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BACKGROUND@#The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients' adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula (, JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer.@*METHODS@#A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy.@*DISCUSSION@#This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518).
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Humans , Chemotherapy, Adjuvant , Colonic Neoplasms/drug therapy , Double-Blind Method , Multicenter Studies as Topic , Nausea , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome , VomitingABSTRACT
BACKGROUND@#Clinical observational studies revealed that 99Tc-methylene diphosphonate (99Tc-MDP) could reduce joint pain and swollenness in rheumatoid arthritis (RA) patients. This multicenter, randomized, double-blind, double-dummy study aimed to evaluate the effects of 99Tc-MDP plus methotrexate (MTX) vs. MTX alone or 99Tc-MDP alone on disease activity and structural damage in MTX-naïve Chinese patients with moderate to severe RA.@*METHODS@#Eligible patients with moderate to severely active RA were randomized to receive 99Tc-MDP plus MTX (n = 59) vs. MTX (n = 59) alone or 99Tc-MDP (n = 59) alone for 48 weeks from six study sites across four provinces in China. The primary outcomes were the American College of Rheumatology 20% improvement (ACR20) response rates at week 24 and changes in modified total Sharp score at week 48.@*RESULTS@#At week 24, the proportion of participants achieving ACR20 was significantly higher in the MTX + 99Tc-MDP combination group (69.5%) than that in the MTX group (50.8%) or 99Tc-MDP group (47.5%) (P = 0.03 for MTX + 99Tc-MDP vs. MTX, and MTX + 99Tc-MDP vs.99Tc-MDP, respectively). The participants in the MTX + 99Tc-MDP group and the 99Tc-MDP group had significantly less important radiographic progression than the participants in the MTX group over the 48 weeks (MTX + 99Tc-MDP vs. MTX: P = 0.03, 99Tc-MDP vs. MTX: P = 0.03, respectively). There was no significant difference in terms of adverse events (AEs) among the groups. No serious AEs were observed.@*CONCLUSIONS@#This study demonstrated that the combination of 99Tc-MDP with MTX inhibited structural damage and improved disease activity in RA patients compared with MTX and 99Tc-MDP monotherapies, without increasing the rate of AEs. Additional clinical studies of 99Tc-MDP therapy in patients with RA are warranted.@*TRIAL REGISTRATION@#Chictr.org, ChiCTR-IPR-14005684; http://www.chictr.org.cn/showproj.aspx?proj=10088.
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Humans , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , China , Diphosphonates , Double-Blind Method , Drug Therapy, Combination , Methotrexate/therapeutic use , Technetium/therapeutic use , Treatment OutcomeABSTRACT
Objectives Anticardiolipin antibody (aCL) is an important component of antiphospholipid antibody (aPL) and a marker antibody of antiphospholipid syndrome (aPS). APL is positive in 20% to 40% of patients with systemic lupus erythematosus(SLE). This article investigated the clinical features and prognosis of SLE patients with aCL. Methods From January 1999 to December 2009, 495 cases of SLE patients detected aCL who were hospitalized for the first time in 26 hospitals in Jiangsu Province including Nanjing Drum Tower Hospital were divided into aCL-positive group and aCL-negative group according to the test results. The patients were followed up in survival status, and the demographic characteristics, affected organs, laboratory tests, treatment drugs, and prognosis were compared between two groups. Results 146 of the SLE patients in this group were positive for aCL. The proportion of women in aCL- positive group (96.6%) was significantly higher than that in aCL-negative group (90.8%), and the difference was statistically significant (P<0.05). The proportion of anemia (74.7% vs 61.3%), decreased C3(81.5% vs 71.1%), positive antinuclear antibody(97.2% vs 92.4%), and positive anti-dsDNA antibody (61.9% vs 49.6%) in aCL-positive group were significantly higher than those of aCL-negative group, and the difference was statistically significant (P<0.05). The aCL-positive group received a higher proportion of cyclophosphamide immunosuppressive therapy (39.5% vs 50.7%, P<0.05). At the end of follow-up, the mortality rate of aCL-positive group was 13.7%, and the mortality rate of aCL-negative group was 14.9% and there was no significant difference in mortality (P>0.05). Kaplan-Meier survival analysis showed that the 1-year, 5-year, and 10-year survival rates of aCL-positive group were 94.5%, 89.0%, and 82.9%, respectively, and there was no significant difference compared with aCL-negative group(P=0.776). The main causes of death in aCL-positive group were lupus encephalopathy (6 cases, 30.0%), renal failure (5 cases, 25.0%), heart failure (4 cases, 20.0%) and infection (3 cases, 15%). The main causes of death in aCL-negative group were infection (21 cases, 40.4%), lupus encephalopathy (11 cases, 21.2%) and heart failure (5 cases, 9.6%) and renal failure (4 cases, 7.7%). Conclusion SLE patients with aCL represent a high propotion in anemia, decreased C3, positive antinuclear antibody, positive anti-dsDNA antibody. There was no significant difference in disease activity and significant organ involvement between two groups. More SLE patients with aCL were treated with cyclophosphamide, and there was no significant difference in survival status between SLE patients with and without aCL during long-term follow-up.
