1.Safety and efficacy of immunoadsorption therapy for rheumatoid arthritis:a network meta-analysis and systematic review
Yin ZHENG ; Zhenhua WU ; Cheng ZHANG ; Kexin RUAN ; Xiaolin GANG ; Hong JI
Chinese Journal of Tissue Engineering Research 2026;30(5):1260-1268
OBJECTIVE:To evaluate the efficacy and safety of different immunosorbent columns in the treatment of rheumatoid arthritis through a network meta-analysis,and provide evidence-based basis for clinical diagnosis and treatment.METHODS:By computer,the databases of VIP,WanFang,CNKI,PubMed,CBM,CochraneLibrary,and Web of Science were searched for published cohort studies of immunosorbent column for the treatment of rheumatoid arthritis,with a time limit until August 2024.The quality of the included randomized controlled trials was assessed using the Cochrane5.4 manual.The quality of retrospective cohort studies were evaluated via the Newcastle-Ottawa Scale(NOS).Bayesian network meta-analysis was performed using R4.1.1 software.RESULTS:A total of 13 studies were included,with a total sample size of 891 cases,and 4 immunosorbent columns were included.The results of the network meta-analysis showed that the top three orders that reduce C-reactive protein level:HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional Western medicine>A protein adsorption column;the top three orders that reduce erythrocyte sedimentation rates:leukocyte adsorption column>HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional western medicine;the top three orders that reduce swollen joint count:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 type adsorption column+conventional Western medicine;the top three orders that reduce tenderness joint counts:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 adsorption column+conventional Western medicine;the top three orders that reduce patients' disease activity evaluation:PH-350 adsorption column+conventional western medicine>leukocyte adsorption column>A protein adsorption column;the top three orders that reduce visual analogue scale scores:PH-350 adsorption column+conventional Western medicine>A protein adsorption column>leukocyte adsorption column;the top three orders that reduce physician's disease activity assessment:PH-350 adsorption column+conventional Western medicine>leukocyte adsorption column>conventional Western medicine.CONCLUSION:Based on the 13 articles,in terms of reducing C-reactive protein level,HA280 adsorption column and conventional Western medicine are the preferred choice.In terms of reducing erythrocyte sedimentation rate,swollen joint count,and tender joint count,leukocyte adsorption column is the preferred choice.In terms of reducing patient's disease activity evaluation,physician's disease activity evaluation and visual analogue scale scores,PH-350 adsorption column and conventional Western medicine are the first choice.Different immunosorbent columns can be reasonably and accurately selected according to the patient's specific conditions.
2.Clinical application of KASP-based RHCE genotyping in RhD-positive patients
Xiaoyu LIAN ; Mengdan LI ; Xiaoyu GUAN ; Li TIAN ; Chenying WANG ; Di WU ; Tianqiong LUO ; Xiaolin DU ; Xin JI ; Haixia XU ; Jue WANG ; Ling LI ; Zhong LIU
Chinese Journal of Blood Transfusion 2026;39(5):596-602
Objective: To develop a RHCE genotyping assay based on kompetitive allele-specific PCR (KASP) and assess its clinical accuracy for RhCE blood group determination. Methods: KASP primers were designed to interrogate three RHCE loci: the 109 bp insertion/deletion in intron 2, c. 307T>C, and c. 676C>G. A total of 1 194 RhD-positive inpatients from Chengdu were typed by both KASP genotyping and manual tube serology. Discordant samples (n=10) were retested by both methods and further resolved by Sanger sequencing. An additional 377 cases were tested for the c. 48C>G locus to evaluate the predictive accuracy of individual loci and combined locus testing for RhC antigen. Results: Genotyping concordance with serology was 100.0% for both the c. 676C>G locus (RhE/Rhe) and the c. 307T>C locus (Rhc). For RhC prediction using the 109 bp insertion, overall accuracy was 99.7% (1 191/1 194); the 3 discordant cases were confirmed by Sanger sequencing to be false negatives attributable to 109 bp deletion in intron 2. Testing the c. 48C>G allele for RhC prediction yielded 7 false positives, with an accuracy of 98.1% (370/377). RhC antigen status was determined by combining the 109 bp insertion and the c. 48C allele. After excluding 10 samples with inconsistent results between the two loci, the accuracy reached 100% in the remaining 367 samples. When both loci were applied in combination, accuracy reached 100% in the 367 cases with concordant results. Among the 1 194 patients, CCee (45.8%) and CcEe (31.7%) were the most common RhCE phenotypes. The e antigen had the highest positivity rate (92.2%), and the Ce haplotype was the most frequent (66.9%). Conclusion: The KASP-based RHCE genotyping method achieves high accuracy for clinical RhCE typing. Combining the 109 bp insertion/deletion with the c. 48C allele significantly improves RhC antigen prediction compared with either locus alone. This method was applied to RhCE genotyping of 1 194 RhD-positive inpatients in Chengdu, providing local RhCE phenotype and haplotype distribution data to support RhCE-matched transfusion practice.
