1.Preliminary study on the antibacterial material basis of Coptidis Rhizoma extracts by different methods based on spectrum-effect relationship
Xiaoxia NI ; Qiaoxiu CHEN ; Yuru YANG ; Yixiang CAO
Journal of Pharmaceutical Practice and Service 2026;44(2):80-84
Objective To establish the HPLC fingerprints for the different extracts from Coptidis Rhizoma,and investigate the spectrum-effect relationship between HPLC fingerprints and anti-Staphylococcus aureus activity in vitro to analyze the pharmacodynamic material basis. Methods Nine kinds of Coptidis Rhizoma extracts were prepared, and establish the HPLC fingerprints for them. The antibacterial rate of each extract was determined by the broth microdilution method with Staphylococcus aureus as the test bacteria. The grey relational analysis (GRA) method was used to analyze the correlation between the fingerprint data and the in vitro antibacterial test data. Results The HPLC fingerprints of nine kinds of Coptidis Rhizoma extracts were established, nine common characteristic fingerprint peaks were calibrated, and 5 peaks were identified by the reference substance comparison method. GRA analysis experiments showed that the correlation between nine peaks and antibacterial effect was 0.559 1~0.803 3; and the peak 3, peak 8 (palmatine hydrochloride), peak 9 (berberine hydrochloride) were positively correlated with the inhibition of Staphylococcus aureus,while the peak 9 (berberine hydrochloride) had the strongest effect, and its correlation degree was 0.803 3. Conclusion The effective substance of antibacterial was preliminarily determined through the study of spectrum-effect relationship for Coptidis Rhizoma extracts,which may be the alkaloids, mostly containing hydrochloride, which provided a reference for further research on the pharmacodynamic material basis of Coptidis Rhizoma.
2.A multicenter, randomized, double-blind clinical trial on the efficacy and safety of Gongxuening Capsule in reducing postoperative bleeding after induced abortion
Lirong TENG ; Chunying LI ; Ping PENG ; Shuping ZHAO ; Xiangying GU ; Xiaoxia ZHENG ; Jing JIANG ; Yali NI ; Min WANG ; Banglan WANG ; Chenchen REN ; Li SHAN ; Qing LIN ; Xinyan LIU
Chinese Journal of Reproduction and Contraception 2025;45(1):39-44
Objective:To assess the efficacy and safety of Gongxuening Capsules in reducing post-abortion bleeding following artificial abortion.Methods:A multicenter, randomized, double-blind study was conducted. From May 31, 2022 to March 31, 2023, 484 women who underwent vacuum aspiration abortion for early intrauterine pregnancy were enrolled in 11 centers and randomly assigned to control group and the study group at a 1∶1 ratio using a center-block randomization method. Control group were administered a placebo of Gongxuening Capsules for 9 d, while the study group received the actual Gongxuening Capsules for the same duration. The outcomes measured included vaginal bleeding volume, duration of vaginal bleeding, endometrial thickness, time to menstrual recovery, and complications.Results:1) A total of 484 subjects were enrolled, and 472 completed the study. Totally 450 subjects were included in the efficacy analysis set, with 224 in control group and 226 in the study group; 468 subjects were included in the safety analysis set, with 236 in control group and 232 in the study group. The baseline characteristics of the two groups were comparable (all P>0.05). 2) The vaginal bleeding volume was lower in the study group [(13.30±12.14) mL] than in control group [(19.00±17.67) mL, P<0.001]. The proportion of subjects in the study group with bleeding days less than 4 d [29.65% (67/226)] was higher than that in control group [19.20% (43/224), P=0.010]. 3) No significant differences were observed between the two groups in terms of time to menstrual recovery and endometrial thickness (all P>0.05). 4) In the study group, 3 subjects experienced non-therapeutic-related complications, while 11 subjects in control group. The incidence of complications was lower in the study group [1.29% (3/232)] than in control group [4.66% (11/236), P=0.033]. Conclusion:The administration of Gongxuening Capsules to women following artificial abortion significantly reduced vaginal bleeding volume and was associated with good safety, with the treatment being well-tolerated by the subjects.
