû, ÷òî ïðèâîäèò ê íàêîïëåíèþ èîäèäà â ýòèõ òêàíÿõ
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    .  ùèòîâèäíîé æåëåçå ïðîèñõîäèò îêèñëåíèå éîäèäà è éîäèðîâàíèå òèðîçèíîâûõ îñòàòêîâ òèðåîãëîáóëèíà (ñåìåéñòâî ñåðèíîâûõ ãèäðîëàç), ñîñòàâëÿþùåãî îñíîâó êîëëîèäà ôîëëèêóëîâ ùèòîâèäíîé æåëåçû. Ïðîöåññ ïðîèñõîäèò ñ ó÷àñòèåì òèðåîïåðîêñèäàçû (TÏO), òðàíñìåìáðàííîãî ãëèêîïðîòåèíà, ôåðìåíòà êëàññà îêñèäîðåäóêòàç, èñïîëüçóþùåãî ïåðåêèñü âîäîðîäà â êà÷åñòâå îêèñëèòåëÿ, ïðè ýòîì óâåëè÷èâàåòñÿ êîíöåíòðàöèÿ

3
Boron WF. Medical Physiology: A Cellular And Molecular Approach. Elsevier/Saunders; 2003.
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    Ïðîöåññ ïðîèñõîäèò ñ ó÷àñòèåì òèðåîïåðîêñèäàçû (TÏO), òðàíñìåìáðàííîãî ãëèêîïðîòåèíà, ôåðìåíòà êëàññà îêñèäîðåäóêòàç, èñïîëüçóþùåãî ïåðåêèñü âîäîðîäà â êà÷åñòâå îêèñëèòåëÿ, ïðè ýòîì óâåëè÷èâàåòñÿ êîíöåíòðàöèÿ âíóòðèêëåòî÷íîãî êàëüöèÿ
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    . Ïîìèìî òèðåîãëîáóëèíà ÒÏÎ ìîæåò éîäèðîâàòü è äðóãèå áåëêè. Ò4 îáðàçóåòñÿ â îñíîâíîì â N-êîíöåâîé îáëàñòè òèðåîãëîáóëèíà, Ò3 — â Ñ-êîíöåâîé îáëàñòè. Ñêîðîñòü ñèíòåçà íà ðàçíûõ êîíöàõ ìîëåêóëû òèðåîãëîáóëèíà çàâèñèò îò êîëè÷åñòâà äîñòóïíîãî éîäèäà è óðîâíÿ òèðåîòðîïíîãî ãîðìîíà ãèïîôèçà (ÒÒÃ) [4].

4
Dunn JT, Ray SC. Changes in the structure of thyroglobulin following the administration of thyroid-stimulating hormone. J Biol Chem. 1975; 250: 5801–7.
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    Ò4 îáðàçóåòñÿ â îñíîâíîì â N-êîíöåâîé îáëàñòè òèðåîãëîáóëèíà, Ò3 — â Ñ-êîíöåâîé îáëàñòè. Ñêîðîñòü ñèíòåçà íà ðàçíûõ êîíöàõ ìîëåêóëû òèðåîãëîáóëèíà çàâèñèò îò êîëè÷åñòâà äîñòóïíîãî éîäèäà è óðîâíÿ òèðåîòðîïíîãî ãîðìîíà ãèïîôèçà (ÒÒÃ)
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    . ÒÒà ñåêðåòèðóåòñÿ èìïóëüñíî, äîñòèãàÿ ìàêñèìóìà â âå÷åðíèå è íî÷íûå ÷àñû, äåéñòâóÿ íà ðåöåïòîðû ÒÒà íà ìåìáðàíå òèðîöèòîâ. Åñëè éîäà íå õâàòàåò, ñèíòåç òèðåîèäíûõ ãîðìîíîâ ñíèæàåòñÿ, âîçðàñòàåò (ïî ìåõàíèçìó îòðèöàòåëüíîé îáðàòíîé ñâÿçè) ñåêðåöèÿ ÒÒÃ, è ïðîèñõîäèò ãèïåðïëàçèÿ ùèòîâèäíîé æåëåçû.

5
Greer MA, Grimm Y, Studer H. Qualitative changes in the secretion of thyroid hormones induced by iodine deficiency. Endocrinology 1968; 83: 1193–8.
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    Åñëè éîäà íå õâàòàåò, ñèíòåç òèðåîèäíûõ ãîðìîíîâ ñíèæàåòñÿ, âîçðàñòàåò (ïî ìåõàíèçìó îòðèöàòåëüíîé îáðàòíîé ñâÿçè) ñåêðåöèÿ ÒÒÃ, è ïðîèñõîäèò ãèïåðïëàçèÿ ùèòîâèäíîé æåëåçû.  ýòèõ óñëîâèÿõ òðàíñìåìáðàííûé ãðàäèåíò éîäèäà â òèðîöèòàõ ìîæåò óâåëè÷èòüñÿ â äåñÿòü ðàç. Ïðè íèçêîì óðîâíå éîäèäà îáðàçóåòñÿ áîëüøå ìîíîéîäòèðîçèíà
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    . Îáðàçîâàíèå ìîíîéîäòèðîçèíà ñïîñîáñòâóåò ïîâûøåíèþ ïðîäóêöèè Ò3, äåôèöèò äèéîäòèðîçèíà ìîæåò ïðèâåñòè ê íàðóøåíèþ ñèíòåçà îáîèõ ãîðìîíîâ. Ò3 â ùèòîâèäíîé æåëåçå îáðàçóåòñÿ íå òîëüêî ïóòåì ñèíòåçà, íî è çà ñ÷åò äåéîäèðîâàíèÿ Ò4 â ïîëîæåíèè 5¢[6].

6
Laurberg P. Mechanisms governing the relative proportions of thyroxine and 3,5,3-triiodothyronine in thyroid secretion. Metab Clin Exp. 1984; 33: 379–92.
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    Îáðàçîâàíèå ìîíîéîäòèðîçèíà ñïîñîáñòâóåò ïîâûøåíèþ ïðîäóêöèè Ò3, äåôèöèò äèéîäòèðîçèíà ìîæåò ïðèâåñòè ê íàðóøåíèþ ñèíòåçà îáîèõ ãîðìîíîâ. Ò3 â ùèòîâèäíîé æåëåçå îáðàçóåòñÿ íå òîëüêî ïóòåì ñèíòåçà, íî è çà ñ÷åò äåéîäèðîâàíèÿ Ò4 â ïîëîæåíèè 5¢
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    . Ïðåâðàùåíèå Ò4 â Ò3 îñóùåñòâëÿåò ôåðìåíò 5¢-äåéîäèíàçà òèïà I, íàõîäÿùèéñÿ â ïå÷åíè, ïî÷êàõ è ùèòîâèäíîé æåëåçå; ñ åå ïîìîùüþ îáðàçóåòñÿ Ò3, ðàáîòàþùèé â áîëüøèíñòâå ïåðèôåðè÷åñêèõ òêàíåé. Ïðè ãèïîòèðåîçå àêòèâíîñòü 5¢-äåéîäèíàçû òèïà I ñíèæåíà. 5¢-äåéîäèíàçà òèïà II ïðèñóòñòâóåò â ãîëîâíîì ìîçãå, ãèïîôèçå, ìèîêàðäå è ñêåëåòíûõ ìûøöàõ.

7
Leonard JL, Kohrle J. Intracellular pathways of iodothyronine metabolism. In: Braverman LE, Utiger RD, eds. The Thyroid. 8th ed. Lippincott, Philadelphia; 2000.
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    Ñðîäñòâî 5¢-äåéîäèíàçû òèïà II ê ñóáñòðàòó íà íåñêîëüêî ïîðÿäêîâ âûøå, ÷åì ó 5¢-äåéîäèíàçû òèïà I. Ïðè ãèïîòèðåîçå àêòèâíîñòü ôåðìåíòà âîçðàñòàåò, çà ñ÷åò ÷åãî ðåãóëèðóåòñÿ âûðàáîòêà Ò3 â ãîëîâíîì ìîçãå, ãèïîôèçå, ñåðäöå
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    . Ýòî ñòàíîâèòñÿ êðèòè÷íûì äëÿ ïàöèåíòîâ ñ ïîëèìîðôèçìîì ãåíà, êîäèðóþùåãî ñèíòåç äåéîäèíàçû òèïà II ÑÑ-àëëåëü rs225014, ÷òî àññîöèèðóåòñÿ ñî ñíèæåíèåì óðîâíÿ Ò3. Äëÿ ïîëèìîðôèçìà Ñ-àëëåëü rs2235544 õàðàêòåðíî óñèëåíèå àêòèâíîñòè ôåðìåíòà äåéîäèíàçû òèïà I è óâåëè÷åíèå îáðàçîâàíèÿ Ò3 [8, 9].

