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.Analysis of drug resistance and virulence genes of clinical isolates of Staphylococcus aureus in Northwest Hubei Province
Yating ZHANG ; Wuhui JIANG ; Kang YANG ; Lanfang LIU ; Yan YANG
International Journal of Laboratory Medicine 2024;45(19):2311-2315,2322
Objective To investigate the drug resistance and virulence genes of Staphylococcus aureus iso-lated from clinical specimens of hospitals in northwest Hubei province.Methods A total of 142 clinical iso-lates of Staphylococcus aureus were collected from 5 hospitals in Shiyan City from 2019 to 2021.Broth mi-crodilution method was used to detect drug resistance,and PCR method was used to detect 9 enterotoxin genes such as sea,mecA and Panton-Valentine leukocidein(PVL)virulence genes.Results A total of 44 methicillin-resistant Staphylococcus aureus(MRSA)strains were detected in 142 strains of Staphylococcus aureus,and the detection rate was 30.99%(44/142).The resistance rates of MRSA to erythromycin,clindamycin,levo-floxacin,tetracycline and gentamicin were higher than those of methicillin-sensitive Staphylococcus aureus(MSSA),and the differences were statistically significant(P<0.05).The detection rate of enterotoxin genes was 70.42%(100/142),among which the detection rates of classic enterotoxin genes(sea-see)and new ente-rotoxin genes(seg-sej)were 47.18%(67/142)and 42.25%(60/142),respectively.The detection rate of PVL virulence genes was 13.38%(19/142),among which the detection rates of MSSA and MRSA were 9.18%(9/98)and 22.73%(10/44),respectively,and the difference was statistically significant(P<0.05).Conclusion The detection rate of enterotoxin and PVL gene of Staphylococcus aureus isolated from clinical isolates is high.In clinical di-agnosis and treatment,it is necessary to control hospital infection,take effective isolation measures in time and strengthen the monitoring of PVL gene.
4.Landing practices of national medical insurance negotiated drugs in tertiary medical institutions of Zhejiang province
Jin PENG ; Junnan JIANG ; Zenghui QIU ; Lanfang LIU ; Lan YAO
China Pharmacy 2023;34(10):1159-1164
OBJECTIVE To provide reference for the subsequent landing of national medical insurance negotiated drugs (referred to as “national negotiated drugs”) at the provincial level. METHODS By reviewing the data publicly released by the official websites of National Healthcare Security Administration and the Healthcare Security Administration of Zhejiang Province, combined with policy documents, the descriptive analysis was conducted on the number of tertiary medical institutions, the actual allocation of national negotiated drugs, the availability rate of national negotiated drugs, the allocation rate of national negotiated drug varieties, and the allocation rate of medical institutions of various cities in Zhejiang province. The Spearman rank correlation test was used to analyze the correlation between the number of types of national negotiated drugs equipped in tertiary medical institutions in Zhejiang province and the per capita disposable income, the number of tertiary medical institutions equipped with national negotiated drugs, and the implementation time of disease diagnosis-related grouping (DRG) of various cities in Zhejiang province. RESULTS As of the first quarter of 2022, 135 tertiary medical institutions in Zhejiang province were equipped with a total of 261 types of national negotiated drugs, accounting for 94.91% of the 2021 edition of the National Negotiated Drugs Catalogue (275 types). The allocation rates of Goserelin acetate sustained-release implant, Sacubitril valsartan sodium tablets, Alteplase for injection and other varieties were at high level, and the types of national negotiated drugs equipped were highly coincident with the top 10 causes of death with disease of urban and rural residents in Zhejiang province. The tertiary medical institutions in Hangzhou had the most types of national negotiated drugs, with 230 types, while Quzhou had the lowest, with only 34 types; allocation rate of national negotiated drugs in medical institutions of Zhoushan was the highest (100%), while that of Lishui was the lowest (57.14%). The types of national negotiated drugs equipped were positively correlated with per capita disposable income in various cities and the number of tertiary medical institutions equipped with national negotiated drugs (P<0.01), and there was no significant correlation with the length of implementation of DRG (P>0.05). CONCLUSIONS mail:lanyao@mails.tjmu.edu.cn The landing of national negotiated drugs in Zhejiang province is generally good, with a high rate of equipping tertiary medical institutions with national negotiated drugs and a high rate of equipping drug varieties. Therefore, it is recommended that the provincial implementation of national negotiated drugs should be multi-faceted, and policy-making departments should adopt a dual-channel of “unbundling” and “driving” to smooth the drug chain into hospitals. The health insurance sector should improve the “dual channel” management mechanism to share the pressure on hospitals to use drugs. At the same time, it should also improve the multi-level medical security system and raise the level of reimbursement of medical insurance for national negotiated drugs.
