1.A comparative study of different methods for treatment switching analysis in clinical trials.
Zhiyue LIANG ; Lishan XU ; Keke LI ; Milai YU ; Shengli AN
Journal of Southern Medical University 2025;45(5):1093-1102
OBJECTIVES:
To compare the commonly used methods for analyzing treatment switching in clinical trials to facilitate selection of optimal methods in different scenarios.
METHODS:
Based on the data characteristics of patient conversion in oncology clinical trials, we simulated the survival time of patients across different scenarios and compared the bias, mean square error and coverages of the treatment effects derived from different methods.
RESULTS:
The sample size had an almost negligible impact on the outcomes of the various methods. Compared to conventional methods, more complex methods (RPSFTM, IPCW, TSE, and IPE) resulted in lower errors across different scenarios. The IPCW method could cause a significant increase in errors in cases where the probability of conversion was high. The TSE method had the lowest error and mean squared error when the risk was low and the probability of conversion was high. The IPE method had an obvious advantage in the scenario with a low probability of conversion, but it may slightly underestimate the treatment effect when the inflation factor was small.
CONCLUSIONS
The choice of a specific method for analyzing cohort transition should be made based on considerations of both the probability of conversion and inflation factor in different scenarios.
Humans
;
Clinical Trials as Topic/methods*
;
Neoplasms/therapy*
2.Textual Research and Clinical Application Analysis of Classic Formula Fangji Fulingtang
Xiaoyang TIAN ; Lyuyuan LIANG ; Mengting ZHAO ; Jialei CAO ; Lan LIU ; Keke LIU ; Bingqi WEI ; Yihan LI ; Jing TANG ; Yujie CHANG ; Jingwen LI ; Bingxiang MA ; Weili DANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):270-277
The classic formula Fangji Fulingtang is from ZHANG Zhongjing's Synopsis of the Golden Chamber in the Eastern Han dynasty. It is composed of Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma, with the effects of reinforcing Qi and invigorating spleen, warming Yang and promoting urination. By a review of ancient medical books, this paper summarizes the composition, original plants, processing, dosage, decocting methods, indications and other key information of Fangji Fulingtang, aiming to provide a literature basis for the research, development, and clinical application of preparations based on this formula. Synonyms of Fangji Fulingtang exist in ancient medical books, while the formula composition in the Synopsis of the Golden Chamber is more widespread and far-reaching. In this formula, Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma are the dried root of Stephania tetrandra, the dried root of Astragalus embranaceus var. mongholicus, the dried shoot of Cinnamomum cassia, the dried sclerotium of Poria cocos, and the dried root and rhizome of Glycyrrhiza uralensis, respectively. Fangji Fulingtang is mainly produced into powder, with the dosage and decocting method used in the past dynasties basically following the original formula. Each bag is composed of Stephaniae Tetrandrae Radix 13.80 g, Astragali Radix 13.80 g, Cinnamomi Ramulus 13.80 g, Poria 27.60 g, and Glycyrrhizae Radix et Rhizoma 9.20 g. The raw materials are purified, decocted in water from 1 200 mL to 400 mL, and the decoction should be taken warm, 3 times a day. Fangji Fulingtang was originally designed for treating skin edema, and then it was used to treat impediment in the Qing dynasty. In modern times, it is mostly used to treat musculoskeletal and connective tissue diseases and circulatory system diseases, demonstrating definite effects on various types of edema and heart failure. This paper clarifies the inheritance of Fangji Fulingtang and reveals its key information (attached to the end of this paper), aiming to provide a theoretical basis for the development of preparations based on this formula.
