1.Treatment of Diabetic Retinopathy with Blood Stasis, Collateral Obstruction, and Qi and Yin Deficiency Syndrome with Tongluo Mingmu Capsules: A Randomized, Double-blind, and Multi-center Phase Ⅲ Clinical Trial
Junxia REN ; Yongzheng WANG ; Xiaofei LIU ; Li SUN ; Libo YANG ; Lie WU ; Fengmei LIAN ; Qiping WEI ; Lijuan WEI ; Jingsheng YU ; Jianke HAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):170-178
ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis, collateral obstruction, and Qi and Yin deficiency syndrome. MethodA randomized, double-blind, positive-control, and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis, collateral obstruction, and Qi and Yin deficiency syndrome in four test centers were included (the ratio of the treatment group to the control group was 3∶1). On the basis of standardized hypoglycemic treatment, the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day, while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy, traditional Chinese medicine(TCM) syndrome score, corrected visual acuity, fundus changes, fundus fluorescence angiography, and other curative effect indexes before and after treatment in the two groups. At the same time, general examination, laboratory examination, and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable, with the difference not statistically significant. After 12 weeks of treatment, the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group (61.0%, 189/310) was better than that in the control group (44.1%, 45/102), and the difference was statistically significant (χ2=8.880, P<0.01). The total effective rate of TCM syndromes in the treatment group (88.4%, 259/293) was better than that in the control group (69.9%, 65/93), and the difference was statistically significant (χ2=17.927, P<0.01). The disappearance rate of dry eyes (χ2=8.305), dull complexion (χ2=4.053), lassitude (χ2=10.267), shortness of breath (χ2=8.494), and dry stool (χ2=8.657) in the treatment group was higher than that in the control group, and the difference between the groups was statistically significant (P<0.05, P<0.01). In terms of improving corrected visual acuity (χ2=8.382), fundus changes (χ2=6.026) , the treatment group was significantly better than the control group (P<0.05). During the trial, the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%, respectively. There was no significant difference between the two groups. In addition, there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes, visual acuity, fundus changes, and fundus fluorescein angiography, with great safety. Therefore, it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.
2.Preparation and in vitro dissolution behaviors evaluation of silymarin phospholipid complex
Qiping ZENG ; Jianqing LIU ; Li'na YANG ; Zhihong LIU ; Hongtao SONG
Journal of Pharmaceutical Practice and Service 2024;42(3):101-107
Objective To prepare silymarin phospholipids complex(SM-PC) and investigate its physicochemical properties. Methods On the basis of single-factor tests, the drug-lipid ratio, drug concentration and reaction temperature were selected as the factors of the central composite design and response surface methodology in the preparation of SM-PC by solvent volatilization, and the best process was optimized with the compound rate as the index. And its in vitro dissolution was measured. Results The optimum preparation technology of SM-PC was as follows: acetone was used as compound solvent, the concentration of SM was 8.0 mg/ml, the mass ratio of SM to phospholipid was 1∶1.8, the reaction temperature was 56 ℃ and the recombination rate was(95.15±1.55)% with deviation of less than 3%. The in vitro dissolution test showed that the dissolution of SM-PC was close to 90% in 60 min. The dissolution behavior of main component of silybin was similar to that of silymarin capsules(Legalon ®), which was higher than SM-API. Conclusion SM-PC was successfully prepared by central composite design response surface method, which significantly improved the dissolution and laid a foundation for the study of subsequent preparations.