5.Mechanism of propofol inhibiting carotid sinus baroreflex in rats with type 2 diabetes mellitus: GluR2 subunit-containing AMPA receptors in nucleus ambiguus
Chunxin HAN ; Lanfang JIANG ; Aozhang JI ; Zhao ZHUANG ; Qianqian CAO ; Shoushi WANG
Chinese Journal of Anesthesiology 2023;43(9):1067-1071
Objective:To evaluate the relationship between the mechanism of propofol inhibiting carotid sinus baroreflex (CSR) and GluR2 subunit-containing AMPA receptors in the nucleus ambiguus of rats with type 2 diabetes mellitus (T2DM).Methods:SPF healthy male Sprague-Dawley rats, aged 3 weeks, were selected and fed a high glucose and high fat diet for 6 weeks, and then streptozotocin 30 mg/kg was intraperitoneally injected to prepare a T2DM model of rats. Twenty-four T2DM rats were divided into 4 groups ( n=6 each) using a random number table method: diabetes mellitus-normal saline group (DN group), diabetes mellitus-propofol group (DP group), AMPA receptor agonist-normal saline group (AN group), and AMPA receptor agonist-propofol group (AP group). Another 12 normal rats were selected and divided into 2 groups ( n=6 each) using a random number table method: normal-normal saline group (NN group) and normal-propofol group (NP group). AMPA receptor agonist mibamitor 1 nmol/L (50 nl) was injected into the nucleus ambiguus using a micropipette at 30 min before perfusion of isolated carotid sinus in AN and AP groups. Propofol 45 mg·kg -11·h -1 was infused for 2 h via the femoral vein in NP group, DP group and AP group, and the equal volume of normal saline was given instead in the other groups. A model for perfusing isolated carotid sinus was developed at 20 min after infusion of propofol or normal saline, the intracarotid sinus pressure (ISP)-mean arterial blood pressure (MAP) curve was drawn, and CSR parameters such as maximum slope (PS), threshold pressure (TP), saturation pressure (SP), equilibrium pressure (EP), maximum decrease in MAP reflexivity (RD), and carotid sinus baroreceptor operating range (OR) were recorded. Brain tissues were taken at the end of perfusion, and the expression of GluR2 subunit in the nucleus ambiguus was detected by Western blot and immunofluorescence. Results:Compared with the corresponding normal saline groups (NN group, DN group, AN group), PS and RD were significantly decreased, TP, SP and OR were increased ( P<0.05), and the ISP-MAP curve was shifted upward in propofol groups (NP group, DP group, AP group), the expression of GluR2 subunit in the nucleus ambiguus was down-regulated in NP and DP groups ( P<0.05), and no significant change was found in the expression of GluR2 subunit in the nucleus ambiguus in AP group ( P>0.05). Compared with NP group, PS and RD were significantly decreased, TP, SP and OR were increased ( P<0.05), the ISP-MAP curve was shifted upward, and the expression of GluR2 subunit in the nucleus ambiguus was down-regulated in DP group ( P<0.05). Compared with DP group, PS and RD were significantly increased, TP, SP and OR were decreased ( P<0.05), the ISP-MAP curve was shifted downward, and the expression of GluR2 subunit in the nucleus ambiguus was up-regulated in AP group ( P<0.05). Conclusions:The mechanism by which propofol inhibits CSR may be related to down-regulation of the expression of GluR2 subunits-containing AMPA receptors in the nucleus ambiguus of rats with T2DM.
