1.Study on the prevention of sufentanil-induced cough reflex during general anesthesia induction of breast mass resection by auricular point bean embedding
Rui LUO ; Yao LI ; Yongli WU ; Weiwei WANG
Chinese Journal of Pharmacoepidemiology 2025;34(4):391-397
Objective To explore the preventive effect of auricular point bean embedding on sufentanil-induced cough reflex during induction of general anesthesia undergoing breast mass resection.Methods Clinical data of patients undergoing elective mammary mass resection with general anesthesia from June 2021 to May 2023 were retrospectively collected.The patients who received auricular point bean embedding therapy before surgery were included in the observation group,and patients who did not receive auricular point bean embedding therapy before surgery were included in the control group.The propensity score matching(PSM)method was used to perform 1∶1 matching based on basic data.The time effect,intergroup effect and interaction effect of vital signs parameters were analyzed by repeated measures analysis of variance.The GEE was used to analyze visual analogue scale(VAS)at different time points after operation.The Log-binomial regression model was used to analyze the incidence of postoperative adverse reactions and the association between subtypes.Results After PSM,50 patients were included in the observation and control groups.The time effect,intergroup effect and interaction effect of systolic blood pressure(SBP),diastolic blood pressure(DBP),mean arterial pressure(MAP),heart rate(HR)and blood oxygen saturation(SpO2)in 2 groups were statistically significant(P<0.05).Within the same group,SBP,DBP,MAP,HR and SpO2 were statistically significant at immediately after intravenous sufentanil injection(T1),2 min after injection(T2),1 min before intubation(T3)and 1 min after intubation(T4)(P<0.05).At T2,SBP,DBP,MAP and HR in the observation group were significantly lower than those in the control group,and SpO2 was significantly higher than that in the control group(P<0.05).The cough control,VAS score and total incidence of postoperative adverse reactions in the observation group were significantly better than those in the control group(P<0.05).The result of GEE model analysis showed that the improvement of postoperative VAS scores of patients in the observation group was better than that in the control group(P<0.05).Conclusion Preoperative auricular point bean embedding has a specific preventive effect on sufentanil induced cough reaction in patients with breast mass resection under general anesthesia.
2.Exploration on medication pattern of traditional Chinese medicine treatment for non-small cell lung cancer based on real world data
Junya LI ; Yanglin SHI ; Jianya YANG ; Ya LI ; Suyun LI
Chinese Journal of Pharmacoepidemiology 2025;34(4):398-409
Objective To explore the prescription patterns and core medication characteristics of traditional Chinese medicine(TCM)in the real-world treatment of non-small cell lung cancer(NSCLC).Methods Outpatient prescription data for NSCLC patients treated in the department of respiratory medicine at the First Affiliated Hospital of Henan University of Chinese Medicine from January 1,2020,to December 31,2023,were extracted through the Hospital Information System(HIS)to establish a standardized Chinese herbal medicine database.Latent structure models were constructed using Lantern 5.0 software,while association rule analysis was conducted with SPSS Modeler 18.0 software.Additionally,clustering analysis of high-frequency herbs was performed using SPSS 26.0 software to systematically analyse the laws of medicine identification and administration.Results A total of 620 TCM prescriptions involving 329 herbs were included,with a cumulative frequency of 10,461 herb applications.The most frequently used herbs were Citri Reticulatae pericarpium,Poria,Codonopsis radix,and Astragali radix.Tonifying and replenishing herbs constituted the primary category,with warm-natured and sweet-flavored herbs predominating.Most herbs targeted the lung meridian.Twenty core prescriptions,such as Xuefu Zhuyu decoction were identified.Core herb combinations included"Ligustri Lucidi fructus-Glycyrrhizae radix et rhizoma-Astragali radix"and"Solani nigri herba-Coicis semen-Astragali radix,"primarily reflecting therapeutic strategies of supplementing Qi,nourishing yin,detoxifying,and dispersing toxins.Conclusion TCM prescriptions for NSCLC predominantly utilize sweet and warm-natured herbs,adhering to the principle of strengthening the body's resistance and eliminating pathogenic factors.Therapeutic approaches integrate methods such as supplementing qi and nourishing yin,clearing heat and detoxifying,and activating blood circulation and resolving stasis.Core prescriptions are derived from classical formulas like Xuefu Zhuyu decoction and Baihe Gujin decoction through syndrome differentiation.The prescription patterns and core herb groups revealed by real-world data mining provide evidence-based insights for optimizing clinical treatment strategies for NSCLC.
