1.Textual Research on Key Information of Classic Formula Shengma Gegentang
Yuli LI ; Ping JIANG ; Zhenyi YUAN ; Yuanyuan HE ; Ya'nan MAO ; Shasha WANG ; Wenyan ZHU ; Zhouan YIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):187-197
Shengma Gegentang is one of the classic formulas in the Catalogue of Ancient Classic Prescriptions (Second Batch). This study reviewed ancient and modern literature and used literature tracing and bibliometric methods to analyze the historical evolution, efficacy, indications, dosage decoctions, and modern clinical disease spectrum of Shengma Gegentang. The results indicated that the earliest record of Shengma Gegentang can be found in the Taiping Huimin Heji Jufang of the Song dynasty, but its origin can be traced back to the Shaoyao Siwu Jiejitang in the Beiji Qianjin Yaofang of the Tang dynasty. The composition dosage of Shengma Gegentang is 413 g of Cimicifugae Rhizoma, 619.5 g of Puerariae Lobatae Radix, 413 g of Paeoniae Radix Alba, and 413 g of Glycyrrhizae Radix et Rhizoma, which are ground into coarse powder. Each dose is 12.39 g, and the amount of water added is 300 mL. 100 mL of solution is decocted and taken at the right time. The four drugs in the formula play the role of relieving exterior syndrome, penetrating pathogenic factors, and detoxicating together. Its indications are widely involved in internal medicine, pediatrics, surgery, ophthalmology and otorhinolaryngology, obstetrics and gynecology, sexually transmitted diseases, and other diseases, such as measles, sores, acne, spots, surgical gangrene, red eyes, toothache, chancre, and fetal poison. The epidemic diseases treated by Shengma Gegentang are complicated, including rash, pox, macula, numbness, summer diarrhea, dysentery, sha disease, febrile symptoms, spring warmth, winter warmth, and cold pestilence. At the same time, it is a plague prevention formula. Although Shengma Gegentang has a wide range of indications, it cannot be separated from the pathogenic mechanism of evil Qi blocking the muscle surface and heat in the lungs and stomach. The modern clinical disease spectrum of Shengma Gegentang involves the ophthalmology and otorhinolaryngology system, nervous system, pediatric-related diseases and syndromes, skin system, hepatobiliary system, and digestive system. It plays a key role in the treatment of epidemic diseases such as measles, chronic hepatitis B, dysentery, and tetanus.
2.Analysis on Registration Status of Clinical Trials of Common Anorectal Diseases in China Based on ChiCTR
Biao LIANG ; Yiheng YANG ; Jiachun NI ; Shiwei QIAN ; Shuo HUANG ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):55-59
Objective To analyze the current status of clinical trial registration of common anorectal diseases in Chinese Clinical Trial Registry(ChiCTR)and the research of TCM.Methods The ChiCTR database was retrieved to collect and organize clinical trials related to hemorrhoids,anal fissures,anal fistulas,perianal abscesses,and perianal eczema.The retrieval time was from the establishment of the database to December 10,2023.Characterization of included registration trials was analyzed.Results A total of 148 registered projects were included,75 of which were TCM-related clinical trials.Among them,134 clinical trials were pre-registered and 121 passed the ethical review.Shanghai,Jiangsu,Guangdong,Beijing and Sichuan accounted for 76.35%of the total number of registrations,and the largest number of registered projects was in Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine.The top 3 funding sources were local finance,self-funding and hospital funding.The registered projects were mainly intervention studies.114 studies used randomized methods and 34 studies were blinded.Conclusion At present,the number of ChiCTR-registered clinical trials on anorectal diseases is on an increasing trend,and the treatment of anorectal diseases with TCM has obvious characteristics.However,there are cases of irregular filling of registration content and uneven regional distribution.
