目的:通过随机对照的研究方法,用EORTC QLQ生活质量测定量表、LCSS肺癌症状量表、肺癌患者生存质量测定量表(FACT-L)、生活质量QOL评分量表、中医证候积分,研究45例Ib~IIb期非小细胞肺癌术后化疗患者生活质量的变化。方法:将符合入组条件的45例Ib~IIb期非小细胞肺癌术后患者,随机分成治疗组(金复康口服液联合化疗) 23例、对照组(单纯化疗) 22例。两组均予术后辅助含铂双药化疗2周期,治疗组在化疗的基础上,联合口服金复康口服液,完成2周期治疗后评价两组患者治疗前后生活质量及中医证候情况。结果:1) 治疗后EORTC QLQ生活质量测定量表中治疗组躯体功能、疲乏、食欲减退、睡眠障碍改善优于对照组(P < 0.05),总体健康状况治疗组优于对照组(P < 0.01),子量表中疲乏、气促、咳嗽症状改善疗效优于对照组(P < 0.01);2) LCSS肺癌症状量表评分、生活质量QOL治疗组改善优于对照组(P < 0.05);3) FACT-L量表评分治疗组改善优于对照组(P < 0.05);4) 中医症候疗效治疗组好于对照组(P < 0.05)。结论:金复康口服液能改善术后Ib~IIb期非小细胞肺癌化疗患者的疲乏、气促、咳嗽、睡眠障碍症状,减轻化疗造成的食欲下降,改善总体健康状况,提高患者生活质量,减轻患者中医症候,具有良好的安全性。 Objective: To evaluate the curative effect in the quality of life of 45 patients with chemotherapy af-ter surgery Ib~IIb stage non-small cell lung cancer, by using the randomized and controlled method. The main outcome measures are the EORTC QLQ Quality of Life Measurement Scale, Lung Cancer Symptom Scale (LCSS), Functional Assessment of Cancer Therapy (FACT-L), Quality of Life QOL Score Scale and Traditional Chinese Medicine Syndrome Score. Methods: 45 cases of non-small cell lung cancer patients in the Ib~IIb stage after complete resection were randomizedly divided into two groups according to the order of the patients. One group was the treatment group (Jinfukang Oral liquid combined chemotherapy), which included 23 patients. The other group was the control group (chemotherapy), which included 22 patients. Both two groups received 2 cycles of platinum-based chemotherapy. The treatment group was added to Jinfukang oral liquid. To evaluate the curative effect of two groups in the term of quality of life, TCM symptoms before and after completing 2 cycles of treatment. Results: 1) The improvement of physical function, fatigue, loss of appetite and sleep disorder in the treatment group on the EORTC QLQ quality of life measurement scale after treat-ment was better than that of the control group (P < 0.05), the treatment group of general health was better than that of the control group (P < 0.01), and the improvement of fatigue, shortness of breath and cough symptoms on the subscale was better than that of the control group (P < 0.01). 2) The LCSS lung cancer symptom scale score and quality of life QOL treatment group improved better than the control group (P < 0.05); 3) The improvement of the FACT-L scale scoring treatment group was better than that of the control group (P < 0.05); 4) The treatment group of TCM symptoms was bet-ter than that of the control group (P < 0.05). Conclusion: Jinfukang oral liquid can improve the symptoms of fatigue, shortness of breath, cough and sleep disorder in postoperative stage Ib~IIb non-small cell lung cancer chemotherapy patients, reduce the loss of appetite caused by chemo-therapy, improve the overall health status, improve the quality of life of patients, and reduce TCM symptoms , and has a good safety profile.
