1.Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina
Jingui WANG ; Haining ZHANG ; Shun FAN ; Yusheng LI ; Hongyi WANG ; An BAO ; Wei ZHANG ; Huanan LI
Journal of Traditional Chinese Medicine 2025;66(11):1128-1132
The rationale for the design of control groups in tuina clinical trial is the foundation for rigorously validating the effectiveness and safety of this therapy. This article reviewed the current state of the design of tuina placebo in control groups of clinical trials, pointed out the necessity of setting up tuina placebo in clinical trials of tuina, analyzed the challenges in implementing blinding of tuina manipulation, and concluded that tuina placebo is still challenged by the placebo effect, the diversification of tuina manipulation but the lack of standardization, and the difficulty of implementing blinding due to the high level of public awareness of tuina. This article also summarized the design of placebo manipulation in three types of clinical trials, including spinal manipulation, acupressure, and paediatric tuina, and proposed four strategies for designing placebo tuina manipulation-controlling placebo effects, developing operational standards for placebo tuina manipulation, ensuring the rigor of blinding implementation, and applying new technologies to enhance the standardization and blinding capacity of placebo tuina methods. So the article is aimed at improving the methodological quality of tuina clinical trial designs, and promoting the standardization and scientificity of tuina clinical trial design.
2.Exploring the causal relationship between leukocyte telomere length and prostatitis, orchitis, and epididymitis based on a two-sample Mendelian randomization.
Dan-Yang LI ; Shun YU ; Bo-Hui YANG ; Jun-Bao ZHANG ; Guo-Chen YIN ; Lin-Na WU ; Qin-Zuo DONG ; Jin-Long XU ; Shu-Ping NING ; Rong ZHAO
National Journal of Andrology 2025;31(4):306-312
OBJECTIVE:
To investigate the genetic causal relationship of leukocyte telomere length (LTL) with prostatitis, orchitis and epididymitis by two-sample Mendelian randomization (MR).
METHODS:
Using LTL as the exposure factor and prostatitis, orchitis and epididymitis as outcome factors, we mined the Database of Genome-Wide Association Studies (GWAS). Then, we analyzed the causal relationship of LTL with prostatitis, orchitis and epididymitis by Mendelian randomization using inverse variance weighting (IVW) as the main method and weighted median and MR-Egger regression as auxiliary methods, determined the horizontal multiplicity by MR-Egger intercept test, and conducted sensitivity analysis using the leaving-one-out method.
RESULTS:
A total of 121 related single nucleotide polymorphisms (SNPs) were identified in this study. IVW showed LTL to be a risk factor for prostatitis (OR = 1.383, 95% CI: 1.044-1.832, P = 0.024), and for orchitis and epididymitis as well (OR = 1.770, 95% CI: 1.275-2.456, P = 0.000 6).
CONCLUSION
Genetic evidence from Mendelian randomized analysis indicates that shortening of LTL reduces the risk of prostatitis, orchitis and epididymitis.
Humans
;
Male
;
Mendelian Randomization Analysis
;
Epididymitis/genetics*
;
Prostatitis/genetics*
;
Polymorphism, Single Nucleotide
;
Leukocytes
;
Orchitis/genetics*
;
Genome-Wide Association Study
;
Telomere
;
Risk Factors
4.Cellular and Histopathological Characteristics of Ultrasonically Underdiagnosed 3/4a Thyroid Nodules.
