1.Jingmaiyan Granules Combined with External Application of Jinhuang Ointment in Treatment of Acute Stage Blood Heat Stasis Type Superficial Thrombophlebitis of Lower Extremities: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Qiaoyilan LIANG ; Hong CHEN ; Weijing FAN ; Hongshuo SHI ; Fangfang WU ; Guobin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):196-202
ObjectiveTo evaluate the clinical efficacy and safety of Jingmaiyan granules (composed of Lonicerae Japonicae Flos, Sedi Herba, Paeoniae Radix Rubra, Moutan Cortex, Rhei Radix et Rhizoma Praeparata, and Glycyrrhizae Radix et Rhizoma) combined with external application of Jinhuang Ointment in treating acute-stage blood heat stasis type superficial thrombophlebitis (ST) of lower extremities, and to explore their effects on hemorheology and serum inflammatory factors. MethodsA randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 124 patients with lower extremity ST were randomized into two groups(62 cases in each group). The control group received external application of Jinhuang ointment and oral placebo treatment, while the observation group received external application of Jinhuang ointment and oral Jingmaiyan granules. Both groups were treated for 2 weeks. The clinical symptom scores, therapeutic efficacy of traditional Chinese medicine (TCM) syndrome, pain visual analog scale (VAS) scores, hemorheological indices [including whole blood high-shear, medium-shear, and low-shear viscosity, as well as plasma viscosity (PV)], and inflammatory factors [C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α)] were compared before and after treatment. ResultsAfter 2 weeks of treatment, the total effective rate in the observation group (98.3%, 60/62) was significantly higher than that in the control group (83.8%, 52/62), with a statistically significant difference (Z=3.512 1, P<0.05). Compared with pre-treatment scores, the scores for skin color, skin temperature, swelling, pain, and cord or nodules were significantly reduced in both groups (P<0.05), with more pronounced improvement in the observation group (P<0.05). Additionally, compared with pre-treatment levels, the whole blood viscosity (low-, medium-, and high-shear) significantly improved in both groups after treatment (P<0.05), with more marked improvement in the observation group (P<0.05). Furthermore, the plasma viscosity, CRP, IL-6, and TNF-α levels were significantly reduced in both groups after treatment (P<0.05), with more pronounced improvement observed in the observation group (P<0.05). ConclusionThe combination of external application of Jinhuang ointment and oral Jingmaiyan granules effectively improves clinical symptoms, hemorheological abnormalities, and inflammatory responses in patients with acute stage blood heat stasis type ST of lower extremities. The treatment is safe and holds clinical promotion value.
2.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
3.Key Quality Attributes and Technical Control Points of Aluminum Foil for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Yanchun RAO ; Wei XIONG ; Junfeng ZUO ; Lei CHEN ; Huizheng FU ; Majian XIONG ; Fangfang ZHANG ; Liang CHANG
Herald of Medicine 2025;44(11):1763-1767
Aluminum foil for pharmaceutical packaging is a material used for solid dosage forms.Guideline 9625 of the Pharmacopoeia of the People's Republic of China(2025 edition),built on the concepts of whole-process quality control and risk management,specifies the quality requirements for aluminum foil.This article analyzed and discussed the critical quality attributes and technical control points of aluminum foil by examining its fundamental characteristics,production processes,and relevant domestic and international standards.This article aimed to provide guidance for stakeholders in understanding and applying the guidelines,thereby enhancing pharmaceutical packaging quality and fostering standardization across the industry.
