肿瘤合并肝损伤患者血小板减少症管理中国专家共识（2022版）
详细信息Chinese Expert Consensus on Management of Thrombocytopenia in Cancer Patients with Liver Injury (2022 Edition)
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摘要:
血小板减少症和肝损伤是肿瘤患者常见且严重的临床问题。肿瘤合并肝损伤患者血小板减少症（thrombocytopenia in cancer patients with liver injury, TCLI）的病因更加复杂，但常见于肝损伤和肿瘤治疗。肿瘤治疗所致血小板减少症的管理已逐渐形成规范，肝损伤相关血小板减少症随着相关药物的获批上市，管理日益明晰。但肿瘤合并肝损伤患者血小板减少症的管理仍是空白，血小板减少症和肝损伤的叠加进一步增加了肿瘤治疗的难度。为此，中国抗癌协会肿瘤支持治疗专业委员会组织专家对文献进行分析和讨论，形成肿瘤合并肝损伤患者血小板减少症管理中国专家共识（2022版），以指导临床实践。
Abstract:Thrombocytopenia and liver injury are common and serious clinical problems in cancer patients. The etiology of thrombocytopenia in cancer patients with liver injury (TCLI) is complicated, which is common in liver injury and tumor treatment. The management of cancer therapy-induced thrombocytopenia has gradually become standardized, and the management of liver injury-associated thrombocytopenia is becoming clear with the approval and marketing of relevant drugs. However, the management of TCLI is still blank, and the superposition of thrombocytopenia and liver injury further increases the difficulty of cancer treatment. Therefore, the Committee of Neoplastic Supportive-care, China Anti-Cancer Association organizes experts to analyze and discuss relevant literatures to form a Chinese expert consensus on the management of thrombocytopenia in cancer patients with liver injury (2022 Edition) to guide clinical practice.
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Key words:
- Cancer /
- Liver disease /
- Liver injury /
- Thrombocytopenia /
- Expert consensus
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0 引言
厌食已成为大多数肿瘤晚期患者的一种常见症状，在某些胃肠道肿瘤的发生发展过程中，食欲减退可能是肿瘤早期患者的唯一症状。肿瘤患者常因食欲不振而减少食量，继而导致肿瘤患者营养及整个机体状态发生改变，增加了治疗的失败率、不良反应和死亡的发生率等[1]。准确地测量厌食的发生发展过程无论对科学研究还是临床管理都极为重要，科学、准确、有效的食欲评价方法和技术不仅是营养及临床工作者客观评价食欲的手段，也是进一步认识和预测肿瘤患者发生营养不良的基础。常用的食欲评价方法包括询问法、视觉模拟测量、厌食/恶液质治疗的功能评估、简单营养食欲评估问卷及口头评价量表等[2]，但在实际操作过程中缺乏标准化的评价方法。英国诺丁汉大学营养学部V.Halliday教授通过一系列的研究证实，营养食欲问卷（council on nutrition appetite questionnaire, CNAQ）的改进版—肿瘤患者食欲症状问卷（cancer appetite and symptom questionnaire, CASQ）可预测肿瘤患者的体重丢失[3]。由于目前国内尚未见CASQ中文版的使用报道，因此欲对中文版CASQ的信度和效度进行分析研究。
1 资料与方法
1.1 问卷的翻译和回译
遵循Brislin[4]的翻译原则，在翻译的过程中进行严格的质量控制以保证问卷翻译的准确性，先由2名临床营养学专业的硕士研究生将英文版问卷译成中文，译后的CASQ由专家进行评价和修改以确定中文版的CASQ；再由2名临床营养学专业的硕士研究生将中文版问卷回译成英文，回译后的CASQ由河北医科大学英语教研室的英语老师对回译后的问卷内容进行判定，以确定回译后的CASQ与原版英文问卷有无概念歧义等问题，最后得到一个基本等值的中文版CASQ。
