Objective:To establish a high-performance liquid chromatography(HPLC)method for the determina-tion of related substances in buprenorphine active pharmaceutical ingredient(API)using advanced ACD/Auto-Chrom method development software for comprehensive parameter simulation and design.Methods:An Agilent ZORBAX Eclipse Plus C18 column(4.6 mm × 150 mm,3.5 μm)was used with a mobile phase consisting of 40 mmol·L-1 potassium dihydrogen phosphate solution and acetonitrile in a gradient elution mode.The flow rate was set at 1.3 mL·min-1,the column temperature was maintained at 35 ℃,the detection wavelength was 240 nm,and the injection volume was 5 μL.Results:The impurities A,B,D,E,F,G,H,I,and J in buprenorphine were effectively separated from the main component.The linear ranges were 0.33-83.73,0.20-78.74,0.20-40.28,0.22-43.31,0.32-78.98,0.13-63.74,0.51-101.54,0.22-43.72,and 0.40-80.37 μg·mL-1,respectively.The limits of detection(LOD)were 0.10,0.06,0.06,0.06,0.09,0.04,0.15,0.07,and 0.12 μg·mL-1,respectively,while the limits of quantification(LOQ)were 0.33,0.20,0.20,0.22,0.32,0.13,0.51,0.22,and 0.40 μg·mL-1,respectively.The accuracy,precision,and robustness of the method met the required standards.Conclusion:This method is suitable for the determi-nation and quality control of related substances such as impurities A,B,D,E,F,G,H,I,and J in buprenorphine API.

Objective:With the help of the advanced ACD Labs/AutoChrom method development software,param-eter simulation design was carried out.Based on the results of software simulation and actual investigation,an HPLC method for the determination of related impurities in safinamide mesylate raw material drug was established.Methods:A Waters Atlantis T3 column(4.6 mm ×250 mm,5 μm)was used.The phosphate buffer with a pH of 7.0 was used as mobile phase A,and acetonitrile was used as mobile phase B.Gradient elution was performed at a flow rate of 1.3 mL·min-1,the detection wavelength was 228 nm,the column temperature was 35 ℃,and the injection volume was 10 μL.Results:Impurities 1-12 in safinamide mesylate could be effectively separated from the main component.The linear ranges were 0.102 1-5.329,0.102 9-5.379 7,0.106 8-4.972 9,0.102 1-5.135,0.103 8-5.314 7,0.097 7-4.869 8,0.095 2-4.760 5,0.095 3-5.109 5,0.050 5-5.287 5,0.098 7-4.885 6,0.102 4-4.997 5,0.050 8-5.134 7 μg·mL-1,respectively.The limits of detection(LOD)were 0.051,0.051 4,0.053 4,0.051 1,0.051 9,0.048 8,0.047 6,0.047 7,0.025 3,0.049 3,0.051 2,0.025 4 μg·mL-1,and the limits of quantification(LOQ)were 0.102 1,0.102 9,0.106 8,0.102 1,0.103 8,0.097 7,0.095 2,0.095 3,0.050 5,0.098 7,0.102 4,0.050 8 μg·mL-1.The accuracy,preci-sion and durability all met the requirements.Conclusion:This method is suitable for the determination and quality control of the related substances of 12 impurities in safinamide mesylate raw materials.

