1.A Meta-Analysis on the Efficacy and Safety of Xihuang Pill/Capsule( 西黄丸/胶囊) as an Adjuvant to Radio⁃therapy and Chemotherapy in the Treatment of Malignant Digestive Tract Tumors
Mengyi LI ; Lei ZHANG ; Lijun WANG ; Xing GAO
Journal of Traditional Chinese Medicine 2025;66(9):912-919
ObjectiveTo evaluate the efficacy and safety of Xihuang Pill/Capsule (西黄丸/胶囊, XP/XC) as an adjuvant to radiotherapy and/or chemotherapy in the treatment of malignant digestive tract tumors. MethodsA systematic search was conducted in the China Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, VIP Database, PubMed, Web of Science, Embase, and Cochrane Library for randomized controlled trials (RCTs) published before March 6, 2024, regarding the use of XP/XC in clinical adjuvant treatment of malignant digestive tract tumors. The methodological quality of the included studies was assessed using the risk of bias assessment tool. RevMan 5.4 was used to perform a Meta-analysis on 1-year survival rate, 2-year survival rate, clinical efficacy, including objective response rate and disease control rate, Karnofsky Performance Status (KPS) score, immune markers (CD3+, CD4+, CD8+, and CD4+/CD8+ ratio), and adverse event rates (incidence of gastrointestinal reactions and bone marrow suppression). ResultsThirteen RCTs involving 962 patients were included, with 527 patients in the experimental group and 435 patients in the control group. Meta-analysis results showed that the experimental group had better outcomes than the control group in terms of 2-year survival rate [RR = 0.49, 95% CI (0.31, 0.78)], objective response rate [RR = 0.68, 95% CI (0.60, 0.77)], disease control rate [RR = 0.85, 95% CI (0.80, 0.91)], and immune markers CD3+ [MD = -7.99, 95% CI (-9.12, -6.86)], CD4+ [MD = -5.42, 95% CI (-7.11, -3.74)], and CD4+/CD8+ ratio [MD = -0.26, 95% CI (-0.32, -0.20)] (P<0.05). However, no statistically significant differences were found between the experimental and control groups in terms of 1-year survival rate [RR = 0.91, 95% CI (0.73, 1.14)], KPS [MD = -3.73, 95% CI (-8.67, 1.21)], CD8+ [MD = -0.53, 95% CI (-1.45, 0.39)], incidence of gastrointestinal reactions [RR = 0.82, 95% CI (0.46, 1.46)], and incidence of bone marrow suppression [RR = 0.93, 95% CI (0.72, 1.20)] (P>0.05). ConclusionCompared with radiotherapy/chemotherapy alone, the combination of XP/XC with radiotherapy/chemotherapy can effectively improve clinical efficacy and 2-year survival rate, enhance immune function, and achieve similar adverse event rates as radiotherapy/chemotherapy alone in patients with malignant digestive tract tumors.
2.Correlation study on influenza epidemic in representative 5 cities in the middle and lower reaches of the Yangtze River based on detection of oseltamivir metabolite in wastewater
Chen SHI ; Manlei ZHANG ; Xinxin ZHOU ; Mengyi CHEN ; Chenzhi HOU ; Bin DI
Journal of China Pharmaceutical University 2025;56(2):155-159
By selecting stable and detectable drug prototypes or metabolites in sewage samples, near real-time detection of disease conditions can be achieved. This study selected oseltamivir carboxylate, the primary metabolite of first-line antiviral oseltamivir, as a biomarker. Based on the concentration of oseltamivir carboxylate in wastewater, the consumption and usage rate of oseltamivir were calculated by reverse engineering. Quarterly sampling was conducted at 46 urban sewage treatment plants in representative 5 cities in the middle and lower reaches of the Yangtze River, from November 2022 to December 2023. The concentration range of oseltamivir acid in sewage samples is 1.270−1 279 ng/L, the daily mass load of oseltamivir per 1 000 inhabitants in the surveyed cities ranged from 9.560 to 544.7 mg/d, and the average utilization rate is 0.06‰−3.63‰. The research results indicate that in March 2023, Wuxi City experienced a spring influenza peak, while Bengbu, Tongling, Suzhou, and Changzhou City experienced a small summer influenza peak in May. In November and December 2023, Wuxi, Changzhou, and Bengbu City experienced a winter influenza peak, the results are consistent with the official statistics of the National Center for Disease Control and Prevention and the National Influenza Center, which reflect the influenza epidemic situation in southern cities. The integration of this methodology with clinical diagnostic rates could provide near real-time data support for future influenza prevention and control strategies.
