1.An open-label trial on the safety of recombinant human tumor necrosis factor-Fc treatment in Chinese rheumatic diseases patients
Fang DU ; Chun-de BAO ; Feng-chun ZHANG
Chinese Journal of Rheumatology 2011;15(12):850-854
Objective To compare the safety of recombinant human tumor necrosis factor-Fc (rhTNFR:Fc) and other DMARDs,in patients with rheumatoid arthritis (RA),ankylosing spondylitis (AS),juvenile idiopathetic arthritis (JIA) or psoriatic arthritis (PsA).Methods Patients who received rhTNFR:Fc 25 mg twice weekly from May 2006 to March 2009 were involved in this open-lable study.Safety assessments were carried out at regular intervals.Results Of the 2014 patients enrolled in the open-label trial,1388,421 and 232 were RA,AS or other diseases,such as JIA and P.sA respectively.Frequent adverse events included injection-site reactions (2.67%),rash (1.87%) and hyperamino transferase (1.80%) in RA patients.Similarly,injection-site reactions (5.23%),hyperaminotransferase (2.38%) and rash (0.71%) were frequent in AS patients.Upper respiratory infection was most frequent among infectious adverse events.There were no reports of patients with serious adverse events,dead case,TB infection and malignancies.Conclusion rhTNFR:Fc has shown a favourable safety profile in Chinese rheumatic disease patients.
2.Infliximab versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate:a randomized double blind phase Ⅲ trial in China
Yong HOU ; Feng-Chun ZHANG ; Feng HUANG ; Donghai WU ; Chun-De BAO ; Li-Qing NI ; Chen YAO ;
Chinese Journal of Rheumatology 2003;0(11):-
Objective To evaluate the efficacy and safety of infliximab plus methotrexate combination therpy in Chinese with rheumatoid arthritis patients.Methods This was a double-blind placebo-controlled phaseⅢclinical trial,173 patients who had active rheumatoid arthritis were randomised to placebo(n=86)or infliximab(n=87)group on a background of a stable dosage of methotrexate.Patients were assessed at weeks 0,2,6,14 and 18.Results At week 2,the American College of Rheumatology(20)response criteria,which represent a 20% improvement from baseline,the same results with swollen joint count,tender joint count,du- ration of morning stiffness,VAS score,CRP,ESR were achieved in 52.9% of patients,compared with 14.0% of patients receiving placebo plus methotrexate.A 20% improvement was achieved in 75.9% of infliximab plus methotrexate at week 18,compared with 48.8% of patients on placebo plus methotrexate(P=0.0003).A 50% improvement was achieved in 43.7% of infliximab plus methotrexate at week 18,compared with 25.6% of pa- tients on placebo plus methotrexate(P=0.011).Infliximab was well-tolerated;withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections were similar to those in the placebo group.There was only one case of tuberculosis in the treatment group.Conclusion Treatment with infliximab plus methotrexate is more effective than methotrexate alone in patients with active rheumatoid arthritis.It has rapid onset of effect and the efficacy is persistent.
3.The expression of interferon-?in the peripheral blood and correlation with disease activity in systemic lupus erythematosus patients
Shan DENG ; Da-Wei HU ; Yuan WANG ; Nan SHEN ; Yue-Ying GU ; Chun-De BAO ; Shun-Le CHEN ;
Chinese Journal of Rheumatology 2003;0(11):-
Objective To investigate the mRNA and protein expression levels of interferon(IFN)-?in the peripheral blood of patients with systemic lupus erythematosus(SLE),to analyze the relationship between IFN-?and disease activity,and to evaluate the role of IFN-?in the pathogenesis of lupus.Methods SYBR green dyeⅠbased real-time quantatives PCR method was used to compare the mRNA expression levels of IFN-?in the peripheral blood leucocyte of SLE patients and healthy controls.Surum levels of IFN-?were measured with ELISA method.Results IFNA1 mRNA expression level in SLE patients(2.8?3.5)was signifi- cantly lower than that of normal controls(12.7?10.7,P=0.000).There was no significant difference between patients treated with glucocorticoid and those without in the expression level of IFNA1(P=0.549).Serum levels of IFN-?in SLE patients was significantly higher than that of normal controls(P=0.003).The SLEDAI score and anti-dsDNA antibody correlated positively,and complement components C3,C4 and leukocytes correlated negatively with serum concentration of IFN-?.IFN-?level correlated with the presence of fever and rash. Conclusion The close relationship between IFN-?serum level and disease activity in SLE patients suggests that IFN-?might be of importance in the disease process.