6.Clinical Characteristics and Treatment of Blau Syndrome in Chinese Children-a National Multicenter Study
Junmei ZHANG ; Xiaozhen ZHAO ; Xuemei TANG ; Yi'nan ZHAO ; Li LI ; Fengqiao GAO ; Xinwei SHI ; Yanliang JIN ; Yu ZHANG ; Lanfang CAO ; Wei YIN ; Jihong XIAO ; Weiying KUANG ; Jianghong DENG ; Jiang WANG ; Xiaohua TAN ; Chao LI ; Shipeng LI ; Haiyan XUE ; Cuihua LIU ; Xiaohui LIU ; Dongmei ZHAO ; Yuqing CHEN ; Wenjie ZHENG ; Caifeng LI
JOURNAL OF RARE DISEASES 2022;1(3):252-258
7.Analgesic effect of local anesthesia combined with nerve block anesthesia on golden micro-needles for improving facial aging
Xiaoshu PU ; Ting JIANG ; Lanfang ZHANG ; Hongyan LIU ; Qinglian HE ; Qingjiang HUANG
Chinese Journal of Medical Aesthetics and Cosmetology 2021;27(4):301-304
Objective:To observe the analgesic effect of local anesthesia combined with nerve block anesthesia on golden microneedles for improving facial aging.Methods:Between December 2018 and December 2019 in Burn and Plastic Surgery of Nanchong Central Hospital, sixty female patients (between 30 and 58 years old, with an average of 45.2 years old) with natural facial skin aging were randomly divided into two groups: Group A: surface anesthesia group (30 cases); Group B: local anesthesia combined with nerve block anesthesia (30 cases). Intraoperative and postoperative pain scores, length of operation, and incidence of adverse reactions were compared between groups A and B.Results:Pain score during surgery was (6.90±0.96) points in Group A, (3.63±0.72) points in Group B. The difference between the two groups was statistically significant ( t=14.93, P<0.05); Pain score at 30 minutes after operation was (2.03±0.62) in Group A, (0.77±0.73) in Group B, the difference between the two groups was statistically significant ( t=7.28, P<0.05). There was no statistically significant difference between the two groups in the pain score at 24 hours after operation ( P>0.05); The operation process in group B was simplified, and the treatment time was significantly shortened. The difference between the two groups was statistically significant ( t=17.93, P<0.05). Conclusions:The method of local anesthesia combined with nerve block anesthesia is used in the treatment of gold microneedles to improve the analgesic effect in facial aging, which significantly shortens the treatment time and has fewer adverse reactions. This method is worth popularizing.
8.Pulmonary actinomycosis in children: a case report and literature review
Meixia HUANG ; Bei YE ; Yuan JIANG ; Lanfang TANG ; Zhimin CHEN
Chinese Journal of Pediatrics 2021;59(1):33-36
Objective:To summarize the clinical characteristics, imaging features, diagnosis, treatment and prognosis of pulmonary actinomycosis in children.Methods:The clinical data of a child with pulmonary actinomycosis who was hospitalized in Children′s Hospital, Zhejiang University School of Medicine in December 2019 was retrospectively analyzed. The related literature published from January 1975 to January 2020 was retrieved from Wanfang, CNKI and PubMed databases with "pulmonary" or "thoracic" and "actinomycosis" and "pediatric" or "children" or "child" as the keywords. And the characteristics of pediatric pulmonary actinomycosis were summarized based on the literature review.Results:The patient was a boy aged 12 years and 6 months. He was admitted due to cough and chest pain for more than 20 days, with fever on the first three days. The chest CT scan in local hospital found inflammatory lesions in the right middle lobe, which was also suspected to be cavitation. The flexible bronchoscopy showed congestion and edema of bronchial mucosa in the right middle lobe, and bronchoalveolar lavage fluid smear was positive for acid-fast bacilli DNA, although both purfied protein derivatives tuberculin test and T-spot were negative. During the hospitalization, the child had persistent cough and chest pain, but no fever. Pathogen metagene sequencing of the bronchoalveolar lavage fluid detected Actinomyces (sequence number: 222) and Grevini Actinomycetes (sequence number: 185). The boy received intravenous cefoperazone sulbactam sodium for 2 weeks followed by oral amoxicillin clavulanate potassium for 6 weeks. Until April 2020, his clinical symptoms completely relieved, and the pulmonary lesions were significantly absorbed on the latest chest CT scan. Eight articles and 62 children with pulmonary actinomycosis were reported, but no related reports were retrieved from CNKI and Wanfang databases. The youngest case was 27 months old. The clinical presentations of this disease were nonspecific. The main symptoms included chest wall masses (8 cases), cough (23 cases), pain (chest, back, shoulders and armpits) (24 cases), fever (25 cases), weight loss (26 cases), etc.Conclusions:The clinical manifestations and imaging features of pediatric pulmonary actinomycosis are nonspecific, therefore it could easily be misdiagnosed. For children with pneumonia of unknown etiology and failing to respond to routine antibiotics, the pathogen metagene sequencing of the bronchoalveolar lavage fluid will be helpful for diagnosis. With appropriate course of antibiotic treatment, the prognosis is good in most cases.
