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.Improvement effect and mechanism of Shengmai powder on heart failure mice with qi-yin deficiency
Lanfang KANG ; Jian LI ; Yating ZHAO ; Yingchun CHEN ; Guiyin CHEN ; Xiaobo NIE ; Jiao LIU ; Jie CHENG
China Pharmacy 2025;36(17):2127-2133
OBJECTIVE To study the improvement effect and mechanism of Shengmai powder on heart failure (HF) mice with qi-yin deficiency. METHODS The mice were randomly divided into blank group (water), model group (water), Shengmai powder low-, medium-, and high-dose groups [2.61, 5.22 and 10.44 g/kg (based on crude drug dosage)] and positive control group (metoprolol, 30 mg/kg), with 10 mice in each group. Except for the blank group, all other groups were subcutaneously injected with D-galactose, and a qi-yin deficiency HF mice model was established by continuous food restriction and weight-bearing swimming. At the same time of modeling, the corresponding medicine/water was gavaged once a day for five weeks. The general state of mice was recorded and the traditional Chinese medicine (TCM) syndrome score was evaluated. Behavioral experiments were conducted to investigate the total distance of open field action, the percentage of immobility time, and the swimming exhaustion time of mice. The contents of aspartate transaminase (AST), creatine kinase (CK) and lactate dehydrogenase (LDH) in the serum of mice were detected; cardiac function indexes [heart rate, left ventricular ejection fraction (LVEF), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), left ventricular mass index and whole heart mass index] were all detected; the histopathological morphology of mice myocardium was observed; the level of cardiomyocyte apoptosis in mice was detected; mRNA expression levels of B-cell lymphoma 2 (Bcl-2), Bcl-2 associated X protein (Bax), and Cleaved-caspase-3 in myocardial tissue of mice were detected; the phosphorylation levels of sarcoplasmic reticulum calcium regulatory related proteins [ryanodine receptor 2 (RyR2) and phospholamban (PLB)] in myocardial tissue of mice were detected. RESULTS Compared with the blank group, the body weight, total distance of open field action, swimming exhaustion time, LVEF, LVEDD, Bcl-2 mRNA expression level in myocardial tissue and PLB protein phosphorylation level in the model group were significantly reduced/shortened (P<0.05); TCM syndrome score, the percentage of immobility time, heart rate, LVESD, left ventricular mass index, whole heart mass index, cardiomyocyte apoptosis rate, the contents of CK, LDH and AST in serum, mRNA expression levels of Cleaved-caspase-3 and Bax and the phosphorylation level of RyR2 protein in myocardial tissue were significantly increased (P<0.05); there were inflammatory cell infiltration, disordered cell arrangement and obvious myocardial interstitial fibrosis in myocardial tissue. After the intervention of Shengmai powder, most of the above quantitative indexes in mice were significantly reversed (P<0.05), the inflammatory cell infiltration in myocardial tissue was reduced, and the degree of fibrosis was significantly reduced. CONCLUSIONS Shengmai powder can improve cardiac function, reduce the level of cardiomyocyte apoptosis and myocardial fibrosis in HF mice with qi-yin deficiency. Its mechanism may be related to the regulation of the expression of sarcoplasmic reticulum calcium regulation related proteins.
4.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.
5.The safety and protective effect on resting dry mouth of optimized dose optimization in clinical target volume Ⅱa in patients with N 0-N 1 nasopharyngeal carcinoma
Wenxuan HUANG ; Shengfu HUANG ; Siyu ZHANG ; Lanfang ZHANG ; Lijun WANG ; Juying LIU ; Yizhi GE ; Xia HE
Chinese Journal of Radiation Oncology 2024;33(5):397-404
Objective:To analyze the safety of reduced clinical target volume (CTV) irradiation of suspicious positive lymph nodes in IIa region in patients with N 0-N 1 nasopharyngeal carcinoma (NPC) and the protective effect of submandibular gland and long-term resting dry mouth, and to explore the diagnostic value of multimodal imaging for suspicious cervical lymph nodes. Methods:Clinical data of T 0-4N 0-1M 0 stage NPC patients admitted to Jiangsu Cancer Hospital from July 2015 to April 2017 were retrospectively analyzed. Clinical, radiation therapy planning, multimodal imaging and other relevant data were collected. All patients were treated with an optimized regimen of IMRT with a prophylactic radiation dose of 50.4 Gy (named as CTV50) for IIa region. Imaging characteristics and treatment response of suspicious lymph nodes were monitored by MRI, MRI-DWI, PET-CT and repeated enhanced positioning CT, etc. The dosimetry of the submandibular gland between optimized and standard dose plans (CTV50 vs. CTV60) was compared by paired t-test. The long-term dry mouth degree of the patients was evaluated using advanced radiation injury from Radiation Therapy Oncology Group (RTOG), Jiangsu Cancer Hospital Multi-dimensional Dry Mouth Evaluation Scale and summated xerostomia inventory (SXI). The difference of dry mouth degree was analyzed by rank-sum test. Results:A total of 106 patients were included in this study, including 149 cervical lymph node negative sides, 73 sides of which had ≤3 recognizable lymph nodes, and 76 of which were>3 in Ⅱa region. Among patients with N 1 stage, 63 patients underwent contralateral single neck area optimization, and 43 patients (N 0 stage and N 1 stage patients with retropharyngeal lymph node metastasis) underwent double-neck area optimization. A total of 109 suspicious lymph nodes with a short diameter of >5 mm were found on the largest cross section, of which 105 had clear portal structure. The ratio of long to short diameter was ≥1.5 in 93 cases, and the maximum standardized uptake value (SUV max) in PET-CT was ≥2.5 in 76 cases. No lymph node recurrence was found in the CTV optimized area. There was no significant difference in the average dose of GTV in tumor target area after optimization ( P>0.05), and the D mean and V 39 Gy in submandibular gland were significantly lower than those in unoptimized plan (both P<0.01). There was no significant difference in long-term dry mouth and resting dry mouth between patients with unilateral and bilateral optimization of submandibular gland (both P>0.05). Conclusions:The optimal program of CTV50 reduction irradiation in Ⅱa area of N 0-N 1 NPC patients is safe and effective. The submandibular gland has obvious dosimetric advantages, and patients have a good subjective response to resting dry mouth. The multimodal imaging tools such as enhanced CT, MRI-DWI and PET-CT should be performed to deliver individual evaluation and treatment for suspicious lymph nodes.