3.Textual Research and Clinical Application Analysis of Classic Formula Fangji Fulingtang
Xiaoyang TIAN ; Lyuyuan LIANG ; Mengting ZHAO ; Jialei CAO ; Lan LIU ; Keke LIU ; Bingqi WEI ; Yihan LI ; Jing TANG ; Yujie CHANG ; Jingwen LI ; Bingxiang MA ; Weili DANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):270-277
The classic formula Fangji Fulingtang is from ZHANG Zhongjing's Synopsis of the Golden Chamber in the Eastern Han dynasty. It is composed of Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma, with the effects of reinforcing Qi and invigorating spleen, warming Yang and promoting urination. By a review of ancient medical books, this paper summarizes the composition, original plants, processing, dosage, decocting methods, indications and other key information of Fangji Fulingtang, aiming to provide a literature basis for the research, development, and clinical application of preparations based on this formula. Synonyms of Fangji Fulingtang exist in ancient medical books, while the formula composition in the Synopsis of the Golden Chamber is more widespread and far-reaching. In this formula, Stephaniae Tetrandrae Radix, Astragali Radix, Cinnamomi Ramulus, Poria, and Glycyrrhizae Radix et Rhizoma are the dried root of Stephania tetrandra, the dried root of Astragalus embranaceus var. mongholicus, the dried shoot of Cinnamomum cassia, the dried sclerotium of Poria cocos, and the dried root and rhizome of Glycyrrhiza uralensis, respectively. Fangji Fulingtang is mainly produced into powder, with the dosage and decocting method used in the past dynasties basically following the original formula. Each bag is composed of Stephaniae Tetrandrae Radix 13.80 g, Astragali Radix 13.80 g, Cinnamomi Ramulus 13.80 g, Poria 27.60 g, and Glycyrrhizae Radix et Rhizoma 9.20 g. The raw materials are purified, decocted in water from 1 200 mL to 400 mL, and the decoction should be taken warm, 3 times a day. Fangji Fulingtang was originally designed for treating skin edema, and then it was used to treat impediment in the Qing dynasty. In modern times, it is mostly used to treat musculoskeletal and connective tissue diseases and circulatory system diseases, demonstrating definite effects on various types of edema and heart failure. This paper clarifies the inheritance of Fangji Fulingtang and reveals its key information (attached to the end of this paper), aiming to provide a theoretical basis for the development of preparations based on this formula.
4.Key Information Research and Ancient and Modern Application Analysis of Classic Prescription Houpo Sanwutang
Wenli SHI ; Qing TANG ; Huimin CHEN ; Jialei CAO ; Bingqi WEI ; Lan LIU ; Keke LIU ; Yun ZHANG ; Yujie CHANG ; Yihan LI ; Jingwen LI ; Bingxiang MA ; Lvyuan LIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):214-221
Houpo Sanwutang, included in the Catalogue of Ancient Classical Prescriptions (Second Batch), was first recorded in the Synopsis of Golden Chamber written by ZHANG Zhongjing from the Eastern Han dynasty and was modified by successive generations of medical experts. A total of 37 pieces of effective data involving 37 ancient Chinese medical books were retrieved from different databases. Through literature mining, statistical analysis, and data processing, combined with modern articles, this study employed bibliometrics to investigate the historical origin, composition, decoction methods, clinical application, and other key information. The results showed that the medicinal origin of Houpo Sanwutang was clearly documented in classic books. Based on the conversion of the measurements from the Han Dynasty, it is recommended that 110.4 g Magnolia Officinalis Cortex, 55.2 g Rhei Radix et Rhizoma, and 72 g Aurantii Fructus Immaturus should be taken. Magnolia Officinalis Cortex and Aurantii Fructus Immaturus should be decocted with 2 400 mL water first, and 1 000 mL should be taken from the decocted liquid. Following this, Rhei Radix et Rhizoma should be added for further decoction, and then 600 mL should be taken from the decocted liquid. A single dose of administration is 200 mL, and the medication can be stopped when patients restore smooth bowel movement. Houpo Sanwutang has the effect of moving Qi, relieving stuffiness and fullness, removing food stagnation, and regulating bowels. It can be used in treating abdominal distending pain, guarding, constipation, and other diseases with the pathogenesis of stagnated heat and stagnated Qi in the stomach. The above results provide reference for the future development and research of Houpo Sanwutang.