Objective To observe the efficacy and safety of 3 D video-assisted thoracoscopic segmentectomy in patients with stage Ⅰ lung cancer treated with indocyanine green(ICG)fluorescence reverse-staining.Methods A total of 132 patients with stage Ⅰ lung cancer who were admitted from May 2022 to September 2024 all underwent three-dimensional video-assisted thoracoscopic segmental resection of the lung.They were divided into the observation group(63 cases)and the control group(69 cases)according to the method of intersegmental plane exposure.The control group was treated with the modified expansion and collapse method,while the observation group was treated with the ICG fluorescence backstaining method.The surgical conditions,pulmonary function,postoperative pain degree,quality of life and complications of the two groups were compared.Results The postoperative chest tube retention time,surgical time,postoperative hospitalization time,total postoperative thoracic drainage volume,and inter-segmental plane exposure time in the observation group were as follows(2.13±0.37)d,(145.12±25.26)min,(5.21±0.95)d,(261.41±28.57)ml and(9.15±1.73)s,respectively.The data of the control groups were(3.29±0.48)d,(178.31±30.45)min,(6.34±1.36)d,(352.03±36.74)ml and(1 651.28±179.84)s,respectively.There was a statistically significant difference between the two groups(P＜0.05).There was no statistically significant difference in the number of intraoperative blood loss and intraoperative lymph node dissections between the two groups(P＞0.05).There was no statistically significant difference in the levels of maximal expiratory flow(PEF),forced expiratory volume in one second(FEV1),and FEV1/forced vital capacity(FVC)between the two groups before the operation and one month after the operation(P＞0.05).The Visual Analogue Scale(VAS)scores of the observation group at 12 hours,48 hours and 72 hours after the operation were(3.25±0.46)points,(2.13±0.35)points and(1.02±0.24)points respectively.The control groups were(4.11±0.59)points,(2.98±0.42)points,and(1.73±0.30)points,respectively.There was a statistically significant difference between the two groups(P＜0.05).There was no statistically significant difference in the scores of negative and positive items between the two groups before the operation and one month after the operation(P＞0.05).There was no statistically significant difference in the total incidence of complications between the two groups(P＞0.05).Conclusion The modified dilatation collapse method and ICG fluorescence reverse staining method have no significant effects on lung function and complications in patients with stage Ⅰ lung cancer,and both can improve the quality of life.Compared with the modified dilatation collapse method,ICG fluorescence reverse staining method can shorten the plane exposure time between segments and the operation time,promote postoperative rehabilitation and alleviate postoperative pain.

Objective:With the help of the advanced ACD Labs/AutoChrom method development software,param-eter simulation design was carried out.Based on the results of software simulation and actual investigation,an HPLC method for the determination of related impurities in safinamide mesylate raw material drug was established.Methods:A Waters Atlantis T3 column(4.6 mm ×250 mm,5 μm)was used.The phosphate buffer with a pH of 7.0 was used as mobile phase A,and acetonitrile was used as mobile phase B.Gradient elution was performed at a flow rate of 1.3 mL·min-1,the detection wavelength was 228 nm,the column temperature was 35 ℃,and the injection volume was 10 μL.Results:Impurities 1-12 in safinamide mesylate could be effectively separated from the main component.The linear ranges were 0.102 1-5.329,0.102 9-5.379 7,0.106 8-4.972 9,0.102 1-5.135,0.103 8-5.314 7,0.097 7-4.869 8,0.095 2-4.760 5,0.095 3-5.109 5,0.050 5-5.287 5,0.098 7-4.885 6,0.102 4-4.997 5,0.050 8-5.134 7 μg·mL-1,respectively.The limits of detection(LOD)were 0.051,0.051 4,0.053 4,0.051 1,0.051 9,0.048 8,0.047 6,0.047 7,0.025 3,0.049 3,0.051 2,0.025 4 μg·mL-1,and the limits of quantification(LOQ)were 0.102 1,0.102 9,0.106 8,0.102 1,0.103 8,0.097 7,0.095 2,0.095 3,0.050 5,0.098 7,0.102 4,0.050 8 μg·mL-1.The accuracy,preci-sion and durability all met the requirements.Conclusion:This method is suitable for the determination and quality control of the related substances of 12 impurities in safinamide mesylate raw materials.

