A Prospective Clinical Trial of Treatment Models on Malignant Ovarian Germ Cell Tumor Patients
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摘要: 目的 评价保守性手术在卵巢恶性生殖细胞肿瘤（malignant ovarian germ cell tumor, MOGCT）患者治疗中的价值，为MOGCT患者选择合理的治疗模式提供科学依据。方法 采用多中心、前瞻性对照临床试验方法，将MOGCT患者分为保守性手术组33例和广泛性手术组36例，从卫生经济学、手术安全性、月经、生育情况及疗效指标等多方面对两种治疗模式进行评价。结果 （1）卫生经济学指标：保守性手术组、广泛性手术组患者的平均初次住院时间分别为16.27、19.91天，平均初次住院费用分别为16603.11、24 701.58元，差异均具有统计学意义（P＜0.05）。（2）手术安全性：保守性手术组患者的平均手术时间、平均术中出血量、平均肠道恢复时间均明显短于广泛性手术组患者，差异均具有统计学意义（P＜0.05）；两组间患者平均拔尿管时间差别不大，差异无统计学意义（P＞0.05）；手术并发症发生率分别为12.12%（4/33）、47.22%（17/36）差异有统计学意义（P＜0.05）。（3）保守性手术组、广泛性手术组患者治疗结束后月经规律比率、妊娠率差异均无统计学意义（P＞0.05）。（4）疗效指标：保守性手术组患者3、5年累积生存率分别为94%、87%，广泛手术组患者均为94%；保守手术组患者3、5年累积无进展生存率均为92%，广泛手术组患者均为97%，差异均无统计学意义（P＞0.05）。结论 保守性手术在缩小手术范围、减少手术创伤、提高MOGCT患者生存质量同时，不影响MOGCT患者的预后。
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关键词:
- 卵巢恶性生殖细胞肿瘤 /
- 保守性手术 /
- 治疗模式 /
- 前瞻性临床研究
Abstract: Objective To evaluate the therapeutic value of conservative surgery for malignant ovarian germ cell tumor (MOGCT), to provide scientific evidence for choosing reasonable treatment model on MOGCT patients. Methods We conducted a multi-center, prospective clinical trial. Patients with MOGCT were allocated into conservative surgery group (n=33) and extensive surgery group (n=36). We evaluated the two treatment models by the outcomes of health economics, surgical safety, regular menstruation rate, pregnancy and effectiveness. Results (1) Health economics: the average initial hospital stays of the conservative surgery group and extensive surgery group were 16.27 and 19.91d, respectively; the average initial hospital costs were 16 603.11 and 24 701.58 RMB, respectively (P<0.05). (2) Surgical safety: there were statistical differences between the conservative surgery group and extensive surgery group in the average time of operation, the average recovery time of intestinal tract (P<0.05); there was no significant difference between groups in the average time of pulling out the urine tube (P>0.05); the rates of operative complications were 12.12% (4/33) and 47.22% (17/36) respectively (P<0.05). (3) There were no significant differences between the conservative surgery group and extensive surgery group in the rate of regular menstruation and the pregnancy rates after treatment (P>0.05). (4) Effectiveness: the 3- and 5-year accumulate survival rates of the conservative surgery group were 94% and 87%, while those of the extensive surgery group were both 94%; the 3- and 5-year accumulate progressive-free survival rates of the conservative surgery group were both 92%, while those of the extensive surgery group were both 97% (P>0.05). Conclusion Conservative surgery could reduce the scope of surgery and operative wound, and improve the quality of life without affecting the prognosis of MOGCT patients. -
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