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Accession number;02A0277293
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| Title;Clinical Evaluation of Nicotine Resin Complex as a Smoking Cessation Aid in an OTC setting. A Multi-Center Open Trial. |
| Author;
NAKAMURA MASAKAZU
(Osakafukenkokagakuse)
GOTO YUICHIRO
(Tokai Univ.)
SHIMAO TADAO
(Res. Inst. of Tuberc., Jpn. Anti-Tuberculosis Assoc.)
MIYASATO KATSUMASA
(Seimariannaidai Shinkeiseishinka)
OSHIMA AKIRA
(Center for Adult Dis., Osaka)
ISHII SHUICHI
(East Japan Railway Co., JR Tokyo General Hospital, JPN)
SENSAKI KOJI
(Jieitai Cent. Hosp.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.18;NO.2;PAGE.335-361(2002)
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| Figure&Table&Reference;FIG.7, TBL.29, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;An open clinical trial was conducted to examine the efficacy and safety of nicotine resin complex as adjunctive treatment for smoking cessation in an over-the-counter(OTC) setting. Nicotine was administered as a chewing gum containing 2mg per stick. Each participant took 2mg Nicorette for 3 months. Smoking status was observed and recorded. The main results were as follows. 1) Two hundreds thirty-six participants were enrolled in this study. To examine the efficacy, two hundred twenty-six were analyzed with FAS(Full Analysis Set). Two hundred seventeen were analyzed with PP(Per Protocol Set). To examine the safety, two hundred twenty-nine were analyzed. 2) The efficacy rates of the group analyzed with FAS and that of the group analyzed with PP were 50.0% and 50.3% respectively. 3) Smoking cessation rate at one week follow-up was 39.4% (89/226 cases). From the second week to eleventh week, it stayed around 40%, which ended up with 41.6% at the twelfth week. 4) Adverse reactions such as disturbances in upper digestive system and jaw joints pain were observed at 27.1% of the cases (62/229 cases), but none were serious. 5) There was no big difference in the amount of nicotine resin complex use between complete abstinent cases and others among low or medium nicotine dependent groups (lower than 7 FTND points). On the other hand, there was a significant difference in the amount of nicotine resin complex use between complete abstinent cases and others among high nicotine dependent groups (higher than 8 FTND points) in the first one and two weeks. It was concluded that the nicotine resin complex was a safe and effective aid for smoking cessation in an OTC setting. (author abst.) |
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