Objective:To establish a high-performance liquid chromatography(HPLC)method for the determina-tion of related substances in buprenorphine active pharmaceutical ingredient(API)using advanced ACD/Auto-Chrom method development software for comprehensive parameter simulation and design.Methods:An Agilent ZORBAX Eclipse Plus C18 column(4.6 mm × 150 mm,3.5 μm)was used with a mobile phase consisting of 40 mmol·L-1 potassium dihydrogen phosphate solution and acetonitrile in a gradient elution mode.The flow rate was set at 1.3 mL·min-1,the column temperature was maintained at 35 ℃,the detection wavelength was 240 nm,and the injection volume was 5 μL.Results:The impurities A,B,D,E,F,G,H,I,and J in buprenorphine were effectively separated from the main component.The linear ranges were 0.33-83.73,0.20-78.74,0.20-40.28,0.22-43.31,0.32-78.98,0.13-63.74,0.51-101.54,0.22-43.72,and 0.40-80.37 μg·mL-1,respectively.The limits of detection(LOD)were 0.10,0.06,0.06,0.06,0.09,0.04,0.15,0.07,and 0.12 μg·mL-1,respectively,while the limits of quantification(LOQ)were 0.33,0.20,0.20,0.22,0.32,0.13,0.51,0.22,and 0.40 μg·mL-1,respectively.The accuracy,precision,and robustness of the method met the required standards.Conclusion:This method is suitable for the determi-nation and quality control of related substances such as impurities A,B,D,E,F,G,H,I,and J in buprenorphine API.

Objective To observe the efficacy and safety of 3 D video-assisted thoracoscopic segmentectomy in patients with stage Ⅰ lung cancer treated with indocyanine green(ICG)fluorescence reverse-staining.Methods A total of 132 patients with stage Ⅰ lung cancer who were admitted from May 2022 to September 2024 all underwent three-dimensional video-assisted thoracoscopic segmental resection of the lung.They were divided into the observation group(63 cases)and the control group(69 cases)according to the method of intersegmental plane exposure.The control group was treated with the modified expansion and collapse method,while the observation group was treated with the ICG fluorescence backstaining method.The surgical conditions,pulmonary function,postoperative pain degree,quality of life and complications of the two groups were compared.Results The postoperative chest tube retention time,surgical time,postoperative hospitalization time,total postoperative thoracic drainage volume,and inter-segmental plane exposure time in the observation group were as follows(2.13±0.37)d,(145.12±25.26)min,(5.21±0.95)d,(261.41±28.57)ml and(9.15±1.73)s,respectively.The data of the control groups were(3.29±0.48)d,(178.31±30.45)min,(6.34±1.36)d,(352.03±36.74)ml and(1 651.28±179.84)s,respectively.There was a statistically significant difference between the two groups(P＜0.05).There was no statistically significant difference in the number of intraoperative blood loss and intraoperative lymph node dissections between the two groups(P＞0.05).There was no statistically significant difference in the levels of maximal expiratory flow(PEF),forced expiratory volume in one second(FEV1),and FEV1/forced vital capacity(FVC)between the two groups before the operation and one month after the operation(P＞0.05).The Visual Analogue Scale(VAS)scores of the observation group at 12 hours,48 hours and 72 hours after the operation were(3.25±0.46)points,(2.13±0.35)points and(1.02±0.24)points respectively.The control groups were(4.11±0.59)points,(2.98±0.42)points,and(1.73±0.30)points,respectively.There was a statistically significant difference between the two groups(P＜0.05).There was no statistically significant difference in the scores of negative and positive items between the two groups before the operation and one month after the operation(P＞0.05).There was no statistically significant difference in the total incidence of complications between the two groups(P＞0.05).Conclusion The modified dilatation collapse method and ICG fluorescence reverse staining method have no significant effects on lung function and complications in patients with stage Ⅰ lung cancer,and both can improve the quality of life.Compared with the modified dilatation collapse method,ICG fluorescence reverse staining method can shorten the plane exposure time between segments and the operation time,promote postoperative rehabilitation and alleviate postoperative pain.