3.In vivo pharmacokinetics and in vitro-in vivo correlation of silymarin phospholipid complex microporous osmotic pump controlled-release tablets in beagle dogs
Qiping ZENG ; Lina YANG ; Jianqing LIU ; Hongtao SONG
Journal of Pharmaceutical Practice 2023;41(12):741-746
Objective To evaluate the release characteristics in vitro, pharmacokinetics in rabbits and in vivo-in vitro correlation of silymarin phospholipid complex microporous osmotic pump controlled release tablets(SM-PC MPOP). Methods The release characteristics of SM-PC MPOP in vitro were detected by HPLC in the artificial gastric fluid. Six beagle dogs were subjected to double cycle cross control, which were given SM-PC MPOP and Legalon(30 mg/kg). The concentration of silybin in plasma was determined by HPLC and the data were processed by software. Results The cumulative release rate of SM-PC MPOP in vitro was over 85% in 12 h. The pharmacokinetics in beagle dogs showed that SM-PC MPOP and legalon conformed to double compartment first-order absorption model and the pharmacokinetic parameters were obtained: tmax:(3.2±0.4)and(0.9±0.1)h, Cmax:(0.298 6±0.068 9)and(0.629 9±0.076 5)μg/ml, AUC0→24:(2.996 8±0.583 3)and(2.268 9±0.432 8)h·μg /ml. The relative bioavailability of SM-PC MPOP was(162.21 ± 30.82)%. Conclusion SM-PC MPOP could release slowly, which could increase the relative bioavailability significantly. The correlation between the absorption in vivo and release in vitro was fine(r = 0.839 0).
4.Role of surgeons in the medical model of treating patients infected with COVID-19 in makeshift hospitals
Jinhong CHEN ; Minjie YANG ; Qiping LU
Chinese Journal of Digestive Surgery 2020;19(3):256-258
Since the outbreak of Corona Virus Disease 2019 (COVID-19) in December 2019, the number of new confirmed cases in Wuhan has been increasing, and medical resources are in short supply. Under this grim situation, makeshift hospitals have been used to treat patients with mild symptoms and achieved the largest capacity. Under the model of concentrated admission in makeshift hospitals with limited medical resources, the frontline surgeons adopt strict disease observation and treatment strategies, actively carry out psychological counseling for patients, and organize multidisci-plinary teams to deal with chronic and emergency surgical diseases of patients with COVID-19. Combined with their own clinical practices, the authors summarize a series of clinical experiences for the treatment of patients with COVID-19.
5.Effect of left ventricular hypertrophy and deformation on cardiac function in patients with uremia cardiomyopathy by using quantitative speckle tracking technology
Yi ZHENG ; Xiaohong YANG ; Qiping ZHOU ; Yaoyao HUANG ; Fan ZHANG ; Liangyu WANG
Journal of Central South University(Medical Sciences) 2017;42(4):400-405
Objective:To evaluate the effect of left ventricular hypertrophy and deformation on cardiac function in patients with uremic cardiomyopathy (UCM) by using the technology of two dimensional speckle tracking imaging (2D-STI).Methods:A total of 67 UCM patients were randomly divided into the normal cardiac function group (subgroup A,32 cases) and the abnormal cardiac function group (subgroup B,35 cases)according to the New York Heart Association points (NYHA-P).A total of 30 healthy subjetcs served as the control group.Parameters including left ventricular ejection fraction (LVEF),left ventricular mass index (LVMI),left ventricular spherical index (LVSI),left ventricular myocardial mean radial strain (MRS),mean radial strain rate (MRSR),mean longitudinal strain (MLS),local systolic twist angle (STA),and mitral annulus maximum displacement (TMAD) were detected.Results:MLS,MRS,MRSR,LVSI,STA and TMAD in the Group A and Group B were lower than that in the control group (P<0.05),and LVMI in the Group A and Group B was increased than those in the control group (P<0.05);LVEE MLS,MRS,MRSR,LVSI and STAin the Group B was decreased than that in the Group A (P<0.05).MLS in the Group A and B were positively correlated with LVEF and LVSI,but negatively correlated with LVMI.Using the point of 14.10% for MLS to evaluate UCM patients with NYHA-P>4 points,the sensitivity,the specificity and Yuedden index were 90.5%,71% and 0.585,respectively.STA in UCM patients were lower than that in the control (P<0.05).Conclusion:2D-STI possesses a unique advantage in detecting left ventricular strain and strain rate on left ventricular regional function in UCM with left ventricular hypertrophy and ventricular deformation.There is no direct correlation between the left ventricular hypertrophy and ventricular deformation,but the ventricular hypertrophy and deformation are correlated with regional cardiac function and clinical cardiac function.Left ventricular regional dysfunction may occur before cardiac hypertrophy and deformation.