Wu WEI-QI ; Xu CUN-BAO ; Li YOU-JIA ; Su CHUN-YANG ; Feng-Shun ZHANG ; Yi-Feng CHEN
Acta Academiae Medicinae Sinicae 2025;47(1):23-28
Objective To analyze the cellular and histopathological characteristics of underdiagnosed thyroid nodules of Chinese thyroid imaging reporting and data system(C-TIRADS) categories 3 and 4a,thus improving the understanding of these lesions. Methods The data of ultrasound and fine needle aspiration cytology were collected from 683 nodules diagnosed based on pathological evidence in 549 patients undergoing thyroid surgery.The cellular and histopathological characteristics of C-TIRADS 3 and 4a nodules were analyzed. Results Two hundred and sixty-eight nodules were classified as C-TIRADS category 3,including 236 benign nodules,12 low-risk ones,and 20 (7.46%) malignant ones.Two hundred and twenty-one nodules were classified as C-TIRADS category 4a,including 133 benign nodules,7 low-risk ones,and 81 (36.65%) malignant ones.The malignancy rates differed between C-TIRADS 3 and 4a nodules (χ2=58.93,P<0.001),and both were higher than the recommended malignancy rate in the guidelines for malignancy risk stratification of thyroid nodules (C-TIRADS) (both P<0.001).According to the pathological evidence,the underdiagnosed C-TIRADS 3/4a nodules were mainly papillary thyroid carcinoma,especially in patients with Hashimoto thyroiditis.There was not a consistent one-to-one match between each ultrasound result and each cytological classification of low-risk thyroid nodules.Conclusions When the malignant features in preoprative ultrasound imaging are atypical or absent,papillary thyroid carcinoma (especially with Hashimoto thyroiditis),follicular carcinoma,and medullary carcinoma are likely to be underdiagnosed as C-TIRADS 3 or 4a nodules.Therefore,efforts should be made to fully understand the cellular and pathological characteristics of these lesions.
Humans
;
Thyroid Nodule/diagnostic imaging*
;
Female
;
Male
;
Middle Aged
;
Adult
;
Ultrasonography
;
Biopsy, Fine-Needle
;
Aged
;
Young Adult
;
Thyroid Neoplasms/diagnostic imaging*
;
Adolescent
5.Risk Factors and a Nomogram Construction for Prolonged Length of Hospital Stay in Patients With Peritoneal Dialysis Associated Peritonitis.
Jing YAO ; Xiao-Jian BAO ; Ya-Feng ZHANG ; Bin WU ; Qi-Shun WU
Acta Academiae Medicinae Sinicae 2025;47(2):244-250
Objective To analyze the risk factors for prolonged length of hospital stay in patients with peritoneal dialysis associated peritonitis(PDAP)and construct a nomogram based on Logistic regression model.Methods A retrospective study was conducted on patients with PDAP who were hospitalized at the Affiliated Hospital of Jiangsu University from January 2013 to December 2023.Using the 75th percentile of hospitalization time as the cutoff(>21 days),the patients were divided into prolonged length of hospital stay group and normal length of hospital stay group.Clinical data were compared between the two groups.Logistic regression analysis was used to analyze the risk factors for prolonged hospital stay in PDAP patients and to construct a nomogram.Results A total of 131 PDAP patients were included in this study,including 40 cases in prolonged length of hospital stay group and 91 cases in normal length of hospital stay group.Multivariate Logistic regression analysis showed that Gram-negative bacteria detected in ascites(OR=6.012,95% CI=1.878-19.248,P=0.003)and elevated platelet count(OR=1.010,95% CI=1.005-1.015,P<0.001)were independent risk factors for prolonged length of hospital stay,while elevated serum chloride(OR=0.885,95% CI=0.802-0.978,P=0.016)was a protective factor.Based on the above three indicators,a nomogram was constructed.The multivariate Logistic regression model showed an area under the receiver operating characteristic curve(AUC)of 0.755,with an internal validation AUC of 0.727 using the Bootstrap method.The calibration curve indicated that the predicted probability was consistent with the actual probability.The decision curve showed that the model was clinically applicable when the threshold probabilities were 9%-10%,13% and 18%-92%.Conclusion A nomogram,based on the detection of gram-negative bacteria in ascites,platelet count and serum chloride,was helpful for clinical screening PADP patients at risk for prolonged length of hospital stay,and can provide a basis for optimizing clinical decision-making.
Humans
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Nomograms
;
Risk Factors
;
Peritoneal Dialysis/adverse effects*
;
Retrospective Studies
;
Length of Stay
;
Peritonitis/etiology*
;
Logistic Models
;
Male
;
Female
;
Middle Aged
;
Aged
6.Mechanism of Xianglian Pills in improving dyslipidemia in obese mice induced by high-fat diet based on network pharmacology and intestinal flora.
