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.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.
4.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.
5.Discussion on the validity period determination method of commercial ready-to-use TSA medium
Wenyue KOU ; Yuru JIANG ; Luyao HAO ; Yuyi TANG ; Xueyun ZHOU ; Xiujuan ZHU ; Zhen QIAN ; Ge JIN ; Jiaojiao WANG
Drug Standards of China 2024;25(3):289-295
Objective:To study the quality and stability of commercial ready-to-use tryptone soya agar(TSA)after storing at 2-25 ℃ for different storage duration under dark condition in order to discuss a determination method of validity period for medium.Methods:Three consecutive batches of ready-to-use TSA medium from two manufac-turers were selected and stored at 2-25 ℃ under dark conditions for 30,90 and 180 days,respectively.The appearance,pH,medium suitability and sterility of the medium were tested.Results:The results of appearance,pH,suitability and sterility of TSA medium from two manufacturers for each batch under different storage duration all met the requirements of the Chinese Pharmacopoeia 2020 Volume IV on the quality control of medium.Conclusion:The TSA medium from two manufacturers all met the requirements when stored for 180 days at 2-25 ℃ under dark condition,indicating that the validity period of TSA medium from two manufacturers can reach 180 days.
6.Methodology Study on Rapid Quality Control of Liuwei Dihuang Capsule by AOTF-near Infrared Spectroscopy
Yu BIAN ; Wenyue JIANG ; Meihui WANG ; Xuhua REN ; Jiale QU ; Min LI ; Lu GAO
China Pharmacy 2019;30(9):1203-1209
OBJECTIVE: To establish the method for the rapidly non-destructive quality control of Liuwei dihuang capsule. METHODS: AOTF-NIR spectrometry was adopted. Taking 80 batches of Liuwei dihuang capsule produced by a manufacturer in recent three years as samples, HPLC chromatogram was adopted to determine the contents of loganin, morroniside, paeonol, paeoniflorin and ursolic acid; the content of water was determined according to general principles stated in 2015 edition of Chinese Pharmacopeia (part Ⅰ). Taking 70 batches of samples as correction set, the partial least square method and the cross-validation algorithm were used to establish the NIR quantitative model of 6 indexes in Liuwei dihuang capsules with the Unscrambler quantitative analysis software. Taking residual 10 batches of samples as validation set, external validation was conducted for the model. RESULTS: The correlation coefficients (R2) of internal and external validation of loganin, morroniside, paeonol, paeoniflorin, the content of water quantitative model were all greater than 0.9; the correction of standand deviation (RMSEC) were 0.372 8, 0.025 4, 0.263 3, 0.288 5, 0.186 7 and 0.037 7; the prediction of standard deviation (RMSEP) were 0.462 2, 0.077 5, 0.472 1, 0.634 9, 0.293 4 and 0.206 9; the external verification showed that mean deviations of preclicted value to actual value were 6.04%, 6.05%, 5.87%, 6.97%, 5.62% and 4.83%, with the mean deviation less than 10%.CONCLUSIONS:The established method can achieve rapidly non-destructive analysis Liuwei dihuang capsule.
7.Study on Anti-inflammatory and Detumescent Pharmacodynamic Material Basis of Jingyaokang Capsule
Jie XU ; Wenyue JIANG ; Yali WANG ; Meihui WANG ; Xiaoyu WEI ; Yu BIAN
China Pharmacy 2019;30(4):478-483
OBJECTIVE: To study the anti-inflammatory and detumescent pharmacodynamic material basis of Jingyaokang capsule, and to provide reference for secondary development, the establishment of quality control method and technological upgrading of the preparations. METHODS: The constituents of Jingyaokang capsule were extracted and separated with different solvents and macroporous adsorption resin to obtain constituent A (overall enrichment part), constituent B (chloroform extraction part), constituent C (water-course part) and constituent D (elution part of 60% ethanol). Using dexamethasone acetate as positive control, the anti-inflammatory and detumescent effects of Jingyaokang capsule and different extraction parts (constituents A, B, C, D) were investigated by mice ear edema and rat paw edema tests to screen the active fraction. UPLC-Q-TOF-MS method was used to analyze active constituent, identify compounds and attribute medicinal material. RESULTS: Anti-inflammatory and detumescent effects of constituent B (chloroform extraction part)+constituent D (elution part of 60% ethanol) were similar to those of Jingyaokang capsule in rats or mice, indicating both had synergistic anti-inflammatory and detumescent effects and were active constituents of Jingyaokang capsule. UPLC-Q-TOF-MS detection and identification showed that constituent B contained 13 compounds as strychnine, phellodendrine, periplogenin, tetraketone alcohol, 11-carbonyl-β-mastic acid, attributing to Strychnos nux-vomica, Stephania tetrandra, Periploca sepium, Lycopodium japonicum, Boswellia carterii, etc. Constituent D contained 7 compounds as adenine, hydroxysafflower yellow A, phellodendrine, neoeriocitrin, zingibroside R1, attributing to rainworm, Carthamus tinctorius, Stephania tetrandra, Davallia mariesii, Achyranthes bidentata, etc. CONCLUSIONS: Jingyaokang capsule shows the significant anti-inflammation and detumescent effects. The chloroform extraction part is synergistic with 60% ethanol elution part, which are the active constituents of anti-inflammation and detumescence,mainly including alkaloids, flavonoids and boswellic acids.
