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.Clinical and pathological features of 52 patients with glomerulonephritis with dominant C3
Jinying WEI ; Yao HUANG ; Shuguang YUAN ; Xiaojun CHEN ; Xiao FU ; Zheng LI ; Ying LI ; Lin SUN ; Hong LIU ; Xuejing ZHU
Journal of Central South University(Medical Sciences) 2024;49(1):75-83
Objective:With the in-depth study of complement dysregulation,glomerulonephritis with dominant C3 has received increasing attention,with a variety of pathologic types and large differences in symptoms and prognosis between pathologic types.This study analyzes the clinical,pathological,and prognostic characteristics of different pathological types of glomerulonephritis with dominant C3,aiming to avoid misdiagnosis and missed diagnoses. Methods:The clinical,pathological,and follow-up data of 52 patients diagnosed as glomerulonephritis with dominant C3 by renal biopsy from June 2013 to October 2022 were retrospectively analyzed.According to the clinical feature and results of pathology,15 patients with post-infectious glomerulonephritis(PIGN)and 37 patients with of non-infectious glomerulonephritis(N-PIGN)were classified.N-PIGN subgroup analysis was performed,and 16 patients were assigned into a C3-alone-deposition group and 21 in a C3-dominant-deposition group,or 27 in a C3 glomerulopathy(C3G)group and 10 in a non-C3 nephropathy(N-C3G)group. Results:The PIGN group had lower creatinine values(84.60 μmol/L vs 179.62 μmol/L,P= 0.001),lower complement C3 values(0.36 g/L vs 0.74 g/L,P<0.001)at biopsy,and less severe pathological chronic lesions compared with the N-PIGN group.In the N-PIGN subgroup analysis,the C3-dominant-deposition group had higher creatinine values(235.30 μmol/L vs 106.70 μmol/L,P=0.004)and higher 24-hour urine protein values(4 025.62 mg vs 1 981.11 mg,P=0.037)than the C3-alone-deposition group.The prognosis of kidney in the PIGN group(P=0.049),the C3-alone-deposition group(P=0.017),and the C3G group(P=0.018)was better than that in the N-PIGN group,the C3-dominant-deposition group,and the N-C3G group,respectively. Conclusion:Glomerulonephritis with dominant C3 covers a variety of pathological types,and PIGN needs to be excluded before diagnosing C3G because of considerable overlap with atypical PIGN and C3G;in addition,the deposition of C1q complement under fluorescence microscope may indicate poor renal prognosis,and relevant diagnosis,treatment,and follow-up should be strengthened.
4.Traditional Chinese Medicine Syndrome Element, Evolutionary Patterns of Patients with Hepatitis B Virus-Related Acute on Chronic Liver Failure at Different Stages: A Multi-Center Clinical Study
Simiao YU ; Kewei SUN ; Zhengang ZHANG ; Hanmin LI ; Xiuhui LI ; Hongzhi YANG ; Qin LI ; Lin WANG ; Xiaozhou ZHOU ; Dewen MAO ; Jianchun GUO ; Yunhui ZHUO ; Xianbo WANG ; Xin DENG ; Jiefei WANG ; Wukui CAO ; Shuqin ZHANG ; Mingxiang ZHANG ; Jun LI ; Man GONG ; Chao ZHOU
Journal of Traditional Chinese Medicine 2024;65(12):1262-1268
ObjectiveTo explore the syndrome elements and evolving patterns of patients with hepatitis B virus-related acute on chronic liver failure (HBV-ACLF) at different stages. MethodsClinical information of 1,058 hospitalized HBV-ACLF patients, including 618 in the early stage, 355 in the middle stage, and 85 in the late stage, were collected from 18 clinical centers across 12 regions nationwide from January 1, 2012 to February 28, 2015. The “Hepatitis B-related Chronic and Acute Liver Failure Chinese Medicine Clinical Questionnaire” were designed to investigate the basic information of the patients, like the four diagnostic information (including symptoms, tongue, pulse) of traditional Chinese medicine (TCM), and to count the frequency of the appearance of the four diagnostic information. Factor analysis and cluster analysis were employed to determine and statistically analyze the syndrome elements and patterns of HBV-ACLF patients at different stages. ResultsThere