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目的观察顺铂联合多西他赛治疗中晚期宫颈癌的临床疗效及安全性。方法将180例ⅡB-ⅣA期宫颈癌患者随机分为对照组45例、低剂量组45例、中剂量组45例和高剂量组45例。对照组予以静脉滴注70 mg·m~(-2)多西他赛注射液,每周1次。在对照组的基础上,低剂量组予以静脉滴注20 mg·m~(-2)顺铂,每周1次;中剂量组予以30 mg·m~(-2)顺铂,静脉滴注,每周1次;高剂量组予以40 mg·m~(-2)顺铂,静脉滴注,每周1次。各组均治疗6周。比较各组的临床疗效及药物不良反应的发生情况。结果治疗后,低、中、高剂量组对照组的总有效率分别为60.00%(27例/45例)、53.33%(24例/45例)、40.00%(18例/45例)、33.33%(15例/45例),中、高剂量组分别与对照组和低剂量组比较,差异均有统计学意义(均P<0.05);低、中、高剂量组和对照组的3年生存率分别为64.44%(29例/45例)、84.44%(38例/45例)、80.00%(36例/45例)、51.11%(23例/45例),中、高剂量组分别与对照组和低剂量组比较,差异均有统计学意义(均P<0.05);低、中、高剂量组发生的药物不良反应主要有血象异常与胃部不适;对照组发生的药物不良反应主要有血象异常和过敏反应。低、中、高剂量组和对照组的药物不良反应发生率分别为8.89%(4例/45例)、15.56%(7例/45例)、24.44%(11例/45例)和4.42%(2例/45例),中、高剂量组分别与低剂量组和对照组比较,差异均有统计学意义(均P<0.05)。结论顺铂联合多西他赛治疗中晚期宫颈癌虽能取得良好效果,但药物不良反应较多,3年死亡率较高,因此需在临床上综合分析患者病情确定药物剂量。
Objective To observe the clinical efficacy and safety of cisplatin combined with docetaxel in the treatment of advanced cervical cancer. Methods 180 patients with stage ⅡB-ⅣA cervical cancer were randomly divided into control group (n = 45), low dose group (n = 45), middle dose group (n = 45) and high dose group (n = 45). The control group was given intravenous drip 70 mg · m -2 docetaxel injection once a week. On the basis of the control group, low-dose group was given intravenous infusion of 20 mg · m -2 cisplatin once a week; middle-dose group was given cisplatin 30 mg · m -2 intravenously , Once a week; high-dose group was given 40 mg · m -2 cisplatin intravenously once a week. Each group were treated for 6 weeks. Compare the clinical efficacy of each group and the occurrence of adverse drug reactions. Results After treatment, the total effective rates in the low, middle and high dose groups were 60.00% (27/45), 53.33% (24/45), 40.00% (18/45), 33.33 % (15 cases / 45 cases), middle and high dose group compared with control group and low dose group, the differences were statistically significant (all P <0.05); low, medium and high dose group and control group for 3 years The survival rates were 64.44% (29 cases / 45 cases), 84.44% (38 cases / 45 cases), 80.00% (36 cases / 45 cases) and 51.11% (23 cases / 45 cases) Compared with the control group and the low-dose group, the differences were statistically significant (all P <0.05); low, medium and high doses of adverse drug reactions occur mainly abnormal blood and stomach discomfort; adverse drug reactions occurred in the control group Mainly abnormal blood and allergic reactions. The incidences of adverse drug reactions were 8.89% (4 cases / 45 cases), 15.56% (7 cases / 45 cases), 24.44% (11 cases / 45 cases) and 4.42% in the low, medium and high dosage groups and the control group respectively (2 cases / 45 cases), middle and high dose group compared with low dose group and control group, the differences were statistically significant (P <0.05). Conclusions Although cisplatin combined with docetaxel can achieve good results in the treatment of advanced cervical cancer, it has more adverse drug reactions and higher 3-year mortality rate. Therefore, it is necessary to determine the dose of the drug in a comprehensive clinical analysis.