1.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
2.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
3.Mechanism of Modified Si Junzitang and Shashen Maidong Tang in Improving Sensitivity of Cisplatin in EGFR-TKI Resistant Lung Adenocarcinoma Cells Based on Aerobic Glycolysis
Yanping WEN ; Yi JIANG ; Liping SHEN ; Haiwei XIAO ; Xiaofeng YANG ; Surui YUAN ; Lingshuang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):39-46
ObjectiveTo investigate the mechanism of modified Si Junzitang and Shashen Maidong Tang [Yiqi Yangyin Jiedu prescription (YQYYJD)] in enhancing the sensitivity of cisplatin in epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)-resistant lung adenocarcinoma cells based on aerobic glycolysis. MethodsThe effects of different concentrations of YQYYJD (0, 2, 3, 4, 5, 6, 7, 8 g·L-1) and cisplatin (0, 3, 6, 9, 12, 15, 18, 21, 24, 27 mg·L-1) on the proliferation and activity of PC9/GR cells were detected by the cell counting kit-8 (CCK-8) assay after 24 hours of intervention. The half-maximal inhibitory concentration (IC50) for PC9/GR cells was calculated to determine the concentrations used in subsequent experiments. PC9/GR cells were divided into blank group (complete medium), YQYYJD group (5 g·L-1), cisplatin group (12 mg·L-1), and combined group (YQYYJD 5 g·L-1 + cisplatin 12 mg·L-1). After 24 hours of intervention, cell viability was measured using CCK-8 assay. Cell proliferation was assessed by colony formation assay, and cell migration was evaluated by scratch and Transwell assays. Glucose consumption, lactate production, and adenosine triphosphate (ATP) levels were measured by colorimetric assays. The expression levels of glycolysis-related proteins, including hexokinase 2 (HK2), phosphofructokinase P (PFKP), pyruvate kinase M2 (PKM2), lactate dehydrogenase A (LDHA), glucose transporter 1 (GLUT1), and monocarboxylate transporter 4 (MCT4), were determined by Western blot. ResultsBoth YQYYJD and cisplatin inhibited the viability of PC9/GR cells in a concentration-dependent manner. The IC50 of PC9/GR cells for YQYYJD and cisplatin were 5.15 g·L-1 and 12.91 mg·L-1, respectively. In terms of cell proliferation, compared with the blank group, the cell survival rate and the number of colonies formed in the YQYYJD group, cisplatin group, and combined group were significantly decreased (P<0.01). Compared with the YQYYJD and cisplatin groups, the combined group showed a further significant reduction in cell survival rate and colony formation (P<0.01). In terms of cell migration, compared with the blank group, the cell migration rate and the number of cells passing through the Transwell membrane in the YQYYJD group, cisplatin group, and combined group were significantly decreased (P<0.01). Compared with the YQYYJD and cisplatin groups, the combined group exhibited a further significant reduction in cell migration rate and the number of cells passing through the Transwell membrane (P<0.01). In terms of glycolysis, compared with the blank group, glucose consumption, lactate production, and ATP levels in the YQYYJD group, cisplatin group, and combined group were significantly decreased (P<0.01). Compared with the YQYYJD and cisplatin groups, the combined group showed a further significant reduction in glucose consumption, lactate production, and ATP levels (P<0.05). Compared with the blank group, the protein expression levels of HK2, PFKP, PKM2, and LDHA in the YQYYJD, cisplatin, and combined groups were significantly decreased (P<0.01). The combined group showed a further significant reduction in the expression levels of these proteins compared with the YQYYJD and cisplatin groups (P<0.01). No significant differences were observed in the protein expression levels of GLUT1 and MCT4 among the groups. ConclusionYQYYJD can synergistically inhibit the proliferation and migration of PC9/GR cells and enhance their sensitivity to cisplatin. The mechanism may be related to the downregulation of the expression of glycolysis-related rate-limiting enzymes, including HK2, PFKP, PKM2, and LDHA, thereby inhibiting glycolysis.
