1.Ultrasonic anatomical study and clinical application of stellate ganglion block via C7 transverse process
Ai-Li HU ; Jun-Li WANG ; Xiao-Ai CHU ; Jie-Qing CHEN ; Zong-Yu ZHA ; Da-Sheng LU ; Qin-Zhong XIA
Journal of Regional Anatomy and Operative Surgery 2024;33(7):571-575
		                        		
		                        			
		                        			Objective To investigate the high-frequency ultrasonic anatomical features of the adjacent C7 transverse process and its clinical value in stellate ganglion block(SGB).Methods High-frequency ultrasound was applied to obtain ultrasonographic anatomical sonogram features in the plane of bilateral C7 transverse processes in 52 cases(104 sides in total)of healthy adults and then stored for the operator to learn and correctly label each tissue structure.Fifty patients who underwent ultrasound-guided SGB were selected and divided into the BC7 group(25 cases before study)and AC7 group(25 cases after study).The operation time,SGB success rate,number of adjusted needle tips,dosage of anaesthetic and adverse reaction of patients in both group were recorded.Results The main muscles observed in the C7 plane were the longissimus and anterior scalene muscles,the ultrasonographic anatomical relationships of the vagus nerve located in the carotid sheath,the pleura located posterior to the subclavian artery,and the recurrent laryngeal nerve located in the vicinity of the branches of the inferior thyroid artery are described,and the stellate ganglion was illustrated as a flattened hypoechogenic structure visible on the deep surface of the prevertebral fascia in the region of the external cervical longissimus muscle,vertebral artery and vein,and the medial aspect of the anterior oblique muscle,and emanated the sonographic features of several hypoechoic nerve bundles.Ultrasound guided SGB was completed uneventfully in patients of both groups,and all patients developed Horner syndrome,with the SGB success rate of 100%.The operation time[(5.36±1.11)minutes]of patients in the BC7 group was longer than that in the AC7 group[(3.08±0.86)minutes],the number of adjusted needle tips[(4.20±1.00)times]of patients in the BC7 group was more than that in the AC7 group[(2.24±0.87)times],and the dosage of anaesthetic[(1.82±0.28)mL]of patients in the BC7 group was more than that in the AC7 group[(1.64±0.22)mL],all the differences were statistically significant(P<0.05).There was no significant difference in the incidence of adverse reaction between the two groups(P>0.05).Conclusion After ultrasonic learning of adjacent structures through C7 transverse process,SGB is safe and easy to perform.
		                        		
		                        		
		                        		
		                        	
2.The Role of NK Cells in Allogeneic Hematopoietic Stem Cell Micro-Transplantation for Acute Myeloid leukemia
Ru-Yu LIU ; Chang-Lin YU ; Jian-Hui QIAO ; Bo CAI ; Qi-Yun SUN ; Yi WANG ; Tie-Qiang LIU ; Shan JIANG ; Tian-Yao ZHANG ; Hui-Sheng AI ; Mei GUO ; Kai-Xun HU
Journal of Experimental Hematology 2024;32(2):546-555
		                        		