5.Distribution and drug resistance of Enterobacter cloacae in Gansu Province from 2019 to 2023
Zhifeng WANG ; Xiaofang LIANG ; Dandan DU ; Keke LI ; Qianqian LIU ; Wenjie WANG ; Zhangping LU ; Lianhua WEI
Chinese Journal of Nosocomiology 2025;35(19):3000-3004
OBJECTIVE To analyze the clinical distribution characteristics and drug resistance of Enterobacter cloa-cae in Gansu Province from 2019 to 2023,providing reference for the prevention and control of E.cloacae infec-tions in this region.METHODS Data on the distribution and drug resistance of E.cloacae from hospitals in mem-ber units of the Gansu Antimicrobial Surveillance Network between 2019 and 2023 were collected.In vitro drug susceptibility testing was performed by the Kirby-Bauer disk diffusion(K-B)method,minimum inhibitory con-centration method,and fully automated instrumentation,followed by analysis of the susceptibility results.RESULTS From 2019 to 2023,a total of 402 490 bacterial strains were isolated and cultured in Gansu Province,including 17 417 strains of E.cloacae,with a detection rate of 4.33%.The bacteria were primarily iso-lated from sputum specimens(62.81%),followed by urine(7.37%)and wound pus specimens(6.07%).The de-partmental distribution was dominated by internal medicine(44.96%)and surgery(28.50%).The highest detec-tion rate was observed in the adult group(15-65 years,45.79%).E.cloacae exhibited varying degrees of resist-ance to over 20 antibacterial drugs,but the overall drug resistance rate showed a declining trend(P<0.05).The highest drug resistance rate was observed for cefazolin(96.40%-98.38%),while the lowest was for tigecycline(0.44%—2.92%).Carbapenem-resistant E.cloacae demonstrated an increasing trend in drug resistance rates,with imipenem resistance ranging from 2.79%to 3.71%(P=0.044)and meropenem resistance ranging from 1.29%to 3.41%(P<0.05).CONCLUSIONS The isolation rate of E.cloacae in Gansu Province remains stable,with a declining trend in drug resistance to multiple antibacterial drugs.However,the increasing drug resistance to carbapenems warrants attention.
6.Distribution and drug resistance of Enterobacter cloacae in Gansu Province from 2019 to 2023
Zhifeng WANG ; Xiaofang LIANG ; Dandan DU ; Keke LI ; Qianqian LIU ; Wenjie WANG ; Zhangping LU ; Lianhua WEI
Chinese Journal of Nosocomiology 2025;35(19):3000-3004
OBJECTIVE To analyze the clinical distribution characteristics and drug resistance of Enterobacter cloa-cae in Gansu Province from 2019 to 2023,providing reference for the prevention and control of E.cloacae infec-tions in this region.METHODS Data on the distribution and drug resistance of E.cloacae from hospitals in mem-ber units of the Gansu Antimicrobial Surveillance Network between 2019 and 2023 were collected.In vitro drug susceptibility testing was performed by the Kirby-Bauer disk diffusion(K-B)method,minimum inhibitory con-centration method,and fully automated instrumentation,followed by analysis of the susceptibility results.RESULTS From 2019 to 2023,a total of 402 490 bacterial strains were isolated and cultured in Gansu Province,including 17 417 strains of E.cloacae,with a detection rate of 4.33%.The bacteria were primarily iso-lated from sputum specimens(62.81%),followed by urine(7.37%)and wound pus specimens(6.07%).The de-partmental distribution was dominated by internal medicine(44.96%)and surgery(28.50%).The highest detec-tion rate was observed in the adult group(15-65 years,45.79%).E.cloacae exhibited varying degrees of resist-ance to over 20 antibacterial drugs,but the overall drug resistance rate showed a declining trend(P<0.05).The highest drug resistance rate was observed for cefazolin(96.40%-98.38%),while the lowest was for tigecycline(0.44%—2.92%).Carbapenem-resistant E.cloacae demonstrated an increasing trend in drug resistance rates,with imipenem resistance ranging from 2.79%to 3.71%(P=0.044)and meropenem resistance ranging from 1.29%to 3.41%(P<0.05).CONCLUSIONS The isolation rate of E.cloacae in Gansu Province remains stable,with a declining trend in drug resistance to multiple antibacterial drugs.However,the increasing drug resistance to carbapenems warrants attention.