3.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT
Fuqiang ZHANG ; Ziteng HU ; Yujing ZHANG ; Lijiao YAN ; Juyi WANG ; Cehan ZHANG ; Jiaqi CHEN ; Mengyi WANG ; Shuoming LIU ; Xinyi XIE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):185-191
ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine (CPM) with internationally recognized tools the appraisal of guidelines for research and evaluation (AGEREE) Ⅱ and reporting items for practice guidelines in healthcare (RIGHT), thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI, VIP, Wanfang and Sinomed were searched for CPM guidelines, as well as medlive.cn, websites of China Association of Chinese Medicine and Chinese Medical Association, and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools, and consistency tests were performed using Interclass Correlation Coefficient, and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally, 140 CPM guidelines were included, of which 51 were disease-oriented and 89 were drug-oriented, all of which were issued by China. For 51 disease-oriented CPM guidelines, the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity, and the lowest was 26.80% for application; for 89 drug-oriented CPM guidelines, the highest average score was 55.62% for scope and purpose, and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist, the highest reporting rate was 68.26% for background, and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines; the highest reporting rate was 61.31% for background, and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ (rigour of development, clarity of presentation, editorial independence), as well as four domains of RIGHT checklist (basic information, evidence, funding and declaration and management of interests, and other areas). ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist, and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines, thereby guiding the clinical use of CPM in a better way.
4.Prevention and treatment of lipoic acid-niacin on blue-light-induced retinal damage in rats
Tianhao CHENG ; Yuping ZOU ; Liulian JIAN ; Mengyi ZHANG ; Yixuan DOU
International Eye Science 2024;24(2):196-202
AIM: To investigate the preventive effect and optimal drug dose of lipoic acid-niacin(N2L)against blue light-induced retinal damage in SD rats, and to explore its possible protective mechanism.METHODS: A total of 36 specific pathogen free-grade male SD rats of 150-200 g were selected and randomly divided into normal control group, blue light injury group, N2L low-dose group(1.0 mg/kg), N2L medium-dose group(2.5 mg/kg), N2L high-dose group(5.0 mg/kg), and physiological saline group, with 6 rats in each group. The normal control group was reared in a 12 h dark and light cycle, and the rest of the groups received 9 h of daily light exposure, 3 h of blue light irradiation with a wavelength of 455 nm and an intensity of 3000±50 lx, and 12 h of darkness to establish the injury model, and were exposed to light exposure for 14 d. For 14 consecutive durations, a 1 mL dose of the corresponding drug was injected intraperitoneally. The rats were reared for another 5 d with a regular 12 h light-dark cycle and were examined by electroretinography. Specimens were prepared by over anesthesia, HE staining, and the thickness of the outer nuclear layer was observed under a optical microscope; superoxide dismutases(SOD)activity was detected by CheKineTM SOD Activity Assay Kit; and the retinal Caspase-3, quinone oxidoreductase 1(NQO1), glutathione S transferase(GST), Bcl-2, and Bax protein expression in rat retina were detected by Western blot.RESULTS: The amplitude of b-wave in dark-vision ERG 3.0 and 10.0(cd·s)/m2 stimulated light, b-wave in bright-vision ERG 3.0(cd·s)/m2 stimulated light, and the amplitude of the 2nd wave peak of oscillatory potential were significantly lower in blue light injury group than that in the normal control group(all P<0.01), while the amplitude was significantly higher in the N2L medium-dose group than in the blue light injury group(all P<0.05), and was not statistically different from that of the normal control group; the thickness of the retina in the blue light injury group was decreased in the ONL compared with that of the normal control group(P<0.001), while in the N2L medium dose group, it was thicker than that of the blue light injury group(P<0.001), and there was no statistically significant difference from the normal control group; SOD activity was significantly higher in the N2L medium-dose group than in the remaining 5 groups(P<0.05); the expression of Caspase-3, Bax, and NQO1 in the blue light injury group was higher than that of the normal control group(all P<0.01), and expression of Bax and Caspase-3 was significantly lower in the N2L medium-dose group compared with the blue light injury group(all P<0.001), whereas GST, NQO1 and Bcl-2 were significantly increased(all P<0.01).CONCLUSION:A concentration of 2.5 mg/kg N2L can effectively antagonize the damaging effect of blue light on the retina of SD rats, and it is expected to be a preventive and curative drug for it.
