ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome， and to provide guidance for national medical decision-making， clinical drug promotion， and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （Trial Version， 2021） using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software， this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions， including safety pre- and post-market launch， effectiveness in treating migraine， economy （cost-effectiveness）， and innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics in both its technology and clinical applications. ResultSafety： Duliang soft capsules were found to have good safety based on evidence from known adverse reactions （spontaneous reporting system （SRS） data， literature data， etc.）， pre-marketing toxicological research， and post-marketing drug monitoring. Effectiveness： A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy： Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation： Duliang soft capsules， with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components， hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction （CO₂ supercritical extraction technology） and formulation （soft capsule） processes. The product's innovation was rated as "Better". Suitability： A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility： Duliang soft capsules are moderately priced， making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics： The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio （Shi Zhai Bai Yi Xuan Fang） from the Song Dynasty， and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue （Jing Yue Quan Shu） as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch， and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness， suitability， and accessibility， and outstanding TCM characteristics. The product's safety， economy， and innovation received good ratings. In summary， Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics， the evidence was sufficient， and the result was confirmed， providing crucial references for clinical decision-making and pharmaceutical management.

Objective:To verify the synthetic CT(sCT) images generated by the adaptive radiation therapy (ART) workflow guided by magnetic resonance imaging (MRI), and to evaluate its feasibility for dose calculation in ART for head and neck.Methods:The plan CT (pCT) and T 2WI MRI images before each fraction of treatment were collected from 300 patients with head and neck tumors admitted to Shandong Cancer Hospital from January 1, 2022 to December 1, 2023. MRI was converted into sCT using RegGAN model. Among 300 patients, 240 cases were used for training and validation and 60 for testing. The mean absolute error (MAE), peak signal-to-noise ratio (PSNR) and structural similarity index measure (SSIM) were used to evaluate the image quality of sCT. The original pCT plan conditions were copied to sCT, and the accuracy of sCT was recalculated and verified. Finally, the radiation treatment plan of sCT was verified, and the γ-passing rate was calculated to further verify the accuracy of sCT dose calculation. Results:In terms of index calculation, the MAE of sCT was 32.50±5.46, 31.39±1.14 for PSNR, and 0.93±0.01 for SSIM, respectively. Slight difference was observed in the comparison of CT values. Regarding dose calculation, the accuracy of sCT dose calculation was high. According to the dose volume histogram (DVH), the difference in dose calculation was slight, and the average dose difference was only 0.16%. sCT exhibited a high degree of coincidence with pCT in the evaluation of target delineation for planning target, clinical target and gross tumor volume. The average Dice similarity coefficients were 0.97, 0.95 and 0.94, respectively. The γ-passing rate reached 100% using 3%/2 mm. The total treatment time of all patients was (155.14±9.41) s.Conclusions:The ART workflow has high work efficiency, and the accuracy of the generated sCT can meet the dose calculation accuracy requirements of the online plan. It can be used as a reference image for MRI-guided accelerator ART of nasopharyngeal carcinoma, and is expected to achieve MR radiotherapy based on nasopharyngeal carcinoma.

Objective:To investigate the predictive value of neutrophil-lymphocyte ratio (NLR) for Trousseau’s syndrome (TS) in patients with acute multiple cerebral infarctions (AMCI).Methods:The patients with AMCI in Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine from July 2013 to March 2022 were retrospectively enrolled. The demographic and baseline clinical data of patients with TS and those without TS were compared. Multivariate logistic regression analysis was used to determine the independent influencing factors of TS-AMCI, and receiver operating characteristic (ROC) curve was used to evaluate the predictive value of NLR for TS-AMCI. Results:A total of 59 patients with AMCI were enrolled, including 43 males and 16 females, aged 64.9±14.0 years. There were 16 patients in the TS-AMCI group and 43 in the non-TS-AMCI group. The proportions of patients with diabetes mellitus, hypertension and previous stroke or transient ischemic attack in the TS-AMCI group were significantly lower than those in the non-TS-AMCI group (all P<0.05), while the proportion of patients with ischemic heart disease were significantly higher than that in the non-TS-AMCI group ( P<0.05). The proportion of patients with bilateral infarction in the TS-AMCI group was significantly higher than that in the non-TS-AMCI group ( P<0.001). The D-dimer, NLR, white blood cell count, neutrophil count, monocyte count, percentage of neutrophils, total cholesterol and low-density lipoprotein cholesterol in the TS-AMCI group were significantly higher than those in the non-TS-AMCI group (all P<0.001), while the lymphocyte count, lymphocyte percentage, red blood cell count, hemoglobin and hematocrit were significantly lower than those in the non-TS-AMCI group (all P<0.001). Multivariate logistic regression analysis showed that high NLR was an independent predictor of TS-AMCI (odds ratio [ OR] 2.897, 95% confidence interval [ CI] 1.270-6.527; P=0.011), while high hemoglobin was independently negatively correlated with TS-AMCI ( OR 0.839, 95% CI 0.723-0.975; P=0.022). ROC curve analysis showed that the area under the curve of NLR for predicting TS-AMCI was 0.929 (95% CI 0.831-0.979; P<0.001). When the NLR cutoff value was 4.01, the corresponding Youden index was 0.744. At this time, the sensitivity and specificity were 100% and 74.42% respectively. Conclusion:NLR has high predictive value for TS-AMCI.