8.Spinal Cord Stimulation Frequency Influences the Hemodynamic Response in Patients with Disorders of Consciousness.
Juanning SI ; Yuanyuan DANG ; Yujin ZHANG ; Yaxin LI ; Wenyue ZHANG ; Yi YANG ; Yue CUI ; Xiaoping LOU ; Jianghong HE ; Tianzi JIANG
Neuroscience Bulletin 2018;34(4):659-667
Spinal cord stimulation (SCS) is a promising technique for treating disorders of consciousness (DOCs). However, differences in the spatio-temporal responsiveness of the brain under varied SCS parameters remain unclear. In this pilot study, functional near-infrared spectroscopy was used to measure the hemodynamic responses of 10 DOC patients to different SCS frequencies (5 Hz, 10 Hz, 50 Hz, 70 Hz, and 100 Hz). In the prefrontal cortex, a key area in consciousness circuits, we found significantly increased hemodynamic responses at 70 Hz and 100 Hz, and significantly different hemodynamic responses between 50 Hz and 70 Hz/100 Hz. In addition, the functional connectivity between prefrontal and occipital areas was significantly improved with SCS at 70 Hz. These results demonstrated that SCS modulates the hemodynamic responses and long-range connectivity in a frequency-specific manner (with 70 Hz apparently better), perhaps by improving the cerebral blood volume and information transmission through the reticular formation-thalamus-cortex pathway.
Adolescent
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Adult
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Brain
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physiopathology
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Consciousness
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physiology
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Consciousness Disorders
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physiopathology
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therapy
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Female
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Hemodynamics
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physiology
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Humans
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Male
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Middle Aged
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Pilot Projects
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Spinal Cord
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physiopathology
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surgery
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Spinal Cord Stimulation
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methods
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Young Adult
9.Rapid Quality Evaluation of Astragali Radix by AOTF-NIR
Xuhua REN ; Ting SU ; Wenyue JIANG ; Yadong LI ; Guangjing ZHENG ; Lu GAO
China Pharmacy 2018;29(2):168-171
OBJECTIVE:To establish the method for rapid quality evaluation of Astragali Radix.METHODS:The moisture of medicinal material was determined by oven drying method;the content of astragaloside Ⅳ was determined by HPLC-ELSD;the content of isoflavone glucoside was determined by HPLC (as reference value).The partial least squares (PLS) method combined with acousto-optic turnable filter-NIDRS was adopted to build quantitative model of above indexes in Astragali Radix (as predict value).According to reference value,60 batches of sample were collected.The spectra pretreatment was conducted by first derivative method combined with Savitzky golay.The optimal bands of moisture,astragaloside Ⅳ and isoflavone glucoside were 1 100-2 300 nm,1 080-2 160 nm,1 170-2 230 nm,respectively.RESULTS:The content determination of moisture,astragaloside Ⅳ and isoflavone glucoside in samples were all in line with methodology requirements.The corrected mean square root deviation of quantitative model for moisture,astragaloside Ⅳ,calycosin glucoside were 0.132 3,0.006 6,0.002 5,respectively;predicted mean square root deviation were 0.237 1,0.016 3,0.004 7;internal cross validation coefficient of correction set were 0.975 9,0.953 3,0.968 0;internal verification deviation of quantitative model were 1.43%,1.90%,1.84%;external verification deviation were 1.73 %,2.68 %,2.71%,respectively.CONCLUSIONS:The method is rapid,accurate,simple,pollution-free,and can be used for rapid quality evaluation of Astragali Radix.
10.Rapid Determination of Cryptotanshinone in Salvia miltiorrhiza by AOTF-NIDRS
Ting SU ; Wenyue JIANG ; Cheng XING ; Xuhua REN ; Xindong LI ; Xianli CUI ; Lu GAO
China Pharmacy 2018;29(8):1044-1048
OBJECTIVE:To establish rapid method for content determination of cryptotanshinone in Salvia miltiorrhiza. METHODS:The content of cryptotanshinone in sample was determined by HPLC(as reference value). AOTF-NIDRS combined with PLS was used to establish quantitative correction model for the content of cryptotanshinone in S. miltiorrhiza. According to the results of content determination of cryptotanshinone in samples,35 samples of medicinal material were collected. First-order derivative combined with smoothing filter coefficient method was used to pretreat spectrum,and optimal band range for content determination of cryptotanshinone in sample ranged 1 250-2 150 nm. RESULTS:Methodology validation of content determination of cryptotanshinone in sample was in line with the requirements. Correction mean square deviation of quantitative correction model of cryptotanshinone was 0.014 6,and predicted mean square deviation was 0.022 3,coefficient of association was 0.976 6. The internal verification deviation was 2.41% and the external verification deviation was 4.06%. CONCLUSIONS:This method is rapid,accurate,simple and pollution-free.It can be used for rapid content determination of cryptotanshinone in S.miltiorrhiza.

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