1.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
2.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
3.A latent class analysis of feeding practices among preschoolers’ parents and its correlations with parental depression status
Xiaoxue WEI ; Ruxing WU ; Jian WANG ; Jinjin CHEN ; Xianqing TANG ; Wenzhe HUA ; Runan CHEN ; Daqiao ZHU
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(2):152-158
Objective:To explore the latent classes of parental feeding behaviors in preschool children, and to examine the relationship between potential types of parental feeding behaviors and parental depression status.Methods:From May to July 2021, parents of preschoolers from eight kindergartens in Shanghai were recruited and investigated.A paper-based questionnaire consisting of the Chinese preschooler’s caregivers’ feeding behavior scale (CPCFBS) and the center for epidemiological studies depression scale (CESD-10) was employed.Finally, a total of 1 006 valid questionnaires were retrieved.Mplus 8.0 and SPSS 26.0 were used for statistical analysis.The latent class analysis was used to identify subgroups of parents based on their feeding practices.Multinomial Logistic regression was used to examine the relevant influencing factors.Results:The feeding behaviors of parental of preschool children could be divided into four potential categories: " high responsiveness and high non-responsiveness type" (24.55%), " low responsiveness and high non-responsiveness type" (27.44%), " high responsiveness and low non-responsiveness type" (28.33%) and " low responsiveness and low non-responsiveness type" (19.68%). The parents with depression status were less likely to be categorized as " high responsiveness and low non-responsiveness type" ( OR=0.386, 95% CI: 0.218-0.684). The parents with older children were more likely to be categorized as " low responsiveness and low non-responsiveness type" ( OR=1.318, 95% CI: 1.039-1.672). Conclusion:The feeding practices of parents of preschool children can be categorized into four latent classes.The parents with depression status are more likely to adopt non-responsive feeding practice than responsive feeding practice.Actively paying attention to and improving the depression status of parents may help the feeder to adopt scientific feeding behavior.
4.Analysis of status and influencing factors of parents' discharge preparation for preterm infants in intensive care unit
Qiaomu ZHENG ; Wenzhe HUA ; Jie YAN ; Jingxin ZHOU ; Liping JIANG
Chinese Journal of Practical Nursing 2021;37(25):1979-1984
Objective:To understand the level of discharge preparation of parents of premature infants in intensive care unit, and investigate the status of discharge preparation of parents of premature infants and its influencing factors.Methods:Convenient sampling was used to recruit the 202 parents of preterm infants who stayed in the neonatal intensive care unit in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine from May to December 2018. The characteristics questionnaire and the Chinese version of Readiness for Hospital Discharge Scale-Parent Form were used to collect data.Results:The total score of parents' readiness for discharge of premature infants ranged from 111 to 290 (222.28±34.81). Multiple linear stepwise regression analysis showed that birth gestational age, birth weight, parity, parents' gender, annual family income were the influencing factors of premature parents' discharge readiness( P<0.05). Conclusions:The parents of premature infants in NICU are not well prepared for discharge. Medical staff should pay more attention to premature infants with low birth age and weight, first-born parents and low-income parents, so as to improve the discharge guidance content, help them prepare for discharge in all aspects and improve their care ability after discharge.
5.Measures for promoting interventions of community health workers for overweight or obese adults and its effect evaluation
Wenzhe HUA ; Qing LU ; Daqiao ZHU
Chinese Journal of Modern Nursing 2017;23(3):336-340
Objective To generalize and summarize the interventions of community health workers for overweight or obese adults and its effect evaluation,so as to provide references for advancing the work of adult weight management.Methods Literatures published in PubMed,CINAHL,EMBASE,Elsevier,VIP, Wanfang data from 1996 to March 2016 were retrieved. The retrieval formula was (facilitate OR promote OR improve OR influence OR intervene) AND (nurses OR physicians OR doctors OR health professionals OR medical staff) AND (obesity OR overweight OR weight OR body).Results A total of 13 papers were included involving 11 original researches and 2 systematic reviews. Those papers prompted that the process of weight management carried out by medical staff could be intervened from the level of doctors (training,setting up cues), patients (perfecting and handing out health education material),organization (multi-department cooperation, enhancing supervision) to improve the level and behavior of weight management carried out by medical staff. The indicators of effect evaluation included medical staff indicators (knowledge,skills,behaviors,attitudes and beliefs of weight management) and patient indicators (clinical indexes,health behaviors,attitudes,beliefs). Conclusions The adult weight management can be enhanced by multi-level intervention. At the same time, the intervention effect can be reflected comprehensively by synthesizing evaluation indicators in many aspects.
