CHINESE JOURNAL OF ALLERGY & CLINICAL IMMUNOLOGY 1 1 2 3 4 5 6 7 1# 100730 91 5 mg 2 d 89 10 mg 1 d 14 d 2 0. 597 ± 0. 266 0. 596 ± 0. 282 P = 0. 984 79. 3% 81. 4% P = 0. 730 31. 1% 27. 3% P = 0. 573 23. 3% 20. 5% R593. 1 A 1673-8705 2013 03-0242-06 Evaluation of the Efficacy of Olopatadine Hydrochloride in the Treating Allergic Rhinitis A Multicenter Randomized Double-blind Double-dummy Study LI Hong 1 GU Jian-qing 1 TAN Guo-lin 2 CHENG Lei 3 WANG Pei-hua 4 ZHANG Luo 5 LI Tian-ying 6 WANG De-hui 7 YIN Jia 1# Department of Allergy Peking Union Medical College Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100730 China Objective To evaluate the efficacy and safety of olopatadine hydrochloride a new antihistamine versus cetirizine hydrochloride in the treatment of allergic rhinitis. Methods A multicenter randomized double-blind double-dummy parallel-group controlled clinical trial was performed. Patients received 5 mg olopatadine hydrochloride twice per day in the study group or 10 mg cetirizine hydrochloride once time per day in the control group for 14 day. Ninety-one cases were enrolled in the study group whereas 89 cases in 1 100730 2 410013 3 210029 4 200011 5 100005 6 510080 7 200031 # 010-69151601 doctoryinjia@ 163. com 242
the control group. The symptom score decreasing index was defined as primary outcome of efficacy and global efficacy and total effective rate as secondary outcome. Results The symptom score decreasing index in olopatadine hydrochloride group and cetirizine hydrochloride group were 0. 597 ± 0. 266 and 0. 596 ± 0. 282 respectively after 14 days treatment. The differences were not statistically significant P = 0. 984. The total effective rate was 79. 3% and 81. 4% in two groups respectively. The differences were also not statistically significant P = 0. 730. The adverse reaction rate were 31. 1% 27. 3% in olopatadine hydrochloride and cetirizine hydrochloride group respectively the differences were also not statistically significant P = 0. 573. The incidence of drowsiness was 23. 3% and 20. 5% in two groups respectively. Conclusions Olopatadine hydrochloride was effective in the treatment of allergic rhinitis. The efficacy and adverse reaction of olopatadine hydrochloride was similar to cetirizine hydrochloride. Key words olopatadine hydrochloride cetirizine hydrochloride allergic rhinitis Chin J Allergy Clin Immunol 2013 7 3 242-247 10% ~ 20% 1 IgE I 4 3 1 H1 T- regulated upon activation normal T-expressed and secreted RANTES -1 monocyte chemoattractant protein-1 MCP-1 4 2-3 1 6 7 1 18 ~ 65 2 UniCAP sige 2 3 2 2 2 3 3 4 5 8 9 10 2007 8 2008 1 7 6 1 11 1 12 1 13 4 14 15 16 1 17 243
1 1 2 3 Table 1 Symptoms scoring of allergic rhinitis 5 mg 0199-A 2006 8 22 2009 8 21 0198-A 2006 11 21 2009 11 20 10 mg 20061101 2006 11 10 2009 11 0 9 20061101 2006 11 10 2009 11 9 5 mg 1 + 1 5 mg 1 + 1 4 4 4 1 1 + 10 mg 1 2 2 1 + 1 1 14 d SSRI SSRI = - 4 1 0 1 2 3 * 3 ~ 5 6 ~ 10 11 # 4 5 ~ 9 10 * 1 # 0 symptom score reduce index SSRI H1 5 3 4 1 Fig 1 Disease grades ladder diagram 244