目的:通过随机对照的研究方法,用EORTC QLQ生活质量测定量表、LCSS肺癌症状量表、肺癌患者生存质量测定量表(FACT-L)、生活质量QOL评分量表、中医证候积分,研究45例Ib~IIb期非小细胞肺癌术后化疗患者生活质量的变化。方法:将符合入组条件的45例Ib~IIb期非小细胞肺癌术后患者,随机分成治疗组(金复康口服液联合化疗) 23例、对照组(单纯化疗) 22例。两组均予术后辅助含铂双药化疗2周期,治疗组在化疗的基础上,联合口服金复康口服液,完成2周期治疗后评价两组患者治疗前后生活质量及中医证候情况。结果:1) 治疗后EORTC QLQ生活质量测定量表中治疗组躯体功能、疲乏、食欲减退、睡眠障碍改善优于对照组(P < 0.05),总体健康状况治疗组优于对照组(P < 0.01),子量表中疲乏、气促、咳嗽症状改善疗效优于对照组(P < 0.01);2) LCSS肺癌症状量表评分、生活质量QOL治疗组改善优于对照组(P < 0.05);3) FACT-L量表评分治疗组改善优于对照组(P < 0.05);4) 中医症候疗效治疗组好于对照组(P < 0.05)。结论:金复康口服液能改善术后Ib~IIb期非小细胞肺癌化疗患者的疲乏、气促、咳嗽、睡眠障碍症状,减轻化疗造成的食欲下降,改善总体健康状况,提高患者生活质量,减轻患者中医症候,具有良好的安全性。
肺癌,早期非小细胞肺癌术后,生活质量,中医证候
Yiran Ouyang1, Hegen Li2*
1Oncology Department, Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Suzhou Jiangsu
2Oncology Department, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai
Received: May 21st, 2023; accepted: Jun. 14th, 2023; published: Jun. 25th, 2023
Objective: To evaluate the curative effect in the quality of life of 45 patients with chemotherapy after surgery Ib~IIb stage non-small cell lung cancer, by using the randomized and controlled method. The main outcome measures are the EORTC QLQ Quality of Life Measurement Scale, Lung Cancer Symptom Scale (LCSS), Functional Assessment of Cancer Therapy (FACT-L), Quality of Life QOL Score Scale and Traditional Chinese Medicine Syndrome Score. Methods: 45 cases of non-small cell lung cancer patients in the Ib~IIb stage after complete resection were randomizedly divided into two groups according to the order of the patients. One group was the treatment group (Jinfukang Oral liquid combined chemotherapy), which included 23 patients. The other group was the control group (chemotherapy), which included 22 patients. Both two groups received 2 cycles of platinum-based chemotherapy. The treatment group was added to Jinfukang oral liquid. To evaluate the curative effect of two groups in the term of quality of life, TCM symptoms before and after completing 2 cycles of treatment. Results: 1) The improvement of physical function, fatigue, loss of appetite and sleep disorder in the treatment group on the EORTC QLQ quality of life measurement scale after treatment was better than that of the control group (P < 0.05), the treatment group of general health was better than that of the control group (P < 0.01), and the improvement of fatigue, shortness of breath and cough symptoms on the subscale was better than that of the control group (P < 0.01). 2) The LCSS lung cancer symptom scale score and quality of life QOL treatment group improved better than the control group (P < 0.05); 3) The improvement of the FACT-L scale scoring treatment group was better than that of the control group (P < 0.05); 4) The treatment group of TCM symptoms was better than that of the control group (P < 0.05). Conclusion: Jinfukang oral liquid can improve the symptoms of fatigue, shortness of breath, cough and sleep disorder in postoperative stage Ib~IIb non-small cell lung cancer chemotherapy patients, reduce the loss of appetite caused by chemotherapy, improve the overall health status, improve the quality of life of patients, and reduce TCM symptoms , and has a good safety profile.
Keywords:Lung Cancer, Early Stage Non-Small Cell Lung Cancer after Complete Resection, Quality of Life, TCM Syndrome
Copyright © 2023 by author(s) and
This work is licensed under the Creative Commons Attribution International License (CC BY 4.0).