7.The relationship between serum calcium levels and pain in patients with Parkinson's disease
Xiaohuan LI ; Yongyan FAN ; Jianjun MA ; Dawei YANG ; Keke LIANG ; Dongsheng LI ; Jinhua ZHENG ; Xiaoxue SHI ; Xuelin QI ; Zonghan SHE
Chinese Journal of Geriatrics 2024;43(12):1587-1591
Objective:To investigate the relationship between serum calcium levels and pain in patients with Parkinson's disease(PD).Methods:A total of 111 patients with PD and 50 healthy volunteers were recruited from our hospital between July 2019 and June 2020.Motor symptoms of PD patients were assessed using the Hoehn-Yahr(H&Y)stages and the Unified Parkinson's Disease Rating Scale-Ⅲ(UPDRSⅢ).Non-motor symptoms were evaluated using Mini-Mental State Examination(MMSE), 17-item Hamilton Depression Rating Scale(HAMD-17), 14-item Hamilton Anxiety Rating Scale(HAMA-14), questionnaire for rapid eye movement(REM)sleep behavior disorder(RBDQ-HK), King Parkinson's pain scale(KPPS), Pittsburgh Sleep Quality Index(PSQI), Parkinson's Disease Sleep Scale(PDSS), and Epworth Sleepiness Scale(ESS).The quality of life of PD patients was assessed using the 39-item Parkinson's Disease Questionnaire(PDQ-39).Results:The levels of serum calcium in PD patients were significantly lower than those in the control group( t=3.733, P<0.001).Additionally, the levels of serum calcium in PD patients with pain were higher than those in PD patients without pain( t=-3.238, P<0.05).This suggests a significant positive correlation between serum calcium levels and pain in PD patients( r=0.320, P=0.001).When analyzing serum calcium levels for PD with pain using binary logistic regression, the area under the curve(AUC=0.662)and sensitivity(28.9%)were found to be low.Furthermore, a correlation analysis of KPPS scores in PD patients with pain revealed that KPPS scores were correlated with UPDRSⅢ( r=0.383, P=0.009), HAMD-17( r=0.303, P=0.043), HAMA-14( r=0.303, P=0.043), PSQI( r=0.304, P=0.042), and PDSS( r=-0.417, P=0.004)scores. Conclusions:The levels of serum calcium are decreased in patients with Parkinson's disease(PD), and there is a correlation between serum calcium levels and pain experienced by PD patients.However, it is important to note that pain in PD patients is influenced by various other factors.
8.Textual Research of Pediatric Famous Classical Formula Daochisan Based on Ancient and Modern Literature
Lyuyuan LIANG ; Hejia WAN ; Jinyan ZHANG ; Keke LIU ; Jialei CAO ; Xianghan TAN ; Bingqi WEI ; Bingxiang MA ; Yajing HE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(11):218-227
Daochisan is a pediatric famous classical formula in traditional Chinese medicine(TCM) specializing in clearing the heart, disinhibiting water and enriching Yin, which has been inherited and developed by medical experts of successive generations. The formula can be traced back to Xiaoer Yaozheng Zhijue written by QIAN Yi from Song dynasty, and most of the later-developed Daochisan(Daochitang) is based on this formula with additions and subtractions. So as to promote the literature excavation of this formula, this paper conducts a thorough textual research and analysis of the composition, processing, preparation methods, clinical applications of Daochisan based on a systematic collation of relevant ancient and modern literature in the method of bibliometrics. A total of 127 pieces of data involving 86 antient TCM books were collected. Statistical analysis showed that the drug origin of Daochisan is basically clear, we suggest that Rehmanniae Radix is the root tuber of Rehmannia glutinosa of Scrophulariaceae, Akebiae Caulis is the dry stem of Akebia quinata of Lardizabalaceae, Glycyrrhizae Radix et Rhizoma is the dry root and stem of Glycyrrhiza uralensis of legume, bamboo leaf is the dry leaves of Phyllostachys nigra var. henonis of gramineous plants. Four herbs are recommended to use its raw products. The key information of the dosage and decocting method is supposed to be "4.13 g each of raw Rehmanniae Radix, raw Glycyrrhizae Radix et Rhizoma, Akebiae Caulis, adding 300 mL of water, and then adding 4.13 g of bamboo leaf, decocting together to 150 mL, taking warmly after meal". Daochisan has the effect of clearing the heart and enriching Yin, disinhibiting water and relieving stranguria, and is widely used in treating symptoms such as heart vexed hotness, hydrodipsia and reddish complexion. Modern studies have showed that Daochisan are frequently used in treating oral ulcer, herpetic stomatitis, urinary tract infection, herpes zoster and other diseases. The above research results can provide scientific reference for the future development and research of Daochisan.
