(核)41-1(05)報告33-46
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1 33 Report on Survey of the Adverse Reaction to Radiopharmaceuticals (The 28th Survey in 2002) 6 * Subcommittee of Safety Issue for the Radiopharmaceuticals Medical and Pharmaceutical Committee Japan Radioisotope Association ( 41: 33 46, 2004) I. 28 in vivo RI (adverse reaction) (drug defect) 27 ( 13 ) 24 1) * ( ) 6 II. 28 ( 14 ) in vivo ( 15 ) III. 1,211 1, % (Table 1) 32 38
2 (2004) Table A 1,206 1,197 1,212 1,210 1,211 B 991 1,031 1,044 1,048 1,033 B/A 82.2% 86.1% 86.1% 86.6% 85.3% C C/B 3.8% 2.6% 2.4% 2.6% 3.1% D 1,349,099 1,374,561 1,401,962 1,390,843 1,395,928 E E/D % % % % % F F/D % % % % % Table (% (10 ) (10 ) Table 3 V F A O (%) I- 2, Tc-PYP 3, I- 1, Tc-DTPA 14, Tc-DMSA 7, I- 8, Tc-GSA 11, Tc- 26,378 2* 2* Tc-MIBI 27, Ga- 142, Tc-HM-PAO 31, Tc-MAA 44, Tc-HMDP 360, I-IMP 69, Tl- 218,578 1* 2 3* Tc-MDP 136, (17*) (38*) V; F; A; O; * 2
3 25 35 Table (V) (0.9) (0.6) (0.9) (0.8) (1.1) (F) (A) (0.4) (0.3) (0.7) (0.8) (0.6) (O) (0.7) (0.5) (0.6) (0.8) (0.4) (2.1) (1.4) (2.2) (2.3) (2.1) ( ) 10, Table 5 ( 14 ) Tc V MBq 5 T /90 mmhg T3 200 ml 5 25 (10 ) 02-02* V MBq 5 147/94 mmhg 56/ 201 Tl- (30 ) Tc-PYP V 51 1 vial (2 ) V 71 1 vial CCU A 110/ mmhg 80/ (30 ) Tc-MAA O 66 1vial 12 ()
4 (2004) Tc-HM-PAO V 54 1 vial 20 ml (1 ) Tc-MDP V MBq 112/60 mmhg (5 ) Tc-HMDP V MBq 3 (2 ) A 55 1 vial 24 -VG 6 -VG 3 24 (6 ) O 51 1 vial ml CT 30 CT CT (45 ) A 52 1 vial 10 C C 3 CT 2 (7 )
5 V 14 1 vial /60 mmhg 12/ 80/ (1 ) V 56 1 vial / mmhg /56 mmhg ICU (70 ) V 20 1 vial 1 118/72 mmhg 60/ (5 ) Tc-DMSA V MBq 5 (5 ) Tc-DTPA V 71 1 vial 101/51 mmhg 18/ 72/7 135/60 mmhg 65/SpO 2 100% O 2 2 l/ O 2 1 l/ (15 ) A 71 1 vial 24 2 (13 ) V 41 1 vial 128/80 mmhg (5 ) Tc-GSA A MBq /78 mmhg 60/ (30 )
6 (2004) Tc-MIBI A 66 1 vial P C 3 (3 ) O 50 1 vial /112 mmhg (1 ) 67 Ga O MBq 1 30 C C CRP 132/72 mmhg 70/ (7 ) V MBq 105/85 mmhg (10 ) A MBq (3 ) A MBq 8 3 (3 ) A MBq 6 (2 ) 201 Tl * V MBq 5 147/94 mmhg 56/ Tc- (30 )