Ming-Wei PENG ; Hua-Xin ZHAO ; Fu SHU ; Zhu CHEN ; Lei SHI ; Lyu-Jiang YUAN ; Bao-Shun ZHANG
China Journal of Chinese Materia Medica 2023;48(23):6442-6456
The present study aimed to investigate the effect of Xianglian Pills(XLP) on lipid metabolism in obese mice and explore the underlying mechanism based on network pharmacology and intestinal flora. Firstly, network pharmacology was used to predict the possible effect of XLP on obesity. Secondly, an obese mouse model induced by a high-fat diet was established to observe changes in mouse body weight, adiposity index, liver and adipose tissue pathology. Lipid profiles, liver and kidney function markers, insulin content, and the expression of recombinant uncoupling protein 1(UCP-1) and PR structural domain protein 16(PRDM16) were measured. The 16S rRNA gene sequencing technology was used to analyze the changes in the intestinal flora. Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment analysis showed that XLP mainly played a role in improving obesity by regulating lipolysis, type 2 diabetes mellitus, and insulin resistance. The results of animal experiments showed that XLP significantly reduced body weight, adiposity, blood lipid levels, and serum insulin levels in obese mice, while enhancing the expression of UCP-1 and PRDM16 in adipose tissue without causing damage to the liver or kidneys. The 16S rRNA gene sequencing results showed that XLP decreased the Firmicutes/Bacteroidetes(F/B) ratio at the phylum level, increased the relative abundance of Akkermansia and Bacteroides at the family and genus levels, and reduced the abundance of Allobaculum. Therefore, XLP can effectively improve lipid metabolism disorders in high-fat diet-induced obese mice, and the mechanism is related to the improvement of brown adipose function, the browning of white fat, the accelerated lipid metabolism, and the improvement of intestinal flora. However, its effect on promoting the conversion of white adipose to brown adipose still needs to be further studied.
Mice
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Animals
;
Mice, Obese
;
Diet, High-Fat/adverse effects*
;
Gastrointestinal Microbiome
;
Network Pharmacology
;
RNA, Ribosomal, 16S
;
Diabetes Mellitus, Type 2/complications*
;
Obesity/genetics*
;
Body Weight
;
Lipids
;
Insulin
;
Transcription Factors
;
Dyslipidemias/genetics*
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Mice, Inbred C57BL
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Drugs, Chinese Herbal
7.Early Enteral Nutrition and Sepsis-Associated Acute Kidney Injury: A Propensity Score Matched Cohort Study Based on the MIMIC-III Database
Jun WANG ; Li JIANG ; Sheng DING ; Si-Yi HE ; Shun-Bi LIU ; Zhong-Jie LU ; Yuan-Zhang LIU ; Li-Wen HOU ; Bin-Su WANG ; Jin-Bao ZHANG
Yonsei Medical Journal 2023;64(4):259-268
Purpose:
We aimed to analyze the optimal timing of enteral nutrition (EN) in the treatment of sepsis and its effect on sepsis-associated acute kidney injury (SA-AKI.) Materials and Methods: The MIMIC-III database was employed to identify patients with sepsis who had received EN. With AKI as the primary outcome variable, receiver operating characteristic (ROC) curves were utilized to calculate the optimal cut-off time of early EN (EEN). Propensity score matching (PSM) was employed to control confounding effects. Logistic regressions and propensity score-based inverse probability of treatment weighting were utilized to assess the robustness of our findings. Comparisons within the EEN group were performed.
Results:
2364 patients were included in our study. With 53 hours after intensive care units (ICU) admission as the cut-off time of EEN according to the ROC curve, 1212 patients were assigned to the EEN group and the other 1152 to the delayed EN group. The risk of SA-AKI was reduced in the EEN group (odds ratio 0.319, 95% confidence interval 0.245–0.413, p<0.001). The EEN patients received fewer volumes (mL) of intravenous fluid (IVF) during their ICU stay (3750 mL vs. 5513.23 mL, p<0.001). The mediating effect of IVF was significant (p<0.001 for the average causal mediation effect). No significant differences were found within the EEN group (0–48 hours vs. 48–53 hours), except that patients initiating EN within 48 hours spent fewer days in ICU and hospital.
Conclusion
EEN is associated with decreased risk of SA-AKI, and this beneficial effect may be proportionally mediated by IVF volume.
8.A dry-reagent assay to rapidly detect Mycobacterium tuberculosis using loop-mediated isothermal amplification.
