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新辅助化疗联合维生素A治疗晚期宫颈癌的疗效:一项随机双盲临床试验

Outcome of Combined Neoadjuvant Chemotherapy and Vitamin A in Advanced Cervical Carcinoma: A Randomized Double-Blind Clinical Trial.

作者信息

Sanusi Rizal Sanif

机构信息

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, General Hospital of Dr.Mohammad Hoessin, University of Sriwijaya, Palembang, Sumatra, Indonesia. Email:

出版信息

Asian Pac J Cancer Prev. 2019 Jul 1;20(7):2213-2218. doi: 10.31557/APJCP.2019.20.7.2213.

Abstract

Background: The latest World Health Organization (WHO) inquiry on the epidemiology of cervical cancers indicate there are approximately 528,000 new cases per year, ranking fourth after breast, colorectal and lung cancer. The validity of neoadjuvant chemotherapy (NAC) alone in advanced cervical cancer is still being debated. NAC induces tumor shrinkage prior to pursuing surgery. NAC also has the benefit of sterilizing the lymph nodes and parametria, thereby lowering the need for adjuvant therapy after surgery. This research aims to determine the impact on the treatment of advanced cervical carcinoma with NAC, with the additional provision of Vitamin A during treatment to assess the factors that could affect the outcome of clinical treatment. Methodology: The research methodology and design of this study is a randomized double-blind clinical trial to compare the effects of treatment with NAC and treatment with NAC + Vitamin A, in advanced cervical carcinoma. Both study groups received treatments consisting of a regime of cisplatin and paclitaxel. The study was conducted at the General Hospital of Dr. Mohammad Hoesin. The total number of patients recruited for the trial was 30 with 15 patients per treatment arm. One group received NAC consisting of cisplatin and paclitaxel and the remaining 15 patients received NAC + Vitamin A. Results: The addition of Vitamin A was found to be much better in influencing the clinical response in the treatment of advanced cervical carcinoma, although this was not statistically significant. However, a larger sample size with the reported proportion of higher positive outcome for NAC + Vitamin A may be statistically significant. Conclusion: Based on the results, Vitamin A supplementation in the treatment of advanced cervical carcinoma with neoadjuvant chemotherapy may play a crucial role in the treatment of cervical carcinoma.

摘要

背景

世界卫生组织(WHO)关于宫颈癌流行病学的最新调查显示,每年约有52.8万新发病例,在乳腺癌、结直肠癌和肺癌之后排名第四。单纯新辅助化疗(NAC)在晚期宫颈癌中的有效性仍存在争议。NAC在进行手术前可使肿瘤缩小。NAC还有助于清除淋巴结和宫旁组织,从而降低术后辅助治疗的必要性。本研究旨在确定NAC对晚期宫颈癌治疗的影响,并在治疗期间额外补充维生素A,以评估可能影响临床治疗结果的因素。方法:本研究的方法和设计是一项随机双盲临床试验,比较NAC治疗与NAC + 维生素A治疗对晚期宫颈癌的效果。两个研究组均接受由顺铂和紫杉醇组成的治疗方案。该研究在穆罕默德·霍辛博士综合医院进行。试验招募的患者总数为30例,每个治疗组15例。一组接受由顺铂和紫杉醇组成的NAC,其余15例患者接受NAC + 维生素A。结果:尽管在统计学上不显著,但发现添加维生素A在影响晚期宫颈癌治疗的临床反应方面要好得多。然而,样本量更大且报告的NAC + 维生素A阳性结果比例更高可能具有统计学意义。结论:基于这些结果,在新辅助化疗治疗晚期宫颈癌时补充维生素A可能在宫颈癌治疗中发挥关键作用。

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