клінічні дослідження. Залеплон (анданте): новые возможности фармакотерапии инсомний*. Zaleplone (Andante): NEW PROSPECTS IN INSOMNIA PHARMACOTHERAPY.


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 \r \f  • 4 (30) • 2007   19        —    \r — \f   \n\t \b\t  \b \r\t  (  ..,  .., 1996; \r  ..,  ­ .., 2002;  €..,   ‚.ƒ., 2004).  \n   \r\t \t    \r „  30– 45% \f ,   ­  \r    95% „ (Kryge Kryger M al 1994;   ..,  .., 1996;    .., 2003).  …,  \r  ,   \f \b «  ,  26% \t \b  ,  \t  \b \n„, \r  \r\t  \r\t †\b\t  «   -. ‡   \r  \r  «\b \b„   ( \b   \f  \b \t    ),    \f    , \f \n„  \f ˆ  \b   . ‰  \r  1)  \r     2)  \b \r   3) \t\f  \t /      \f  4) ˆ  \t         ( .., 1995;   \f \r ,  ­„\n       \r\t † \f, —   ,   \t  \f \r (  .., 2006). ‡  \t   ­    \f    \r   ,   , ­ \t \f \f  (‰  Š. ., 1990).   \t \t  \t ­ \f„ ­„  \t \f,   \f\t †\t  \f \f\f \t,      ­ \t\f \n\t  , „ \f\r ‹\b \r †,   „\n   „ ,  , \f„\n        \t \r \r\t \t  „  ­ „ „  \t  .   \r   ­ \b\r ,    , „ \n   \r\t „   \f \f\f † (\t‹\b  ­,     ­ /  \r\t     , ˆ , \r   „\n\t   ­\f     ­,   \r  \r­\f  \f\t   . Œ\r   \b  „  \n   \r,   ­„\n  „, „,   „   . ‡ ‹       \n \n  ­,  \r ­,   ,    -\b  \r\t  \r\t  .     ,     \b  \r    „  \r „     ,  \f ,     \b \r\t ,        , „  \n       \b       (  ):         \n\t\b .   —   \r —  \f \n\f \t \b\b    \b   \f   \f\n\f  30–45% \t ,  \f  \r   \b\n\f  95% \n . \b,\r .  \b,  \r  ,  \t \b «»,  26%  \f , \f   \b \n, \r \n\f \f  \t  : *\r\f \n\t\b\n\n \n , \t\n \t\n «\t\n   \r \f  • 4 (30) • 2007   20 „\n  \r : «   —   ».    \r  \t \r \t     ­ ‡\r \n  \n \f  „  \b  \r    \b\b  ­ \f  \f  ,  „\n\f \f     ,    \t     ,  „\n    †  \f (Œ  .., Ž .., 2004).  \r \t     \r \r\t \t \t   , \t   \f \f, \f    \r\t  ­         \f   ,        ­    \f\r  \r\t \f  \f \t   (‘).  \r ­    , \f \r ­\r\t \r\t   , —    (€). ’   ‹\t \r\t — \r ‹,  \n 5–10  ( 10 \f € 1   ),   ‹  (20 \f, \f   \r„  30–40 \f, 1    ­   1,5–2 )   „\n ‹,    \t ­ \b\r\t  \r\t \t  \t    ‡ \b , ,  \t   „   ­„ \r  \b / \b  ­,      \b„        ­\r. ‡‹   \r\t -\b \r\t   \f  \f   \f \t —  ­ \b \r\t, \t   \t    , ,  . ‘  \t     \f  .  ,        \f   \b   \r\t „ (   \t \f , \t  \f \f)    ­\n  \b  \r  \f     \f   \b„  \t\b \b,   \t   „\n \f  \f  ,  \n \f  „  .  \f     \f     ­  ­ \r \f †  ­   \r \t      -  †\r \t \f. ‡ ‹   \r    „\n\f  \f   — \b\f   \r\t  \t — ­       \t     \f  ­\r\t   \r\t  (   ),    ­\r ‹ † †   \f \b †   \t   \f   \f  .    \n   \n  ­ † (Kr ge etal .,1994;Š..,2001; Kryger etal .,1994;Š..,2001; M etal .,1994;Š..,2001; M. etal .,1994;Š..,2001; .N etal .,1994;Š..,2001; N. etal .,1994;Š..,2001; . etal .,1994;Š..,2001; et al .,1994;Š..,2001; al .,1994;Š..,2001; al ,1994;Š..,2001; 1994; Š .., 2001;    .., 2003;  ’.., 2004; Œ   .., Ž ..; 2004). \f   3% „   25–29% —   „ \r  \r   ,   \t   \r    (  .., 1996; \r .., .., 2002). \b† †    „ ,       \t\t        (  \b\r) ­   \b \b   †   ,        ­   ­  , ­     \n  ­ . ‡‹    «\f 1.  \r \r\r  ,   †\f,   \f \r 2. \t   \t\f      (   3. Š\r ­  \t  \b\b    \r \r ,   4.    \r   \b\r ,  „\n   \f      \f\t ‹†        \r\t    \f  Š\r \r\n\r † -‹††   ­„    \r 7.      \f„   ,    †\b (  ..   ., 1999; Lange ., Mendelso ., Langer ., Mendelso ., S ., Mendelso ., S., Mendelso ., ., Mendelso ., Mendelson ., W ., W., ., ‡ ‹    „ 1.  \f\f\f  \f\b\t   \b \f\t    \b \f \f, \f \f \f\f\f       \n \f \n \f\f  .   \f  ,  \f \f,   \n  \t\f ,  \n\n                 \n\r  \t  \f    \t    \r \f  • 4 (30) • 2007   21 2.  \f\f\f    \r\f \r ­€€\b\f . „ ‹\f    ­   \b\r\t  ,     \r\t „. ‘ -  \n„  \f \t\f † . “      \t, \t\t   \r\t \t  ..,    † \t  \r\t \f\t       \r    \f   \b \r    \f \r  ­\r  \r ‹††  ( ,   ),    \r\t \t   ,     \r,  ­  ­  ‹†† \r      \f  ,    ­ - ­\r ˆ \r  ˆ \r ,    ’ , „\n     \b    \b \f    (    « »,   «\b», ,  \n ,       \r\t \b  „\t).    \r ,   ­\t \b †   ­ \r \r   \n  «­ \n\t «­ \n\t «­ \n\t  ,  „ \n\t  ‹††    †\b\r \r \f,   \t    ­  \r3\b„-  \r3\b„-  \r 3   \b„  †  \r      ‰ ­       \r\t  \r\t  ­    „      ‡ \r   † \f\t ‹††  \f    \f\t \r\t  \r\t   ,     \t    \r  \b    Š\r —   \r   , „\n\t    \r\t  \r ‹  \n \r\t   ,  \r\t   \t \t ‹†† ,  \r , ,  , \n\n \f , \b, \r ­\f  „\n\f  ,   ­ \r ­ \r\t \b\t  \r\t      ­-†  \t \t\t  ,    \f \r  \t    \t \b\r\t  .     \b   (  \t        ), ,  ,  ,    ,    .. \b,        ­     \r (\t\f  †)  \r ,     \r„ \r,           .     \r    \r     \f  \f  (\t, , † , ),  —    \f  (†, ,  ‡     \f\r ‹  —  —   \f\r     \f (\r \r,      ),     \t \b\r\t \f-  \t „\n\t   ­        . ‰ \f,  ­ \r\r  \t  ,  \r,  \b  \f ­  \r \f   †\f   \r\t      \r\t \b , , . ­\r    ‹\f              « \f ».   ­          \b\r ˆ \r \n\n — „,  \r ,   \f   , \f —    ,  \f   \r \f      ,   ­   \r \r \r   \f    ’ ,  \n\f      †    \f ‹    ,   \r   \b  „      \r\t \f  \f † \b \f \r,     \r  \f     \b  \r  ­\r †  , \f \r   „\n\f , „\n\f \n †\f\f      \r­\r \r  \r \r    …  \f      —      ‘ ­,      ( \r \r «Z -\r),     \r \f, ,   \r\t  ,   \t      \r    †\f „    \f ,    \r \f  • 4 (30) • 2007   22 „  \f  ,       \b† \f-1-\b\r —  „  ‰--\b \f  (Pa atA etal .,2001; Barber ., Patat etal .,2001; Barber ., A etal .,2001; Barber ., A. etal .,2001; Barber ., . etal .,2001; Barber ., et al .,2001; Barber ., al .,2001; Barber ., al ,2001; Barber ., 2001; Barber ., Barbera ., J ., J., ., ro .,2005). \b\r\r C .,2005). \b\r\r C.,2005). \b\r\r ., 2005).  \b\r \r    \r      \f†  †\b \t †  —     \b \b ‰-\f   (Z rkov cB etal .,1992; rkov . et al .,1992; al .,1992; al ,1992; 1992; ,1995).\f 1995). \f -\b\r   \r \n   \f \f \f,  \t  \b       \b   \f ‹†† (M .E.,1995;\f- 1995;\f- 1995; \f        \f -†\b\r   \f       ,   ‹\f    \r­\r , „\n   ­\r ‹††\r, \r    ,  ­\r     ‰ \f, \f  \r    „  \r \r ­   (Bod .,2006)— \f .,2006)— \f R .,2006)— \f R.,2006)— \f ., 2006) —  \f ‹\f\f \f \b\r\t  \f .  \b   \r ­  ,   ,   ­\r † ’ , † ‹†† \r  ­ †   ‹ \f    \b \r‹†† \f  \f \f. ‡ ­ \t  \r   \f-   „ †,       \f    „  †\t ‹† †     ­ \r\t  \f †\t \t\t. ‡ \r \r    † \f,   \r     1 ,    \r      \r   \t   \r\t  (   \f\r   „   ­ \n\t   :  — 3– 6 ,  — 3–4 ,   — 5–5,5 ,  — 2–3,5 ). ‰ \f,   \b   †\b \f    \r\t  ,  \f     \f   .  \f , \t  †\f \t   ,   \r   \b \b\r\t ,   „\n\t  „    ‰               \r.   5–20 \f   \n  \r ( 10    ),      ­  \f  (Heydor .E.,2000; .E.,2000; W .E.,2000; W.E.,2000; E.,2000; .,2000; ., 2000; We W. al .,2000; .,2005).  ,2000; .,2005).  2000; Barber .,2005).  Barbera .,2005).  J .,2005).  .,2005).  ., S .,2005).  ro .,2005).  C .,2005).  C.,2005).  ., 2005).     ‹  ­        ,       , \r   \r \r     \f   (Doole etal .,2000). Dooley etal .,2000). M etal .,2000). M. etal .,2000). . etal .,2000). et al .,2000). al .,2000). al ,2000). 2000).   ‹ \t  ­ ‡   \t ,    ,   al .,2000), ­- ,2000), ­- 2000),    ­ „ \r     \r R  ,       \f     5–10 \f   .  ‹      \r\r  \f ;   ­ \b \b \b    ;  \r\r  \b;    \t \r  \f \r †\b ( al 2000; Vers .,2002). Verster ‡   \f ( 3 )       \r         \r ,  \r    \n \r\t ­    (Dog ramj .,2001; Israe Krame ramji .,2001; Israe Krame P .,2001; Israe Krame P. .,2001; Israe Krame .,2001; Israe Krame P.,2001; Israe Krame ., 2001; Israe Krame Israel Krame A Krame Krame Krame Krame ., Krame Kramer J 2002). ­ ,  ‹     \t \f « - \r —   ,    \r\t \r ­ „ \n ( 1999; Fr Fry J al .,2000; al.,2000; ., 2000; Barber Barbera J S o C ., S ro C ’ , \r   10 \f       \r\t ‹††    „  \b.   ­    \r \r  20 \f ­\r  ­ \r  ,    , \t\r  \f \r ,   \b\r \r   “\n  \n     \f \r \b ­  \f     „  ,        \f   \f  \t-  \r .     ,  \r „  „  † \b\t     —   \r\t † \b\t (Hess L al .,2003.).’- ,2003.).’- 2003. ).’