1.Bioequivalence study of buspirone hydrochloride tablets in Chinese healthy subjects
Ping LU ; Rui WANG ; Hui-Hui WU ; Hai-Yan LIU ; Ge-Fei HE ; Shun-Zhi ZHANG ; Wei WU
The Chinese Journal of Clinical Pharmacology 2024;40(5):723-727
Objective To study the pharmacokinetic characteristics of buspirone hydrochloride tablets in healthy adult populations under conditions of fasting and postprandial administration.Methods A single-center,randomized,three-cycle partially repeated crossover trial design was adopted,and 36 subjects were enrolled on fasting/postprandial,one tablet of the test preparation was taken in one cycle,one tablet of reference preparation(5 mg of buspirone tablets)was taken once in each of 2 cycles,the drug concentration of buspirone in plasma was determined by liquid chromatography-tandem mass spectrometry,and the pharmacokinetic parameters were calculated by WinNonlin software.Results Main pharmacokinetics of buspirone after oral administration of test and reference preparations in fasting group,the Cmax was(285.72±286.08)and(308.94±341.03)pg·mL-1;AUC0-t were(577.09±491.10)and(618.62±642.56)pg·mL-1·h;AUC0-∞ were(586.85±510.04)and(655.92±687.95)pg·mL-1·h;tmax was 0.75(0.33-4.00)and 0.75(0.33-1.75)h.Main pharmacokinetics of buspirone after oral administration of test and reference preparations in the postprandial group,the Cmax were(676.36±603.64)and(760.33±610.27)pg·mL-1;AUC0-t were(1 755.58±1 001.69)and(1 743.00±1 073.33)pg·h·mL-1;AUC0-∞ were(1 839.97±1 044.60)and(1 818.00±1 106.95)pg·mL-1·h;tmax was 1.25(0.25-4.50)and 1.00(0.25-3.50)h.The 90%confidence intervals of the AUC0-t and AUC0-∞ geometric mean ratios of the test preparation and the reference preparation in the fasting test and the postprandial test all fell between 80.00%and 125.00%,and the 95%upper confidence limit of of Cmax was ≤0 and geometric mean ratios point estimates fall between 80.00%and 125.00%.Conclusion Two kinds of buspirone hydrochloride are bioequivalent in Chinese healthy adult subject.
2.Review of conductivity reconstruction methods based on magneto-acoustic coupling effects
Yu-Hui NIE ; Zhi-Peng LIU ; Tao YIN ; Shun-Qi ZHANG
Chinese Medical Equipment Journal 2024;45(7):94-104
The theoretical foundations of the forward and inverse problems of two conductivity imaging methods based on magneto-acoustic coupling effects,including magneto-acoustic tomography(MAT)and magneto-acousto-electrical tomogra-phy(MAET),were introduced.The research progress of the conductivity reconstruction methods with different imaging strate-gies was reviewed.The problems of the conductivity reconstruction methods based on magnetoacoustic coupling effects were analyzed in terms of acoustic source model construction,reconstruction algorithm and imaging speed,and the future develop-ment directions were pointed out.[Chinese Medical Equipment Journal,2024,45(7):94-104]
3.Precirrhotic Primary Biliary Cholangitis with Portal Hypertension:Bile Duct Injury Correlate
Yi-Fan HU ; Shun-Xin LI ; Hong-Li LIU ; Zhi-Xiang DU ; Shuang-Shuang WANG ; Miao-Yang CHEN ; Li WANG ; Qing-Fang XIONG ; Yan-Dan ZHONG ; Du-Xian LIU ; Yong-Feng YANG
Gut and Liver 2024;18(5):867-876
Background/Aims:
The histological characteristics and natural history of precirrhotic primary biliary cholangitis (PBC) with portal hypertension (PH) are unclear. Our aim was to clarify the prevalence, risk factors, and histological characteristics of precirrhotic PBC patients with PH.
Methods:
This retrospective study compared the clinical features, histological characteristics, and response to ursodeoxycholic acid (UDCA) between the PH and non-PH groups of precirrhotic PBC patients.