7 A MBq 1 (1 ) A MBq ( ) I A MBq C VG (12 ) I-IMP V MBq 10 (10 ) I V 44 1 MBq / 88/64 mmhg 21 64/ 90/64 mmhg (18 ) I O MBq 2 T T /90 mmhg 72/ (10 ) O MBq (10 ) O MBq 1 ml 9 ml 7 ml 9 ml 163/95 mmhg 86/ (90 )
8 (2004) O MBq /60 mmhg (5 ) O MBq 10 ml 1 O 2 1 l/10 110/60 mmhg (10 ) A MBq 20 ml / mmhg * 2 (3 ) 1, % ,395, % 100, % 100, % % (Table 1) , (Table 2) (Table 1) ( Tc) Tc-HMDP 7 ( I) I-6 ( 67 Ga) 67 Ga- 5 ( Tc) Tc-DTPA ( 201 Tl) 201 Tl- 3 ( Tc) Tc- ( Tc) Tc-PYP (2- ) ( Tc) Tc-MIBI 2 ( Tc) Tc- MAA ( Tc) Tc-HM-PAO ( Tc) Tc-MDP ( Tc) Tc- DMSA ( Tc) Tc-GSA ( I) I- N-
9 ( I) I- IMP ( I) I (V) (F) (A) (O) (Table 3) 1,033 () I % ( 100, ) Tc- PYP % ( 61 ) I % ( 51 ) Tc-DTPA % ( 20 ) Tc-DMSA % ( 13 ) I % ( 12 ) Tc-GSA % ( 9 ) Tc % ( 8 ) Tc-MIBI % ( 7 ) 67 Ga % ( 4 ) Tc-HM-PAO % ( 3 ) Tc-MAA % ( 2 ) Tc-HMDP % ( 2 ) I-IMP % ( 1 ) 201 Tl % ( 1 ) Tc-MDP % ( 1 ) (Table 3) 2) I- 0.1% (Society of Nuclear Medicine) 3) , , (European Association of Nuclear Medicine) 4) 100, Table (18%) (17%) (17%) (11%) (19%) (44%) (24%) (46%) (33%) (35%) (26%) (48%) (33%) (48%) (30%) (9%) (7%) (4%) (16%) (3%) (3%) (4%) (4%) Table (6%) (3%) (32%) (34%) (29%) (19%) (19%) (62%) (66%) (71%) (81%) (78%) (V) 16 ( ) (A) 12 ( ) (O) 9 ( ) (Table 3 5) (Table 4) 1997 (V) (A) (O) 10
10 (2004) Table 8 ( ) Tc-HMDP 3 4 ( 2) 2 ( 1) 4 ( 2) 2 ( 1) 6 ( 2) 1 ( 0) 6 ( 2) 7 ( 2) 35 I (168) 8 (275) 6 (202) 12 (391) 6 (197) 6 (203) 5 (170) 6 (204) Ga ( 1) 2 ( 1) 4 ( 3) 2 ( 1) 5 ( 4) 33 Tc-DTPA 55 1 ( 5) 4 ( 19) 1 ( 5) 3 ( 15) 2 ( 11) 3 ( 20) Tl- 6 2 ( 1) 3 ( 1) 3 ( 1) 4 ( 2) 2 ( 1) 1 ( 0) 2 ( 1) 3 ( 1) 26 Tc ( 4) 2 ( 8) 17 Tc-PYP 28 3 ( 29) 2 ( 35) 1 ( 20) 1 ( 16) 1 ( 18) 2 ( 47) 2 ( 61) 40 Tc-MIBI 3 1 ( 7) 2 ( 12) 2 ( 10) 1 ( 4) 2 ( 7) 11 Tc-MAA 8 1 ( 3) 1 ( 2) 1 ( 2) 1 ( 2) 12 Tc-HM-PAO 3 1 ( 3) 1 ( 3) 5 Tc-MDP 13 1 ( 1) 1 ( 1) 1 ( 1) 1 ( 1) 3 ( 2) 3 ( 2) 3 ( 2) 1 ( 1) 27 Tc-DMSA 5 3 ( 36) 1 ( 13) 9 Tc-GSA 1 1 ( 8) 1 ( 10) 1 ( 8) 1 ( 9) 5 I- 0 1 ( 7) 1 ( 8) 1 ( 12) 3 I-IMP 2 1 ( 2) 1 ( 2) 1 ( 2) 1 ( 2) 1 ( 1) 7 I ( 39) 1 ( 22) 1 ( 27) 3 (102) 1 ( 51) 243 Tc- 4 4 Tc- 6 6 Tc-ECD 0 2 ( 4) 1 ( 2) 3 ( 5) 1 ( 1) 1 ( 1) 8 Tc-HSA-DTPA 1 1 ( 5) 2 ( 13) 1 ( 7) 5 Tc-HSA 4 1 ( 9) 5 Tc-PMT 1 1 Tc- 0 1 ( 4) 1 ( 3) 2 Tc-MAG ( 15) 4 ( 19) 1 ( 5) 1 ( 5) 2 ( 10) 13 I-MIBG 0 1 ( 6) 1 ( 5) 1 ( 5) 3 I-BMIPP 2 1 ( 3) 3 ( 7) 2 ( 4) 8 I-() 1 1 ( 13) 2 I-MIBG 0 1 ( 33) 2 ( 64) 3 I In In-DTPA
