OBJECTIVE To evaluate the operation effect of the drug complaints and reporting system in China， and put forward the suggestions for improving the drug supervision system and enhancing the national drug scientific supervision capacity. METHODS The statistical data of drug supervision from 2012 to 2023 and the complaint data of various provinces and 7 third- party platforms of drug online sales from National 12315 Consumer Complaint Information Disclosure Platform from 2023 to 2024 were collected. The operation effect of drug complaints and reporting system was analyzed from the dimensions of public participation， public satisfaction， case handling efficiency and quality， social effect and risk early warning ability. RESULTS From 2012 to 2019， the acceptance of drug complaints and reporting fluctuated greatly， and the number of drug complaints and reporting cases showed a downward trend as a whole， but the public satisfaction was high and the closure rate continued to increase. From 2023 to 2024， the top five provinces in terms of the number of drug complaints were Guangdong， Henan， Zhejiang， Shandong and Shanghai. Drug complaints in the online platform mainly involved Chinese and Western medicines， traditional Chinese medicines and Chinese herbal medicines sold on the network platforms of Pinduoduo， Jingdong and Taobao. The complaints focused on quality and after-sales service， and there were significant differences in the proportion of mediation agreements in drug complaint cases. From 2021 to 2024， the drug regulatory authorities investigated and dealt with 11 typical cases of online sales violations through complaint and reporting clues. CONCLUSIONS The drug complaints and reporting system in China runs smoothly. It is suggested to further use the data of National 12315 Consumer Complaint Information Disclosure Platform to strengthen the monitoring of key areas and network platforms， and urge enterprises to implement the main responsibility， so as to improve the quality and safety of drugs and ensure the safety of public medication.

Objective·To explore the effect of intermittent theta burst stimulation(iTBS)targeting the left dorsolateral prefrontal cortex(DLPFC)on reducing craving in alcohol-dependent patients during the withdrawal period,as well as its impact on patients'emotions and cognitive functions.Methods·A total of 41 inpatients with alcohol dependence in the withdrawal period were recruited from the Addiction Department of Mental Health Center,Shanghai Jiao Tong University School of Medicine,and randomly assigned to the experimental group(20 patients)and the control group(21 patients).Both groups received routine inpatient treatment for alcohol-dependence.The experimental group received real iTBS stimulation targeting the left DLPFC on the basis of routine inpatient treatment,while the control group received sham stimulation with the same parameters.The intervention course lasted for 2 weeks,with a total of 10 sessions.The Visual Analogue Scale(VAS),Beck Depression Inventory(BDI),and Beck Anxiety Inventory(BAI)were used to measure the craving,anxiety,and depression of the patients before and after the intervention.The behavioral tasks of the detection task(DET),identification task(IDN),two back task(TWOB),the Groton maze learning task(GML),and international shopping list task(ISL)in the CogState software package were used to assess the cognitive processing speed,attention/vigilance,working memory,spatial problem-solving/error monitoring ability,and verbal learning and memory of the patients before and after the intervention.Results·Repeated measures ANOVA showed that the time effect[F=126.713,P＜0.001,partial η2(ηp2)=0.765]and interaction effect(F=7.080.P=0.011,ηp2=0.154)of the VAS scores in the two groups of patients were statistically significant.The time effect(F=9.114,P=0.004,ηp2=0.189),group effect(F=5.557,P=0.024,ηp2=0.125),and interaction effect(F=4.977,P=0.032,η2=0.113)of the TWOB score were all statistically significant.Only the time effects of BDI(F=45.273,P＜0.001,ηp2=0.578),BAI(F=31.432,P＜0.001,ηp2=0.473),GML(F=8.993,P=0.005,ηp2=0.209),and ISL(F=26.657,P＜0.001,ηp2=0.439)scores were statistically significant.There were no statistically significant effects of time,group,or interaction on the DET and IDN scores.Simple effect analysis showed that the VAS score of the real stimulation group was lower than that of the sham stimulation group after the intervention(F=8.805,P=0.005,ηp2=0.184),and the TWOB score of the real stimulation group was higher than that of the sham stimulation group(F=11.293,P=0.002,ηp2=0.225).Conclusion·Combining iTBS with routine inpatient treatment can enhance the efficacy of reducing alcohol craving in alcohol-dependent patients during the withdrawal period,and improve their working memory.