Results:
Out of 165 precirrhotic PBC patients, 40 (24.2%) also had PH. According to histological stage 1, 2 and 3 disease, 5.3% (1/19), 17.3% (17/98), and 45.8% (22/48) of patients also had PH, respectively. Precirrhotic PBC with PH was significantly positively correlated with bile duct loss, degree of cytokeratin 7 positivity, and degree of fibrosis in the portal area, but significantly negatively correlated with lymphoid follicular aggregation. Compared to the non-PH group, patients in the PH group showed a higher prevalence of obliterative portal venopathy, incomplete septal fibrosis, portal tract abnormalities and non-zonal sinusoidal dilatation (p<0.05). In addition, patients with PH were more likely to present with symptoms of jaundice, ascites, epigastric discomfort, a poorer response to UDCA, and more decompensation events (p<0.05). High alkaline phosphatase levels, low white blood cell counts, high Mayo scores, and high FIB-4 index values were risk factors for precirrhotic PBC with PH.
Conclusions
Approximately 24.2% of precirrhotic PBC patients have PH, which is histologically related to the injury of bile ducts. High alkaline phosphatase levels, low white blood cell counts, high Mayo scores, and high FIB-4 index values are associated with increased risk of precirrhotic PBC with PH.
4.Functional dyspepsia treated with acupuncture of different frequencies: a randomized controlled trial.
Kai-Yuan TANG ; Bi-Yun SUN ; Yan YAN ; Xi WANG ; Xin HE ; Zhi-Shun LIU
Chinese Acupuncture & Moxibustion 2023;43(6):622-626
OBJECTIVE:
To compare the clinical efficacy of acupuncture with different frequencies in the treatment of patients with functional dyspepsia (FD).
METHODS:
A total of 90 patients with FD were randomly divided into a 3-time acupuncture treatment per week group (3-A group, 31 cases, 2 cases dropped off), a 1-time acupuncture treatment per week group (1-A group, 30 cases, 2 cases dropped off) and a control group (29 cases, 2 cases dropped off). In the two acupuncture groups, the acupoints were Zhongwan (CV 12) and bilateral Tianshu (ST 25), Neiguan (PC 6), Liangqiu (ST 34), Yanglingquan (GB 34), Zusanli (ST 36) and Taichong (LR 3), stimulated 3 times a week and once a week, respectively; and the treatment was given consecutively for 4 weeks. In the control group, no intervention was adopted, but the compensatory therapy was provided after the end of follow-up. The scores of the symptom index of dyspepsia (SID), self-rating anxiety scale (SAS) and self-rating depression scale (SDS) were compared among the 3 groups before treatment, after 4 weeks of treatment and in 4 and 8 weeks after treatment completion separately. The score of Nepean dyspepsia life quality index (NDLQI) was evaluated before treatment, after 2 and 4 weeks of treatment and in 4 and 8 weeks after treatment completion.
RESULTS:
After 4 weeks of treatment and in 4 and 8 weeks after treatment completion, the scores of SID, SAS and SDS were all reduced in the 3-A group and the 1-A group when compared with the scores before treatment (P<0.000 1, P<0.05). After 4 weeks of treatment, the scores of SID, SAS and SDS in the two acupuncture groups were lower than those in the control group (P<0.000 1). After 2 and 4 weeks of treatment, the increased values of NDLQI score in the two acupuncture groups were all higher than those in the control group (P<0.05). In 4 and 8 weeks after treatment completion, the scores of SID, SAS and SDS in the 3-A group were lower than those in the 1-A group (P<0.001, P<0.05), and the increased values of NDLQI score in the 3-A group were higher than those in the 1-A group (P<0.000 1).
CONCLUSION
Acupuncture given 3 times per week is superior to the treatment given once per week in the aspects of relieving the clinical symptoms, improving the quality of life and regulating the emotional state in patients with FD. This efficacy is persistent for 8 weeks after treatment completion.
