ࡱ> NQMY R62bjbj[[<@9 \9 \OGGGGG[[[8D$[" LG(ooo4 A"C"C"C"C"C"C"$$'Pg"-Gg"GGoo4"!!!GoGoA"!A"!!!oP !-""0"!((!!(G5!g"g"E"(I : DN1 ;NR /eg|~4N^Ջc[SR :NNۏNekĉ;NR /eg|~NT N^MRv4N^Ջ v^c[{|NT3uN(W3uNTlQe4N^ՋDevQY 6R,gc[SR0 ,gc[SR|[;NR /eg|~4N^ՋvN,Bl 3uN^OncwQSONTvyr'`[4N^ՋeHhvQ[ۏLEQ[T~S0,gc[SR}6q:N{|NTv4N^ՋS3uN(W3uNTlQe4N^ՋDevQYcONRekc[T^ FO NOP6R;SuhVhvsQ{t[{|NTvb/g[ċ0L?e[yb NS3uN[{|NT4N^ՋDevQY]\O0 ,gc[SR/f(WsLlĉNSS_MRw4ls^ N6Rv @wlĉv Ne[U NS@{TQO Yb/gvSU\0cؚ ,gc[SRvsQQ[_N\ۏLe0Wte0 N0(uV ,gc[SR(uN 0;SuhVhlQ{tRl 0V[ߘToTvcw{t;`@\N,{4S ĉ[(W-NVXQۏL4N^Ջv;NR /eg|~0 ,gc[SR(uNv{WTy;NR RSW;NR /eg &^;NR _R/e0R R/evR/eW;NR /egdY0 N0W,gSR ;NR /eg|~v4N^Ջ^&{T 0;SuhVh4N^Ջ(ϑ{tĉ 0V[ߘToTvcw{t;`@\ -NNSNlqQTVV[kSuTRuYXTON,{25S SvQNvsQl_0lĉvĉ[0;NR /eg|~NT(W_U\4N^ՋxvzMR ^[b_v0yf[v4N^MRxvzY'`0SOYՋ0uirf[ċN0Rir[xvzI{ Nxvz~gSW,gfNTv[hQ'`TRekSL'`0 N04N^ՋeHh [N(W^:W N\*gQsvhQev;NR /eg (W_U\nx'`4N^ՋMR^HQۏLSL'`4N^Ջxvz0SL'`Ջ^ gnpfTfnxvxvzvh ^:NMRw'`v\7h,gxvz07h,gϑ N\N10O ͑p‰[VKb/gg30)Y v;N NoNN N[NTv[hQ'`0 gHe'`ۏLRekċ0O0 v^9hncvQny/}v~g[Tgvnx'`ՋcOv^vOo`0 3uR(W_U\nx'`Ջxvze (W4N^ՋeHh6R[-N^QN NV } SbFO NPN N 4N^(uV NTv4N^(uV^NN NQ*NebۏLQ0 1(uuu_e ؏^fnxu zRgbRW ^fnx勧NTvwQSO4N^(uuuY;NR $v0;NR 9YB\I{ 0[N;NR 9YB\uu ؏^ۏNekfnxvQRWYDeBakeyRWv`!/a!/b!a/b!bWbStanfordRWvAW/BW 0(WQ~eQY*N4N^(uuue ^EQRQ;NR /eg ieQ[6qu zvq_TSuHeċN/f&TN &T~eQNv^Rg0 2.(uMO(uN@{TQO Yv;NR /eg(WۏL4N^Ջe^Q(uv;NR MO ^9hnc;NR S/}MO [y;NR uuT;NR uuR+R_U\4N^Ջ0 3.(uN1uN`/f&TT^(u;NR /eg ieQQ[NY*N4N^TVRV }04N^V }YTv^uOq_TegTZfgvv^SuT{kNs VRV }Svcq_T;NR /egvb/g~@\TgEN'` Vdk(W_U\4N^Ջe [eQ~`v b^WNΘiSvċ0O ^[N NV }ۏLEQRċ0O 1 /f&T gTv@{eQ 2 ;NR uuv'Y\Tb_`f[OYċ0OR $vv^0҉^0b_rNSяz0܏z[:SI{  3 `t^0g[}T0/f&TTYyKb/g 4 `vwgTgSvTΘiSbR $vvsQ{kNsSKb/g{kNsvΘi 0 N 4N^Ջ-Nvxvz~p ;NR /eggv[hQ'`T gHe'`\*g[hQfnx Vdk(WۏL4N^ՋveP xvzGP TeQ;N[hQ'`~pT;N gHe'`~p0 1.