were 76 four diagnostic information from 1058 HBV-ACLF patients, and 53 four diagnostic information with a frequency of occurrence ≥ 5% were used as factor analysis entries, including 36 symptom information, 12 tongue information, and 5 pulse information. Four types of TCM patterns were identified in HBV-ACLF, which were liver-gallbladder damp-heat pattern, qi deficiency and blood stasis pattern, liver-kidney yin deficiency pattern, and spleen-kidney yang-deficiency pattern. In the early stage, heat (39.4%, 359/912) and dampness (27.5%, 251/912) were most common, and the pattern of the disease was dominated by liver-gallbladder damp-heat pattern (74.6%, 461/618); in the middle stage, dampness (30.2%, 187/619) and blood stasis (20.7%, 128/619) were most common, and the patterns of the disease were dominated by liver-gallbladder damp-heat pattern (53.2%, 189/355), and qi deficiency and blood stasis pattern (27.6%, 98/355); and in the late stage, the pattern of the disease was dominated by qi deficiency (26.3%, 40/152) and yin deficiency (20.4%, 31/152), and the patterns were dominated by qi deficiency and blood stasis pattern (36.5%, 31/85), and liver-gallbladder damp-heat pattern (25.9%, 22/85). ConclusionThere are significant differences in the distribution of syndrome elements and patterns at different stages of HBV-ACLF, presenting an overall trend of evolving patterns as "from excess to deficiency, transforming from excess to deficiency", which is damp-heat → blood stasis → qi-blood yin-yang deficiency.
5.Acupuncture for lumbar myofascial pain syndrome: systematic review and Meta-analysis.
Ran ZHANG ; Sheng-Yue WEN ; Hong-Sheng ZHAN ; Xun LIN ; Min ZHANG ; Jian PANG ; Yue-Long CAO ; Bo CHEN
Chinese Acupuncture & Moxibustion 2023;43(11):1324-1332
This study systematically reviewed the clinical efficacy of acupuncture for lumbar myofascial pain syndrome. The randomized controlled trials (RCTs) regarding acupuncture for lumbar myofascial pain syndrome were searched in PubMed, Cochrane Library, Web of Science, EMbase, Scopus, China national knowledge infrastructure (CNKI), Wanfang database, VIP database, and China biomedical literature service system (SinoMed) from database inception until August 1st, 2022. The Cochrane's risk of bias assessment tool was used to assess the risk of bias in all included studies, and Review Manager 5.3 software was used for statistical analysis of the extracted data. As a result, 12 RCTs, involving 1 087 patients with lumbar myofascial pain syndrome, were ultimately included. The Meta-analysis results showed that the visual analog scale (VAS) score of pain in the observation group was lower than those in the oral non-steroidal anti-inflammatory medication control [SMD=-1.67, 95%CI (-2.44, -0.90), Z=4.26, P<0.000 1] and other treatment control [low-frequency electrical stimulation, tuina, electromagnetic wave irradiation combined with piroxicam gel, SMD=-1.98, 95%CI (-2.48, -1.48), Z=7.74, P<0.000 01]. The pain rating index (PRI) score in the observation group was lower than those in the lidocaine injection control [MD=-2.17, 95%CI (-3.41, -0.93), Z=3.44, P=0.000 6] and other treatment control [low-frequency electrical stimulation, tuina, MD=-5.75, 95%CI (-9.97, -1.53), Z=2.67, P=0.008]. The present pain intensity (PPI) score in the observation group was lower than that in other treatment control [low-frequency electrical stimulation, tuina, MD=-1.04, 95%CI (-1.55, -0.53), Z=4.01, P<0.000 1]. In conclusion, compared with oral non-steroidal anti-inflammatory medication, low-frequency electrical stimulation, tuina, and electromagnetic wave irradiation combined with piroxicam gel, acupuncture is more effective in reducing pain in patients with lumbar myofascial pain syndrome; acupuncture also exhibites advantage over lidocaine injection in improving PRI score and showed better outcomes over tuina and low-frequency electrical stimulation in improving PRI and PPI scores.