		                        			
		                        			Objective:To explore the role of NK cells in allogeneic hematopoietic stem cell micro-transplantation(MST)in the treatment of patients with acute myeloid leukemia(AML).Methods:Data from 93 AML patients treated with MST at our center from 2013-2018 were retrospectively analyzed.The induction regimen was anthracycline and cytarabine combined with peripheral blood stem cells transplantation mobilization by granulocyte colony stimulating factor(GPBSC),followed by 2-4 courses of intensive treatment with medium to high doses of cytarabine combined with GPBSC after achieving complete remission(CR).The therapeutic effects of one and two courses of MST induction therapy on 42 patients who did not reach CR before transplantation were evaluated.Cox proportional hazards regression analysis was used to analyze the impact of donor NK cell dose and KIR genotype,including KIR ligand mismatch,2DS1,haplotype,and HLA-Cw ligands on survival prognosis of patients.Results:Forty-two patients received MST induction therapy,and the CR rate was 57.1%after 1 course and 73.7%after 2 courses.Multivariate analysis showed that,medium and high doses of NK cells was significantly associated with improved disease-free survival(DFS)of patients(HR=0.27,P=0.005;HR=0.21,P=0.001),and high doses of NK cells was significantly associated with improved overall survival(OS)of patients(HR=0.15,P=0.000).Donor 2DS1 positive significantly increases OS of patients(HR=0.25,P=0.011).For high-risk patients under 60 years old,patients of the donor-recipient KIR ligand mismatch group had longer DFS compared to the nonmismatch group(P=0.036);donor 2DS1 positive significantly prolonged OS of patients(P=0.009).Conclusion:NK cell dose,KIR ligand mismatch and 2DS1 influence the therapeutic effect of MST,improve the survival of AML patients.
		                        		
		                        		
		                        		
		                        	
3.Clinical observation on the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis.
Cheng Yuan LI ; Shuang CHEN ; Wei Lu QIAN ; Liu YANG ; Qiu ZHENG ; Ai Jun CHEN ; Jin CHEN ; Kun HUANG ; Sheng FANG ; Ping WANG ; Li HU ; Xin Ran LIU ; Xiao Qin ZHAO ; Na TAN ; Tao CAI
Chinese Journal of Preventive Medicine 2023;57(10):1590-1595
		                        		
		                        			
		                        			To investigate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD) in China. A small sample self-controlled study before and after treatment was conducted to retrospective analysis patients with moderate to severe AD treated with dupilumab in the department of dermatology of the First Affiliated Hospital of Chongqing Medical University from July 2020 to March 2022. Dupilumab 600 mg was injected subcutaneously at week 0, and then 300 mg was injected subcutaneously every 2 weeks. The condition was evaluated by SCORAD(severity scoring of atopic dermatitis), NRS(numerical rating scale), DLQI(dermatology life quality index) and POEM(patient-oriented eczema measure). The improvement of SCORAD, NRS, DLQI and POEM was analyzed by paired t test and non-parametric paired Wilcoxon. The results showed that a total of 67 patients with moderate to severe AD received dupilumab treatment, of which 41 patients (the course of treatment was more than 6 weeks) had reduced the severity of skin lesions, improved quality of life and reduced pruritus. A total of 23 patients completed 16 weeks of treatment. At 4, 8, 12 and 16 weeks, SCORAD, NRS, DLQI and POEM decreased compared with the baseline, and the differences were statistically significant. SCORAD (50.13±15.19) at baseline, SCORAD (36.08±11.96)(t=6.049,P<0.001) at week 4,SCORAD (28.04±11.10)(t=10.471,P<0.001) at week 8, SCORAD (22.93±9.72)(t=12.428,P<0.001) at week 12, SCORAD (16.84±7.82)(t=14.609,P<0.001) at week 16, NRS 7(6,8) at baseline, NRS 4(3,5)(Z=-3.861,P<0.001) at week 4, NRS 2(1,4)(Z=-4.088,P<0.001) at week 8, NRS 1(0,2)(Z=-4.206,P<0.001) at week 12, NRS 2(0,2)(Z=-4.222,P<0.001) at week 16, DLQI (13.83±5.71) at baseline, DLQI (8.00±4.02)(t=6.325,P<0.001) at week 4, DLQI (5.61±3.50)(t=8.060,P<0.001) at week 8, DLQI (3.96±1.99)(t=8.717,P<0.001) at week 12, DLQI (2.70±1.89)(t=10.355,P<0.001) at week 16, POEM (18.04±6.41) at baseline, POEM (9.70±4.70)(t=7.031,P<0.001) at week 4, POEM (7.74±3.48)(t=8.806,P<0.001) at week 8, POEM (6.35±3.33)(t=10.474,P<0.001) at week 12, POEM (4.26±2.51)(t=11.996,P<0.001) at week 16. In the 16th week, 100%(23 patients), 91.3%(21 patients), 34.8%(8 patients) and 8.7%(2 patients) of 23 patients reached SCORAD30, SCORAD50, SCORAD70, and SCORAD90 statuses, respectively. There were 82.6%(19 patients), 95.7%(22 patients) and 95.7%(22 patients) of 23 patients with NRS, DLQI and POEM improved by≥4 points compared with baseline. Twelve patients with AD who continued to receive dupilumab after 16 weeks showed further improvement in skin lesions. The adverse events were conjunctivitis and injection site reaction. In conclusion, dupilumab is an effective and safe treatment for moderate and severe AD. However, the longer-term efficacy and safety require further studies involving larger sample sizes and a longer follow-up time.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Dermatitis, Atopic/drug therapy*
		                        			;
		                        		
