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 analyze the medium- and long-term outcomes of V-Y quadricepsplasty in primary total knee arthroplasty (TKA) to expose an ankylosed or stiff knee joint.Methods:From May 2010 to February 2019, a total of 12 patients with TKA revealed by V-Y quadricepsplasty in West China Hospital of Sichuan University due to knee ankylosis or stiffness were retrospectively analyzed, including 7 males and 5 females, aged (53.9±14.9) years (range, 24 to 72 years), 6 patients on the left side and 6 patients on the right side. Preoperative diagnosis: 7 cases of osteoarthritis, 2 cases of rheumatoid arthritis, 1 case of traumatic arthritis, and 2 cases of haemophilic arthritis. Visual analogue scale (VAS), range of motion, quadriceps muscle strength, Knee Society score (KSS) and postoperative complications were recorded before and after operation.Results:All patients successfully completed the operation and were followed up for 102.2±31.1 months (range, 51-141 months). The operation time was 87.0±15.7 min (range, 73 to 123 min), the intraoperative blood loss was 823.6±237.7 ml (range, 555 to 1 471 ml), and the hospital stay was 13.3±6.3 d (range, 6 to 28 d). Postoperative VAS scores were decreased in all patients, and the difference before and after operation was statistically significant ( F=132.000, P<0.001). The VAS scores at 3 months and the last follow-up were 2.2±0.7 points and 1.2±0.4 points, respectively, lower than those before operation (5.2±0.7 points), and the difference was statistically significant ( P<0.05). KSS knee scores were higher in all patients after operation, and the difference was statistically significant before and after operation ( F=40.960, P<0.001). KSS knee scores at 3 months and the last follow-up were 56.0±14.1 points and 74.3±16.1 points, respectively, higher than those before operation (26.1±7.8 points), and the difference was statistically significant ( P<0.05). Postoperative KSS functional scores were increased in all patients, and the difference before and after operation was statistically significant ( F=24.332, P<0.001). The KSS functional scores at 3 months and the last follow-up were 52.9±19.4 points and 79.2±19.6 points, respectively, higher than those before operation (27.1±15.6 points), and the difference was statistically significant ( P<0.05). Postoperative knee joint motion was increased in all patients, and the difference was statistically significant before and after operation ( F=24.145, P<0.001). The range of motion of the knee joint at 3 months and the last follow-up was 57.5°±22.2° and 70.0°±25.9°, respectively, which was higher than the preoperative 12.5°±14.1°, and the difference was statistically significant ( P<0.05). Preoperative quadriceps muscle strength was grade 3 in 2 cases and grade 4 in 10 cases; at the last follow-up, grade 4 in 1 case and grade 5 in 11 cases, and the muscle strength was improved compared with that before operation, the difference was statistically significant ( Z=11.000, P<0.001). At the last follow-up, there were no complications such as wound seepage, delayed healing, superficial or deep soft tissue infection, periprosthesis infection and loosening, deep vein thrombosis and pulmonary embolism. Conclusion:In patients with ankylosed or stiff knee receiving TKA, the use of V-Y quadricepsplasty can increase the exposure, thereby improving the range of knee motion and quadriceps muscle strength.

Objective:To compare the efficacy and safety of drug-coated balloons (DCB) combined with bare metal stents (BMS) and BMS only for superficial femoral atherosclerosis obliterans.Methods:The clinical and follow-up data of 80 patients (82 limbs) who received combined treatment or BMS implantation at Cardiovascular Surgery Department of China Japan Friendship Hospital from Jan 2017 to Aug 2022 were retrospectively analyzed.Results:43 patients (43 limbs) were included in combined treatment group. 37 patients (39 limbs) were in BMS only. The average lesion length of combined group was longer than BMS group (19.54±7.04 cm vs. 16.25±6.43 cm, P=0.031). The primary patency rate of combined group at 36 months was not statistically different with BMS only group (56.9% vs. 38.5%, P=0.171). The subgroup analysis of superficial femoral artery TASC C/D (Trans-Atlantic Inter-Society Consensus) and CTO (chronic total occlusion) lesions indicated that efficacy of the combined group was superior to BMS only group. The patency rates of the combined group compared with the BMS group at 36 months were 57.6% vs. 23.8%, P=0.046, 60.2% vs. 31.4%, P=0.028, respectively. There was no significant difference in the FCD-TLR (free from clinical driven target lesion revascularization) between the two groups at 36 months (72.6% vs. 66.5%, P=0.706). There was no significant difference in major adverse events between the two groups ( P>0.05). Conclusion:Paclitaxel drug-coated balloon combined with bare metal stent is a safe and effective treatment for superficial femoral atherosclerosis obliterans, which is superior to bare metal stent, especially in TASC C/D and chronic total occlusive lesions.

