200559 675 1 1 13 1 1 1 2 1 2 2 1. (610041) ; 2. (), 96, 3 1 ( ) ( ),,2,2 ;,2,2, 8,( ITT), 12186% (9 /70), 12186% (9 /70),48158% (34 /70) ; 4117% (1 /24) 4117% (1 /24) 45183% (11 /24) ; ( ), 14175% (9 /61), 14175% (9 /61),55173% (34 /61) ; 5100% (1 /20) 5100% (1 /20) 55100% (11 /20), ( > 0105), ITT,18157% (13 /70), 81143% (57 /70), 20185% (5 /24) 75100% (18 /24) ;, 21131% (13 /61),93144% (57 /61), 25100% (5 /20) 85100% (17 /20), ( > 0105),, ; ; ; R 05; R169142 A 1672 2531 (2005) 09 0675 06 Shekag Capule i the Trea tm e t of Chro ic Glom eruloephr iti ( Q iy i liagxu Sy2 drom e) : A D ouble Blid, Radom ized Co trolled Tr ia l HOU L i 1, FU ig 1, SHA hao 2 hu i 13, HON G Hu i 1, Q IU Ho g2yu 1, Q IN W e i 1, TANG W e2fu 2, FAN J u2m ig 1, HAN G Rui2m ig 2, L I Tig2 qia 2. 1. D iviio of N ephrology, W et Chia Hopital of S ichua U iverity, Chegdu 610041, Chia; 2. N atioal Ceter for D rug Cliical Trail ( TCM ), W et Chia Hopital, S ichua U iverity, Chegdu 610041, Chia Abtract Objective To ae the effective ad afety of Shekag cap ule i the treatmet of chroic glomeruloe2 phriti (Q iyiliagxu Sydrome). M ethod A double blid, double dummy ad radomized cotrolled method wa adopted. A total of 96 patiet were radomized to the treatmet group ( Shekag capule, 2 cap ule, twice a day) ad the cotrol group (Sheyakag capule, 2 capule, twice a day). The therapeutic coure for both group wa 2 moth. Reult A ll the reult were aalyzed o the bai of itetio2to2treat( ITT) ad per2protocol2populatio ( ). For effect of chroic glomeruloephriti i the treatmet group, the cliical cotrol rate were 12186% (9 /70) with ITT aalyi ad 14175% (9 /61) with aalyi; the good imp rovemet rate were 12186% (9 /70) with ITT aalyi ad 14175% (9 /61) with aalyi; the total effective rate were 48158% (34 /70) ad 55173% (34 /61). I the cotrol group, the cliical cotrol ratewere 4117% (1 /24) with ITT aalyi ad 5100% (1 /20) with aalyi repectively; the good imp rovemet rate were 4117% (1 /24) with ITT aalyi ad 5100% (1 /20) with aalyi repectively; the total effective ratewere 45183% (11 /24) with ITT aalyi ad 55100% (11 /20) with aalyi. There wa o tatitical differece betwee the two group ( > 0105). For Q iyiliagxu ydrome improvemet, i the treatmet group, the cliical cotrol rate ad good imp rovemet rate were 18157% (13 /70) with ITT aaly2 i ad 21131% (13 /61) with aalyi repectively; the total effective rate were 81143% (57 /70) with ITT aalyi ad 93144% (57 /61) with aalyi repectively; I the cotrol group, the cliical cotrol rate ad good improvemet rate were 20184% (5 /24) with ITT aalyi ad 25100% (5 /20) with aalyi repectively; the total effective rate were 75100% (18 /24) with ITT aalyi ad 85100% (17 /20) with aalyi repectively. The reult howed o tatitical differece be2 twee the two group ( >0105). No advere effect were foud. Cocluio No tatitical differece wa detected betwee : 2005 06 29: 2005 08 12 :,, 3 (Correpodece author) 1994-2010 Chia Academic Joural Electroic ublihig Houe. All right reerved. http://www.cki.et