4.Application of Rodgers evolutionary concept analysis method in defining self-advocacy among patients with chronic diseases
Kangmei WANG ; Yi HUANG ; Fangfang LIANG ; Lu ZHU ; Yiran ZHANG ; Shengcai ZHU
Chinese Journal of Practical Nursing 2025;41(21):1669-1675
Objective:To analyze and clarify the meaning of the concept of self-advocacy among patients with chronic diseases using the Rodgers evolutionary concept analysis method.Methods:A systematic search was conducted in databases including PubMed, Web of Science, Cochrane Library, CINAHL, Embase, Medline, VIP, Wanfang, the China National Knowledge Infrastructure, and Chinese Biomedical Literature Database for studies related to self-advocacy in chronic disease patients from February 1, 1992, to June 30, 2024. The Rodgers evolutionary concept analysis method was applied to analyze the selected literature.Results:A total of 72 articles were included in this study. The concept attributes of self-advocacy in chronic disease patients were identified as cognitive awareness, self-action, and resource integration. The antecedents involved included personal characteristics, skill learning, and available support. The outcomes covered improved symptom management, adherence to treatment plans, enhanced nursing and quality of life, and reduced demand for healthcare. The measurement tools used were the Patient Self-Advocacy Scale, Self-Advocacy Scale, Elderly Safety Advocacy Empowerment Scale, and Female Cancer Patient Self-Advocacy Scale.Conclusions:The conceptual attributes of self-advocacy in chronic disease patients were clarified through the Rodgers evolutionary concept analysis method. Future research can combine quantitative and qualitative studies to further explore the significance of self-advocacy in patients with chronic diseases.
5.Effect of a five-year practice of multidimensional evidence-based interventions on reduction of incidence of central line-associated bloodstream infections in intensive care units of pediatrics department
Linjuan WANG ; Min ZHOU ; Liting ZENG ; Hongtao JIA ; Qi DONG ; Weike MA ; Fangfang LIANG
Chinese Journal of Nosocomiology 2025;35(18):2791-2795
OBJECTIVE T o explore the long-term effect of multidimensional evidence-based interventions based on i-PARIHS theoretical framework on reduction of incidence of central line-associated bloodstream infections(CLABSI)in pediatric intensive care units(PICU)of pediatrics department and evaluate the impact on nurses'compliance to taking the interventions and use intensity of catheters.METHODS By means of quasi-experimental design,the multidimensional intervention system covering multidisciplinary collaboration,standardized operation procedures,information system optimization and hierarchical training was established and staged for implementa-tion of 5 years(from T0 baseline stage to T3 maintenance stage).The variations in implementation rates of cathe-ter maintenance(daily maintenance,dressings change,catheter removal)were analyzed by Chi-square test,and the change of incidence of CLABSI was monitored with the use of statistical process control U chart.RESULTS The nurses'compliance to operations was remarkably improved(P<0.05)o The implementation rate of dressings change continuously increased from 52.91%in T0 to81.62%in T3(x2=72.444,P<0.001),the implementa-tion rate of catheter removal increased from 48.72%to 79.31%(x2=8.179,P=0.042).The incidence rate of CLABSI decreased from 1.92%0 in 2019 to 0.5%0 in 2022,and the control chart showed that most of the months fluctuated within control limits.CONCLUSIONS The multidimensional evidence-based interventions can achieve a long term control of CLABSI by raising the nurses' compliance to operations.The information monitoring and closed-loop management are crucial to maintenance of the interventional effect,and the risk early warning system should be optimized with the combination of artificial intelligence technology.
6.Summary of best evidence for early rehabilitation management of hand function in patients with hand burns
Xueqin YAN ; Songmei CAO ; Fangfang ZHOU ; Liqun ZHU ; Cheng CHEN ; Mengxue ZHU ; Yanhong ZHANG ; Yiqing LIANG ; Suping BAI
Chinese Journal of Nursing 2025;60(8):998-1004
Objective To summarize the best evidence of early rehabilitation management of hand function in patients with hand burn,and provide basis for medical personnel to carry out early rehabilitation management of hand burn.Methods According to the 5S model,all evidence on early rehabilitation management of hand function in patients with hand burns was retrieved from databases and websites including UpToDate,BMJ Best Practice,NICE,RNAO,GIN,and so on.The retrieved evidence included clinical decisions,guidelines,evidence summaries,expert consensuses,systematic reviews,Meta analysis.The search period of the summary of best evidence,expert concensus and guidelines are from the establishment of the database to December 20,2024,and the search period of the systematic reviews is from January 1,2019 to December 20,2024.Quality evaluation of literature,evidence extraction and summary were conducted.The evidence was graded according to JBI evidence pre-grading system 2014.Results Totally 17 pieces of the literature were included,including 1 clinical decision,4 guidelines,6 evidence summaries,3 expert consensus articles,and 3 systematic reviews.Totally pieces of best evidence were summarized,including 7 aspects of assessment,hand positioning,treatment of edema,dressing,use of orthotics,joint mobility training,and health education.Conclusion This study summarized the best evidence of early rehabilitation management of hand function in patients with hand burn,and provided evidence-based evidence for clinical rehabilitation management plan.According to the clinical situation,the medical staff can apply the evidence to clinical practice,so as to improve the hand function and quality of life of patients.