11 25 43 Table 9 Tc-HMDP 360, Table 10 ( 14 ) Tc-HMDP vial % 84% (Table 5 6) 3% 19% 78% (Table 5 7) 1 (02-13) Tc-HMDP 3 56 I (Table 8) I ,6) (Table 9, 10) 1 (02-101) % Table 11
12 (2004) Table (0.4) (0.4) (0.2) (0.2) (0.3) (0.1) (0.1) (0.1) (0) (0.2) (0.1) (0) (0.1) (0) (0.1) (0.1) (0.1) (0) (0.3) (0.3) (0.2) (0) (0) (0.1) (0) (0) (1.4) (1) (0.7) (0.2) (0.2) ( ) 10 PET PET 29 ( 15 ) 15 O- 18 F- (FDG) ) : 1979; 16: ; 18: ( 55 6 ) 1982; 19: ( 56 7 ) 1983; 20: ( 57 8 ) 1984; 21: ( 58 9 ) 1985; 22: ( ) 1986; 23: ( ) 1987; 24: ( ) 1988; 25: ( ) 1989; 26: ( ) 1991; 28: ( 15 ) 1991; 28: ( 2 16 ) 1992; 29: ( 3 17 ) 1993; 30: ( 4 18 ) 1994; 31: (
13 ) 1995; 32: ( 6 20 ) 1996; 33: ( 7 21 ) 1997; 34: ( 8 22 ) 1998; 35: ( 9 23 ) 1999; 36: ( ) 2000; 37: ( ) 2001; 38: ( ) 2002; 39: ( ) 2003; 40: ) 607 ( ): 3) Silberstein EB, Ryan J and the Pharmacopoeia Committee of the Society of Nuclear Medicine: Prevalence of Adverse Reactions in Nuclear Medicine. J Nucl Med 1996; 37: ) Hesslewood SR, Keeling DH and the Radiopharmacy Committee of the European Association of Nuclear Medicine: Frequency of adverse reactions to radiopharmaceuticals in Europe. Eur J Nucl Med 1997; 24: ) : (2003 ) 6) : (2003 )
14 (2004) ( 14 ) TcO 4 ( ) () 16, () 6, () 1, () 1, TcO 4 26, Tc 1, , MAA 44, PYP 3, PYP (RBC ) 6, HM-PAO 31, ECD 68, MDP 136, HMDP 360, DMSA 7, DTPA 14, HSA 4, HSA-DTPA 10, PMT 3, GSA 11, MIBI 27, , MAG 3 18, , Tc 856,213 1, Ga () 124, () 17, () Ga 142, Tl () 191, () 20, ( ) 3, () 1, Tl 218, I NaI () 8, () IMP 69, MIBG 18, BMIPP 45, I 142, I NaI () 6, () () 2, () 1, , , MIBG 3, I 19, In 1, DTPA 1, () () In 3, Cr Fe Xe ( ) 4, ( ) 2, () Xe 7, m Kr , m Kr 5, ,395,928 1, (1) A 45 B 39 B/A 86.7% (2) 15 O 1, F 34, ,711 39
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