8
Panicker V, Saravanan P, Vaidya B, Evans J, Hattersley AT, Frayling TM, et al. Common variation in the DIO2 gene predicts baseline psychological well-being and response to combination thyroxine plus triiodothyronine therapy in hypothyroid patients. J Clin Endocrinol Metab. 2009; 94(5): 1623–9.
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    Ýòî ñòàíîâèòñÿ êðèòè÷íûì äëÿ ïàöèåíòîâ ñ ïîëèìîðôèçìîì ãåíà, êîäèðóþùåãî ñèíòåç äåéîäèíàçû òèïà II ÑÑ-àëëåëü rs225014, ÷òî àññîöèèðóåòñÿ ñî ñíèæåíèåì óðîâíÿ Ò3. Äëÿ ïîëèìîðôèçìà Ñ-àëëåëü rs2235544 õàðàêòåðíî óñèëåíèå àêòèâíîñòè ôåðìåíòà äåéîäèíàçû òèïà I è óâåëè÷åíèå îáðàçîâàíèÿ Ò3
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    . Êëèíè÷åñêàÿ ýôôåêòèâíîñòü òèðåîèäíûõ ãîðìîíîâ îïðåäåëÿåòñÿ, ïîìèìî ñòðóêòóðíûõ ðàçëè÷èé Ò3 è Ò4, ñêîðîñòè ïðåâðàùåíèÿ Ò4 â Ò3, âûñîêèì ñðîäñòâîì ê áåëêàì. Òèðîêñèíñâÿçûâàþùèé ãëîáóëèí, îñíîâíîé ïåðåíîñ÷èê òèðåîèäíûõ ãîðìîíîâ, ïðî÷íî ñâÿçûâàåòñÿ ñ Ò4, íàìíîãî ñëàáåå ñ Ò3.

9
Panicker V, Cluett C, Shields B, Murray A, Parnell KS, Perry JR, et al. A common variation in deiodinase 1 gene DIO1 is associated with the relative levels of free thyroxine and triiodothyronine. J Clin Endocrinol Metab. 2008; 93(8): 3075–81.
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    Ýòî ñòàíîâèòñÿ êðèòè÷íûì äëÿ ïàöèåíòîâ ñ ïîëèìîðôèçìîì ãåíà, êîäèðóþùåãî ñèíòåç äåéîäèíàçû òèïà II ÑÑ-àëëåëü rs225014, ÷òî àññîöèèðóåòñÿ ñî ñíèæåíèåì óðîâíÿ Ò3. Äëÿ ïîëèìîðôèçìà Ñ-àëëåëü rs2235544 õàðàêòåðíî óñèëåíèå àêòèâíîñòè ôåðìåíòà äåéîäèíàçû òèïà I è óâåëè÷åíèå îáðàçîâàíèÿ Ò3
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    . Êëèíè÷åñêàÿ ýôôåêòèâíîñòü òèðåîèäíûõ ãîðìîíîâ îïðåäåëÿåòñÿ, ïîìèìî ñòðóêòóðíûõ ðàçëè÷èé Ò3 è Ò4, ñêîðîñòè ïðåâðàùåíèÿ Ò4 â Ò3, âûñîêèì ñðîäñòâîì ê áåëêàì. Òèðîêñèíñâÿçûâàþùèé ãëîáóëèí, îñíîâíîé ïåðåíîñ÷èê òèðåîèäíûõ ãîðìîíîâ, ïðî÷íî ñâÿçûâàåòñÿ ñ Ò4, íàìíîãî ñëàáåå ñ Ò3.

10
Mendel CM. The Free Hormone Hypothesis: A Physiologically Based Mathematical Model. Endocrine reviews 1989; 10(3): 232–74.
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    Èç-çà ðàçëè÷èÿ â êîíñòàíòàõ àññîöèàöèè ñ áåëêàìè Ò4 è Ò3 ïåðèîäû ïîëóâûâåäåíèÿ (Ò1/2) ýòèõ ãîðìîíîâ îòëè÷àþòñÿ â 10–100 ðàç. Ñâîáîäíûå ãîðìîíû, ñïîñîáíûå âñòóïàòü âî âçàèìîäåéñòâèå ñî ñïåöèôè÷åñêèìè ðåöåïòîðàìè, ñîñòàâëÿþò ìàëóþ ÷àñòü îò îáùåãî êîëè÷åñòâà òèðåîèäíûõ ãîðìîíî⠗ îêîëî 0,03 % äëÿ Ò4 è 0,3 % äëÿ Ò3
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    . Ò1/2Ò4 ñîñòàâëÿåò 6–8 ñóòîê, ñîêðàùàÿñü ïðè òèðåîòîêñèêîçå äî 3–4 ñóòîê, ïðè ãèïîòèðåîçå âîçðàñòàÿ äî 9–10 ñóòîê, ÷òî ÿâëÿåòñÿ îòðàæåíèåì ñïîñîáíîñòè ê ìåòàáîëèçìó è âûñâîáîæäåíèþ èç ñâÿçè ñ áåëêàìè-ïåðåíîñ÷èêàìè.

11
Wilber JF, Xu AH. The thyrotropin-releasing hormone gene: cloning, characterization, and transcriptional regulation in the central nervous system, heart, and testis. Thyroid 1998; (8): 897–901.
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    Ñâîáîäíûå òèðåîèäíûå ãîðìîíû, â îñíîâíîì Ò3, âçàèìîäåéñòâóþò ñ âûñîêîàôôèííûìè âíóòðèêëåòî÷íûìè ðåöåïòîðàìè, èçìåíÿÿ èõ ñðîäñòâî ê Ò3-÷óâñòâèòåëüíûì ðåãóëÿòîðíûì ýëåìåíòàì, âëèÿÿ íà ýêñïðåññèþ òåõ èëè èíûõ ãåíîâ. Îò óðîâíÿ Ò3 çàâèñÿò ñåêðåöèÿ òèðîëèáåðèíà ãèïîòàëàìóñîì è ïëîòíîñòü ðåöåïòîðîâ òèðîëèáåðèíà íà òèðåîòðîïíûõ êëåòêàõ àäåíîãèïîôèçà
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    . Àêòèâíàÿ ôîðìà Ò3 íàïðÿìóþ óñèëèâàåò ñèíòåç êàðäèîñïåöèôè÷íûõ áåëêîâ è òåì ñàìûì îáåñïå÷èâàåò óñèëåíèå ñîêðàòèòåëüíîé ôóíêöèè ñåðäöà. Òàêæå èìåþòñÿ ñâåäåíèÿ è î âíåÿäåðíîì äåéñòâèè ãîðìîíîâ íåïîñðåäñòâåííî íà öèòîïëàçìàòè÷åñêóþ ìåìáðàíó è îðãàíåëëû êëåòêè.

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Zakharenko RV. Clinical aspects of thyroid disease in patients with cardiac pathology. Dalnevostochny meditsinskiy zhurnal 2010; (3): 18–22 (in Russian).
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    Òàêæå èìåþòñÿ ñâåäåíèÿ è î âíåÿäåðíîì äåéñòâèè ãîðìîíîâ íåïîñðåäñòâåííî íà öèòîïëàçìàòè÷åñêóþ ìåìáðàíó è îðãàíåëëû êëåòêè. Óñòàíîâëåíî, ÷òî Ò3 è â ìåíüøåé ñòåïåíè Ò4 ñïîñîáíû óâåëè÷èâàòü ïëîòíîñòü áåòà-àäðåíîðåöåïòîðîâ íà ïîâåðõíîñòè êëåòîê ñåðäå÷íîé ìûøöû
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    . Ðåöåïòîðû ê Ò4 ðàñïîëîæåíû â îñíîâíîì â ïåðåäíåé äîëå ãèïîôèçà è ÿäðàõ ãèïîòàëàìóñà. ×åðåç èõ àêòèâèçàöèþ ðåàëèçóåòñÿ ìåõàíèçì îòðèöàòåëüíîé îáðàòíîé ñâÿçè ùèòîâèäíîé æåëåçû. Àôôèííîñòü ðåöåïòîðîâ ê Ò4 â ïåðèôåðè÷åñêèõ òêàíÿõ â 6–10 ðàç íèæå, ÷åì ê Ò3, ïîýòîìó àêòèâàöèÿ ýòèõ ðåöåïòîðîâ îñóùåñòâëÿåòñÿ òîëüêî â ñëó÷àÿõ î÷åíü íèçêîãî óðîâíÿ Ò3 è/èëè î÷åíü âûñîêîãî óðîâíÿ Ò4 â êðîâè [13].