4.Clinical study on the treatment of knee osteoarthritis by acupuncture plus manipulative regulation of knee muscle.
Kui SUN ; Xue-Mei BAO ; Yang-Chun SONG ; De-Chun LIU
China Journal of Orthopaedics and Traumatology 2010;23(12):895-898
OBJECTIVETo investigate and research the appraisal scores of the symptoms and physical signs index for the evaluation of the clinical efficacy of acupuncture and manipulative regulation of knee muscle balance for the treatment of knee osteoarthritis, and provide clinical basis for the treatment.
METHODSFrom January 2008 to December 2009, 121 patients with knee osteoarthritis were randomly divided into two groups. In the treatment group there were 63 cases of 83 knees including 16 males and 47 females, with an average age of (59.88 +/- 7.97) years; in the control group there were 58 cases of 73 knees including 13 males and 45 females, with an average age of (57.95 +/- 10.37) years. The patients in the treatment group were treated with acupuncture plus manipulative regulation of knee muscle balance, and the patients in the control group were treated with Diclofenac Sodium Sustained Release Tablets. The appraisal scores of the symptoms and physical signs index, numerical rating scale of pain, joint function, joint swelling were evaluated before and after the treatment, as well as 3 months after the treatment. All data were statistical analyzed by package SPSS 10.0.
RESULTS1) In the treatment group, before and after treatment the appraisal scores of the symptoms and physical signs index were (39.81 +/- 3.92) and (9.69 +/- 8.08); numerical rating scale of pain were (7.61 +/- 0.97) and (2.17 +/- 2.09); joint function were (1.47 +/- 0.50) and (0.61 +/- 0.58); joint swelling were (1.23 +/- 0.79) and (0.42 +/- 0.52). As well in the control group, above data were (39.89 +/- 3.78), (13.62 +/- 7.83), (7.55 +/- 0.71), (3.34 +/- 2.32), (1.33 +/- 0.47), (0.93 +/- 0.67), an (0.97 +/- 0.88), (0.58 +/- 0.52) respectively. Both group had obvious differences in the appraisal scores of the symptoms and physical signs index, numerical rating scale of pain, joint function, joint swelling between after and before treatment. The comparison between the two groups suggested that after the treatments the treatment group had better therapy effect than those of the control group in the appraisal scores of the symptoms and physical signs index, numerical rating scale of pain, joint function, but both group had no differences in the appraisal scores of joint swelling. 2) After the treatment, 12 patients in the treatment group were clinically cured, 48 had remarkable effects,19 good, and 4 ineffective. As well in the control group, above data were 5, 31, 34 and 3 respectively. Three months after the treatment, above data were 8, 42, 27 and 6 respectively in the treatment group. In the control group, above data were 5, 21, 37 and 10 respectively. The treatment group was superior to the control group after the treatments and 3 months after the treatment.
CONCLUSIONAcupuncture plus manipulative regulation of knee muscle balance can effectively improve the clinical symptoms and knee joint's motor function of patients with knee osteoarthritis, and can avoid the further development of disease. It is a proved effective method for knee osteoarthritis.
Acupuncture Therapy ; Aged ; Combined Modality Therapy ; Female ; Humans ; Male ; Manipulation, Orthopedic ; methods ; Middle Aged ; Osteoarthritis, Knee ; physiopathology ; therapy
5.Clinical comparative study of minimally invasive esophagectomy versus open esophagectomy for esophageal carcinoma.
Bao-fu CHEN ; Cheng-chu ZHU ; Chun-guo WANG ; De-hua MA ; Jiang LIN ; Bo ZHANG ; Min KONG
Chinese Journal of Surgery 2010;48(16):1206-1209
OBJECTIVETo explore and evaluate the feasibility, safety, radicality and the short-term outcome of minimally invasive esophagectomy versus open esophagectomy for esophageal cancer.
METHODSFrom July 2007 to October 2009, 67 patients with esophageal cancer received minimally invasive esophagectomy (MIE group), while 38 patients underwent conventional open esophagectomy (OE group: via right thorax, abdomen, left neck). The operative procedures, clinicopathological data and short-term outcome were collected and compared between the two groups.
