1.Study on the characteristic chromatogram of Shexiang Jiegu Capsule and determination of seven components by HPLC
Xiaocui YU ; Xiwen WANG ; Guiying ZHANG ; Junwei XU ; Yuwei ZHU ; Dan HU
Journal of Pharmaceutical Practice and Service 2025;43(8):395-399
Objective To establish the characteristic atlas of Shexiang Jiegu Capsule and determine the contents of seven active components (hydroxysafflor Yellow A, paeoniflorin, ferulic acid, naringin, ligustilide, catechin, epicatechin). Methods Octadecyl silane bonded silica gel was used as the filling agent, the mobile phase was composed of methanol-0.05% phosphoric acid by gradient elution, the detection wavelength was 245 nm, flow rate was 1.0 ml/min, column temperature was 30℃. The similarity of the fifteen batches of sample was evaluated in line with the TCM Chromatographic Fingerprint (2012 edition), and the contents of seven active components were determined. Results The HPLC fingerprint of Shexiang Jiegu Capsules was established. The similarity of fingerprint between fifteen batches of samples and control fingerprint was between 0.893 and 0.992. The results of methodological investigation for the determination of seven active components in fifteen batches of samples all met the requirements. Conclusion The established characteristic atlas of Shexiang Jiegu Capsules had high specificity and good repeatability, which could provide scientific basis for quality control of Shexiang Jiegu Capsules.
2.Peripheral blood cell count composite score as a prognostic factor in patients with colorectal cancer
Peiyuan GUO ; Xuhua HU ; Baokun LI ; Ti LU ; Jiaming LIU ; Chaoyu WANG ; Wenbo NIU ; Guiying WANG ; Bin YU
Chinese Journal of Gastrointestinal Surgery 2024;27(9):953-965
Objective:To develop a prognostic prediction model for patients with colorectal cancer based on a peripheral blood cell composite score (PBCS) system.Methods:This retrospective observational study included patients who had primary colorectal cancer without distant metastasis, who did not undergo radiotherapy or chemotherapy before surgery, who did not receive leukocyte or platelet-raising therapy within 1 month before surgery, and whose postoperative pathology confirmed colorectal adenocarcinoma with complete tumor resection. Patients with severe anemia, infection, or hematologic diseases before surgery, as well as those with severe heart, lung, or other important organ diseases or concurrent malignant tumors, were excluded. In total, 1021 patients with colorectal cancer who underwent surgical treatment in the Department of Gastrointestinal Surgery of the Fourth Hospital of Hebei Medical University from April 2018 to April 2020 were retrospectively included as the training set (766 patients) and the internal validation set (255 patients). Additionally, using the same criteria, 215 patients with colorectal cancer who underwent surgical treatment in another treatment group from March 2015 to December 2020 were selected as the external validation set. The "surv_cutpoint" function in R software was used to analyze the optimal cut-off values of neutrophils, lymphocytes, and platelets, and a PBCS system was established based on the optimal cut-off values. The scoring rules of the PBCS system were as follows: Neutrophils and platelets below the optimal cut-off value = 1 point, otherwise 0 points; Lymphocytes above the optimal cut-off value = 1 point, otherwise 0 points. The scores of the three cell types were added together to obtain the PBCS. Univariate and multivariate Cox regression analyses were performed to explore the correlation between patients' clinicopathological features and prognosis, and a nomogram was constructed based on the Cox regression analysis to predict patients' prognosis. The accuracy of the nomogram prediction model was validated using the C-index, calibration curve, and decision curve analysis.Results:The optimal cut-off values for neutrophils, lymphocytes, and platelets were 4.40×10 9/L, 1.41×10 9/L, and 355×10 9/L, respectively. The patients were divided into high and low groups according to the optimal cut-off values of these cells. Survival curve analysis showed that a high lymphocyte count (training set: P=0.042, internal validation: P=0.010, external validation: P=0.029), low neutrophil count (training set: P=0.035, internal validation: P=0.001, external validation: P=0.024), and low platelet count (training set: P=0.041, internal validation: P=0.030, external validation: P=0.024) were associated with prolonged overall survival (OS), with statistically significant differences in all cases. Survival analysis of different PBCS groups showed that patients with a high PBCS had longer OS than those with a low PBCS ( P<0.05). Univariate and multivariate Cox regression analysis results showed that aspirin use history, vascular thrombus, neural invasion, CA19-9, N stage, operation time, M stage, and PBCS were independent factors affecting OS (all P<0.05). The PBCS was also an independent factor affecting disease-specific survival ( P<0.05), but not progression-free survival ( P>0.05). The above independent risk or protective factors were included in R software to construct a nomogram for predicting OS. The C-index (0.873), calibration curve, and decision curve analysis (threshold probability: 0.0%–75.2%) all indicated that the nomogram prediction model had good predictive performance for OS. Conclusion:This study demonstrates that the PBCS constructed based on preoperative peripheral blood levels of neutrophils, lymphocytes, and platelets is an independent factor associated with the prognosis of patients with colorectal cancer. The nomogram model constructed based on this score system exhibits good predictive efficacy for the prognosis of these patients.