6.Extraction Optimization of Total Flavonoids from Oxytropis Falcata Bunge by Central Composite Design-response Surface Methodology
Qiping ZENG ; Yihong WANG ; Xiaohui CAI ; Lina YANG ; Jinshan CHEN
China Pharmacist 2017;20(5):801-804
Objective: To optimize the extraction process of total flavonoids from Oxytropis falcata bunge.Methods: With the content of total flavonoids as the index,and based on the results of single factor tests, central composite design-response surface methodology was adopted to optimize the extraction technology with the solvent amount, ethanol concentration and extraction time as the factors.Results: The optimal extraction conditions were as follows: extracted twice with 20-fold amount of 66% ethanol, and 84 minute per time.Under the above conditions, the extraction rate of total flavonoids was up to 23.21 mg·g-1.Conclusion: The central composite design-response surface methodology is convenient and highly predictive for the extraction optimization of total flavonoids from oxytropis falcata bunge.
7.Narrative medical enlightenment on medical humanities quality education in China
Qiong YANG ; Xinhua ZHANG ; Qiping HUANG ; Gebo WEN ; Zhihan TANG ; Juan PENG
Chinese Journal of Medical Education Research 2016;15(9):943-946
Narrative medicine has brought new ideas to medical humanities education, and its con-notation is suitable to Undergraduate Medical Education Standards-Clinical Medicine (Trial). By analyz-ing the proposal and development of narrative medicine, its foundation and core, its programs and methods, as well as its forms and values, the author deepened the understanding of narrative medicine. And through the following four pathways including strengthening the renewal of ideas and concepts on medical humanities quality education, promoting the diversification of teaching ways and methods of medical humanities educa-tion, enhancing the effect of early exposure to clinical medical students, opening the path of integration narrative medicine and evidence-based medicine, the author analyzed narrative medical enlightenment on medical humanities quality education in China.
8.Comparison of nasojejunal tube insertion and percutaneous endoscopic gastrostomy for enteral nutrition in elderly patients
Yichan ZHOU ; Aijuan WU ; Zhenguo LUO ; Ping YANG ; Qiping XUE ; Weihao SUN ; Yun SHAO
Chinese Journal of Geriatrics 2016;35(8):867-870
Objective To evaluate the clinical application of enteral nutrition by nasojejunal tube insertion and by percutaneous endoscopic gastrostomy (PEG) in elderly patients.Methods A total of 65 elderly patients with dysphagia recruited at our department from January 2010 to November 2014 were divided into the nasojejunal tube feeding group (35 cases) and the PEG feeding group (30 cases).Differences between these two groups in nutritional indexes,immunological indexes,complications and mortality were analyzed retrospectively.Results Serum total protein,albumin and prealbumin and upper arm circumferences all increased after treatment with nasojejunal tube feeding or percutaneous endoscopic gastrostomy (P>0.05).There was overall improvement in nutritional status,as assessed by Nutritional Risk Screening 2002 (NRS2002).Specifically,the before/one month-after-treatment ratio of scores was 3.72±0.91/1.90±0.61 (t=7.24,P<0.01) for the nasojejunal tube feeding group and 3.52±1.23/2.02±0.53 (t=4.17,P<0.01) for the PEG feeding group.Compared with NRS2002 scores at one month post-operation,further improvement was achieved at 3 months postoperation both for the nasojejunal tube feeding group (1.89±0.65,t=5.21,P<0.01) and for the PEG feeding group (1.91±0.62,t=4.40,P<0.01).There was no difference in the indexes of nutrition,immune status or mortality between the two groups (P>0.05).Although improvement in CD3+,CD4+,CD8+,CD4+/CD8+,IgA,IgG,and IgM was seen in both groups after operation,the differences did not reach statistical significance (P>0.05).The incidence of aspiration pneumonia was notably lower (P<0.05) while the incidence of diarrhea was much higher (P<0.05) in the nasojejunal tube feeding group than in the PEG feeding group at one month and three months.The two groups had similar causes of death and mortality rates.Conclusion Both nasojejunal tube and PEG feeding can improve the nutritional status of elderly patients with dysphagia.However,the choice for the route of nutrition should be individualized.
