1.Survey on the perception and current status of drug risk management in medical institutions
Xuelin SUN ; Mingqing XING ; Zixuan ZHANG ; Wenjing ZHAO ; Dongfang QIAN ; Yan LIANG ; Li XU ; Pengfei JIN ; Yatong ZHANG
China Pharmacy 2025;36(1):7-12
OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions,providing insights and recommendations for enhancing the drug risk management system in medical institutions.METHODS A questionnaire survey was conducted across 28 provinces,cities,and autonomous regions;stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide.The survey included information on the survey population,the current status of drug risk management implementation in medical institutions,the cognition,definition and process of drug risk management related concepts,and the content and mode of drug risk management work in medical institutions.Finally,suggestions were collected from various medical institutions on the system construction of drug risk management.Descriptive statistical analysis was adopted to summarize the obtained data.RESULTS A total of 446 questionnaires were collected in this survey,including 420 valid questionnaires and 26 invalidquestionnaires.The questionnaire collection rate was 100%,and the effective rate was 94.17%.51.19% of the respondents based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring,while 87.38% recognized the need for drug risk management throughout the drug use process.63.33% of the participants stated that their medical institutions had dedicatedpositions related to drug risk management,with the highest proportion (72.17%) was in third-grade class A medical institutions.66.43% reported implementing risk management across all drug use stages.Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents,clarifying concepts,establishing information-sharing mechanisms.CONCLUSIONS The overall awareness of drug risk management in China's medical institutions is high,with practices in place across various stages in multiple forms.However,there remains a need to strengthen institutional documents,management regulations,system development,and information-sharing mechanisms to improve collaborative governance,improve drug management levels,and ensure patient safety.
2.Safety of local anesthetics and the research progress of their new dosage forms
Yuanchao ZHU ; Yatong ZHANG ; Liang LIANG
Adverse Drug Reactions Journal 2024;26(2):111-117
Local anesthetics are a class of medications that can reversibly block the occurrence and transmission of sensory nerve impulses in the local administration area, which are widely used in clinic for skin and mucous membrane anesthesia, peripheral nerve block anesthesia, spinal nerve anesthesia, and the treatment of chronic pain. The adverse reactions of local anesthetics mainly include allergic reactions, cardiotoxicity, and neurotoxicity. The new dosage forms of local anesthetics include cutaneous administration and sustained-release formulations. The advantage of cutaneous administration is to achieve surface local anesthesia, avoid liver first pass effect, reduce local damage and stimulation caused by injection anesthesia, and improve patient tolerance. The sustained-release dosage form can help maintain a longer lasting anesthetic effect, avoid excessive blood drug concentration caused by rapid absorption of local anesthetic drugs, and thus reduce adverse drug reactions.
3.Safety of local anesthetics and the research progress of their new dosage forms
Yuanchao ZHU ; Yatong ZHANG ; Liang LIANG
Adverse Drug Reactions Journal 2024;26(2):111-117
Local anesthetics are a class of medications that can reversibly block the occurrence and transmission of sensory nerve impulses in the local administration area, which are widely used in clinic for skin and mucous membrane anesthesia, peripheral nerve block anesthesia, spinal nerve anesthesia, and the treatment of chronic pain. The adverse reactions of local anesthetics mainly include allergic reactions, cardiotoxicity, and neurotoxicity. The new dosage forms of local anesthetics include cutaneous administration and sustained-release formulations. The advantage of cutaneous administration is to achieve surface local anesthesia, avoid liver first pass effect, reduce local damage and stimulation caused by injection anesthesia, and improve patient tolerance. The sustained-release dosage form can help maintain a longer lasting anesthetic effect, avoid excessive blood drug concentration caused by rapid absorption of local anesthetic drugs, and thus reduce adverse drug reactions.
