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.Application of drug-coated balloon in the treatment of heterogeneous in-stent restenosis
Jingsheng WU ; Linguang WANG ; Xiucai FAN ; Zhu ZHANG ; Jiancheng QI
Journal of Clinical Medicine in Practice 2023;27(23):27-30
Objective To analyze the efficacy of drug-coated balloon in the treatment of hetero-geneous in-stent restenosis.Methods A total of 118 patients who received treatment and diagnosed with heterogeneous in-stent restenosis were selected as study objects,and were divided into two groups using a random table method.The experimental group(n=59)received drug-coated balloon thera-py,and the control group(n=59)received drug-eluting stent therapy.The therapeutic effects of the two different treatment methods on heterogeneous in-stent restenosis were compared.Results There was no significant difference in the incidence of in-stent restenosis in the right coronary artery,cir-cumflex artery,and anterior descending artery between the two groups(P>0.05).There was no sig-nificant difference between the two groups in the preoperative reference vessel diameter,lesion length,lumen stenosis degree,and localized restenosis(P>0.05).The postoperative residual ste-nosis rate in the experimental group was significantly higher than that in the control group(P<0.05).There was no significant difference between the two groups in the preoperative lumen area,neointimal load,stent inner area,neointimal area,incidence of neoatherosclerosis and thrombus(P>0.05).Operative lumen area of the experimental group was smaller than that of the control group(P<0.05).No target vessel reconstruction,stent thrombosis,nonfatal myocardial infarction,or cardiac death occurred in two groups during 12 months of follow-up.Conclusion Drug-coated balloons are effective and safe in the treatment of heterogeneous in-stent restenosis,and can obtain similar effects to drug-eluting stents.
3.Application of drug-coated balloon in the treatment of heterogeneous in-stent restenosis
Jingsheng WU ; Linguang WANG ; Xiucai FAN ; Zhu ZHANG ; Jiancheng QI
Journal of Clinical Medicine in Practice 2023;27(23):27-30
Objective To analyze the efficacy of drug-coated balloon in the treatment of hetero-geneous in-stent restenosis.Methods A total of 118 patients who received treatment and diagnosed with heterogeneous in-stent restenosis were selected as study objects,and were divided into two groups using a random table method.The experimental group(n=59)received drug-coated balloon thera-py,and the control group(n=59)received drug-eluting stent therapy.The therapeutic effects of the two different treatment methods on heterogeneous in-stent restenosis were compared.Results There was no significant difference in the incidence of in-stent restenosis in the right coronary artery,cir-cumflex artery,and anterior descending artery between the two groups(P>0.05).There was no sig-nificant difference between the two groups in the preoperative reference vessel diameter,lesion length,lumen stenosis degree,and localized restenosis(P>0.05).The postoperative residual ste-nosis rate in the experimental group was significantly higher than that in the control group(P<0.05).There was no significant difference between the two groups in the preoperative lumen area,neointimal load,stent inner area,neointimal area,incidence of neoatherosclerosis and thrombus(P>0.05).Operative lumen area of the experimental group was smaller than that of the control group(P<0.05).No target vessel reconstruction,stent thrombosis,nonfatal myocardial infarction,or cardiac death occurred in two groups during 12 months of follow-up.Conclusion Drug-coated balloons are effective and safe in the treatment of heterogeneous in-stent restenosis,and can obtain similar effects to drug-eluting stents.
5. Comparison of arterial stiffness in non-hypertensive and hypertensive population of various age groups
Yajing ZHANG ; Shouling WU ; Huiying LI ; Quanhui ZHAO ; Chunhong NING ; Ruiying ZHANG ; Junxing YU ; Wei LI ; Shuohua CHEN ; Jingsheng GAO
Chinese Journal of Cardiology 2018;46(1):56-63
Objective:
To investigate the impact of blood pressure and age on arterial stiffness in general population.
