替莫唑胺联合干扰素治疗晚期黑色素瘤的临床研究

A Clinical Research on the Temozolomide Combined with Interferon in the Treatment of Advanced Melanoma

目的探讨替莫唑胺联合干扰素治疗晚期黑色素瘤的疗效及安全性。方法 68例晚期黑色素瘤患者按随机数字表随机分为治疗组和对照组,各34例,治疗组应用替莫唑胺联合干扰素治疗方案,对照组单独采用替莫唑胺方案。分析和比较两组患者T细胞亚群的变化情况及临床效果。结果治疗组的有效率为64.7%,对照组为38.2%,显著低于治疗组,两组之间差异有统计学意义(P<0.05);治疗组3、6、12、24个月生存率分别为85.3%、67.6%、41.1%、26.5%,均明显高于对照组的61.8%、44.1%、17.6%、5.9%(P<0.05)。治疗后,治疗组CD3、CD4、CD8、CD4/CD8分别为(69.50±4.62)、(47.03±6.38)、(36.07±6.21)、(1.66±0.78),均明显高于对照组(P<0.05);治疗组白细胞减少和血小板减少的发生率均显著高于对照组(P<0.05),而两组恶心呕吐,肝、肾功能损害,血红蛋白减少的发生率比较差异无统计学意义(P>0.05)。结论替莫唑胺联合干扰素治疗晚期黑色素瘤的疗效比单用替莫唑胺更好,且不良反应可耐受。

Objective To explore the curative effects and security of Temozolomide combined with interferon in the treat-ment of advanced melanoma. Methods 68 cases of advanced melanoma patients were randomly divided into the treatment group and control group （34 cases in each group）. The treatment group was given Temozolomide combined with interferon, while the control group was treated only by Temozolomide. The changes of T cell subsets and clinical effects as well as adverse reactions were observed and compared between the two groups. Results The effective rate of treatment group and control group were respectively 64.7% and 38.2%; it was significantly higher in the treatment group （P〈0.05）. The survival rates of treatment group at 3rd, 6th, 12th and 24th month were respectively 85.3%, 67.6%, 41.1%, 26.5%, which were all sigraficanfly higher than those in the control group（respectively 61.8%, 44.1%, 17.6%, 5.9%, P〈0.05）. After treatment, the CD3, CD4, CD8 and CD4/CD8 of treatment group were （69.50±4.62）, （47.03±6.38）, （36.07±6.21）, （1.66±0.78） respectively, all significantly higher than those in the control group （P〈 0.05）. The incidence rates of leukopenia and thrombocytopenia in treatment group were evidently higher than those in the control group （P〈 0.05）, but no significant difference was found in the incidence of nausea and vomiting, liver and kidney damage and decreased hemoglobin （P〉0.05）. Conclusion Temozolorrfide combined with interferon was more effec- tive in the treatment of advanced melanoma than Temozolomide alone, and its adverse effects were tolerable.