3.A multicenter, randomized, double-blind clinical trial on the efficacy and safety of Gongxuening Capsule in reducing postoperative bleeding after induced abortion
Lirong TENG ; Chunying LI ; Ping PENG ; Shuping ZHAO ; Xiangying GU ; Xiaoxia ZHENG ; Jing JIANG ; Yali NI ; Min WANG ; Banglan WANG ; Chenchen REN ; Li SHAN ; Qing LIN ; Xinyan LIU
Chinese Journal of Reproduction and Contraception 2025;45(1):39-44
Objective:To assess the efficacy and safety of Gongxuening Capsules in reducing post-abortion bleeding following artificial abortion.Methods:A multicenter, randomized, double-blind study was conducted. From May 31, 2022 to March 31, 2023, 484 women who underwent vacuum aspiration abortion for early intrauterine pregnancy were enrolled in 11 centers and randomly assigned to control group and the study group at a 1∶1 ratio using a center-block randomization method. Control group were administered a placebo of Gongxuening Capsules for 9 d, while the study group received the actual Gongxuening Capsules for the same duration. The outcomes measured included vaginal bleeding volume, duration of vaginal bleeding, endometrial thickness, time to menstrual recovery, and complications.Results:1) A total of 484 subjects were enrolled, and 472 completed the study. Totally 450 subjects were included in the efficacy analysis set, with 224 in control group and 226 in the study group; 468 subjects were included in the safety analysis set, with 236 in control group and 232 in the study group. The baseline characteristics of the two groups were comparable (all P>0.05). 2) The vaginal bleeding volume was lower in the study group [(13.30±12.14) mL] than in control group [(19.00±17.67) mL, P<0.001]. The proportion of subjects in the study group with bleeding days less than 4 d [29.65% (67/226)] was higher than that in control group [19.20% (43/224), P=0.010]. 3) No significant differences were observed between the two groups in terms of time to menstrual recovery and endometrial thickness (all P>0.05). 4) In the study group, 3 subjects experienced non-therapeutic-related complications, while 11 subjects in control group. The incidence of complications was lower in the study group [1.29% (3/232)] than in control group [4.66% (11/236), P=0.033]. Conclusion:The administration of Gongxuening Capsules to women following artificial abortion significantly reduced vaginal bleeding volume and was associated with good safety, with the treatment being well-tolerated by the subjects.
4.Cost calculation of centralized dispensing of 4 categories of drugs in pharmacy intravenous admixture service
Changkun LI ; Qiyang WANG ; Xiaoxia ZHANG ; Chengqian CUI ; Chengsen PANG ; Ni MA ; Yating ZHANG ; Weiyi FENG ; Weihua DONG
China Pharmacy 2024;35(11):1386-1390
OBJECTIVE To calculate the cost of centralized dispensing of four categories of drugs (ordinary drugs, antibacterial drugs, hazardous drugs, and parenteral nutrition solutions) in pharmacy intravenous admixture service (PIVAS), and provide reference for setting charging standards for relevant departments. METHODS The operating costs of PIVAS in 12 medical institutions from Shaanxi province were collected through questionnaire survey, including labor costs, medical and health material costs, fixed asset depreciation and repair costs, water and electricity costs, and management costs. The operation time allocation coefficient method and workload allocation coefficient method were comprehensively used to allocate the above costs, and the unit preparation costs of four categories of drugs were calculated. RESULTS The average annual total costs of dispensing ordinary drugs, antibacterial drugs, hazardous drugs, and parenteral nutrition solutions in Shaanxi province were (2 195 900.25±1 680 893.73) yuan, (746 341.59±725 839.39) yuan, (331 420.15±183 258.83) yuan, and (330 322.68±277 281.70) yuan, respectively, with labor costs accounting for the highest proportion, averaging 85.49%. The costs of dispensing a set of ordinary drugs, antibacterial drugs, and hazardous drugs were 5.89, 7.60, and 14.37 yuan, respectively; the cost of dispensing one bag of parenteral nutrition solution was 32.15 yuan (excluding the cost of disposable intravenous nutrition bags). CONCLUSIONS The cost calculation method and data of different types of intravenous drugs obtained in this study can provide reference for relevant departments to formulate and adjust PIVAS fee standards.
5.Cost calculation of centralized dispensing of 4 categories of drugs in pharmacy intravenous admixture service
Changkun LI ; Qiyang WANG ; Xiaoxia ZHANG ; Chengqian CUI ; Chengsen PANG ; Ni MA ; Yating ZHANG ; Weiyi FENG ; Weihua DONG
China Pharmacy 2024;35(11):1386-1390
OBJECTIVE To calculate the cost of centralized dispensing of four categories of drugs (ordinary drugs, antibacterial drugs, hazardous drugs, and parenteral nutrition solutions) in pharmacy intravenous admixture service (PIVAS), and provide reference for setting charging standards for relevant departments. METHODS The operating costs of PIVAS in 12 medical institutions from Shaanxi province were collected through questionnaire survey, including labor costs, medical and health material costs, fixed asset depreciation and repair costs, water and electricity costs, and management costs. The operation time allocation coefficient method and workload allocation coefficient method were comprehensively used to allocate the above costs, and the unit preparation costs of four categories of drugs were calculated. RESULTS The average annual total costs of dispensing ordinary drugs, antibacterial drugs, hazardous drugs, and parenteral nutrition solutions in Shaanxi province were (2 195 900.25±1 680 893.73) yuan, (746 341.59±725 839.39) yuan, (331 420.15±183 258.83) yuan, and (330 322.68±277 281.70) yuan, respectively, with labor costs accounting for the highest proportion, averaging 85.49%. The costs of dispensing a set of ordinary drugs, antibacterial drugs, and hazardous drugs were 5.89, 7.60, and 14.37 yuan, respectively; the cost of dispensing one bag of parenteral nutrition solution was 32.15 yuan (excluding the cost of disposable intravenous nutrition bags). CONCLUSIONS The cost calculation method and data of different types of intravenous drugs obtained in this study can provide reference for relevant departments to formulate and adjust PIVAS fee standards.