		                        			Quality of Life
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Severity of Illness Index
		                        			;
		                        		
		                        			Treatment Outcome
		                        			
		                        		
		                        	
4.Clinical observation on the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis.
Cheng Yuan LI ; Shuang CHEN ; Wei Lu QIAN ; Liu YANG ; Qiu ZHENG ; Ai Jun CHEN ; Jin CHEN ; Kun HUANG ; Sheng FANG ; Ping WANG ; Li HU ; Xin Ran LIU ; Xiao Qin ZHAO ; Na TAN ; Tao CAI
Chinese Journal of Preventive Medicine 2023;57(10):1590-1595
		                        		
		                        			
		                        			To investigate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD) in China. A small sample self-controlled study before and after treatment was conducted to retrospective analysis patients with moderate to severe AD treated with dupilumab in the department of dermatology of the First Affiliated Hospital of Chongqing Medical University from July 2020 to March 2022. Dupilumab 600 mg was injected subcutaneously at week 0, and then 300 mg was injected subcutaneously every 2 weeks. The condition was evaluated by SCORAD(severity scoring of atopic dermatitis), NRS(numerical rating scale), DLQI(dermatology life quality index) and POEM(patient-oriented eczema measure). The improvement of SCORAD, NRS, DLQI and POEM was analyzed by paired t test and non-parametric paired Wilcoxon. The results showed that a total of 67 patients with moderate to severe AD received dupilumab treatment, of which 41 patients (the course of treatment was more than 6 weeks) had reduced the severity of skin lesions, improved quality of life and reduced pruritus. A total of 23 patients completed 16 weeks of treatment. At 4, 8, 12 and 16 weeks, SCORAD, NRS, DLQI and POEM decreased compared with the baseline, and the differences were statistically significant. SCORAD (50.13±15.19) at baseline, SCORAD (36.08±11.96)(t=6.049,P<0.001) at week 4,SCORAD (28.04±11.10)(t=10.471,P<0.001) at week 8, SCORAD (22.93±9.72)(t=12.428,P<0.001) at week 12, SCORAD (16.84±7.82)(t=14.609,P<0.001) at week 16, NRS 7(6,8) at baseline, NRS 4(3,5)(Z=-3.861,P<0.001) at week 4, NRS 2(1,4)(Z=-4.088,P<0.001) at week 8, NRS 1(0,2)(Z=-4.206,P<0.001) at week 12, NRS 2(0,2)(Z=-4.222,P<0.001) at week 16, DLQI (13.83±5.71) at baseline, DLQI (8.00±4.02)(t=6.325,P<0.001) at week 4, DLQI (5.61±3.50)(t=8.060,P<0.001) at week 8, DLQI (3.96±1.99)(t=8.717,P<0.001) at week 12, DLQI (2.70±1.89)(t=10.355,P<0.001) at week 16, POEM (18.04±6.41) at baseline, POEM (9.70±4.70)(t=7.031,P<0.001) at week 4, POEM (7.74±3.48)(t=8.806,P<0.001) at week 8, POEM (6.35±3.33)(t=10.474,P<0.001) at week 12, POEM (4.26±2.51)(t=11.996,P<0.001) at week 16. In the 16th week, 100%(23 patients), 91.3%(21 patients), 34.8%(8 patients) and 8.7%(2 patients) of 23 patients reached SCORAD30, SCORAD50, SCORAD70, and SCORAD90 statuses, respectively. There were 82.6%(19 patients), 95.7%(22 patients) and 95.7%(22 patients) of 23 patients with NRS, DLQI and POEM improved by≥4 points compared with baseline. Twelve patients with AD who continued to receive dupilumab after 16 weeks showed further improvement in skin lesions. The adverse events were conjunctivitis and injection site reaction. In conclusion, dupilumab is an effective and safe treatment for moderate and severe AD. However, the longer-term efficacy and safety require further studies involving larger sample sizes and a longer follow-up time.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Dermatitis, Atopic/drug therapy*
		                        			;
		                        		