[hQ'`~p 1 ;N[hQ'`~p [N;NR $vb;NR 9YB\uu ;N[hQ'`~p^:N/gT30)YQv;N NoNNMajor Adverse Event MAE vSu`Q0 2 !k[hQ'`~p [N;NR $vb;NR 9YB\uu vQN[hQ'`~p؏SNQhQV{kN0;NR $vb;NR 9YB\ vsQ{kN0[hQ'`v^Su I{0 2. gHe'`~p 1 ;N gHe'`~p  = 1 \* GB3 `$;NR $vuu[N[;NR $vuuv4N^Ջ ^;N gHe'`~p b YT~p ^\^Q12*NgvR $vlubRs0R $vvlubRs:N YT~p \^S_Sb;NR /egvTU\_bR0R $vvu^0Qo0/egy iiryMOSu`QI{eb0  = 2 \* GB3 a$;NR 9YB\uu;N gHe'`~p^:N12*Ngv YT~p ~TQ4N^~gYsS;Rb/gbRs0Qo0/egy iiryMO0;NR 4xˆI{Su`Q T;NR ͑QX~gY[hQ/ N[hQ/eGPT@hb_b wT'Y\0GPT'Y\NSs;NR v_vSSI{ 0 2 !k gHe'`~p [N;NR $vb;NR 9YB\uu vQN gHe'`~p؏SNQ/gTsS;Rb/gbRsNSQoSus0R $ve~~ub;NR 9YB\wT0GPT'Y\SS 0R $v4xˆb;NR 4xˆ 0l0RKb/g~I{`Q0  ,.0l v ~  z ( ñzi֍VA֍Vi)h,vh{+0J@B*CJ PJaJ ph%h [h{+0JB*CJ PJaJ ph!h [h{+B*CJ PJaJ ph$h [hB*CJ PJ\aJ ph$h [h{+B*CJ PJ\aJ ph h [h{+B*PJ\aJph#h [h{+5B*CJ,\aJ,ph$h [h{+B*CJ,PJ\aJ,ph$h [h{+B*CJ PJ\aJ ph,h,vh{+B*CJ OJPJQJ\aJ ph .0 ~ z >d7$8$WD`gd,v dWD`gd,vd@&WD`gd,vdgd,v $da$gd,v $da$gdC $da$gd.D >.<tvzʷʢ݋݋݋݋ʢxxgx!h [h{+B*CJ PJaJ ph$h [h{+5B*CJ PJaJ ph,h [h{+B*CJ OJQJ^JaJ o(ph(h [h{+0J5B*CJ PJaJ ph%h [h{+0JB*CJ PJaJ ph%h [h{+0JB*CJ PJaJ ph!h [h{+B*CJ PJaJ ph!h [hB*CJ PJaJ ph!.\v(>|$$r%% 'D( dWD`gd,v dWD`gd,v(.>Z\.ٴ١ىkZDZD*jh [h{+B*CJ PJUaJ ph!h [h{+B*CJ PJaJ ph;h [h{+0JB*CJ OJQJ^JaJ mHnHo(phu.jh [h{+0JB*CJ PJUaJ ph$h [h{+5B*CJ PJaJ ph(h [h{+0J5B*CJ PJaJ phh.D0JB*CJ PJaJ ph%h [h{+0JB*CJ PJaJ ph%h [h0JB*CJ PJaJ ph*v $z$|$$r%%Z&h&p&&'T'D((ͼnn[[HH%h [h{+B*CJ KHPJaJ ph%h [h{+0JB*CJ PJaJ ph!h [h{+B*CJ PJaJ phU(h [h{+0J5B*CJ PJaJ ph$h [h{+5B*CJ PJaJ ph%h [h{+0JB*CJ PJaJ ph!h [h{+B*CJ PJaJ ph*jh [h{+B*CJ PJUaJ ph7h [h{+B*CJ OJQJ^JaJ mHnHo(phuYg;NR 9YB\T;NR $v~eQ TNxvz-N ^Q$N gHe'`~pT[hQ'`~pv]_ ^$N~NR+RRg GW&{T~f[Bl0  N eTe_ۏLgvq_Pf[egċ0O;NR /egv gHe'`0^(W/gT30)Y06*Ng012gۏL (W6*Ng012*NgeۏLN!kq_Pf[ċ0ONt^T^ۏLkt^N!kv \ޏ~5t^0[b;N~pċ0OTS3u N^MRlQ0 V Ջ YagNS ^ۏL go}YvMRw'`0[gqvY-N_4N^Ջ0[gq~^Ǒ(u](W-NV N^ NVElQuHe}Yv T{|hVh03uR^yf[0Wnx[Ջ{|W Tt0W{7h,gϑv^cO7h,gϑ{Ǐ z-NvsQSpevnx[Onc0[N^RHeՋ N,^SSO0.05  N'YN0.20 c11vkOeQ~ (W&{T~f[vW@x NSċNuO N\N75[;`7h,gϑ150O 3uNS9hnc[E`QTtQ1=s {Qg~7h,gϑ0 Y gTvt1u _NSǑ(uUSՋ FO^ۏLTt vh1@1B1D1F1J1P1ۺ˩u$h&7h9B*CJ PJ\aJ phh9B*CJ PJ\aJ ph!h9B*CJ PJ\aJ o(ph!h{+B*CJ PJ\aJ o(ph!h,vB*CJ PJ\aJ o(phh.DB*CJ PJ\aJ ph$h [h{+B*CJ PJ\aJ ph!h.DB*CJ PJ\aJ o(ph&P1\1111111111111111111111111111 2ȵ}r}`}TrPL}rh