CDHS 801在光动力学治疗膀胱癌中的有效性和安全性研究

目的 验证新型光敏剂CDHS 801的临床有效性和安全性。方法 54例膀胱癌患者随机分为试验组(27例)和对照组(27例)。病理为Tl、T2期。治疗组口服CDHS 801(4mg／kg)24h后进行光动力学治疗(PDT)，能量密度为50J/cm^2；治疗期间不避光；72h后行经尿道膀胱肿瘤电切术(TURBT)取标本。对照组不服药，行TURBT治疗。所有患者随访6—12个月。结果 治疗组的肿瘤坏死发生率和面积均明显高于对照组(P＜0．05)；样本的平均DNA质量，治疗组的均数低于对照组(P＜0．05)。治疗后肿瘤巨体发生明显改变：轮廓增大呈水池样疏松的结构，并有成片坏死灶和“卫星灶”出现。治疗组未出现光敏性皮炎或肝、肾功能异常。结论 CDHS 801治疗T1、T2期膀胱癌，该PDT方法是有效的、药物是安全的。

CDHS 801 as a new photosensitizer in the photodynamic therapy of stage T1 and T2 bladder cancer

Objective To estimate the safety and efficacy of CDHS 801 as a new photosensitizer in the photodynamic therapy of transitional bladder cancer. Methods A total of 54 patients were enrolled and randomized into controll group( 27 patients) and photodynamic therapy (PDT) treated group(27 patients) with an average age of 62.3 years and an average course of 7 months. All the patients were confirmed to have stage T 1 and T 2 transitional bladder cancer by cystoscopic examination and biopsy. Following oral administration of CDHS 801 (4 mg/kg) 24 h before PDT procedure, in the treated group, all patients received regional irradiation using semiconductor laser at wavelength of 650nm,with a dose of 50 J/cm 2( depending on the size of tumor ). The optic fiber was introduced into the bladder under the assistance of cystoscope. At the same time a video recorder with TV monitor was used for supervising the manipulation and recording the macroscopic tumor changes. No light avoiding step was taken during the trial. Three days later, TURBT was performed for the purpose of getting tumor specimen and for further pathological analysis. And then, a comparison including size of the nacrotic tumor and DNA mass was understaken. All patients then entered a 12 month follow up after the procedure. Results Both larger area and higher incidence of necrosis were found in the irradiated tumor of the treated group than those of the controlled one ( P <0.05). And the mean DNA mass also showed significant difference, in the treated group it was much less than that of the controlled ones ( P <0.05). In many PDT treated patients significant tumor swelling was found, while the outline of the tumor became vague caused by tumor necrosis. Considerable satellite foci were found after PDT, showing fusion of CDHS 801 and tumor cells. No adverse event such as skin photosensitive dermatitis or bladder dysfunction occurred. Conclusion CDHS 801 assisted photodynamic therapy is a safe and effective alternative for T1 and T2 transitional bladder cancer.