9.A comparative study of MRI and ultrasonic cardiography in morphology and blood flow of cavopulmonary anastomosis for patients with bidirectional Glenn shunt
Rongpin WANG ; Changhong LIANG ; Meiping HUANG ; Hui LIU ; Qiping DENG ; Mingfang YANG
Chinese Journal of Radiology 2011;45(11):999-1003
Objective To investigate the difference of morphology and blood flow of cavopulmonary anastomosis by MRI and that by ultrasonic cardiography (UCG) in patients with bidirectional Glenn shunt (BGS).Methods Phase-contrast MRI (PC-MRI) and contrast enhanced MRI (CE-MRI) were performed for superior vena cava ( SVC ) and inferior vena cava (IVC) in 22 patients with BGS on 3.0 T MR scanner.PC-MRI was used for measuring blood flow and CE-MRI for illustrating morphology.The width,peak flow velocity and gradient pressure of cavopulmonary anastomosis were calculated by using Report Card software.The similar data of UCG was collected.The parameters by MRI and that by UCG were compared statistically by t test and Pearson correlation.Results Based on the MRI data,the blood flow of SVC [ ( 1.002 ±0.208) L/min ] was significantly lower than that of IVC [ ( 1.794 ± 0.392 ) L/min ] ( t =- 15.148,P <0.01 ),while the regurgitation fraction of SVC [ (26.54 ± 12.82)% ] was significantly higher than that ofIVC [ ( 17.44 ± 10.17)% ] (t =11.060,P <0.01 ).The morphology displayed with MRI angiography couldnot be detected with UCG.The width of cavopulmonary anastomosis measured by MRI [ (12.46 ±3.43 ) mm ] was significantly higher than that of UCG[ ( 11.04 ± 2.63 ) mm] ( t =4.048,P < 0.01 ),while the peak flow velocity of cavopulmonary anastomosis measured by MRI [ (47.77 ± 10.44) cm/s] was significantly lower than that of UCG [ (52.19 + 9.63) cm/s] ( t =- 2.237,P < 0.05 ).No significant difference was found in gradient pressure of cavopulmonary anastomosis between the values by MRI [(0.95+0.42) mm Hg(1 mm Hg =0.133 kPa)] and that by UCG [(1.12+0.38)mm Hg] (t=2.010,P > 0.05).The width,peak flow velocity and gradient pressure of cavopulmonary anastomosis by MRI were closely correlated with those by UCG (r =0.858,0.489,0.427,all P< 0.05 ).Conclusions A good correlation is found in the width,peak flow velocity,and gradient pressure of the cavopulmonary anastomosis obtained by 3.0 T MRI and UCG.MRI is more useful tool to display the width and abnormal morphology of cavopulmonary anastomosis than UCG.
10.Detection of peripheral dendritic cell subsets and T cell subpopulations expressing different intracellular cytokines in patients with syphilis
Yilong GUO ; Minhong XU ; Xiaodan CAI ; Qiping YANG
Chinese Journal of Dermatology 2008;41(9):612-615
Objective To investigate the role of dendritic cell (DC) subsets and T cell subpopulations expressing different intracellular cytokines in the pathogenesis of syphilis. Methods Flow cytometry was utilized to measure the frequencies of peripheral DC subsets and IFN-γ-, IL-2-, IL-4-, IL-10-expressing peripheral CD4+ and CD8+ T cell subpopulations in 20 patients with syphilis before and after therapy, and in 15 healthy human controls. Results The frequency of CD11c+ DC was significantly lower in pretreated patients than that in treated patients (P<0.01), but higher than that in the normal controls (P<0.05), and the same was true for the frequency of IFN-γ-expressing T cells, IL-2-expressing T cells, and IL-12-expressing T cells. By contrast, a decrease was noticed in the frequency of IL-4-expressing T cells and IL-10-expressing T cells in pretreated patients compared with that in the normal controls. Furthermore, in patients with syphilis, the frequency of CD11c+ and CD123+ DC was unrelated to the percentage of IFN-γ-expressing and IL-12- expressing T cells (both P>0.05). Conclusions IFN-γ, IL-2 and IL-12 may exert an immunoregnlatory effect in the eliminating of Treponema pallidum, whereas IL-4 and IL-10 may perform an imrnunoinhibitory effect.

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