4.Effect of Yiqi Yangyin Jiedu Prescription on sPD-L1 in Peripheral Blood of Patients Treated with EGFR-TKIs and Prognosis Analysis
Liping SHEN ; Yuqing CAI ; Yanping WEN ; Yi JIANG ; Lingshuang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):219-226
ObjectiveTo observe the prognosis effect of soluble programmed death ligand-1(sPD-L1) in treating patients with advanced lung adenocarcinoma treated with epidermal growth factor receptor-tyrosine kinase inhibitors(EGFR-TKIs) and the influence of Yiqi Yangyin Jiedu prescription. MethodA prospective cohort-controlled study was conducted to enroll patients treated with EGFR-TKIs in the first line of treatment,who were admitted to the Oncology Department of Longhua Hospital and Shanghai Chest Hospital from May 1st, 2021 to June 30th, 2023, and they were evaluated as non-progressive and identified with deficiency of Qi and Yin after one month of treatment. The patients were divided into an exposed group (EGFR-TKIs combined with Yiqi Yangyin Jiedu prescription) and a non-exposed group (EGFR-TKIs alone)according to whether or not they were treated with Yiqi Yangyin Jiedu prescription and were treated until disease progression, or death and intolerable adverse reactions occurred. The enzyme-linked immunosorbent assay (ELISA) was applied to detect the level of sPD-L1 in patients at the time of enrollment and disease progression,and Cox risk proportionality model was used to analyze the independent prognostic factors affecting disease progression of patients treated with EGFR-TKIs. ResultA total of 90 patients (39 in the exposed group and 51 in the non-exposed group) undergoing disease progression after EGFR-TKI treatment were enrolled. At the time of enrolment and after disease progression,the levels of serum sPD-L1 in the 90 patients were 12.06 (27.54) ng·L-1 and 41.99 (62.93) ng·L-1,respectively. Compared with that at the time of enrollment, the serum sPD-L1 level in the 90 patients was significantly increased after disease progression (P<0.01). The serum sPD-L1 level in patients in the exposed group was 12.27 (24.78) ng·L-1 and 29.57 (61.12)ng·L-1 respectively at the time of enrolment and after disease progression. In the non-exposed group, patients had serum sPD-L1 levels of 11.81 (28.46) ng·L-1 and 49.54 (74.12) ng·L-1 respectively at the time of enrolment and after disease progression. Compared with that at the time of enrollment, the serum sPD-L1 level in the two groups of patients was significantly increased after disease progression (P<0.01). In addition, compared with that in the non-exposed group, the sPD-L1 level in the exposed group was greatly reduced after disease progression(P<0.01). Cox multifactorial analysis showed that sPD-L1 level and age at the time of enrolment were associated with patients' progression-free survival(PFS),and that low levels of sPD-L1 (<12.06 ng·L-1) prolonged the PFS and reduced the risk of disease progression in patients treated with EGFR-TKIs compared with high levels of sPD-L1. ConclusionElevated sPD-L1 level is a poor prognostic factor for the long-term efficacy of EGFR-TKIs,and treatment with Yiqi Yangiin Jiedu prescription can down-regulate sPD-L1 level of patients treated with EGFR-TKIs.
5.Prevention and Treatment of Asthma by Traditional Chinese Medicine Regulating PI3K/Akt Signaling Pathway: A Review
Yasheng DENG ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinjiang XU ; Haobin CHEN ; Qiuye WU ; Jiang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):262-275
Asthma is a chronic inflammatory respiratory disease involving multiple cells and cellular components, characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing, significantly impacting patients' quality of life. The phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway, as a crucial hub in intracellular signaling, is widely involved in the regulation of cell growth, proliferation, survival, metabolism, and a series of pathophysiological processes. Its regulatory role in the pathological progression of asthma is particularly significant, specifically in promoting airway inflammation, mediating epithelial mesenchymal transition, accelerating airway remodeling, regulating cell autophagy, inducing mucus hypersecretion, and influencing immune response balance. This study analyzed potential molecular targets of the PI3K/Akt pathway, including activators such as cysteine proteinase inhibitor 1(CST1), found in inflammatory zone 1(FIZZ1) and free fatty acid receptor 1(FFAR1), and inhibitors such as human β-defensin-3(hBD-3), disintegrins, metalloproteinase 33(ADAM33) and interleukin-27(IL-27), and initially revealed the potential molecular mechanisms of traditional Chinese medicine(TCM) in asthma intervention. Based on this, the authors systematically summarized the efficacy and specific mechanisms of TCM monomers, compounds, and external treatments for asthma by regulating the PI3K/Akt signaling pathway through literature review and analysis, aiming at establishing a robust foundation for the wide application and advanced development of TCM in asthma treatment, offering innovative insights for clinical research and drug development of asthma.