9.Inhibition and mechanisms of non-T cell binding peptide(FNS007)in collagen Ⅱ-induced arthritis mice models
Liping LI ; Lijun XIE ; Na HAO ; Guofeng LI ; Chao LIU ; Lijing HUANG ; Lan GE ; Shaofeng YAN ; Xiaohong XU ; Qinzeng ZHANG ; Hong JIANG ; Lanfang LI ; Jianxin ZHANG
Chinese Pharmacological Bulletin 2017;33(5):611-616
Aim To investigate the effect of non-T cell binding peptide(FNS007)on collagen type Ⅱ-induced arthritis(CIA)in mice and the possible mechanisms.Methods The CIA model was induced by intradermal injection of bovine CⅡ+Freunds adjuvant.At the clinical onset of CIA,mice were randomly divided into 6 groups: blank control group(Control),model group,ORENCIA(abatacept)group,FNS007 low dose(1.2 mg·kg-1)group,FNS007 middle dose(2.4 mg·kg-1)group and FNS007 high dose(4.8 mg·kg-1)group.FNS007 was given by intravenous injection on the first day of arthritis and every other day until the study was terminated on d 28 after injection of the drug.The paw thickness and the ankle joint width were measured,and the arthritis scores were recorded.At termination,interferon-γ(IFN-γ),tumor necrosis factor-α(TNF-α),interleukin-6(IL-6)and level of anti-CⅡ antibody in serum were examined by enzyme-linked immunosorbent assay(ELISA).Bone injury was analyzed by X-ray imaging,and HE staining was conducted to observe the histopathologic changes and pathological score of ankle tissues.Results CIA models were successfully induced.Compared with CIA group,FNS007 high dose significantly reduced the paw thickness and the ankle joint left-right diameter,lowered arthritis scores in CIA mice,reduced serum concentrations of IFN-γ,IL-6 and anti-CⅡ antibodies,and lowered the radiographic and histologic scores.Compared with CIA group,FNS007 middle dose group showed marked reduction in the arthritis scores,IL-6 content in serum,and inhibion in the radiographic and histologic scores.The arthritis scores,concentration of IFN-γ,the radiographic and histologic scores were significantly reduced in FNS007 low dose group compared with those in model group.Conclusion FNS007 can effectively inhibit the progression of CIA through inhibiting T-cell activation and reducing inflammatory cytokines,anti-CⅡ antibodies,and histoclasia and bone destruction.
10.Analysis and adscription of volatiles fromGuizhi Tang using gas chromatography-mass spectroscopy and improvement of the learning and memory in mice
Qingsen RAN ; Xiaoling ZHAN ; Xiaodong LI ; Liwei GU ; Lanfang LI ; Shuying GUO ; Canghai LI ; Tingliang JIANG
International Journal of Traditional Chinese Medicine 2017;39(5):435-441
Objective Analysis and adscription of volatiles from Guizhi Tang and study on its improvement of the learning and memory in dementia mice induced by scopolamine.Methods The volatile oil from Guizhi Tang(GZT),Guizhi and Shengjiang was extracted using steam distillation method and was analyzed by GC-MS. Morris water maze and step-down test were carried out for obtain the difference of the learning and memory improvement in 40 ICR mice from randomized groups, such as the control group, the model group, the donepezil group (2 mg/kg), the low dose of volatile oil of GZT (5 mg/kg), and the high dose of volatile oil of GZT (20 mg/kg), and ACh, AchE, BchE and chE in serum were detected by ELISA. Results Among 38 identyfied volatile ingredients from GZT, 18(44% in weight) was from Guizhi, and 9 was from Shengjiang. Compared with the model group, the low and high dose of GZT volatile oil significantly increased swimming distance ratio in destination quadrant (26.74% ± 16.42%vs.9.42% ± 8.50%, P<0.05); goal quadrant time scale (43.51% ± 25.12%vs. 14.50% ± 12.23%,P<0.05)) increased significantly than the model group ; the number of errors in the experiment platform (1.63 ± 1.19vs. 0.25 ± 0.46, P<0.05) obviously increased than model group ; platform test in the made errors times (0.57 ± 0.98vs. 4.43 ± 2.4, P<0.05) significantly reduced. The GZT total volatile oil groups significantly reduced cognitive obstacles small rat serum in the cholinester enzyme (chE) (140.90 ± 3.27, 144.79 ± 6.71vs. 134.49 ± 3.36,P<0.05); acetylcholinesterase (AchE) (3.30 ± 1.31, 3.94 ± 0.78 vs.8.52 ± 3.39,P<0.05); butyrylcholinesterase (BchE) (3.22 ± 0.45, 3.66 ± 0.53vs. 7.99 ± 0.79,P<0.05); and acetylcholine (Ach) (4.10 ± 0.38, 3.03 ± 0.25vs.1.72 ± 0.50, P<0.05) significantly increased.Conclusions The GZT volatile oil mainly from Guizhi and Shengjiang can improve the learning and memory ability in dementia mice induced by scopolamine via a cholinergic mechnism.

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