中医辨证治疗方案对老年社区获得性肺炎出院后患者生存质量和疗效满意度的评价研究

Evaluation Study of Traditional Chinese Medicine Syndrome Differentiation Therapy on the Quality of Life and Efficacy Satisfaction in Elderly Community-acquired Pneumonia Patients after Discharge

背景社区获得性肺炎(CAP)为常见的感染性疾病之一,尤其在老年患者中,其临床症状不典型,易出现严重并发症,缺乏有效的治疗措施,常预后不良。目的探究中医辨证治疗方案对老年CAP出院(1周内)患者的生存质量及其疗效满意度情况。方法本研究为多中心、随机双盲安慰剂临床研究。选取河南中医药大学第一附属医院、河南省胸科医院、河南省人民医院、郑州市中医院、郑州人民医院5家医院呼吸科2018年4月—2020年1月病房收治的老年CAP出院后患者为研究对象,采用中央随机入组模式将患者分为试验组和对照组。试验组患者经中医辨证后给予相应中药颗粒剂进行治疗,气虚痰湿证给予补肺健脾化痰方,气阴虚痰热证给予益气养阴清肺方。对照组则给予与中药颗粒外观、重量、颜色、气味基本一致的安慰剂。治疗疗程为2个月,随访至治疗开始后6个月。比较两组患者治疗前、治疗1个月、治疗2个月、随访3个月、随访6个月的生存质量[采用中文版生存质量评分量表(SF-36)评价]和疗效满意度[采用肺炎患者疗效满意度问卷(ESQ-CAP)评价]。结果纳入120例患者中,脱落8例,最终纳入符合方案集的病例112例,其中试验组54例、对照组58例。治疗前两组性别、年龄、出院后时间、中医辨证分型、CUBR-65评分、基础疾病比较,差异无统计学意义(P>0.05)。组别对SF-36生理机能领域评分(F组间=5.057,P组间=0.027)、一般健康状况领域评分(F组间=7.286,P组间=0.008)、情感职能领域评分(F组间=6.858,P组间=0.010)主效应显著。组间比较:治疗2个月、随访3个月、随访6个月,试验组SF-36生理机能领域评分高于对照组(P<0.05);治疗1、2个月和随访3、6个月,试验组SF-36一般健康状况领域、情感职能领域评分高于对照组(P<0.05);随访3、6个月,试验组SF-36精神健康领域评分高于对照组(P<0.05)。组别对ESQ-CAP日常生活与能力领域评分(F组间=16.218,P组间<0.001)、方便领域评分(F组间=25.013,P组间<0.001)及ESQ-CAP总分(F组间=13.843,P组间<0.001)主效应显著。治疗2个月和随访3、6个月,试验组ESQ-CAP日常生活与能力领域评分高于对照组(P<0.05)。治疗1、2个月和随访3、6个月,试验组ESQ-CAP方便领域评分及ESQ-CAP总分高于对照组(P<0.05)。随访3个月,试验组ESQ-CAP总体疗效领域评分高于对照组(P<0.05)。结论中医辨证治疗方案对于老年CAP出院后患者的生存质量和疗效满意度具有较好的改善作用。

Background Community-acquired pneumonia(CAP)is one of the common infectious diseases,especially in elderly patients,with atypical clinical symptoms,which is susceptibility to serious complications,lacks effective treatment measures,and often has a poor prognosis.Objective To investigate the effect of traditional Chinese medicine(TCM)syndrome differentiation therapy on the quality of life and efficacy satisfaction of elderly patients with CAP discharged from hospital(within 1 week).Methods This study was designed as a multicentre,randomized double-blind placebo clinical study.Elderly CAP post-discharge patients admitted to the respiratory departments of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Henan Chest Hospital,Henan People's Hospital,Zhengzhou Hospital of Traditional Chinese Medicine and Zhengzhou People's Hospital from April 2018 to January 2020 were selected as the study subjects and divided into the experimental group and control group by using a central randomized group enrolment model.The patients in the experimental group were treated with corresponding TCM granules based on syndrome differentiation,and the lung-tonifying spleen-invigorating phlegm-reducing formula was given for syndrome of phlegm-dampness due to qi deficiency,and the qisupplementing yin-nourishing lung-clearing formula was given for qi and yin deficiency and phlegm-heat syndrome.The control group was given a placebo with the same appearance,weight,color,and smell as the Chinese medicine granules.The treatment course was 2 months,and the follow-up was up to 6 months.The quality of life evaluated by the Chinese version of the Quality of Life Rating Scale(SF-36)and efficacy satisfaction evaluated by the Efficacy Satisfaction Questionnaire for CAP(ESQ-CAP)were compared between the two groups before the treatment,1 month after the treatment,2 months after the treatment,3 months after the follow-up,and 6 months after the follow-up.Results Among the 120 subjects included,8 were dislodged and 112 were finally included that met the protocol set,including 54 cases in the experimental group and 58 cases in the control group.There was no significant difference in gender,age,time after discharge,TCM syndrome differentiation,CUBR-65 score,and underlying diseases between the two groups before treatment(P>0.05).The main effects of the group were significant on SF-36 physiological function domain score(Fgroup=5.057,Pgroup=0.027),general health domain score(Fgroup=7.286,Pgroup=0.008),and role limitations due to emotional problems domain score(Fgroup=6.858,Pgroup=0.010).Comparison between the two groups showed that SF-36 physical function domain score of the experimental group was higher than that of the control group at 2 months of treatment,3 months of follow-up,and 6 months of follow-up(P<0.05);SF-36 general health status domain and role limitations due to emotional problems domain scores of the experimental group were higher than those of the control group at 1 and 2 months of treatment,3 and 6 months of follow-up(P<0.05);the SF-36 domain score for role limitations due to mental health was higher than that of the control group(P<0.05)at 3 and 6 months of follow-up.The main effect of group on ESQ-CAP daily living and ability domain score(Fgroup=16.218,Pgroup<0.001),convenience domain score(Fgroup=25.013,Pgroup<0.001),and ESQ-CAP total score(Fgroup=13.843,Pgroup<0.001)was significant.The ESQ-CAP daily living and ability domain scores were higher in the experimental group than the control group at 2 months of treatment,3 and 6 months of follow-up(P<0.05).At 1 and 2 months of treatment and 3 and 6 months of follow-up,ESQ-CAP convenience domain score and ESQCAP total score were higher in the experimental group than in the control group(P<0.05).At 3 months of follow-up,the ESQCAP overall efficacy domain score was higher in the experimental group than the control group(P<0.05).Conclusion The TCM syndrome differentiation therapy scheme can improve the quality of life and efficacy satisfaction of elderly patients with CAP after discharge.