3.Peripheral blood cell count composite score as a prognostic factor in patients with colorectal cancer
Peiyuan GUO ; Xuhua HU ; Baokun LI ; Ti LU ; Jiaming LIU ; Chaoyu WANG ; Wenbo NIU ; Guiying WANG ; Bin YU
Chinese Journal of Gastrointestinal Surgery 2024;27(9):953-965
Objective:To develop a prognostic prediction model for patients with colorectal cancer based on a peripheral blood cell composite score (PBCS) system.Methods:This retrospective observational study included patients who had primary colorectal cancer without distant metastasis, who did not undergo radiotherapy or chemotherapy before surgery, who did not receive leukocyte or platelet-raising therapy within 1 month before surgery, and whose postoperative pathology confirmed colorectal adenocarcinoma with complete tumor resection. Patients with severe anemia, infection, or hematologic diseases before surgery, as well as those with severe heart, lung, or other important organ diseases or concurrent malignant tumors, were excluded. In total, 1021 patients with colorectal cancer who underwent surgical treatment in the Department of Gastrointestinal Surgery of the Fourth Hospital of Hebei Medical University from April 2018 to April 2020 were retrospectively included as the training set (766 patients) and the internal validation set (255 patients). Additionally, using the same criteria, 215 patients with colorectal cancer who underwent surgical treatment in another treatment group from March 2015 to December 2020 were selected as the external validation set. The "surv_cutpoint" function in R software was used to analyze the optimal cut-off values of neutrophils, lymphocytes, and platelets, and a PBCS system was established based on the optimal cut-off values. The scoring rules of the PBCS system were as follows: Neutrophils and platelets below the optimal cut-off value = 1 point, otherwise 0 points; Lymphocytes above the optimal cut-off value = 1 point, otherwise 0 points. The scores of the three cell types were added together to obtain the PBCS. Univariate and multivariate Cox regression analyses were performed to explore the correlation between patients' clinicopathological features and prognosis, and a nomogram was constructed based on the Cox regression analysis to predict patients' prognosis. The accuracy of the nomogram prediction model was validated using the C-index, calibration curve, and decision curve analysis.Results:The optimal cut-off values for neutrophils, lymphocytes, and platelets were 4.40×10 9/L, 1.41×10 9/L, and 355×10 9/L, respectively. The patients were divided into high and low groups according to the optimal cut-off values of these cells. Survival curve analysis showed that a high lymphocyte count (training set: P=0.042, internal validation: P=0.010, external validation: P=0.029), low neutrophil count (training set: P=0.035, internal validation: P=0.001, external validation: P=0.024), and low platelet count (training set: P=0.041, internal validation: P=0.030, external validation: P=0.024) were associated with prolonged overall survival (OS), with statistically significant differences in all cases. Survival analysis of different PBCS groups showed that patients with a high PBCS had longer OS than those with a low PBCS ( P<0.05). Univariate and multivariate Cox regression analysis results showed that aspirin use history, vascular thrombus, neural invasion, CA19-9, N stage, operation time, M stage, and PBCS were independent factors affecting OS (all P<0.05). The PBCS was also an independent factor affecting disease-specific survival ( P<0.05), but not progression-free survival ( P>0.05). The above independent risk or protective factors were included in R software to construct a nomogram for predicting OS. The C-index (0.873), calibration curve, and decision curve analysis (threshold probability: 0.0%–75.2%) all indicated that the nomogram prediction model had good predictive performance for OS. Conclusion:This study demonstrates that the PBCS constructed based on preoperative peripheral blood levels of neutrophils, lymphocytes, and platelets is an independent factor associated with the prognosis of patients with colorectal cancer. The nomogram model constructed based on this score system exhibits good predictive efficacy for the prognosis of these patients.
