1.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.
2.Efficacy and Economic Evaluation of Weishi Qingjin Formula (苇石清金方)in the Treatment of Adult Community-Acquired Pneumonia with Phlegm-Heat Obstructing the Lung Syndrome:A Multicenter Retrospective Real-World Cohort Study
Yeqing JI ; Ye MA ; 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):975-984
ObjectiveTo observe the real‑world effectiveness and economic outcomes of Weishi Qingjin Formula (苇石清金方, WQF) in the treatment of adult community‑acquired pneumonia (CAP) with phlegm‑heat obstructing the lung syndrome. MethodsBased on a multicenter, real-world retrospective cohort study, clinical data were collected from hospitalized adult patients diagnosed with non‑severe CAP and phlegm‑heat obstructing the lung syndrome in 10 traditional Chinese medicine (TCM) hospitals in Jiangsu province. Patients were divided into an exposure group (those who received oral WQF) and a non‑exposure group (those who did not). The following outcomes were compared between the two groups before and after treatment, which were remission rates of clinical symptoms including cough, expectoration (sputum volume, color, consistency), and chest pain, levels of inflammatory markers including C‑reactive protein (CRP) and white blood cell count (WBC), and the rate of pulmonary inflammatory absorption on chest CT. Subgroup analyses were performed based on age, gender, smoking status, presence of hypertension, and the severity of community-acquired pneumonia (CURB‑65) score, comparing the two groups in terms of cough remission rate, chest pain remission rate, and chest CT absorption rate. For health economic evaluation, cost‑effectiveness analysis was used to calculate the cost‑effectiveness ratio (CER) and incremental cost‑effectiveness ratio (ICER). Univariate sensitivity analysis and probabilistic sensitivity analysis were performed to test the robustness of the results. ResultsA total of 647 patients in the exposure group and 1491 patients in the non-exposure group were included in the final statistical analysis. There was no statistically significant difference in length of hospital stay, gender, marital status, smoking history, bronchoscopy history, and comorbidities between the groups (P>0.05), but age, CURB-65 score, and antibiotic use. The exposure group had significantly higher remission rates of cough and sputum consistency than the non-exposure group (P<0.05). After adjusting for confounders using propensity score matching and logistic regression, the cough remission rate in the exposure group was 1.49 times that of the non-exposure group (P<0.01). No significant difference was observed between groups in the reduction rates of CRP and WBC, and in the rate of pulmonary inflammatory absorption on chest CT (P>0.05). Subgroup analyses revealed that the cough remission rate in the exposure group was significantly better than that in the non-exposure group except for patients aged ≥65 years, smokers, hypertensive patients, those using other type antibiotics or not using antibiotics, and those with a CURB-65 score ≥1 (P<0.05). Among smokers, the chest pain remission rate in the exposure group was 4.38 times that of the non-exposure group (P<0.01). No significant difference in chest CT absorption rate was found between groups across subgroups of gender, age, hypertension status, or antibiotic type (P>0.05). In terms of economic evaluation, CER was 10,877.60 CNY/case in the exposure group and 16,773.10 CNY/case in the non-exposure group. Compared to the exposure group, the non-exposure group incurred an additional 15,034.26 CNY to achieve one case of cough resolution, indicating a more favorable cost-effectiveness profile. Probabilistic sensitivity analysis yielded results consistent with the cost-effectiveness analysis, confirming the robustness of the findings. ConclusionWQF demonstrates significant efficacy in improving cough symptoms in the treatment of adult CAP with phlegm-heat obstructing the lung syndrome, and also exhibits favorable economic benefits.