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Veintraub BV, ed. Molecular endocrinology. Fundamental study and it’s reflection in the clinic. Moscow: Meditsina; 2003 (in Russian).
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    Àôôèííîñòü ðåöåïòîðîâ ê Ò4 â ïåðèôåðè÷åñêèõ òêàíÿõ â 6–10 ðàç íèæå, ÷åì ê Ò3, ïîýòîìó àêòèâàöèÿ ýòèõ ðåöåïòîðîâ îñóùåñòâëÿåòñÿ òîëüêî â ñëó÷àÿõ î÷åíü íèçêîãî óðîâíÿ Ò3 è/èëè î÷åíü âûñîêîãî óðîâíÿ Ò4 â êðîâè
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    . Òàêèì îáðàçîì, â óñëîâèÿõ òèðåîèäíîãî äåôèöèòà àêòèâèçèðóþòñÿ âñå ìåõàíèçìû ïîëó÷åíèÿ Ò3, îáåñïå÷èâàÿ îïòèìàëüíûé ñèíòåç áåëêà ïðè ïîâûøåííîé ÷óâñòâèòåëüíîñòè òêàíåé ê òèðåîèäíûì ãîðìîíàì è êàòåõîëàìèíàì.

14
Pearce SHS, Brabant G, Duntas L, Monzani F, Peeters R, Razvi S, Wemeau JL. 2013 ETA Guideline: Management of Subclinical Hypothyroidism. Eur Thyroid J 2013; 2(4): 215–28.
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    Ïîêàçàòåëü ÒÒà ïðåäñòàâëÿåòñÿ îñîáåííî âàæíûì â îòíîøåíèè êàðäèîâàñêóëÿðíûõ ðèñêîâ: ÷àñòîòà èøåìè÷åñêîé áîëåçíè ñåðäöà ïðè ñóáêëèíè÷åñêîì ãèïîòèðåîçå (ÑÃ) ðàñòåò ïðîïîðöèîíàëüíî óâåëè÷åíèþ ÒÒà (ð< 0,001) âíå çàâèñèìîñòè îò âîçðàñòà, ïîëà, èìåþùåéñÿ ñåðäå÷íî-ñîñóäèñòîé ïàòîëîãèè
    Exact
    [14]
    Suffix
    . Óñïåøíîìó ëå÷åíèþ Ñà ïðåïÿòñòâóåò òî, ÷òî äîêàçàíà îáðàòíàÿ ñâÿçü ìåæäó ÒÒà è ðèñêîì âîçíèêÒàáëèöà 1 ÄÈÀÃÍÎÑÒÈÊÀ ÂÀÐÈÀÍÒΠÊËÈÍÈ×ÅÑÊÎÃÎ ÒÅ×ÅÍÈß ÃÈÏÎÒÈÐÅÎÇÀ Ëàáîðàòîðíûå ïîêàçàòåëèÑóáêëèíè÷åñêèé âàðèàíò Ìàíèôåñòíûé âàðèàíò Îñëîæíåíèÿ ÃîðìîíûÍîðìàÄåêîìïåíñèðîâàííûé Êîìïåíñèðîâàííûé ÒÒà (ÌÅ/ë)0,4–4,0>4,0 è <10,0³10,0ìåäèêàìåíòîçíàÿ êëèíèêî-ëàáîðàòîðíàÿ ðåìèññèÿ íà ôîíå äåêîìïåíñàöèè âîçíèêàþò òÿæ

15
Selmer C, Olesen JB, Hansen ML, Lindhardsen J, Olsen AM, Madsen JC, et al. The spectrum of thyroid disease and risk of new onset atrial fibrillation: a large population cohort study. BMJ 2012; 345.
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    (ÌÅ/ë)0,4–4,0>4,0 è <10,0³10,0ìåäèêàìåíòîçíàÿ êëèíèêî-ëàáîðàòîðíàÿ ðåìèññèÿ íà ôîíå äåêîìïåíñàöèè âîçíèêàþò òÿæåëûå è óãðîæàþùèå æèçíè ñèíäðîìû* Ò4ïî íîðìàì ëàáîðàòîðèè â ïðåäåëàõ íîðìû íèæå íîðìû * Îñëîæíåíèÿ ãèïîòèðåîçà — âûïîò â ïëåâðàëüíóþ, ïåðèêàðäèàëüíóþ è áðþøíóþ ïîëîñòè, ñåðäå÷íàÿ íåäîñòàòî÷íîñòü, âòîðè÷íàÿ àäåíîìà ãèïîôèçà, ãèïîòèðåîèäíàÿ êîìà, êðåòèíèçì íîâåíèÿ ôèáðèëëÿöèè ïðåäñåðäèé
    Exact
    [15]
    Suffix
    . Êîððåêöèÿ òèðåîèäíîãî äåôèöèòà â ãðóïïå ëþäåé ñòàðøå 55 ëåò ïðîâîäèòñÿ êðàéíå îñòîðîæíî, òàê êàê äîïîëíèòåëüíîå ââåäåíèå â îðãàíèçì éîäà, ñâîáîäíîãî Ò3 èëè áîëüøîãî êîëè÷åñòâà Ò4 ìîæåò âûçâàòü àðèòìèþ.

16
Tsareva YuO. Features of daily fluctuations of thyroid hormones in patients with cardiovasculardisease. BulletenmeditsinskihInternetkonferentsiy 2014; 4(3): 232. Available from: https://goo.gl/783enU (in Russian).
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    Îêàçàëîñü, ÷òî ÷åì ìåíüøå äëèòåëüíîñòü çàáîëåâàíèÿ ãèïåðòîíèåé ó ïàöèåíòîâ, òåì ó íèõ íàáëþäàåòñÿ çíà÷èìî áîëåå óçêèé èíòåðâàë êîëåáàíèé ÒÒÃ. Ó ïàöèåíòîâ ñ íàèìåíüøèì ñòàæåì ãèïåðòîíèè îòìå÷àëèñü îòíîñèòåëüíî íèçêèå óòðåííèå è âå÷åðíèå êîíöåíòðàöèè ÒÒÃ
    Exact
    [16]
    Suffix
    . Ïî ñðàâíåíèþ ñ êîíòðîëåì, æåíùèíû ôåðòèëüíîãî âîçðàñòà ñ ÑÃ, íå èìåþùèå êàðäèàëüíîãî àíàìíåçà, â áîëüøåé ñòåïåíè ïðåäðàñïîëîæåíû ê ðàçâèòèþ äèñëèïèäåìèé, îêèñëèòåëüíîãî ñòðåññà, äèàñòîëè÷åñêîé è ýíäîòåëèàëüíîé äèñôóíêöèé, àíåìèé è íàðóøåíèé îáìåíà æåëåçà.

17
Nekrasova TA, Strongin LG, Ledentsova OV, Kazakova LV. The relationship between TTG levels and some of the factors of cardiovascular risk in patients with autoimmune thyroiditis and subclinical hypothyroidism. Klinicheskaya i eksperimentalnaya tireoidologiya 2014; (2): 16–22 (in Russian).
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    Íà÷àëüíûå ïðîÿâëåíèÿ ýòèõ íàðóøåíèé ÷àùå âîçíèêàþò ïðè çíà÷åíèÿõ ÒÒà â äèàïàçîíå 4,4–5,85 ìÅä/ë. Óðîâåíü ÒÒà áîëåå 5,25 ìÅä/ë ìîæåò ðàññìàòðèâàòüñÿ êàê ïðåäèêòîð ðàçâèòèÿ àññîöèèðîâàííûõ ñ Ñà êàðäèîâàñêóëÿðíûõ èçìåíåíèé
    Exact
    [17]
    Suffix
    . Ñî ñíèæåíèåì òèðåîèäíîãî ñòàòóñà ó æåíùèí ñâÿçàíû ïðîáëåìû ôåðòèëüíîñòè, íåâûíàøèâàåìîñòè áåðåìåííîñòè [18] è âðîæäåííîãî ãèïîòèðåîçà [19]. Öåëüþ çàìåñòèòåëüíîé òåðàïèè ïðè ýòîì ÿâëÿåòñÿ ñîçäàíèå óñëîâèé îïòèìàëüíîãî ñíàáæåíèÿ òêàíåé îðãàíèçìà Ò3.

18
Bartáková J, Potlukova E, Rogalewicz V, Fait T, Schöndorfova D, Telivcka Z, et al.Screening for autoimmune thyroid disorders after spontaneous abortion is cost-saving and it improves thesubsequent pregnancy rate. BMC Pregnancy Childbirth 2013; 13: 217.
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    Óðîâåíü ÒÒà áîëåå 5,25 ìÅä/ë ìîæåò ðàññìàòðèâàòüñÿ êàê ïðåäèêòîð ðàçâèòèÿ àññîöèèðîâàííûõ ñ Ñà êàðäèîâàñêóëÿðíûõ èçìåíåíèé [17]. Ñî ñíèæåíèåì òèðåîèäíîãî ñòàòóñà ó æåíùèí ñâÿçàíû ïðîáëåìû ôåðòèëüíîñòè, íåâûíàøèâàåìîñòè áåðåìåííîñòè
    Exact
    [18]
    Suffix
    è âðîæäåííîãî ãèïîòèðåîçà [19]. Öåëüþ çàìåñòèòåëüíîé òåðàïèè ïðè ýòîì ÿâëÿåòñÿ ñîçäàíèå óñëîâèé îïòèìàëüíîãî ñíàáæåíèÿ òêàíåé îðãàíèçìà Ò3. Êðîìå çàìåñòèòåëüíîé òåðàïèè, ïðåïàðàòû ëåâîòèðîêñèíà â âûñîêèõ äîçàõ (ìàêñèìàëüíî ïåðåíîñèìûõ êîíöåíòðàöèé) èñïîëüçóþòñÿ ñ öåëüþ äîñòèæåíèÿ ñóïðåññèâíîãî äåéñòâèÿ íà ÒÒà ó áîëüíûõ, ïîëó÷àâøèõ ëå÷åíèå ïî ïîâîäó ðàêîâûõ çàáîëåâàíèé ùèòîâèäíîé æåëåçû.