4.HPLC method for the simultaneous determination of hydroxyphenyl esters and quaternary ammonium bacteriostatic agents in eye drops
Jin GAO ; Dan HU ; Yi BAO ; Xiaocui YU ; Zexin WANG ; Jing LIU ; Guiying ZHANG ; Yingying ZHAO ; Zhenyu CAO ; Chunpu LI ; Xiaoxu HONG
Drug Standards of China 2024;25(3):234-243
Objective:To establish a general method for the simultaneous determination of hydroxyphenyl esters and quaternary ammonium bacteriostatic agents in eye drops.Methods:The chromatographic analysis was per-formed on an Agilent C18 column(4.6 mm ×250 mm,5 μm)with 1%triethylamine solution(pH adjusted to 5.0 with phosphoric acid)as mobile phase A and methanol as mobile phase B.Gradient elution was performed at col-umn temperature of 40 ℃.The detection wavelength was 214 nm,the flow rate was 1 mL·min-1,and the injec-tion volume was 20 μL.Results:Methylparaben,ethylparaben,propylparaben,butylparaben,benzalkonium chlo-ride and benzalkonium bromide were 0.11-559.0,0.10-513.0,0.10-258.8,0.11-270.5,1.07-537.0 and 1.03-512.8 μg·mL-1,respectively.The linear range was good(r>0.999).The average recoveries of meth-ylparaben,benzalkonium bromide and benzalkonium chloride were 104.7%(RSD=1.3%),102.6%(RSD=1.1%)and 100.9%(RSD=1.1%),respectively.The contents of bacteriostatic agent in 100 batches of eye drops from 36 varieties of 12 enterprises were determined,and the accurate results were obtained.Conclusion:This meth-od provides a reference for the content quality control and safety evaluation of bacteriostatic agents in eye drops.
5.Effect of intra-operative chemotherapy with 5-fluorouracil and leucovorin on the survival of patients with colorectal cancer after radical surgery: a retrospective cohort study.
Xuhua HU ; Zhaoxu ZHENG ; Jing HAN ; Baokun LI ; Ganlin GUO ; Peiyuan GUO ; Yang YANG ; Daojuan LI ; Yiwei YAN ; Wenbo NIU ; Chaoxi ZHOU ; Zesong MENG ; Jun FENG ; Bin YU ; Qian LIU ; Guiying WANG
Chinese Medical Journal 2023;136(7):830-839
BACKGROUND:
The effect of intra-operative chemotherapy (IOC) on the long-term survival of patients with colorectal cancer (CRC) remains unclear. In this study, we evaluated the independent effect of intra-operative infusion of 5-fluorouracil in combination with calcium folinate on the survival of CRC patients following radical resection.
METHODS:
1820 patients were recruited, and 1263 received IOC and 557 did not. Clinical and demographic data were collected, including overall survival (OS), clinicopathological features, and treatment strategies. Risk factors for IOC-related deaths were identified using multivariate Cox proportional hazards models. A regression model was developed to analyze the independent effects of IOC.
RESULTS:
Proportional hazard regression analysis showed that IOC (hazard ratio [HR]=0.53, 95% confidence intervals [CI] [0.43, 0.65], P < 0.001) was a protective factor for the survival of patients. The mean overall survival time in IOC group was 82.50 (95% CI [80.52, 84.49]) months, and 71.21 (95% CI [67.92, 74.50]) months in non-IOC group. The OS in IOC-treated patients were significantly higher than non-IOC-treated patients ( P < 0.001, log-rank test). Further analysis revealed that IOC decreased the risk of death in patients with CRC in a non-adjusted model (HR=0.53, 95% CI [0.43, 0.65], P < 0.001), model 2 (adjusted for age and gender, HR=0.52, 95% CI [0.43, 0.64], P < 0.001), and model 3 (adjusted for all factors, 95% CI 0.71 [0.55, 0.90], P = 0.006). The subgroup analysis showed that the HR for the effect of IOC on survival was lower in patients with stage II (HR = 0.46, 95% CI [0.31, 0.67]) or III disease (HR=0.59, 95% CI [0.45, 0.76]), regardless of pre-operative radiotherapy (HR=0.55, 95% CI [0.45, 0.68]) or pre-operative chemotherapy (HR=0.54, 95% CI [0.44, 0.66]).