3.Clinical characteristics of liver injury induced by different types of drugs and Logistic analysis of the influencing factors on the prognosis
Yafei ZHANG ; Yi CAO ; Zhihao WANG ; Yuanyuan WANG
Chinese Journal of Pharmacoepidemiology 2025;34(4):410-418
Objective To analyze the clinical characteristics of drug-induced liver injury(DILI)caused by different drug categories,and to investigate factors influencing DILI prognosis.Methods Medical records of DILI patients diagnosed in our hospital from January 1,2019 to December 31,2023 were retrospectively collected.Clinical characteristics of DILI induced by different drug categories were analyzed.Multivariate Logistic regression was employed to identify prognostic factors of DILI.Results A total of 347 DILI patients were included.The predominant DILI pattern was hepatocellular injury(67.15%),followed by cholestatic(20.46%)and mixed types(12.39%).The top three causative drug categories were traditional Chinese medicine(25.34%),antineoplastic drugs(24.15%)and anti-infective agents(21.26%).Regarding prognosis outcomes,7 cases(2.02%)achieved complete recovery,269 cases(77.52%)showed improvement,and 71 cases(20.46%)demonstrated no improvement.Significant differences were observed among prognosis groups in age,gender,alanine aminotransferase level,aspartate transaminase level,alkaline phosphatase levels,DILI patterns,number of combined hepatoprotective drugs used,and causative drug categories(P<0.05).Multivariate analysis revealed that cholestatic type[OR=0.237,95%CI(0.083,0.673),P=0.007]and combination therapy with>2 hepatoprotective drugs[OR=0.551,95%CI(0.295,0.998),P=0.018]were independent risk factors for prognosis.Conclusion The number of hepatoprotective drugs used in combination and DILI patterns may serve as potential indicators for prognosis evaluation.Particular attention should be paid to the hepatotoxicity of traditional Chinese medicine,antineoplastic agents,and anti-infective drugs.Rational drug selection is essential for improving DILI prevention and treatment.
4.Effect of flurbiprofen axetil on postoperative catheter-related bladder discomfort:a randomized,controlled,double-blind trial
Zhidan LIU ; Bo SONG ; Liping LI ; Yinhao GUO ; Hongxia HE ; Suihan XU ; Yonghong ZHANG ; Jun LI
Chinese Journal of Pharmacoepidemiology 2025;34(4):373-379
Objective To investigate the effect of intravenous flurbiprofen axetil on the incidence and severity of catheter-related bladder discomfort(CRBD)after transurethral resection of the prostate(TURP).Methods The elderly patients undergoing TURP under general anesthesia were enrolled,and randomly divided into two groups:flurbiprofen axetil group(group F)and control group(group C).Ten minutes before the end of surgery,group F was given 50 mg of flurbiprofen axetil intravenously,group C was given an equal amount of 0.9%sodium chloride injection.The primary outcome indicator was the incidence of moderate to severe CRBD immediately after entering the resuscitation room(T0).Secondary indicators included the incidence and severity of CRBD at 1 h(T1),2 h(T2),and 6 h(T3)after entering the resuscitation room,the amount of sufentanil used within 24 hours after surgery,postoperative NRS score,flurbiprofen axetil-related and analgesic adverse reactions 24 hours after surgery,and patient satisfaction.Results A total of 90 patients were included and each group was 45 patients.The incidence of moderate to severe CRBD at T0 was significantly lower in group F than that in group C(8.9%vs.33.3%,P=0.004).The incidence of CRBD in T1,T2,and T3 was lower in group F than in group C(P<0.05).The incidence of mild CRBD at T3 in group F was lower than that in group C(P<0.05).The incidence of moderate to severe CRBD at T1 and T2 in groups F was lower than that in group C(P<0.05).The amount of sufentanil used in group F at 24 hours after surgery was significantly lower than that in group C(P=0.001).The pain scores in group F at T0,T1,T2,and T3 were lower than those in group C(P<0.05);The postoperative patient satisfaction score in group F was higher than that in group C(P=0.001).However,there were no significant differences between the two groups in postoperative anesthesia resuscitation time and 24-hour adverse reactions incidence(P>0.05).Conclusion Intravenous flurbiprofen axetil can safely and effectively reduce the incidence and severity of CRBD after TURP.It can significantly relieve pain,reduce sufentanil use,and have high clinical application value.