676 Chiee J Evidece2Baed Medicie, 2005, Vol15 (9) Shegkag cap ule ad Sheya cap ule group. No obviou toxic advere effect were foud. Key word Shekag cap ule; Chroic glomeruloephriti; Q iyiliagxu ydrome; Double blid radom ized cotrolled trial,,,,,,,, ( : 2002L0167), 2004 5 2005 3,, 1 111 [ 1 ] [ 2 ] 11111, ; ; ( Scr) 265 mol/l; 18 65 ; 140 /90 mmhg 11112 24 h> 3 g; ; ; 112 3 1 SAS ROCLAN,, ( ),,,,,,, :,,, 113 ( ) : 72,: 040217 2,2, 1 ( ) : 24,,,z20026763,: 040322 2,2, 1 8, 114 11411 :, 0 2 4 6;:, 0 1 2 3 11412 (BUN) Scr,24 h 11413 [ 1 ], : - ( % ) = 100% : :, 95% :, 70% :, 30% : 1994-2010 Chia Academic Joural Electroic ublihig Houe. All right reerved. http://www.cki.et
200559 677,, < 30% : :, 24h ; (RBC) ; : 2 +, 24 h 40% ; RBC 3 /H 2 + ; ( 15% ) : 1 +, 24 h < 40% ; RBC< 3 / H 1 + ; : 11414 () ( ) 2 1, :,,, 1 :,, ; 2 :,,, ; 3 :,,, ; 4 :, 115, 2 4 6 ( 8 ) 11, ( 4 ) 1 116,,, Fiher W ilcoxocmh ;, t W ilc2 oxo,, t W ilcoxo, SSS 10. 0,, Fiher 117, 2 211, 96,72, 24 2 ( ),13 81,61, 20, F ig Flow d iagram of ubject progre through the tr ia l 1,,, 212 2 213 3 214 4 9 215,, 1994-2010 Chia Academic Joural Electroic ublihig Houe. All right reerved. http://www.cki.et
678 Chiee J Evidece2Baed Medicie, 2005, Vol15 (9) Item 1( ITT) Table 1 Com par io of characteritic of two group ( ITT) Trial group 70 24 Cotrol group value Sex (M /F), (Cae) 25 /45 9 /15 2 = 0. 025 0. 875 Mea age ( x, year) 35. 0 10. 1 41. 0 12. 6 2 = 4. 634 0. 068 Severity (m ild /moderate / evere), (Cae) 21 /19 /30 5 /11 /8 = - 0. 106 0. 915 Coure (6 12 36 60 ), ( h) 41 /19 /6 /4 11 /11 /0 /2 2 = 4. 730 0. 193 Accumulated poit of ymp tom 10. 0 3. 293 10. 5 4. 043 = 0. 362 0. 717 U rie p rotei (1 + /2 + /3 + /4 + ), ( g) 14 /19 /23 /7 4 /9 /5 /2 = - 0. 541 0. 589 U rie red blood cell (1 + /2 + /3 + /4 + ) 21 /6 /3 /4 7 /2 /0 /1 = - 0. 523 0. 601 24 U rie p rotei of 24 hour ( g/24h) BUN abormal (mmol/l) Creatiie abormal ( mol/l) 1. 176 1. 016 1. 159 1. 411 = - 0. 422 0. 673 15 (10. 46 3. 423) 6 (8. 4 1. 373) = - 1. 56 0. 119 10 (195. 25 44. 75) 9 (179. 78 29. 01) t = 2. 38 0. 266 Cocom itat medicie ( Ye/No) 2 /68 0 /24 2 = 0. 701 0. 403 2[ ( %) ] Table 2 Com par io of effect o chro ic glom eruloephr iti [ ( %) ] Method Cliical cotrol Good imp rovemet Imp rovemet No improvemet ITT T 70 9 (12. 86) 9 (12. 86) 16 (22. 86% ) 36 (51. 43) C 24 1 (4. 17) 1 (4. 17) 9 (37. 5% ) 13 (54. 17) T 61 9 (14. 75) 9 (14. 75) 16 (26. 23% ) 27 (44. 26) C 20 1 (5. 00) 1 (5. 00) 9 (45. 00% ) 9 (45. 00) T: ( Trial group) ; C: (Cotrol group), 0. 829 0. 407 0. 806 0. 420 3[ ( %) ] Table 2 Com par io of effect o Q iy i liagxu ydrom e [ ( %) ] Method Cliical cotrol Good imp rovemet Imp rovemet No improvemet ITT T 70 2 (2. 86) 11 (15. 71) 44 (62. 86% ) 13 (18. 57% ) C 24 1 (4. 17) 4 (16. 67) 13 (54. 17% ) 6 (25. 00% ) T 61 2 (3. 28) 11 (18. 03) 44 (72. 13% ) 4 (6. 56% ) C 20 1 (5. 00) 4 (20. 00) 12 (60. 00% ) 3 (15. 00% ) 0. 263 0. 793 0. 236 0. 814 4 24 h ( g) Table 4 Com par io of chage o 24 h ur ie prote i of two group ( g) D ifferece T 70 1. 134 0. 860 0. 874 0. 863 286. 5 < 0. 01 0. 260 0. 711-1. 639-1. 639 C 24 0. 813 0. 597 1. 724 3. 343 6. 5 0. 75-0. 912 3. 495 5 Table 5 Com pario of chage o urie prote i of two group Cotet of urie p rotei 0 1 + 2 + 3 + 4 + T ( = 58) Before treatmet 0 13 17 21 7 After treatmet 14 15 16 9 4 C ( = 17) Before treatmet 0 3 9 3 2 After treatmet 2 2 7 6 0 D ifferece 346. 5 < 0. 01 0. 828 1. 094 9 0. 4 0. 235 0. 831 t - 2. 002 0. 045 1994-2010 Chia Academic Joural Electroic ublihig Houe. All right reerved. http://www.cki.et