		                        			Quality of Life
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Severity of Illness Index
		                        			;
		                        		
		                        			Treatment Outcome
		                        			
		                        		
		                        	
5.Overexpression of NAT10 induced platinum drugs resistance in breast cancer cell.
Pan QI ; Ya Ke CHEN ; Rui Li CUI ; Rui Juan HENG ; Sheng XU ; Xiao Ying HE ; Ai Min YUE ; Jiang Kun KANG ; Hao Han LI ; Yong Xin ZHU ; Cong WANG ; Yu Lu CHEN ; Kua HU ; Yan Yan YIN ; Li Xue XUAN ; Yu SONG
Chinese Journal of Oncology 2022;44(6):540-549
		                        		
		                        			
		                        			Objective: To observe the platinum drugs resistance effect of N-acetyltransferase 10 (NAT10) overexpression in breast cancer cell line and elucidate the underlining mechanisms. Methods: The experiment was divided into wild-type (MCF-7 wild-type cells without any treatment) group, NAT10 overexpression group (H-NAT10 plasmid transfected into MCF-7 cells) and NAT10 knockdown group (SH-NAT10 plasmid transfected into MCF-7 cells). The invasion was detected by Transwell array, the interaction between NAT10 and PARP1 was detected by co-immunoprecipitation. The impact of NAT10 overexpression or knockdown on the acetylation level of PARP1 and its half-life was also determined. Immunostaining and IP array were used to detect the recruitment of DNA damage repair protein by acetylated PARP1. Flow cytometry was used to detect the cell apoptosis. Results: Transwell invasion assay showed that the number of cell invasion was 483.00±46.90 in the NAT10 overexpression group, 469.00±40.50 in the NAT10 knockdown group, and 445.00±35.50 in the MCF-7 wild-type cells, and the differences were not statistically significant (P>0.05). In the presence of 10 μmol/L oxaliplatin, the number of cell invasion was 502.00±45.60 in the NAT10 overexpression group and 105.00±20.50 in the NAT10 knockdown group, both statistically significant (P<0.05) compared with 219.00±31.50 in wild-type cells. In the presence of 10 μmol/L oxaliplatin, NAT10 overexpression enhanced the binding of PARP1 to NAT10 compared with wild-type cells, whereas the use of the NAT10 inhibitor Remodelin inhibited the mutual binding of the two. Overexpression of NAT10 induced PARP1 acetylation followed by increased PARP1 binding to XRCC1, and knockdown of NAT10 expression reduced PARP1 binding to XRCC1. Overexpression of NAT10 enhanced PARP1 binding to LIG3, while knockdown of NAT10 expression decreased PARP1 binding to LIG3. In 10 μmol/L oxaliplatin-treated cells, the γH2AX expression level was 0.38±0.02 in NAT10 overexpressing cells and 1.36±0.15 in NAT10 knockdown cells, both statistically significant (P<0.05) compared with 1.00±0.00 in wild-type cells. In 10 μmol/L oxaliplatin treated cells, the apoptosis rate was (6.54±0.68)% in the NAT10 overexpression group and (12.98±2.54)% in the NAT10 knockdown group, both of which were statistically significant (P<0.05) compared with (9.67±0.37)% in wild-type cells. Conclusion: NAT10 overexpression enhances the binding of NAT10 to PARP1 and promotes the acetylation of PARP1, which in turn prolongs the half-life of PARP1, thus enhancing PARP1 recruitment of DNA damage repair related proteins to the damage sites, promoting DNA damage repair and ultimately the survival of breast cancer cells.
		                        		