6.Prevention and Treatment of Asthma by Traditional Chinese Medicine Regulating PI3K/Akt Signaling Pathway: A Review
Yasheng DENG ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinjiang XU ; Haobin CHEN ; Qiuye WU ; Jiang LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):262-275
Asthma is a chronic inflammatory respiratory disease involving multiple cells and cellular components, characterized by recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing, significantly impacting patients' quality of life. The phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway, as a crucial hub in intracellular signaling, is widely involved in the regulation of cell growth, proliferation, survival, metabolism, and a series of pathophysiological processes. Its regulatory role in the pathological progression of asthma is particularly significant, specifically in promoting airway inflammation, mediating epithelial mesenchymal transition, accelerating airway remodeling, regulating cell autophagy, inducing mucus hypersecretion, and influencing immune response balance. This study analyzed potential molecular targets of the PI3K/Akt pathway, including activators such as cysteine proteinase inhibitor 1(CST1), found in inflammatory zone 1(FIZZ1) and free fatty acid receptor 1(FFAR1), and inhibitors such as human β-defensin-3(hBD-3), disintegrins, metalloproteinase 33(ADAM33) and interleukin-27(IL-27), and initially revealed the potential molecular mechanisms of traditional Chinese medicine(TCM) in asthma intervention. Based on this, the authors systematically summarized the efficacy and specific mechanisms of TCM monomers, compounds, and external treatments for asthma by regulating the PI3K/Akt signaling pathway through literature review and analysis, aiming at establishing a robust foundation for the wide application and advanced development of TCM in asthma treatment, offering innovative insights for clinical research and drug development of asthma.
7.Iodine nutrition among children aged 8-10 in Baoshan City from 2018 to 2024
LI Yanping, LIU Guihua, WANG Anwei, LIU Zengkan, JIANG Zongqi, HUANG Dongsheng
Chinese Journal of School Health 2025;46(11):1559-1563
Objective:
To analyze the iodine nutritional status of children aged 8-10 in Baoshan City, so as to comprehensively evaluate the effectiveness of eliminating and consolidating iodine deficiency disorders in Baoshan City.
Methods:
From 2018 to 2024, a stratified random sampling method was used to sample 7 363 non boarding children aged 8-10 from 35 survey sites in 5 counties of Baoshan City (Longyang County, Shidian County, Changning County, Tengchong City, Longling County). The salt iodine content and urinary iodine concentration were detected, and the thyroid volume of children was measured by ultrasound. Group comparison was conducted by using Mann-Whitney U test, Kruskal-Wallis H test, and Chi square test. Spearman rank correlation analysis was used to investigate the correlation of salt iodine, urinary iodine and thyroid volume.
Results:
A total of 7 361 samples of household edible salt for children were detected. The iodized salt coverage rate was 99.70%, the qualified iodized salt consumption rate was 97.02 %. The proportion of unqualified iodized salt fluctuated and decreased from 3.14% in 2018 to 2.14% in 2024. The median iodine content of household edible salt for children was 23.70 (21.60, 25.80) mg/kg. The median urinary iodine of children was 217.41 (152.40, 294.59) μg/L, and the proportions of iodine deficiency, adequate iodine, and iodine excess were 9.75 %, 66.66%, and 23.58%, respectively. There were statistically significant differences in the median urinary iodine of children among different years, ages, genders and before and after the supply of non iodized salt ( Z/H =134.88, 11.04,-4.28,-2.66, all P < 0.01). An average thyroid volume of children was 3.32 (2.77, 3.93) mL, with a goiter rate of 1.91%. Before and after the implementation of non iodized salt supply in Baoshan City in 2023, there were no statistically significant differences in the median iodine content of household edible salt and the goiter rate of children ( Z/χ 2=-1.54, 3.25, both P >0.05), but there were statistically significant differences in the qualified status of iodized salt, the median urinary iodine, and the frequency distribution of urinary iodine ( χ 2/Z =15.53,-2.66, 10.14, all P <0.05). Salt iodine was positively correlated with urinary iodine ( r =0.04) and negatively correlated with thyroid volume ( r =-0.07), and urinary iodine was negatively correlated with thyroid volume ( r =-0.03) (all P < 0.05 ). The thyroid volume of children consuming iodized salt was larger than that of children consuming non iodized salt ( H = 9.99 ), and there were statistically significant differences in thyroid volume among children with different urinary iodine levels ( H =15.13) (both P <0.01).
