机构地区:[1]上海中医药大学附属曙光医院肿瘤科,上海中医药大学附属曙光医院中西医结合肿瘤研究所,上海201203 [2]上海市宝山区中西医结合医院肿瘤科,上海201203 [3]上海中医药大学中西医结合研究院,上海201203
出 处:《上海中医药杂志》2021年第7期59-63,共5页Shanghai Journal of Traditional Chinese Medicine
基 金:国家自然科学基金重点项目(82030118);上海市卫健委进一步加快中医药事业发展三年行动计划项目(ZY〔2018-2020〕-CCCX-2003-03);上海市科委中医引导类项目(19401933100)。
摘 要:目的观察补肾解毒方联合姑息化疗对晚期结直肠癌患者癌因性疲乏的影响。方法采用前瞻、随机、双盲、安慰剂平行对照的试验设计方法,将72例晚期结直肠癌癌因性疲乏患者随机分为治疗组、对照组,每组36例。对照组采用姑息化疗联合补肾解毒方安慰剂治疗,治疗组采用姑息化疗联合补肾解毒方治疗,两组均持续治疗6个化疗周期或至疾病进展。比较两组Piper疲乏量表及简易疲乏量表中国版(BFI-C)评分的变化情况,观察、记录不良反应的发生情况。结果①治疗组、对照组各脱落4例,最终完成试验者64例,治疗组、对照组各32例。②治疗前后组内比较,两组Piper疲乏量表各维度(行为疲乏、情感疲乏、躯体感觉疲乏、认知情绪疲乏)评分及量表总分差异均有统计学意义(P<0.05);组间治疗后比较,治疗组Piper疲乏量表各维度评分及量表总分低于对照组(P<0.05)。③治疗前后组内比较,治疗组BFI-C量表中的现疲乏程度、24 h疲乏程度、24 h最严重疲乏程度、对生活的影响(一般活动、情绪、行走、工作、与他人关系、生活乐趣)评分及总分差异均有统计学意义(P<0.05),对照组仅24 h最严重疲乏程度、影响一般活动、影响情绪评分差异有统计学意义(P<0.05);组间治疗后比较,治疗组BFI-C量表各项评分及总分均低于对照组(P<0.05)。④组间不良反应发生情况比较,差异无统计学意义(P>0.05),且均以Ⅰ度、Ⅱ度为主。结论补肾解毒方联合姑息化疗可明显减轻晚期结直肠癌患者癌因性疲乏程度,且安全性良好。Objective To observe the effect of Bushen Jiedu Recipe combined with palliative chemotherapy on cancer-related fatigue(CRF)in patients with advanced colorectal cancer(ACC).Methods In a prospective,randomized,double-blind,placebo-controlled trial design,72 ACC patients with cancer-related fatigue were randomly divided into treatment group(n=36)and control group(n=36).The control group was administered with palliative chemotherapy combined with Bushen Jiedu Recipe placebo,while the treatment group was administered with palliative chemotherapy combined with Bushen Jiedu Recipe.The treatment lasted until the expiration of 6 chemotherapy cycles or the disease progression.The score changes of the Piper Fatigue Scale(PFS)and a Chinese version of the Brief Fatigue Inventory(BFI-C)were compared between the two groups,and the incidence of adverse reactions was observed and recorded.Results①The treatment group and the control group each shed 4 cases,and the remaining 64 subjects completed the trial,32 cases in the treatment group and 32 cases in the control group.②The intra-group comparison before and after treatment showed that there were significant differences in the scores of each dimension(behavioral fatigue,affective fatigue,somatosensory fatigue,cognitive emotional fatigue)and the total scores of PFS between the two groups(P<0.05).After treatment,the scores of each dimension and the total scores of PFS in the treatment group were lower than those in control group(P<0.05).③According to the intra-group comparison before and after treatment,the BFI-C scores of fatigue now,usual fatigue at 24 hours,worst fatigue at 24 hours,impact on life(general activities,mood,walking,normal work,relations with other people,enjoyment of life)and the total scores differed significantly in the treatment group(P<0.05),while in the control group,only differences in the BFI-C scores of worst fatigue at 24 hours,impact on general activities and mood were statistically significant(P<0.05).After treatment,the scores of each dimension and
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