Objective:To investigate the pathogenesis, selection of endovascular treatment (EVT) strategies, and efficacies of acute vertebrobasilar artery occlusion (AVBAO) of different lesion sites.Methods:One hundred and five patients with AVBAO, admitted to and accepted EVT in our hospital from February 2017 to September 2019, were chosen in our study. The data of disease onset, imaging findings, EVT status, perioperative complications, and prognoses of these patients were collected. According to DSA results, the involved lesions were divided into 4 sites: the upper segment of basilar artery (BA), the middle segment of BA, the lower segment of BA, and the intracranial segment of vertebral artery (V4 segment), and patients with tandem lesions would be recorded as distal lesions. The risk factors, EVT strategies, and prognoses 90 d after follow-up (modified Rankin scale [mRS] scores≤3: good prognosis) were compared in patients with 4 different lesion sites.Results:There were significant differences in etiological classifications and percentage of patients combined with atrial fibrillation among patients with 4 different lesion sites ( P<0.05). There was significant difference in proportion of patients accepted emergency stent implantation among patients with 4 different lesion sites ( P<0.05): those with lesions at the V4 segment had the highest proportion of patients accepted emergency stent implantation (79.55%), followed by those with lesions at the lower segment of BA (50.00%). There was significant difference in EVT time (the time from arterial puncture to successful recanalization of occluded vessels) among patients with 4 different lesion sites ( P<0.05): the EVT time in patients with lesions at the middle segment of BA was the shortest (87.5 [58.5, 130.8] min), and the EVT time in patients with lesions at the lower segment of BA was the longest (115.0 [81.0, 163.0] min). There was no statistical difference among patients with different lesion sites in good prognosis rate 90 d after follow-up ( P>0.05). Conclusion:The pathogenesis of patients with different AVBAO lesion sites is different, so different EVT strategies should be adopted.

Objective:To investigate the influence of low-dose ionizing radiation on the expression level of serum insulin-like growth factor binding protein-3 (IGFBP-3) in radiation workers in hospitals.Methods:183 radiation workers were randomly selected and grouped by work type including interventional radiology ( n=37), nuclear medicine ( n=43), radiotherapy ( n=48), and diagnostic radiology ( n=55). The content of IGFBP-3 in the serum of radiation workers was detected by ELISA assay. Results:It was observed that the expression level of serum IGFBP-3 in the four groups had significant differences ( F=6.056, P<0.05), and the content of serum IGFBP-3 in the interventional radiology group was significantly higher than that of nuclear medicine, radiotherapy, and diagnostic radiology groups ( t= 2.815, 3.611, 3.936, P<0.05). The concentration of IGFBP-3 in the serum of radiation workers among different annual effective dose groups was statistically different ( F=8.380, P<0.05), which gradually increased with the increase of annual effective dose and length of service ( rs=0.202, 0.151, P<0.05). Conclusions:The expression level of serum IGFBP-3 has the potential to be used as a biomarker to reflect the cumulative exposure of long-term chronic low-dose ionizing radiation.