AIM:To explore the correlation be-tween trimethylamine N-oxide(TMAO)and Hashi-moto's thyroiditis(HT)and to provide new ideas for early clinical diagnosis of HT.METHODS:A total of 102 patients with Hashimoto's thyroiditis(HT group)and 204 healthy individuals(control group)were included in the study and clinical data were collected.Serum TMAO levels was determined by stable isotope dilution high-performance liquid chromatography tandem mass spectrometry(HPLC-MS/MS).SPSS 26.0 was used for statistical analysis.RESULTS:Analysis of the baseline data revealed that there was a statistically significant difference between the TMAO levels and gender between the HT group and the control group(P<0.05).In the high-level TMAO group,the proportion of HT(63.7%)was significantly higher than that of the control group(18.6%),the regression analysis showed that high levels of TMAO were correlated with HT and positively correlated with the levels of thyroid peroxidase antibody(TPOAb),thyroglobulin antibody(TgAb),Logistic regression analysis further revealed that serum TMAO was a risk factor for the development of HT.CONCLUSION:In the TMAO>6.80 μmol/L group,the level of TMAO was correlat-ed with HT,and the high level of TMAO was posi-tively correlated with TPOAb and TgAb,which were risk factors for the occurrence of HT.It is suggested that TMAO can predict the risk of HT and has cer-tain clinical value.

AIM:To explore the correlation be-tween trimethylamine N-oxide(TMAO)and Hashi-moto's thyroiditis(HT)and to provide new ideas for early clinical diagnosis of HT.METHODS:A total of 102 patients with Hashimoto's thyroiditis(HT group)and 204 healthy individuals(control group)were included in the study and clinical data were collected.Serum TMAO levels was determined by stable isotope dilution high-performance liquid chromatography tandem mass spectrometry(HPLC-MS/MS).SPSS 26.0 was used for statistical analysis.RESULTS:Analysis of the baseline data revealed that there was a statistically significant difference between the TMAO levels and gender between the HT group and the control group(P<0.05).In the high-level TMAO group,the proportion of HT(63.7%)was significantly higher than that of the control group(18.6%),the regression analysis showed that high levels of TMAO were correlated with HT and positively correlated with the levels of thyroid peroxidase antibody(TPOAb),thyroglobulin antibody(TgAb),Logistic regression analysis further revealed that serum TMAO was a risk factor for the development of HT.CONCLUSION:In the TMAO>6.80 μmol/L group,the level of TMAO was correlat-ed with HT,and the high level of TMAO was posi-tively correlated with TPOAb and TgAb,which were risk factors for the occurrence of HT.It is suggested that TMAO can predict the risk of HT and has cer-tain clinical value.

Objective·To explore the effect of intermittent theta burst stimulation(iTBS)targeting the left dorsolateral prefrontal cortex(DLPFC)on reducing craving in alcohol-dependent patients during the withdrawal period,as well as its impact on patients'emotions and cognitive functions.Methods·A total of 41 inpatients with alcohol dependence in the withdrawal period were recruited from the Addiction Department of Mental Health Center,Shanghai Jiao Tong University School of Medicine,and randomly assigned to the experimental group(20 patients)and the control group(21 patients).Both groups received routine inpatient treatment for alcohol-dependence.The experimental group received real iTBS stimulation targeting the left DLPFC on the basis of routine inpatient treatment,while the control group received sham stimulation with the same parameters.The intervention course lasted for 2 weeks,with a total of 10 sessions.The Visual Analogue Scale(VAS),Beck Depression Inventory(BDI),and Beck Anxiety Inventory(BAI)were used to measure the craving,anxiety,and depression of the patients before and after the intervention.The behavioral tasks of the detection task(DET),identification task(IDN),two back task(TWOB),the Groton maze learning task(GML),and international shopping list task(ISL)in the CogState software package were used to assess the cognitive processing speed,attention/vigilance,working memory,spatial problem-solving/error monitoring ability,and verbal learning and memory of the patients before and after the intervention.Results·Repeated measures ANOVA showed that the time effect[F=126.713,P＜0.001,partial η2(ηp2)=0.765]and interaction effect(F=7.080.P=0.011,ηp2=0.154)of the VAS scores in the two groups of patients were statistically significant.The time effect(F=9.114,P=0.004,ηp2=0.189),group effect(F=5.557,P=0.024,ηp2=0.125),and interaction effect(F=4.977,P=0.032,η2=0.113)of the TWOB score were all statistically significant.Only the time effects of BDI(F=45.273,P＜0.001,ηp2=0.578),BAI(F=31.432,P＜0.001,ηp2=0.473),GML(F=8.993,P=0.005,ηp2=0.209),and ISL(F=26.657,P＜0.001,ηp2=0.439)scores were statistically significant.There were no statistically significant effects of time,group,or interaction on the DET and IDN scores.Simple effect analysis showed that the VAS score of the real stimulation group was lower than that of the sham stimulation group after the intervention(F=8.805,P=0.005,ηp2=0.184),and the TWOB score of the real stimulation group was higher than that of the sham stimulation group(F=11.293,P=0.002,ηp2=0.225).Conclusion·Combining iTBS with routine inpatient treatment can enhance the efficacy of reducing alcohol craving in alcohol-dependent patients during the withdrawal period,and improve their working memory.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