http://creativecommons.org/licenses/by/4.0/
近年来,肿瘤发病率逐年升高,在美国肺癌是发病率和死亡率前三位的恶性肿瘤 [
2018~2021年期间上海龙华医院、上海胸科医院、苏州市中医医院进行化疗的肺癌患者。入组标准:1) 18~75岁;2) 经术后病理明确为非小细胞肺癌,术后分期Ib~IIb期,术后6周内开始含铂双药方案化疗;3) 中医辨证属气阴两虚证;4) KPS评分 > 70分;5) 有一定文化程度,能看懂量表。排除标准:1) 存在化疗禁忌症;2) 妊娠或哺乳期妇女;3) 糖尿病患者;4) 有精神病病史者。
将符合入组标准的患者45例,采用数字表法随机分为治疗组23例、对照组22例,两组患者均予含铂双药化疗,包括AP/AC、GP/GC、DP/DC方案,3周为1周期,共治疗2周期。治疗组在化疗的基础上予口服金复康口服液(吉林金复康药业有限公司,国药准字Z19991043),每支30 ml,1支/次,3次/天,第6~21天口服),观察治疗前后各量表变化情况。本研究经上海中医药大学附属龙华医院医学伦理委员会批准(伦理号批件号:2016LCSY080号)。
1) 生活质量测定量表(European Organization of Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer, EORTC QLQ):包括a) 5个功能量表:躯体功能(Physical function, PF)、角色功能(Role function, RF)、认知功能(Cognitive function, CF)、情绪功能(Emotional function, EF)、社会功能(Social function, SF);b) 3个症状量表:疲乏(fatigue, FA)、疼痛(Pain, PA)、恶心呕吐(Nausea/Vomiting, NV);c) 6个单项测试项目:呼吸困难(Dyspnea, DY)、睡眠障碍(Sleep disturbance, SL)、食欲下降(Appetite loss, AP)、便秘(Constipation, CO)、腹泻(Diarrhea, DI)、经济困难(Financial difficulties, FI);d) 1个整体生活质量量表(global quality of life, GOL)。
2) 肺癌患者生存质量测定量表肺癌症状量表(Lung Cancer Symptom Scale, LCSS):包含9个条目,通过肺癌相关症状来全面评价生活质量。
3) 肺癌治疗的功能评价(Functional Assessment of Cancer Treatment-Lung, FACT-L)量表共分为5个领域:生理状况(PWB)、社会/家庭状况(SWB)、情感状况(EWB)、功能状况(FWB)、肺癌相关症状(LCS),共36个条目。
4) 生活质量QOL评分:包含食欲、精神、睡眠、疲乏、疼痛、家庭理解与配合、同事的理解与配合、自身对癌症的认识、对治疗的态度、日常生活、治疗的副作用、面部表情12条目,并按总分进行生活质量分级。
5) 中医证候评分:包括咳嗽、咯痰、气短、胸闷、胸痛、神疲乏力、食欲不振、痰中带血、口干咽燥、发热、自汗盗汗、失眠、腹泻、夜尿频多、五心烦热15项,计算总分,根据尼莫地平法进行疗效评分。
采用SPSS26.0软件进行统计分析,符合正态分布的计量资料以均数 ± 标准差( X ¯ ± s )表示,采用t检验,非正态分布采用非参数检验,计数资料采用卡方检验。以P < 0.05认为差异有统计学意义。
共纳入患者45例,治疗前后两组共完成量表540份。治疗组中男性13例,女性10例,平均年龄(59.65 ± 9.42)岁;对照组中男性10例,女性12例,平均年龄(58.96 ± 12.93)岁;治疗前年龄、性别、病理类型、术后分期无统计学差异。
治疗前两组各功能量表、症状量表、单项症状差异无统计学意义,治疗后,对照组躯体功能评分、总健康水平积分较前下降(P < 0.05),睡眠障碍、食欲下降、经济困难评分较前升高(P < 0.05);治疗组角色功能、情绪功能评分较前升高(P < 0.05),疲乏、睡眠障碍评分较前下降(P < 0.05);治疗后治疗组躯体功能、疲乏、食欲减退、睡眠障碍较对照组改善(P < 0.05),总体健康水平较对照组明显改善(P < 0.01)。在症状子量表(EORTC QLQ-LC13)中,治疗后治疗组在气促、咳嗽改善疗效优于对照组(P < 0.01),其余8种症状两组疗效无明显差异。见表1、表2。
领域 | 组别 | 治疗前 | 治疗后 |
---|---|---|---|