3.Analysis on Current Status of Clinical Trial Registration on TCM Prevention and Treatment of Constipation in China
Shuo HUANG ; Biao LIANG ; Yiheng YANG ; Jiachun NI ; Shiwei QIAN ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(5):62-67
Objective To investigate the distribution characteristics and future trends of clinical trials related to TCM prevention and treatment of constipation by analyzing the clinical trials registered in the Chinese Clinical Trial Registry(ChiCTR).Methods The clinical trials data related to TCM prevention and treatment of constipation in the ChiCTR database were retrieved from the establishment of the database to April 15,2024.Excel 2019 was utilized for de-duplication.Subsequently,SPSS 26.0 was employed to analyze the general characteristics,research types,intervention measures,etc.of the included trials,charts were drawn,and the clinical trial characteristics were summarized.Results A total of 107 clinical trials were included,with 102 being pre-registered,involving 21 provincial-level administrative regions and 75 clinical institutions.The top five regions in terms of the number of registered clinical trials were Beijing(19.63%),Shanghai(15.89%),Guangdong(14.02%),Sichuan(10.28%)and Jiangsu(9.35%).The top three sources of funding were local finance(28.97%),self-raised funds(18.69%)and hospital-funded funds(15.89%).The research types were mostly intervention studies(92.52%),of which 41 explicitly stated the use of blinding methods,and the main research design type is randomized parallel controlled trial.Conclusion The number of clinical trials related to TCM prevention and treatment of constipation registered in ChiCTR is on an upward trend.However,there is a noticeable geographical imbalance in the distribution of these trials,and there is a need for further improvement in the quality of trial design and the standardization of registration information.
4.Study on fingerprint establishment,content determination,and spectrum-effect relationship of in vitro antioxidant activity for Bushen ningshen ointment
Li WANG ; Wenhua XU ; Yang YANG ; Lingyi XIN ; Zhenyi ZHANG ; Guangyi YANG
China Pharmacy 2025;36(14):1749-1754
OBJECTIVE To establish the fingerprint of Bushen ningshen ointment, determine the contents of its major constituents, and investigate its in vitro antioxidant activity. METHODS High performance liquid chromatography (HPLC) fingerprints of 10 batches of Bushen ningshen ointment were established. Similarity evaluation and identification of common peaks were subsequently performed. The contents of 10 components such as salidroside were determined using the same HPLC method. Using the scavenging rates against 2,2′-azino bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS) and 1,1-diphenyl-2- picrylhydrazyl (DPPH) radicals, as well as ferric ion reducing antioxidant power (FRAP) as indicators, the anti-oxidant activity of the ointment was evaluated; grey relational analysis and partial least squares regression were conducted using SIMCA 14.1 software to establish the spectrum-effect relationship. RESULTS The fingerprint chromatogram of 10 batches of Bushen ningshen ointment contained 24 common peaks, with similarity values all exceeding 0.96. Eleven peaks were identified as adenosine (peak 1), salidroside (peak 4), morroniside (peak 6), catechin (peak 7), paeoniflorin (peak 10), spinosin (peak 11), ferulic acid (peak 12), isoquercitrin (peak 13), E-mail:wli1743@163.com verbascoside (peak 14), paeonol (peak 23), and emodin (peak 24). Content determination results showed that the average contents of salidroside, morroniside, catechin, paeoniflorin, spinosin, ferulic acid, isoquercitrin, verbascoside, paeonol, and emodin were 0.725, 1.962, 0.214, 3.395, 0.124, 0.107, 0.286, 0.019, 0.034 and 0.067 mg/g, respectively. The antioxidant potency composite index (APC) for the 10 batches ranged from 85.08% to 96.35%. Spectrum-effect relationship analysis indicated that all 24 common peaks were positively correlated with the antioxidant capacity. Seventeen peaks had variable importance in projection values >1, specitically peaks 2, 5, 6, 7, 9, 10, 13- 21, 23, and 24. CONCLUSIONS This study successfully established the HPLC fingerprint and content determination method for Bushen ningshen ointment. The compounds represented by the 17 common peaks such as morroniside may be the active components contributing to its antioxidant effects.