6.Necessity and methodological progress on the establishment of continuous reference intervals for pediatric age-dependent indicators
Ruohua YAN ; Xiaoxia PENG ; Yaguang PENG ; Kun LI ; Xin NI
Chinese Journal of Laboratory Medicine 2023;46(8):872-878
Accurate and applicable reference intervals can provide important information for disease diagnosis, efficacy evaluation, and health monitoring. Age-dependent trends exist for many clinical laboratory indicators, and the interpretation of such indicators should consider the effect of age carefully. However, age-specific reference intervals have certain limitations in clinical application. Continuous reference intervals can not only help accurate interpretation of laboratory test results, but also provide a baseline value for dynamic monitoring of their changing trends. Based on the researches on pediatric reference intervals from our team, this paper introduces different algorithms for establishing continuous reference intervals, and their applicable conditions and implementation steps. The aim of this paper is to provide methodological guidance for the establishment of continuous reference intervals, so as to improve the quality of laboratory reports and the accuracy of clinical diagnosis in China.
7.Evidence summary of intra-abdominal pressure-guided enteral nutrition in patients with intra-abdominal hypertension
Jiaying TANG ; Yuping ZHANG ; Yao LI ; Mei LI ; Yuanquan NI ; Mengmei YUAN ; Xiaoxia HUANG ; Yue MAO ; Jing ZHANG ; Xiuqin FENG
Chinese Journal of Practical Nursing 2022;38(31):2420-2428
Objective:To retrieve and obtain relevant evidence of intra-abdominal pressure-oriented enteral nutrition assessment and management in patients with intra-abdominal hypertension, in order to provide evidence-based evidence for clinical medical staff to make enteral nutrition-related clinical decisions for patients with intra-abdominal hypertension.Methods:Systematic retrieval of Chinese National Knowledge Infrastructure, Wanfang, Chinese Biomedical Literature, UpToDate, PubMed, Cochrane Library, BMJ Best Practice and other English data, as well as domestic and foreign guidelines such as American Society for Parenteral and Enteral Nutrition, Scottish Intercollegiate Guidelines Network, etc. All evidence available on the Internet in both Chinese and English on intra-abdominal pressure-guided enteral nutrition strategies in adults with intra-abdominal hypertension, study types including clinical decision-making, systematic reviews/meta-analyses, evidence summaries, expert consensus, guidelines or related to the subject of this study closely related high-quality original research. The retrieval time was from the establishment of the database to November 2021. The literature evaluation tool was selected according to the research type. Two researchers trained in the evidence-based system independently evaluate the quality of the included literature, fully considering the clinical situation and expert opinions, and completed the evidence. Extracted and summarized.Results:Totally 13 articles were finally included, including 5 guidelines, 3 expert consensuses, 1 evidence summary and 4 original studies, and 29 evidence-based practice evidence of enteral nutrition in patients with intra-abdominal hypertension were collected, including the monitoring timing of enteral pressure, the pressure of enteral high pressure and the way of enteral nutrition, the pressure measurement of the abdominal cavity, the setting of abdominal pressure, the temperature conditions for early start of enteral nutrition, the selection of enteral pressure, the temperature setting of enteral nutrition nine aspects such as speed and regulation of internal nutrition and abdominal compartment syndrome prevention.Conclusions:This study summarizes the best evidence of intra-abdominal pressure management and enteral nutrition therapy in patients with intra-abdominal hypertension, and provides evidence-based basis for risk management, standardizing clinical practice, and ensuring treatment safety. In the stage of evidence transformation, clinical medical staff need to comprehensively weigh the benefits and risks of early enteral nutrition, and integrate evidence in combination with clinical practical application scenarios, so as to form a standardized early enteral nutrition management plan suitable for patients with intra-abdominal hypertension.
