1.Clinical research of bioabsorbable membrane in prevention of Frey syndrome after parotidectomy
Xiaoming LIAO ; Kai YANG ; Xinghe LIU ; Fujun ZHANG
Chinese Journal of Primary Medicine and Pharmacy 2012;19(2):171-172
Objective To evaluate the effect of bioabsorbable membrane in prevention of Frey syndrome after parotidectomy.Methods 105 patients who suffering from benign tumor of parotid gland were divided into experimental group and control group randomly.53 cases in experimental group underwent insertion of bioabsorbable membrane after parotidectomy,while 52 cases in control group underwent parotidectomy without bioabsorbable membrane.After operation 6 to12 months,all 105 patients were evaluated for gustatory sweating by both questionnaire and minor starchiodine test.Results Subjective evaluation of Frey syndrome revealed that the incidence rate of experimental group and control group were 3.8%(2/53),28.9%(15/52)respectively(P < 0.05).Objective evaluation of Frey syndrome revealed that the incidence rate of experimental group and control group were 9.4%(5/53),55.8%(29/52)(13/21)respectively(P <0.05).Conclusion Insertion of bioabsorbable membrane is an effective method for prevention of Frey's syndrome after parotidectomy.
2.Role of spinal mTOR/S6K1/Gli1 signaling pathway in chronic morphine tolerance in mice
Long WANG ; Lingfei XU ; Xinghe WANG ; Tong LI ; Junli CAO ; Su LIU
Chinese Journal of Anesthesiology 2021;41(2):172-176
Objective:To evaluate the role of spinal mammlian target of rapamycin (mTOR)/ribosomal S6 kinase 1 (S6K1)/glioma associated oncogene homolog 1 (Gli1) signaling pathway in chronic morphine tolerance in mice.Methods:Healthy male Kunming mice, aged 8-10 weeks, weighing 23-25 g, were used in the study.The experiment was performed in two parts.Experiment I Fifty mice were randomly assigned into 2 groups: normal saline group (group S, n=10) and morphine group (group M, n=40). In M and S groups, morphine and normal saline 10 mg/kg were injected subcutaneously, respectively, twice a day for 7 consecutive days.The thermal pain threshold (TPT) was measured and the maximum analgesic effect percentage (MPE) was calculated at 1 day before administration and 30 min after the last administration every day.Ten mice in each group were randomly selected and sacrificed after measurement of TPT at 1, 3, 5 and 7 days after administration in group M and after the last measurement of TPT in group S, and the lumbar segment (L 4-6) of the spinal cord was removed.Experiment Ⅱ Forty mice were randomly divided into 4 groups ( n=10 each): KU-0063794+ morphine group (group KU+ M), dimethyl sulfoxide (DMSO)+ morphine group (group DM+ M), morphine+ KU-0063794 group (group M+ KU) and morphine + DMSO group (group M+ DM). Morphine 10 mg/kg was injected subcutaneously twice a day for 7 consecutive days in 4 groups.At 1-3 days of morphine injection, mTOR specific inhibitor KU-0063794 200μl (1 μg/μl) and 10% DMSO 200 μl was injected intraperitoneally in KU+ M group and DM+ M group at 30 min before administration twice a day.At 5-7 days of morphine injection, KU-0063794 200μl (1 μg/μl) or 10% DMSO 200 μl was injected intraperitoneally in group M+ KU or group M+ DM at 30min before administration, respectively, twice a day.TPT was measured and MPE was calculated at 1 day before morphine injection and at 30 min after the last administration every day.The animals were sacrificed after the last measurement of TPT, and the lumbar segment (L 4-6) of the spinal cord was removed for determination of the expression of spinal mTOR, phosphorylated mTOR (p-mTOR), S6K1, phosphorylated S6K1 (p-S6K1) and Gli1 (using Western blot). Results:Experiment Ⅰ Compared with group S, MPE was significantly increased at each time point after administration at 3, 5 and 7 days after administration, expression of spinal p-mTOR, p-S6K1 and Gli1 was significantly down-regulated ( P<0.05), and no significant change was found in mTOR and S6K1 in group M ( P>0.05). Experiment Ⅱ Compared with group DM+ M, MPE was significantly decreased at 3-7 days after morphine injection, expression of p-mTOR, p-S6K1 and Gli1 in spinal cord was down-regulated ( P<0.05), and no significant change was found in expression of mTOR and S6K1 in group KU+ M ( P>0.05). Compared with group M+ DM, MPE was significantly increased at 6-7 days after morphine injection, expression of p-mTOR, p-S6K1 and Gli1 in spinal cord was down-regulated ( P<0.05), and no significant change was found in mTOR and S6K1 in group M+ KU ( P>0.05). Conclution:Spinal mTOR/S6K1/Gli1 signaling pathway is involved in the development and maintenance of chronic morphine tolerance in mice.
