8 2000 10 2001 5 ADR ADR 415 ADR44 ADR 10.6% 2661 ADR105 ADR 3.9% P<0.05 ADR 4.5% 4.8% ADR 22.7% 19.9% 60 1
ADR ADR ADR : 2
ADVERSE DRUG REACTION AND RATIONAL USE OF OFLOXACIN AND LEVOFLOXACIN: A PERSPECTIVE INVESTIGATION Department of Epidemiology and Biostatistics School of Public Health, Peking University, Postgraduate: Zhangzheng Tutor: Professor Siyan Zhan Professor Jiancun Zhen Abstract This prospective study was conducted to investigate the rate of adverse drug reaction (ADR) and the situation of rational uses of ofloxacin and levofloxacin in clinical practice. Meanwhile, the relevant factors and economical evaluation of ADR and irrational use were preliminary explored and analyzed. All in-patients treated with ofloxacin and levofloxacin were prospectively observed in 8 hospitals of Beijing from Oct.2000 to May 2001.The results showed that the ADR rate was 10.6%(44/415) in ofloxacin and 3.9% 105/2661 in levofloxacin group respectively. The ADR rate of ofloxacin was significantly higher than the rate of levofloxacin(p<0.05). However, the severe ADR rate was 4.5% and 3
4.8%, respectively, no significant difference. All severe ADR cases had a nature of double infection. The ADR of levofloxacin occurrence was related to irrational drug use, older age, combination therapy and allergic history. The irrational use rate of ofloxacin and levofloxacin was 22.7% and 19.9%, respectively. The irrational use was significantly increased in the elderly population. The irrational use mainly referred to extra long or short course of treatment. The average expenses per hundred cases for treating ADR of levofloxacin were lower than ofloxacin, but the expenses of anti-infection were higher because of irrational drug use and the higher expenses of medicine. In conclusion, ofloxacin and levofloxacin are kinds of safe injection in clinical practice; the ADR rate of levofloxacin is lower. However, combination therapy and elderly patients should be paid more attention. The irrational use of antibiotics in clinic is severe, and the irrational drugs use is one of main reasons related to increasing ADR and the expenses. Keywords Ofloxacin Levofloxacin Adverse drug reaction Rational drugs use Perspective investigation 4
ofloxacin (levofloxacin) Quinolones [1-3] [4] 1982 ADR 2.6%~12.3% [5-8] ADR [9] ADR ADR [10-11] 1991 [12] ADR [13] ADR ADR 3.25% [14] ADR [15-17] 5
ADR ADR [18] ADR ADR ADR ADR 90 88 270.00 /0.2g 30 /0.2g 88.9% 95 8.7% 99 15.9% 80~90% 6
ADR ADR ADR 1 ADR 2 3 ADR 7
1 1.1 8 (ADR) 1.2 2000 10 2001 5 8 ADR 2 2.1 ADR ADR ADR ADR ADR 1 ADR ADR ADR ADR 4 ADR ADR [19] 2 2.2 : 8
3 2.3 ADR ADR 3 3.1 ADR 3.2 EpiInfo6.04 DBF SPSS10.0 t χ² SPSS10.0 logistic ADR 9
4 4.1 4.2 5% 155 96.8% 96.1% 4.3 4.4 ADR ADR149 2 1.3% 4 2.7% 10
3076 415 2661 41 100% 1 1 χ 2 P % % 169 40.7 1444 54.3 26.40 <0.05 246 59.3 1217 45.7 <60 241 58.1 1664 62.5 3.13 >0.05 60 174 41.9 997 37.5 250 60.2 1287 48.4 20.25 <0.05 165 39.8 1374 51.6 P<0.05 P>0.05 P<0.05 2 2.1 # 2 % % 64 15.4 1253 47.1 113 27.2 401 15.1 95 22.9 386 14.5 54 13.0 305 11.5 63 15.2 241 9.1 26 6.3 75 2.8 415 100.0 2661 100.0 χ 2 =159.34 P<0.05 11
50.1% 47.1% P<0.05 2.2 3 % % 62 14.9 1262 47.4 339 81.7 1335 50.2 14 3.4 64 2.4 415 100.0 2661 100.0 χ 2 =154.88 P<0.05 81.7% 50.2% 47.4% 3.4% 2.4% P<0.05 34.3% 21.9% 2.3 4 % % 347 89.9% 2348 90.9% 39 10.1% 236 9.1% # 386 100% 2584 100% # χ 2 =0.374 P>0.05 347 89.9% 2348 90.9% 12
P>0.05 3 5 % % 300 72.3 2013 75.7 78 18.8 493 18.5 26 6.3 112 4.2 11 2.6 43 1.6 415 100.0 2661 100.0 27.7% 24.3% 44.2% 53.3% P>0.05 4 4.1 0.39±0.05g 0.37±0.08g P<0.05 0.40±0.05g 0.38±0.07g 0.38±0.06g 0.37±0.09g 5.8±4.4 5.6±4.3 P>0.05 6.3±4.6 7.2±5.0 4.0±2.2 4.0±2.7 75.9% 3~5 17.2% 2 62.2% 3~7 10% 14 5% 3 13
4.2 6 % % 177 42.7 1604 60.3 161 38.8 615 23.1 57 13.7 271 10.2 20 4.8 171 6.4 415 100.0 2661 100.0 # χ 2 =45.76 P<0.05 ## χ 2 =60.01 P<0.05 57.3% 39.7% P<0.05 5 63 15.2% 23 11 12 5 G + 11 G - 6 73.9% G + 33.3% 66.7% G - 91.0% 9.0% 427 16.0% 123 39 57 G + 22 66 G - 17 65.9% G + 54.8% 45.2% G - 46.0% 52.0% 34.2% 34.2% 13.2% 14
10.5% 1 ADR 1 ADR 1.1 ADR 7 ADR ADR % % 8 1.9 9 0.3 26 6.3 65 2.4 7 1.7 26 1.0 3 0.7 5 0.2 371 0 2556 0 415 10.6 2661 3.9 ADR χ 2 =34.51 P<0.05 44 ADR ADR 10.6% 105 ADR ADR 3.9% P<0.05 ADR 8 1.9% 26 6.3% 7 1.7% 3 0.7% 9 0.3% 65 2.4% 26 1.0% 5 0.2% ADR 8 ADR 8 ADR ADR % ADR % P 169 13 7.7 1444 54 3.7 <0.05 246 31 12.6 1217 51 4.2 <0.05 250 31 12.4 1287 66 5.1 <0.05 165 13 7.9 1374 39 2.8 <0.05 238 30 12.6 1057 59 5.6 <0.05 177 14 7.9 1604 46 2.9 <0.05 15
1.2 ADR 9 ADR % % % % 33 8.0 75.0 54 2.0 51.4 9 2.1 20.5 46 1.7 43.8 2 0.5 4.5 5 0.2 4.8 44 10.6 100.0 105 3.9 100.0 χ 2 =7.54 P<0.05 ADR 75.0% ADR 51.4% 43.8% P<0.05 7 ADR 1.3 ADR ADR 11.0% 7.5% P>0.05 ADR 4.1% 3.6% 4.1% P>0.05 2 ADR ADR 2.9% 2.4% 1.4% 1.0% 0.7% 0.5% 0.5% 1.9% ADR 16