Humans
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Piroxicam
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Acupuncture Therapy/methods*
;
Pain
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Myofascial Pain Syndromes/therapy*
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Anti-Inflammatory Agents, Non-Steroidal/therapeutic use*
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Lidocaine
6.Influence of wind, cold and dampness on clinical manifestation of knee osteoarthritis patients based on the stratifications of traditional Chinese medicine constitution.
Ze-Cheng TAN ; Ding JIANG ; Qin-Guang XU ; Lin WANG ; Xue-Zong WANG ; Bo CHEN ; Jian PANG ; Hong-Sheng ZHAN ; Yue-Long CAO
China Journal of Orthopaedics and Traumatology 2023;36(12):1130-1135
OBJECTIVE:
To explore influence of external factors of wind, cold and dampness on clinical symptoms in knee osteoarthritis (KOA) patients with different constitutions of traditional Chinese medicine.
METHODS:
A cross-sectional stratified study was performed to select 108 patients with GradeⅡKOA in Kellgren & Lawrence (K-L) classification, including 22 males and 86 females, aged from 47 to 75 years old with an average of (60.7±6.0) years old;body mass index(BMI) ranged from 17.87 to 31.22 kg·m-2 with an average of (23.80±2.86) kg·m-2. According to Classification and Judgment of TCM Physique (ZYYXH/T157-2009), the types of TCM physique were determined and divided into 4 layers according to the deficiency and actual physique. Among them, there were 24 patients without biased physique, 12 males and 12 females, aged from 51 to 73 years old with an average of(62.8±6.0) years old, BMI ranged from 17.87 to 31.14 kg·m-2 with an average of (24.32±3.25) kg·m-2;there were 46 patients with virtual bias constitution, including 7 males and 39 females, aged from 47 to 70 years old with an average of (60.0±5.8) years old, BMI ranged from 19.38 to 31.22 kg·m-2 with an average of(23.42±2.97) kg·m-2;There were 26 patients with solid bias constitution, including 2 males and 24 females, aged from 48 to 75 years old with an average of (60.4±5.8) years old, BMI ranged from 21.16 to 30.76 kg·m-2 with an average of (24.15±2.33) kg·m-2;there were 9 patients with special constitution, 1 male and 8 female, aged from 53 to 75 years old with an average of (59.8±7.5) years old, BMI ranged from 19.26 to 26.67 kg·m-2 with an average of (23.79±2.49) kg·m-2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate severity of clinical symptoms. The wind-cold-dampness external factor score was calculated through the questionnaire of wind-cold-dampness syndrome scale to evaluate degree of influence of wind-cold-dampness external factor. Pearson correlation analysis and partial correlation analysis were used to calculate the correlation coefficient between severity of external factors affecting wind, cold and dampness and severity of clinical symptoms in patients with different TCM constitution stratification.
RESULTS:
There was no statistical significance between total score of wind-cold-dampness and WOMAC score in patients with no biased constitution and special condition. Total wind-cold-dampness score of patients with virtual biased constitution was positively correlated with WOMAC stiffness score (r=0.327, P=0.032), and total wind-cold-dampness score of patients with solid biased constitution was positively correlated with WOMAC pain score (r=0.561, P=0.005) and WOMAC overall score (r=0.446, P=0.033). After further adjusting for the interaction of external factors of wind-cold-dampness, there was no statistical significance between wind-cold-dampness scores and WOMAC scores in patients with solid biased constitution. The score of dampness and pathogenic factors was positively correlated with WOMAC stiffness score (r=0.414, P=0.007).
CONCLUSION
The external factors of wind-cold dampness have different effects on the clinical symptoms of KOA patients with different TCM constitutions. Compared with other constitutions, the rigid symptoms of patients with asthenic biased constitutions are more susceptible to dampness pathogenic factors.
Aged
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Female
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Humans
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Male
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Middle Aged
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Cross-Sectional Studies
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Medicine, Chinese Traditional
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Osteoarthritis, Knee
;
Syndrome
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Wind
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Cold Temperature
7.Systematic review and Meta-analysis of Gusongbao preparation in treatment of primary osteoporosis.