3.Differentiation and Treatment of Small Cell Lung Cancer from the Perspective of "Internal Wind in Hidden Circulation"
Shengjuan HU ; Li HOU ; Tao SUN ; Li FENG
Journal of Traditional Chinese Medicine 2026;67(9):1003-1007
Small cell lung cancer (SCLC) is characterized by rapid onset, high invasiveness, and a strong tendency for recurrence and metastasis, which aligns with the pathogenic characteristics of wind pathogen in traditional Chinese medicine (TCM). This paper explores the pathological mechanism and dynamic pattern identification and treatment of SCLC from the perspective of "internal wind in hidden circulation". It is proposed that the core pathogenesis of SCLC is rooted in depletion of healthy qi, with binding of phlegm, stasis, and toxin. When pathogenic factors become excessive, the ascending and descending of yang qi becomes disordered, transforming into wind. This leads to internal wind in hidden circulation, which moves erratically and damages healthy qi. In the limited stage, cancer toxin accumulates and internal wind arises covertly, treatment for which should focus on regulating qi and resolving toxin, defending against wind and resisting pathogen with modified Bufei Decoction (补肺汤) and Shengjiang Powder (升降散). In the early extensive stage, phlegm and stasis generate wind, and internal wind spreads through collate-rals; treatment should resolve phlegm and dispel stasis, extinguish wind and resolve toxin, with modified Lingjiao Gouteng Decoction (羚角钩藤汤) combined with Tianma Gouteng Beverage (天麻钩藤饮). During the treatment stage, there is qi and yin depletion, and deficient wind harassing the interior, for which it is recommended to boost qi and nourish yin, soften the liver and extinguish wind, with modified Zhengan Xifeng Decoction (镇肝熄风汤) combined with Qingzao Jiufei Decoction (清燥救肺汤). In the progression stage, internal wind stirs again and cancer toxin scurries; treatment should focus on strengthening the healthy qi and replenishing essence, restraining wind and penetrating toxin, with modified Sanjia Fumai Decoction (三甲复脉汤). In the terminal stage, yin and yang are on the verge of dissociation and depleted yang floats upward; treatment should constrain and astringe to prevent collapse, rescue yang and contain yin, with modified Dihuang Drink (地黄饮子) combined with Laifu Decoction (来复汤).
4.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.
5.Efficacy and Economic Evaluation of Weishi Qingjin Formula (苇石清金方)in the Treatment of Adult Community-Acquired Pneumonia with Phlegm-Heat Obstructing the Lung Syndrome:A Multicenter Retrospective Real-World Cohort Study
Yeqing JI ; Ye MA ; 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):975-984
ObjectiveTo observe the real‑world effectiveness and economic outcomes of Weishi Qingjin Formula (苇石清金方, WQF) in the treatment of adult community‑acquired pneumonia (CAP) with phlegm‑heat obstructing the lung syndrome. MethodsBased on a multicenter, real-world retrospective cohort study, clinical data were collected from hospitalized adult patients diagnosed with non‑severe CAP and phlegm‑heat obstructing the lung syndrome in 10 traditional Chinese medicine (TCM) hospitals in Jiangsu province. Patients were divided into an exposure group (those who received oral WQF) and a non‑exposure group (those who did not). The following outcomes were compared between the two groups before and after treatment, which were remission rates of clinical symptoms including cough, expectoration (sputum volume, color, consistency), and chest pain, levels of inflammatory markers including C‑reactive protein (CRP) and white blood cell count (WBC), and the rate of pulmonary inflammatory absorption on chest CT. Subgroup analyses were performed based on age, gender, smoking status, presence of hypertension, and the severity of community-acquired pneumonia (CURB‑65) score, comparing the two groups in terms of cough remission rate, chest pain remission rate, and chest CT absorption rate. For health economic evaluation, cost‑effectiveness analysis was used to calculate the cost‑effectiveness ratio (CER) and incremental cost‑effectiveness ratio (ICER). Univariate sensitivity analysis and probabilistic sensitivity analysis were performed to test the robustness of the results. ResultsA total of 647 patients in the exposure group and 1491 patients in the non-exposure group