CONCLUSIONS:
IOC is an independent factor that influences the survival of CRC patients. It improved the OS of patients with stages II and III CRC after radical surgery.
TRIAL REGISTRATION
chictr.org.cn, ChiCTR 2100043775.
Humans
;
Fluorouracil/therapeutic use*
;
Leucovorin/therapeutic use*
;
Colorectal Neoplasms/pathology*
;
Retrospective Studies
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Proportional Hazards Models
;
Prognosis
6.Clinical application of modified pancreaticogastrostomy based on the concept of " Hong's one-stitch method" in digestive tract reconstruction in pancreaticoduodenectomy
Jianhua LIU ; Xinbo ZHOU ; Xueqing LIU ; Shubin ZHANG ; Jianzhang QIN ; Zixuan HU ; Zhongqiang XING ; Guiying WANG
Chinese Journal of Hepatobiliary Surgery 2023;29(2):119-123
Objective:To study the safety and therapeutic effects of the modified pancreaticogastrostomy based on the concept of " Hong's one-stitch method" in digestive tract reconstruction in pancreatic surgery.Methods:The clinical data of 44 patients who underwent modified pancreaticogastresstomy at the Department of Hepatobiliary Surgery, the Second Hospital of Hebei Medical University from May 2022 to October 2022 were analyzed retrospectively. There were 23 males and 21 females , with a median age of 54 years old (range 18 to 70 years old). The operation time, intraoperative blood loss, postoperative condition and complications were analysed.Results:All the 44 patients completed the operation successfully. There were 29 patients who underwent laparoscopic pancreaticoduodenectomy, 11 patients laparoscopic duodenum-preserving pancreatic head resection, 1 patient laparoscopic central pancreatectomy, and 3 patients open pancreaticoduodenectomy. The time required for the pancreaticogastrostomy was (15.4±1.0) min in laparoscopic surgery, and (9.1±0.5) min in open surgery. There were 2 patients who developed grade A pancreatic fistula (4.55%, 2/44) and 7 patients gastric emptying disorder (15.91%, 7/44). There were no grade B or C pancreatic fistula, biliary fistula, gastrointestinal anastomotic fistula, abdominal infection, postoperative bleeding and perioperative death.Conclusion:The modified pancreaticogastrostomy for digestive tract reconstruction in pancreatic surgery was safe and reliable. It effectively reduced the incidence of postoperative pancreatic fistula and improved prognosis of patients.
7.Study on quality standard of Jingtian Zhitong cream
Dan HU ; Ming YIN ; Xiwen WANG ; Hong CAO ; Guiying ZHANG ; Chuanyang SU ; Shuai ZHANG
Journal of Pharmaceutical Practice 2022;40(2):157-160
Objective To revise the determination method in the quality standard of Jingtian Zhitong cream. Methods The total saponins of angelica sinensis, Ligusticum wallichii, Rhizoma corydalis, and Panax notoginseng saponins were qualitatively identified by thin-layer chromatography (TLC). The contents of notoginsenoside R1, ginsenoside Rg1, and ginsenoside Rb1 in the preparation were determined by high performance liquid chromatography (HPLC). Results TLC showed strong specificity and good resolution. The concentration of notoginsenoside R1 showed a good linear relationship in the range of 0.1604 and 2.0050μg (r=0. 999). The concentration of ginsenoside Rg1 showed a good linear relationship in the range of 0.8003 and 10.0035μg (r=1.000). The concentration of ginsenoside Rb1 showed good linearity in the range of 0.6182 and 7.7275μg (r=1.000). The sample recovery rates were 101.43%, 98.75% and 100.95%, respectively. The relative standard deviation (RSD) were 2.56%, 2.71% and 2.75%, respectively. Conclusion The developed method is accurate and reliable with high sensitivity, which can be used for the quality control of Jingtian Zhitong cream.