Jie-Hang LU ; Zheng-Yan LI ; Guo-Qing DU ; Jun ZHANG ; Yu-Peng WANG ; Jin-Yu SHI ; You-Zhi LIAN ; Fu-Wei PAN ; Zhen-Lin ZHANG ; Hong-Sheng ZHAN
China Journal of Chinese Materia Medica 2023;48(11):3086-3096
This study aims to provide evidence for clinical practice by systematically reviewing the efficacy and safety of Gusongbao preparation in the treatment of primary osteoporosis(POP). The relevant papers were retrieved from four Chinese academic journal databases and four English academic journal databases(from inception to May 31, 2022). The randomized controlled trial(RCT) of Gusongbao preparation in the treatment of POP was included after screening according to the inclusion and exclusion criteria. The quality of articles was evaluated using risk assessment tools, and the extracted data were subjected to Meta-analysis in RevMan 5.3. A total of 657 articles were retrieved, in which 15 articles were included in this study, which involved 16 RCTs. A total of 3 292 patients(1 071 in the observation group and 2 221 in the control group) were included in this study. In the treatment of POP, Gusongbao preparation+conventional treatment was superior to conventional treatment alone in terms of increasing lumbar spine(L2-L4) bone mineral density(MD=0.03, 95%CI[0.02, 0.04], P<0.000 01) and femoral neck bone mineral density, reducing low back pain(MD=-1.69, 95%CI[-2.46,-0.92], P<0.000 1) and improving clinical efficacy(RR=1.36, 95%CI[1.21, 1.53], P<0.000 01). Gusongbao preparation was comparable to similar Chinese patent medicines in terms of improving clinical efficacy(RR=0.95, 95%CI[0.86, 1.04], P=0.23). Gusongbao preparation was inferior to similar Chinese patent medicines in reducing traditional Chinese medicine syndrome scores(MD=1.08, 95%CI[0.44, 1.71], P=0.000 9) and improving Chinese medicine syndrome efficacy(RR=0.89, 95%CI[0.83, 0.95], P=0.000 4). The incidence of adverse reactions of Gusongbao preparation alone or combined with conventio-nal treatment was comparable to that of similar Chinese patent medicines(RR=0.98, 95%CI[0.57, 1.69], P=0.94) or conventio-nal treatment(RR=0.73, 95%CI[0.38, 1.42], P=0.35), and the adverse reactions were mainly gastrointestinal discomforts. According to the available data, Gusongbao preparation combined with conventional treatment is more effective than conventional treatment alone in increasing lumbar spine(L2-L4) bone mineral density and femoral neck bone mineral density, reducing low back pain, and improving clinical efficacy. The adverse reactions of Gusongbao preparation were mainly gastrointestinal discomforts, which were mild.
Humans
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Bone Density
;
Low Back Pain
;
Medicine, Chinese Traditional
;
Osteoporosis/drug therapy*
8.Expert consensus on recombinant B subunit/inactivated whole-cell cholera vaccine in preventing infectious diarrhea of enterotoxigenic Escherichia coli
Chai JI ; Yu HU ; Mingyan LI ; Yan LIU ; Yuyang XU ; Hua YU ; Jianyong SHEN ; Jingan LOU ; Wei ZHOU ; Jie HU ; Zhiying YIN ; Jingjiao WEI ; Junfen LIN ; Zhenyu SHEN ; Ziping MIAO ; Baodong LI ; Jiabing WU ; Xiaoyuan LI ; Hongmei XU ; Jianming OU ; Qi LI ; Jun XIANG ; Chen DONG ; Haihua YI ; Changjun BAO ; Shicheng GUO ; Shaohong YAN ; Lili LIU ; Zengqiang KOU ; Shaoying CHANG ; Shaobai ZHANG ; Xiang GUO ; Xiaoping ZHU ; Ying ZHANG ; Bangmao WANG ; Shuguang CAO ; Peisheng WANG ; Zhixian ZHAO ; Da WANG ; Enfu CHEN
Chinese Journal of Clinical Infectious Diseases 2023;16(6):420-426
Enterotoxigenic Escherichia coli(ETEC)infection can induce watery diarrhea,leading to dehydration,electrolyte disturbance,and even death in severe cases. Recombinant B subunit/inactivated whole-cell cholera(rBS/WC)vaccine is effective in preventing ETEC infectious diarrhea. On the basis of the latest evidence on etiology and epidemiology of ETEC,as well as the effectiveness,safety,and health economics of rBS/WC vaccine,National Clinical Research Center for Child Health(The Children’s Hospital,Zhejiang University School of Medicine)and Zhejiang Provincial Center for Disease Control and Prevention invited experts to develop expert consensus on rBS/WC vaccine in prevention of ETEC infectious diarrhea. It aims to provide the clinicians and vaccination professionals with guidelines on using rBS/WC vaccine to reduce the incidence of ETEC infectious diarrhea.