7.The effect of inflammation on the outcome of assisted conception in patients with endometriosis
Wenxia LIU ; Rusi LUO ; Bijun WANG ; Fangfang LIANG ; Xiaodan WANG ; Menglu JI ; Jiaheng LI ; Bingnan REN ; Yichun GUAN
China Modern Doctor 2025;63(28):1-4,22
Objective To exploring the effect of inflammatory indicators on the outcome of assisted conception of in vitro fertilization/intracytoplasmic sperm injection(IVF/ICSI)in patients with ovarian endometriosis(OEM).Methods The study subjects were selected as the patients with OEM who received IVF/ICSI treatment at the Third Affiliated Hospital of Zhengzhou University from January 2019 to February 2024.Based on whether previous surgery for uterine endometriosis cyst removal had been performed,they were divided into non-surgery group(n=73)and surgery group(n=112).To explore the differences in inflammatory markers between two groups and to determine whether they have an impact on the outcome of assisted reproduction.Results The lymphocytes(L)and blastocyst formation rates of patients in surgery group were significantly higher than those in non-surgery group,platelet to lymphocyte ratio(PLR)and carbohydrate antigen 125(CA125)were significantly lower than those in non-surgery group(P<0.05).There were no statistically significant differences in the clinical pregnancy rate and live birth rate between two groups of patients(P>0.05).After adjusting for confounding factors,the results of multivariate Logistic regression analysis showed that L,PLR,and CA125 had no statistically significant impact on the clinical pregnancy rate and live birth rate(P>0.05).Both maternal age and the number of embryos transferred exerted a certain influence on clinical pregnancy rates and live birth rates(P<0.05),furthermore,the type of embryo transferred had a significant effect on clinical pregnancy rates(P<0.05).Conclusion Compared with non-surgery group,surgery group had higher L level and lower PRL and CA125 levels,but these changes did not significantly affect clinical pregnancy or live birth outcomes in OEM patients undergoing IVF/ICSI assisted reproduction.
8.Preventive effect of a subanesthetic dose of esketamine on emergence agitation in pediatric patients undergoing fracture fixation surgery under general anesthesia
Fangfang YANG ; Meichao WU ; Liang ZHAO ; Qiufeng WANG ; Chenxu DAI ; Xingjun MA ; Ning CAI
Chinese Journal of Anesthesiology 2025;45(7):818-822
Objective:To investigate the preventive effect of a subanesthetic dose of esketamine on emergence agitation (EA) in pediatric patients undergoing fracture fixation surgery under general anesthesia.Methods:This study was a randomized, double-blind, placebo-controlled trial. Eighty-two pediatric patients, aged 3-6 yr, with American Society of Anesthesiologists Physical Status classification Ⅰ or Ⅱ, scheduled for elective closed reduction and internal fixation of humeral fractures at the People′s Hospital of Fuyang City from March 2023 to August 2024, were divided into 2 groups ( n=41 each) using simple random sampling: esketamine group (group E) and control group (group C). Group E received an intravenous injection of esketamine at a dose of 0.3 mg/kg before anesthesia induction, while the equal volume of normal saline was given instead in group C. The induction and maintenance of general anesthesia were the same in both groups. The drug was discontinued after operation and the children were transferred to the post-anesthesia care unit. The primary outcome was the occurrence of EA assessed using the Pediatric Anesthesia Emergence Delirium scale. Secondary outcome measures included the acceptance of the facemask during anesthesia induction, the rate of propofol use during the emergence period, the Children′s Hospital of Eastern Ontario Pain Scale scores at awakening and at 2 and 6 h postoperatively, the requirement for rescue analgesia in the emergence period, and the occurrence of adverse reactions. Results:Compared with group C, the incidence of EA [38% (15/39) vs. 15% (6/40)] was significantly decreased, the usage rate of propofol during the emergence period was decreased, the degree of acceptance of the facemask during anesthesia induction was increased, and Children′s Hospital of Eastern Ontario Pain Scale scores at all time points and the rate of rescue analgesia in the emergence period were decreased in group E ( P<0.05). There was no statistically significant difference in the incidence of postoperative adverse reactions between the two groups ( P>0.05). Conclusions:Administering a subanesthetic dose of esketamine before anesthesia induction can reduce the risk of EA in pediatric patients undergoing fracture fixation surgery under general anesthesia and raise the the quality of recovery with a high safety.