- ). ’  ,  \f\r   34 (   \r,  \t,  -\r,      \r\t  ) \r „ \f    †       \t ­           \r \f  • 4 (30) • 2007   23 ’ ,  \r \n   1) \r   \f     ‹††   \b \r 2)   \f ,  4) \r      5)    \r,     6) ­   \t  7)  \b † \r  ,  \f    «Z - , ,  ,  . ’,  , \f \r \b\f ,   80%   \b „  ‹  ,   „  ,   „ «Z -\r  \r     \r\t †  (S i- i r i ardena .,2006.). ,2006.). ’ ,  ­     \r  \b\r\t  ,  ­„\n\t \r \r . ‡ ‹     \r\t   10 \f ,  „ ­ \f      \f    — 5 \f ( \r   \r     „). ‡   \f   ‰    ­  \r ‡    ­     , ,  ‹  ,  ­        18 ,   … \r\t   \f    \r­\r \r ‹† †\r (\f  , ,  , \f  ­), \r, ,  „   (10 \f)   „   …  \n           «  €\t» (\f).  \r„ †  , ­\n\t 5  10 \f   7   (1–2   ),       \r      ,  ­   „  ,       †\b  \r    ()   ‹††          \r\t †   \r   \r ­    \r\t  \b    .. (2003)  \n: \t\n \f \n \n­ \n€\n\n\b. . \n \n\n\b    ..,  .\r. \n  ‚\t\n\n’\f ƒ \f \n\t .. (2001) \n \n\n \t. \b  .. (2006) \n\f \n\n\n\b\f  \n\n   \f \n\n  \n. \n\n \t\r  \b\t .. (1995) \n­ , \n\n \n\b‡  ‚, \n\t \n\r. … .: \n­ . \n \b..,  \b..,  \n .. ( 1999) 1999) ˆ ƒ\r\f €\n\n\b \n\n \t: \n \n\b\n\f  ‚\n  \t. . \n \n\n\b   . . \n\n 99(8): 63–67. \n\n\t \f.. (1990) \n‚. ‰\t\r, ‰\n,  .., \b\t .. (1996) \n \n  \nŠ \n .\b. (2004) ‹\n, \n\t \n\r. \n .\b., \b .., \t  .. (1998) \r \n  \t‡\n \n\t\f .  . . € ­\n€‚ƒ „.., …\n †‚  .. (2002) ‡  \n­   \r\n \nƒ\r\n\n\b\n \n‚. \n\n \t ‡ ƒ „.„., ˆ „.. ‡„ „\t\n\t \t\n „ Barber ., ShapiroC Barbera ., Shapiro . (2005) Benefit-riskassessmen zaleplo Benefit-risk assessment of zaleplon treatment ., 28: 301–318. Bo zs R. (2006) S leep-mo du lation an d hy pnoti : effe ts of enzo iazepine-re eptor onists . N rops ych op arma ol . Hu g., 8: 113–125. hra P.P. (2001) T reatment w ra y M., Pl G.L. (2000) Z re u treatment , 60: 413–445. El ie R., Rut her E., F arr I. t l. ( 1999)S lee laten cy ortene 1999) S leep laten cy is ortene du rin g 4 w eeks of treatment w it h zaleplon , no el non enz jd iazepine hy ro f M., M R. (2000) Z impro sleep w it pro duc in g re d effe ts in tpatients w it h insomnia . Z ro ., 15: 141–152. L.M., v n M L.L., G ree tt D. (2003) C important d intera w . CNS ., 17: 513–532. yd or n W.E. (2000) aleplon – re ie w of no el se ati c u treatment . Ex . O . I . D 9: 841–858. rae l A.G., K ra (2002) S ., 36: 852–859. M.N., R T., D nt W. (1994) P pra . W. ers S n W. (1999) Sy mptomati treatment , 15: 437–444. W.E. (1995) Ph GA Sy . Ph S . S . 211– t A., P ty I., H I. (2001) Ph profile hy . Hu . P ., 16: 369–392.  \r \f  • 4 (30) • 2007   24 A.N., Qu re Z., G (2006) GP’ to b d «Z pres b to d gu hy . J. G . P ra 56: 964–967. er st er ., V lk er ts E.R., hre ud er A.H. t l. ( 2002) Resi 2002) Resi effe ministration ri in g ilit y, memor y tions , an d ps ych omotor performan . J. lin ., 22: 576–583. .K., V l G.W., f M. (2000) A w pol somno rap c assessment of zaleplon 10 g for treatment of pri d., 1: 41–49. tz l K.W., W .M., August ( 2000)Z 2000) Z razolop treatment ., 22: 1254–1267. ., P erra t G., D. (1992) eptor d w g eneration d hy . I : T eptors A d Hy from M Ph to erape . 