3.Bioequivalence of metformin hydrochloride sustained-release tablets under fed condition in healthy subjects
Mingli SUN ; Chen LIU ; Yali WEI ; Qian GAO ; Qianying LIU ; Xinghe WANG
Journal of China Pharmaceutical University 2023;54(1):89-94
To evaluate bioequivalence and safety of two kinds of metformin hydrochloride sustained-release tablets (test preparation vs reference preparation) under the condition of fed and single administration.A single center, randomized, open, single-dose, two-period, two-sequence, and double-crossover design was used.32 healthy subjects took 0.5 g of test preparation or reference preparation under fed and single-dose administration.4 mL of venous blood was collected from before administration (0 h) to 1, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12, 15, 24, 36 and 48 h after administration.The concentration of metformin in plasma samples was detected, and then the pharmacokinetic parameters were calculated by WinNonlin 7.0 software.When the 90% confidence intervals of cmax, AUC0-t and AUC0-∞ geometric mean ratio of test preparation and reference preparation were within 80.00%-125.00% equivalent intervals respectively, the bioequivalence of the two preparations was proved.One subject fell off due to adverse events.The main pharmacokinetic parameters of test preparation and reference preparation as follows: cmax were (0.68 ± 0.14) and (0.65 ± 0.11) mg/L, AUC0-t were (7.33 ± 1.65) and (7.00 ± 1.89) h·mg/L, AUC0-∞ were (7.39 ± 1.67) and (7.06 ± 1.91) h·mg/L, respectively.The 90% confidence intervals of the geometric mean ratio of the two main pharmacokinetic parameters were 101.45%-109.14%, 100.08%-112.32% and 100.24%-112.28%, respectively, which fell within the bioequivalence interval of 80.00%-125.00%.There were no serious adverse events and unexpected adverse events during the trial.The results show that test preparation and reference preparation are bioequivalent under fed and single-dose administration, safe and well tolerated in healthy subjects.
4.Feasibility study on deep learning image reconstruction algorithm to improve the quality of low-dose CT images of the brain
Jinjin CUI ; Guanzhong LIU ; Xinghe HU ; Shaojun HAN ; Hong SUN ; Xinjiang WANG ; Hongxiang YAO
Chinese Journal of Radiological Medicine and Protection 2023;43(9):736-740
Objective:To explore the effectiveness of deep learning image reconstruction (DLIR) algorithm compared to adaptive statistical iterative reconstruction (ASIR-V) algorithm in improving the quality of low-dose brain CT images.Methods:Retrospective inclusion of patients who underwent brain CT examination in the People's Liberation Army General Hospital from November 2021 to August 2022. Four different algorithms were used to reconstruct low-dose CT scans of all patients to obtain 30% intensity ASIR-V (ASIR-V-30%) images, low intensity DLIR (DLIR-L) images, medium intensity DLIR (DLIR-M) images, and high intensity DLIR (DLIR-H) images. The regions of interest were selected from four sets of images, including superficial white matter, superficial gray matter, deep white matter, and deep gray matter, and their CT values and standard deviations were measured for calculating signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR).Subjective evaluation of image quality was conducted by three neuroimaging physicians based on the Likert 5-component scale. The objective and subjective scores of the 4 groups of images were analyzed using ANOVA or Kruskal Wallis. If there are overall differences, pairwise comparisons were conducted within the group.Results:A total of 109 patients were enrolled, including 104 males and 5 females, aged 65-110 years (89.16 ± 9.53) years. The radiation exposure of brain CT low-dose scanning was (0.93 ± 0.01)mSv, significantly lower than that of conventional scanning (2.92 ± 0.01) mSv ( t = 56.15, P < 0.05). The differences in objective image quality analysis of ASIR-V-30%, DLIR-L, DLIR-M, and