篇名 | Intravesical Instillation of Taipei-NIPM Bacillus Calmette-Guerin in Prophylactic Treatment of Superficial Bladder Cancer: A Preliminary Report of Phase I-II Clinical Trial |
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卷期 | 1:1 |
並列篇名 | 膀胱內灌注卡介苗(Taipei-IPM)預防表淺性膀胱癌復發之第I-II期臨床試驗初報 |
作者 | 張聖原 、 于大雄 、 閻中原 、 楊泰和 、 蘇忠仁 、 程千里 、 王曉暹 、 馬正平 、 廖明一 |
頁次 | 17-23 |
關鍵字 | Taipei-NIPM BCG 、 intravesical instillation 、 superficial bladder cancer 、 TSCI |
出刊日期 | 199003 |
我們利幅預防醫學研究所提供自製衍生於日本Tokyo-172菌種之卡介苗(暫定名為Taipei-IPM)從事臨床罹患表淺性膀性癌病人手術後行膀胱內灌注以預防復發之第I-II期臨床試驗,以初步探討其可能產生之毒性、副作用及其治療效果。共有7位男性,4位女性病患接受術後膀胱內灌注卡介苗之治療,每週一次,每次將50毫克卡介苗溶於50毫升蒸餾水內灌入膀胱內置2小時。病人共追蹤5至12個月,追蹤項目包括血液學,生化學,尿液檢查、結核菌素皮膚試驗,細胞學檢查及膀胱鏡或切片檢查。其治療相關之併發症包括55%病人產生膀胱炎,27%病人產生血尿情形,9%分別發生低燒或類似或冒症狀。血液學檢查發現治療過程中白血球及血色素有逐漸下降之趨勢,而淋巴球對中性白血球之比例則有升高之現象。追蹤期間僅有4位產生復發,其預防復發率達64%。這些初步結果說明了國產卡介苗Taipei-IPM的確可明顯降低表淺性膀胱癌術後之復發率,且其副作用並不嚴重。
A domestically produced bacillus Calmette-Guerin (named), derived from Tokyo-172 strain, was used to treat 11 patients (M: F=7: 4) with superficial bladder cancer (10 stage A and 1 stage B2; 2 grade I, 8 grade II, and 1 grade III). The phase I-II clinical trial was performed to assess the side effects and efficacy of BCG as a prophylaxis againt recurrence. BCG, 50 mg in 50 ml distilled water, was instilled intravesically without cutaneous inoculation. Instillations were given weekly for 6 consecutive weeks. Hematology and biochemistry, including hepatic and renal function, were monitored. Only minor toxicity and/or side effects were observed during therapy and for a period of 5 to 12 months after treatment. Complications included cystitis in 55 per cent of the patients, hematuria in 27 per cent, fever in 9 per cent, and a flu-like syndrome in 9 per cent. A progressive decrease of white blood cell count (55%), hemoglobin (73%), and an increase in the lymphocytic ratio in peripheral white cells (82%) were noticed. Of the patients, 64 per cent had no tumor recurrence 5 to 12 months (mean 8.7 months) after therapy. These preliminary results suggest that intravesical Taipei-NIPM strian BCG instillation is effective as a prophylaxis against recurrent superficial bladder tumors.