3.Correlation analysis of the severity of OSAHS with visual field defects and visual evoked potentials in patients with AION
Pengfei DUAN ; Shuo LI ; Yuman WU ; Yufeng MA ; Sujuan JI
International Eye Science 2026;26(7):1258-1263
AIM: To investigate the correlation between different severity grades of obstructive sleep apnea-hypopnea syndrome(OSAHS)and visual field defects as well asvisual evoked potential(VEP)parameters in patients with anterior ischemic optic neuropathy(AION). METHODS: A retrospective case-control study. Patients diagnosed with AION complicated by OSAHS at the Department of Ophthalmology, the Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University, between June 2022 and October 2025 were selected as the study subjects. According to the AHI and mSaO2, the patients were divided into three groups: a mild group(AHI 5-15 events/h, mSaO2 85%-90%), moderate group(AHI 16-30 events/h, mSaO2 80%-85%), and severe group(AHI >30 events/h, mSaO2 <80%). General demographic data, retinal nerve fiber layer(RNFL)thickness, visual field defect indicators including mean defect(MD)and pattern standard deviation(PSD), as well as VEP parameters(P100 latency and amplitude)were compared among the three groups. RESULTS: This study included a total of 110 patients with AION complicated by OSAHS. Based on the severity of OSAHS, the patients were divided into a mild group of 37 patients(21 men and 16 women, mean age 62.15±9.37 y), a moderate group of 35 patients(20 men, 15 women; mean age 61.82±8.94 y), and a severe group of 38 patients(22 men, 16 women; mean age 63.02±9.61 y). There were no significant differences among the three groups in terms of age, sex, TG, TC, LDL-C, HDL-C levels, or AION severity(all P>0.05); however, there were significant differences in history of hypertension, history of diabetes, systolic blood pressure, diastolic blood pressure, and FPG levels(all P<0.05). The mean RNFL thickness in the severe group(63.27±5.58 μm)was significantly lower than that in the moderate group(74.14±6.28 μm)and the mild group(83.22±7.02 μm), and the moderate group was lower than the mild group(all P<0.05); The MD value(-11.57±1.82 dB)and PSD value(7.35±0.87 dB)in the severe group were both higher than those in the moderate group [(-7.62±1.31 dB),(4.89±0.62 dB)] and the mild group [(-4.38±1.05 dB),(2.57±0.45 dB)](all P<0.05); the P100 latency in the severe group(132.41±8.57 ms)was longer than that in the moderate group(118.75±7.32 ms)and the mild group(105.62±6.14 ms), and the amplitude(7.65±1.53 μV)was lower than that of the moderate group(11.24±1.89 μV)and the mild group(15.38±2.11 μV)(all P<0.05). Spearman's correlation analysis revealed that the severity of OSAHS was negatively correlated with the MD value(rs=-0.901, P<0.05)and positively correlated with the PSD value and P100 latency(rs=0.947, 0.807, P<0.05), and was negatively correlated with P100 amplitude(rs=-0.878, P<0.05). CONCLUSION:The severity of OSAHS is closely associated with RNFL thickness, visual field defects, and VEP parameters in patients with AION; the more severe the OSAHS, the more pronounced the structural and functional damage to the optic nerve. Monitoring AHI and mSaO2 can aid in assessing the condition of patients with AION and developing personalized intervention plans.