DLIR-H images of low-dose CT in SNR deep gray matter, SNR deep white matter, SNR superficial gray matter, SNR superficial white matter, CNR deep gray white matter, and CNR superficial gray white matter were statistically significant( F =98.23, 72.95, 68.43, 58.24, 241.13, 289.91, P < 0.05). Among them, DLIR-H images had the lowest noise in deep gray matter, deep white matter, superficial gray matter, and superficial white matter, and had statistically significant differences compared to other image groups ( t = 167.43, 275.46, 182.32, 361.54, P < 0.05). The subjective score of DLIR-H image quality was superior to ASIR-V-30%, DLIR-L, and DLIR-M, with the statistically significant difference ( t = 7.25, 8.32, 9.63, P < 0.05). Conclusions:Compared with ASIR-V, DLIR algorithm can effectively reduce image noise and artifacts in low-dose brain CT, and improve SNR and CNR. The subjective and objective image quality evaluation of DLIR-H is the best.
5. Progress on clinical trials of cancer drugs in China, 2019
Huiyao HUANG ; Dawei WU ; Haixue WANG ; Jun WANG ; Qi FAN ; Shuhang WANG ; Ying BAI ; Yue YU ; Yuan FANG ; Chao SUN ; Hong FANG ; Hua BAI ; Xin WANG ; Zeyuan LIU ; Min JIANG ; Zhe LIU ; Xinghe WANG ; Haiyan LI ; Ning LI ; Cai CAO ; Binghe XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2020;42(2):127-132
Objective:
To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019.
Methods:
The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies, while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug. Characteristics on stage, scope, indication of those trials, classification and mechanism of involved products, as well as listed anticancer drugs were summarized and depicted.
Results:
There were 474 cancer drug trials registered in China in 2019, accounting for 21.8% of the total, and 397 (83.8%) were initiated by domestic pharmaceutical enterprises. Overall, international multicenter trials accounted for 13.1%, and phase I trials accounted for 47.3%. Compared with global enterprises, the proportion of international multi-center trials initiated by domestic companies is lower (4.8% vs. 55.8%,
6.Characteristics of high cardiovascular risk in 360 000 adults in Northwest China
Wei XU ; Xingyi ZHANG ; Jiapeng LU ; Xinghe HUANG ; Bo GU ; Lijuan SONG ; Jianlan CUI ; Yan LI ; Haibo ZHANG ; Xi LI ; Jiamin LIU
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(5):784-790
【Objective】 To assess the prevalence and treatment of high cardiovascular disease (CVD) risk, and identify individual characteristics related to high CVD risk. 【Methods】 Based on the data of the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Million Persons Project (MPP) from 2016 to 2019, this study enrolled local residents aged 35 to 75 years from 39 counties or districts in Northwest China. Rates of high CVD risk and individual characteristics were assessed in the overall study population. Statin and aspirin use was also evaluated among those at high risk for CVD. Multivariable mixed models were fitted to evaluate the relationship between individual characteristics and high CVD risk. 【Results】 Among 364 537 participants, the average age was (54.6±9.7)years, and 5.8% was at a high risk for CVD. Multivariate mixed models showed that individuals who were currently using alcohol, overweight or obese tended to have a high risk for CVD, while married persons, those with a higher education level or a higher household income were correlated with a lower risk for CVD (all P<0.05). Among high-risk persons, hypertension was the most prevalent risk factor (98.1%), and only 1.3% and 3.5% reported their use of statins and aspirin, respectively. 【Conclusion】 Of the 364 537 participants, about 1 in 17 had a high risk for CVD. Among those at a high CVD risk, only less than 4% reported taking statins or aspirin. These findings indicate that there is still much room for risk mitigation in this population in China.