RESULTSThe clinical data of the two groups were comparable. No significant differences was found in demographics between the two groups. Median blood loss in MIE group was less than that in OE group (chest: 112.3 ml vs. 175.3 ml, P = 0.035, abdominal: 31.4 ml vs. 100.5 ml, P = 0.026). More patients in OE group were transferred to ICU (P = 0.042) and more obvious pain (P = 0.005). The rate of pulmonary infection and intestinal obstruction in OE group were higher than MIE group (P = 0.046 and 0.045). There were no differences in the number of lymph node dissection for two groups, the average was 20.9 and lymph node metastasis rate was 26.9% in MIE group. Mean follow up was (14.0 ± 2.2) months (range, 2 to 29 months). Recurrence rate and survival rate were no differences.
CONCLUSIONThe Minimally invasive esophagectomy for esophageal cancer is feasible, safe, and reliable short-term effect, and can achieve radical tumor resection, which may lead to better future of surgical treatment for esophageal carcinoma.
Aged ; Esophageal Neoplasms ; surgery ; Esophagectomy ; methods ; Female ; Follow-Up Studies ; Humans ; Laparoscopy ; Male ; Middle Aged ; Retrospective Studies ; Thoracoscopy ; Treatment Outcome
6.Brain imaging with a novel β-amyloid plaque probe 131 I-IMPY in Alzheimer's disease
Wan-zhong, YE ; Zao-huo, CHENG ; Chun-xiong, LU ; De-liang, CAI ; Min, YANG ; Jian-dong, BAO ; Zhi-qiang, WANG ; Bi-xiu, YANG
Chinese Journal of Nuclear Medicine 2011;31(5):297-300
Objective To evaluate the diagnostic value of brain SPECT imaging with a novel Aβ plaque probe,131 I-2-(4'-dimethylaminophenyl) -6-iodoimidazo[ 1,2-α ] pyridine ( 131 I-IMPY) in early AD.Methods Thirteen patients with AD (3 males,10 females,age ranged 52 - 79 y),11 with mild cognitive impairment (MCI,4 males,7 females,age ranged 48 - 67 y) and 14 normal controls (6 males,8 females,age ranged 42 - 67 y) were enrolled in this study.131I-IMPY SPECT imaging was acquired in 2 -3 h after the agent injection.ROIs were drawn on cerebral lobes and cerebellum.The ratios of mean radioactivity of cerebral lobes over cerebellum (Rcl/cb) were calculated.The t-test was used for data analysis.Results In patients with MCI,Rcl/cb ratios were increased in parietal gyrus,temporal gyrus and frontal gyrus (right:1.15±0.18,1.18±0.12,1.14±0.14; left:1.16±0.11,1.19±0.18,1.15±0.09)compared with those in normal control group ( right:1.02 ± 0.12,1.05 ± 0.14,1.01 ± 0.12 ; left:1.03 ±0.13,1.05 ±0.13,1.01 ±0.14; t:2.1642 to 2.8757,all P <0.05).Rcl/cb ratios of basel ganglia and occipital gyms in MCI group (right:0.92 ±0.18,1.12 ±0.15; left:0.94 ±0.15,1.13 ±0.17) showed no statistical difference compared with those in normal control group (right:0.82 ±0.15,1.06 ±0.18;left:0.85 ±0.16,1.08 ±0.15; t:0.7805 to 1.4344,all P>0.05).In patients with AD,Rcl/cb ratios were increased in parietal,temporal,basal ganglia and occipital lobes (right:1.16 ±0.19,1.24 ±0.17,1.16 ±0.13,1.14±0.11,1.23±0.10; left:1.17±0.21,1.25±0.15,1.18±0.08,1.17±0.16,1.25±0.11)compared with those in normal control group( t:2.1001 to 6.2789,all P <0.05).Rcl/cb ratios of parietal,temporal and frontal lobes in AD group showed no statistical difference compared with those in MCI group (t:0.1316 to 0.9806,all P > 0.05 ),while Rcl/cb ratios of basal ganglia and occipital lobes in AD group were increased compared with those in MCI group ( t:2.0850 to 3.6772,all P < 0.05 ).Conclusion 131 I-IMPY as a β- amyloid plaque probe for brain SPECT imaging may be potentially helpful for early diagnosis of AD.