were included in the final statistical analysis. There was no statistically significant difference in length of hospital stay, gender, marital status, smoking history, bronchoscopy history, and comorbidities between the groups (P>0.05), but age, CURB-65 score, and antibiotic use. The exposure group had significantly higher remission rates of cough and sputum consistency than the non-exposure group (P<0.05). After adjusting for confounders using propensity score matching and logistic regression, the cough remission rate in the exposure group was 1.49 times that of the non-exposure group (P<0.01). No significant difference was observed between groups in the reduction rates of CRP and WBC, and in the rate of pulmonary inflammatory absorption on chest CT (P>0.05). Subgroup analyses revealed that the cough remission rate in the exposure group was significantly better than that in the non-exposure group except for patients aged ≥65 years, smokers, hypertensive patients, those using other type antibiotics or not using antibiotics, and those with a CURB-65 score ≥1 (P<0.05). Among smokers, the chest pain remission rate in the exposure group was 4.38 times that of the non-exposure group (P<0.01). No significant difference in chest CT absorption rate was found between groups across subgroups of gender, age, hypertension status, or antibiotic type (P>0.05). In terms of economic evaluation, CER was 10,877.60 CNY/case in the exposure group and 16,773.10 CNY/case in the non-exposure group. Compared to the exposure group, the non-exposure group incurred an additional 15,034.26 CNY to achieve one case of cough resolution, indicating a more favorable cost-effectiveness profile. Probabilistic sensitivity analysis yielded results consistent with the cost-effectiveness analysis, confirming the robustness of the findings. ConclusionWQF demonstrates significant efficacy in improving cough symptoms in the treatment of adult CAP with phlegm-heat obstructing the lung syndrome, and also exhibits favorable economic benefits.
6.Differentiation and Treatment of Small Cell Lung Cancer from the Perspective of "Internal Wind in Hidden Circulation"
Shengjuan HU ; Li HOU ; Tao SUN ; Li FENG
Journal of Traditional Chinese Medicine 2026;67(9):1003-1007
Small cell lung cancer (SCLC) is characterized by rapid onset, high invasiveness, and a strong tendency for recurrence and metastasis, which aligns with the pathogenic characteristics of wind pathogen in traditional Chinese medicine (TCM). This paper explores the pathological mechanism and dynamic pattern identification and treatment of SCLC from the perspective of "internal wind in hidden circulation". It is proposed that the core pathogenesis of SCLC is rooted in depletion of healthy qi, with binding of phlegm, stasis, and toxin. When pathogenic factors become excessive, the ascending and descending of yang qi becomes disordered, transforming into wind. This leads to internal wind in hidden circulation, which moves erratically and damages healthy qi. In the limited stage, cancer toxin accumulates and internal wind arises covertly, treatment for which should focus on regulating qi and resolving toxin, defending against wind and resisting pathogen with modified Bufei Decoction (补肺汤) and Shengjiang Powder (升降散). In the early extensive stage, phlegm and stasis generate wind, and internal wind spreads through collate-rals; treatment should resolve phlegm and dispel stasis, extinguish wind and resolve toxin, with modified Lingjiao Gouteng Decoction (羚角钩藤汤) combined with Tianma Gouteng Beverage (天麻钩藤饮). During the treatment stage, there is qi and yin depletion, and deficient wind harassing the interior, for which it is recommended to boost qi and nourish yin, soften the liver and extinguish wind, with modified Zhengan Xifeng Decoction (镇肝熄风汤) combined with Qingzao Jiufei Decoction (清燥救肺汤). In the progression stage, internal wind stirs again and cancer toxin scurries; treatment should focus on strengthening the healthy qi and replenishing essence, restraining wind and penetrating toxin, with modified Sanjia Fumai Decoction (三甲复脉汤). In the terminal stage, yin and yang are on the verge of dissociation and depleted yang floats upward; treatment should constrain and astringe to prevent collapse, rescue yang and contain yin, with modified Dihuang Drink (地黄饮子) combined with Laifu Decoction (来复汤).