Background: There are a variety of endoscopic techniques for treatment of gastrointestinal submucosal tumors (SMTs). However, because of the difficulties in operation, high technique needs of operator and long period of training needed, some of these techniques could not be promoted and implemented in primary hospitals. Aims: To evaluate the feasibility and safety of endoscopic submucosal excavation assisted with ligation device (ESE-LD) for treatment of small gastrointestinal SMTs. Methods: The clinical data of 75 patients who underwent ESE-LD during January 2014 to July 2019 at the Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine and Jinling Hospital for treatment of small gastrointestinal SMTs (<2 cm in diameter) were retrospectively collected and analyzed. Results: In the 75 small gastrointestinal SMTs, 42 were originated from submucosa and 33 from muscularis propria. Eighteen lesions were located in esophagus, 30 in stomach, 6 in duodenum and 21 in colorectum. All tumors (mean diameter: 13 mm±3 mm, range: 0.5-2 cm) achieved en bloc resection. The mean time of ESE-LD procedure was (16.7±3.2) min, and the mean time of hospitalization was (5.08±1.21) d. No delayed bleeding and perforation requiring further intervention occurred. There were no recurrences during the follow-up period of (33.8±5.2) months. Conclusions: ESE-LD is safe and effective for treatment of gastrointestinal SMTs less than 2 cm in diameter. Moreover, it is easy to operate with short operation time. ESE-LD might be recommended to be promoted in primary hospitals.

Objective:To explore the gene mutations of UGT1A1 * 6 and UGT1A1 * 28 in patients with unconjugated hyperbilirubinemia after renal transplantation and understand their clinical significance.Methods:UGT1A1*6 and UGT1A1*28 gene fragments in blood samples of patients with unconjugated hyperbilirubinemia after renal transplantation were detected by digital fluorescent molecular hybridization sequencing.Results:A total of 21 patients with unconjugated hyperbilirubinemia after renal transplantation were examined for UGT1A1*6 and UGT1A1*28 alleles. The results showed that there were 3 UGT1A1*28 and UGT1A1*6 combined heterozygous mutations, 4 UGT1A1*28 gene heterozygous mutations, 2 UGT1A1*6 heterozygous mutations and 4 UGT1A1*6 homozygous mutations. Among them, the mutation rates of UGT1A1*28 gene and UGT1A1*6 gene were 33%(7/21) and 43%(9/21) respectively and the total mutation rate of both was 62%(13/21).Conclusions:UGT1A1 polymorphism is associated with unconjugated hyperbilirubinemiaafter renal transplantation. By detecting the sequence of UGT1A1*6 and UGT1A1*28 gene fragments in blood samples of renal transplant patients, it is helpful to clarify the etiology of unconjugated hyperbilirubinemia after renal transplantation to confirm the diagnosis of Gilbert syndrome and rule out the effect of immunosuppressive drugs on liver function so as to guide the clinical medication of renal transplant patients.

Objective:To investigate the efficacy and safety of endovascular recanalization treatment for acute vertebral basilar artery occlusion (AVBAO) underlying intracranial atherosclerotic disease (ICAD) using a balloon-mounted stent.Methods:A total of 16 cases of consecutive AVBAO patients who underwent endovascular treatment with the balloon-mounted stent within 24 h after onset were retrospectively enrolled in Henan Provincial People′s Hospital from February 2017 to August 2019. And the recanalization rate, operation-related complications, symptomatic intracranial hemorrhage, the improvement of 1 week National Institutes of Health Stroke Scale (NIHSS) score and 3 months modified Rankin Scale (mRS) after treatment were recorded.Results:In all of the 16 patients, 4 patients underwent direct stenting angioplasty, 12 patients received salvage stenting. Stent placement was successful in all 16 patients. Balloon-mounted stent were implanted in basilar artery of 4 cases, in intracranial segment of vertebral artery of 8 cases, and in origination segment of vertebral artery of 4 cases. Recanalization was successful (thrombolysis in cerebral infarction grade 2b and 3) in 15 patients. The time between arterial puncture and recanalization was 79.0 (72.3, 109.3) min. One patient experienced distal thrombosis during surgery. Two patients suffered symptomatic intracranial hemorrhage within 48 h after surgery. The scores of the NIHSS were improved more than 4 points at 1 week after operation in 8 patients. At 3 months follow-up, 9 patients had a good outcome (mRS 0-3 points) and 4 patients died.Conclusion:Selective stenting angioplasty treatment with a balloon-mounted stent seems to be feasible and safe for AVBAO patients underlying ICAD.

