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手术/非手术治疗脊柱转移性肿瘤患者健康相关生命质量研究

Study on Health-related Quality of Life in Patients with Spinal Metastases Treated with or Without Spinal Surgery

【作者】 吴娟

【导师】 郭强;

【作者基本信息】 第二军医大学 , 社会医学与卫生事业管理, 2010, 博士

【摘要】 现在越来越多的研究者意识到健康相关生命质量(Health-related Quality of Life, HRQL)的测量,可以为癌症的治疗决策提供许多重要信息。近年来,癌症患者治疗前、后的生命质量评价已成功的应用于包括前列腺癌、乳腺癌、肺癌和肝癌在内的许多恶性肿瘤的治疗研究中。肿瘤的脊柱转移常见于晚期癌症患者,可以引起病理性骨折、恶性肿瘤高钙血症和脊髓受压。脊髓受压是脊柱肿瘤的严重并发症之一,在脊柱转移性肿瘤患者中的发生率为5~14%。脊髓受压可以引起顽固性疼痛、行走功能丧失以及大小便失禁。由于大多数脊柱转移性肿瘤确诊时已到了晚期,无法治愈,所以在做治疗决策时应重点考虑所选用的治疗方法对患者生命质量的影响。脊柱肿瘤是临床肿瘤学中相对较少见的一类肿瘤,按其肿瘤的来源可以分为原发脊柱肿瘤和转移性脊柱肿瘤。通过对2000年1月~2007年1月在长征医院脊柱外科行手术治疗脊柱肿瘤的557名患者的病历资料进行回顾性分析,发现原发脊柱肿瘤患者(356名)和转移性脊柱肿瘤患者(201名)的预后有很大差异,前者的术后生存时间远远长于后者,证明手术治疗对原发脊柱肿瘤是有效的。长期以来对于转移性脊柱肿瘤的手术治疗一直是临床上争论的焦点,国内外文献中关于脊柱转移性肿瘤患者健康相关生命质量方面的信息很有限,之前没有关于脊柱转移性肿瘤患者手术后长期生命质量研究的报道。因此,本研究设计并实施了一项前瞻性、纵向、非随机对照研究,目的在于辨别、比较接受脊柱肿瘤手术的患者和未接受脊柱肿瘤手术的患者生命质量随时间变化的情况,为临床治疗决策提供科学依据。将2007年7月1日到2009年3月31日在第二军医大学上海长征医院确诊为转移性脊柱肿瘤且符合本研究条件的312名患者按其是/否接受脊柱肿瘤手术分为手术组(147名)和非手术组(165名)。所有入选患者分别在确诊时,确诊后(手术后)第1、3、6、9个月,应用FACT-G (Functional Assessment of Cancer Therapy-General)癌症患者生命质量评价量表进行了5次生命质量测评。在研究进行过程中,对所有2009年1月1后入组的患者在生命质量测量的基础上增加了焦虑、抑郁症状和疼痛程度的测量。共有216名患者符合条件,其中手术组(101名),非手术组(115名)。焦虑状态的测评选用Zung氏焦虑自评量表,抑郁状态的测评选用Zung氏抑郁自评量表,疼痛程度的测评选用数字疼痛分级法。研究结果显示手术治疗能够显著提高脊柱转移性肿瘤患者的生命质量,有效缓解患者的焦虑、抑郁症状,明显控制疼痛状况,但不能延长脊柱转移性肿瘤患者的生存时间。设计并实施这一前瞻性、纵向、对照研究的目的在于揭示脊柱手术对脊柱转移性肿瘤患者生命质量的影响,辨别、比较手术/非手术后患者生命质量,焦虑、抑郁症状和疼痛程度随时间变化的规律,为临床决策提供科学依据。从总体上说转移癌不可能治愈,因此治疗的目的大多在于延长存活时间及减轻症状。一些研究者主张把放疗作为脊柱转移性肿瘤的标准疗法,手术仅仅作为放疗失败后的二线疗法,或仅仅用于疼痛的控制。近年来,随着外科技术的发展,手术治疗越来越多的应用于脊柱转移性肿瘤的治疗当中。脊柱手术能否提高脊柱转移性肿瘤患者的生命质量?虽然健康相关生命质量的重要性已得到广泛认同,但关于手术对脊柱转移性肿瘤患者长期生命质量影响方面的资料几乎没有。具了解,本研究是最早关注这个问题的。本研究的结果提示手术对脊柱转移性肿瘤的治疗很有效。