8.Study on quality standard for Xuanxi Rongjin powder
Dan HU ; Chunguang LIU ; Hong CAO ; Guiying ZHANG ; Zihui MA ; Mingming ZHENG
Journal of Pharmaceutical Practice 2022;40(4):347-349
Objective To revise the qualitative and quantitative determination methods of Xuanxi Rongjin powder. Methods TLC was used to qualitatively identify Chuanxiong and Chuanshanlong. The content of cinnamaldehyde in the preparation was determined by HPLC with KR100-5C18 column (250 mm×4.6 mm, 5μm). The mobile phase was acetonitrile-water (35:65) and the detection wavelength was 290 nm. Results TLC can qualitatively identify Chuanxiong and Chuanshanlong. Cinnamaldehyde has a good linear relationship in the range of 0.0489~0.3260 µg/ml (r=1.00), The average recovery was 95.71% (RSD=1.78%). Conclusion The method has high sensitivity, good specificity, simple operation and good reproducibility.
9.Genetic variant analysis and prenatal diagnosis for Chinese pedigrees affected with cblC methylmalonic acidemia.
Lei LI ; Yanjie XIA ; Shuang HU ; Guiying CHENG ; Xiaofan ZHU ; Yang LIU ; Xiangdong KONG
Chinese Journal of Medical Genetics 2022;39(10):1058-1064
OBJECTIVE:
To detect variants of the MMACHC gene among 110 ethnic Han Chinese pedigrees affected with metabolic deficiency methylmalonic acidemia (MMA) of cobalamin C (cblC).
METHODS:
Peripheral blood samples were collected from the probands and their parents. Following DNA extraction, the coding regions of the MMACHC gene were subjected to PCR amplification, Sanger sequencing and quantitative PCR assaying. For 48 pedigrees, chorionic villus samples were taken for prenatal genetic diagnosis.
RESULTS:
Thirty five types of variants were detected among the 110 pedigrees, which included missense, nonsense, frameshifting, splicing variants and exonic deletions. Most variants have occurred in exons 4 (73.18%). The detection rate for c.609G>A (p.Trp203Ter) variant was the highest (33.64%), followed by c.658_660delAAG (12.27%), c.567dupT (9.09%) and c.80A>G (6.82%). Two variants, namely c.57_58insT (p.Gly20Trpfs*14) and c.505_506delAT (p.Ile169Argfs*12), were unreported previously and both were of frameshifting types. For the 48 pedigrees undergoing prenatal diagnosis, 14 fetuses were found to be normal, 24 have carried heterozygous variants, the remaining 10 have carried compound heterozygous or homozygous variants.
CONCLUSION
The discovery of the two novel variants has expanded the spectrum of the MMACHC gene variants among ethnic Han population. Above finding has provide a basis for the prenatal diagnosis and genetic counseling for the affected pedigrees.
Amino Acid Metabolism, Inborn Errors/genetics*
;
China
;
DNA
;
Female
;
Humans
;
Mutation
;
Oxidoreductases/genetics*
;
Pedigree
;
Pregnancy
;
Prenatal Diagnosis
;
Vitamin B 12/genetics*
10.Treatment strategy of gastrointestinal stromal tumors in the background of COVID-19.
XiaoRan WANG ; XuHua HU ; Zheng LI ; BaoKun LI ; WenBo NIU ; ChaoXi ZHOU ; Bin YU ; ZhenYa ZHANG ; XueNa ZHANG ; Yang GAO ; GuiYing WANG
Chinese Journal of Gastrointestinal Surgery 2021;24(9):825-829
COVID-19, caused by SARS-COV-2, has the characteristics of world epidemic, highly infectious and large base of death. In China, transmission route of SARS-COV-2 has been contained so effectively that COVID-19 has been well controlled due to the proactive national prevention and control strategy. However, not only does it bring a huge impact on the existing medical structure model, but also an objective impact on the treatment of patients with chronic diseases such as malignant tumors. Based on the progress reported in the domestic and international literatures and the actual management experience of our team, this paper reflects on the treatment strategies for patients with gastrointestinal stromal tumor (GIST) during the epidemic period of COVID-19. We focus on risk stratification for primary GIST and forming treatment strategies accordingly. Major considerations include the impact of delayed operation, the burden of medical resources, the waiting time for elective operation, and the principle of emergency operation. In addition, we focus on the level of evidence for non-surgical approaches with a view to developing a holistic strategy of "priority management principles" to guide clinical treatment in the context of limited resources and different GIST priorities.
COVID-19
;
China
;
Gastrointestinal Stromal Tumors
;
Humans
;
SARS-CoV-2

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