4.Risk of major bleeding and major adverse cardiac events in patients with acute coronary syndrome after novel oral anticoagulants therapy:a meta﹣analysis
Zinan ZHAO ; Yuanchao ZHU ; Liang LIANG ; Di CHEN ; Yatong ZHANG
Adverse Drug Reactions Journal 2019;21(4):244-251
Objective To systematically evaluate the risk of major bleeding and major adverse cardiac events(MACE)in patients with acute coronary syndrome(ACS)after combined use of novel oral anticoagulants(NOAC)and antiplatelet therapy. Methods Randomized controlled trials( RCTs)about NOAC treatment for ACS patients with basic antiplatelet therapy in related databases(up to July 2018)were searched. The outcome indicators included major bleeding events ( safety indicators ) and MACE ( effectiveness indicators). Quality of methodology was evaluated using bias risk assessment tool of Cochrane collaboration networks. Meta﹣analysis was performed using RevMan 5. 3 software. Results A total of 6 RCTs were entered,including comparative studies of single antiplatelet therapy(SAPT)or dual antiplatelet therapy(DAPT)combined with NOAC and combined with placebo or warfarin,involving 20 070 patients. Drugs used in the trial group included apixaban,rivaroxaban,and dabigatran etexilate. The quality evaluation showed that 4 of the 6 RCTs were with low risks of bias and 2 with high risks of bias. The meta﹣ analysis showed that the risk of clinical major bleeding events in patients in the SAPT+NOAC group was significantly higher than that in the SAPT+placebo group[3. 14%(44/1 402)vs. 1. 07%(19/1 770), RR=3. 47,95% CI:2. 01﹣5. 97,P﹤0. 001]. The incidence of clinical major bleeding events in patients in the DAPT+NOAC group was significantly higher than that in the DAPT+placebo group[5. 72%(387/6 761)vs. 2. 79%(251/8 984),RR=2. 59,95% CI:1. 73﹣3. 86,P﹤0. 001],but significantly lower than that in the DAPT+warfarin group[17. 22%(422/2 450)vs. 25. 68%(627/2 442),RR=0. 68, 95% CI:0. 56﹣0. 82,P﹤0. 001]. The risk of MACE in patients in the SAPT+NOAC group was significantly lower than that in the SAPT+placebo group[8. 61%(121/1 405)vs. 12. 20%(217/1 779),OR=0. 69, 95% CI:0. 55﹣0. 88,P =0. 003];there were no significant differences in the risks of MACE between patients in the DAPT+NOAC group and the DAPT+placebo group or DAPT+warfarin group(P﹥0. 05 for both). Conclusions Combination of anticoagulants and SAPT or DAPT in ACS patients may all increase the risk of clinical major bleeding,but combination of SAPT and NOAC may reduce the risk of MACE,and should be used after weighing. For patients who must be treated with triple antithrombotic therapy,DAPT combined with NOAC can be chosen and warfarin should be avoided.
5.Risk of major bleeding and major adverse cardiac events in patients with acute coronary syndrome after novel oral anticoagulants therapy:a meta﹣analysis
Zinan ZHAO ; Yuanchao ZHU ; Liang LIANG ; Di CHEN ; Yatong ZHANG
Adverse Drug Reactions Journal 2019;21(4):244-251
Objective To systematically evaluate the risk of major bleeding and major adverse cardiac events(MACE)in patients with acute coronary syndrome(ACS)after combined use of novel oral anticoagulants(NOAC)and antiplatelet therapy. Methods Randomized controlled trials( RCTs)about NOAC treatment for ACS patients with basic antiplatelet therapy in related databases(up to July 2018)were searched. The outcome indicators included major bleeding events ( safety indicators ) and MACE ( effectiveness indicators). Quality of methodology was evaluated using bias risk assessment tool of Cochrane collaboration networks. Meta﹣analysis was performed using RevMan 5. 