Objective To analyze the relationship between serum a proliferation inducing ligand(APRIL)and galactin-1(Gal-1)levels with clinical features and prognosis in patients with epithelial ovarian cancer(EOC).Methods EOC patients(n=132)who admitted in Handan Hangang Hospital of Hebei Province from January 2018 to June 2020 were selected as the cancer group,and were grouped into a survival group(n=56)and a death group(n=76)based on their three-year survival after discharge.Meanwhile,healthy in-dividuals(n=68)who underwent physical examination were regarded as the healthy group.Enzyme linked immunosorbent assay was applied to detect serum APRIL and Gal-1 levels in all subjects.Clinical data of all patients were collected and their relationship with serum APRIL,Gal-1 levels and prognosis was analyzed.Ka-plan-Meier method was applied to analyze the relationship between serum APRIL and Gal-1 levels and the prognosis of EOC patients.Cox regression was applied to analyze the relevant factors affecting the prognostic death of EOC patients.The prognostic value of serum APRIL in patients with EOC was analyzed by receiver operating characteristic(ROC)curve.Results The serum APRIL and Gal-1 expression levels in the cancer group were greatly higher than those in the healthy group,and the differences were statistically significant(P＜0.05).The serum APRIL and Gal-1 levels in the death group were greatly higher than those in the sur-vival group,and the differences were statistically significant(P＜0.05).Clinical data analysis showed that se-rum APRIL and Gal-1 levels were not related to the age of EOC patients(P＞0.05),but were related to tumor location,tumor diameter,The International Febderation of Gynecology and Obstetrics(FIGO)staging,differentiation degree,lymph node metastasis,histological classification,and levels of cancer antigen 125(CA125)and human epididymis protein 4(HE4),and FIGO staging,differentiation degree,lymph node me-tastasis,histological classification,and levels of CA125 and HE4 also significantly affected the prognosis of pa-tients(P＜0.05).FIGO stage Ⅲ+Ⅳ,low differentiation,lymph node metastasis,serous tissue classification,CA125≥200 U/mL,HE4≥200 pmol/L,and high expression of APRIL and Gal-1 were all risk factors for prognostic death in EOC patients(P＜0.05).The three-year survival rate of APRIL high expression patients(25.37％)was greatly lower than that of APRIL low expression patients(60.00％),and the three-year sur-vival rate of Gal-1 high expression patients(27.94％)was greatly lower than that of Gal-1 low expression pa-tients(57.81％),,and the differences were statistically significant(P＜0.05).ROC curve showed that the ar-ea under the curve(AUC)of the combination of APRIL and Gal-1 for predicting the prognosis was 0.925,which was significantly higher than that of the diagnosis of the two alone,(Zcombined-APRIL=4.061,P＜0.001,Zcombined-Gal-1=3.424,P＜0.001),with a sensitivity and specificity of 86.84％and 83.93％,respectively.Conclu-sion The expression levels of serum APRIL and Gal-1 are greatly elevated in EOC patients,and their levels are related to tumor location,tumor diameter,FIGO staging,lymph node metastasis,histological classifica-tion,CA1 25,HE4,and differentiation degree.The expression levels of both have great application value in the prognosis evaluation of EOC patients.

This study reviewed 37 patients who received neoadjuvant ADT in our center and analyzed the change of 68Ga-PSMA PET/CT before and after treatment. This study found that neoadjuvant ADT significantly reduced the tumor visibility on 68Ga-PSMA PET/CT.