2 SAS V8. 2 P 0. 05 85 2 83 3 2 1 SSRI 0. 460 ± 0. 223 95% 0. 412 ~ t wilcoxon 0. 508 0. 422 ± 95% 95% 0. 281 95% 0. 360 ~ 0. 483 0. 1 P = 0. 329 95% SSRI 0. 038-0. 039 ~ 0. 115 Pearson χ2 Fisher 87 0 86 0 0. 597 ± 0. 266 95% 0. 540 ~ 0. 654 0. 596 ± full analysis set FAS 0. 282 95% 0. 536 ~ 0. 657 safety set SS SSRI FAS P = 0. 984 95% 0. 001-0. 082 ~ 0. 083 FAS P = 0. 517 7 200 95% 70. 6% 180 91 89 60. 9 ~ 80. 3 95% 173 FAS 60. 2% 49. 7 ~ 70. 8 87 86 7 FAS P = 0. 158 1 1 95% 10. 3% - 4. 0 ~ 24. 7 3 1 1 178 P = 0. 917 SS 90 88 95% 79. 3% 70. 8 ~ 87. 8 95% Table 2 2 Analysis of clinical basic information n % ± n % IgE * n % + ++ ± 33 37. 9 54 62. 1 36. 3 ± 12. 4 0 0. 0 15 17. 2 72 82. 8 17 19. 8 69 80. 2 7. 9 ± 1. 7 n = 87 35 40. 7 51 59. 3 36. 0 ± 11. 1 0 0. 0 14 16. 3 72 83. 7 20 23. 8 64 76. 2 7. 8 ± 1. 8 n = 86 P 0. 71 0. 565 0. 228 0. 523 0. 789 * 0. 70 kua L 245
81. 4% 73. 2 ~ 89. 6 6 6. 8% P = 0. 730 1 1. 1% 95% - 2. 1% - 13. 9 ~ 9. 8 4 1. 1% 5 1 1. 1% 1 5 mg 2 d 2 28 31. 1% 10 mg 1 d 2 24 27. 3% P = 0. 573 1 2 18 20. 0% 7 7. 8% 17 19. 3% Table 3 3 Global efficacy of the two groups during treatments full analysis set n % n % n % n % 87 85 2 6 7. 1 54 63. 5 21 24. 7 4 4. 7 86 83 3 14 16. 9 36 43. 4 23 27. 7 10 12. 0 Table 4 4 Global efficacy of the two groups after treatments full analysis set n % n % n % n % 87 87 0 20 23. 0 49 56. 3 16 18. 4 2 2. 3 86 86 0 21 24. 4 49 57. 0 12 14. 0 4 4. 7 Table 5 5 Incidence of adverse drug reactions between two groups n % 18 20. 0 7 7. 8 5 5. 6 0 0. 0 1 1. 1 1 1. 1 0 0. 0 5 a 5. 6 2 b 2. 2 2 c 2. 2 n = 90 17 19. 3 6 6. 8 1 1. 1 3 3. 4 0 0. 0 0 0. 0 1 1. 1 2 2. 3 1 1. 1 1 d 1. 1 n = 88 a 72 68 59 62 53 U L b 68 30 U L c Ⅰ 1 T 1 d ST T QRS M 246
H1 nasal epithelial cells J. Allergol Int 2007 56 171-177. 4-6 3 Ono SJ Lane K. Comparison of alcaftadine and tachykinin 7 olopatadine on conjunctival epithelium and eosinophil recruitment in a murine model of allergic conjuntivititis J. Drug Des Devel Ther 2011 5 77-84. 8-9 4. H1 KW-4679 platelet-activating factor PAF H1 J. 2 M1 1995 106 347-357. 10 5. KW-4679 30% 70% J. 1995 5 1837-1849. 2 6 Ikemura T Manabe H Sasaki Y et al. KW-4679 an 5 antiallergic drug inhibits the production of inflammatory lipids in human polymorphonuclear leukocytes and guinea pig eosinophils J. Int Arch Allergy Immunol H1 11 1996 110 57-63. 2 7 Ikemura T Okarmura K Sasaki Y et al. KW-4679-1 induced inhibition of tachykininergic contraction in the guinea-pig bronchi by prejunctional inhibition of peripheral sensory nerves J. Br J Pharmacol 1996 117 967-973. 1 1 8. 9620 KW-4679 1 1 0. 01% J. 1995 106 289-298. 9. KW-4679 - PCA J. 1995 29 3543-3559. 10. KW-4679 ex vivo 1 Brozek JL Bousquet J Baena-Cagnani CE et al. Allergic Rhinitis and its impact on Asthma guidelines 2010 revision J. JACI 2010 126 466-476. 2 Yamauchi Y Fujikura T Shimosawa T. The effect of H1 antagonists carebastine and olopatadine on histamine induced expression of CC chemokines in cultured human H1 J. 1995 5 1817-1824. 11 Soldovieri MV Miceli F Taglialatela M. Cardiotoxic effects of antihistamines from basics to clinics and back J. Chem Res Toxicol 2008 21 997-1004. 2013-06-05 247