国产治疗用卡介苗预防浅表性膀胱癌术后复发及不良反应的观察

Clinical Trial of Effect and Adverse Reaction of Domestic Therapeutic BCG for Prevention of Recurrence of Superficial Bladder Cancer

目的观察我国治疗用卡介苗(CT-BCG)预防浅表性膀胱癌术后复发情况及其不良反应。方法对117例浅表性膀胱癌患者术后给予CT-BCG治疗,另对53例患者采用丝裂霉素C(MI-C)治疗,作为对照。CT-BCG组每次用药120mg,MI-C组40mg。用导管灌注膀胱,2h后自行排出。术后2或3周开始,不同时间用药1次,直至1年。观察两组的复发情况及不良反应发生率。结果CT-BCG组复发率为18.8%,MI-C组为13.2%,二者差异无统计学意义;不良反应主要为膀胱炎症状(尿痛、尿频、血尿等)及低热,MI-C组无低热患者,且膀胱炎症状也较CT-BCG组轻。结论CT-BCG预防浅表性膀胱癌术后复发药效良好,无严重不良反应发生。

Objective To observe the effect and adverse reaction of domestic therapeutic BCG, i.e. Chinese therapeutic BCG （CT-BCG）for prevention of recurrence of superficial bladder cancer. Methods A total of 117 patients with superficial bladder cancer after surgery were treated with 120 mg of CT-BCG, using 53 patients treated with 40 mg of milomycin-c （MI-C）as control. The CT-BCG and MI-C were infused into bladder through a vessel and excreted by the patients themselves 2 h later. The drugs were administered 2 or 3 weeks after surgery, at various intervals for one year. The recurrences and adverse reactions of patients were observed. Results The recurrence rates of patients treated with CT-BCG and MI-C were 18. 8% and 13. 2% respectively, which showed no significant difference. Most of adverse reactions were symptoms of cystitis, such as dysuria, frequent micturition and hemuresis, as well as mild fever. No mild fever were observed in the patients treated with MI-C, while the symptoms of cystitis were mild as compared with those treated with CT-BCG. Conclusion CT-BCG showed satisfactory preventive effect on recurrence of superficial bladder cancer after surgery, and caused only mild adverse reactions.