7.Guidelines for standardized implementation of pharmacist-managed clinics (2026 edition)
Pengxiang ZHOU ; Maobai LIU ; Xiaoli DU ; Xiaoyang LU ; Mei DONG ; Rong DUAN ; Ruigang HOU ; Xiaoyu LI ; Qi CHEN ; Yanxiao XIANG ; Weiyi FENG ; Rong CHEN ; Deshi DONG ; Yong YANG ; Li LI ; Xiaocong ZUO ; Jinfang HU ; Hongliang ZHANG ; Qingchun ZHAO ; Qi LIN ; Yang HU ; Jiaying WU ; Rongsheng ZHAO
China Pharmacy 2026;37(9):1105-1112
OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics ( 2026 edition ) in response to the challenges faced by such clinics in China, including uneven development, large discrepancies in service specifications, insufficient patient awareness, and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association, the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association, a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research, current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections: definition and connotation of pharmacist-managed clinics, establishment requirements, implementation and management, post competency, and practical research. Firstly, the definition and connotation included three operational forms of pharmacist-managed clinics (independent mode, physician-pharmacist joint mode, and online pharmacist-managed clinic mode) and classified service modes (specialty-specific, drug-specific, and disease-specific pharmacist-managed clinics). The establishment requirements were further refined, covering system construction (pharmaceutical service management system, quality control and assessment mechanism), personnel qualifications (professional credentials, continuing education and professional training, etc), service recipients, as well as service venues and facilities. Subsequently, the implementation and management of pharmacist-managed clinics were proposed, involving service procedures, intervention measures, documentation and records, patient education and follow-up, humanistic care, as well as risk management and quality control. Finally, post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics, as well as the suggestions on teaching methods; practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment, management, teaching, and research, fill the guideline gap in this field, and can promote the high-quality development of pharmacist-managed clinics.
8.Establishment and clinical application of a method for the determination of tacrolimus concentration in human whole blood
Simin LIU ; Yamin CHU ; Yahui HU ; Guangfeng LONG ; Feng CHEN ; Yuanyuan ZHANG
China Pharmacy 2026;37(9):1180-1184
OBJECTIVE To develop a method for the determination of tacrolimus (TAC) concentration in human whole blood and to apply it in clinical therapeutic drug monitoring. METHODS Whole blood samples were processed by protein precipitation with methanol. The determination was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS), with ascomycin serving as the internal standard. Chromatographic separation was carried out on a Kinetex F5 100Å column with a mobile phase consisting of 0.1 mmol/L ammonium acetate containing 0.2 mmol/L formic acid and methanol. Gradient elution was performed at a flow rate of 0.4 mL/min. The injection volume was 5 μL. Detection was conducted using multiple reaction monitoring ( m / z 821.6→768.6 for TAC; m / z 809.4→756.1 for ascomycin) with an electrospray ionization source in positive ion mode. The study focused on 86 whole blood samples collected from 83 pedi atric patients who received TAC therapy at Children’s Hospital of Nanjing Medical University from September 1 to 30, 2025. The aforementioned method was employed to measure the TAC concentration in the whole blood samples. The correlation and agreement between the aforementioned method and the traditional enzyme multiplied immunoassay technique (EMIT) were evaluated through Spearman correlation analysis, Bland-Altman analysis, and Passing-Bablok regression analysis. RESULTS The linear range of TAC was 0.5-100 ng/mL; the evaluation results for accuracy, precision, extraction recovery, matrix effect, and stability tests all met the relevant requirements. Clinical application results showed that the median concentration of TAC in pediatric whole blood measured by LC-MS/MS and EMIT methods were 4.4 and 4.0 ng/mL, respectively. Moreover, the two methods exhibited a strong correlation (correlation coefficient of 0.848 1) and good agreement (average relative deviation of 6.5%). CONCLUSIONS A reliable LC-MS/MS method for the determination of TAC concentration in human whole blood is successfully established. This method demonstrates strong correlation and good agreement with the EMIT method, making it suitable for clinical therapeutic drug monitoring.