19
Peroni E, Vigone MC, Mora S, Bassi LA, Pozzi C, Passoni A, Weber G. Congenital hypothyroidism treatment in infants: a comparative study between liquid and tablet formulations of levothyroxine. Hormone Research in Paediatrics 2013; 81(1): 50–4.
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    Óðîâåíü ÒÒà áîëåå 5,25 ìÅä/ë ìîæåò ðàññìàòðèâàòüñÿ êàê ïðåäèêòîð ðàçâèòèÿ àññîöèèðîâàííûõ ñ Ñà êàðäèîâàñêóëÿðíûõ èçìåíåíèé [17]. Ñî ñíèæåíèåì òèðåîèäíîãî ñòàòóñà ó æåíùèí ñâÿçàíû ïðîáëåìû ôåðòèëüíîñòè, íåâûíàøèâàåìîñòè áåðåìåííîñòè [18] è âðîæäåííîãî ãèïîòèðåîçà
    Exact
    [19]
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    . Öåëüþ çàìåñòèòåëüíîé òåðàïèè ïðè ýòîì ÿâëÿåòñÿ ñîçäàíèå óñëîâèé îïòèìàëüíîãî ñíàáæåíèÿ òêàíåé îðãàíèçìà Ò3. Êðîìå çàìåñòèòåëüíîé òåðàïèè, ïðåïàðàòû ëåâîòèðîêñèíà â âûñîêèõ äîçàõ (ìàêñèìàëüíî ïåðåíîñèìûõ êîíöåíòðàöèé) èñïîëüçóþòñÿ ñ öåëüþ äîñòèæåíèÿ ñóïðåññèâíîãî äåéñòâèÿ íà ÒÒà ó áîëüíûõ, ïîëó÷àâøèõ ëå÷åíèå ïî ïîâîäó ðàêîâûõ çàáîëåâàíèé ùèòîâèäíîé æåëåçû.

20
Garber JR, Cobin RH, Gharib H, Hennessey JV, Klein I, Mechanick JI, et al. Clinical Practice Guidelines for Hypothyroidism in Adults: Cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012; 18(6): 988–1028.
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    ëåâîòèðîêñèíà â âûñîêèõ äîçàõ (ìàêñèìàëüíî ïåðåíîñèìûõ êîíöåíòðàöèé) èñïîëüçóþòñÿ ñ öåëüþ äîñòèæåíèÿ ñóïðåññèâíîãî äåéñòâèÿ íà ÒÒà ó áîëüíûõ, ïîëó÷àâøèõ ëå÷åíèå ïî ïîâîäó ðàêîâûõ çàáîëåâàíèé ùèòîâèäíîé æåëåçû. Ïðèìåíåíèå òèðåîèäíûõ ãîðìîíîâ â êàæäîé íîçîëîãè÷åñêîé è âîçðàñòíîé ãðóïïå èìååò ñâîè îñîáåííîñòè, ÷òî íàõîäèò îòðàæåíèå â ïîñòîÿííî óòî÷íÿþùèõñÿ è èçìåíÿþùèõñÿ ðåêîìåíäàöèÿõ
    Exact
    [20]
    Suffix
    . ÊËÈÍÈ×ÅÑÊÀß ÔÀÐÌÀÊÎËÎÃÈß ÏÐÅÏÀÐÀÒΠËÅÂÎÒÈÐÎÊÑÈÍÀ È ËÈÎÒÈÐÎÍÈÍÀ Ïîïûòêè ëå÷åíèÿ ïàöèåíòîâ òîëüêî ïðåïàðàòàìè ëèîòèðîíèíà, ñèíòåòè÷åñêîãî àíàëîãà Ò3, íà ïðàêòèêå îêàçàëèñü ìåíåå óäà÷íûìè, ÷åì ðåçóëüòàòû èñïîëüçîâàíèÿ ëåâîòèðîêñèíà.

21
Gkotsina M, Michalaki M, Mamali I, Markantes G, Sakellaropoulos GC, Kalfarentzos F, et al. Improvedlevothyroxine pharmacokinetics after bariatric surgery. Thyroid 2013; 23: 414–9.
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    Åãî àêòèâíîñòü â òàáëåòèðîâàííîé ôîðìå õîðîøî èçó÷åíà. Ïðè ïðèåìå âíóòðü ëåâîòèðîêñèí âñàñûâàåòñÿ â òîíêîé è ïîäâçäîøíîé êèøêå â òå÷åíèå 3 ÷àñîâ; åãî áèîäîñòóïíîñòü íå âñåãäà îäèíàêîâà è ñîñòàâëÿåò 50–80 % (ïî íåêîòîðûì äàííûì äî 90 %)
    Exact
    [21]
    Suffix
    . Ìàêñèìóì âñàñûâàíèÿ ïðîèñõîäèò íàòîùàê è çàâèñèò îò êèñëîòíîñòè æåëóäî÷íîãî ñîêà, ÷òî èìååò çíà÷åíèå äëÿ ðàñòâîðåíèÿ òàáëåòêè, óäàëåíèÿ èîíîâ íàòðèÿ è ïðåâðàùåíèÿ ëåâîòèðîêñèíà â ëèïîôèëüíóþ ìîëåêóëó [22].

22
Wenzel KW, Kirschsieper HE. Aspects of the absorption of oral L-thyroxine in normal man. Metabolism 1977; 26: 1–8.
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    Ìàêñèìóì âñàñûâàíèÿ ïðîèñõîäèò íàòîùàê è çàâèñèò îò êèñëîòíîñòè æåëóäî÷íîãî ñîêà, ÷òî èìååò çíà÷åíèå äëÿ ðàñòâîðåíèÿ òàáëåòêè, óäàëåíèÿ èîíîâ íàòðèÿ è ïðåâðàùåíèÿ ëåâîòèðîêñèíà â ëèïîôèëüíóþ ìîëåêóëó
    Exact
    [22]
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    . Íà ôàðìàêîêèíåòèêó ïðåïàðàòîâ ëåâîòèðîêñèíà âëèÿþò çàáîëåâàíèÿ ÆÊÒ (ãàñòðèò, àòðîôè÷åñêèé ãàñòðèò), àññîöèèðîâàííûå ñ óâåëè÷åíèåì ðÍ ñîäåðæèìîãî æåëóäêà è ïðèñóòñòâèåì Helicobacter pylori. Ýòî ïðèâîäèò ê èçìåíåíèþ èîíèçàöèè è ïðîñòðàíñòâåííîé êîíôèãóðàöèè ìîëåêóëû ëåâîòèðîêñèíà, óõóäøàåò âñàñûâàíèå è â ðåçóëüòàòå òðåáóåò ââåäåíèÿ áîëüøåé äîçû ëåâîòèðîêñèíà (îò 22 äî 34 %) [23].

23
Centanni M, Gargano L, Canettieri G, Viceconti N, Franchi A, Delle Fave G, et al. Thyroxine in goiter, Helicobacter pilori infection, and chronic gastritis. N Engl J Med 2006; 354: 1787–95.
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    Íà ôàðìàêîêèíåòèêó ïðåïàðàòîâ ëåâîòèðîêñèíà âëèÿþò çàáîëåâàíèÿ ÆÊÒ (ãàñòðèò, àòðîôè÷åñêèé ãàñòðèò), àññîöèèðîâàííûå ñ óâåëè÷åíèåì ðÍ ñîäåðæèìîãî æåëóäêà è ïðèñóòñòâèåì Helicobacter pylori. Ýòî ïðèâîäèò ê èçìåíåíèþ èîíèçàöèè è ïðîñòðàíñòâåííîé êîíôèãóðàöèè ìîëåêóëû ëåâîòèðîêñèíà, óõóäøàåò âñàñûâàíèå è â ðåçóëüòàòå òðåáóåò ââåäåíèÿ áîëüøåé äîçû ëåâîòèðîêñèíà (îò 22 äî 34 %)
    Exact
    [23]
    Suffix
    . Ê íàñòîÿùåìó âðåìåíè ïîëó÷åíû äàííûå â ðåçóëüòàòå êëèíè÷åñêèõ èññëåäîâàíèé â ãðóïïàõ áîëüíûõ ñ àóòîèììóííûì òèðåîèäèòîì è ãèïîòèðåîçîì è ñîïóòñòâóþùèì çàáîëåâàíèåì — öåëèàêèåé. Ïàöèåíòû, íå ñîáëþäàþùèå àãëþòåíîâóþ äèåòó, òðåáóþò óâåëè÷åíèÿ äîçû Ò4 â 2 ðàçà [24].