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Objective:Our previous study demonstrated serum leptin in patients with systemic lupus erythematosus(SLE) ac-celerated the senescence of mesenchymal stem cells (MSC),the aim of this study is to observe the effects of leptin-treated MSC on immune cells.Methods:Umbilical cord derived MSCs were isolated,and peripheral blood mononuclear cells (PBMC) in SLE patients were obtained by density gradient centrifugation with Ficoll.Three groups were divided,PBMC only,the co-culture of PBMC and MSC treated with or without leptin (100 ng/ml).The frequencies of immune cells were detected by flow cytometry,including CD4+CD25+Foxp3+regulatory T (Treg) cells,CD4+IL-17+Th17 cells,CD4+CXCR5+PD-1+T follicular helper (Tfh) cells,and CD19+B cells.Results:The frequency of regulatory T cells was lower in leptin-treated MSC group,compared with MSC group.The frequency of Th17 cells was increased by MSC pretreated with leptin.The frequency of Tfh cells was elevated by leptin-treated MSC compared with MSC control,but there was no statistical significance.MSC pretreated with leptin also restored the activation of T cells evaluated by CD25 and CD69,compared with untreated MSC.In addition,leptin-treated MSC increased the median fluorescence intensity of CD25, but not CD69 on B cells.Conclusion:Leptin not only accelerated cell senescence of MSC in vitro,but also impaired the capacity of MSC modulating the immune cells.
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<p><b>OBJECTIVE</b>To study the effects of Zhengqing Fengtongning Tablet (ZFT) and methotrexate (MTX) on the expression of osteoprotegerin (OPG), receptor activator of nuclear factor-kappaB ligand (RANKL), and interleukin 17 (IL-17) in collagen-induced arthritis (CIA) rats, thus addressing their bone protection.</p><p><b>METHODS</b>The CIA rat model was established by intradermally injecting type II collagen emulsion from the rats' back and tail. Totally 28 successfully modeled rats [with the arthritis index (AI) more than 2] were randomly divided into the model group, the Chinese medicine (CM) treatment group, the MTX group, and the ZFT + MTX treatment group, 7 rats in each group. Another 7 rats were recruited as the normal control group. Rats were administered from the 7th day of modeling. Rats in the MTX group were treated with MTX at 3.8 mg/kg once a week. Those in the CM group were treated with ZFT at the daily dose of 130 mg/kg, once a day. Those in the ZFT + MTX treatment group were treated with both MTX (at 3.8 mg/kg once a week) and ZFT (at the daily dose of 130 mg/kg, once a day). Those in the model group and the normal control group were administered with normal saline of the equal volume by gastrogavage. All the intervention lasted for 26 days. The destruction of joints in the four limbs were observed using X-ray. The AI was recorded. The expression levels of serum OPG, RANKL, and IL-17 were detected at the end of the experiment.</p><p><b>RESULTS</b>During the whole process, all rats except those in the model group were in a good condition. On the 21st day of modeling the AI of all rats reached the peak, but it decreased after treatment. Compared with the model group, the AI decreased in the CM treatment group, the MTX group, and the ZFT + MTX treatment group with statistical difference (P < 0.05). Compared with the model group, the OPG increased and RANKL decreased in the MTX group; the OPG and OPG/RANKL increased in the CM treatment group; the OPG, RANKL, and OPG/RANKL increased, and IL-17 decreased in the ZFT + MTX treatment group, all showing statistical difference (P < 0.05). Compared with the MTX and the ZFT + MTX treatment group, OPG/RANKL increased and IL-17 decreased in the ZFT + MTX treatment group (both P < 0.05).</p><p><b>CONCLUSION</b>ZFT + MTX could synergistically elevate peripheral OPG/RANKL and down-regulate IL-17 in CIA model rats.</p>
