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脂质体紫杉醇联合卡铂与紫杉醇联合卡铂治疗上皮性卵巢癌的疗效和安全性比较

Comparison of Efficacy and Safety Between Liposome-paclitaxel plus Carboplatin and Paclitaxel plus Carboplatin on Epithelial Ovarian Cancer

  • 摘要:
    目的 比较脂质体紫杉醇联合卡铂与紫杉醇联合卡铂治疗上皮性卵巢的疗效和安全性。
    方法 198例术后完成不少于六周期化疗的上皮性卵巢癌患者随机分为试验组和对照组,分别给予脂质体紫杉醇(175 mg/m2)+卡铂AUC5方案(试验组)和紫杉醇注射液(175 mg/m2)+卡铂AUC5方案(对照组),两组化疗周期均为21 d。从第2化疗周期开始比较两组患者的疗效和不良反应。
    结果 试验组和对照组的总有效率分别为50.50% vs. 53.60%,差异无统计学意义(P=0.738)。22例(11.11%)患者在化疗结束停药后出现复发,其中试验组6例(27.27%),对照组16例(72.72%),(P=0.029)。试验组患者的过敏反应、脱发、恶心呕吐、腹泻、白细胞减少、血小板减少、肝功能损害情况均明显低于对照组患者,两组间差异有统计学意义(均P < 0.05)。而在其他不良反应方面两组比较差异无统计学意义(均P > 0.05)。
    结论 脂质体紫杉醇联合卡铂与紫杉醇联合卡铂方案治疗上皮性卵巢癌的疗效相当,随访期复发率更低,同时过敏反应、骨髓抑制、胃肠道反应及肝功能损害方面的不良反应发生率明显低于紫杉醇联合卡铂方案。

     

    Abstract:
    Objective To compare the efficacy and safety between liposome-paclitaxel plus carboplatin and paclitaxel plus carboplatin on epithelial ovarian cancer.
    Methods We randomly divided 198 cases of epithelial ovarian cancer who had undertook at least six chemotherapy circles after operation into two groups: the experimental group were treated with liposome-paclitaxel (175mg/m2)+carboplatin AUC5 and the control group were treated with paclitaxel (175mg/m2)+carboplatin AUC5. One cycle of chemotherapy was 21 days. A strict observation in the efficacy and adverse reactions of two groups was started from the second chemotherapy cycle.
    Results The total effective rates (CR+PR) in the experimental group and control group were 50.50% vs. 53.60% (P=0.738). There were 22(11.11%) recurrent cases after chemotherapy, among which six patients 6(27.27%) patients in the experimental group and 16(72.72%) patients in the control group (P=0.029). The incidences of allergic reactions, alopecia, nausea, vomiting, diarrhea, leukopenia, thrombocytopenia, hepatic dysfunction in the experimental group were significantly lower than those in the control group (P < 0.05), while there was no significant difference in terms of other adverse reactions (P > 0.05).
    Conclusion Compared with paclitaxel plus carboplatin group, the efficacy of liposome-paclitaxel plus carboplatin group is equivalent, the recurrence rate is lower in follow-up period, and the incidence of adverse events is significantly lower, including allergic reactions, bone marrow suppression, gastrointestinal reactions and liver dysfunction.

     

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