Humans
;
Dyspepsia/therapy*
;
Quality of Life
;
Acupuncture Therapy
;
Acupuncture Points
;
Emotions
5.Influencing factors for prognosis in patients with ST-segment elevation myocardial infarction with cardiogenic shock treated with extracorporeal membrane oxygenation combined with percutaneous coronary intervention
Li-Fang SU ; Wei ZHI ; Heng-Bo GAO ; Hao XIAO ; Chang-Chang LIU ; Qing ZHOU ; Yan-Bo WANG ; Xin-Shun GU
Chinese Journal of Interventional Cardiology 2023;31(12):904-910
Objective To investigate the influencing factors for prognosis in patients with ST-segment elevation myocardial infarction(STEMI)with cardiogenic shock(CS)treated with extracorporeal membrane oxygenation(ECMO)combined with percutaneous coronary intervention(PCI).Methods The clinical data of patients with STEMI and CS who received ECMO combined with PCI treatment in the cardiology department of our hospital from May 2019 to July 2023 were retrospectively analyzed.According to the clinical outcome,the patients were divided into death group and survival group.The clinical data of the two groups was compared.Results The study analyzed a total of 37 patients,including 34 males with an average age of(52.4±11.7)years.There were 15 survivors and 22 deaths,with a survival rate of 40.5%.Compared with the death group,the survival group had higher systolic blood pressure[(100.6±17.7)mmHg vs.(84.6±22.0)mmHg,P=0.025]and diastolic blood pressure[(64.5±11.8)mmHg vs.(54.3±16.0)mmHg,P=0.043]at admission,and longer time from shock to ECMO support[4.0(3.0,10.0)h vs.2.8(1.9,5.1)h,P=0.048]and shorter time from ECMO support to passage of guide wire[1.5(0.5,3.0)h vs.3.8(2.3,7.0)h,P=0.008].The proportion of thrombolysis in myocardial infarction(TIMI)blood flow classification reaching level Ⅲ in the first frame is higher[9(60.0%)vs.5(22.7%),P=0.038].The level of serum alanine aminotransferase[261.8(100.1,944.9)U/L vs.106.6(27.4,193.3)U/L,P=0.033]and shorter time from aspartate aminotransferase[753.6(432.7,1533.0)U/L vs.244.7(113.7,594.3)U/L,P=0.009]in the death group are significantly higher than that in the survival group.Conclusions This study suggests that the time from ECMO support and ECMO support to passage of guide wire,and the first frame TIMI blood flow grading are important factors affecting the prognosis of STEMI patients with CS treated with ECMO combined with PCI.
6.Epidemiological Survey of Hemoglobinopathies Based on Next-Generation Sequencing Platform in Hunan Province, China.
Hui XI ; Qin LIU ; Dong Hua XIE ; Xu ZHOU ; Wang Lan TANG ; De Guo TANG ; Chun Yan ZENG ; Qiong WANG ; Xing Hui NIE ; Jin Ping PENG ; Xiao Ya GAO ; Hong Liang WU ; Hao Qing ZHANG ; Li QIU ; Zong Hui FENG ; Shu Yuan WANG ; Shu Xiang ZHOU ; Jun HE ; Shi Hao ZHOU ; Fa Qun ZHOU ; Jun Qing ZHENG ; Shun Yao WANG ; Shi Ping CHEN ; Zhi Fen ZHENG ; Xiao Yuan MA ; Jun Qun FANG ; Chang Biao LIANG ; Hua WANG
Biomedical and Environmental Sciences 2023;36(2):127-134
OBJECTIVE:
This study was aimed at investigating the carrier rate of, and molecular variation in, α- and β-globin gene mutations in Hunan Province.
METHODS:
We recruited 25,946 individuals attending premarital screening from 42 districts and counties in all 14 cities of Hunan Province. Hematological screening was performed, and molecular parameters were assessed.
RESULTS:
The overall carrier rate of thalassemia was 7.1%, including 4.83% for α-thalassemia, 2.15% for β-thalassemia, and 0.12% for both α- and β-thalassemia. The highest carrier rate of thalassemia was in Yongzhou (14.57%). The most abundant genotype of α-thalassemia and β-thalassemia was -α 3.7/αα (50.23%) and β IVS-II-654/β N (28.23%), respectively. Four α-globin mutations [CD108 (ACC>AAC), CAP +29 (G>C), Hb Agrinio and Hb Cervantes] and six β-globin mutations [CAP +8 (C>T), IVS-II-848 (C>T), -56 (G>C), beta nt-77 (G>C), codon 20/21 (-TGGA) and Hb Knossos] had not previously been identified in China. Furthermore, this study provides the first report of the carrier rates of abnormal hemoglobin variants and α-globin triplication in Hunan Province, which were 0.49% and 1.99%, respectively.
CONCLUSION
Our study demonstrates the high complexity and diversity of thalassemia gene mutations in the Hunan population. The results should facilitate genetic counselling and the prevention of severe thalassemia in this region.
Humans
;
beta-Thalassemia/genetics*
;
alpha-Thalassemia/genetics*
;
Hemoglobinopathies/genetics*
;
China/epidemiology*
;
High-Throughput Nucleotide Sequencing
7.Risk factors for residual cancer or lymph node metastasis after endoscopic noncurable resection of early colorectal cancer.