3 software. Results A total of 6 RCTs were entered,including comparative studies of single antiplatelet therapy(SAPT)or dual antiplatelet therapy(DAPT)combined with NOAC and combined with placebo or warfarin,involving 20 070 patients. Drugs used in the trial group included apixaban,rivaroxaban,and dabigatran etexilate. The quality evaluation showed that 4 of the 6 RCTs were with low risks of bias and 2 with high risks of bias. The meta﹣ analysis showed that the risk of clinical major bleeding events in patients in the SAPT+NOAC group was significantly higher than that in the SAPT+placebo group[3. 14%(44/1 402)vs. 1. 07%(19/1 770), RR=3. 47,95% CI:2. 01﹣5. 97,P﹤0. 001]. The incidence of clinical major bleeding events in patients in the DAPT+NOAC group was significantly higher than that in the DAPT+placebo group[5. 72%(387/6 761)vs. 2. 79%(251/8 984),RR=2. 59,95% CI:1. 73﹣3. 86,P﹤0. 001],but significantly lower than that in the DAPT+warfarin group[17. 22%(422/2 450)vs. 25. 68%(627/2 442),RR=0. 68, 95% CI:0. 56﹣0. 82,P﹤0. 001]. The risk of MACE in patients in the SAPT+NOAC group was significantly lower than that in the SAPT+placebo group[8. 61%(121/1 405)vs. 12. 20%(217/1 779),OR=0. 69, 95% CI:0. 55﹣0. 88,P =0. 003];there were no significant differences in the risks of MACE between patients in the DAPT+NOAC group and the DAPT+placebo group or DAPT+warfarin group(P﹥0. 05 for both). Conclusions Combination of anticoagulants and SAPT or DAPT in ACS patients may all increase the risk of clinical major bleeding,but combination of SAPT and NOAC may reduce the risk of MACE,and should be used after weighing. For patients who must be treated with triple antithrombotic therapy,DAPT combined with NOAC can be chosen and warfarin should be avoided.
6.Correlation between sodium-glucose co-transporter protein 2 inhibitors and fracture risk in patients with type 2 diabetes mellitus:a Meta-analysis
Zinan ZHAO ; Liang LIANG ; Xuelin SUN ; Yuanchao ZHU ; Yufei FENG ; Yatong ZHANG
Adverse Drug Reactions Journal 2018;20(2):110-116
Objective To systematically evaluate the correlation between sodium-glucose co-tran-sporter 2(SGLT2)inhibitors and fracture risk in type 2 diabetes mellitus(T2DM)patients. Methods The related databases were searched. The randomized controlled trials(RCTs)which the outcome index included fracture in T2DM patients treated with SGLT2 inhibitors from the inception to August 2017 were enrolled into the study. The documents were selected according to the inclusion and exclusion criteria. After the data extraction and evaluation of methodological quality of RCTs,Meta-analysis was conducted using Rev Man 5.3 software. Results A total of 12 RCTs involving 28 181 patients were entered,including 17 747 patients in the test group(SGLT2 inhibitors)and 10 434 in the control group. The drugs used in the test group were canagliflozin(7 RCTs)and empagliflozin(5 RCTs). The drugs used in the control group were non-SGLT2 inhibitors including metformin,glimetazide and/or placebo. The results of Meta-analysis showed that the incidence of fractures in the test group was significantly higher than that in the control group[5.05%(897/17 747)vs. 4.40%(459/10 434),RR=1.27,95%CI:1.14-1.42,P<0.01]. Subgroup analysis showed that the incidence of fractures in the canagliflozin group was significantly higher than that in the control group[6.21%(679/10 938)vs. 5.28%(365/6 913),RR=1.31,95%CI:1.15-1.48,P<0.01]. There were no significant differences in the incidence of fractures between the empagliflozin group and the control group[3.20%(218/6 809)vs. 2.67%(94/3 521),RR=1.44,95%CI:0.35-5.90, P=0.61]. Conclusions Canagliflozin(a kind of SGLT2 inhibitors)can increase the incidence of fractures. It is suggested that the risk assessment should be done before medication for the benefit of patients.