1.2 预调查
在正式调查前，随机抽取河北省某三甲医院肿瘤科的10名肿瘤患者进行预实验。首先征得患者主管医师的同意与配合，研究者向患者详细说明本次研究的目的及意义，并向患者承诺相关调查资料的保密性。在征得患者的知情同意后，采用一对一的方式，进行问卷的发放，以便能更好地了解患者是否能够完全认识问卷中的问题或词语的意义。研究者对患者难以理解的个别字句进行标注，记录他们的意见和建议。调查结果表明，问卷各条目方便理解，患者完成本问卷所需的时间约为8分钟。
1.3 问卷的构成和计分
问卷由12个条目构成，计分按原作者的计分方法。每一条目得分范围为0~4分，该问卷总得分范围为0~48分，总得分越低代表患者食欲越差。
1.4 研究对象
选取2016年3月—2016年12月在河北省某三甲医院住院的肿瘤患者88例。研究样本量采取本问卷条目总数的5~10倍，为抵消应答率导致的样本量缺失，同时扩大了20%的样本量，故本研究样本量的例数至少为72例，本研究最终确定的样本量例数为88例。
1.4.1 纳入标准
（1）年龄：18~90岁；（2）病理诊断确诊的恶性肿瘤患者；（3）患者可正常沟通；（4）愿意参与本研究。
1.4.2 排除标准
（1）患者昏迷，存在意识障碍或交流障碍，无法回答问题；（2）AIDS以及接受器官移植的患者。
1.5 研究方法
采用PG-SGA评估纳入研究对象存在的营养风险，同时研究者向患者发放问卷，若患者不识字或自己不能独立填写，则由研究者口述并帮助其填写问卷，填写完毕立即收回。检查问卷是否填全，如果有缺失内容，立即补填。对中文版CASQ进行条目区分度及信度与效度检验。第一次测量与第二次测量间隔时间为1周。
1.6 统计学方法
采用EpiData软件进行数据录入，利用SPSS17.0及SAS9.3进行统计分析。如果条目得分与问卷总分之间的相关系数大于0.3[5]，且差异具有统计学意义，则应该保留该条目。信度分析包括重测信度系数、分半信度和内部一致性信度。其中重测信度由加权kappa值表示，分半信度通过Spearman-Brown公式进行计算和校正，内部一致性信度由Cronbach's α系数进行评估（Cronbach's α coefficient）。Kappa值为0.41~0.60、0.61~0.80和0.81~1分别被认为反映中等一致性、高度一致性和几乎完全一致。效度分析：（1）结构效度：先通过KMO-Bartlett球形检验了解问卷是否符合因子分析的条件，若符合则采用主成分分析法进行因子分析；（2）效标效度：通过计算CASQ总分与PG-SGA总分的Spearman相关系数rs评价效标效度。
2 结果
2.1 纳入研究对象的一般资料
入组患者平均年龄（61.5±12.2）岁。头颈部肿瘤患者6人，CASQ平均得分为（22.67±2.88）；肺癌患者36人（26.67±4.54）；消化道肿瘤患者34人（26.83±3.92）；其他部位肿瘤患者12人，具体资料见表 1。
表 1 信效度研究对象基本资料(n=88)Table 1 Basic data of subjects in the study of reliability and validity (n=88)
2.2 条目分析
CASQ各条目得分与问卷总分的相关系数在0.242~0.653之间，P < 0.05为差异有统计学意义，见表 2。
表 2 各条目得分与问卷总分的相关系数Table 2 Correlation coefficient between the score of each item and total score of the questionnaire
2.3 信度分析
2.3.1 重测信度系数
加权Kappa值结果显示2项问题一致性低于0.41，6项问题为中等一致性，4项问题为高度一致性，见表 3。以2次测量结果总得分的差值为纵轴，2次测量结果总得分的均数为横轴，绘制Bland-Altman图，结果表明数据行为良好[6]，见图 1。
表 3 中文版问卷与原英文版问卷加权κ值的比较Table 3 Comparison of weighted kappa value of questionnaire between Chinese version and original English version
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图 1 两次CASQ得分均值与差值的Bland-Altman图Figure 1 Bland-Altman plot of the mean and difference of two CASQ scores2.3.2 分半信度
分半信度通过Spearman-Brown公式进行计算和校正，结果为0.560。
2.3.3 内部一致性信度
内部一致性信度由Cronbach' s α系数进行评估，结果为0.436。
2.4 效度分析
2.4.1 结构效度