Xin ZHAO ; Li Zhou DOU ; Yue Ming ZHANG ; Yong LIU ; Shun HE ; Yan KE ; Xu Dong LIU ; Yu Meng LIU ; Hai Rui WU ; Zheng Qi LI ; Zhi Hao CHEN ; Gui Qi WANG
Chinese Journal of Oncology 2023;45(4):335-339
Objective: Risk factors related to residual cancer or lymph node metastasis after endoscopic non-curative resection of early colorectal cancer were analyzed to predict the risk of residual cancer or lymph node metastasis, optimize the indications of radical surgical surgery, and avoid excessive additional surgical operations. Methods: Clinical data of 81 patients who received endoscopic treatment for early colorectal cancer in the Department of Endoscopy, Cancer Hospital, Chinese Academy of Medical Sciences from 2009 to 2019 and received additional radical surgical surgery after endoscopic resection with pathological indication of non-curative resection were collected to analyze the relationship between various factors and the risk of residual cancer or lymph node metastasis after endoscopic resection. Results: Of the 81 patients, 17 (21.0%) were positive for residual cancer or lymph node metastasis, while 64 (79.0%) were negative. Among 17 patients with residual cancer or positive lymph node metastasis, 3 patients had only residual cancer (2 patients with positive vertical cutting edge). 11 patients had only lymph node metastasis, and 3 patients had both residual cancer and lymph node metastasis. Lesion location, poorly differentiated cancer, depth of submucosal invasion ≥2 000 μm, venous invasion were associated with residual cancer or lymph node metastasis after endoscopic (P<0.05). Logistic multivariate regression analysis showed that poorly differentiated cancer (OR=5.513, 95% CI: 1.423, 21.352, P=0.013) was an independent risk factor for residual cancer or lymph node metastasis after endoscopic non-curative resection of early colorectal cancer. Conclusions: For early colorectal cancer after endoscopic non-curable resection, residual cancer or lymph node metastasis is associated with poorly differentiated cancer, depth of submucosal invasion ≥2 000 μm, venous invasion and the lesions are located in the descending colon, transverse colon, ascending colon and cecum with the postoperative mucosal pathology result. For early colorectal cancer, poorly differentiated cancer is an independent risk factor for residual cancer or lymph node metastasis after endoscopic non-curative resection, which is suggested that radical surgery should be added after endoscopic treatment.
Humans
;
Lymphatic Metastasis
;
Neoplasm, Residual
;
Retrospective Studies
;
Endoscopy
;
Risk Factors
;
Colorectal Neoplasms/pathology*
;
Neoplasm Invasiveness
8.Response characteristics of tislelizumab combined with chemotherapy in first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.
Shun LU ; Xin Min YU ; Yan Ping HU ; Zhi Yong MA ; Xing Ya LI ; Wei Dong LI ; Yun Peng LIU ; Dong WANG ; Xiu Wen WANG ; Zhe Hai WANG ; Jing Xun WU ; Dian Sheng ZHONG ; Gao Feng LI ; Wan Yu HE ; Yuan Yuan BAO ; Yuan YUAN ; Jing Hui FAN
Chinese Journal of Oncology 2023;45(4):358-367
Objective: To investigate the response characteristics of patients with locally advanced/metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) treated with tislelizumab in combination with chemotherapy in the first line. Methods: Patients with nsq-NSCLC who achieved complete or partial remission after treatment with tislelizumab in combination with chemotherapy or chemotherapy alone in the RATIONALE 304 study, as assessed by an independent review board, were selected to analyze the response characteristics and safety profile of the responders. Time to response (TTR) was defined as the time from randomization to the achievement of first objective response. Depth of response (DpR) was defined as the maximum percentage of tumor shrinkage compared with the sum of the baseline target lesion length diameters. Results: As of January 23, 2020, 128 patients treated with tislelizumab in combination with chemotherapy achieved objective tumor response (responders), representing 57.4%(128/223) of the intention-to-treat population, with a TTR of 5.1 to 33.3 weeks and a median TTR of 7.9 weeks. Of the responders (128), 50.8%(65) achieved first remission at the first efficacy assessment (week 6), 31.3%(40) at the second efficacy assessment (week 12), and 18.0%(23) at the third and subsequent tumor assessments. The percentages of responders who achieved a depth of tumor response of 30% to <50%, 50% to <70% and 70% to 100% were 45.3%(58/128), 28.1%(36/128) and 26.6%(34/128), respectively, with median progression-free survival (PFS) of 9.0 months (95% CI: 7.7 to 9.9 months), 11.5 months (95% CI: 7.7 months to not reached) and not reached (95% CI: 11.8 months to not estimable), respectively. Tislelizumab plus chemotherapy were generally well tolerated in responders with similar safety profile to the overall safety population. Conclusion: Among responders to tislelizumab in combination with chemotherapy for nsq-NSCLC, 82.0%(105/128) achieves response within the first two tumor assessments (12 weeks) and 18.0%(23/128) achieves response at later (18 to 33 weeks) assessments, and there is a trend toward prolonged PFS in responders with deeper tumor response.