6.Efficacy and Safety in Secondary Prevention of Ischemic Stroke with Cilostazol or Aspirin: A Systematic Review
Haixia FENG ; Man YANG ; Huaili JIANG ; Wenzhe HUA ; Junfang HE ; Huixia YAO ; Yabin LI ; Tao XU ; Lianxiu HE ; Xiue SHI ; Jinqiu YUAN ; Yali LIU
Chinese Journal of Rehabilitation Theory and Practice 2010;16(10):961-965
ObjectiveTo review the efficacy and safety in secondary prevention of ischemic stroke with cilostazol or aspirin.Methodswe searched Cochrane Library(the 4th issue, 2009 ), PubMed(1980.1~2009.11), EMBASE(1980.1~2009.11), CBM(1978.1~2009.11), CNKI(1979.1~2009.11) and some other databases, then collected all of the studies describing the outcomes in curing the ischemic stroke after taking cilostazol or aspirin. According to the strict inclusion and exclusion criteria, two reviewers independently selected trials, extracted datas, made cross-checking and methodological quality assessment of the homogeneity studies by using the Cochrane systematic review methods, then made Meta analysis using RevMan 5.0 software.ResultsThis systematic review study included two randomized controlled trials and a cross-over trial, which contained a total of 838 participants. The evidence quality of one of the randomized controlled trials was high, however, the evidence quality of another randomized controlled trial and the cross-over trial was poor. Meta analysis results suggested that the effectiveness of cilostazol and aspirin in the secondary prevention of ischemic stroke performed no significantly statistical difference: primary endpoint(30 d[RR=3.00, 95%CI(0.31,28.70)]; 90 d[RR=1.67, 95%CI(0.40,6.92)]; 180 d[RR=1.25, 95%CI(0.50, 3.13)]; 360 d[RR=0.65, 95%CI(0.33, 1.29)]; 540 d[RR=0.80,95%CI(0.54, 1.18)]); combined endpoint(30 d[RR=4.00, 95%CI(0.45,35.61)]; 90 d [RR=1.75,95%CI(0.52,5.93)]; 180 d[RR=1.00, 95%CI(0.48, 2.07)]; 360 d [RR=0.77, 95%CI(0.45, 1.29)]; 540 d[RR=0.66,95%CI(0.40,1.09)]); the recurrence of ischemic stroke: cilostazol group: RR=0.64, 95%CI(0.31,1.30),aspirin group: RR=0.21, 95%CI(0.04,1.06); PDMP[RR=1.00, 95%CI(0.39, 2.58)]. But in terms of the probability of intracranial hemorrhage ([RR=7.14, 95%CI(0.7,58.33)]) and other safety standards, taking cilostazol performed lower than taking aspirin.ConclusionThe side effects of cilostazol and aspirin in the treatment for ischemic stroke were similar to each other, but in terms of the probability of dizziness, headache, tachycardia and palpitation, taking cilostazol performed higher than taking aspirin, however, taking cilostazol performed lower in the probability of intracranial hemorrhage and other organ hemorrhage than taking aspirin. Since this study included a small amount of studies, in which the evidence quality of one of the randomized controlled trials and the cross-over study was poor, therefore, it would be necessary to make a further validation with lots of high-quality clinical trials.


Result Analysis
Print
Save
E-mail