7.Correlation between sodium-glucose co-transporter protein 2 inhibitors and fracture risk in patients with type 2 diabetes mellitus:a Meta-analysis
Zinan ZHAO ; Liang LIANG ; Xuelin SUN ; Yuanchao ZHU ; Yufei FENG ; Yatong ZHANG
Adverse Drug Reactions Journal 2018;20(2):110-116
Objective To systematically evaluate the correlation between sodium-glucose co-tran-sporter 2(SGLT2)inhibitors and fracture risk in type 2 diabetes mellitus(T2DM)patients. Methods The related databases were searched. The randomized controlled trials(RCTs)which the outcome index included fracture in T2DM patients treated with SGLT2 inhibitors from the inception to August 2017 were enrolled into the study. The documents were selected according to the inclusion and exclusion criteria. After the data extraction and evaluation of methodological quality of RCTs,Meta-analysis was conducted using Rev Man 5.3 software. Results A total of 12 RCTs involving 28 181 patients were entered,including 17 747 patients in the test group(SGLT2 inhibitors)and 10 434 in the control group. The drugs used in the test group were canagliflozin(7 RCTs)and empagliflozin(5 RCTs). The drugs used in the control group were non-SGLT2 inhibitors including metformin,glimetazide and/or placebo. The results of Meta-analysis showed that the incidence of fractures in the test group was significantly higher than that in the control group[5.05%(897/17 747)vs. 4.40%(459/10 434),RR=1.27,95%CI:1.14-1.42,P<0.01]. Subgroup analysis showed that the incidence of fractures in the canagliflozin group was significantly higher than that in the control group[6.21%(679/10 938)vs. 5.28%(365/6 913),RR=1.31,95%CI:1.15-1.48,P<0.01]. There were no significant differences in the incidence of fractures between the empagliflozin group and the control group[3.20%(218/6 809)vs. 2.67%(94/3 521),RR=1.44,95%CI:0.35-5.90, P=0.61]. Conclusions Canagliflozin(a kind of SGLT2 inhibitors)can increase the incidence of fractures. It is suggested that the risk assessment should be done before medication for the benefit of patients.
8.The application of nalmefene in sufentanil and propofol anesthesia for abortion
Na LI ; Fei LIANG ; Xiaoshan XIAO ; Yatong LIANG ; Daiwei ZHOU
The Journal of Practical Medicine 2015;(13):2190-2193
Objective To investigate the effect of nalmefene on sufentanil and propofol anesthesia for abortion and its impact on BIS. Methods One hundred and twenty patients undergoing abortion patients were randomly divided into group A, B, C, and D (n = 30 each). Patients in group A and B received 0.2 μg/kg or 0.3 μg/kg sufentanil, respectively, followed with 1.5 mg/kg propofol for induction of anesthesia post-pretreatment with 0.2 μg/kg nalmefene. Patients in group C and D received induction of anesthesia as patients in group A and B. According to the BIS and fluctuation of hemodynamic , the amount of propofol was adjusted. If necessary, additional single intravenous injection of 0.5 mg/kg propofol. The mean arterial pressure (MAP), heart rate (HR), pulse oxygen saturation (SpO2) and respiratory rate (RR) in patient before injection (T1), the eyelash reflex (T2), dilatation (T3), curettage (T4) and surgery awake (T5) were detected. The additional amount of propofol , operation time , recovery time of surgery , the steward score of orientation recovery after 1min of surgery , body movement reaction , cough , respiratory depression , postoperative visual analog digital score (VAS) 15 min later were also recorded in each group. Results Compared with group A, propofol could reduce the intraoperative body movement reaction rate , with lower postoperative VAS in group B and group D (P <0.05, respectively), with no significant difference between group C and group A (P > 0.05). The rapid recovery, surgery within 1 min orientation recovery were higher in group B, C, D compared with group A (P <0.05). However, orientation recovery score in group D was higher than that in group B (P < 0.05); The respiratory depression and choking were higher in group A and B than those in group C , D (P < 0.05, respectively). Conclusion The doses of 0.2 μg/kg nalmefene can effectively antagonize the respiratory depression , delay recovery and other adverse reactions in painless which induced by sufentanil , and the dose of nalmefene in this study failed to enhance the effect of analgesic and change the BIS values.

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