5.Clinical efficacy of drug-coated balloons in the treatment of infrapopliteal artery disease in hemodialysis patients
Shengxing WANG ; Zhenyi JIN ; Chunmin LI ; Wangde ZHANG ; Yang ZHANG
Chinese Journal of General Surgery 2025;40(11):869-873
Objective:To evaluate the efficacy of drug-coated balloons (DCB) in hemodialysis patients with peripheral artery disease (PAD) involving infrapopliteal lesions.Methods:A retrospective analysis was conducted on 53 hemodialysis patients (56 limbs, 66 lesions) with infrapopliteal PAD who underwent DCB treatment between Dec 2018 and Dec 2021. The primary outcome was improvement in Rutherford classification, while secondary outcomes included target lesion revascularization (TLR) and wound healing rate. Safety endpoints were all-cause mortality, amputation-free survival, and amputation rate.Results:The mean lesion length was (145.2±78.4) mm, and 87.5% of patients were of Rutherford grade ≥4. The median follow-up period was 14 months. Rutherford classification significantly improved at 3 and 12 months ( P< 0.001). At 12 months, TLR was 16.6%, wound healing rate was 68.6%, amputation-free survival was 73.2%, all-cause mortality was 19.8%, and amputation rate was 8.9%. Multivariate Cox regression indicated that high WIfI risk ( HR=3.936, 95% CI: 1.079-14.355, P=0.038) was an independent predictor of amputation-free survival. Conclusion:DCB is effective and safe for hemodialysis patients with infrapopliteal artery disease, while high WIfI risk predicts poor prognosis.
6.The parallel mediating effects of anxiety and depression states between life events and behavior problems in adolescents
Zihao YANG ; Qingqing ZHANG ; Dan WANG ; Lei ZHANG ; Hua ZHENG ; Lijing SHI ; Nana WANG ; Yihan ZHANG ; Zhenyi LI ; Min SUN ; Huimin CHEN ; Huiping CHENG ; Ruiling ZHANG ; Chuansheng WANG
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(3):259-265
Objective:To explore the relationship between life events, anxiety, depression, and behavior problems in adolescents.Methods:From September to October 2022, the cluster sampling method was used to select 5 341 adolescents from 4 middle schools in Xinxiang urban area.The subjects and their parents were investigated by the adolescent self-rating life events check list (ASLEC), generalized anxiety disorder scale (GAD-7), patient health questionnaire (PHQ-9), and child behavior checklist (CBCL). SPSS 27.0 software was used for Spearman correlation analysis, and AMOS 28.0 software was used to construct the structural equation model.Results:The scores of anxiety, depression, and behavioral problems were 1 (0, 4), 1 (0, 4), and 3 (0, 10). The total score of life events was 5 (1, 13), and the dimensions scored as follows: interpersonal conflict 1 (0, 4), academic pressure 2 (0, 5), punishment 0 (0, 2), loss 0 (0, 0), health and adaptation problem 0 (0, 1), and others 0 (0, 2). There were positive correlations between life events and its dimensions, depression, anxiety and behavioral problems ( r=0.28-0.69, all P<0.01). In the overall population, anxiety and depression played parallel mediating roles in the impact of life events on behavior problems. Life events could positively predict anxiety ( β=0.68, P<0.01), and anxiety could positively predict behavior problems ( β=0.04, P=0.02). Life events could positively predict depression ( β=0.77, P<0.01), and depression could positively predict behavior problems ( β=0.18, P<0.01). The standardized total effect size of the impact of life events on behavioral problems was 0.622 (95% CI=0.564-0.675). The standardized direct effect size and indirect effect size were 0.460 (95% CI=0.374-0.539) and 0.162 (95% CI=0.108-0.218), accounting for 74.0% and 26.0%of the total effect, respectively. After stratification by gender, the results for male adolescents were consistent with the overall population, while the mediating effect of anxiety was not significant in the female adolescents. Conclusion:Life events can lead to anxiety and depression in adolescents, thereby increasing the risk of behavior problems.