4.Qijia Rougan Decoction Ameliorates Liver Fibrosis Through miRNA-mRNA Network
Yumei WANG ; Peijie WU ; Shaoxiu JI ; Han YU ; Xiaohong ZUO ; Xiaofeng CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):84-90
ObjectiveTo explore the mechanism by which Qijia Rougan decoction ameliorates liver fibrosis through amino acid/fatty acid metabolic reprogramming and phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) pathway, based on the miRNA-mRNA regulatory network and the interaction between metabolism and signaling pathways. MethodsSprague-Dawley (SD) rats were randomized into four groups (n=8): control, model, and low-dose and high-dose (7.0, 28.0 g·kg-1·d-1, respectively) Qijia Rougan decoction. Liver fibrosis was induced by subcutaneous injection of carbon tetrachloride (CCl4). From week 9, drug intervention was implemented for 7 weeks. After the final administration, the pathological changes in the liver were evaluated through hematoxylin-eosin (HE) and picrosirius red (PSR) staining. An automated biochemical analyzer was used to measure the serum levels of biochemical indicators, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bile acid (TBA), albumin (ALB), and cholesterol (TC). High-throughput miRNA sequencing was performed to identify differentially expressed miRNAs (DemiRs) during liver fibrosis. A miRNA-mRNA interaction network was constructed to identify key targets, which were then subjected to GO and KEGG enrichment analyses. The expression levels of selected DemiRs were validated by Real-time PCR. ResultsCompared with the control group, the model group showed marked hepatic lobular necrosis, increased collagen deposition, significant fibrosis, elevated serum levels of ALT, AST, ALP, and TBA (P<0.01), and declined levels of ALB and TC (P<0.01). Compared with the model group, Qijia Rougan decoction treatment reduced hepatic necrosis, collagen accumulation, and fibrosis, lowered the serum levels of ALT, AST, ALP, and TBA (P<0.01), and raised the levels of ALB and TC (P<0.01). Integrated miRNA-seq and RNA-seq analysis identified 31 DemiRs (6 upregulated and 25 downregulated) and 498 targets. The expression trends of four selected DemiRs, including rno-miRNA-376b-3p, were consistent with sequencing results (R2=0.93). Functional annotation revealed that top 20 upregulated targets were enriched in amino acid and fatty acid metabolism, while top 20 downregulated targets were significantly associated with the PI3K/Akt signaling pathway and cancer progression. ConclusionQijia Rougan decoction alleviates liver fibrosis by reconstructing the miRNA-mRNA regulatory network, promoting metabolic reprogramming, and inhibiting the PI3K/Akt signaling pathway. These findings provide mechanism evidence supporting the multi-targeted antifibrotic effects of traditional Chinese medicine compound formulas.
5.Clinical efficacy and pharmacological basis of Mongolian medicine Manggari hot compress therapy for cervical spondylotic radiculopathy: a randomized controlled trial and serum pharmacochemistry study
Xiong Ling ; Sachula Baoyin ; Desi Aobi ; Ha Ni ; Zhiheng Dong ; Lan Wu ; Bao Jin ; Linbayaer Ji
Digital Chinese Medicine 2026;9(2):302-316
Objective:
To systematically evaluate the clinical efficacy of topical preparations of Mongolian medicine Manggari hot compress therapy (hereafter referred to as Manggari hot compress therapy) in treating cervical spondylotic radiculopathy (CSR) and explore the possible pharmacological material basis in the formula, providing evidence for the clinical application of Mongolian medicine in the treatment of CSR.