Background: DNA methylation plays an important role in the development of gastric cancer, but it needs the modification with DNA methyltransferases (DNMTs). Aims: To investigate the expression and clinical significance of DNMTs in the occurrence and development of gastric cancer. Methods: A total of 80 cases of gastric cancer tissues and corresponding adjacent normal tissues were collected. Immunohistochemistry was used to detect the expressions of DNMT1, DNMT3a, DNMT3b, and their correlations with clinicopathological features of gastric cancer were analyzed. mRNA and protein expressions of DNMT1, DNMT3a, DNMT3b in 4 gastric cancer cell lines and human gastric epithelial cell line were determined by qRT-PCR and Western blotting, respectively. Results: Compared with adjacent normal tissue, the positive expression rate of DNMT1 was significantly increased in gastric cancer (68.8% vs. 10.0%, P<0.01). The positive expression of DNMT1 in gastric cancer tissue was significantly higher than that of DNMT3a and DNMT3b (68.8% vs. 38.8%, 40.0%, P<0.05), while the positive expression of DNMT1 in adjacent tissue was significantly lower than that of DNMT3a and DNMT3b (10.0% vs. 60.0%, 52.5%, P<0.05). The positive expression of DNMT1 was correlated with depth of invasion, lymph node metastasis and TNM stage in patients with gastric cancer (P<0.05), while the positive expression of DNMT3a, DNMT3b were not correlated with clinicopathological features of gastric cancer. The expression of DNMT1 in gastric cancer cells was significantly higher than that in normal gastric epithelial cells, while the expressions of DNMT3a and DNMT3b were significantly decreased. Moreover, the expression of DNMT1 was related to the degree of differentiation of gastric cancer cells (P<0.05). Conclusions: DNMT1 maybe play an important role in the occurrence and development of gastric cancer.

Objective This retrospective study compared the detection rates of prostate cancer between freehand transperineal biopsy (FTPB) and template-guided transperineal biopsy (TYPB) in the patients with PSA levels ＜ 20 ng/ml.Methods From April 2017 to April 2019,768 patients with PSA levels ＜ 20 ng/ml were included into this study.Of these patients,406 underwent FTPB procedures and 362 underwent TTPB procedures.There were no significant differences of median age [66.00(61.00,70.00)vs.66.00 (61.00,71.25) years],height [170.00 (165.00,172.00) vs.170 (165.00,173.00) cm],weight [70.00 (63.88,75.00) vs.70.00 (63.75,75.00) kg],BMI [24.22 (22.22,25.95) vs.24.22 (22.49,25.82) kg/m2],PSA [8.75 (6.49,12.40) vs.8.69 (6.49,11.96) ng/ml],fPSA [1.18 (0.33,2.15) vs.1.15(0.76,1.88)ng/ml],prostate volume [39.79(25.55,53.94)vs.39.88(24.46,55.11)ml] between two groups.Patients' biopsy results were recorded,the differences of prostate cancer detection rates between these two groups were analyzed,specifically including the cancer with Gleason score ≥ 7 and the anterior zone cancer.Results The total prostate cancer detection rates were 33.7％ (137/406) and 39.0％ (141/362,P =0.134) in FTPB group and TTPB group respectively,and the detection rates of cancer with Gleason score≥7 were 23.9％ (97/406) and 32.0％ (116/362,P =0.012) respectively.The detection rates of anterior zone prostate cancer were 15.5％ (63/406) and 27.3％ (99/362,P ＜0.001).Moreover,in thepatients with PSA ＜ 10 ng/ml,the prostate cancer detection rates were 29.8％ (74/248) and 36.2％ (81/224,P =0.144) respectively,while the detection rates of cancer with Gleason score ≥7 were 19.4％ (48/248) and 29.9％ (67/224,P =0.008) respectively.Conclusions There was no significant difference in the total prostate cancer detection rates between 12-core TTPB group and 20-core FTPB group in the patients with PSA ＜ 20 ng/ml,but for the detection rate of cancer with Gleason score ≥ 7,TTPB group was significantly higher than FTPB group,especially in the patients with PSA ＜ 10 ng/ml.In addition,for anterior zone prostate cancer,the detection rate of TrPB group was also higher than FTPB group.