Objective:To evaluate the efficacy and safety of comprehensive treatment for retinoblastoma (RB).Methods:A retrospective clinical study. From January to December in 2019, 157 cases (203 eyes) of RB who were diagnosed by the Department of Ophthalmology of Xinhua Hospital and received comprehensive treatment were included in this study. Of cases, 76 were male, and 81 were female; 111 were unilateral, and 46 were bilateral. The medium of age at diagnosis was 20.1 months. All patients received treatment for the first time. Patients with intraocular tumors were divided into A-E stages, extraocular stage and distant metastasis according to international intraocular RB classification standard. The median follow-up time was 37.4 months. Clinical features, treatment, prognosis and ocular complications of all cases were recorded.Results:Among 157 cases (203 eyes), 137 cases (180 eyes) were in intraocular stage; 6, 14, 10, 98, and 52 of eyes were in A-E stages, respectively. Twelve cases (12 eyes) were in extraocular stage; 8 cases (11 eyes) were in distant metastasis stag; 8 cases died due to distant metastasis; 149 cases (94.9%, 149/157) survived; 48 eyes were enucleated, 34 of which underwent initial enucleation, and 14 eyes underwent enucleation after eye-preserving treatment. The overall global salvage rate was 155 eyes (76.4%,155/203), and that after eye-preserving treatment was 91.7% (155/169). Severer eye for bilateral cases was taken into account for statistic; 120 cases (120 eyes) received initial eye-preserving treatment. Among them, 36 and 84 eyes underwent initial intravenous chemotherapy (IVC) and initial intra-arterial chemotherapy (IAC), respectively. The enucleation of the two groups was 7(19.4%, 7/36), 7(8.3%, 7/84); 33 (91.7%, 33/36) and 33 (39.3%, 33/84) eyes received the second treatment, respectively. There was no significant difference in the rate of enucleation between the two treatments ( χ2=2.037, P=0.154). There was significant difference in the percentage of secondary treatment ( χ2=27.937, P<0.001). Fifty-four eyes (45.0%, 54/120) stabilized after initial treatment, and 66 eyes (55.0%, 66/120) underwent secondary treatments due to poor response or tumor recurrence. For 66 eyes receiving secondary treatments, enucleation, IAC, intravitreous chemotherapy (IVitC), IAC combined with IVitC, and laser and/or cryotherapy was performed in 6, 18, 12, 13, and 17 eyes, respectively. The number of eyes of enucleation among the IAC, IVitC, and IAC combined with IVitC group was 5 (27.8%, 5/18), 1 (9.3%, 1/12), and 2 (15.4%, 2/13) eyes, which was no significantly different ( χ2=2.001, P=0.368). Until the last follow-up, visual acuity outcomes were acquired in 148 eyes (72.9%, 148/203). Among them, 41, 53, 16 and 38 eyes had no light perception, light perception to finger counting, 20/400, and ≥20/200, respectively. In total, among 203 eyes, 121 eyes received IAC, of which 2, 4, and 1 eyes had optic disc atrophy, vitreous hemorrhage, and severe retinal-choroidal atrophy, respectively; 60 eyes received IVitC, of which one and one eye had vitreous hemorrhage and macular hemorrhagic necrosis, respectively. Conclusions:In this study, the overall survival rate was 94.9% after comprehensive treatment and the rate of global salvage after eye-preserving treatment was 91.7%. The comprehensive treatment of retinoblastoma had a relatively high efficacy and safety.

Objective:To explore the clinical features and risk factors of systemic inflammatory responses syndrome (SIRS) after flexible ureteroscopic lithotripsy (FURL) with upper urinary tract stones.Methods:A retrospective of 157 patients with upper urinary calculi treated by FURL who were admitted to Suzhou First People′s Hospital from January 2018 to October 2020 were selected to analyze the treatment results and complications of the patients. Patients were divided into SIRS group ( n=31) and non-SIRS group ( n=126) according to whether they were complicated by SIRS. The clinical data between the two groups were analyzed by a single factor, and the factors with statistical significance were included in the LASSO-Logistic regression analysis. Visualize the model through the Nomogram, and verify and evaluate the discrimination and accuracy of the model. Results:The results of univariate analysis showed that gender( P=0.010), average stone size ( P<0.05), preoperative urine white blood cell count ( P<0.05), operation time ( P<0.05) and postoperative stone bacterial culture ( P<0.05) were different between the two groups and the differences were statistically significant. The LASSO-Logistic regression analysis results show that the above factors were all independent risk factors for patients with SIRS. The Nomogram complicated SIRS risk prediction model constructed based on the above risk factors has good discrimination and high consistency with actual observations. Conclusion:Females, large stones, high preoperative white blood cell counts, longer operation time, and positive bacterial culture of postoperative stones are independent risk factors for SIRS after FURL in patients with upper urinary calculi.