24
Hadithi M, de Boer H, Meijer JW, Willekens F, Kerckhaert JA, Heijmans R, et al. Coeliac disease in Dutch patients with Hashimoto’s thyroditis and vice versa. World J Gastroenterol. 2007; 13: 1715–22.
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    Ê íàñòîÿùåìó âðåìåíè ïîëó÷åíû äàííûå â ðåçóëüòàòå êëèíè÷åñêèõ èññëåäîâàíèé â ãðóïïàõ áîëüíûõ ñ àóòîèììóííûì òèðåîèäèòîì è ãèïîòèðåîçîì è ñîïóòñòâóþùèì çàáîëåâàíèåì — öåëèàêèåé. Ïàöèåíòû, íå ñîáëþäàþùèå àãëþòåíîâóþ äèåòó, òðåáóþò óâåëè÷åíèÿ äîçû Ò4 â 2 ðàçà
    Exact
    [24]
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    . Ïðè ôåðìåíòîïàòèÿõ (äåôèöèò ëàêòàçû) íåïåðåíîñèìîñòü ëàêòîçû òàêæå ìîæåò ïðèâåñòè ê ïîâûøåíèþ ïîòðåáíîñòè â ïðåïàðàòå Ò4 [25]. Íàðóøåíèå ïåðåâàðèâàíèÿ ëàêòîçû ïðèâîäèò ê áàêòåðèàëüíîé ôåðìåíòàöèè, âëèÿåò íà îñìîñ è óñêîðÿåò ïåðèñòàëüòèêó, ÷òî, â ñâîþ î÷åðåäü, ñîêðàùàåò âðåìÿ êîíòàêòà ìåæäó ëàêòîçîé è ôåðìåíòàìè è äàëåå óìåíüøàåò ãèäðîëèç ëàêòîçû [26].

25
Muñoz-Torres M, Varsavsky M, Alonso G. Lactose intolerance revealed by severe resistance to treatment with levothyroxine. Thyroid 2006; 16: 1171–3.
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    Ïàöèåíòû, íå ñîáëþäàþùèå àãëþòåíîâóþ äèåòó, òðåáóþò óâåëè÷åíèÿ äîçû Ò4 â 2 ðàçà [24]. Ïðè ôåðìåíòîïàòèÿõ (äåôèöèò ëàêòàçû) íåïåðåíîñèìîñòü ëàêòîçû òàêæå ìîæåò ïðèâåñòè ê ïîâûøåíèþ ïîòðåáíîñòè â ïðåïàðàòå Ò4
    Exact
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    Suffix
    . Íàðóøåíèå ïåðåâàðèâàíèÿ ëàêòîçû ïðèâîäèò ê áàêòåðèàëüíîé ôåðìåíòàöèè, âëèÿåò íà îñìîñ è óñêîðÿåò ïåðèñòàëüòèêó, ÷òî, â ñâîþ î÷åðåäü, ñîêðàùàåò âðåìÿ êîíòàêòà ìåæäó ëàêòîçîé è ôåðìåíòàìè è äàëåå óìåíüøàåò ãèäðîëèç ëàêòîçû [26].

26
Ladas S, Papanikos J, Arapakis G. Lactose malabsorption in Greek adults: correlation of small bowel transit time with the severity of lactose intolerance. Gut 1982; 23: 968–73.
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    Íàðóøåíèå ïåðåâàðèâàíèÿ ëàêòîçû ïðèâîäèò ê áàêòåðèàëüíîé ôåðìåíòàöèè, âëèÿåò íà îñìîñ è óñêîðÿåò ïåðèñòàëüòèêó, ÷òî, â ñâîþ î÷åðåäü, ñîêðàùàåò âðåìÿ êîíòàêòà ìåæäó ëàêòîçîé è ôåðìåíòàìè è äàëåå óìåíüøàåò ãèäðîëèç ëàêòîçû
    Exact
    [26]
    Suffix
    . Êîíñòèòóöèîíàëüíàÿ ëàêòàçíàÿ íåäîñòàòî÷íîñòü íàñåëåíèÿ Ðîññèè ñîñòàâëÿåò 16–18 % [27], ñ ìàêñèìóìîì ïðîÿâëåíèÿ ó äåòåé ìëàäøåãî âîçðàñòà. ÂÑÏÎÌÎÃÀÒÅËÜÍÛÅ ÂÅÙÅÑÒÂÀ, ÂÕÎÄßÙÈÅ Â ÏÐÅÏÀÐÀÒÛ ËÅÂÎÒÈÐÎÊÑÈÍÀ, È ÈÕ ÂËÈßÍÈÅ ÍÀ ÀÁÑÎÐÁÖÈÞ Ïðîáëåìà èñïîëüçîâàíèÿ ëàêòîçîñîäåðæàùèõ êîìïîíåíòîâ â êà÷åñòâå âñïîìîãàòåëüíûõ âåùåñòâ â ïðîèçâîäñòâå ëåêàðñòâåííûõ ñðåäñòâ ïðèñòàëüíî èçó÷àåòñÿ.

27
Belmer SV, Mukhina YuG, Chubarova AI, et al. Lactose intolerance in children and adults. Voprosy detskoy dietologii 2004; 2(1): 101–3 (in Russian).
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    Íàðóøåíèå ïåðåâàðèâàíèÿ ëàêòîçû ïðèâîäèò ê áàêòåðèàëüíîé ôåðìåíòàöèè, âëèÿåò íà îñìîñ è óñêîðÿåò ïåðèñòàëüòèêó, ÷òî, â ñâîþ î÷åðåäü, ñîêðàùàåò âðåìÿ êîíòàêòà ìåæäó ëàêòîçîé è ôåðìåíòàìè è äàëåå óìåíüøàåò ãèäðîëèç ëàêòîçû [26]. Êîíñòèòóöèîíàëüíàÿ ëàêòàçíàÿ íåäîñòàòî÷íîñòü íàñåëåíèÿ Ðîññèè ñîñòàâëÿåò 16–18 %
    Exact
    [27]
    Suffix
    , ñ ìàêñèìóìîì ïðîÿâëåíèÿ ó äåòåé ìëàäøåãî âîçðàñòà. ÂÑÏÎÌÎÃÀÒÅËÜÍÛÅ ÂÅÙÅÑÒÂÀ, ÂÕÎÄßÙÈÅ Â ÏÐÅÏÀÐÀÒÛ ËÅÂÎÒÈÐÎÊÑÈÍÀ, È ÈÕ ÂËÈßÍÈÅ ÍÀ ÀÁÑÎÐÁÖÈÞ Ïðîáëåìà èñïîëüçîâàíèÿ ëàêòîçîñîäåðæàùèõ êîìïîíåíòîâ â êà÷åñòâå âñïîìîãàòåëüíûõ âåùåñòâ â ïðîèçâîäñòâå ëåêàðñòâåííûõ ñðåäñòâ ïðèñòàëüíî èçó÷àåòñÿ.

28
Eadala P, Waud JP, Matthews SB, Green JT, Campell AK, Quantifying the «hidden» lactose in drugs used for the treatment of gastrointestinal conditions. Aliment Pharmacol Ther. 2009; 29: 677–87.
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    Òàê, ïî ðåçóëüòàòàì èññëåäîâàíèÿ, ïðîâåäåííîãî â Âåëèêîáðèòàíèè íà ïðåïàðàòàõ, ïðèìåíÿåìûõ â ãàñòðîýíòåðîëîãèè, ñäåëàí âûâîä î òîì, ÷òî ïðèñóòñòâèå ëàêòîçû â òàáëåòêå ìîæåò áûòü çíà÷èìî äëÿ àáñîðáöèè è íîñèò äîçîçàâèñèìûé õàðàêòåð
    Exact
    [28]
    Suffix
    . Ìíîãèå ïðåïàðàòû ëåâîòèðîêñèíà ñîäåðæàò ëàêòîçó.  Ðîññèè ýòî Ýóòèðîêñ, Áàãîòèðîêñ, L-TèðîêñèíÔàðìàê, L-Òèðîêñèí-Àêðè. Èíòåðåñíû ðåçóëüòàòû èññëåäîâàíèÿ ïðåïàðàòîâ ëåâîòèðîêñèíà â óñëîâèÿõ óñêîðåííîãî èñêóññòâåííîãî ñòàðåíèÿ: ñîäåðæàíèå ëàêòîçû ïðèâîäèëî ê íàêîïëåíèþ âëàãè íà 0,8–5,0 % è ïîòåðå àêòèâíîñòè ëåâîòèðîêñèíà íà 30 %.

