A clinical evaluation of CMX nasal preparation in the nebulizer mist inspiration therapy of sinusitis

• Published in: jibi to rinsho Vol. 41; no. 2; pp. 192 - 217
• Main Authors: BABA, Shunkichi, MIYAMOTO, Naoya, KOBAYASHI, Takehiro, YOKOTA, Akira, KATO, Kaori, KOKETSU, Masakazu, SAKAKURA, Yasuo, MAJIMA, Yuichi, TAKEUCHI, Masahiko, KAWAGUCHI, Syinya, HAMAGUCHI, Yukiyoshi, SUZUMURA, Hidehisa, ARIMA, Shinobu, SAKAKURA, Kenji, YAMADA, Hiroyuki, SHINOKI, Jun, YAMADA, Tetsuo, ITO, Yukiko, FUKUYAMA, Tomoko, MOGI, Goro, KAWAUCHI, Hideyuki, ICHIMIYA, Issei, SHIMAMURA, Koichiro, YOSHIMURA, Hiroyuki, CHAEN, Atsuo, TAKADA, Junko, FUJIYOSHI, Tatsuya, KANEDA, Noritsugu, OYAMA, Masaru, FURUTA, Shigeru, MATSUZAKI, Tsutomu, NOBORI, Takuo, MIYAZAKI, Yasuhiro, HARAGUCHI, Kaneaki, AJISAKA, Koji, DEGUCHI, Koichi, KOMEMUSHI, Sadao
• Format: Journal Article
• Language: Japanese
• Published: JIBI TO RINSHO KAI 20.03.1995
• Subjects: Cefmenoxime
• ISSN: 0447-7227; 2185-1034
• DOI: 10.11334/jibi1954.41.2_192

To assess the efficacy, safety and optimum concentration of CMX for nasal use in nebulizer mist inspiration therapy of sinusitis, a multicenter comparative clinical study using 0.5% CMX and 1.0% CMX nasal preparations was conducted. The results were as follows: 1. The clinical efficacy rate covering effective and very effective cases was 78% for 1.0% CMX vs. 60*% for 0.5 CMX, but no statistically significant difference was found. In the equivalency test, however, the clinical effect of 1.0% CMX was more than equivalent to that of 0.5% CMX. Furthermore, based on Fisher's exact test of efficacy between the groups, 1.0% CMX tended to be superior to 0.5% CMX (p=0.856). 2. The clinico-bacteriological efficacy rate based on clinical efficacy and bacteriological efficacy, covering both effective and very effective cases, was 76.3% for the 1.0% CMX nasal preparation vs. 68.4% for the 0.5% CMX nasal preparation, but no significant difference was found between the groups. 3. The improvement rate based on the X-ray findings, and covering the improved and the markedly improved cases, was 52% (67%, including the slightly improved cases) for 1.0% CMX vs. 46% (66%, including the slightly improved cases) for 0.5% CMX. Thus, a higher improvement rate was generated for the 1.0% CMX nasal preparation but no significant difference was found between the groups. 4. While no side effects were observed in the 1.0% CMX nasal preparation, the 0.5% CMX nasal preparation caused side effects in two cases. The side effects included transient nasal itching which developed after inhaling the nebulizer spray but was invariably not remarkable or serious. Based on the above results, 1.0% was thus considered to be the optimal concentration of CMX for the nebulizer mist inspiration therapy of sinusitis. The results of the present study are generally consistent with the past clinical results with CMX nasal preparations and in view of the reproducibility of effectiveness in sinusitis, the present study can be regarded as having further verified the usefulness of this drug in the treatment of sinusitis.