9.Study on seroloy and RHD genotyping of 602 RhD-negative pregnant women and a case of hemolytic jaundice in a neonatal with Del phenotype
Yuli ZHU ; Bin HU ; Zhihui FENG ; Shuxian JIAO
Chinese Journal of Blood Transfusion 2026;39(2):229-235
Objective: To characterize the serological profile, RHD genetic spectrum, and their frequencies among pregnant women preliminary screened as RhD-negative and weak positive in Qingdao and surrounding areas, and correlate these findings with unexpected antibody detection results, thereby providing testing recommendations and suggestions for such individuals. Methods: Blood samples of pregnant women who were initially identified as RhD negative and weak positive in hospitals in Qingdao and surrounding areas over the past five years were collected. Different cloned IgG anti-D antibodies were used for RhD negative confirmation experiments. RHD genotyping was performed by combining PCR-SSP and Sanger sequencing. Unexpected antibody screening and identification were carried out using test tube method and microcolumn gel card. The immunologic status of newborns delivered by anti-D pregnant women was also tracked. Results: A total of 602 blood samples were collected from pregnant women initially identified as RhD-negative and weak positive. Among them, 569 (94.5%) were confirmed as RhD-negative in the RhD confirmation test, and 33 (5.5%) were D variant phenotype. Except for 4 cases where no definite mutations were found, gene analysis revealed 474 (78.7%) D-negative cases with 5 genotypes (RHD
01N.01, RHD
01N.03, RHD
01N.16, RHD
01N.05, and 1 new allele), 90 (15.0%) Del cases with 2 genotypes (RHD
01EL.01, and RHD
01EL.18), 23 (3.8%) weak D cases with 2 genotypes (RHD
15 and 1 new allele), and 11 (1.8%) partial D cases with 2 genotypes (RHD
06.03.01 and RHD
05.04). Anti-D and complex antibodies containing anti-D were detected in 96 RhD-negative and partial D pregnant women (15.9%). After injection of anti-D immunoglobulin, One O-type RhD-negative pregnant woman delivered a newborn with hyperbilirubinemia. The newborn was typed to be B Del, and anti-D was detected in both serum and eluate. Conclusion: The serological profiles, RHD gene types and frequencies among RhD negative pregnant women in Qingdao and surrounding areas are basically consistent with domestic published data. Pregnancy can stimulate anti-D production in D-negative and partial D individuals. However, anti-D antibody has not been detected in Del type pregnant women. Since anti-D immunoglobulin can binds to Del type red blood cells, its administration is not recommended for Del type pregnant women.
10.Comorbidity Mechanism Between Ulcerative Colitis and Atrial Fibrillation Based on "Gut Microbiota-gut-heart" Axis
Meiyu FENG ; Wenjing ZHANG ; Yihang DU ; Xuanye DING ; Yuanhui HU ; Haitai YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):276-281
The gut microbiota is regarded as the "eighth organ" of the human body and plays a critical regulatory role in the occurrence and progression of various diseases. Ulcerative colitis (UC) is a chronic inflammatory bowel disease with a complex etiology and a tendency toward recurrent episodes. In recent years, studies have shown that gut microbiota dysbiosis plays a key role in its pathological processes. Meanwhile, an increasing number of studies have demonstrated that imbalances in the gut microbiota and abnormalities in its metabolites are closely associated with the development of atrial fibrillation (AF). Although UC and AF belong to diseases of the digestive system and cardiovascular system, respectively, both exhibit systemic inflammatory characteristics and are often accompanied by gut microbiota dysregulation and abnormal metabolic products. However, systematic investigations into the mechanisms by which gut microbiota-derived metabolites act in these two diseases remain limited. Based on this, the present study adopts literature review and theoretical analysis methods, taking the "gut microbiota-gut-heart" axis as the entry point, to systematically summarize the signaling networks of three key classes of metabolites, i.e., short-chain fatty acids (SCFAs), bile acids (BAs), and trimethylamine N-oxide (TMAO), in the comorbidity mechanism of UC and AF. The findings indicate that these metabolites may activate key inflammatory pathways, such as NF-κB and NLRP3, thereby synergistically mediating intestinal barrier dysfunction and systemic inflammation and constructing a potential comorbidity network. On this basis, potential intervention strategies for the treatment of UC-AF comorbidity, including probiotic intervention and fecal microbiota transplantation, are further discussed. This study aims to provide new theoretical evidence and research perspectives for prevention and treatment strategies of cross-system diseases.

Result Analysis
Print
Save
E-mail