5.Predictive value of cardiopulmonary exercise test in the postoperative complications in patients with esophageal cancer: A retrospective cohort study
Mengyi REN ; Jin LI ; Ming ZHANG ; Miao ZHANG ; Min GAO ; Wei CHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(08):1148-1155
Objective To explore the predictive value of cardiopulmonary exercise test (CPET) combined with clinical indexes in the postoperative complications. Methods The clinical data and CPET data (including lung function) of patients undergoing radical esophagectomy in Xuzhou Central Hospital from January 2018 to March 2022 were collected. Univariate analysis and multivariate logistic regression analysis were used to analyze the meaningful evaluation index for the occurrence of postoperative complications. Results A total of 77 patients with esophageal cancer were included, including 59 (76.6%) males and 18 (23.4%) females aged 47-80 years. There were 42 (54.5%) patients in the non-complication group and 35 (45.5%) patients in the complication group. Univariate analysis results showed that the occurrence of postoperative complications was significantly correlated with age, body mass index (BMI), smoking index, tumor stage, the length of postoperative hospital stay, peak work rate (WRpeak), peak kilogram oxygen uptake (VO2peak/kg), the ventilatory equivalent for carbon dioxide slope (VE/VCO2 slope), forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and maximum expiratory flow rate (MMEF) (P<0.05). The results of multivariate logistic regression analysis showed that BMI [OR=1.35, 95%CI (1.03, 1.77), P=0.031], peakVO2/kg [OR=0.64, 95%CI (0.45, 0.93), P=0.018], oxygen uptake-anaerobic threshold (ATVO2) [OR=0.66, 95%CI (0.44, 0.98), P=0.044] and VE/VCO2 slope [OR=1.49, 95%CI (1.10, 2.02), P=0.011] were the related indexes of complications after radical resection of esophageal cancer. The sensitivity of BMI, VO2peak/kg, ATVO2/kg and VE/VCO2 slope in predicting postoperative complications was 82.10%, and the specificity was 87.44%, 95%CI (0.744, 0.955). Conclusion BMI, VO2peak/kg, ATVO2/kg and VE/VCO2 slope can be used as predictors for postoperative complications of esophageal cancer.
