肺复康方治疗中晚期非小细胞肺癌癌因性疲乏的疗效及安全性观察

Observation on the Efficacy and Safety of Feifukang Prescription(肺复康方)in the Treatment of Cancer-induced Fatigue in Advanced Non-small Cell Lung Cancer

目的:观察肺复康方治疗中晚期非小细胞肺癌癌因性疲乏的临床疗效及安全性。方法:将60例气阴两虚、痰瘀毒结证中晚期非小细胞肺癌癌因性疲乏患者随机分为治疗组和对照组,每组30例。治疗组患者采用肺复康方联合标准化疗治疗,对照组患者采用标准化疗治疗。两组均以21 d为1个周期,共治疗4个周期。治疗结束后比较两组患者癌症疲乏评分(CFS)、生活质量评分(EORTC QLQ-C30问卷)、中医证候积分、近期疗效、体质量变化及毒副反应。结果:治疗组临床获益率为80.00%(24/30),对照组临床获益率为53.33%(16/30),治疗组临床获益率高于对照组(P<0.05)。治疗组中医证候疗效总有效率为73.33%(22/30),对照组中医证候疗效总有效率为40.00%(12/30),治疗组中医证候疗效总有效率高于对照组(P<0.05)。治疗后,两组患者中医证候评分均降低(P<0.05),且治疗组患者治疗后中医证候评分低于对照组(P<0.05)。治疗组体质量改善率为53.33%(16/30),对照组体质量改善率为26.67%(8/30),治疗组体质量改善率高于对照组(P<0.05)。治疗后,两组患者CFS评分均降低(P<0.05),且治疗组患者治疗后CFS评分低于对照组(P<0.05)。治疗后,两组患者EORTC QLQ-C30(version3.0)问卷总分及各维度评分均较治疗前升高(P<0.05),症状得分均较治疗前降低(P<0.05);两组患者治疗后认知功能评分、社会功能评分和疼痛症状评分比较,差异均无统计学意义(P>0.05);治疗组患者治疗后总体健康评分、其余各维度评分均高于对照组(P<0.05),其余症状评分均低于对照组(P<0.05)。治疗组骨髓抑制、肝功能损伤、胃肠反应等不良反应发生率均低于对照组(P<0.05)。结论:肺复康方能有效改善中晚期非小细胞肺癌癌因性疲乏患者总体、躯体、情感维度的疲乏,提高躯体、情绪和角色功能,改善中医证候,增加临床获益率,增加患者体质量,减轻化疗后的不良反应,提高患者的生活质量。

Objective:To observe the clinical efficacy and safety of Feifukang Prescription in the treatment of cancer-related fatigue in advanced non-small cell lung cancer.Methods:A total of 60 cases of cancer-related fatigue in advanced non-small cell lung cancer patients with deficiency of both Qi and Yin syndrome and phlegm,blood stasis and toxin binding syndrome were randomly divided into treatment group and control group,with 30 cases in each group.The treatment group was treated with Feifukang Prescription combined with standard chemotherapy.The control group was treated with standard chemotherapy.Two groups were treated with 21 days as a cycle,a total of 4 cycles.After treatment,cancer fatigue score(CFS),quality of life score(EORTC QLQ-C30 questionnaire),TCM syndrome score,short-term efficacy,changes of body mass and side effects were compared between the two groups.Results:The clinical benefit rate of the treatment group was 80.00%(24/30),and that of the control group was 53.33%(16/30).The clinical benefit rate of the treatment group was higher than that of the control group(P<0.05).The total effective rate of TCM syndrome in the treatment group was 73.33%(22/30),and that in the control group was 40.00%(12/30).The total effective rate of TCM syndrome in the treatment group was higher than that in the control group(P<0.05).After treatment,the TCM syndrome scores of the two groups were decreased(P<0.05).After treatment,the TCM syndrome score of the treatment group was lower than that of the control group(P<0.05).The improvement rate of body mass in the treatment group was 53.33%(16/30),and that in the control group was 26.67%(8/30).The improvement rate of body mass in the treatment group was higher than that in the control group(P<0.05).The CFS scores of the two groups were decreased after treatment(P<0.05),and the CFS scores of the treatment group was lower than that of the control group(P<0.05).After treatment,the total score and each dimension score of EORTC QLQ-C30(version 3.0)in the two groups were higher than before treatment(P<0.05),and the clinical symptom scores were lower than before treatment(P<0.05).There was no significant difference in cognitive function score,social function score and pain symptom score between the two groups after treatment(P>0.05).After treatment,the overall health score and other dimension scores of the treatment group were higher than those of the control group(P<0.05),and the other clinical symptom scores of the treatment group were lower than those of the control group(P<0.05).The incidence of adverse reactions such as bone marrow suppression,liver function injury and gastrointestinal reaction in the treatment group were lower than those in the control group(P<0.05).Conclusion:Feifukang Prescription can effectively improve the overall and physical and emotional fatigue of patients with cancer-related fatigue of advanced non-small cell lung cancer,improve the physical,emotional and role functions,improve TCM syndromes,increase the clinical benefit rate,increase the body weight of patients,reduce the adverse reactions after chemotherapy,and improve the quality of life of patients.