【Abstract】 There has been growing recognition that patient-reported outcome measures, in particular, measures of health-related quality of life (HRQOL), can convey important information for the choosing and decision-making of treatment of cancer. In recent years, successful quality of life (QOL) evaluation has been performed on patients with prostate, breast, lung, and hepatic cancer after treatment. Spine metastases are common among patients with advanced-stage cancer, which can lead to pathologic fracture, hypercalcemia of malignancy, and spinal cord compression. Spinal cord compression is a severe complication of cancer, occurring in 5-14% of the metastatic cancer patients, which can cause intractable pain, loss of mobility, and incontinence. Since most spinal metastases are detected at later stages, by when it is in general incurable, the impact of treatment on QOL should therefore be an important consideration in our treatment decisions.Spinal tumors, including primary spine tumor and metastatic spinal tumor. We compiled 557 patients who underwent spinal surgery in Changzheng Hospital from January,2000 to January 2007. Through retrospective analysis, we found surgical treatment of primary spinal tumors is effective.The surgical treatment of metastatic spinal tumors has been the focus of debate in clinical for quite some time. However, HRQOL data for spinal metastases is limited. To our knowledge, there has been no previous report on the QOL outcome after surgery for spinal metastases. The purpose of this prospective, longitudinal study was to identify and compare the QOL of patients over a certain period of time after spinal surgery.From July 1,2007 to March 31,2009, we identified 312 patients who were eligible for the observational study from Changzheng Hospital, the Second Military Medical University in Shanghai, China. All eligible patients were separated into two groups depending on whether they would undergo the surgery or not (surgery group n=147, non-surgery group n=165). When diagnosed, all eligible patients completed a baseline QOL assessment using the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire. The surgery group patients received surgical treatment within 3 days after diagnosis. Patients were assessed again at 4 time points:1 month,3 months,6 months and 9 months during the postoperative period. The non-surgery group QOL assessments were performed at 1 month,3 months,6 months and 9 months following diagnosis.During the course of the study, we added anxiety, depression and pain assessment to the QOL assessment to those patients who enter after January 1,2009.216 patients were eligible, including surgery group 101 and non-surgery group 115. Use Zung’s Self-Rating Anxiety Scale (SAS) for anxiety assessment, Zung’s Self-Rating Depression Scale (SDS) for depression assessment, and Numeric Rating Scale (NRS) for pain assessment.The results of this study suggest that surgical treatment can improve the QOL of patients with spinal metastases greatly, reduce anxiety and depression, and control pain, but can not prolong the survival time.In order to reveal the impacts of spinal surgery on the QOL, anxiety, depression, and pain of patients with spinal metastases, this prospective, longitudinal study has been designed and implemented, using a non-surgery group as the control group. Metastatic disease is generally incurable, so treatments are usually aimed at the prolongation of survival and palliation of symptoms. QOL assessment in studies helps evaluate the benefits or risks of any therapy. Some researchers claim the standard treatment for spinal metastases is radiotherapy; and surgery is only applied as a second-line treatment when radiotherapy has failed, or sometimes merely for pain control. However, in recent years, with the development of surgical techniques, surgeries have been increasingly applied to treat spinal metastases. Can spinal surgery indeed improve the QOL of patients with spinal metastases? Although the importance of health-related quality of life outcome has been widely recognized, information and study on the impact of surgery on QOL of patients with spinal metastases is far from sufficient. To our knowledge, this study is actually the first attempt to address the issue. This finding supports the use of surgery as an effective treatment for spinal metastases.

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