6.Development of evidence-based practice protocols for post-stroke insomnia
Xinqi WANG ; Ying ZHU ; Mengyi CAI ; Meijie ZHANG ; Weiying ZHANG
Chinese Journal of Practical Nursing 2024;40(24):1841-1847
Objective:To develop a post-stroke insomnia (PSI) evidence-based nursing practice protocol to provide reference for the implementation of insomnia nursing in stroke patients.Methods:In January 2022, a research team was formed. Based on evidence-based principles, systematically searched and summarized high-quality evidence of Western medicine care and Chinese medicine care related to PSI to develop the first draft of the evidence-based nursing practice protocol for PSI, invited medical experts and nursing experts in the field of stroke care, medical treatment, research and teaching, and the protocol was revised through 2 rounds of Delphi expert consultation to form the final draft of the protocol.Results:A total of 15 experts were invited, 3 males and 12 females; 2 between 31 and 40 years of age, 6 between 41 and 50 years of age, and 7 between 51 and 60 years of age.The positive coefficient for both rounds of expert consultation was 100% and the expert authority coefficient was 0.89; the Kendall coordination coefficients for the importance and feasibility scores of the entries in the 2 rounds expert consultation were 0.188 and 0.146, 0.224 and 0.188 (all P<0.01). The PSI evidence-based nursing practice protocol included 27 entries in 6 dimensions: assessment of sleep quality, diagnosis of PSI, development of an individualized plan, non-pharmacological interventions, Chinese medicine nursing interventions, preparation for discharge and follow-up. Conclusions:The PSI evidence-based nursing practice protocol is scientific, reliable and applicable, and can provide a reference for the nursing practice of PSI patients.
7.Functional gastrointestinal disorders, mental health, genetic susceptibility, and incident chronic kidney disease
Mengyi LIU ; Panpan HE ; Ziliang YE ; Sisi YANG ; Yanjun ZHANG ; Qimeng WU ; Chun ZHOU ; Yuanyuan ZHANG ; Fan Fan HOU ; Xianhui QIN
Chinese Medical Journal 2024;137(9):1088-1094
Background::Whether functional gastrointestinal disorders (FGIDs) are associated with the long-term risk of chronic kidney disease (CKD) remains unclear. We aimed to investigate the prospective association of FGIDs with CKD and examine whether mental health mediated the association.Methods::About 416,258 participants without a prior CKD diagnosis enrolled in the UK Biobank between 2006 and 2010 were included. Participants with FGIDs (including irritable bowel syndrome [IBS], dyspepsia, and other functional intestinal disorders [FIDs; mainly composed of constipation]) were the exposure group, and non-FGID participants were the non-exposure group. The primary outcome was incident CKD, ascertained from hospital admission and death registry records. A Cox proportional hazard regression model was used to investigate the association between FGIDs and CKD, and the mediation analysis was performed to investigate the mediation proportions of mental health.Results::At baseline, 33,156 (8.0%) participants were diagnosed with FGIDs, including 21,060 (5.1%), 8262 (2.0%), and 6437 (1.6%) cases of IBS, dyspepsia, and other FIDs, respectively. During a mean follow-up period of 12.1 years, 11,001 (2.6%) participants developed CKD. FGIDs were significantly associated with a higher risk of incident CKD compared to the absence of FGIDs (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.28–1.44). Similar results were observed for IBS (HR, 1.27; 95% CI, 1.17–1.38), dyspepsia (HR, 1.30; 95% CI, 1.17–1.44), and other FIDs (HR, 1.60; 95% CI, 1.43–1.79). Mediation analyses suggested that the mental health score significantly mediated 9.05% of the association of FGIDs with incident CKD and 5.63–13.97% of the associations of FGID subtypes with CKD. Specifically, the positive associations of FGIDs and FGID subtypes with CKD were more pronounced in participants with a high genetic risk of CKD.Conclusion::Participants with FGIDs had a higher risk of incident CKD, which was partly explained by mental health scores and was more pronounced in those with high genetic susceptibility to CKD.