7.The parallel mediating effects of anxiety and depression states between life events and behavior problems in adolescents
Zihao YANG ; Qingqing ZHANG ; Dan WANG ; Lei ZHANG ; Hua ZHENG ; Lijing SHI ; Nana WANG ; Yihan ZHANG ; Zhenyi LI ; Min SUN ; Huimin CHEN ; Huiping CHENG ; Ruiling ZHANG ; Chuansheng WANG
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(3):259-265
Objective:To explore the relationship between life events, anxiety, depression, and behavior problems in adolescents.Methods:From September to October 2022, the cluster sampling method was used to select 5 341 adolescents from 4 middle schools in Xinxiang urban area.The subjects and their parents were investigated by the adolescent self-rating life events check list (ASLEC), generalized anxiety disorder scale (GAD-7), patient health questionnaire (PHQ-9), and child behavior checklist (CBCL). SPSS 27.0 software was used for Spearman correlation analysis, and AMOS 28.0 software was used to construct the structural equation model.Results:The scores of anxiety, depression, and behavioral problems were 1 (0, 4), 1 (0, 4), and 3 (0, 10). The total score of life events was 5 (1, 13), and the dimensions scored as follows: interpersonal conflict 1 (0, 4), academic pressure 2 (0, 5), punishment 0 (0, 2), loss 0 (0, 0), health and adaptation problem 0 (0, 1), and others 0 (0, 2). There were positive correlations between life events and its dimensions, depression, anxiety and behavioral problems ( r=0.28-0.69, all P<0.01). In the overall population, anxiety and depression played parallel mediating roles in the impact of life events on behavior problems. Life events could positively predict anxiety ( β=0.68, P<0.01), and anxiety could positively predict behavior problems ( β=0.04, P=0.02). Life events could positively predict depression ( β=0.77, P<0.01), and depression could positively predict behavior problems ( β=0.18, P<0.01). The standardized total effect size of the impact of life events on behavioral problems was 0.622 (95% CI=0.564-0.675). The standardized direct effect size and indirect effect size were 0.460 (95% CI=0.374-0.539) and 0.162 (95% CI=0.108-0.218), accounting for 74.0% and 26.0%of the total effect, respectively. After stratification by gender, the results for male adolescents were consistent with the overall population, while the mediating effect of anxiety was not significant in the female adolescents. Conclusion:Life events can lead to anxiety and depression in adolescents, thereby increasing the risk of behavior problems.
8.Clinical efficacy of laser ablation and closure in the treatment of sacrococcygeal pilonidal disease and analysis of risk factors for postoperative recurrence in male patients
Zhicheng LI ; Lei JIN ; Zhenyi WANG ; Jialin QIN ; Jiong WU
Chinese Journal of Gastrointestinal Surgery 2025;28(12):1448-1454
Objective:To investigate the clinical efficacy and safety of laser ablation and closure for the treatment of sacrococcygeal pilonidal disease (SPD) and to analyze risk factors for postoperative recurrence in male patients.Methods:A retrospective observational study was conducted to collect clinical data of 369 patients with SPD who underwent laser ablation and closure in the Anorectal Department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine between March 2019 and December 2024. Perioperative outcomes and postoperative recurrence were analyzed. The cohort included 313 males and 56 females, with 43 patients aged ≤18 years. The median body mass index was 26.3 (IQR: 22.9, 29.6) kg/m2, and the median disease duration was 28 months (IQR: 4, 76). Among them, 218 male SPD patients who underwent surgery received preoperative sex hormone testing. A logistic regression model was used to analyze the risk factors for recurrence.Results:All patients completed the surgery. The median intraoperative ablation energy delivered was 426.8 (IQR: 243.9, 683.9) J, with no occurrence of major intraoperative complications. Postoperatively, a total of 31 patients (8.4%) required analgesic medication. Within the first postoperative week, 12 patients experienced wound oozing/bleeding; hemostasis was achieved by compression alone in 5 cases, while the remaining 7 instances required suture hemostasis after failed compression attempts. No other complications were observed. The median postoperative hospital stay was 6 (IQR: 4, 8) days, and the median time to return to regular work and life was 7 (IQR: 5, 12) days. The wound healing rate was 100%, with a median wound healing time of 35 (IQR: 30, 42) days. Postoperative recurrence occurred in 19 patients (5.1%), all of whom were male. Multivariate logistic regression analysis identified age ≤18 years (OR = 4.764, 95%CI: 2.424-34.905, P = 0.008) and a history of previous SPD surgery (OR = 5.078, 95%CI: 1.431-18.019, P = 0.012) as independent risk factors for recurrence after SPD laser ablation and closure surgery. Conclusion:Laser ablation and closure are safe, effective, and minimally invasive treatments for SPD. However, particular attention should be paid to the risk of recurrence in young male patients and those with a history of previous SPD surgery.
