A clinical evaluation of CMX nasal preparation in the nebulizer mist inspiration therapy of sinusitis
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...
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Published in | jibi to rinsho Vol. 41; no. 2; pp. 192 - 217 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | Japanese |
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JIBI TO RINSHO KAI
20.03.1995
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Abstract | 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. |
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AbstractList | 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. |
Author | SUZUMURA, Hidehisa MATSUZAKI, Tsutomu ICHIMIYA, Issei OYAMA, Masaru KOBAYASHI, Takehiro NOBORI, Takuo KOMEMUSHI, Sadao SAKAKURA, Kenji ARIMA, Shinobu YOSHIMURA, Hiroyuki SHIMAMURA, Koichiro MAJIMA, Yuichi YOKOTA, Akira FUKUYAMA, Tomoko YAMADA, Hiroyuki TAKEUCHI, Masahiko KATO, Kaori CHAEN, Atsuo HAMAGUCHI, Yukiyoshi TAKADA, Junko ITO, Yukiko MIYAMOTO, Naoya KAWAUCHI, Hideyuki KAWAGUCHI, Syinya DEGUCHI, Koichi FURUTA, Shigeru BABA, Shunkichi MIYAZAKI, Yasuhiro YAMADA, Tetsuo HARAGUCHI, Kaneaki SHINOKI, Jun FUJIYOSHI, Tatsuya KANEDA, Noritsugu MOGI, Goro AJISAKA, Koji KOKETSU, Masakazu SAKAKURA, Yasuo |
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References | 6) 日本化学療法学会: 最少発育阻止濃度 (MIC) 測定法再改訂について. Chemotherapy 29: 76-79, 1981. 8) 馬場駿吉: 耳鼻咽喉科領域の感染症, その検出菌の動向と薬剤選択. JOHNS 4: 525-528, 1988. 3) 松根彰志他: 副鼻腔炎におけるCefmenoxime (CMX) 局注の効果-家兎を用いた組織化学的観察-. 耳鼻臨床83: 119-128, 1990. 9) 丹後俊郎: 医学への統計学. 259-270頁,(株) 朝倉書店, 東京, 1993. 5) 馬場駿吉他: 副鼻腔炎に対するCefmenoxime (CMX) 鼻科用剤のネブライザー療法による薬効評価, 耳鼻37: 851-880, 1991. 1) 馬場駿吉: 細菌感染症の当科における最近の動向. 耳鼻臨床71: 505-512, 1987. 2) 馬場駿吉: エアロゾル吸入療法 (馬場駿吉他編). 南江堂, 東京, 1989. 10) 馬場駿吉他: CMXネブライザー療法における上顎洞への薬物到達性の検討. 薬理と治療 7) 大山勝: 鼻副鼻腔炎の病態からみた薬物療法. ProMed 9: 1181-1187, 1989. 4) 奴久妻聡一他: Cefmenoxime鼻科用剤のネブライザー療法における実験的研究-家兎急性副鼻腔炎に対する薬効薬理試験, 組織移行性試験-, 薬理と治療19 No.4 Apr: 1991. |
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