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目的评价甘氨双唑钠(CMNa)对鼻咽癌患者放疗增敏作用的远期疗效和安全性。方法1999年5月至2002年5月,211例初诊为鼻咽癌的患者随机分为CMNa组(A组)和安慰剂组(B组)。两组放射治疗方法、程式和剂量相同。采用1992年福州分期标准分期,以CTC2．0标准评定早期不良反应,以RTOG／EORTC晚期毒性标准评定晚期不良反应。中位随访时间52个月。所有数据用SPSS 13．0软件处理,两组间一般情况的比较用t检验,生存率统计用Kaplan-Meier法,预后分析用单因素分析法和Cox多因素回归模型。结果两组患者临床资料具有可比性。A组患者的3年生存率为88．4％,B组为75．2％,差异有统计学意义(P=0．010)。经单因素分析显示,3年生存率与N分期(N0～186．9％,N2～3 73．8％,P<0.001)、T分期(T1～2 85．6％,T3～479．3％,P=0．014)、总分期(P= 0．039)及分组因素(A组88．4％,B组75．2％,P=0．010)相关。A组患者的5年无复发生存率、5年无转移生存率和5年总生存率分别为75．8％、74．9％和77．7％,B组患者分别为63．0%、63．0％和62．4％,两组差异有统计学意义(P值分别为0．013、0．022和0．010)。对5年总生存率的亚组分析显示,两组Ⅲ～Ⅳ期患者差异有统计学意义(P=0．009),I～Ⅱ期患者差异无统计学意义(P=0．502)。Cox多因素回归分析显示,与生存相关的预后因素为N分期(RR=3．288)、T分期(RR=2．147)和CMNa(RR=0．407)。两组患者不良反应差异无统计学意义,说明CMNa的使用不会增加放射损伤的发生,长期随访未观察到明显的神经、心脏毒性。结论CMNa能提高鼻咽癌患者放疗的远期疗效,Ⅲ～Ⅳ期患者生存获益明显;耐受性好,未发现明显毒副作用。
Objective To evaluate the long-term efficacy and safety of glycopyrrolate sodium (CMNa) in radiosensitization of patients with nasopharyngeal carcinoma. Methods From May 1999 to May 2002, 211 patients with newly diagnosed nasopharyngeal carcinoma were randomly divided into CMNa group (group A) and placebo group (group B). Radiation therapy in both groups, procedures and doses of the same. Adopting the staging of Fuzhou staging in 1992, the early adverse reactions were evaluated according to the CTC 2.0 standard and the late adverse reactions were evaluated with the late RTOG / EORTC toxicity criteria. The median follow-up time was 52 months. All data were processed with SPSS 13.0 software, t test was used to compare the general situation between the two groups, Kaplan-Meier survival rate statistics, univariate analysis of prognosis and Cox multivariate regression model. Results The clinical data of two groups were comparable. The 3-year survival rate was 88.4% in group A and 75.2% in group B, the difference was statistically significant (P = 0.010). The univariate analysis showed that the 3-year survival rate was significantly correlated with the N stage (N0 ~ 186.9%, N2 ~ 3 73.8%, P <0.001), T stage (T1 ~ 2 85.6%, T3 ~ 479.3 %, P = 0.014), total stage (P = 0.039) and grouping factors (88.4% in group A, 75.2% in group B, P = 0.010). The 5-year recurrence-free survival, 5-year metastasis-free survival and 5-year overall survival in group A were 75.8%, 74.9% and 77.7%, respectively, in group B were 63.0% 63.0% and 62.4%, respectively, with significant difference between the two groups (P = 0.013, 0.022 and 0.010, respectively). A subgroup analysis of 5-year overall survival showed that the difference between the two groups was statistically significant (P = 0.009). There was no significant difference between I and II patients (P = 0.502). Cox regression analysis showed that survival-related prognostic factors were N stage (RR = 3.288), T stage (RR = 2.147) and CMNa (RR = 0.407). There was no significant difference in adverse reactions between the two groups, indicating that the use of CMNa does not increase the incidence of radiation injury, long-term follow-up did not observe significant neurological and cardiac toxicity. Conclusion CMNa can improve the long-term efficacy of radiotherapy for patients with nasopharyngeal carcinoma. Patients in stage Ⅲ ~ Ⅳ have obvious survival benefits. They are well tolerated and have no obvious side effects.