6.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.
7.HPCAL1 is a novel driver of autophagy-dependent ferroptosis.
Liwen WANG ; Qin LI ; Huimei LIU ; Lanfang LI
Journal of Zhejiang University. Science. B 2023;24(11):1053-1056
自噬是细胞内一种高度保守的生理过程,可通过溶酶体系统降解过量或受损的细胞器、有毒的蛋白聚集体和病原体等。最新研究表明,海马钙素样1(HPCAL1)可作为特异性自噬受体和铁死亡的正调节因子。HPCAL1可选择性降解钙粘素2(CDH2),加速脂质过氧化,促进癌细胞铁死亡。iHPCAL1是抑制HPCAL1的小分子化合物,可抑制Erastin诱导的肿瘤细胞铁死亡。此外,它还可以抑制铁死亡诱导的急性胰腺炎。本文通过对HPCAL1在铁死亡中的具体作用机制进行概述,为HPCAL1作为铁死亡相关疾病的潜在治疗靶点提供新思路和理论依据。
Ferroptosis
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Cell Line, Tumor
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Autophagy
8.The feasibility of individualized primary CTV for lateralized nasopharyngeal carcinoma
Siyu ZHANG ; Wenxuan HUANG ; Lijun WANG ; Juying LIU ; Lijun ZHAO ; Lirong WU ; Dejun WANG ; Wenjing XU ; Yesong GUO ; Pengwei YAN ; Lanfang ZHANG ; Zhenyu ZHAI ; Shengfu HUANG ; Xia HE
Chinese Journal of Radiation Oncology 2023;32(8):675-682
Objective:To investigate the feasibility of individualized primary clinical target volume (CTV) delineation in intensity-modulated radiotherapy for nasopharyngeal carcinoma (NPC).Methods:Clinical data of 87 consecutive patients newly diagnosed with lateralized NPC in Jiangsu Cancer Hospital between October 2016 and February 2018 were retrospectively analyzed. Lateralized NPC is defined as tumor invasion not exceeding the contralateral wall. According to the tumor spread, the primary CTV was optimized as follows: CTV2 only covered the medial part of the contralateral pterygopalatine fossa, whereas the contralateral foramen oval was not included; on the level of parapharyngeal space, the contralateral side of CTV only covered the posterior lateral lymph nodes, whereas the contralateral internal jugular vein was not regularly covered. Failure patterns and 5-year survival [local control rate (LCR), progression-free survival (PFS) and overall survival (OS)] were evaluated by Kaplan-Meier method. Paired t-test and rank-sum test were used to analyze the dose variation in the optimized region and adverse reactions. Results:The median follow-up time was 59.5 months. The 5-year LCR, PFS, and OS were 98.9%, 86.5% and 92.1%, respectively. There was no local recurrence in the optimized area of CTV. Dosimetric comparison results showed that the doses of parotid gland, temporal lobe, cochlea and middle ear on the contralateral side were reduced by 13.45%, 9.14%, 38.83%, and 29.36%, respectively. Four cases (4.6%) developed grade 3 hearing loss, all on the ipsilateral side. The optimized scheme significantly alleviated the hearing loss on the contralateral side compared to that on the ipsilateral side ( P<0.001). Other grade 3 late adverse reactions included cranial nerve injury, subcutaneous fibrosis in the neck and visual impairment, with 1 case each. Conclusion:Individualized primary CTV for lateralized NPC is feasible and safe, with obvious dosimetric advantages and reduced adverse reaction rate, which is worthy of clinical promotion.
9.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
10.Comparison of the Legiolert enzyme-substrate method and the conventional cultivation for the detection of Legionella pneumophila in water samples from public places
Yanli LI ; Kang YANG ; Lei FU ; Lili GONG ; Lanfang LIU ; Jingzhi GAO
Journal of Public Health and Preventive Medicine 2021;32(1):51-54
Objective To compare the detection effects of Legionella pneumophila in water samples from public places by the Legiolert enzyme-substrate method and the conventional cultivation. Methods The Legiolert enzyme-substrate method and the conventional cultivation method were used to detect Legionella pneumophila in cooling water and shower water samples collected in public places. Isolated strains were verified and serotyped. Results A total of 68 samples were collected and tested. The positive rate of the conventional cultivation and the Legiolert enzyme-substrate method were 5.88%(4/68)and 35.29%(24/68), respectively, with a significant difference (χ2=16.41,P<0.01). The coincidence rate of the two methods was 64.71% (44/68), and the difference of the detection effects of the two methods was statistically significant (χ2=16.41,P=0.000). A total of 25 strains of Legionella pneumophila were isolated,and the serum types were mainly LP1(14/25). Conclusion The Legiolert enzyme-substrate method represente a higher detection rate of Legionella pneumophila in water samples from public places than the conventional cultivation.


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