中医辨证治疗方案降低老年社区获得性肺炎患者再住院率的疗效评价

Efficacy evaluation of traditional Chinese medicine syndrome differentiation therapy on reducing the rehospitalization rate of elderly patients with community-acquired pneumonia

目的:评价中医辨证治疗方案对老年社区获得性肺炎(CAP)患者再住院率、医生报告结局及患者报告结局的影响。方法:采用多中心随机双盲安慰剂对照试验设计,以老年CAP出院后患者为研究对象,120例患者中央随机分为试验组和对照组各60例,试验组辨证给予相应中药颗粒剂,对照组辨证给予相应中药安慰剂,均治疗2个月,随访6个月。主要结局指标为再住院率(肺炎再住院率、全因再住院率),次要结局指标包括肺炎的医生报告结局量表(CAP-CRO)、肺炎患者报告结局量表(CAP-PRO),采用SPSS 23.0进行统计分析。结果:共纳入120例患者,脱落8例,符合方案集112例(试验组54例、对照组58例)。(1)再住院率:试验组治疗2个月及随访3、6个月的肺炎再住院率显著低于对照组(P<0.05);各时间点的全因再住院率组间比较差异均无统计学意义。(2)CAP-CRO:疾病症状领域、病情改善综合评价领域和量表总评分不同时间点重复测量方差分析有时间效应和组别效应(P<0.01),主要体征领域评分有时间效应(P<0.01)。(3)CAP-PRO:疾病症状领域评分和量表总评分不同时间点重复测量方差分析有时间效应和组别效应(P<0.01);健康满意度领域评分、疗效满意度领域评分有时间效应(P<0.01)。结论:中医辨证治疗能够降低老年CAP患者肺炎再住院率,改善咳嗽、咳痰、乏力、胸痛等症状,提高临床疗效。

Objective: To evaluate the influence of traditional Chinese medicine(TCM) syndrome differentiation therapy on the rehospitalization rate, clinician reported outcome, and patient reported outcome of elderly patients with community-acquired pneumonia(CAP) after discharge. Methods: In this study, a multicenter, randomized, double-blind, placebo-controlled trial design was used. The elderly patients with CAP after discharge were taken as the research objects, and 120 patients were randomly divided into an experimental group and a control group with 60 cases each group. The experimental group was given TCM granules by syndrome differentiation, and the control group was given TCM placebo by syndrome differentiation. The patients were treated for 2 months and followed up for 6 months. The primary outcome index was the rehospitalization rate(pneumonia rehospitalization rate, all-cause rehospitalization rate), the secondary outcome indexs were CAP-CRO and CAP-PRO.The SPSS 23.0 was used for statistical analysis. Results: A total of 120 patients were enrolled, of which 8 cases were dropped, 112 cases were in line with the protocol set(54 cases in the experimental group and 58 cases in the control group).(1)Rehospitalization rate: The rehospitalization rate of pneumonia in the experimental group was significantly lower than the control group after 2 months of treatment, 3 months of follow-up and 6 months of follow-up(P<0.05);There was no statistically significant difference in the all-cause rehospitalization rate between the two groups at each time point.(2)CAP-CRO: There were time effect and group effect in the field of disease symptom, comprehensive evaluation of disease improvement score and the total score of the scale at different time points after repeated measurement and analysis(P<0.01);there was time effect in the scores of main physical signs(P<0.01).(3)CAP-PRO: There were time effect and group effect in the field of disease symptom score and the total score of the scale at different time points after repeated measurement and analysis(P<0.01);there was time effect in the scores of health satisfaction and efficacy satisfaction(P<0.01). Conclusion: TCM syndrome differentiation therapy can reduce the pneumonia rehospitalization rate of elderly patients with CAP after discharge, improve cough, expectoration, hypodynamia, chest pain, etc.,and improve clinical efficacy.