29
United States Pharmacopoeia. Available from: http:// www.usp.org.
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    Òàáëåòêè ñ ëàêòîçîé áåçâîäíîé, êðàõìàëîì èëè ìèêðîêðèñòàëëè÷åñêîé öåëëþëîçîé íå ñîîòâåòñòâîâàëè òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ ïðè ïðîâåäåíèè èñïûòàíèé äëÿ 3 ìåñÿöåâ õðàíåíèÿ ïðè òåìïåðàòóðå 40 °Ñ è 75 % îòíîñèòåëüíîé âëàæíîñòè
    Exact
    [29, 30]
    Suffix
    . Òàáëåòêè, èçãîòîâëåííûå ñ äâóõîñíîâíûì ôîñôàòîì êàëüöèÿ èëè ñ ìàííèòîì, îòâå÷àëè òðåáîâàíèÿì èñïûòàíèé äëÿ 3 ìåñÿöåâ õðàíåíèÿ, íî íå äëÿ 6 ìåñÿöåâ. Òàáëåòêè, èçãîòîâëåííûå ñ äâóõîñíîâíûì ôîñôàòîì êàëüöèÿ è îñíîâíûì ìîäèôèêàòîðîì ðÍ (êàðáîíàò íàòðèÿ, áèêàðáîíàò íàòðèÿ èëè îêñèä ìàãíèÿ), îòâå÷àëè òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ êàê äëÿ 3, òàê è äëÿ 6 ìåñÿöåâ õðàíåíèÿ.

  2. In-text reference with the coordinate start=17556
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    Òàáëåòêè, èçãîòîâëåííûå ñ äâóõîñíîâíûì ôîñôàòîì êàëüöèÿ è îñíîâíûì ìîäèôèêàòîðîì ðÍ (êàðáîíàò íàòðèÿ, áèêàðáîíàò íàòðèÿ èëè îêñèä ìàãíèÿ), îòâå÷àëè òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ êàê äëÿ 3, òàê è äëÿ 6 ìåñÿöåâ õðàíåíèÿ. Áûë ñäåëàí âûâîä, ÷òî èñïîëüçîâàíèå îñíîâíûõ ìîäèôèêàòîðîâ ðÍ ÿâëÿåòñÿ ïîòåíöèàëüíûì ìåòîäîì äëÿ óëó÷øåíèÿ ñòàáèëüíîñòè òàáëåòîê ëåâîòèðîêñèíà íàòðèÿ
    Exact
    [29]
    Suffix
    . Äëÿ óëó÷øåíèÿ ñòàáèëüíîñòè òàáëåòîê ëåâîòèðîêñèíà íàòðèÿ íå âñå ïðîèçâîäèòåëè èñêëþ÷àþò ëàêòîçó èç ñîñòàâà òàáëåòîê. Ðàçðàáîò÷èêè òàáëåòîê L-Òèðîêñèí-Àêðè âûáðàëè â êà÷åñòâå ðåôåðåíòíîãî ïðåïàðàòà L-Òèðîêñèí 100 ôèðìû «Áåðëèí-Õåìè».

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    Ïî ðåçóëüòàòàì èçó÷åíèÿ ñòàáèëüíîñòè ïðåïàðàòà â åñòåñòâåííûõ óñëîâèÿõ áûë óâåëè÷åí ñðîê åãî ãîäíîñòèñ2äî 3 ëåò. Ñ öåëüþ óíèôèêàöèè ìåòîäîâ ñòàíäàðòèçàöèè ïðåïàðàòà èñïîëüçîâàëè ÂÝÆÕ. Áûëî ïðåäëîæåíî íîðìèðîâàòü ñîäåðæàíèå ïðèìåñè ëèîòèðîíèíà íà óðîâíå 2,0 %, ÷òî ñîîòâåòñòâóåò òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ
    Exact
    [29, 31, 32]
    Suffix
    . Ðàáîòà çàâåðøèëàñü ðåãèñòðàöèåé ïðåïàðàòà 07.08.2007 ã. [33]. Ïàðàëëåëüíî êîìïàíèÿ «Áåðëèí-Õåìè/À. Ìåíàðèíè», ïðîâîäèâøàÿ ðàáîòó ïî óñîâåðøåíñòâîâàíèþ ïðåïàðàòà, èñêëþ÷èëà ëàêòîçó èç âñïîìîãàòåëüíûõ âåùåñòâ, èñïîëüçóåìûõ â ïðîèçâîäñòâå ëåâîòèðîêñèíà, çàìåíèâ åå íà äâóõîñíîâíûé ôîñôàò êàëüöèÿ [33].

30
Patel H, Stalcup A, Dansereau R, Sakr A. The effect of excipients on the stability of levothyroxine sodium pentahydrate tablets. Int J Pharm. 2003; 264(1–2): 35–43.
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    Òàáëåòêè ñ ëàêòîçîé áåçâîäíîé, êðàõìàëîì èëè ìèêðîêðèñòàëëè÷åñêîé öåëëþëîçîé íå ñîîòâåòñòâîâàëè òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ ïðè ïðîâåäåíèè èñïûòàíèé äëÿ 3 ìåñÿöåâ õðàíåíèÿ ïðè òåìïåðàòóðå 40 °Ñ è 75 % îòíîñèòåëüíîé âëàæíîñòè
    Exact
    [29, 30]
    Suffix
    . Òàáëåòêè, èçãîòîâëåííûå ñ äâóõîñíîâíûì ôîñôàòîì êàëüöèÿ èëè ñ ìàííèòîì, îòâå÷àëè òðåáîâàíèÿì èñïûòàíèé äëÿ 3 ìåñÿöåâ õðàíåíèÿ, íî íå äëÿ 6 ìåñÿöåâ. Òàáëåòêè, èçãîòîâëåííûå ñ äâóõîñíîâíûì ôîñôàòîì êàëüöèÿ è îñíîâíûì ìîäèôèêàòîðîì ðÍ (êàðáîíàò íàòðèÿ, áèêàðáîíàò íàòðèÿ èëè îêñèä ìàãíèÿ), îòâå÷àëè òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ êàê äëÿ 3, òàê è äëÿ 6 ìåñÿöåâ õðàíåíèÿ.

31
Emshanova SV, Sadchikova NP, Zuev AP. Drug particle shape and size control: A necessary factor for high-quality drug production. Pharmaceutical Chemistry Journal 2007; 41(1): 40–9.
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  1. In-text reference with the coordinate start=19796
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    Ïî ðåçóëüòàòàì èçó÷åíèÿ ñòàáèëüíîñòè ïðåïàðàòà â åñòåñòâåííûõ óñëîâèÿõ áûë óâåëè÷åí ñðîê åãî ãîäíîñòèñ2äî 3 ëåò. Ñ öåëüþ óíèôèêàöèè ìåòîäîâ ñòàíäàðòèçàöèè ïðåïàðàòà èñïîëüçîâàëè ÂÝÆÕ. Áûëî ïðåäëîæåíî íîðìèðîâàòü ñîäåðæàíèå ïðèìåñè ëèîòèðîíèíà íà óðîâíå 2,0 %, ÷òî ñîîòâåòñòâóåò òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ
    Exact
    [29, 31, 32]
    Suffix
    . Ðàáîòà çàâåðøèëàñü ðåãèñòðàöèåé ïðåïàðàòà 07.08.2007 ã. [33]. Ïàðàëëåëüíî êîìïàíèÿ «Áåðëèí-Õåìè/À. Ìåíàðèíè», ïðîâîäèâøàÿ ðàáîòó ïî óñîâåðøåíñòâîâàíèþ ïðåïàðàòà, èñêëþ÷èëà ëàêòîçó èç âñïîìîãàòåëüíûõ âåùåñòâ, èñïîëüçóåìûõ â ïðîèçâîäñòâå ëåâîòèðîêñèíà, çàìåíèâ åå íà äâóõîñíîâíûé ôîñôàò êàëüöèÿ [33].

32
Emshanova SV. Ensuring the quality of domestic medical products (technology optimization and improvement of tablet dosage forms standardization). Dr. Pharm. Sci [thesis]. Moscow; 2007 (in Russian).
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    Ïî ðåçóëüòàòàì èçó÷åíèÿ ñòàáèëüíîñòè ïðåïàðàòà â åñòåñòâåííûõ óñëîâèÿõ áûë óâåëè÷åí ñðîê åãî ãîäíîñòèñ2äî 3 ëåò. Ñ öåëüþ óíèôèêàöèè ìåòîäîâ ñòàíäàðòèçàöèè ïðåïàðàòà èñïîëüçîâàëè ÂÝÆÕ. Áûëî ïðåäëîæåíî íîðìèðîâàòü ñîäåðæàíèå ïðèìåñè ëèîòèðîíèíà íà óðîâíå 2,0 %, ÷òî ñîîòâåòñòâóåò òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ
    Exact
    [29, 31, 32]
    Suffix
    . Ðàáîòà çàâåðøèëàñü ðåãèñòðàöèåé ïðåïàðàòà 07.08.2007 ã. [33]. Ïàðàëëåëüíî êîìïàíèÿ «Áåðëèí-Õåìè/À. Ìåíàðèíè», ïðîâîäèâøàÿ ðàáîòó ïî óñîâåðøåíñòâîâàíèþ ïðåïàðàòà, èñêëþ÷èëà ëàêòîçó èç âñïîìîãàòåëüíûõ âåùåñòâ, èñïîëüçóåìûõ â ïðîèçâîäñòâå ëåâîòèðîêñèíà, çàìåíèâ åå íà äâóõîñíîâíûé ôîñôàò êàëüöèÿ [33].