55–73.   (  ):    \f\r      ‚  — ƒƒ„ ƒƒ\f „  — \t\n\f \tƒ \b  ƒ  ƒ  ƒ ƒ .  \tƒ   \f \b„   ƒ \n\f  30–45% \t ,  \f\t \f\f  ƒ  \b\n\f  95% \n \b„ƒ,    \t \bƒ…\n « ƒ,  26% ƒ ƒ…\fƒ , \bƒ    \n \t\n,  \n\f ZALEPLONE ( NDANTE): NE P PE S I I RM OT AP Summary. Sleep disorders — insomnias of diverse origins — are considered today as one of the lead ing medical and social problems. In the developed countries some 30–45% of all the population cur rently suffers from sleep disorders, whereas sleep related problems were encountered in 95% of people during their lifespan. In Ukraine, based on the study conducted by «MDM corporation, certain sleep dis orders were evident in 26% of all patients asking for medical aid.      ­ €‚ƒ„ …€­‚…‚­ †„ …€ …€­ ‚ ‚„‡€ˆ­ \b‚ˆ€ƒ: €„‚­ †„ ‚­ \b„ ‰\n€ „ „ ƒ„„Š ƒˆ\n­ †„‹ \b ƒ‚Œ‚„ „‰\tƒ­ †„Š ‚ €„ƒ\b‚\n‚€„„Š Scott P.A., Kingsley G.H. , Smith C.M., Choy E.H., Scott D.L. (2007) steroidal anti inflammatory drugs and myo cardial infarctions: comparative systematic review of evidence from observational studies and randomized controlled trials. Ann. Rheum .Dis.,66:1296–1304. Dis.,66:1296–1304. .,66:1296–1304. ˜   —    \r    †  ()    \r\t \f \b\f \r (˜)-2,  ­ \b\r\t \r\t €  \r    \f   \b    \f   ,  \r   \f \r,  \r\t ­ \r \r     \r\t   ‹\r \r Medl ,E e hl(2000– ne,E e hl(2000– e hl(2000– mbase hl(2000–  C hl(2000– l(2000– (2000– 2006),  ­ \f†„.  \t \t        -\r\t \f\r\t  \t,  ­  \r\t \r\t  14 -\r\t  \t (74 673 \b  , 368 968 — )          ­   ‡‡      ‹  \r   † (O R1,17;95%  OR1,17;95%  1,17; 95%   0,99–1,37)    —   † \r   † (O R1,32;95% 1,29– OR1,32;95% 1,29– 1,32; 95%   1,29– 1,35). \r     \r      \t  \t  \t, „„\n  \r  .  6 \f\r\t  \t (387 983  \b-, 1 120 812 -)       \f       ‡‡ (R R1,03;95% 1,00–1,07), RR1,03;95% 1,00–1,07), 1,03; 95%   1,00–1,07),  \r \r   †  (R R1,25;95% 1,17–1,34),- RR1,25;95% 1,17–1,34),- 1,25; 95%   1,17–1,34),    \f- \f\f ‡‡.  4 €‰  „ ‡‡   \f  (6000  \b ) \r   \r\r     (R R2,68;95% 1,43–5,01).14€‰- RR2,68;95% 1,43–5,01).14€‰- 2,68; 95%   1,43–5,01).  14 €‰   \b   (45 425  )    \r\r        ˜-2- \r\t  (Pe to R1,6; Peto R1,6; O R1,6; OR1,6; 1,6; 95%   1,1  2,4),   ­        \r\t \r   \r \t  \n \f  (Pe to Peto OR0,40;95% 0,31–0,53). 0,40; 95%   0,31–0,53). ’ , \n       ‡‡  ˜-2- \r\t   \r, \r  \t    †. ‡ \r         ˜-2-  \r\t  \t \r ­   \r \t   \r \f  • 4 (30) • 2007   25

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