5.Effect of dexmedetomidine on the median effective concentration of ropivacaine during sciatic nerve block combined with femoral nerve block in patients undergoing lower extremity surgery
Zuquan CHEN ; Xiaoping GU ; Wenjun ZOU ; Fuqiang HE
Chinese Journal of Pharmacoepidemiology 2025;34(4):380-390
Objective To investigate the effect of dexmedetomidine on the median effect concentration(EC50)of ropivacaine during sciatic nerve block combined with femoral nerve block in patients undergoing lower extremity surgery.Methods Patients with sciatic nerve block combined with femoral nerve block anesthesia who underwent lower extremity surgery from November 2021 to November 2023 were selected as the study objects.They were randomly divided into control group(0.9%saline),group D1(0.50 μg·kg-1 dexmedetomidine),group D2(0.75 μg·kg-1 dexmedetomidine)and group D3(1.00 μg·kg-1 dexmedetomidine).The stress response,serum pain mediators,vital signs and visual analogue scale(VAS)of patients at different time points during operation were analyzed by repeated measures ANOVA.ropivacaine EC50 was measured by sequential method,and the relationship between dexmedetomidine dose and ropivacaine EC50 was analyzed by Logistic regression.Results A total of 208 patients were include and each group was 52 patients.Compared with the same group before surgery,the stress response level of the 4 groups after surgery and 1 h after surgery was significantly decreased,and the serum pain mediators level was significantly increased(P<0.05).Compared with the control group,the stress response and serum pain mediators levels in groups D1,D2 and D3 were more normal after surgery and 1 h after surgery,among them,group D3 was most close to the normal value(P<0.05).There were no significant differences in blood oxygen saturation and bifrequency index of EEG among the four groups at each time point(P>0.05).At T1 and T2,the heart rate(HR)of the control group was significantly higher than that of the group D2 and D3(P<0.05).At T1,the control group had a significantly higher mean arterial pressure(MAP)than the other three groups,at T2,the control group had a significantly higher MAP than the group D2 and D3,and at T3,the control group had a significantly higher MAP than the group D3(P<0.05).VAS scores in 4 groups were significantly lower after surgery and 1 h after surgery than before surgery(P<0.05).The VAS score in group D3 was significantly lower than that in group D1 and D2(P<0.05).Repeated measurement ANOVA showed that the effects of time on stress response and serum pain mediators were different with different anesthesia methods.The influence of time on HR,MAP and VAS scores varied with different anesthesia methods.Sequential assay results showed that the EC50 of ropivacaine in control group,group D1,group D2 and group D3 was 5.985,5.631,5.329 and 5.125 μg·mL-1,respectively.Logistic results showed that the dose of dexmedetomide was a protective factor for ropivacaine EC50 in sciatic nerve block combined with femoral nerve block in limb surgery patients(P<0.05).Conclusion The ropivacaine EC50 can be significantly reduced by 1.00 μg·kg-1 dexmedetomidine.This is a protective factor for sciatic nerve block combined with femoral nerve block in patients undergoing lower limb surgery,and it can be applied clinically.
6.Signals mining and analysis of deucravacitinib adverse drug events based on FAERS database
Ye HU ; Qineng GONG ; Linlin ZHANG ; Aming WANG ; Wang QI ; Yang MIAO
Chinese Journal of Pharmacoepidemiology 2025;34(4):419-427
Objective To mine adverse drug event(ADE)signals of deucravacitinib,and to guide its rational clinical use.Methods ADE reports reported to the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from the third quarter of 2022 to the third quarter of 2024 were collected,ADE reports with deucravacitinib as the primary suspect drug were selected for analysis.ADE signals were identified using reporting adds ratios method and Bayesian confidence propagation neural networks method.Results A total of 1,777 ADE reports were collected involving 3,258 ADEs.Sixty-two ADE signals were identified,spanning 14 system-organ classifications.The top five ADE signals based on the number of reported cases were acne,oral ulcers,folliculitis,urticaria,and oral pain.The top five ADE signals based on signal intensity were cystic acne,hepatitis A,acne vulgaris,pustular acne,and folliculitis.ADE signals such as pigmenturia,hepatitis A,and gingival swelling were not included in the drug instructions.The median duration of ADEs associated with deucravacitinib was 22 days,with 58.33%occurring within the first month of treatment.Women may have a higher risk of developing acne than men.Conclusions When using deutericolaxitinib,healthcare professionals should focus on skin and subcutaneous tissue disorders,gastrointestinal system disorders,and infections and infestations to monitor the occurrence of acne in female patients.The latent ADEs that are not mentioned in the instructions should be remained vigilant to ensure safe drug use.