Humans
;
Antibodies, Monoclonal, Humanized/therapeutic use*
;
Antineoplastic Combined Chemotherapy Protocols/adverse effects*
;
Carcinoma, Non-Small-Cell Lung/pathology*
;
Lung Neoplasms/pathology*
;
Treatment Outcome
9.Risk factors analysis and prediction model construction of submucosal deep infiltration of early colorectal tumor.
Zhi Hao CHEN ; Li Zhou DOU ; Yue Ming ZHANG ; Yong LIU ; Shun HE ; Yan KE ; Xu Dong LIU ; Yu Meng LIU ; Hai Rui WU ; Shuang Mei ZOU ; Gui Qi WANG
Chinese Journal of Oncology 2023;45(7):613-620
Objective: To investigate the risk factors for the development of deep infiltration in early colorectal tumors (ECT) and to construct a prediction model to predict the development of deep infiltration in patients with ECT. Methods: The clinicopathological data of ECT patients who underwent endoscopic treatment or surgical treatment at the Cancer Hospital, Chinese Academy of Medical Sciences from August 2010 to December 2020 were retrospectively analyzed. The independent risk factors were analyzed by multifactorial regression analysis, and the prediction models were constructed and validated by nomogram. Results: Among the 717 ECT patients, 590 patients were divided in the within superficial infiltration 1 (SM1) group (infiltration depth within SM1) and 127 patients in the exceeding SM1 group (infiltration depth more than SM1). There were no statistically significant differences in gender, age, and lesion location between the two groups (P>0.05). The statistically significant differences were observed in tumor morphological staging, preoperative endoscopic assessment performance, vascular tumor emboli and nerve infiltration, and degree of tumor differentiation (P<0.05). Multivariate regression analysis showed that only erosion or rupture (OR=4.028, 95% CI: 1.468, 11.050, P=0.007), localized depression (OR=3.105, 95% CI: 1.584, 6.088, P=0.001), infiltrative JNET staging (OR=5.622, 95% CI: 3.029, 10.434, P<0.001), and infiltrative Pit pattern (OR=2.722, 95% CI: 1.347, 5.702, P=0.006) were independent risk factors for the development of deep submucosal infiltration in ECT. Nomogram was constructed with the included independent risk factors, and the nomogram was well distinguished and calibrated in predicting the occurrence of deep submucosal infiltration in ECT, with a C-index and area under the curve of 0.920 (95% CI: 0.811, 0.929). Conclusion: The nomogram prediction model constructed based on only erosion or rupture, local depression, infiltrative JNET typing, and infiltrative Pit pattern has a good predictive efficacy in the occurrence of deep submucosal infiltration in ECT.
Humans
;
Retrospective Studies
;
Colorectal Neoplasms/pathology*
;
Nomograms
;
Neoplasm Staging
;
Risk Factors
10.LIU Zhi-shun's experience in treatment of infertility with decreasing ovarian reserve with electroacupuncture.
Chinese Acupuncture & Moxibustion 2022;42(3):307-310
To summarize LIU Zhi-shun's clinical experience in treatment of infertility with decreasing ovarian reserve (DOR) with electroacupuncture. LIU Zhi-shun believes that the location of infertility with DOR is the uterus, mainly involving the kidney, thoroughfare and conception vessels. He advocates to select acupoints by combining "disease-symptom-position" with prescription, and selects acupoint prescription of Bushen Tiaochong Zhuyun included Guanyuan (CV 4), Zigong (EX-CA 1), Tianshu (ST 25), Sanyinjiao (SP 6), Ciliao (BL 32) and Zhongliao (BL 33) for electroacupuncture treatment. The key points of operation are accurate positioning and deep acupuncture, focusing on regulating mind and getting qi, adopting electroacupuncture treatment and low frequency stimulation and treating slowly for long-term disease.
Acupuncture Points
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Acupuncture Therapy
;
Electroacupuncture
;
Female
;
Humans
;
Infertility
;
Ovarian Reserve

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