Bao Hua LI ; Ying ZHANG ; Shun TAO ; Yan Ni GUO ; Qing LIU ; Qi Qi SUN
Chinese Journal of Preventive Medicine 2023;57(10):1625-1629
A molecular diagnostic assay which could be stored at room temperature was developed to rapidly detect Mycobacterium tuberculosis (MTB) based on loop-mediated isothermal amplification (LAMP) technology and dry-reagent process. LAMP uses 4 or 6 primers and Bst DNA polymerase to amplify DNA at a constant temperature. The results showed that the LAMP assay could detect the amplification of IS6110 target gene within 20 min using real-time fluorescence signal detection. The sensitive of LAMP assay was similar to the PCR technology while the precision of PCR was better than LAMP (coefficient of variation, LAMP 18.9%, PCR 3.4%), meaning LAMP was more suitable for qualitative detection. The LAMP assay did not amplify DNA of other 10 types of pathogens, including Neisseria meningitidis, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Rubivirus, mumps virus, adenovirus (type 3), adenovirus (type 7), respiratory syncytial virus B and parainfluenza virus type 2, indicating a good specificity. Furthermore, a dry-reagent assay was developed using air-drying and freeze-drying process. The performance of dried reagents did not change after 10 days storage at 50 ℃, meaning the dried reagents could be stored at room temperature (25 ℃) for more than six months. The dry-reagent LAMP assay also successfully amplified MTB DNA from several clinical samples within 20 min. In conclusion, the developed LAMP assay together with isothermal amplifier could rapidly detection MTB.
Humans
;
Mycobacterium tuberculosis/genetics*
;
Indicators and Reagents
;
Sensitivity and Specificity
;
Nucleic Acid Amplification Techniques/methods*
;
DNA
9.A dry-reagent assay to rapidly detect Mycobacterium tuberculosis using loop-mediated isothermal amplification.
Bao Hua LI ; Ying ZHANG ; Shun TAO ; Yan Ni GUO ; Qing LIU ; Qi Qi SUN
Chinese Journal of Preventive Medicine 2023;57(10):1625-1629
A molecular diagnostic assay which could be stored at room temperature was developed to rapidly detect Mycobacterium tuberculosis (MTB) based on loop-mediated isothermal amplification (LAMP) technology and dry-reagent process. LAMP uses 4 or 6 primers and Bst DNA polymerase to amplify DNA at a constant temperature. The results showed that the LAMP assay could detect the amplification of IS6110 target gene within 20 min using real-time fluorescence signal detection. The sensitive of LAMP assay was similar to the PCR technology while the precision of PCR was better than LAMP (coefficient of variation, LAMP 18.9%, PCR 3.4%), meaning LAMP was more suitable for qualitative detection. The LAMP assay did not amplify DNA of other 10 types of pathogens, including Neisseria meningitidis, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Rubivirus, mumps virus, adenovirus (type 3), adenovirus (type 7), respiratory syncytial virus B and parainfluenza virus type 2, indicating a good specificity. Furthermore, a dry-reagent assay was developed using air-drying and freeze-drying process. The performance of dried reagents did not change after 10 days storage at 50 ℃, meaning the dried reagents could be stored at room temperature (25 ℃) for more than six months. The dry-reagent LAMP assay also successfully amplified MTB DNA from several clinical samples within 20 min. In conclusion, the developed LAMP assay together with isothermal amplifier could rapidly detection MTB.
Humans
;
Mycobacterium tuberculosis/genetics*
;
Indicators and Reagents
;
Sensitivity and Specificity
;
Nucleic Acid Amplification Techniques/methods*
;
DNA
10.Expert consensus on rational usage of nebulization treatment on childhood respiratory system diseases.
Han Min LIU ; Zhou FU ; Xiao Bo ZHANG ; Hai Lin ZHANG ; Yi Xiao BAO ; Xing Dong WU ; Yun Xiao SHANG ; De Yu ZHAO ; Shun Ying ZHAO ; Jian Hua ZHANG ; Zhi Min CHEN ; En Mei LIU ; Li DENG ; Chuan He LIU ; Li XIANG ; Ling CAO ; Ying Xue ZOU ; Bao Ping XU ; Xiao Yan DONG ; Yong YIN ; Chuang Li HAO ; Jian Guo HONG
Chinese Journal of Pediatrics 2022;60(4):283-290

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