7.Evidence-based evaluation for guidelines or consensus on pediatric off-label medication
Zhenyu PAN ; Zhaojie WANG ; Hua CHENG
Chinese Journal of Pharmacoepidemiology 2025;34(4):428-436
Objective To systematically review the quality of pediatric off-label medication guidelines and consensus,compare the differences among guidelines and consensus,and to provide recommendations for clinical application.Method Searching the guidelines and literature databases and websites such as TRIP,GIN,NICE,PubMed,CNKI,WanFang Data,MedLink,to collect off-label drug use guidelines or consensus.The AGREE Ⅱ was used to evaluate the methodological quality of the included guidelines or consensus,and the differences among the recommendations of guidelines and consensus were analyzed and compared.The differences in scores between guidelines and consensus and international and domestic guidelines and consensus were compared in each domain.Results A total of 7 papers were included,comprising 3 guidelines and 4 consensuses,1 from Austria and 6 from China.The AGREE Ⅱ results showed that the scores of 2 domains,"Scope and Purpose"and"Stakeholder Involvement",were above 60%.There were significant differences in scores in the remaining four domains(Rigour of Development,Clarity of Presentation,Applicability,and Editorial Independence).There were differences in the insufficient items of the guidelines and consensus.The"Scope and Purpose"of the guidelines scored significantly higher than the consensus.In addition,the grading of evidence and grading of recommendations of the guidelines and consensus were different,including GRADE,Micromedex,Oxford Centre for Evidence-based Medicine standards,and custom methods.According to the AGREE Ⅱ,among the 7 guidelines and consensus,3 were recommended,3 were recommended after modification,and 1 was not recommended.Conclusion There are relatively few existing pediatric guidelines and consensus on off-label medication.At present,there are differences in the quality of guidelines and consensus,with inconsistent standards for evidence quality and recommendation strength.
8.Research progress on the role of vitamin D and its signaling pathway in disease development
Xiaomei ZHANG ; Hui YE ; Fang YANG ; Rui MIN ; Yeqing TONG
Chinese Journal of Pharmacoepidemiology 2025;34(4):456-466
Vitamin D is a fat-soluble vitamin primarily synthesized through skin exposure to ultraviolet B irradiation and dietary intake.Its biological effects are not limited to the regulation of calcium and phosphorus metabolism but also involve a variety of physiological functions such as immune modulation,anti-inflammation,and anti-tumor.In recent years,as research deepens,the role of the vitamin D signaling pathway in various diseases has been gradually revealed,and its regulatory mechanisms are complex and diverse.This paper systematically reviews the molecular mechanisms underlying the vitamin D signaling pathway,including the two-step hydroxylation activation process of vitamin D,the regulation of gene transcription mediated by the vitamin D receptor(VDR),the homeostatic regulation involving vitamin D-binding protein and metabolic enzymes such as 1α-hydroxylase and 24-hydroxylase,and interactions with other signaling pathways,including NF-κB,Wnt,and Hedgehog.This study highlights the role of vitamin D in various multi-system diseases such as inflammatory bowel disease,diabetes and its complications,obesity,cardiovascular disease,colorectal cancer,breast cancer,among others.The systematic cognitive framework for understanding the vitamin D signaling pathway was conducted,providing a theoretical basis for precision treatment strategies targeting VDR.
9.Application progress of novel targeted drugs in precision treatment of membranous nephropathy
Chinese Journal of Pharmacoepidemiology 2025;34(4):467-473
With the deepening understanding of the pathogenesis of membranous nephropathy(MN),novel targeted drugs,including those targeting B cells,plasma cells,and the complement system,have provided new treatment options for MN,especially for refractory membranous nephropathy(RMN).These novel targeted drugs precisely act on key pathological components such as B cells,plasma cells,and the complement system,demonstrating significant efficacy with minimal adverse effects.This review systematically summarizes the clinical research progress of drugs such as anti-CD20 monoclonal antibodies,anti-B cell activating factor monoclonal antibodies,and anti-CD38 monoclonal antibodies in the treatment of MN and RMN,analyzing the mechanisms by which these novel targeted drugs precisely regulate immune responses to enhance clinical outcomes.It emphasizes the importance of individualized treatment strategies based on the pathogenesis and disease state,explores the potential of combination therapies,and aims to provide new insights for the precise treatment of MN and RMN.
10.Pharmaceutical practice of a clinical pharmacist in the treatment of a patient with ulcerative colitis recurrence complicated by autoimmune pancreatitis
Chinese Journal of Pharmacoepidemiology 2025;34(4):474-479
This article reported the process of individualized medication management by a clinical pharmacist in the treatment of a patient with autoimmune pancreatitis(AIP)complicated by a relapse of ulcerative colitis(UC).Upon admission,in collaboration with the clinical pharmacist,the physician formulated a combined treatment plan of oral prednisone and mesalazine based on the patient's condition and the latest research literature.After 3 days of medication,the patient's diarrhea symptoms worsened,and colonoscopy revealed a severe,extensive flare of UC.After discussing,the physician and clinical pharmacist decided to switch the oral prednisone to intravenous methylprednisolone sodium succinate and replace mesalazine suppositories with mesalazine enema.Subsequently,the patient developed a fever and was diagnosed with Clostridiodes difficile infection.After a comprehensive evaluation,the clinical pharmacist recommended the use of metronidazole and implemented careful pharmaceutical monitoring.After 5 days of treatment,the patient's symptoms significantly improved without any adverse reactions.This case highlights the critical role of clinical pharmacists in managing complex clinical situations,particularly in optimizing treatment regimens and ensuring medication safety.It also provides practical experience and guidance for physicians and clinical pharmacists in handling similar cases.

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