7.Susceptibility gene of systemic lupus erythematosus in 16q12 in Chinese cohort.
Xue-bing FENG ; Nan SHEN ; Sun-le CHEN ; Jie QIAN ; Hui WU ; Chun-de BAO ; Yuan WANG
Chinese Journal of Medical Genetics 2003;20(1):27-30
OBJECTIVETo localize susceptibility loci in Chinese systemic lupus erythematosus (SLE) cohort by linkage disequilibrium mapping the genomic interval in human chromosome 16 so as to understand whether the pathogenesis of human SLE is related to chromosome 16.
METHODSFive microsatellite markers in chromosome 16 spanning from 57.79 cM to 65.1 cM were used for fluorescence based genotyping in 157 SLE families. Evidence for linkage disequilibrium was assessed using the extended transmission disequilibrium test (ETDT) program and Genehunter software. Susceptibility gene was searched in the positive locus, and real-time PCR method was used to detect gene expression.
RESULTSWith the ETDT, evidence for linkage disequilibrium of the marker D16S409 (P=0.0278) and D16S517 (P<0.0001) with SLE were found. It was observed that 271 bp allele of D16S517 was much in evidence for preferential transmission, while 277 bp allele was found to be transmitted less often than expected. Genehunter analysis is concordant with ETDT. By real-time PCR, OAZ(OLF1/ EBF-associated zinc finger protein) gene which is located in the positive locus showed higher expression in SLE patients than in normal controls.
CONCLUSIONResults reveal that 16q12 (58.46 cM) is associated with Chinese SLE. OAZ is a likely susceptibility gene in this locus for SLE.
Adolescent ; Adult ; Alleles ; China ; Chromosomes, Human, Pair 16 ; genetics ; Cohort Studies ; DNA ; genetics ; Female ; Gene Frequency ; Genetic Predisposition to Disease ; genetics ; Humans ; Linkage Disequilibrium ; Lupus Erythematosus, Systemic ; genetics ; Male ; Microsatellite Repeats ; Middle Aged
8.Management of sinonasal inverted papilloma: endoscopic excision vs traditional procedures.
Chun-Quan ZHENG ; Bao-Bin SUN ; Ying LIU ; De-Hui WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2005;40(4):283-286
OBJECTIVETo evaluate the effect of endoscopic resection and traditional procedure in the management of sinonasal inverted papilloma with a staging system based on endoscopic examination of the nasal cavity and computed tomography (CT) scan evaluation.
METHODSTwo hundred and twenty-two patients with sinonasal inverted papilloma treated surgically were retrospectively reviewed. There were 23 cases in stage I; 119 cases in stage II; 65 cases in stage III and 15 cases in stage IV. Among these patients, 122 cases were treated endoscopically; 100 cases were treated by traditional surgical techniques, including 56 cases with lateral rhinotomy; 27 cases with intranasal approach and 15 cases with Caldwell-Luc technique.
RESULTSThe inverted papilloma was removed completely and no serious complications were encountered by all four kinds of techniques used. With an average follow-up of 3. 8 years, the recurrence rate for endoscopic group was 14.8% (18/122, four patients were in group I; nine in group II; four in group III; and one patient in group IV. No recurrence was found in group III who underwent endoscopic excision combined with Caldwell-Luc procedure. The recurrence rate for lateral rhinotomy group was 33. 9% (19/56, one patients in group I; six in group II; nine in group III; three in group IV). The recurrence rate for intranasal approach group was 51.9% (14/27, two patients were in group I; ten in group II; and two in group III). The recurrence rate for Caldwell-Luc procedure group was 29.4% (5/17, all in group II and group III). Regardless of approaches, patients who had primary resection had a recurrence of 26. 8%, whereas those with secondary resection had a recurrence of 20. 9% (P = 0.39).