9.Research Progress of IL-13 Regulating Mucus Hypersecretion in Allergic Rhinitis and the Intervention of Traditional Chinese Medicine
ZHAO Yue ; WANG Zhiwang ; HUANG Keting ; LIANG Keke ; QUAN Ping ; ZHANG Yue
Chinese Journal of Modern Applied Pharmacy 2024;41(13):1836-1843
Allergic rhinitis(AR) is an allergic inflammatory disease of the nasal mucosa in which the immune inflammatory response alters the local microenvironment of the nasal mucosa, causing mucus hypersecretion as one of the main pathological features of AR. Interleukin-13(IL-13) is the main inflammatory factor secreted by Th2 cells, it can be involved in AR mucus hypersecretion process by regulating Goblet cell proliferation and Mucin 5ac expression through various signaling pathways. Traditional Chinese medicine has obvious advantages in the treatment of AR and its mucus hypersecretion, while the IL-13-mediated signaling pathways are one of the important mechanisms in treating AR mucus hypersecretion. This article reviews the regulation of IL-13-mediated signaling pathways on AR mucus hypersecretion and the intervention effects of traditional Chinese medicine, which providing a theoretical basis for experimental research and new drug development in AR mucus hypersecretion.
10.Real-world study of tenofovir amibufenamide in the treatment of patients with hepatitis B cirrhosis
Ying HAN ; Ajuan ZENG ; Xueying LIANG ; Yanna LIU ; Keke JIN ; Huiguo DING
Chinese Journal of Hepatology 2024;32(S1):30-34
Objective:To evaluate the short-term antiviral efficacy and safety profile of tenofovir amibufenamide (TMF) in patients with hepatitis B cirrhosis.Methods:The biochemical indexes, renal function, and complication status in patients with hepatitis B cirrhosis who were treated with tenofovir amibufenamide (TMF) in Beijing You'an Hospital Affiliated to Capital Medical University from March 2022 to June 2024 were retrospectively analyzed.Results:A total of 98 cases with hepatitis B cirrhosis were included. Among them, 62 and 36 cases with hepatitis B cirrhosis had previously undergone partial resection for hepatocellular carcinoma. 66.7% (62/93) of the treated patients were HBV DNA negative before treatment. The longest follow-up time for medication was 24 months, with an average follow-up of (14.1±4.7) months. There were no statistically significant differences in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin (TBil) levels at 18 months of treatment compared with those before treatment ( P>0.05). The ALT return to normal rate was 91.3%. The HBV DNA negativity rate was 90.6% and 93.5% at 18 and 12 months of follow-up, respectively. There were no significant changes in the estimated glomerular filtration rate (eGFR) and low-density lipoprotein cholesterol (LDL-C) compared with those before treatment ( P>0.05). 36 cases were still HBV DNA positive (including 31 treated and 5 never treated) before treatment. A total of 29 cases were followed up for 12 months, and 24 cases (82.8%) had HBV DNA negative conversion. Conclusion:TMF antiviral therapies have an HBV DNA negative rate of over 80% at 12 months and can improve the liver function in patients with hepatitis B cirrhosis. However, there were no significant changes in renal function and blood lipids before and after treatment.


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