Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.

Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.

Objective:To study the iodine nutritional status of pregnant women in the third trimester in the Southwest of Shandong Province, analyze its impact on their cardiac electrical activity, and provide a basis for scientific supplementation of iodine during pregnancy.Methods:From January 2021 to June 2022, a cross-sectional survey was conducted using cluster random sampling method. According to the inclusion and exclusion criteria, 200 pregnant women in the third trimester were selected from 3 tertiary hospitals in three cities in the Southwest of Shandong Province, and were divided into the third trimester group ( n = 600), and 100 non-pregnant women were selected as the control group ( n = 300). The urinary iodine content was detected by arsenic-cerium catalytic spectrophotometry, and the pregnant women in the third trimester group were subdivided into iodine deficiency subgroup [G1 subgroup, median urinary iodine (MUIC) < 150 μg/L] based on the MUIC, iodine excess subgroup (G2 subgroup, MUIC≥500 μg/L) and moderate iodine subgroup (G3 subgroup, 150 μg/L≤MUIC < 500 μg/L). Chemiluminescence immunoassay was used to measure the serum levels of thyroid-stimulating hormone (TSH), free thyroxine (FT 4) and free triiodothyronine (FT 3). The cardiac electrical indexes were detected by a 12-lead surface electrocardiogram (ECG) machine. Results:There was no statistically significant difference in urinary iodine levels between pregnant women in the third trimester group and non-pregnant women in the control group among the 3 tertiary hospitals in the Southwest of Shandong Province ( H = 3.63, 3.27, P > 0.05). In the third trimester group, the proportion of pregnant women in the G1, G2 and G3 subgroups was 27.67% (166/600), 6.83% (41/600) and 65.50% (393/600), respectively. There was a statistically significant difference in urinary iodine levels between the subgroups and the control group ( H = 11.56, P < 0.001). The serum FT 3 and FT 4 levels in the G2 subgroup were lower than those in the G1 and G3 subgroups ( P < 0.001), but there was no statistically significant difference in serum TSH levels among the three subgroups ( P > 0.05). The normal rates of ECG in the G1, G2, G3 subgroups, and the control group were 38.55% (64/166), 41.46% (17/41), 92.37% (363/393), and 95.33% (286/300), respectively. The difference between the groups were statistically significant (χ 2 = 461.25, P < 0.001), the normal rate of ECG in the G1 and G2 subgroups was lower than that in the control group ( P < 0.001). Short P-R intervals and ST-T changes were the most common abnormal ECG in the third trimester group. Conclusions:The incidence of iodine deficiency, iodine excess, and other abnormal iodine nutritional status in pregnant women in the third trimester of the Southwest of Shandong Province is relatively high. Short P-R intervals, ST-T changes, and other arrhythmia caused by this are more common. It is necessary to strengthen monitoring of iodine nutritional status and ECG during pregnancy, and adjust intervention strategies such as iodine supplementation in a timely manner.

Objective:To analyze the effect of meteorological conditions on mortality and population susceptibility of patients with acute myocardial infarction (AMI) in the Shantou area and to provide a scientific basis for the local public health system to prevent AMI.Methods:The AMI mortality data recorded in the resident cause of death surveillance database of Shantou from January 1, 2015, to December 31, 2020, were collected and the distribution lag nonlinear model was used to analyze the diurnal temperature range (DTR) and relative humidity (RH) on AMI mortality and the lag effect.Results:There were 13 932 deaths due to AMI in Shantou during the study period, with a male-to-female sex ratio of 1.3∶1. There was a significant association between high diurnal temperature difference exposure and low RH exposure and AMI deaths, with both single-day lag effects appearing and reaching a maximum at lag 2 day ( RR=1.019, 95% CI: 1.000-1.039; RR=1.018, 95% CI: 1.003-1.034); the cumulative lag effect was all maximal at lag 0-14 day ( RR=1.199, 95% CI: 1.025-1.401; RR=1.279, 95% CI: 1.117-1.465). The elderly (≥75 years) and female populations were susceptible to high DTR exposure and low RH exposure conditions. Conclusions:There was a significant association between DTR and RH and mortality of AMI in Shantou with a significant lag in their effects. Both female and elderly populations ≥75 years old were susceptible populations under high DTR and low RH exposure conditions.