躯体功能PF | 治疗组 | 92.17 ± 6.560 | 96.89 ± 4.266a |
对照组 | 92.73 ± 5.001 | 89.84 ± 7.541a | |
角色功能RF | 治疗组 | 91.30 ± 9.885 | 97.78 ± 5.684a |
对照组 | 93.94 ± 8.206 | 86.27 ± 16.910 | |
认知功能CF | 治疗组 | 99.28 ± 3.475 | 100.00 ± 0.000 |
对照组 | 99.24 ± 3.553 | 96.67 ± 6.900 | |
情绪功能EF | 治疗组 | 94.20 ± 11.077 | 100.00 ± 0.000a |
对照组 | 98.86 ± 2.927 | 97.65 ± 3.284 | |
社会功能SF | 治疗组 | 92.75 ± 14.058 | 96.67 ± 9.344 |
对照组 | 90.91 ± 15.195 | 90.20 ± 13.253 | |
疲乏FA | 治疗组 | 24.15 ± 6.402 | 12.59 ± 12.505ab |
对照组 | 21.21 ± 9.643 | 29.41 ± 11.070 | |
疼痛PA | 治疗组 | 4.345 ± 9.014 | 0.00 ± 0.000 |
对照组 | 5.30 ± 15.758 | 7.84 ± 19.648 | |
恶心呕吐NV | 治疗组 | 0.72 ± 3.475 | 2.22 ± 5.864 |
对照组 | 0.00 ± 0.000 | 3.92 ± 7.287 | |
呼吸困难DY | 治疗组 | 27.54 ± 12.918 | 26.67 ± 13.801 |
对照组 | 33.33 ± 10.287 | 31.37 ± 8.085 | |
睡眠障碍SL | 治疗组 | 26.09 ± 19.991 | 8.89 ± 15.258ab |
对照组 | 18.18 ± 26.681 | 33.33 ± 28.868a | |
食欲下降AP | 治疗组 | 1.45 ± 6.950 | 2.22 ± 8.607 |
对照组 | 0.00 ± 0.000 | 21.57 ± 20.211a | |
经济困难FI | 治疗组 | 1.45 ± 6.950 | 2.22 ± 8.607 |
对照组 | 0.00 ± 0.000 | 7.84 ± 14.575a | |
总健康水平GOL | 治疗组 | 77.17 ± 8.782 | 79.44 ± 22.464c |
对照组 | 76.14 ± 12.143 | 67.65 ± 7.146a |
表1. 两组EORTC QLQ生活质量量表比较( X ¯ ± s )
注:a与治疗前比较,P < 0.05;b与对照组比较,P < 0.05;c与治疗前比较,P < 0.01;“便秘”、“腹泻”条目在本研究治疗前后变化不明显,故表内略。
症状 | 组别 | 治疗前 | 治疗后 |
---|---|---|---|
气促LC-DY | 治疗组 | 17.17 ± 6.620 | 8.33 ± 4.969ab |
对照组 | 18.69 ± 11.051 | 25.49 ± 12.889a | |
咳嗽LC-CO | 治疗组 | 30.30 ± 14.213 | 16.67 ± 17.213ab |
对照组 | 30.30 ± 9.808 | 33.33 ± 0.000 | |
脱发LC-HR | 治疗组 | 3.301 ± 9.808 | 1.96 ± 8.085 |
对照组 | 1.52 ± 7.107 | 2.082 ± 8.333 | |
胸痛LC-PC | 治疗组 | 1.52 ± 7.107 | 1.96 ± 8.085 |
对照组 | 4.55 ± 11.708 | 0.00 ± 0.000 |
表2. 两组EORTC QLQ-LC13生存质量量表比较( X ¯ ± s )
注:a与治疗前比较,P < 0.01;b与对照组比较,P < 0.01;“咯血”、“口腔疼痛”、“吞咽困难”、“手足刺痛”、“其他部位痛”子量表积分在本研究治疗前后变化不明显,故表内略。
两组患者治疗前FACT-L量表评分差异无统计学意义(P > 0.05);治疗后对照组情感状况、总积分较前明显下降(P < 0.01),治疗组生理状况、功能状况、情感状况、总积分明显下降(P < 0.01),社会/家庭状况、肺癌相关症状积分较前下降(P < 0.05);治疗后治疗组功能状况、总积分低于对照组(P < 0.05)。提示治疗组5个领域均可得到改善,对照组均可改善情感状况、生存质量总积分,治疗组在功能领域、生存质量总积分改善上更明显(P < 0.05)。见表3。