Methods:
The clinical trial employed a randomized, controlled, open-label, and outcome-assessor-blinded design. The CSR patients who were treated at the Department of Traditional Therapeutics Outpatient Clinic, Xilinguole Meng Mongolian General Hospital between July 1, 2024 and August 31, 2025, were enrolled. They were randomly assigned to three groups: an oral control group (administration of oral administration of mecobalamin tablets combined with cervical electric traction), an experimental group (Manggari external hot compress), and a patch control group (flurbiprofen gel plaster). The intervention lasted two weeks. Before and after treatment, the following subjective indicators were recorded: Mongolian Medicine Syndrome (MMS) score, Visual Analog Scale (VAS) score, Northwick Park Neck Pain Questionnaire (NPQ) score, and tongue morphology. Serum levels of inflammatory markers [tumor necrosis factor (TNF)-α, interleukin (IL)-6, and IL-1β)] and oxidative stress markers [malondialdehyde (MDA) content, superoxide dismutase (SOD) activity, and glutathione peroxidase (GSH-Px) activity] were measured using enzyme-linked immunosorbent assay (ELISA). Overall therapeutic efficacy was evaluated. One month after treatment completion, a follow-up assessment was conducted, and the MMS, VAS, and NPQ scores were recorded again for all patients. For the pharmacological substance exploration, ultra-high-performance liquid chromatography-Q-exactive orbitrap-mass (UHPLC-QE-MS) was employed to analyze blood-absorbed prototype components of Manggari, under both positive and negative ion modes. The targeting relationship between the core active compounds and the target protein was validated using molecular docking.
Results:
This study ultimately included 90 patients with CSR for analysis. Baseline characteristics showed no statistically significant differences among the three groups (P > 0.05). (i) Symptom scores. After treatment, the MMS, VAS, and NPQ scores decreased significantly from baseline in all three groups (P < 0.001). At follow-up, there was no significant difference in MMS, VAS, and NPQ scores of the experimental group compared with those at the end of the treatment (P > 0.05). After treatment, the experimental group showed significantly greater reductions in MMS, VAS, and NPQ scores than oral control and patch control groups (P < 0.001). At follow-up, these differences remained significant (P < 0.001). (ii) Inflammatory and oxidative stress markers. After treatment, serum levels of TNF-α, IL-6, and IL-1β, and MDA activity decreased significantly from baseline in all three groups (P < 0.001), and SOD content and GSH-Px activity increased significantly from baseline (P < 0.05). After treatment, the experimental group had significantly lower serum levels of TNF-α, IL-6, and IL-1β than oral and patch control groups. Additionally, it exhibited lower MDA activity and higher SOD content and GSH-Px activity compared with the two control groups. (P < 0.05). (iii) Overall efficacy. The total effective rate was 93.33% in the experimental group, 86.66% in the oral control group, and 83.33% in the patch control group. (iv) Pharmacological substance analysis. A total of 152 compounds were identified in the blood-absorbed components of Manggari. Among them, the core compounds—4-hydroxycoumarin, N-methylanthranilic acid, genistein, and ginsenoside-Rk1—showed binding energies to the key target proteins TNF-α and IL-1β range from − 4.7 to − 7.1 kcal/mol, with the majority of the binding energies being below − 5.0 kcal/mol, suggesting that it generally has a good binding affinity.
Conclusion
Mongolian medicine hot compress therapy effectively modulates inflammatory and oxidative stress responses through the combined action of its thermal effects and active pharmaceutical ingredients Manggari. It inhibits cervical nerve root inflammation and alleviates radicular pain, improving clinical symptoms, reducing pain severity, and alleviating neck functional disability.
6.Fetal development of chromogranin A-positive gastrointestinal endocrine cells revisited: a histological study using human fetuses
Ji Hyun KIM ; Zhe-Wu JIN ; Eri MIYAMOTO ; Sakiko TAKAHASHI ; Sayako SUZUKI ; Gen MURAKAMI ; Shin-ichi ABE
Anatomy & Cell Biology 2026;59(1):82-93
Initial gastrointestinal endocrine cells (GIECs) likely appear at the proximal and distal sites of abdominal intestines and may take a close topographical relation with neural elements in the gut. We examined immunohistochemically-stained sections from 10 fetuses at approximately 8–18 weeks of gestational age (36–155 mm of crown-rump length). Irrespective of whether physiological herniation was present (early 5 specimens) or absent (the other 5), the duodenum and jejunum had well-developed mucosa with villi containing abundant flask-like chromogranin-positive cells. In the earlier 5 specimens, the rectum, standing up to a level of the umbilicus, had a lumen and villi with a few positive cells, but the colon carried neither the lumen or chromogranin-positive cells. The initial GIECs seemed to appear in the basal payer of the epithelium at the distal and proximal foci depending on double pathways of neural crest cell migration. Less number of the colic chromograninpositive cells, more than 5-times difference in density relative to small intestine, was seen in the larger 5 specimens. The appearance of GIECs was delayed at the anal transitional zone (a border area between the columnar and squamous epithelia).The reactivity of neuronal nitric oxide synthase was restricted in the myenteric plexus, whereas clusters of slender calretininpositive cells existed in the lamina propria or core of villi in the duodenum and colon. Relatively small, round or oval positive cells were also seen in the basal layer of the columnar epithelium. Therefore, calretinin-positive cells might exist closely to GIECs in the developing villi.