Femoral neck fracture (FNF) in the elderly patients is currently a major health challenge worldwide, with excessive consumption of medical resources, high incidence of complications as well as suboptimal outcome and prognosis. Hip joint arthroplasty (HJA) has been the mainstream treatment for FNF in the elderly, but the conventional surgical approaches and techniques are still confronted with a series of bottlenecks such as dislocation, limp and limb length discrepancy. In recent years, direct anterior approach (DAA) for HJA (DAA-HJA) has been a major new choice in the field of joint replacement, which achieves improved clinical effectiveness of HJA in the treatment of elderly FNF, due to the fact that DAA approach involves the neuromuscular interface and accords with the idea of soft tissue retention and enhanced recovery after surgery. However, there is still a lack of unified understanding of standard technique and procedure of DAA-HJA in the treatment of elderly FNF. Therefore, relevant experts from the Hip Joint Group of Chinese Orthopedics Association of Chinese Medical Association, Youth Arthrology Group of Orthopedic Committee of PLA, Orthopedic Committee of Chongqing Medical Association, Branch of Orthopedic Surgeons of Chongqing Medical Doctor Association and Sport Medicine Committee of Chongqing Medical Association were organized to formulate the " Chinese expert consensus on the technical standard of direct anterior hip arthroplasty for elderly femoral neck fracture ( version 2023)" based on evidence-based medicine. This consensus mainly proposed 13 recommendations covering indications, surgical plans, prosthesis selections, surgical techniques and processes, and postoperative management of DAA-HJA in elderly patients with FNF, aiming to promote standardized, systematic and patient-specific diagnosis and treatment to improve the functional prognosis of the patients.

OBJECTIVE：To stu dy the effects of R&D expense additional deduction policy on R&D investment and profitability of pharmaceutical manufacturing industry ， and to provide reference for improving R&D investment and profitability of pharmaceutical manufacturing industry. METHODS ：Based on the data of Chinese pharmaceutical listed enterprises during 2012-2019，regression discontinuity design and descriptive method were adopted to analyze the effect of R&D expenses additional deduction policy on R&D investment and profitability of pharmaceutical manufacturing industry. RESULTS ：Both R&D investment and the main business profit margin had significant “jump”at the policy cutoff point ，and the policy effect coefficient of the R&D expenses additional deduction policy on R&D investment and profitability of the pharmaceutical manufacturing industry were 0.310 and －1.197 respectively（P＜0.001）. The policy effect coefficient of the policy on R&D investment in the eastern region was 0.413（P＜0.001），while the effect on central and western regions were not significant ；the policy effect coefficient of the policy on R&D investment of large-scale and small- and medium-scale pharmaceutical manufacturing industry were 0.502 and 0.264 respectively（P＜0.001）. CONCLUSIONS ：On the whole ，R&D expenses additional deduction policy has a positive incentive impact on R&D investment of pharmaceutical manufacturing industry ，but does not have a positive incentive impact on the profitability which is greatly affected by other factors. The policy has regional differences in the incentive impact on R&D investment of pharmaceutical manufacturing industry ；the incentive impact of the policy on the R&D investment of large-scale pharmaceutical manufacturing industry is better than that of small-and medium-scale one. It is recommended to improve the R&D expenses additional deduction policy ，reasonably increase the profit margin of the pharmaceutical manufacturing industry ，adjust the policy for different regions and focus on guiding policies to favor small- and medium-scale pharmaceutical manufacturing industry，so as to improve the R&D investment and profitability of pharmaceutical manufacturing industry.

In the past, hernia and abdominal wall surgery has been ignored, which may endanger the life of patients due to untimely treatment. In 1997, the concept of tension-free hernia repair was introduced to China. Chinese hernia and abdominal wall surgery entered a new era and developed rapidly. In 2015, scholars in China decided to create our own Hernia Registry. In 2017, Hernia Registry was officially released, and the Chinese Hernia Surgery Alliance was established in the same period. The Chinese Hernia Registry has became the second largest Hernia clinical registry database in the world. Although the follow-up rate needs to be improved, it is possible to have a preliminary understanding and analysis of the incidence of hernia disease in China. There are many difficulties in its application, and it requires the multi-level coordination and long-term commitment. The authors hope that through this work, the diagnosis and treatment of hernia and abdominal wall can be improved, and the ability of communication and cooperation at home and abroad will be enhanced, benefiting the general population of hernia patients.