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.

In 2016, the median of 24-hour urinary sodium, sodium-to-potassium ratio, and sodium intake per capita of residents in Jiaodong area of Shandong Province were 161.7 ( IQR:120.5, 218.9) mmol/d, 3.4 ( IQR: 2.4, 5.0) and 9.5 ( IQR:7.1, 12.8) g/d, all were lower than that of 2011[193.3( IQR:149.2,243.3)mmol/d, 4.5( IQR:3.3,5.9), 11.3( IQR:8.7, 14.2)g/d] ( P<0.05); the median of 24-hour urinary potassium was 47.2 ( IQR:34.4, 66.5) mmol/d, higher than that of 2011[42.9( IQR:33.6,56.0)] ( P<0.05); the proportion of salt intake per capita per day exceeding 5 g (89.9%) was lower than that in 2011 (90.0%). The results of the generalized linear regression model showed that the 24-hour urinary sodium was positively correlated with systolic and diastolic blood pressure [β values were 0.04 (95% CI: 0.00, 0.07), 0.03 (95% CI 0.01, 0.05), respectively], and the sodium-to-potassium ratio was positively correlated with diastolic blood pressure [β(95% CI): 0.78 (0.09, 1.47)].

In 2016, the median of 24-hour urinary sodium, sodium-to-potassium ratio, and sodium intake per capita of residents in Jiaodong area of Shandong Province were 161.7 ( IQR:120.5, 218.9) mmol/d, 3.4 ( IQR: 2.4, 5.0) and 9.5 ( IQR:7.1, 12.8) g/d, all were lower than that of 2011[193.3( IQR:149.2,243.3)mmol/d, 4.5( IQR:3.3,5.9), 11.3( IQR:8.7, 14.2)g/d] ( P<0.05); the median of 24-hour urinary potassium was 47.2 ( IQR:34.4, 66.5) mmol/d, higher than that of 2011[42.9( IQR:33.6,56.0)] ( P<0.05); the proportion of salt intake per capita per day exceeding 5 g (89.9%) was lower than that in 2011 (90.0%). The results of the generalized linear regression model showed that the 24-hour urinary sodium was positively correlated with systolic and diastolic blood pressure [β values were 0.04 (95% CI: 0.00, 0.07), 0.03 (95% CI 0.01, 0.05), respectively], and the sodium-to-potassium ratio was positively correlated with diastolic blood pressure [β(95% CI): 0.78 (0.09, 1.47)].