		                        		
		                        		
		                        			Breast Neoplasms/enzymology*
		                        			;
		                        		
		                        			Cell Line, Tumor
		                        			;
		                        		
		                        			Drug Resistance, Neoplasm
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			MCF-7 Cells
		                        			;
		                        		
		                        			N-Terminal Acetyltransferases/metabolism*
		                        			;
		                        		
		                        			Organoplatinum Compounds/pharmacology*
		                        			;
		                        		
		                        			Oxaliplatin/pharmacology*
		                        			;
		                        		
		                        			X-ray Repair Cross Complementing Protein 1
		                        			
		                        		
		                        	
6.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
		                        		
		                        			BACKGROUND:
		                        			Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
		                        		
		                        			OBJECTIVE:
		                        			This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
		                        		
		                        			DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
		                        			This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
		                        		
		                        			MAIN OUTCOME MEASURES:
		                        			The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
		                        		
		                        			RESULTS:
		                        			A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
		                        		
		                        			CONCLUSION:
		                        			SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
		                        		
		                        			TRIAL REGISTRATION NUMBER
		                        			NCT02063100 on ClinicalTrials.gov.
		                        		
		                        		
		                        		
		                        	
7.Expert consensus on management principles of orthopedic emergency in the epidemic of coronavirus disease 2019.
Pei-Fu TANG ; Zhi-Yong HOU ; Xin-Bao WU ; Chang-Qing ZHANG ; Jun-Wen WANG ; Xin XING ; Zeng-Wu SHAO ; Ai-Xi YU ; Gang WANG ; Bin CHEN ; Ping ZHANG ; Yan-Jun HU ; Bo-Wei WANG ; Xiao-Dong GUO ; Xin TANG ; Dong-Sheng ZHOU ; Fan LIU ; Ai-Mi CHEN ; Kun ZHANG ; Kai-Nan LI ; Yan-Bin ZHU
Chinese Medical Journal 2020;133(9):1096-1098
		                        		
		                        		
		                        		
		                        			Betacoronavirus
		                        			;
		                        		
		                        			Consensus
		                        			;
		                        		
		                        			Coronavirus Infections
		                        			;
		                        		
		                        			complications
		                        			;
		                        		
		                        			epidemiology
		                        			;
		                        		
		                        			prevention & control
		                        			;
		                        		
		                        			Epidemics
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Minimally Invasive Surgical Procedures
		                        			;
		                        		
		                        			Musculoskeletal Diseases
		                        			;
		                        		
		                        			complications
		                        			;
		                        		
		                        			therapy
		                        			;
		                        		
		                        			Pandemics
		                        			;
		                        		
		                        			prevention & control
		                        			;
		                        		
		                        			Pneumonia, Viral
		                        			;
		                        		
		                        			complications
		                        			;
		                        		
		                        			epidemiology
		                        			;
		                        		
		                        			prevention & control
		                        			
		                        		
		                        	
8.Analysis of Correlation between Gene Polymorphisms of CRHBP in Yunnan Han Population and Schizophrenia and Aggressive Behavior.
Yang CHEN ; Li Ping HU ; Lin Lin LIU ; Xiu Feng ZHANG ; Ai Cen JI ; Jia Jue LI ; Sheng Jie NIE
Journal of Forensic Medicine 2020;36(5):672-676
		                        		