Methods:
Participants who took part in 2010, 2012 and 2014 Kailuan health examination were included. Data of brachial ankle pulse wave velocity (baPWV) examination were analyzed. According to the WHO criteria of age, participants were divided into 3 age groups: 18-44 years group (
6. A prospective study of the efficacy and safety of maintenance therapy with recombinant human thrombopoietin in patients with primary immune thrombocytopenia: a multicenter study
Huacong CAI ; Shujie WANG ; Ling FU ; Xiaomin WANG ; Ming HOU ; Ping QIN ; Fangping CHEN ; Xiaohui ZHANG ; He HUANG ; Jingsong HE ; Runhui WU ; Jingyao MA ; Renchi YANG ; Xiaofan LIU ; Ying TIAN ; Aijun LIU ; Jingsheng WU ; Weibo ZHU ; Yuhong ZHOU ; Wenbin LIU ; Yu HU ; Wenjuan HE ; Yan LI ; Deng PAN ; Yongqiang ZHAO
Chinese Journal of Hematology 2017;38(5):379-383
Objective:
To evaluate the efficacy and safety of maintenance therapy with reduced dose of rhTPO in the patients with primary immune thrombocytopenia (ITP) who attained stable platelet (PLT) counts after daily administration of rhTPO.
Methods:
Treatment was started with a daily administration of rhTPO (300 U/kg) for 2 consecutive weeks. Patients who attained stable PLT≥50×109/L were enrolled to maintenance therapy starting with every other day administration of rhTPO, then adjusted dose interval to maintain platelet count (30-100) ×109/L.
Results:
A total of 91 eligible patients were enrolled. Fourteen patients discontinued the study due to noncompliance (12/14) and investigator decision (2/14) . Among 77 patients who completed the study, 38 patients with the administration of rhTPO at every other day or less could maintain PLT≥30×109/L for 12 weeks. The percentage of patients with a platelet response (PLT≥30×109/L) at 4th week, 8th week and 12th week of maintain therapy was 92.6% (63/68) , 82.7% (43/52) and 85.0% (34/40) , respectively. Median platelet counts remained in the range of (70-124) ×109/L. The overall incidence of rhTPO-related adverse events was 7.7%. All the adverse events were generally mild.
Conclusion
Extending the dose interval of rhTPO is feasible to maintain stable platelet count in the patients with ITP, but the optimal dose interval is uncertain and might vary with individuals.
7.Effect of comprehensive intervention for patients with hypertension in Kailuan community
Yuntao WU ; Jingsheng GAO ; Shouling WU
Chinese Journal of Health Management 2016;10(3):173-176
Objective To investigate the effect of comprehensive intervention including education, lifestyle intervention and drug intervention for patients with hypertension in Kailuan community. Methods Employees who took part in the health checkup of Kailuan Group, Ltd. from June 2008 to June 2009 were enrolled in this study. The changes of hypertension awareness, treatment and control rates and cardiovascular health behaviors and factors have been observed in the follow-up. Results A total of 5 361 patients with hypertension were enrolled. After a period of 2 years of follow-up, the treatment rate and up to standard rate hypertension were significantly increased compared to pre-intervention (11.90%vs. 100.00%;0.82% vs. 36.93%. P<0.01). After comprehensive intervention, the average score of ideal cardiovascular health behaviors and factors increased from (6.85 ± 1.90) to (7.52 ± 1.92) (P<0.01). Conclusion Comprehensive intervention is an effective means for the prevention and control of hypertension in the community.
8.Risk Factors Analysis for Prevalence of Acute Myocardial Infarction in Young and Middle-aged Population
Quanle HAN ; Ruiying MAO ; Jing YU ; Shouling WU ; Jingsheng GAO ; Qi ZHANG ; Meiling WU ; Qinghua ZHANG ; Xiaoming LIU ; Xiaoming SHANG ; Xiaokun LIU
Chinese Circulation Journal 2016;31(7):632-635
Objective: To study the risk factors for prevalence of acute myocardial infarction (AMI) in young and middle-aged population. Methods: A prospective cohort study was conducted in 110100 subjects at the age of (18-98) years who received physical examination in Kailuan Group from 2012-06 to 2014-10. Based on the limitations of male≤53 years and female≤63 years, a total of 62367 subjects were enrolled in our study. The subjects were followed-up for 2 years by the end point event of AMI to analyze the risk factors ofAMI occurrence. Results: According to AMI occurrence at the follow-up period, the subjects were divided into 2 groups: AMI group, n=56 and Control group, n=62152. Compared with Control group, AMI group had increased BMI, SBP, DBP and elevated blood levels of LDL-C, TG; AMI group also showed the higher ratios of subjects with the history of diabetes and taking anti-hypertension medication. Cox proportional hazard regression analysis indicated that age (RR=1.37), male (RR=60.54), LDL-C (RR=1.12), and TG (RR=5.93) were the risk factors forAMI occurrence in young and middle-aged population, allP<0.05. Conclusion: Age, male gender, blood levels of LDL-C, and TG were the risk factors for AMI occurrence in young and middle-aged population.