Objective To investigate the effect of Ⅲ-type phosphatidylinositide 3 kinase (PI3K) pathway adjusting autophagy on brain damage mechanism after cardiopulmonary resuscitation (CPR) and hypothermia treatment.Methods The asphyxia induce cardiac arrest-CPR model was reproduced on healthy male Sprague-Dawley (SD) rats.Sixty rats after restoration of spontaneous circulation (ROSC) were randomly divided into normothermia group,therapeutic hypothermia group and PI3K inhibitor 3-methyl adenine (3-MA) pretreatment group,differentiated by 24 hours and 48 hours after ROSC.Each group had 10 rats at each time point.The anal temperature in the normothermia group was maintained at (37.0 ± 0.2) ℃,and the rats in the hypothermia group were given cooling treatment immediately after ROSC,and the target rectal temperature was 32-34 ℃.In the 3-MA pretreatment group,10 mmol/L 3-MA 5 μL was injected into the ventricle 20 minutes before asphyxia,and other groups were given the same amount of normal saline.Ten rats without CPR were included in Sham group only received anesthesia and catheterization.The rats were sacrificed at 24 hours and 48 hours after ROSC respectively,and the brain tissues were harvested,the brain water content (BWC) was measured by dry-wet weight method.Western Blot was used to determine the autophagy related proteins Beclin-1 and microtubule-associated protein 1 light chain 3 (LC3),apoptosis related proteins Bcl-2 and caspase-3,and the Ⅲ-type PI3K pathway proteins Vps34 and Atgl4.Ultrastructural changes in brain tissue were observed with transmission electron microscope.Neurological deficit scores (NDS) was obtained in each group at 48 hours after ROSC.Results Compared with Sham group,the cortex at 24 hours after ROSC in normothermic group showed obvious edema,apeptosis and autophagy began to appear under transmission electron microscope,and the expressions of autophagy,apoptosis and Ⅲ-type PI3K-related proteins in brain tissue were significantly increased in a time-dependent manner,and the neurological function at 48 hours after ROSC was significantly damaged.After hypothermia intervention,brain edema of rats was significantly reduced,no obvious apoptosis was found,but autophagy was increased,the expressions of autophagy-related proteins Vps34,Atg14 and Ⅲ-type PI3K-related proteins Beclin-1 and LC3 at 48 hours after ROSC were further higher than those of normothermic group (Vps34/GAPDH:0.25±0.03 vs.0.15±0.04,Atg14/GAPDH:0.12±0.03 vs.0.05±0.04,Beclin-1/GAPDH:0.060±0.002 vs.0.018±0.002,LC3-Ⅱ/GAPDH:0.160±0.010 vs.0.050± 0.010,all P ＜ 0.05),the expressions of apoptosis related proteins Bcl-2 and caspase-3 were significantly lowered (Bcl-2/GAPDH:0.05±0.03 vs.0.20±0.04,caspase-3/GAPDH:0.050±0.002 vs.0.140±0.015,both P ＜ 0.05),neurological function was significantly improved (NDS:157±85 vs.343± 198,P ＜ 0.05).Pretreatment with 3-MA inhibited the protective effect of hypothermia on brain tissues.The expressions of Vps34,Atg14,Beclin-1 and LC3 in brain tissues at 48 hours after ROSC in 3-MA pretreatment group was significantly lower than those in the hypothennia group (Vps34/GAPDH:0.18±0.03 vs.0.25±0.03,Atg44/GAPDH:0.07±0.04 vs.0.12±0.03,Beclin-1/GAPDH:0.015±0.003 vs.0.060±0.002,LC3-Ⅱ/GAPDH:0.045±0.030 vs.0.160±0.010,all P ＜ 0.05),the expressions of Bcl-2 and caspase-3 were significantly increased (Bcl-2/GAPDH:0.15±0.04 vs.0.05±0.03,caspase-3/GAPDH:0.120±0.015 vs.0.050±0.002,both P ＜ 0.05),and NDS score was significantly increased (341±208 vs.157±85,P ＜ 0.05).Conclusion Hypothermia treatment reduced brain edema and ameliorated brain function after CPR,which might be related to increase autophagy and inhibit apoptosis adjustment by activating Ⅲ-type PI3K pathway.

Objective To study the clinical value of brain natriuretic peptide (BNP) and soluble urokinase plasminogen activator receptor (suPAR) in the diagnosis and prognosis of bloodstream infection.Methods Totally 165 patients suspected of bloodstream infection admitted in intensive care unit (ICU) of the Second Hospital Affiliated to Suzhou University were enrolled in this study.According to the diagnosis standard of bloodstream inflection,patients were divided into the bloodstream infection group and non-bloodstream infection group.According to the prognosis of the patients,the bloodstream infection group was further divided into the survival group and the death group.Serum levels of suPAR,BNP,CRP,PCT,and chronic health evaluation Ⅱ acute physiology score (APACHE Ⅱ),and mortality of the patients were analyzed,and the possible relation of the above indexes between the two groups were compared.Based on the receiver operating characteristic curve (ROC) and the area under the curve (AUC),the early diagnostic value of suPAR,BNP,CRP,PCT,and APACHE Ⅱ score in the bloodstream infection patients was determined.Results Serum levels of suPAR,BNP,CRP,PCT and APACHE Ⅱ score in the bloodstream infection group were higher than those in the non-bloodstream infection group (P＜0.05);Serum levels of suPAR,BNP,CRP,PCT and APACHE Ⅱ score in the death group were higher than those in the survival group (P＜0.05).There was a positive correlation between serum suPAR,BNP,PCT and APHCHE Ⅱ] score in patients of bloodstream infection(r=0.503,0.548,0.781,all P＜0.05).The levels of suPAR,BNP,PCT and APACHE Ⅱ in the patients of blood stream infection were related to significant the prognosis (P＜0.05).And these indexes can provide good evaluation on the prognosis of the patients.Conclusion Detection of serum suPAR,BNP can evaluate the severity of bloodstream infection and preliminarily determine the prognosis of patients with bloodstream infection.Therefore,the method is worth applying in the clinical field.