9.Effects of vitamin D supplementation on the clinical efficacy of Crohn′s disease treated with ustekinumab: a retrospective analysis
Shunyu RAO ; Dingyuan HU ; Daopo LIN ; Shuguang CAO ; Hao WU ; Yi JIANG
Chinese Journal of Digestion 2023;43(11):755-763
Objective:To retrospectively analyze the effects of vitamin D supplementation on the clinical efficacy of ustekinumab (UST) in treatment of patients with Crohn′s disease (CD).Methods:Seventy-one patients with moderate to severe active CD who received the first-line treatment UST from May 2021 to February 2023 were collected by searching the clinical database of the Second Affiliated Hospital of Wenzhou Medical University. The disease activity of CD was evaluated by Harvey-Bradshaw index (HBI) and intestinal inflammation was assessed by simplified endoscopic score for Crohn′s disease (SES-CD). The CD patients were divided into supplementary group ( n=41) and non-supplementary group ( n=30) based on whether vitamin D supplementation (400 U/d) was performed during UST treatment. According to the baseline serum 25 (OH) D level, the patients were divided into vitamin D deficiency group (<20 μg/L, n=42) and non-deficiency group (≥20 μg/L, n=29). The main end points were the differences in the clinical remission (HBI score ≤4) rate and mucosal healing (SES-CD score ≤2) rate between supplementary group and non-supplementary group at week 24 of UST treatment. The secondary end points were the differences in the clinical response (the reduction of HBI score ≥3 compared to week 0) rate and biochemical remission (C-reactive protein (CRP)≤5 mg/L) rate between supplementary group and non-supplementary group at week 8 of UST treatment. A multiple linear regression analysis was performed to investigate the relation between serum 25(OH) D levels and the clinicopathological characteristics of CD patients. Multivariate binary logistic regression models were used to analyze the factors affecting the clinical efficacy of UST at week 8 and 24. Independent sample t test, Mann-Whitney U test, Chi-square test and Fisher′s exact test were used for comparisons between the two groups. Paired t test was used to analyze the differences before and after UST treatment. Results:The results of multiple linear regression analysis for 71 CD patients showed that the baseline serum 25(OH)D level was independent influencing factor for the baseline CRP level ( β=-0.33, 95% confidence interval (95% CI) -0.41 to -0.08, P=0.041) and baseline HBI score ( β= -0.52, 95% CI -0.68 to -0.33, P=0.027). Compared with week 0, the serum 25(OH)D level of supplementary group increased at week 8 ((17.18±5.46) μg/L vs. (13.71±7.73) μg/L), and the difference was statistically significant ( t=-7.81, P<0.001), however, there was no significant difference of serum 25(OH)D in non-supplementary group ((14.85±3.92) μg/L vs. (15.69±5.48) μg/L, P>0.05). At week 8, the HBI score and median CRP level of supplementary group were both lower than those of non-supplementary group (5.71±1.88 vs. 8.34±2.27, 10.83 mg/L (3.95 mg/L, 21.07 mg/L) vs. 16.17 mg/L (6.91 mg/L, 35.48 mg/L)), and the diffierences were statistically significant ( t=0.48, Z=2.87; P<0.001 and =0.001). However, the clinical response rate and biochemical remission rate were both higher than those of non-supplementary group (68.3%, 28/41 vs. 40.00%, 12/30 and 43.9%, 18/41 vs. 13.3%, 4/30), and the differences were statistically significant ( χ2=5.64 and 6.21, P=0.018 and 0.013). Compared with week 0, the serum 25(OH)D level of supplementary group increased ((24.73±8.34) μg/L) at week 24, and the difference was statistically significant ( t=-6.83, P<0.001), however, there was no statistically significant difference in the serum 25(OH)D level of non-supplementary group ((15.59±7.24) μg/L vs. (15.69±5.48) μg/L, P>0.05). At week 24, the decrease of HBI score and SES-CD score of supplementary group were both greater than those of non-supplementary group (difference between week 24 and week 0 -8.96±1.45 