		                        			
		                        			Objective To explore the correlation between 4 tag single nucleotide polymorphisms (Tag SNP) sites (rs7721799, rs32897, rs7718461, rs10062367) of corticotropin releasing hormone binding protein (CRHBP) and schizophrenia and aggressive behavior in the Yunnan Han population. Methods Case-control correlation analysis was used to establish a complex amplification system. Improved multiplex ligase detection reaction (iMLDR) technology was used to detect the genotypes of 4 SNP sites of CRHBP gene of 163 Han schizophrenic patients (including 81 patients with aggressive behavior, 82 patients without aggressive behavior) and 345 healthy Han individuals, which were analyzed statistically by SPSS 19.0, Haploview 4.2 and PHASE 2.1 software. Results There was no correlation between the 3 SNP sites of CRHBP gene and the onset of schizophrenia except for the rs7718461 site (P>0.05). The relative risk of aggressive behavior of patients carrying GG or GA genotype at rs7718461 site were 4.903 times higher than those carrying AA genotype (P<0.05). Conclusion The CRHBP gene may not be associated with the occurrence of schizophrenia in Yunnan Han population, but AA genotype of rs7718461 may reduce the risk of aggressive behavior in schizophrenia patients.
		                        		
		                        		
		                        		
		                        			Asian People/genetics*
		                        			;
		                        		
		                        			Carrier Proteins/genetics*
		                        			;
		                        		
		                        			China
		                        			;
		                        		
		                        			Gene Frequency
		                        			;
		                        		
		                        			Genetic Predisposition to Disease
		                        			;
		                        		
		                        			Genotype
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Polymorphism, Single Nucleotide
		                        			;
		                        		
		                        			Schizophrenia/genetics*
		                        			
		                        		
		                        	
9.Risk-factors analysis of graft failure after allogeneic hematopoietic stem cell transplantation.
Yang FEI ; Xiao Xia HU ; Qi CHEN ; Ai Jie HUANG ; Hui CHENG ; Xiong NI ; Li CHEN ; Lei GAO ; Gu Sheng TANG ; Jie CHEN ; Wei Ping ZHANG ; Jian Min YANG ; Jian Min WANG
Chinese Journal of Hematology 2020;41(1):64-68
10.Effects of Niaoduqing Particles () on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study.
Ying ZHENG ; Nian-Song WANG ; Yu-Ning LIU ; Li-Qun HE ; Gui-Hua JIAN ; Xu-Sheng LIU ; Zhao-Hui NI ; Xiao-Hong CHENG ; Hong-Li LIN ; Wen-Hua ZHOU ; Ya-Ping WANG ; Jing-Ai FANG ; Ya-Ni HE ; Hong-Tao YANG ; Li-Juan ZHAO ; Han-Lu DING ; Li-Hua WANG ; Ren-Huan YU ; Wen-Ge LI ; Zhi-Ming YE ; Wang GUO ; Yong-Li ZHAN ; Hui-Juan MAO ; Zhao HU ; Chen YAO ; Guang-Yan CAI ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2019;25(3):168-174
		                        		
		                        			OBJECTIVE:
		                        			To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction.
		                        		
		                        			METHODS:
		                        			Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period.
		                        		
		                        			RESULTS:
		                        			After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (-10.0-41.9) and 17.5 (-6.0-50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were-2.3 (-6.4-1.9) and-3.7 (-7.5-1.1) mL•min•1.73 m, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min•1.73 m per year.
		                        		
		                        			CONCLUSION
		                        			Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448).
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Disease Progression
		                        			;
		                        		
		                        			Double-Blind Method
		                        			;
		                        		
		                        			Drugs, Chinese Herbal
		                        			;
		                        		
		                        			therapeutic use
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Follow-Up Studies
		                        			;
		                        		
		                        			Glomerular Filtration Rate
		                        			;
		                        		
		                        			drug effects
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Kidney Diseases
		                        			;
		                        		
		                        			drug therapy
		                        			;
		                        		
		                        			physiopathology
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Outcome Assessment (Health Care)
		                        			
		                        		
		                        	
            
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