zh)h.DhK$CJaJo(#h&h&CJaJmHnHsHuh,vhK$CJaJjh,vhK$CJUaJh,vhK$CJaJo( h,vhK$B*CJaJo(phh(^[jh(^[U$h&hyFB*CJPJaJo(ph$h [h9B*CJ PJ\aJ ph%h&7h9B*CJ KHPJaJ ph"h9B*CJ KHPJaJ o(ph111.202224262 $da$gd& $4$a$gdN $4$a$gd,vh]hgdN 2"2$2&2*2,2.202224262$h&hyFB*CJPJaJo(phh(^[hv hNhNh,vhK$B*CJaJph h,vhK$B*CJaJo(phh,vhK$CJaJo(#h&h&CJaJmHnHsHujh,vhK$CJUaJ :&P 182P:p,v. A!"#$%S s002 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@ 0@PJ_HmH nHsH tHJ`J cke $1$a$ CJKH_HaJmH nHsH tH$A $ ؞k=W[SOBiB nfh-\".B-?7}>FTlon77Ԝx?|+NST2 XiEꭶ?j]m^_^+P[wD+PW-W_YW ͶW5 R ~,VAFXuVKsKTCV]rŦZ-t  ;b6#42% qv8›q. B˟TDFLڐAB&~ ^] ُ=q==~NV;(VG:=ՃxiJ!x?>?< }a\G5TLx?y;~nьHbwc:EGP~Ds |w<4rg!Rt|+c m߆6Il!Q] sZ;aQITjYV`<$6D='Ienb~k3MHýS^P\wr^+j~k~vt~t«(:zQk_۶sWb/?ѹS)uzݜnrʵ+Am~޽: 5ˁWrbJAүsUTjzf5η1T>汀*^PK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 0_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!.theme/theme/theme1.xmlPK-! ѐ' theme/theme/_rels/themeManager.xml.relsPK] @ -NNNQ (-P1 262 D(162 p}  o + ""XX%'/EGQ!!@ @H 0(  0(  B S  ?zhengwen _Toc2534049315XFZjl  @q{JRljn-1DHkoy  -D\_dho!&2;QUZ]^ab&*.Z\]`bijmo$ & + , - 0 4 6 7 8 9 Q S Y \ _ { & 7 = @ F d m n . < = ?   pvw{|m n A B ! x=5"'mnU)  Bg . pX}fPze}g,IB(?iK VO!/$?$$}' Q*S*(+o+ -\-,/0355/5k26/E;/<6J<=|>Za.l;Hܲ'2%ڳg i^=mnPnurFPs,vov@{r|blDY IVW5<WbF^t1m)bxyFU}Ci)-@e|:NT Qb#F[ (,*SK$c3-9er8X{+CqZvN0 Wnrx*+&!+e z?bl#q>d:rBC\6Zv7 .j 1 pRP3vGKb[h`">DMuRd@($Unknown G*Ax Times New Roman5Symbol3. *Cx Arial;= |8ўSOSimHei7E eck\h[{SO;5 N[_GB2312;5 wiSO_GB2312;([SOSimSunA$BCambria Math!1h0 s7 s2 2 -!),.:;?]}    & 6"0000 0 0 00000 =@\]^([{  0 0 00000;[i2""2qHX?`2!xx @\Se_7h Xtzj.UserwxlOh+'0x  ( 4 @ LX`hpַʽ Xtzj.User Normal.dotmwxl3Microsoft Office Word@Ik@zmR@]y @ʴs 2 ՜.+,D՜.+, X`t|  Xtzj.Com l 8@ _PID_HLINKSA$  X -http://www.sda.gov.cn/WS01/CL0053/25844.html[-http://www.sda.gov.cn/WS01/CL0063/16570.html  "#$%&'(*+,-./0123456789:;<>?@ABCDFGHIJKLOPSRoot Entry F RData !1Table)(WordDocument <@SummaryInformation(=DocumentSummaryInformation8EMsoDataStorez P JVGESG4B1==2z P Item  PropertiesUCompObj n   FMicrosoft Word 97-2003 ĵ MSWordDocWord.Document.89q