Conclusions
From 2018 to 2024, the overall iodine nutritional level of children aged 8-10 in Baoshan City is at an adequate level. The elimination status of iodine deficiency disorders has been continuously consolidated.
8.Analysis of Risk Factors for Meningeal Metastasis in Patients with Lung Adenocarcinoma Following Non-surgical Interventions.
Yi YUE ; Yuqing REN ; Jianlong LIN ; Chunya LU ; Nan JIANG ; Yanping SU ; Jing LI ; Yibo WANG ; Sihui WANG ; Junkai FU ; Mengrui KONG ; Guojun ZHANG
Chinese Journal of Lung Cancer 2025;28(4):267-280
BACKGROUND:
Meningeal metastasis (MM) is a form of malignant metastasis where tumor cells spread from the primary site to the pia mater, dura mater, arachnoid, subarachnoid space, and other cerebrospinal fluid compartments. Lung cancer is one of the most common malignant tumor types with MM. MM not only signifies that the lung cancer has progressed to an advanced stage but also leads to a range of severe clinical symptoms due to meningeal involvement. Currently, the risk factors associated with the development of MM are not fully elucidated. The aim of this study was to investigate the risk factors for MM in patients with lung adenocarcinoma (LUAD) who underwent non-surgical interventions, in order to identify LUAD patients at high risk for MM.
METHODS:
This retrospective study analyzed the clinical data of patients diagnosed with LUAD at the First Affiliated Hospital of Zhengzhou University from January 2020 to July 2024. Missing data were imputed using multiple imputation methods, and risk factors were identified through LASSO, univariate, and multivariate Logistic regression analyses.
RESULTS:
A total of 170 patients with LUAD were included in this study and divided into two groups: 87 patients with MM and 83 patients without MM. Univariate and multivariate Logistic regression analyses revealed that younger age at diagnosis (P=0.004), presence of the epidermal growth factor receptor (EGFR) L858R gene mutation (P=0.008), and concurrent liver metastasis at baseline (P=0.004) were independent risk factors for developing MM in LUAD patients who did not undergo surgical intervention. Conversely, higher baseline globulin levels (P=0.039) and the presence of the anaplastic lymphoma kinase (ALK) gene mutation (P=0.040) were associated with a reduced risk of MM development.
CONCLUSIONS
Age at diagnosis, EGFR L858R mutation status, ALK gene mutation status, concurrent liver metastasis, globulin levels at baseline were significantly associated with the risk of developing MM in patients with LUAD patients who did not undergo surgical intervention. For patients diagnosed at a younger age, carrying the EGFR L858R mutation, or presenting with baseline liver metastasis, early implementation of tertiary prevention strategies for MM is crucial. Regular monitoring of MM status should be conducted in these high-risk groups.