9.Comparison of intranasal nebulized remimazolam versus esketamine for preoperative sedation in pediatric patients
Meichao WU ; Fangfang YANG ; Jingwen LI ; Liang ZHAO ; Dongfeng LIANG
Chinese Journal of Anesthesiology 2025;45(7):846-851
Objective:To compare the efficacy of intranasal nebulized remimazolam versus esketamine for preoperative sedation in pediatric patients.Methods:In this randomized double-blind controlled trial, 90 pediatric patients scheduled for elective surgery with general anesthesia at Fuyang People′s Hospital between October 2024 and January 2025, were divided into 3 groups ( n=30 each) using a simple randomization: remimazolam group (group R), esketamine group (group S) and normal saline group (group C). Group R received intranasal nebulization of remimazolam 1.5 mg/kg, group S received intranasal nebulization of esketamine 1 mg/kg, and group C received intranasal nebulization of normal saline 0.05 ml/kg. Primary outcome: The preoperative anxiety was assessed using the modified Yale Preoperative Anxiety Scale before intranasal drug administration (baseline), at 10 and 20 min after administration, and before anesthesia induction. Secondary outcomes included sedation level (Ramsay Sedation Scale score), satisfaction with intranasal administration acceptance, parental separation anxiety and mask acceptance, development of emergence agitation, emergence time, time of recovery from anesthesia, and nausea and vomiting and increased secretions. Results:Compared to group C, the incidence of anxiety was significantly decreased at 10 and 20 min after intranasal nebulization and before anesthesia induction, the level of sedation was deepened (to light sedation), and the satisfaction with intranasal administration acceptance was decreased in group R ( P<0.017), the incidence of anxiety was significantly decreased before anesthesia induction, the level of sedation was deepened (to deep sedation), and the satisfaction with intranasal administration acceptance was increased in group S ( P<0.017), and the satisfaction with parental separation anxiety and mask acceptance and anesthesiologists′ satisfaction were significantly increased in R and S groups( P<0.017). Compared to group R, the incidence of anxiety was significantly increased at 10 min after intranasal nebulization (7 cases [23%] versus 20 cases [67%]), the level of sedation was lighter at 10 min after intranasal nebulization, the level of sedation was deeper, and the satisfaction with intranasal administration acceptance was increased in group S ( P<0.017). Compared to groups C and R, the emergence time and time of recovery from anesthesia were significantly prolonged in group S ( P<0.017). There was no significant difference in the incidence of emergence agitation, nausea and vomiting and increased secretions or in parental satisfaction among three groups ( P>0.05). Conclusions:Both intranasal nebulized remimazolam and esketamine can produce good preoperative sedation in pediatric patients. Compared to esketamine, remimazolam provides a more appropriate level of sedation with a faster onset and does not prolong the recovery from anesthesia, making it more suitable for preoperative sedation in minor procedures.
10.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

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