Objective To analyze crossed cerebellar diaschisis(CCD) after subacute phase of spontaneous cerebral hemorrhage(SPSCH)and it's relevant factors with whole-brain CT perfusion(CTP) imaging. Methods Eighty-six patients diagnosed with unilateral SPSCH by CT were prospectively enrolled in our study from July 2015 to October 2016. Whole-brain CTP was performed in each patient.Cerebral blood flow(CBF), cerebral blood volume(CBV), mean transit time(MTT)and time-to-peak(TTP) inipsilateral and contralateral cerebellum were manually measured.The asymmetric indexs(AIs) were also calculated. Moreover, the volume of hematoma, the maximumarea of peri-hematomahypoperfusionin CBF and clinical factors(age, gender, time intervals from symptom onset)were analyzed,and NIHSS scores were used to evaluate the neurological status before patient admission, inspection, and discharge.CCD was rated positive when a unilateral supratentorial hematomawas appeared and an accompanying perfusion decrease was showed in the contralateral cerebellum on at least two sequential slices of CTP maps.All the individuals were divided into two groups including CCD-positive groupand CCD-negative group. The perfusion parameters (CBF, CBV, MTT, and TTP)between the contralateral and ipsilateral cerebellum were analyzed by the two-tailed paired t-test in CCD-positive group. The differences in the perfusion and clinical variables between the two groups were analyzed by the independent sample t-test and the Chi-squared test. Therelationships between the AI values and clinical or radiologic variables were assessed with Pearson correlation test. Results We found 35 CCD positive cases and 51 negative cases in the 86 patients.In CCD-positive groups, the perfusion values of cerebellumipsilateral and contralateral to the hematomawere as follows:CBF were (40.88±11.23) vs. (33.91±9.96) ml·100 g-1·min-1, CBV were (3.30±1.18) vs. (2.75±1.13) ml/100 g and TTP were (22.09±3.98) vs. (22.88±4.15) s, respectively, and there was statistical significance (t=10.231,8.223,-2.883,P<0.05).In CCD positive group, CBF, CBV, TTP, and MTT of the contralateral cerebellar hemisphere was changed in 35, 32, 26, and 16 cases,respectively.The AI value of CBF(AICBF)in CCD-positive group was (17.10±9.10)%, which was higher than that in the negative group (-0.95±17.01)%, there was statistical significance(t=6.367,P<0.05).The AI value of CBV(AICBV)was (17.43 ± 11.65)% in CCD-positive group, also significantly higher than that in negative group which was (1.55±21.06)%(t=4.477, P<0.05). No statistical difference(P>0.05)was found in hematoma location,hematoma volume, supratentorialhypoperfusion area and NIHSS scores(at admission, inspection)between CCD-positive and negative groups.The AICBF and AITTP showed linear correlation with time intervals in CCD-positive patients(P<0.05). Conclusions CCD is a common phenomenon in patients with SPSCH.Of all the perfusion parameters,CBF abnormalities are more common.The severity of CCD has a certain correlation with time intervals.There is no significant correlation between CCD and the clinical or radiological data(age, NIHSS scores,hematoma volume, and supratentorial hypoperfusion area).

OBJECTIVETo evaluate the reliability of diagnostic ultrasound-based temperature and elasticity imaging during radiofrequency ablation (RFA) through ex vivo experiments.

METHODSProcine liver samples (n=7) were employed for RFA experiments with exposures of different power intensities (10 and 50w). The RFA process was monitored by a diagnostic ultrasound imager and the information were postoperatively captured for further temperature and elasticity image analysis. Infrared thermometry was concurrently applied to provide temperature change calibration during the RFA process.

RESULTSResults from this study demonstrated that temperature imaging was valid under 10 W RF exposure (r=0.95), but the ablation zone was no longer consistent with the reference infrared temperature distribution under high RF exposures. The elasticity change could well reflect the ablation zone under a 50 W exposure, whereas under low exposures, the thermal lesion could not be well detected due to the limited range of temperature elevation and incomplete tissue necrosis.

CONCLUSIONDiagnostic ultrasound-based temperature and elastography is valid for monitoring thr RFA process. Temperature estimation can well reflect mild-power RF ablation dynamics, whereas the elastic-change estimation can can well predict the tissue necrosis. This study provide advances toward using diagnostic ultrasound to monitor RFA or other thermal-based interventions.