Objective To estimate effective and organ doses to prostate cancer patients result ing from the whole-body 18F-Choline,11C-Choline and 68Ga-PSMA PET-CT examinations.Methods A total of 150 prostate cancer patients who underwent PET-CT scanning from May 2017 to June 2018 were retrospectively analyzed.They were divided into three groups,each with 50 patients,according to the type of positron radiopharmaceuticals injected.All patients used the same PET-CT scan protocol.PET component dose was calculated by using OLINDA/EXM (version 1.1) software which was based on the MIRD method.The CTDI values were measured by the standard CT phantoms and computed by ImPACT (version 1.0.4) CT,and ImPACT was used for dose calculation from CT.The tissue weighting factors according to ICRP Report 103 were used for effective dose calculation.Results The effective dose and organ equivalent dose from 18F/11C-Choline and 68Ga-PSMA PET/CT examinations were estimated.The voltage and current of Topogram scan were 120 kV and 35 mA,respectively,as well as 120 kV and (135.6±9.4) mA for low-dose CT scan.The injected activity of 18 F-Choline,11 C-Choline and68Ga-PSMA was (279.2±13.2),(350.2±39.9) and (186.8±19.4) MBq,respectively.The effective dose was (5.0±0.2),(1.6±0.2) and (3.0±0.3) mSv,respectively (F=837.0,P＜0.001).The CT effective dose was (11.4±0.2) mSv.The total effective dose for three groups were (16.4±0.3),(13.0±0.3) and (14.4±0.4) mSv,respectively.The mean organ equivalent doses were statistically significantly different among groups (F=381.2-1 637.7,P＜0.001).The highest organ equivalent dose was to kidney for18F-Choline and68 Ga-PSMA PET/CT scans and thyroid for11 C-Choline PET/CT scan.Conclusions The effective dose to the prostate cancer patients who underwent PET-CT scanning was from 13.0 to 16.4 mSv,with vast majority of these doses coming from CT scans.The lowest radiation dose to the patients was caused by 11C-Choline PET-CT examination,suggesting that it would be a potential prostate cancer PET radiotracer.

Objective: To explore the diagnostic value and efficiency of using whole body bone scintigraphy (WBS) combined with the levels of tumor markers to evaluate non-small cell lung cancer (NSCLC) patients with bone metastases. Methods: One-hundred and eighty-five cases of NSCLC, confirmed by pathology or cytological examination from January 2014 to June 2016, were emrolled from the Affiliated Tumor Hospital of Guangxi Medical University. WBS and test results of tumor markers, such as serum carcinoembryonic antigen (CEA), serum carbohydrate antigen (CA125), and cytokeratin CK19 (CYFRA21-1), were analyzed. WBS results were assessed by the Soloway classification criteria and divided into four grades: Correlations between WBS classification and the levels of tumor mark-ers were determined with Spearman correlation analyses. Results: Seventy-eight of the 185 NSCLC patients had bone metastases (a rate of 42.16%). The sensitivity and specificity of WBS were 91.02%(71/78) and 85.98%(92/107), respectively. The CEA, CA125, and CYFRA21-1 levels in bone metastases patients were higher than those in NSCLC patients without bone metastases (P＜0.05). In the 78 patients with bone metastases, there were seven cases of EOD0 (8.98%), 39 cases of EOD1 (50%), 17 cases of EOD2 (21.8%), and 15 cases of EOD3 (19.2%). The correlations between WBS grade and CEA, CA125, and CYFRA21-1 levels were: rs=0.579, 0.274, and 0.327, respectively (P＜0.05). The combined WBS and tumor marker diagnostic performance was significantly better than either alone (AUC=0.922), and their sensitivity and specificity increased (92.3%and 86.0%, respectively). Conclusions: WBS shows high clinical efficacy in the diagnosis of NSCLC with bone metastases. Furthermore, it can be used as a screening test for bone metastases of NSCLC, which has important clinical implications. WBS combined with CEA, CA125, and CYFRA21-1 examination improves the detection rate of NSCLC bone metastases, thereby enhancing its clinical utility.

OBJECTIVETo evaluate the effect and safety of Kuanxiong Aerosol (, KA) on patients with angina pectoris.

METHODSBlock randomization was performed to randomly allocate 750 patients into KA (376 cases) and control groups (374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA (0.6 mL per spray). The control group received 1 sublingual nitroglycerin tablet (NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment (1, 2, 3, 4, 5, and >5 min). Logistic regression analysis was performed to observe the factors inflfluencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society (CCS) classes of angina.

RESULTSThe 5-min remission rates in the KA and control groups were not signifificantly different (94.41% vs. 90.64%, P>0.05). The angina CCS class signifificantly inflfluenced the rate of remission (95% confidence interval = 0.483-0.740, P<0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSII and III subgroups (P>0.05), while they were signifificantly better for KA in the CCSI and II subgroups (P<0.05 or P<0.01). Furthermore, the incidence of adverse reactions was signifificantly lower in the KA group than in the control group for the CCSII and III subgroups (9.29% vs. 26.22%, 10.13% vs. 20.88%, P<0.05 or P<0.01).

CONCLUSIONSKA is not inferior to NT in the remission of angina. Furthermore, in CCSII and III patients, KA is superior to NT, with a lower incidence of adverse reactions. (Registration No. ChiCTRIPR-15007204).

Aerosols ; adverse effects ; therapeutic use ; Angina Pectoris ; drug therapy ; Case-Control Studies ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Kaplan-Meier Estimate ; Logistic Models ; Male ; Middle Aged ; Remission Induction ; Treatment Outcome