9.Observation of the effed of tiotropium bromide combined with ambroxol in of the treatment of chronic ob-structive pulmonary disease
Kangning LIU ; Qunfeng LI ; Jingsheng WU
Chinese Journal of Primary Medicine and Pharmacy 2013;20(z1):13-14
Objective To explore the effect of tiotropium bromide combined with ambroxol hydrochloride oral liquid on chronic obstructive pulmonary disease (COPD) at remission.Methods According to the digital table, 38 patients with COPD at remission were randomly divided into treatment group and control group .The control group was given with conventional treatment ,and anti-infection and symptomatic treatment when acute attacking ,while the treatment group was treated with inhaled tiotropium bromide and ambroxol Hydrochloride oral liquid base on the con -trol group.Both groups were treated and observed for 6 months.Times of expectoration and acute attack of COPD were observed,and scores of COPD Assessment Test ( CAT) were noted everyday during therapy .Results Compared with the control group ,the total times and means of expectoration in treatment group were much less ,with very significant statistical difference(t=5.19,P<0.05);the cases,times and means of acute attack of COPD were obviously less than those in control group,with very significant statistical difference (t=2.92,P<0.05);the total scores and means of CAT in treatment group were much lower,with significant statistical difference(t=2.65,P<0.05).Conclusion With long-term treatment ,inhaled tiotropium bromide combined with ambroxol hydrochloride oral liquid can effectively decrease the times of expectoration and acute attack in patients with COPD at remission,and improve their qualities of life.
10.Real-time quantitative PCR monitoring of minimal residual disease in CML after treatment
Feifei HUO ; Xin LIU ; Zimin SUN ; Weibo ZHU ; Yujie SUN ; Changcheng ZHENG ; Jingsheng WU ; Xiaoyan GAI ; Yongsheng HAN ; Huizhi YANG
Journal of Leukemia & Lymphoma 2012;21(4):199-202
Objective To set up a real-time quantitative PCR approach for detection and quantification for bcr-abl transcripts in CML patients,and detect minimal residual disease (MRD) in CML by real-time quantitative PCR (RQ-PCR)and evaluate the significance of MRD detection.Methods The ber-abl.fusion gene expression in 80 patients with CML was analyzed by RQ-PCR. The patients were divided into three groups according to the different treatment, allogeneic hematopoietic stem cell transplantation group,imatinib group and hydroxyurea group. The change of bcr-abl fusion gene was monitored in CML patients before and after treatment.Results The average of RQ-PCR detection on newly diagnosed patients with CML in chronic phase was 6847.67 copies / 104 cells,the accelerated phase was 306 176.08 copies / 104 cells,and the average results were 944.33, 2.37, 0.29, 0 copies / 104 cells after allogeneic hematopoietic stem cell transplantation one month,6 months,12 months or 24 months respectively.The average of RQ-PCR detection after use imatinib mesylate 3 months was 3720.23 copies / 104 cells and not be detected after one year. The average was 7290.11 and 3143.24 copies / 104 cells after hydroxyurea treatment 0 and 9 months respectively.The difference in first two groups was not significant (t=1.74,P=0.17), but the difference between the third group and the first two groups was significant (t=3.74,P=0.01.t=2.97,P=0.02). The upregulation of bcr-abl transcript levels could be detected when disease progression. The transcripts level in accelerated phase was significantly higher than that in chronic phase. Conclusion RQ-PCR can be used to detect the MRD,monitor the treatment outcome,predict disease recurrence and give early intervention.

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