Organ transplantation is the optimal treatment for end-stage organ failure. Nevertheless, organ shortage is a global problem, which limits further development of organ transplantation. Recent research shows that genetically modified pig may become a realistic alternative source of clinical organ transplantation donor. Xenotransplantation may serve as one of the effective measures to resolve the problem of organ shortage. Since 2021, 2 cases of living xenotransplantation and 6 cases of xenotransplantation in brain death recipients have been performed worldwide, and phase Ⅰ clinical trial of xenotransplantation has been launched, and the results have exceeded expectations. Therefore, in this article, recent clinical trial results of xenotransplantation in living and brain death recipients were retrospectively analyzed, and scientific, technical and ethical issues related to clinical research of xenotransplantation were illustrated, hoping to provide reference for clinical research of xenotransplantation in China and promote the development of xenotransplantation in clinical practice.

Objective:To explore the safety and efficacy of radiofrequency in the treatment of overactive bladder(OAB).Methods:A prospective, multicenter, non-randomized controlled trial was conducted. Eligible patients were divided into test group and control group in Zhejiang Provincial People’Hospital, The First Affiliated Hospital of Wenzhou Medical University, and Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine from March 2019 to June 2020. Inclusion criteria: patients diagnosed with OAB, and bladder capacity>100ml. Exclusion criteria: pregnant and lactating women; patients with secondary OAB symptoms such as urinary tract obstruction; patients with uncontrolled urinary tract infection within 1 week; patients in stable stage by using other treatment methods; patients implanted with any nerve stimulator, cardiac pacemaker or implantable defibrillator; patients with malignant tumors, serious cardiovascular, cerebrovascular diseases, renal insufficiency or received BTX treatment in recent 12 months. The patients were allocated to test group and the control group in a ratio of 2∶1 according to the time sequence of the visit. The patients in the test group were treated with radiofrequency treatment. After entering the group, they were treated for 4 times at the 1st, 2nd, 7th and 8th week respectively. In the control group, the energy was turned off during the radiofrequency treatment. The patients were followed-up every week until the end of the 12th week. The treatment success rate [the average frequency of urination in 24 h was reduced more than 50% from the baseline or returned to the normal (≤8 times/day) or the average frequency of urgent urination in 24 h was reduced more than 50% from the baseline], the frequency of urination, urgent urination and nocturnal urination before and after treatment, the residual urine volume of the bladder, the quality of life (QOL) score and the occurrence of catheter related adverse events in two groups were compared.Results:114 patients were enrolled in the study, including 76 patients in the test group and 38 patients in the control group. There were no significant differences in the age [(44.2±12.8) vs. (41.7 ± 12.1) years old], male female ratio (13/63 vs. 4/34), average course of disease [2.0(1.2, 5.0) vs. 2.0 (1.0, 4.0) years], the frequency of urination[12.8 (10.6, 16.8) vs. 12.8 (10.3, 17.0) times], urgency urination [11.8(9.3, 15.8) vs. 11.8 (9.0, 17.0) times], nocturia [2.7 (1.3, 3.7) vs. 2.3(0.7, 3.3) times], residual urine volume of bladder [12.0 (3.0, 28.0) vs. 14.0 (3.7, 20.0) ml ] and the QOL score [5.0(4.0, 5.0) vs. 4.0(4.0, 5.0)]before the treatment between the two groups ( P>0.05). The treatment success rate in the test group was 76.3% (58/76), while 26.3% (10/38) in the control group, with a statistically significant difference ( P<0.01). There were significant differences between the test group and control group in the frequency of urination [9.7 (7.7, 12.0) vs. 12.9 (9.6, 15.7) times], urgent urination [7.3 (5.0, 10.0) vs. 11.7 (7.3, 15.3) times], nocturia [1.3 (0.7, 2.0) vs. 1.7 (1.0, 3.0) times] and the QOL score of the patients[3.0(1.0, 3.0) vs. 4.0(3.0, 4.5)]after the treatment(all P<0.05). The frequency of urination, urgency urination, nocturia, the residual urine volume and the QOL score in the test group were significantly improved ( P<0.05) after the treatment.The frequency of urination, nocturia, residual urine volume and the QOL score in the control group were improved ( P<0.05) after the treatment. 13 (11.4%) patients had catheter related adverse events. In the test group and the control group, there were 7 cases of macroscopic hemorrhage caused by the placement of instruments (5/76 vs. 2/38), 5 cases of acute urinary tract infection within 3 days (3/76 vs. 2/38), and 1 case of instrument breakage (catheter breakage) (0/76 vs. 1/38). There were no significant differences in the adverse events between the two groups ( P> 0.05). Conclusions:Radiofrequency treatment of OAB can effectively improve the symptoms of patients, improve the QOL of patients, and has low incidence of adverse events, with good efficacy and safety.