Humans
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Male
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Adenocarcinoma of Lung/therapy*
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Female
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Middle Aged
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Risk Factors
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Lung Neoplasms/therapy*
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Retrospective Studies
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Aged
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Meningeal Neoplasms/genetics*
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Adult
9.Application Analysis of Animal Models for Pelvic Inflammatory Disease Based on Data Mining
Yiqing ZHENG ; Yasheng DENG ; Yanping FAN ; Tianwei LIANG ; Hui HUANG ; Yonghui LIU ; Zhaobing NI ; Jiang LIN
Laboratory Animal and Comparative Medicine 2024;44(4):405-418
Objective To investigate the key elements for model establishment and determine the evaluation indicators of animal models for pelvic inflammatory disease(PID),providing a reference for improving modelling methods and optimizing the application of PID animal models.Methods The search query"Pelvic Inflammatory Disease"AND"Animal Model"OR"Rat"OR"Mouse"OR"Guinea Pig"OR"Rabbit"OR"Dog"OR"Pig"was used to retrieve relevant literature on PID animal models published from 2013 to 2023 in China Knowledge Network Infrastructure(CNKI),Wanfang,and PubMed databases.The studies were analyzed and categorized based on experimental animal types,modelling methods,modelling cycles,detection indicators,positive control drugs,and administration duration.A database was established for statistical analysis.Results A total of 214 research articles on PID animal models meeting the inclusion criteria were identified.The most commonly used model animals are Sprague Dawley(SD)rats,followed by Wistar rats.The most frequently employed modelling method is a combination of mechanical injury and bacterial infection,followed by the phenol mucilage method.The most common modelling cycles for acute pelvic inflammatory disease(APID)and chronic pelvic inflammatory disease(CPID)/sequelae of pelvic inflammatory disease(SPID)are 8 to 14 days,while for PID models without specific staging,the cycles are 7 days.High-frequency detection methods and indicators include histopathological observation using hematoxylin-eosin staining,enzyme-linked immunosorbent assay(ELISA)for serum-related indicators,morphological changes of tissues observed with the naked eye,and immunohistochemical detection of related protein expression in uterine tissues,and pathological scoring.The most frequently used positive control drugs are Fuke Qianjin Tablets,followed by Jingangteng Capsules.The most common administration duration for APID is 7 days,and for CPID/SPID models,it ranges from 15 to 21 days.Conclusion Currently,SD rats and Wistar rats are commonly used as experimental animals for PID models.The dual modelling method of mechanical injury combined with mixed bacterial infection aligns closely with clinical pathogenesis and can be used to establish a PID model that simulates postoperative uterine cavity infection.Depending on the research objectives,different positive drugs and detection indicators should be selected for comprehensive evaluation.Most existing PID animal model studies are based on western medical diagnosis,with fewer studies focusing on Traditional Chinese Medicine(TCM)syndromes.There is a need to integrate TCM theories of etiology and pathogenesis to construct PID animal models that are more in line with TCM clinical symptoms.
10.Diagnostic value of cell-free DNA detection in tuberculous pleurisy
CHENG Liang ; HUA Shaopeng ; JIANG Yanping ; JIA Xiujie ; HU Xiaofang ; ZHAO Xinguo
China Tropical Medicine 2024;24(2):162-
Objective To assess the diagnostic efficacy of the cell-free Mycobacterium tuberculosis DNA testing (CF-TB) in tuberculous pleurisy. Methods A total of 71 patients diagnosed with tuberculous pleurisy and 35 patients with non-tuberculous pleurisy were selected from the Fifth People's Hospital of Wuxi between January to December 2022. The standard pleural puncture was conducted to collect pleural effusion, which was then utilized for Mycobacterium tuberculosis culture, GeneXpert Mycobacterium tuberculosis/rifampicin resistance (GeneXpert MTB/RIF), CF-TB, and adenosine deaminase (ADA) testing. Blood samples were subjected to tuberculosis infection T-cell spotting test (T-SPOT.TB) assay. The receiver operator characteristic curve (ROC) was applied to obtain the optimal cut-off value for pleural fluid CF-TB and to compare the diagnostic performance of CF-TB with other methods. Data analysis was conducted using SPSS 22.0 software, with statistical significance defined as P<0.05. Results The ROC curve analysis determined that the optimal cycle threshold (Ct) value for diagnosing tuberculous pleurisy using CF-TB in pleural fluid was 38.489, with a sensitivity of 91.5% and specificity of 97.1%. In comparison, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of T-SPOT.TB and pleural fluid ADA in diagnosing tuberculous pleurisy were 86.0%, 71.4%, 86.0%, 71.4%, 81.1%, and 55.0%, 91.4%, 92.9%, 50.8%, 67.0%, respectively, all of which were lower than the diagnostic efficiency of CF-TB. Furthermore, the specificity of pleural fluid CF-TB in diagnosing tuberculous pleurisy (97.1%) was not significantly different from GeneXpert MTB/RIF (100%) and Mycobacterium tuberculosis culture (100%), but its sensitivity (91.5%) was significantly higher than both GeneXpert MTB/RIF (19.7%) and Mycobacterium tuberculosis culture (28.2%), with a statistically significant difference (P<0.001). Conclusions Compared to the conventional gold standard for diagnosing tuberculous pleurisy, CF-TB exhibits a higher sensitivity and its specificity is superior to that of tuberculosis immunological test. Consequently, CF-TB can serve as a valuable complement to other traditional detection methods in aiding the diagnosis of tuberculous pleurisy.


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