7.Safety and efficacy of immunoadsorption therapy for rheumatoid arthritis:a network meta-analysis and systematic review
Yin ZHENG ; Zhenhua WU ; Cheng ZHANG ; Kexin RUAN ; Xiaolin GANG ; Hong JI
Chinese Journal of Tissue Engineering Research 2026;30(5):1260-1268
OBJECTIVE:To evaluate the efficacy and safety of different immunosorbent columns in the treatment of rheumatoid arthritis through a network meta-analysis,and provide evidence-based basis for clinical diagnosis and treatment.METHODS:By computer,the databases of VIP,WanFang,CNKI,PubMed,CBM,CochraneLibrary,and Web of Science were searched for published cohort studies of immunosorbent column for the treatment of rheumatoid arthritis,with a time limit until August 2024.The quality of the included randomized controlled trials was assessed using the Cochrane5.4 manual.The quality of retrospective cohort studies were evaluated via the Newcastle-Ottawa Scale(NOS).Bayesian network meta-analysis was performed using R4.1.1 software.RESULTS:A total of 13 studies were included,with a total sample size of 891 cases,and 4 immunosorbent columns were included.The results of the network meta-analysis showed that the top three orders that reduce C-reactive protein level:HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional Western medicine>A protein adsorption column;the top three orders that reduce erythrocyte sedimentation rates:leukocyte adsorption column>HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional western medicine;the top three orders that reduce swollen joint count:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 type adsorption column+conventional Western medicine;the top three orders that reduce tenderness joint counts:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 adsorption column+conventional Western medicine;the top three orders that reduce patients' disease activity evaluation:PH-350 adsorption column+conventional western medicine>leukocyte adsorption column>A protein adsorption column;the top three orders that reduce visual analogue scale scores:PH-350 adsorption column+conventional Western medicine>A protein adsorption column>leukocyte adsorption column;the top three orders that reduce physician's disease activity assessment:PH-350 adsorption column+conventional Western medicine>leukocyte adsorption column>conventional Western medicine.CONCLUSION:Based on the 13 articles,in terms of reducing C-reactive protein level,HA280 adsorption column and conventional Western medicine are the preferred choice.In terms of reducing erythrocyte sedimentation rate,swollen joint count,and tender joint count,leukocyte adsorption column is the preferred choice.In terms of reducing patient's disease activity evaluation,physician's disease activity evaluation and visual analogue scale scores,PH-350 adsorption column and conventional Western medicine are the first choice.Different immunosorbent columns can be reasonably and accurately selected according to the patient's specific conditions.