8.Exploring the Core Medication and Efficacy Evaluation of Hypoxic Pulmonary Hypertension Based on the Traditional Chinese Medicine Inheritance Assistance Platform
Zhengwei DONG ; Min ZHANG ; Yun DING ; Zuoying XING ; Rui YU ; Mengyi ZHAO ; Guanwei FAN ; Yongxia WANG ; Mingjun ZHU
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(8):2016-2022
Objective To investigate the core drugs of traditional Chinese medicine(TCM)for the treatment of hypoxic pulmonary hypertension(HPH),and to verify the drug efficacy by hypoxia combined with Su5416(Hypoxia+Su5416,HySu)-induced PH mouse model.Methods Relevant literatures on TCM treatment of HPH in China Knowledge Network,Wanfang,Weipu were collected,screened and set up a database through the nerf criteria,and inputted into the software of traditional Chinese medicine inheritance assistance platform(V2.5)for the excavation of medication law.The HySu-PH mouse model was established,and the core drugs were evaluated for drug efficacy through force exhaustion exercise running table,blood oxygen saturation,right ventricular pressure,and right heart hypertrophy index test.Results The 102 relevant formulas for the treatment of HPH were screened,involving a total of 158 traditional Chinese medicines,and the top 5 drug frequencies were Salvia miltiorrhiza,Rhizoma Chuanxiong,Astragalus membranaceus,Draba hebecarpa,and Angelica sinensis,with the highest use of blood-activating and blood-stasis removing drugs,and deficiency-tonifying drugs in the categories of drugs used,and Salvia miltiorrhiza was the core drug used.HySu-PH mouse models were constructed and given 2 weeks of treatment with the danshen preparation Danshen injection.Danshen injection significantly elevated body weight(P<0.01),oxygen saturation(P<0.05),displacement of exhaustion(P<0.01),and duration of exhaustion(P<0.05),and lowered the right ventricular systolic blood pressure(P<0.01)and the right cardiac hypertrophy index(P<0.01).Conclusion Salvia miltiorrhiza is a core drug for the treatment of HPH,and the danshen preparation Danshen injection can effectively treat HySu-PH.
9.Rapid Analysis of Components in Longshengzhi Capsules Based on UPLC-Q/TOF-MS Technology
Mengyi ZHAO ; Chenghao BI ; Mengjiao LI ; Zhengwei DONG ; Jiawei FAN ; Jinyue ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(8):2144-2153
Objective To establish a rapid detection and identification method for the chemical components of Longshengzhi capsules based on UPLC-Q-TOF/MS.Method UPLC-Q/TOF-MS technology was used to analyze and identify the chemical components of Longshengzhi capsules.The chromatographic column was a Waters Acquity UPLC BEH C18 column(100mm×2.1mm,1.7 μm),and the mobile phase A was 0.1%formic acid water.The mobile phase B was a methanol acetonitrile(1∶1)solution containing 0.1%formic acid(B).The flow rate is 0.3mL/min,the column temperature is 40℃,and the injection volume is 2 μL.The ion source adopts the electric spray ion source.The data is collected in the positive and negative ion modes,and the collection range is m/z 50~1200.The identification and matching are carried out through UNIFI software combined with manual verification of chemical components.Result 87 chemical components were preliminarily and rapidly identified.Conclusion The established method can systematically and rapidly analyze the chemical components in Longsheng leeches,providing a basis for the study of medicinal substances and having important significance for the quality control of Longsheng leeches.
10.The mechanism of bariatric surgery in the treatment of non-alcoholic fatty liver disease
Yiyang MIN ; Peng ZHANG ; Peirong TIAN ; Mengyi LI ; Jingyu ZHANG ; Guanda LU ; Zhongtao ZHANG
Chinese Journal of Digestive Surgery 2024;23(9):1231-1236
Non-alcoholic fatty liver disease (NAFLD), as a metabolic disease, has shown a constant upward trend in prevalence among the people in recent years. In addition to changing lifestyles and conventional drug treatment, bariatric surgery, represented by Roux-en-Y gastric bypass surgery and sleeve gastrectomy, has gradually become one of the treatment options for NAFLD. However, the mechanism of bariatric surgery in treating NAFLD remains to be studied. The "multiple-hit theory", which has gradually been recognized in recent years, believes that NAFLD is formed by the combined effect of multiple mechanisms such as insulin resistance, bile acid metabolism pathway, and intestinal flora. Based on relevant literatures and clinical practices, the authors explore the relevant mechanisms of bariatric surgery for direct or indirect treatment of NAFLD.

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