CONCLUSIONSThe endoscopic surgical technique was proved to be a better method for treating sinonasal inverted papilloma in stage I and stage II. Better results for patients in stage III would be achieved by combining endoscopic technique with Caldwell-Luc procedure. As to patients with stage IV, radical external approaches should be considered.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Endoscopy ; Female ; Humans ; Male ; Middle Aged ; Otorhinolaryngologic Surgical Procedures ; Papilloma, Inverted ; surgery ; Paranasal Sinus Neoplasms ; surgery ; Retrospective Studies ; Treatment Outcome ; Young Adult
9.Effect of RNAi on the expression of COX-2 in human rheumatoid arthritis synovial fibroblasts
Lin-Di JIANG ; Han-Zhou WANG ; Feng-Di ZHAO ; Ru-Yi XUE ; Jin-Sheng GUO ; Chun-De BAO ; Ji-Yao WANG ;
Chinese Journal of Rheumatology 2001;0(05):-
Objective To design,synthesize and screen high efficient small interfering RNA(siRNA) targeting to cyclooxygenase-2(COX-2)on rheumatoid arthritis synovial fibroblasts(RASF).To further study the effect of specific COX-2 siRNA interfering on mediators of inflammatory cytokines.Methods Four pairs of siRNA for human COX-2 mRNA were synthesized by utilizing RNA design software,while another random sequence was designed as control.They were divided into group A to H.Among them,group A was used as the negative control(CTL),and group B to F were transfected as random siRNA(NC),1#~4#siRNA in order. These siRNAs were transferred into RASF by LipofectAMINE2000 package and PMA(phorbol-12-myristate- 13-acetate)was added into each culture and with a final concentration of 100 nmol/l.RASF was collected 48 hours after transfection.The expression of hCOX-2 at mRNA level was determined by reverse transcription- polymerase chain reaction(RT-PCR)and hCOX-2 protein level by Western Blot.The supernatant levels of PGE_2,IL-1?,IL-6,TNF-?and vascular endothelial growth factor(VEGF)of the above groups were detected by ELISA.Results The levels of hCOX mRNA and protein in RASF treated with 4-#siRNA were significantly lower than those of the negative control and other groups.The level of PGE_2 and cytokines like IL-1?,IL-6, TNF-?and VEGF in the supernatant were lower in the 4#siRNA group than in other groups.Conclusion 4#siRNA can effectively inhibit the expression of COX-2 mRNA and the synthesis of the COX-2 protein in human synovial fibroblasts.The level of PGE_2,IL-1?,IL-6,TNF-?and VEGF is the lowest in the super- natant.Thus 4#siRNA has been confirmed to specifically block the COX-2 in human synovial fibroblasts.
10.Clinical characteristics of 115 Chinese patients with antiphospholipid syndrome and the analysis of different classification criteria
Jie QIAN ; Xiao-Xiang CHEN ; Shu-Jie LI ; Mei-Fang WU ; Ting ZENG ; Yu-Qiong ZOU ; Yue-Ying GU ; Yuan WANG ; Chun-De BAO ; Shunle CHEN ; Chengde YANG ;
Chinese Journal of Rheumatology 2000;0(06):-
Objective To analyze three different classification criteria, the clinical characteristics of antiphospholipid syndrome(APS)in a cohort of Chinese patients. Methods From January 1996 to October 2006, APS patients diagnosed with different classification criteria were retrospectively studied. Results There were totally 120 APS patients fulfilled at least one criterion, One hundred and one patients fulfilled the 1988 Asherson criteria, 96 patients fulfilled the 1999 Sapporo criteria, and 115 patients fulfilled the 2006 Sydney criteria. The ratio of male to female in a cohort of 115 definite APS patients was 1 to 10.5. The mean period of the disease until entry into the study was 82.6 months, the mean age at study entry was(41?12)years. Ninety patients had thrombosis episodes, among which the most common presenting manifestations were deep venous thrombosis, stroke and skin vasculitis. Forty-six of 92 married women in our cohort had fetal morbidity. Catas- trophic APS occurred in 7 patients. The presence of anticardiolipin antibodies(aCL)was detected in 86 pa- tients, anti-beta-2 glycoproteinⅠantibodies in 58 patients and lupus anticoagulant(LA)in 27 patients. Conclusion The most common presenting manifestations are deep venous thrombosis, stroke and cutaneous manifestations. The sensitivity of Sydney classification criteria is improved by adding anti-beta-2 glycopreteinⅠantibody as one of the laboratory criteria. However, primary APS patients who only presented with thrombo- cytupenia and positive laboratory tests could not satisfy this criterion. In addition, the significance of autoanti- bodies to some coagulant factors in APS needs further study.