8.Monitoring and Analysis of Environmental Microbial Contamination in Laboratory Animal Barrier Facilities
Ying WANG ; Wentao JI ; Shaoqiong XU ; Guoyuan CHEN ; Jie FENG ; Baojin WU
Laboratory Animal and Comparative Medicine 2026;46(2):222-230
ObjectiveTo investigate microbial contamination status and distribution characteristics in laboratory animal barrier facilities, so as to provide a scientific basis for environmental quality control in barrier facilities. MethodsIn accordance with the national standard "Laboratory Animals—Environment and Housing Facilities" and the "Standard Operating Procedures" of the barrier facility, bacterial monitoring was performed on samples of air-settling bacteria, materials, and personnel gloves in the single-corridor barrier facility of the Animal Core Facility, Center for Excellence in Molecular Cell Science, Chinese Academy of Sciences (CEMCS). The monitoring data from January 2020 to December 2024 were collected, organized and statistically analyzed, and partial samples were subjected to species identification using PCR and sequencing methods. ResultsA total of 7 898 samples were collected from 2020 to 2024, including 3 175 air-settling bacteria samples, 3 353 material samples, and 1 370 glove samples. The overall compliance rate was 95.7% (7 559/7 898), among which the compliance rate of air-settling bacteria was 97.1% (3 084/3 175), that of materials was 93.2% (3 125/3 353), and that of personnel gloves was 98.5% (1 350/1 370). Over the five years, the compliance rates of all three types of monitored samples were above 90%. There were statistically significant differences in the compliance rates of air-settling bacteria and material samples among different quarters (P<0.05). Further investigation was conducted on samples collected from January to March 2024, and 190 bacterial strains were obtained through isolation and culture, including 126 strains from air-settling bacteria, 52 strains from materials, and 12 strains from personnel gloves. The strains were identified by PCR amplification and sequencing, and the 190 bacterial strains belonged to 9 genera and 20 species. Gram-positive bacteria accounted for the majority, with Staphylococcus as the dominant genus, accounting for 77.9% (148/190). ConclusionMicroorganisms carried by air, materials, and personnel gloves in barrier facilities are mainly Gram-positive bacteria. Regular monitoring of air-settling bacteria, materials, and personnel gloves in barrier facilities enables timely detection and control of potential risks during husbandry management and facility operation, which is of great significance for maintaining the sound operation of the barrier facility system and ensuring the quality of animal experiments.
9.Construction and Application of a Real-World Cohort of Community-Acquired Pneumonia Based on a Multimodal Large-Scale Traditional Chinese Medicine Big Data Platform
Zhichao WANG ; Xianmei ZHOU ; Fanchao FENG ; Mengqi WANG ; Xin WANG ; Bin KANG ; Xiaofan YU ; Xiaoxiao WANG ; Lei XIAO ; Juan LI ; Zhichao ZHANG ; Ye MA ; Yeqing JI ; Xin TONG ; Zhuoyue WU ; Jia LIU
Journal of Traditional Chinese Medicine 2026;67(9):961-965
This paper introduces a real-world cohort research model for community-acquired pneumonia (CAP) based on the Jiangsu Traditional Chinese Medicine (TCM) Dominant Diseases Diagnosis and Treatment Data Platform. Firstly, data cleaning is performed by standardizing diagnosis, symptoms, treatment and imaging, intelligently extracting unstructured information, and cleaning and constructing a standardized database. Secondly, for cohort establishment, CAP patients across the province are screened in accordance with CAP diagnostic criteria to build a high-quality disease-specific cohort. Lastly, in terms of protocol design, the characteristics of TCM research and the CAP disease profile are considered to determine appropriate inclusion and exclusion criteria, estimate sample size, define interventions, outcomes and economic evaluations, providing a reference for real-world TCM research on CAP.
10.Clinical Efficacy and Economic Evaluation of 1293 Non-Severe Adult Patients with Community-Acquired Pneumonia Treated by the Jiangsu Traditional Chinese Medicine Diagnosis and Treatment Protocol for Dominant Diseases:A Multicenter,Retrospective Real-World Cohort Study
Ye MA ; Yeqing JI ; Zhichao WANG ; Fanchao FENG ; Mingzhi PU ; Hong LYU ; Xiaodong HU ; Gaohua FENG ; Xiaoqian FANG ; Guicai ZHANG ; Yanfen TANG ; Yeqing ZHANG ; Yao ZHUFU ; Wenpan PENG ; Hao WANG ; Cheng GU ; Zhichao ZHANG ; Shuang YANG ; Xinyu SUN ; Qi ZHAO ; Aojie GUO ; Xin TONG ; Zhuoyue WU ; Xiaoxiao WANG ; Jia LIU ; Hailang HE ; Xianmei ZHOU
Journal of Traditional Chinese Medicine 2026;67(9):966-974
ObjectiveTo 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. MethodsA 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 resolution 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. ResultsA 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. ConclusionOn 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.

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