8.New Metabolic Alterations and A Predictive Marker Pipecolic Acid in Sera for Esophageal Squamous Cell Carcinoma
Liu LEI ; Wu JIA ; Shi MINXIN ; Wang FENGYING ; Lu HAIMIN ; Liu JIBING ; Chen WEIQIN ; Yu GUANZHEN ; Liu DAN ; Yang JING ; Luo QIN ; Ni YAN ; Jin XING ; Jin XIAOXIA ; Chen WEN-LIAN
Genomics, Proteomics & Bioinformatics 2022;20(4):670-687
Esophageal squamous cell carcinoma(ESCC)is a major histological subtype of esopha-geal cancer with a poor prognosis.Although several serum metabolomic investigations have been reported,ESCC tumor-associated metabolic alterations and predictive biomarkers in sera have not been defined.Here,we enrolled 34 treatment-naive patients with ESCC and collected their pre-and post-esophagectomy sera together with the sera from 34 healthy volunteers for a metabo-lomic survey.Our comprehensive analysis identified ESCC tumor-associated metabolic alterations as represented by a panel of 12 serum metabolites.Notably,postoperative abrosia and parenteral nutrition substantially perturbed the serum metabolome.Furthermore,we performed an examina-tion using sera from carcinogen-induced mice at the dysplasia and ESCC stages and identified three ESCC tumor-associated metabolites conserved between mice and humans.Notably,among these metabolites,the level of pipecolic acid was observed to be progressively increased in mouse sera from dysplasia to cancerization,and it could be used to accurately discriminate between mice at the dysplasia stage and healthy control mice.Furthermore,this metabolite is essential for ESCC cells to restrain oxidative stress-induced DNA damage and cell proliferation arrest.Together,this study revealed a panel of 12 ESCC tumor-associated serum metabolites with potential for monitor-ing therapeutic efficacy and disease relapse,presented evidence for refining parenteral nutrition composition,and highlighted serum pipecolic acid as an attractive biomarker for predicting ESCC tumorigenesis.
9.Development of case report form based on clinical data interchange standards consortium on special diseases to promote the ecology construction of real-world data in China
Xiaoxia PENG ; Jian SU ; Siyu CAI ; Ruiling PENG ; Yaguang PENG ; Xiaoli MA ; Xin NI
Chinese Journal of Epidemiology 2021;42(12):2201-2207
Real world data (RWD) refers to the data generated in routine clinical practices, daily life, and real work environment and has been widely used in clinical or public health research. Still, issues related to the quality of RWD, such as incompleteness, inconsistency, and inaccuracy, would affect the validity of real-world research. To overcome the challenges due to the lack of standardization of real world source data, case report form based on clinical data interchange standards consortium (CDISC-CRF) on certain diseases was developed to promote the ecology construction of RWD based on the data standards set by the CDISC which has been widely used. Firstly, we described how to apply data standards to make up the gap between RWD and real world evidence. Then, the process was designed to build RWD ecology based on CDISC-CRF, in which the development technology of CDISC-CRF form is mainly introduced. Finally, the application prospect and significance of building real-world data based on disease-specific CDISC-CRF are described. It is believed that the present paper can provide a new idea for promoting the ecology construction of RWD in China.
10.Clinical value of free-talk language functional cortex mapping methods based on high frequency response in epileptogenic focus resection
Xin GAO ; Xiaoxia ZHOU ; Jianbin WEN ; Tianyi ZHOU ; Duanyu NI ; Liang QIAO ; Xueyuan WANG ; Xiaohua ZHANG ; Xiaoli LI ; Tao YU
Chinese Journal of Neuromedicine 2021;20(10):989-995
Objective:To investigate the clinical value of free-talk language functional cortex mapping methods based on high frequency response in epileptic foci resection.Methods:Twenty patients with intractable epilepsy admitted to our hospital from January 2016 to May 2019 were chosen in our study. According to the different intraoperative mapping methods of language functional region, these patients were divided into test group ( n=10, using free-talk language function localization based on high frequency response [new method]+ electrical cortical stimulation [ECS]) and control group ( n=10, using ECS localization only). The overlap rate of the two methods in the test group were calculated and the postoperative follow-up results of patients in the two groups were analyzed. Results:In 10 patients from the test group, 33 positive loci in the Broca's area and 33 positive loci in the Wernicke's area were detected by new method; at the meantime, 16 positive loci in the Broca's area and 8 positive loci in the Wernicke's area were detected by ECS method, which had a overlap rate of 93.75% (15/16) in the Broca's area and 75.00% (6/8) in the Wernicke's area, respectively, as compared with the new method. In the 10 patients from the control group, 18 positive loci in the Broca's area and 3 positive loci in the Wernicke's area were detected by ECS method. In the test group, 7 patients achieved Engel grading I and 2 patients developed transient language function impairment after surgery; while in the control group, 5 patients achieved Engel grading I and 4 patients developed transient language function impairment after surgery.Conclusion:The new method has a high overlap rate with ECS method; the combination of the two methods can help to decrease the speech function impairment after excision of epileptogenic foci in patients with epilepsy.

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