9.Analysis on Current Status of Clinical Trial Registration on TCM Prevention and Treatment of Irritable Bowel Syndrome
Shiwei QIAN ; Biao LIANG ; Shuo HUANG ; Yiheng YANG ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):62-66
Objective To explore the distribution characteristics and development trend of TCM prevention and treatment for irritable bowel syndrome(IBS)by analyzing the clinical trials of TCM prevention and treatment for IBS registered in China Clinical Trial Registry(ChiCTR).Methods The ChiCTR database was retrieved to collect and organize clinical trials related to the TCM prevention and treatment of IBS from the establishment of the database to May 1,2024.Characteristics of the included trials were analyzed and summarized using SPSS 25.0 and Excel 2021.Results A total of 73 clinical trials were included,of which 65 were pre-registered.The registered research projects involved 14 provincial-level administrative regions,including Beijing,Jiangsu,Guangdong,Shanghai,and Sichuan,and 46 clinical trial institutions,among which Beijing University of Chinese Medicine(6 items,7.89%)registered a higher number.The top three sources of research funding were,in order,local finance(26 items,35.62%),state finance(20 items,27.40%),and hospital funding(10 items,13.70%).The types of studies were predominantly interventional(68 items,93.15%),and the study designs were predominantly randomized parallel controlled studies(64 items,87.67%),but only 27 studies(36.99%)used a blinded approach.The main interventions included acupuncture and moxibustion,Chinese patent medicines,classic prescriptions/hospital-prepared remedies,etc.Conclusion The number of clinical research registrations in this field has been gradually increasing in recent years,but there are problems such as uneven regional distribution,low use of blinding,and lack of standardization of registration information.
10.Analysis of the Current Status of Clinical Trial Registration for TCM in the Treatment of Psoriasis
Yiheng YANG ; Zhan ZHANG ; Biao LIANG ; Shiwei QIAN ; Jiachun NI ; Shuo HUANG ; Changpeng HAN ; Zhenyi WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):67-72
Objective To analyze the clinical trial projects of TCM treatment for psoriasis registered at the China Clinical Trial Registry(ChiCTR);To provide references for clinical research in this field.Methods Clinical trial studies on the TCM treatment for psoriasis were retrieved from the ChiCTR database from the establishment of the database to June 17,2024.Excel 2019 and GraphPad Prism 9.0 were used to organize and analyze the general characteristics included in registered clinical trials.Results Totally 65 TCM-related trials were included,of which 58(89.23%)were prospectively registered,and 55(84.62%)had undergone ethical review.The majority of trials were registered in Guangdong,Beijing and Shanghai,collectively accounting for 78.46%(n=51)of the total.The leading institution,Guangdong Provincial Hospital of Chinese Medicine,contributed 19 trials.Funding was predominantly sourced from governmental bodies,with 72.31%(n=47)supported by national or regional grants.Among the registered studies,interventional trials predominated(n=56),including 46 randomised parallel-controlled designs.Blinding was implemented in 23 trials,and biospecimen collection was reported in 48 studies.40 trials were single-centre studies,and a cumulative sample size was 17 695 participants.Common interventions included oral administration of classical TCM formulations or hospital-prepared remedies,alongside topical applications such as medicated baths and ointments.The primary outcome measure in most trials was the Psoriasis Area and Severity Index.Conclusion While the number of registered clinical trials on TCM for psoriasis in China demonstrates a fluctuating yet upward trend,the overall volume remains modest.Disparities in regional distribution,methodological variability,and incomplete trial registration details highlight areas for improvement.

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