vs. -5.33±0.59, -7.00(-10.00, -3.00) vs. -2.00(-2.50, -1.50), and the differences were statisticalcy significant ( t=-5.64 and Z=-3.27, P<0.001 and =0.039). Moreover, the clinical remission rate and mucosal healing rate were both higher than those of non-supplementary group (65.9%, 27/41 vs. 26.7%, 8/30, and 61.0%, 25/41 vs. 30.0%, 9/30), and the differences were statistically significant ( χ2=10.64 and 6.66, P=0.001 and 0.010). At week 24, the analysis of non-supplementary group indicated that the clinical remission rate and mucosal healing rate of patients received vitamin D supplementary therapy were both higher than those of patients without vitamin D supplementary therapy (69.0%, 20/29 vs. 3/13, and 58.6%, 17/29 vs. 2/13), and the differences were statistically significant ( χ2=4.43 and 5.14, P=0.035 and 0.023). Vitamin D supplementing therapy was an independent influencing factor of clinical response rate and biochemical remission rate at week 8, clinical remission rate and mucosal healing rate at week 24 for UST treatment of CD ( OR(95% CI) were 5.83(1.15 to 7.59), 4.91(3.67 to 6.98), 5.13(2.88 to 9.44), 7.01(1.16 to 20.97), respectively; P<0.001, <0.001, <0.001, =0.036). Conclusion:Vitamin D supplementation may help to improve the clinical efficacy of UST treatment in CD patients, especially in patients with vitamin D deficiency.
10.Pathological Change of Chronic Hepatitis B Patients with Different Tongue Coatings by Circular Multi-Omics Integrated Analysis.
Yi-Shuang TANG ; Jian-Chun GUO ; Lin XU ; Xiao-Na ZHANG ; Xiao-Ping SHEN ; Ya-Mei HAI ; Yu-Feng MAO ; Yi-Yang HU ; Yu ZHAO
Chinese journal of integrative medicine 2022;28(1):28-35
OBJECTIVE:
To compare the circular pathological changes of chronic hepatitis B (CHB) patients according to the tongue diagnosis.
METHODS:
Totally 41 CHB patients with typical white tongue coating (WTC) or yellow tongue coating (YTC) were enrolled and 14 healthy volunteers with normal tongue manifestation served as controls. The mRNA expression of peripheral leukocytes was detected by GeneChips, and 9 genes were randomly selected for expression validation. Circular metabolites were detected by gas chromatographymass spectrometry. Biological information was analyzed based on ingenuity pathways analysis or metabolomics database and the integrated networks were constructed by ClueGO.
RESULTS:
A total of 945 and 716 differentially expressed genes were found in patients with WTC and YTC relative to healthy volunteers respectively. The biological information analysis indicated that CHB patients had obviously increased functions in cell death, apoptosis and necrosis (Z-score ⩾2, P<0.05) and decreased activation in T lymphocytes (Z-score ⩽-2, P<0.05), regardless of the tongue manifestation. Compared to patients with WTC, the YTC patients were predicted to be more active in functions related to virus replication (Z-score ⩾2, P<0.05), and the content of circular fatty acids, such as oleic acid (P=0.098) and lauric acid (P=0.035), and citric acid cycle-related metabolites were higher in the YTC patients (P<0.1). The integrated analysis based on differential genes and metabolites indicated that the most difference in the biological function network between the WTC and YTC patients was tumor necrosis factor receptor associated factor 6 mediated-nuclear factor kappa-B activation process.
CONCLUSIONS
CHB patients with YTC had more severe inflammation and fatty acids metabolism aberrant than patients with WTC. The results facilitate the modern pathological annotation of Chinese medicine tongue diagnosis theory and provide a reference for the interpretation of pharmacological mechanisms of Chinese medicine treatment.
Fatty Acids
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Hepatitis B virus/genetics*
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Hepatitis B, Chronic
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Humans
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Metabolomics
;
T-Lymphocytes
;
Tongue

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