Objective:To observe the expression changes of microRNA(miR)-122 in liver tissue of rats infected with Clonorchis sinensis and its correlation with expression level of inflammatory cytokines. Methods:Totally 24 SPF grade Wistar male rats were selected and randomly divided into a control group (100 μl physiological saline gavage), a 4-week infection group (100 Clonorchis sinensis metacercariae gavage), and an 8-week infection group (100 Clonorchis sinensis metacercariae gavage) based on body weight (100-120 g) using a random number table method, with 8 rats in each group. Starting from the third week of infection, rat feces were collected and directly smeared with physiological saline for identification of Wistar rat animal models infected with Clonorchis sinensis. After 4 and 8 weeks of infection, the rats in the 4- and 8-week infection groups were euthanized, while 4 rats in the control group were euthanized, respectively. The heart blood and left lobe liver tissue and serum samples were collected from each group of rats. Using hematoxylin-eosin (HE) staining to observe liver pathological damage under the light microscope, real-time fluorescence quantitative PCR to detect the expression level of miR-122 in liver tissue, and Luminex 200 liquid suspension chip to detect the expression levels of serum inflammatory cytokines [tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β), interleukin-6 (IL-6)]. The correlation between miR-122 and inflammatory cytokines was analyzed using Pearson correlation. Results:Under the light microscope, the morphology of hepatocytes in control group was normal, and no inflammatory cell infiltration was observed. There was inflammatory cells such as lymphocyte, eosinophil and other inflammatory cell infiltration around the portal area in the 4-week infection group. The hepatocytes of the 8-week infected rats were arranged in a disordered manner, with varying degrees of swelling, loose and lightly stained cytoplasm, and some hepatocytes showed watery degeneration; additionally, bile duct dilation and thickening of the bile duct wall were observed in the liver tissue. There were statistically significant differences of liver miR-122 (1.00 ± 0.32, 2.57 ± 0.60, 3.63 ± 1.63), serum TNF-α [(0.14 ± 0.06), (0.43 ± 0.09), (0.61 ± 0.10) ng/ml], and IL-6 expression levels [(0.03 ± 0.01), (1.06 ± 0.24), (1.48 ± 0.33) ng/ml] in control group, 4- and 8-week infection groups ( F = 13.36, 69.99, 82.23, P < 0.001). There was no statistically significant difference in expression level of IL-1β between different groups ( F = 2.15, P = 0.141). The Pearson correlation analysis showed that the expression level of miR-122 was positively correlated with the expression levels of inflammatory cytokines TNF-α and IL-6 ( r = 0.67, 0.80, P < 0.001). Conclusion:Clonorchis sinensis infection can increase the expression of miR-122 in the host liver tissue, and the miR-122 is closely related to the expression levels of inflammatory cytokines TNF-α and IL-6.

As the special subject of the applicant for registration of medical device, the research and development institutions have insufficient conditions and abilities to become medical device registrants, and there are certain difficulties in the actual registration application process, such as not clearing the certification path for the research and development institutions to hold the certificate. In view of the existing problems, by comparing the path of medicine research and development institutions to become medical device registrants and combining with the actual medical device industry to give relevant suggestions, including improving quality management over the whole life cycle of medical devices, quality and safety responsibility ability of research and development institutions, establishing the registration and certification path of research and development institutions, supporting laws and regulations, etc., so as to ensure that the research and development institutions become medical device registrants successfully.
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