中医杂志

目的 基于真实世界临床数据评价“江苏中医优势病种诊疗方案”（简称“诊疗方案”）治疗成人非重症社区获得性肺炎的临床疗效和经济性。方法 采用回顾性真实世界队列研究方法，纳入江苏省10家中医院2023年9月1日至2024年12月31日因非重症社区获得性肺炎住院的成人患者病历资料，依据是否按照“诊疗方案”服用中药分为暴露组和非暴露组。非暴露组仅给予西医常规治疗，暴露组在西医常规治疗基础上按照“诊疗方案”给予中药辨证治疗，需连续服用中药≥5天。比较两组患者咳嗽缓解率、咳痰（包括痰量、痰色、痰质）缓解率、C反应蛋白（CRP）异常率、白细胞计数（WBC）异常率、肺部炎症影像吸收率；采用多因素Logistic回归分析，进行疗效影响因素分析；再根据年龄、性别、吸烟情况、高血压病情况以及社区获得性肺炎严重程度评分（CURB-65评分）生成相应的亚组，进行不同亚组患者咳嗽、咳痰疗效分析。以咳嗽缓解率为效果指标，采用成本-效果分析评价两组的药物经济性。结果 共纳入1688例患者的病历资料，其中暴露组1293例，非暴露组395例。暴露组咳嗽缓解率、痰量缓解率、痰色缓解率、痰质缓解率均高于非暴露组，CRP异常率低于非暴露组（P<0.05），两组WBC异常率和肺部炎症影像吸收率比较差异无统计学意义（P>0.05）。Logistic回归分析结果显示，暴露组咳嗽缓解率是非暴露组的1.83倍，痰量、痰色、痰质缓解的概率分别是非暴露组的1.37倍、2.09倍和1.56倍（P<0.05）。亚组分析结果显示，除了CURB-65评分≥2分以及患有高血压的人群外，其余各亚组中暴露组咳嗽缓解率均优于非暴露组（P<0.05）；在女性、年龄≥18岁且<65岁、非吸烟者、无高血压、CURB-65评分为0分的人群中，暴露组咳嗽缓解率优于非暴露组（P<0.05）。经济学评价方面，两组患者总费用、住院时间、抗生素费用、中草药费用差异均具有统计学意义（P<0.05），其中暴露组成本-效果比为10 788.80元/例，非暴露组为22 513.80元/例；与暴露组比较，非暴露组每使1例患者达到咳嗽缓解需要多花费17 302.27元；意愿支付值在0～50 000元时，暴露组具有的经济性概率均高于非暴露组。结论 在西医常规治疗基础上，按照“诊疗方案”进行中药治疗能有效改善成人非重症社区获得性肺炎的临床症状，降低炎症水平，促进患者临床康复，且更具有经济性。

Objective To evaluate the clinical efficacy and economic value of the Jiangsu Traditional Chinese Medicine(TCM) Diagnosis and Treatment Protocol for Dominant Diseases(abbreviated as the Diagnosis and Treatment Protocol) in adult patients with non-severe community-acquired pneumonia(CAP) based on real-world clinical data.Methods A retrospective real-world cohort study was conducted using electronic medical records of adult patients hospitalized for non-severe CAP from September 1st, 2023 to December 31st, 2024 across 10 TCM hospitals in Jiangsu province. Patients were classified into an exposure group and a non-exposure group based on whether they received Chinese herbal medicine(CHM) according to the Diagnosis and Treatment Protocol. The non-exposure group received only conventional western medicine, while the exposure group additionally received differentiated CHM for at least five consecutive days. Outcomes were compared between two patient groups, including cough resolu-tion rate, sputum resolution rate(assessed by volume, color, and consistency), incidence of abnormal C-reactive protein(CRP), incidence of abnormal white blood cell(WBC) count, and radiographic resolution rate of pulmonary infiltrates on chest imaging. Multivariable logistic regression was performed to identify factors influencing clinical efficacy. Subgroup analyses were conducted according to age, gender, smoking status, history of hypertension, and pneumonia severity score(CURB-65), and the efficacy of treatment for cough and sputum was analyzed within each subgroup. Cost-effectiveness analysis was conducted using cough resolution rate as the outcome measure, evaluating the pharmacoeconomics of the two groups. Results A total of 1688 patients were included with 1293 in the exposure group and 395 in the non-exposure group. Compared to the non-exposure group, the exposure group demonstrated significantly higher resolution rates of cough, sputum volume, color, and consistency, as well as a significantly lower incidence of abnormal CRP(P<0. 05). No statistically significant difference was observed between the groups in terms of abnormal WBC count and radiographic resolution rate of pulmonary infiltrates(P>0. 05). Logistic regression analysis showed that the cough resolution rate in the exposure group was 1. 83 times that of the non-exposure group, while the probabilities of resolution in sputum volume, color, and consistency were 1. 37, 2. 09, and 1. 56 times those of the non-exposure group, respectively(P<0. 05). Subgroup analyses showed that the exposure group achieved significantly higher cough resolution rates across most subgroups except for populations with a CURB-65 score ≥2 or those with a history of hypertension(P<0. 05). Specifically, among females, patients aged ≥18 and <65 years, non-smokers, those without hypertension, and those with a CURB-65 score of 0, the exposure group showed a higher cough resolution rate than the non-exposure group(P<0. 05). From an economic perspective, total hospitalization cost, length of stay, antibiotic cost, and CHM cost all differed significantly between groups(P<0. 05). The cost-effectiveness ratio(CER) was 10,788. 80 CNY/case in the exposure group, while 22,513. 80 CNY/case in the non-exposure group. This implies that, compared with the exposure group, the non-exposure group incurred an additional 17,302. 27 CNY to achieve one case of cough resolution. When the willingness-to-pay threshold ranged from 0 to 50,000 CNY, the probability of economic advantage was consistently higher in the exposure group than in the non-exposure group. Conclusion On the basis of conventional western medicine, the addition of CHM in accordance with the Diagnosis and Treatment Protocol can effectively improve clinical symptoms, reduce inflammatory markers, promote clinical recovery, and is more cost-effective in treating adults with non-severe CAP.