200559 679 6 Table 6 Com pario of um ber of aborma l ur ie RBC of two group Cotet of urie p rotei 10 /H 1 + 2 + 3 + 4 + T ( = 28) Before treatmet 0 17 5 3 3 After treatmet 9 12 3 3 1 C ( = 9) Before treatmet 0 6 2 0 1 After treatmet 2 7 0 0 0 D ifferece 50 0. 02 0. 607 1. 166 7. 5 0. 06 0. 778 0. 972 0. 378 0. 706 Idex BUN (mmol/l) Scr ( mol/l) 7 Table 7 Com pario of effect o aborma l rea l fuctio of two group Before treatmet After treatmet D ifferece T 15 10. 46 3. 423 8. 247 4. 295 33. 5 0. 06 2. 213 4. 376 C 6 8. 35 1. 387 8. 117 1. 952-1. 5 0. 81 0. 233 3. 143 T 10 195. 25 44. 794 180. 540 41. 776 2. 5 0. 85 14. 710 50. 622 C 8 179. 813 29. 038 170. 575 40. 552 10 0. 11 9. 238 13. 654-1. 013 0. 311 13. 75 0. 002 8() Table 8 Com pario of effect o ym ptom tota l va lue of two group Group Before treatmet After treatmet T 61 10. 066 3. 188 4. 459 2. 306 915 <0. 01 C 20 10. 550 4. 286 4. 500 2. 965 105 <0. 01 9() Table 9 Compario of effect o differece of ymptom value betwee two group Symptom ale or yellow face Breath horte ad debility Fever of had & foot Back pai Edema Dry mouth ad throat Swellig ad pai of throat Total value 3 Group Differece T 61 0. 328 0. 831 C 20 0. 700 1. 174 T 61 1. 410 1. 116 C 20 1. 400 1. 142 T 61 0. 656 0. 947 C 20 0. 700 0. 979 T 61 0. 787 1. 112 C 20 0. 700 0. 979 T 61 1. 213 1. 380 C 20 1. 200 1. 508 T 61 0. 787 0. 661 C 20 0. 650 0. 489 T 61 0. 426 0. 499 C 20 0. 700 0. 657 T 61 5. 607 2. 679 C 20 6. 050 3. 103 1. 646 0. 100-0. 275 0. 783 0. 174 0. 862-0. 170 0. 865-0. 140 0. 889-0. 816 0. 415 1. 649 0. 099 0. 680 0. 497 ( ACE I) (ARB) [ 3 ],,,,,,,,,,,,,,,,,,,, ( ),,, : ( ITT/ ) 12186% / 14175%, 12186% /14175%, 48158% /55173% ;( ITT/ ) 18157% /21131%, 81143% /93144% ;, 0101 ( > 0105), 1994-2010 Chia Academic Joural Electroic ublihig Houe. All right reerved. http://www.cki.et
680 Chiee J Evidece2Baed Medicie, 2005, Vol15 (9), 01828 11094 01235 01831, ( = 01045),, ( = 0102) ; ( = 0106), ( = 01706),, ( = 01002 ),,,,,,,,,,, 1 Chiee p ricip le of cliical reearch for ew traditioal herb i trea2 tig chroic glomeruloephriti. heg XY, chief editor. Chiee pricip le of cliical reearch for ew traditioal herb [M ], 1t iue, Beijig. Chiee medicie ciece ad techology publihig houe, May 2005. p. 156 162.. : [M ]. 1. :, 2002. p. 156 162. 2 hag YK. Chroic glomeruloephriti[m ]. Ye RG, Chief editor. IteralMedicie. houe, 1999. p. 528 530. Fifth editio. Beijig: eopleπ medical publihig. [M ]. :. 5. :, 1999. p. 528 530. 3 W ilmerwa, Rovi BH, Hebert CJ, Rao SV, Kumor K, Hebert LA. Maagemet of glomerular proteiuria: a commetary [ J ]. N ephrol, 2003; 14 (12) : 3217 3232. ( : ) ( : hilw iffe) J Am Soc New, 2006,,,, (CA ) ( IdexMedicu) MEDL INE ubmed,, 16, 80,,, : 28, 257, 10100, 120100 ( ), : 305 ; : 210002, 1995,,, /: 025-84815775; E - mail: editor@ adrol1c;: www1adrol1c 1994-2010 Chia Academic Joural Electroic ublihig Houe. All right reerved. http://www.cki.et