采用主成分分析法和最大方差正交旋转法对全部88份问卷进行因子分析以验证CASQ的结构效度，得到KMO-Bartlett统计量为0.790，P < 0.05，问卷适合做因子分析。因子分析结果见表 4。釆用主成分分析法，特征值大于1的因子有3个，对总方差的累积贡献率分别27.8%、43.4%和56.3%。因子分析时要求问卷公因子的累计方差贡献率要超过40%，且各条目在相应公因子上的负荷绝对值要超过0.4[7]，在本研究中各条目的因子负荷绝对值为0.481~0.893，表明该问卷结构效度较好。提取3个因子，进行最大方差正交旋转，因子负荷矩阵见表 5，所有条目在所属因子上的负荷为0.102~0.893。条目1~7对应因子1，条目8~10对应因子2，条目11~12对应因子3。
表 4 CASQ主因子解释的总方差Table 4 Total variance explained by principal factor for CASQ
表 5 旋转成分矩阵（因子分类与贡献度）Table 5 Rotated component matrix (Factor classification and contribution)
2.4.2 效标效度
本研究采用中文版CASQ总分与PG-SGA总分的关联性来考察问卷的效标关联效度。CASQ总分与PG-SGA总分的Spearman相关系数rs为-0.475，两者相关程度显著，说明该问卷具有较好的效标效度。
3 讨论
问卷作为测量工具，主要用于评价研究对象的一些特征[8]。因此，选用问卷进行研究前必须首先要考虑问卷的质量问题。信度和效度是问卷质量评价中的两个重要指标。为提高问卷调查的准确性和得出结论的科学性，分析问卷的信度和效度是问卷质量设计中必不可少的重要环节[9]。好的测量工具首先必须拥有很好的信度，包括重测信度及内部一致性信度。为防止两次测验间隔时间太短，研究对象对第一次回答结果尚有记忆或是由于间隔时间较长，研究对象的食欲状况随时间的进展发生变化，本研究参考以往的研究设计设定两次测验的时间间隔为一周。本研究中重测信度系数采用加权Kappa值表示，结果显示，与原问卷信度研究结果相比，除第一和第三项条目的Kappa值高于原英文版问卷外，其他条目的Kappa值都有所减低。结果显示问卷中2项问题一致性低于0.41，6项问题为中等一致性，4项问题为高度一致性。另外Bland-Altman图结果显示数据行为良好，表明中文版CASQ两次测量结果的一致性较好，数据可靠，表明问卷条目被日常环境中随机因素影响的可能性小。内部一致性信度指标中，Cronbach's α系数为0.436，低于原问卷（0.72）。Wilson等[10]对CASQ的来源问卷CNAQ进行研究时发现，对于医护人群进行CNAQ的内部一致性评价，Cronbach's α系数为0.47，而社区居住群体Cronbach's α系数为0.72，提示随着纳入研究对象的变化，条目之间的相关性也在发生变化，这可能是本研究Cronbach's α系数较低的原因。根据条目奇、偶数折半计算CASQ的折半信度系数，结果为0.560，可以认为该问卷两半题项得分间的一致性较好。
因子分析时要求问卷公因子的累计方差贡献率超过40%，且各条目在相应公因子上的负荷绝对值要求超过0.4[7]，本研究中量表公因子累计贡献率达56.3%，各条目的因子负荷绝对值为0.481~0.893。利用中文版CASQ总分和PG-SGA总分的关联性来评价量表的效标关联效度，二者之间的rs值为-0.475，相关程度显著，提示中文版CASQ具有较好的结构效度和效标效度。巴西的研究人员[11]对此问卷的葡萄牙语版进行了研究，证实该问卷的葡萄牙语版同样具有较好的信度和效度。
此外，相比于国内研究采用的数字食欲评价量表（numberic rating scale, NRS）和食欲不振恶液质综合征治疗的功能性评价量表[12]，CASQ评估了包括影响食欲在内的疼痛、活动能力及味觉变化等相关因素，为医护人员综合判断肿瘤患者食欲改变的原因以及为患者提供个体化的干预措施奠定了基础。本研究不足之处在于，首次对CASQ的中文版进行研究，国内对食欲评价相关问卷及量表的研究和报道较少，尚无相关经验可借鉴和比较。同时研究对象均来自于同一家医疗单位，且研究中未能考虑患者的疾病分期，肿瘤的类型和所接受的治疗等因素，有待将来更大范围、更大数量的研究。本研究通过对肿瘤患者食欲症状问卷的英文版进行翻译、回译和修订，形成了中文版的肿瘤患者食欲症状问卷，该问卷经过统计学检验，具有较好的信效度，有望成为国内评价肿瘤患者食欲状况的有效测量工具，为肿瘤患者实施后续营养干预和临床治疗提供科学指导。
利益冲突声明：所有作者均声明不存在利益冲突。Competing interests: The authors declare that they have no competing interests. -
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图 1 肿瘤合并原发肝病相关血小板减少症管理流程
Figure 1 Management of thrombocytopenia in cancer patients with primary liver disease
表 5 临床常见引起肝损伤的抗肿瘤药物
Table 5 Common anti-cancer drugs causing liver injury in clinical practice
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