33
State Register of medicines. Available from: http:// grls.rosminzdrav.ru/grls.aspx.
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    Ñ öåëüþ óíèôèêàöèè ìåòîäîâ ñòàíäàðòèçàöèè ïðåïàðàòà èñïîëüçîâàëè ÂÝÆÕ. Áûëî ïðåäëîæåíî íîðìèðîâàòü ñîäåðæàíèå ïðèìåñè ëèîòèðîíèíà íà óðîâíå 2,0 %, ÷òî ñîîòâåòñòâóåò òðåáîâàíèÿì Ôàðìàêîïåè ÑØÀ [29, 31, 32]. Ðàáîòà çàâåðøèëàñü ðåãèñòðàöèåé ïðåïàðàòà 07.08.2007 ã.
    Exact
    [33]
    Suffix
    . Ïàðàëëåëüíî êîìïàíèÿ «Áåðëèí-Õåìè/À. Ìåíàðèíè», ïðîâîäèâøàÿ ðàáîòó ïî óñîâåðøåíñòâîâàíèþ ïðåïàðàòà, èñêëþ÷èëà ëàêòîçó èç âñïîìîãàòåëüíûõ âåùåñòâ, èñïîëüçóåìûõ â ïðîèçâîäñòâå ëåâîòèðîêñèíà, çàìåíèâ åå íà äâóõîñíîâíûé ôîñôàò êàëüöèÿ [33].

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    Ïàðàëëåëüíî êîìïàíèÿ «Áåðëèí-Õåìè/À. Ìåíàðèíè», ïðîâîäèâøàÿ ðàáîòó ïî óñîâåðøåíñòâîâàíèþ ïðåïàðàòà, èñêëþ÷èëà ëàêòîçó èç âñïîìîãàòåëüíûõ âåùåñòâ, èñïîëüçóåìûõ â ïðîèçâîäñòâå ëåâîòèðîêñèíà, çàìåíèâ åå íà äâóõîñíîâíûé ôîñôàò êàëüöèÿ
    Exact
    [33]
    Suffix
    . Ðåçóëüòàòû ñðàâíåíèÿ ïðåïàðàòîâ, ñîäåðæàùèõ ëàêòîçó èëè ôîñôàò êàëüöèÿ, áûëè îïóáëèêîâàíû â 2007 ãîäó [34]. ÑÏÎÑÎÁÛ ÐÅØÅÍÈß ÇÀÄÀ×È ÂÇÀÈÌÎÇÀÌÅÍßÅÌÎÑÒÈ ÏÐÅÏÀÐÀÒΠËÅÂÎÒÈÐÎÊÑÈÍÀ  ñâÿçè ñ òåì, ÷òî ïåðâûé ñèíòåòè÷åñêèé ïðåïàðàò è ïåðâûå âîñïðîèçâåäåííûå ïðåïàðàòû ëåâîòèðîêñèíà ïîÿâèëèñü â ÑØÀ, ýòà ñòðàíà ê íàñòîÿùåìó âðåìåíè âûðàáîòàëà ñèñòåìó ìåð ïî ïîäòâåðæäåíèþ âçàèìîçàìåíÿåìîñòè.

34
Fadeev VV, Morgunova TB. Topical issues of substitution treatment of hypothyroidism. Farmateka 2007; (11): 36–40 (in Russian).
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    Ìåíàðèíè», ïðîâîäèâøàÿ ðàáîòó ïî óñîâåðøåíñòâîâàíèþ ïðåïàðàòà, èñêëþ÷èëà ëàêòîçó èç âñïîìîãàòåëüíûõ âåùåñòâ, èñïîëüçóåìûõ â ïðîèçâîäñòâå ëåâîòèðîêñèíà, çàìåíèâ åå íà äâóõîñíîâíûé ôîñôàò êàëüöèÿ [33]. Ðåçóëüòàòû ñðàâíåíèÿ ïðåïàðàòîâ, ñîäåðæàùèõ ëàêòîçó èëè ôîñôàò êàëüöèÿ, áûëè îïóáëèêîâàíû â 2007 ãîäó
    Exact
    [34]
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    . ÑÏÎÑÎÁÛ ÐÅØÅÍÈß ÇÀÄÀ×È ÂÇÀÈÌÎÇÀÌÅÍßÅÌÎÑÒÈ ÏÐÅÏÀÐÀÒΠËÅÂÎÒÈÐÎÊÑÈÍÀ  ñâÿçè ñ òåì, ÷òî ïåðâûé ñèíòåòè÷åñêèé ïðåïàðàò è ïåðâûå âîñïðîèçâåäåííûå ïðåïàðàòû ëåâîòèðîêñèíà ïîÿâèëèñü â ÑØÀ, ýòà ñòðàíà ê íàñòîÿùåìó âðåìåíè âûðàáîòàëà ñèñòåìó ìåð ïî ïîäòâåðæäåíèþ âçàèìîçàìåíÿåìîñòè.

35
ApprovedDrug Products with Therapeutic Equivalence Evaluations. 37th ed. 2017. Available from: https:// goo.gl/YDrmMM.
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    Âíóòðè ïîäãðóïïû âçàèìîçàìåíÿåìîñòü äîêàçàíà, ïðåïàðàòû èç ðàçíûõ ïîäãðóïï íå âçàèìîçàìåíÿåìû. Ïðè ýòîì âíóòðè ïîäãðóïïû ðåôåðåíòíûì ñòàíîâèòñÿ íå îáÿçàòåëüíî îðèãèíàëüíûé ïðåïàðàò, à òîò, ñ êîòîðûì ìîæíî ñðàâíèâàòü íàèáîëüøåå êîëè÷åñòâî ïðåïàðàòîâ
    Exact
    [35]
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    . Àìåðèêàíñêèå òèðåîèäîëîãè ñ÷èòàþò, ÷òî ïàðàìåòðû áèîýêâèâàëåíòíîñòè ëåâîòèðîêñèíà ìåíÿþòñÿ â çàâèñèìîñòè îò âíóòðèñóáüåêòíîé âàðèàáåëüíîñòè ðåôåðåíòíîãî ïðîäóêòà («reference-scaled ABE»).

36
American Thyroid Association, Endocrine Society, American Association of Clinical Endocrinologists. Joint statement on the U. S. Food and Drug Administration’s decision regarding bioequivalence of levothyroxine sodium. Thyroid 2004; 14: 486.
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    Àìåðèêàíñêèå òèðåîèäîëîãè ñ÷èòàþò, ÷òî ïàðàìåòðû áèîýêâèâàëåíòíîñòè ëåâîòèðîêñèíà ìåíÿþòñÿ â çàâèñèìîñòè îò âíóòðèñóáüåêòíîé âàðèàáåëüíîñòè ðåôåðåíòíîãî ïðîäóêòà («reference-scaled ABE»). Åñëè ðåôåðåíòíàÿ âàðèàáåëüíîñòü ñîñòàâëÿåò 10 % è ìåíåå, òîãäà ïðåäåëû áèîýêâèâàëåíòíîñòè ìàñøòàáèðóþòñÿ ïî ðåôåðåíòíîìó ïðåïàðàòó è ñîñòàâëÿþò 90–111,11 %
    Exact
    [36]
    Suffix
    , â íàñòîÿùåå âðåìÿ ýòîò äèàïàçîí óìåíüøåí äî 95–105 % [37].  Ðîññèè îðèãèíàëüíûé ïðåïàðàò ëåâîòèðîêñèíà íå çàðåãèñòðèðîâàí. Ïåðâûì â ñòðàíå áûë çàðåãèñòðèðîâàí (01.11.1990 ã.) L-Tèðîêñèí Áåðëèí-Õåìè («Áåðëèí-Õåìè Àû, Ãåðìàíèÿ), çàòåì Ýóòèðîêñ («Merck KGaA») (24.04.1992 ã.) [38].