组别(例) | 生理状况(PWB) | 社会/家庭状况 (SWB) | 情感状况(EWB) | 功能状况 (FWB) | 肺癌相关症状 (LCS) | 总积分 | |
---|---|---|---|---|---|---|---|
治疗组(23) | 治疗前 | 14.78 ± 2.486 | 15.00 ± 2.629 | 16.96 ± 2.915 | 16.43 ± 2.063 | 15.35 ± 2.604 | 78.52 ± 9.462 |
治疗后 | 12.26 ± 1.685a | 13.96 ± 1.397c | 14.30 ± 2.055a | 13.83 ± 2.269ab | 13.87 ± 1.632c | 68.22 ± 4.210ab | |
对照组(33) | 治疗前 | 14.73 ± 2.313 | 15.23 ± 2.581 | 16.86 ± 2.336 | 15.55 ± 2.540 | 15.86 ± 2.494 | 78.23 ± 8.412 |
治疗后 | 13.36 ± 1.529 | 14.55 ± 1.625 | 14.14 ± 2.295a | 15.68 ± 2.495 | 13.95 ± 1.397 | 71.68 ± 5.223a |
表3. 两组FACT-L量表比较( X ¯ ± s )
注:a与治疗前比较,P < 0.01;b与对照组比较,P < 0.05,c与治疗前比较,P < 0.05。
两组患者治疗前LCSS肺癌症状量表评分、生活质量QOL总积分、中医证候总积分差异均无统计学意义(P > 0.05),基线一致。两组患者治疗前LCSS肺癌症状量表评分、生活质量QOL总积分、中医证候总积分差异均无统计学意义(P > 0.05);治疗后治疗组LCSS评分、中医证候总积分较治疗前明显下降(P < 0.01),生活质量QOL总积分明显升高(P < 0.01);治疗后治疗组LCSS评分、生活质量QOL总积分、中医证候总积分改善更明显(P < 0.05)。见表4。
组别(例) | LCSS量表总积分 | 生活质量QOL总积分 | 中医证候总积分 | |
---|---|---|---|---|
治疗组(23) | 治疗前 | 35.65 ± 5.288 | 33.70 ± 5.380 | 8.78 ± 2.066 |
治疗后 | 22.35 ± 5.280ab | 38.87 ± 4.808ab | 7.04 ± 1.718ab | |
对照组(33) | 治疗前 | 32.55 ± 6.323 | 35.91 ± 5.731 | 7.04 ± 1.718 |
治疗后 | 32.95 ± 5.323 | 34.59 ± 4.216 | 9.59 ± 2.823 |
表4. 两组LCSS量表、QOL总积分、中医证候积分比较( X ¯ ± s )
注:a与治疗前比较,P < 0.01;b与对照组比较,P < 0.05。
祖国医学中对于肿瘤的命名并不统一,中医古籍中未见“肺癌”病名的记载,肺癌可属于“积聚”、“癥瘕”等病症,根据肺癌症状也可见于“咳嗽”、“咯血”、“胸痛”、“肺痿”、“痰饮”等病症的古文条目中。通常认为,肺癌的发生是邪正交争、正不胜邪的结果。其病机主要是机体正气亏虚、邪毒侵袭,气滞、血瘀、痰凝等邪毒,胶结于肺而成肺积。李中梓的《医宗必读·积聚》:“积之成也,正气不足,而后邪气踞之。”而气阴两虚证是肺癌最常见证型 [
金复康口服液在1999年研制成功,原名益肺抗瘤饮,是根据国医大师刘嘉湘教授的经验方提炼总结研制。由黄芪、北沙参、天冬、麦冬、女贞子、石上柏、重楼等组成,主要用于治疗原发性非小细胞肺癌,辨证论治属于气阴两虚证的患者。前期已有相关研究相继从抑制肺癌细胞的增殖、诱导人肺腺癌细胞凋亡、免疫调节等角度探讨金复康的作用机理 [
生活质量评定是选择治疗方案、评估整体情况的一项指标,可以评价治疗效果、评估预后,在肿瘤治疗中尤为重要 [
上海申康医学发展中心项目(SHDC12016114),苏州市科技局民生科技项目(编号:SYSD2020216)。
欧阳怡然,李和根. Ib~IIb期非小细胞肺癌术后生活质量观察Observation of Quality of Life for Ib~IIb Stage Non-Small Cell Lung Cancer after Complete Resection[J]. 临床医学进展, 2023, 13(06): 9871-9877. https://doi.org/10.12677/ACM.2023.1361380
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