Fig. 1 Chemical structure of Flurbiprofen Molecular formula : C1S H13 F02 Molecular weight : Chemical name : 2-( 2 -fluoro - 4 -biphenyly1 ) pr

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1 Key words : Flurbiprofen, Acute Upper Respiratory Tract Inflammation, Double-Blind Clinical Evaluation

2 Fig. 1 Chemical structure of Flurbiprofen Molecular formula : C1S H13 F02 Molecular weight : Chemical name : 2-( 2 -fluoro - 4 -biphenyly1 ) propionic acid Fig. 2 Packages of the Drugs Flurbiprofen group ( 120 mg /day ) Ibuprofen group ( 6 00 mg /day )

3 Table 1. Items of clinical symptoms Pains. Sore throat, Swallowing pain, Headache, Muscle pain, Arthralgia Local inflammations : Pharynx swelling, Pharynx redness, Tonsil swelling, Tonsil redness Airway symptoms. Cough, Sputum, Abnormal feeling in throat, Hoarseness, Nasal stuffiness Nasal secretion General symptoms : Sensation of fever, Body temperature Table 2. Improvement rating of symptoms by committee 0 : asymptomatic 1: slightly 2 : moderately 3 : markedly

4 Table 3. Total number of cases FP : Flurbiprofen group IP : Ibuprofen group FGIR : Final Global Improvement Rating OSR : Overall Safety Rating GUR : Global Utility Rating

5 Table 4. Background of patients Concomitant drug-1: medication before trial Concomitant drug-2: Concomitant drug during trial FP: Flurbiprofen group IP: Ibuprofen group

6 Table 5. Severity of each symptom before treatment FP: Flurbiprofen group IP: Ibuprofen group 0: None 1: Mild 2: Moderate 3: Severe Table 6. Body temperature FP: Flurbiprofen group IP: Ibuprofen group

7 Table 7. Final global improvement rating FP: Flurbiprofen group IP: Ibuprofen group Table 8 Efficacy in clinical symptoms

8

9 FP: Flurbiprofen group : P<0.05 IP: Ibuprofen group 3: Markedly improved, 2: Moderately improved, 1: Slightly improved, 0: Unchanged,-: Aggravated

10 Fig. 3-1 Improvement rating of symptoms by committee (marked improvement rate) Fig. 3-2 Improvement rating of symptoms by committee (accumulative rate of more than moderate improvement) 1 St day

11 Fig. 3-3 Improvement rating of symptoms by committee (accumulative rate of more than slight improvement)

12 Table 9. Abnormal laboratory finding FP: Flurbiprofen group IP: Ibuprofen group Table 10. Adverse reactions FP: Flurbiprofen, IP: Ibuprofen, DM: Diabetes mellitus : Other reason (Symptoms unchanged)

13 Table 11. Overall safety rating FP: Flurbiprofen group IP: Ibuprofen group Table 12. Global utility rating FP: Flurbiprofen group IP: Ibuprofen group

14

15 A Double-Blind Clinical Evaluation of Flurbiprofen on Acute Upper Respiratory Tract Inflammation \Comparative Masao TAMURA, Takashi ITO, Morio SUDO, Minoru TAZAWA, Tsuneo SAYAMA & Masami YOSHIDA The Third Department of Internal Medicine, School of Medicine, Iwate Medical College Ayako SUZUKI Department of Internal Medicine, Akita Rosai Hospital Masao SATO The Second Department of Internal Medicine, Ofunato Prefectural Hospital Takehisa MURAKAMI & Shinya MIYAMOTO Department of Internal Medicine, Fukuoka Prefectural Hospital Hiroshi ENDO Endo Clinic Nobuhisa SATO Department of Internal Medicine, Kanan Hospital Hiroshi KURAMITSU, Katsuyoshi MORIYA & Kazutoshi GOMI Department of Internal Medicine, Kitakami Saiseikai Hospital Kazumichi MIYA & Ikuo SATO Department of Internal Medicine, Kuzumaki Choritsu Hospital Hisaaki HOSOKAWA & Hidemitsu MORI Department of Internal Medicine, Sanai Hospital Shotaro MITSUI, Kazuji MIKAMI & Kenichi TAKEUCHI Department of Internal Medicine, Takizawa Central Hospital Hisashi TOGASAWA Togasawa Clinic Kunio SUZUKI Tokiwa Clinic Yasuyuki NISHIJIMA Nishijima Clinic Syunichi KITAZAWA & Kazuo TANIFUJI Department of Internal Medicine, Hachinohe Red Cross Hospital Takeshi BANDO Department of Internal Medicine, Morioka Red Cross Hospital Kiichi YAMAZAKI Yamazaki Clinic Terukazu SHIMODA Department of Internal Medicine, Public Yokote Hospital Toni YOSHIDA Yoshida Clinic Eiji WAKAYAMA Wakayama Clinic Kazunobu SUGAWARA (Controller) Hospital Pharmacy, Faculty of Medicine, Yamagata University The efficacy and safety of non-steroidal analgesic/anti-inflammatory agent, Flurbiprofen were compared those of Ibuprofen in patients with acute upper respiratory tract inflammation by a double blind method. The result were as follows:

16 1. Final glocal improvement rate in the Flurbiprofen group (120 mg/day) was 59.2% and 59.3% in the Ibuprofen group (600 mg/day), showing no significant difference between two groups. However, the cases of excellent improvement were more in Flurbiprofen group (18.4%) than Ibuprofen group (14.8%). 2. The development of the effect was early after administration of the drug in flurbiprofen group than Ibuprofen group, especially in the symptoms of muscle pain, joint pain and hoaseness (p<0.05). 3. The incidence of side effects in Flurbiprofen was 5.1% and 2.4% in the Ibuprofen group, and there was no signicant difference between two groups. 4. In global utility rate, usefulness was 60.0% in the Flurbiprofen group and 61.2% in the Ibuprofen group, showing no significant difference between two groups. However, the case of excellent usefulness were more in Flurbiprofen group than Ibuprofen group. From these result, it is concluded that Flurbiprofen is a useful drug for the treatment on acute upper respiratory tract inflammation and that the clinical efficacy and safety of Flurbiprofen were slightly better than Ibuprofen.

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