37
Wiersinga WM. Adult hypothyroidism. In: Endotext. 2014.
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  1. In-text reference with the coordinate start=22456
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    Åñëè ðåôåðåíòíàÿ âàðèàáåëüíîñòü ñîñòàâëÿåò 10 % è ìåíåå, òîãäà ïðåäåëû áèîýêâèâàëåíòíîñòè ìàñøòàáèðóþòñÿ ïî ðåôåðåíòíîìó ïðåïàðàòó è ñîñòàâëÿþò 90–111,11 % [36], â íàñòîÿùåå âðåìÿ ýòîò äèàïàçîí óìåíüøåí äî 95–105 %
    Exact
    [37]
    Suffix
    .  Ðîññèè îðèãèíàëüíûé ïðåïàðàò ëåâîòèðîêñèíà íå çàðåãèñòðèðîâàí. Ïåðâûì â ñòðàíå áûë çàðåãèñòðèðîâàí (01.11.1990 ã.) L-Tèðîêñèí Áåðëèí-Õåìè («Áåðëèí-Õåìè Àû, Ãåðìàíèÿ), çàòåì Ýóòèðîêñ («Merck KGaA») (24.04.1992 ã.) [38].

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    Prefix
    Íåîáõîäèìî óñîâåðøåíñòâîâàòü è óíèôèöèðîâàòü ïðîöåññ ïðîèçâîäñòâà, îáðàùàÿ îñîáîå âíèìàíèå íà ïðèñóòñòâèå éîäñîäåðæàùèõ ïðèìåñåé, à òàêæå óñèëèòü ñèñòåìó êîíòðîëÿ çà êà÷åñòâîì ïðåïàðàòà ïðè ïðèáëèæåíèè îêîí÷àíèÿ ñðîêà åãî õðàíåíèÿ. Ïðè ïðîâåäåíèè êëèíè÷åñêèõ èññëåäîâàíèé ïî îïðåäåëåíèþ áèîýêâèâàëåíòíîñòè íàäî ó÷èòûâàòü àêòóàëüíûå ðåêîìåíäàöèè
    Exact
    [37]
    Suffix
    . Êëèíè÷åñêèå èññëåäîâàíèÿ ïðåïàðàòîâ ëåâîòèðîêñèíà ðåêîìåíäóåòñÿ ïðîâîäèòü â ñîîòâåòñòâèè ñ ìåòîäè÷åñêèìè ðåêîìåíäàöèÿìè «Ðóêîâîäñòâà ïî ïðîâåäåíèþ êëèíè÷åñêèõ èññëåäîâàíèé ëåêàðñòâåííûõ ñðåäñòâ», èçäàííîãî ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè [41].

38
State Register of medicines. Available from: http:// grls.rosminzdrav.ru/grls.aspx.
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     Ðîññèè îðèãèíàëüíûé ïðåïàðàò ëåâîòèðîêñèíà íå çàðåãèñòðèðîâàí. Ïåðâûì â ñòðàíå áûë çàðåãèñòðèðîâàí (01.11.1990 ã.) L-Tèðîêñèí Áåðëèí-Õåìè («Áåðëèí-Õåìè Àû, Ãåðìàíèÿ), çàòåì Ýóòèðîêñ («Merck KGaA») (24.04.1992 ã.)
    Exact
    [38]
    Suffix
    . Ïî îáúåìàì ïðîäàæ íà 2012 ãîä L-Tèðîêñèí Áåðëèí-Õåìè çàíèìàë 59 % äîëè ðûíêà, Ýóòèðîêñ — 29,9 %, îáúåìû ïðîäàæ ïðåïàðàòîâ äðóãèõ ïðîèçâîäèòåëåé áûëè ñóùåñòâåííî íèæå [39]. Îáà ýòè ïðåïàðàòà ïîçâîëÿþò ïîëó÷àòü ìàëûé øàã èçìåíåíèÿ äîçû, íî ýòè øàãè íå âñåãäà ñîïîñòàâèìû, íàïðèìåð, Ýóòèðîêñ âûïóñêàåòñÿ â ôîðìå òàáëåòîê, ñîäåðæàùèõ 88 ìêã ëåâîòèðîêñèíà, L-Tèðîêñèí Áåðëèí-Õåìè äîñòóïåí â äîçè

39
Demidova MA. The problem of interchangeability of L-thyroxine medicines. Effektivnaya farmakoterapiya 2013; 2(22): 8–12 (in Russian). Available from: https:// goo.gl/B1gJxy.
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    Ïåðâûì â ñòðàíå áûë çàðåãèñòðèðîâàí (01.11.1990 ã.) L-Tèðîêñèí Áåðëèí-Õåìè («Áåðëèí-Õåìè Àû, Ãåðìàíèÿ), çàòåì Ýóòèðîêñ («Merck KGaA») (24.04.1992 ã.) [38]. Ïî îáúåìàì ïðîäàæ íà 2012 ãîä L-Tèðîêñèí Áåðëèí-Õåìè çàíèìàë 59 % äîëè ðûíêà, Ýóòèðîêñ — 29,9 %, îáúåìû ïðîäàæ ïðåïàðàòîâ äðóãèõ ïðîèçâîäèòåëåé áûëè ñóùåñòâåííî íèæå
    Exact
    [39]
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    . Îáà ýòè ïðåïàðàòà ïîçâîëÿþò ïîëó÷àòü ìàëûé øàã èçìåíåíèÿ äîçû, íî ýòè øàãè íå âñåãäà ñîïîñòàâèìû, íàïðèìåð, Ýóòèðîêñ âûïóñêàåòñÿ â ôîðìå òàáëåòîê, ñîäåðæàùèõ 88 ìêã ëåâîòèðîêñèíà, L-Tèðîêñèí Áåðëèí-Õåìè äîñòóïåí â äîçèðîâêå 75 ìêã.

40
Madiyarova MSh, Morgunova TB, Fadeyev VV. Treatment of primary hypothyroidism: unresolved issues. Klinicheskaya i eksperimentalnaya tireoidologiya 2015; 11(1): 22–34 (in Russian).
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    Òàê êàê ýòîò êîíòðîëü ïîìîãàåò îöåíèòü ðåçóëüòàò íå ñðàçó, à ñïóñòÿ íåñêîëüêî íåäåëü, ðåêîìåíäóåòñÿ íå ìåíÿòü ïðèíèìàåìûé ïðåïàðàò êîíêðåòíîãî ïðîèçâîäèòåëÿ. Ïîìèìî óðîâíÿ ÒÒÃ, îïûòíûå ýíäîêðèíîëîãè ïðè âûáîðå ïðåïàðàòà äëÿ ëå÷åíèÿ ãèïîòèðåîçà ó÷èòûâàþò ïîêàçàòåëè êà÷åñòâà æèçíè ïàöèåíòîâ
    Exact
    [40]
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    . Ýòî ñîçäàåò îïðåäåëåííûå ñëîæíîñòè äëÿ ïîëèêëèíèê è àïòåê, íî ýòî ñàìûé ëîãè÷íûé ñïîñîá ïîìî÷ü ïàöèåíòó. Íåîáõîäèìî óñîâåðøåíñòâîâàòü è óíèôèöèðîâàòü ïðîöåññ ïðîèçâîäñòâà, îáðàùàÿ îñîáîå âíèìàíèå íà ïðèñóòñòâèå éîäñîäåðæàùèõ ïðèìåñåé, à òàêæå óñèëèòü ñèñòåìó êîíòðîëÿ çà êà÷åñòâîì ïðåïàðàòà ïðè ïðèáëèæåíèè îêîí÷àíèÿ ñðîêà åãî õðàíåíèÿ.

41
Melnichenko GA, Fadeev VV, Proskurina IA, Bogdanov AN, Gorodetsky VV, Gorodetskaya GI. Guidelines for conducting clinical trials of medicinal products used in the thyroid gland pathology. In: Mironov AN, ed. Guide for conducting clinical trials of medicinal products. Moscow: Grif i K; 2012. P. 163–76 (in Russian).
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    Êëèíè÷åñêèå èññëåäîâàíèÿ ïðåïàðàòîâ ëåâîòèðîêñèíà ðåêîìåíäóåòñÿ ïðîâîäèòü â ñîîòâåòñòâèè ñ ìåòîäè÷åñêèìè ðåêîìåíäàöèÿìè «Ðóêîâîäñòâà ïî ïðîâåäåíèþ êëèíè÷åñêèõ èññëåäîâàíèé ëåêàðñòâåííûõ ñðåäñòâ», èçäàííîãî ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè
    Exact
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    . Òàêèì îáðàçîì, äëÿ ïîëó÷åíèÿ ìàêñèìàëüíî ïðèáëèæåííûõ ðåçóëüòàòîâ ïðè ïåðåõîäå ñ ïðåïàðàòà íà ïðåïàðàò, âûïóñêàåìûé äðóãîé êîìïàíèåé, íåîáõîäèìû ñîâìåñòíûå äåéñòâèÿ ïðîèçâîäèòåëåé ëåâîòèðîêñèíà, èññëåäîâàòåëåé áèîýêâèâàëåíòíîñòè, ïðàêòèêóþùèõ âðà÷åé, ïðåïîäàâàòåëåé ìåäèöèíñêèõ è ôàðìàöåâòè÷åñêèõ ó÷åáíûõ çàâåäåíèé, ðàáîòíèêîâ àïòåê.