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Animals , Female , Rats , Arthritis, Experimental , Blood , Drug Therapy , Drugs, Chinese Herbal , Pharmacology , Therapeutic Uses , Interleukin-17 , Blood , Methotrexate , Pharmacology , Therapeutic Uses , Osteoprotegerin , Blood , RANK Ligand , BloodABSTRACT
<p><b>BACKGROUND</b>Acute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.</p><p><b>METHODS</b>A randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n = 178; ≥ 18 years of age) with acute gouty attack (< 48 hours) were treated for 5 days with etoricoxib (120 mg/d; n = 89) or indometacin (75 mg twice daily; n = 89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2 - 5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).</p><p><b>RESULTS</b>Etoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2 - 5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P = 0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n = 31) was less than the indometacin group (n = 34).</p><p><b>CONCLUSIONS</b>Etoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).</p>
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Adult , Aged , Female , Humans , Male , Middle Aged , Arthritis, Gouty , Drug Therapy , Cyclooxygenase Inhibitors , Therapeutic Uses , Double-Blind Method , Indomethacin , Therapeutic Uses , Pyridines , Therapeutic Uses , Sulfones , Therapeutic UsesABSTRACT
ObjectiveTo investigate the clinical features of systemic lupus erythematosus (SLE) patients with fever and find out the related factors.MethodsData was collected by the same methods in the past ten years in fifteen hospitals in Jiangsu province and then the data wereretrospectively analyzed.The potentially possible risk factors of fever in SLE were selected and then analyzed by chi-square test,Wilcoxon rank sum test and Logistic regression analysis.ResultsAll 1762 patients were investigated.Seven hundred and twenty-nine had active fever.Age at hospitalization,initially treated patients,photosensitivity,serositis,nervous system involvement,generalized lymphadenopathy/hepatosplenomegaly,white blood cell count (WBC),haemoglobin (HB),erythrocyte sedimentation rate (ESR),C-reaction protein (CRP),alanine aminotransferase(ALT),albumin(ALB),serum creatinine (Scr),complement C3,anti-dsDNA antibodies positive rate,anti-Sm antibodies positive rate,SLEDAI score and past therapies were factors associatedwith SLE fever.Logistic regression analysis showed that abnormal WBC count (OR=1.396,95%CI 1.114-1.711,P=0.004),CRP(OR=1.005,95%CI 1.002-1.009,P=0.002),ALT(OR=1.003,95%CI 1.001-1.005,P=0.005),Scr (OR=0.997,95%CI0.995-0.999,P=0.007),HB (OR=0.986,95%CI 0.981-0.992,P=0.000),age (OR =0.984,95% CI 0.974-0.993,P=0.001 ) and past usage of cyclophosphamide (CTX) (OR =0.557,95%CI 0.382-0.813,P=0.002) were correlated with SLE fever.ConclusionFever is one of the most common clinical manifestations of SLE patients.Leucopenia,elevated CRP levels,liver function abnormalities,anemia,younger age are risk factors for SLE fever,while renal impairment and past usage of CTX are protective factors.
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<p><b>BACKGROUND</b>A previous study has shown that rs548234 polymorphism at PRDM1-ATG5 region is associated with rheumatoid arthritis (RA) in Caucasian populations. The aim of this study was to investigate the effect of rs548234 polymorphism at PRDM1-ATG5 region on susceptibility to RA in Chinese Han population.</p><p><b>METHODS</b>We genotyped 848 RA patients and 1431 matched healthy controls for rs548234 single-nucleotide polymorphism (SNP) with a predesigned TaqMan SNP genotyping assay. Association analyses were performed on the whole data set and on rheumatoid factors (RF) and anti-cyclic citrullinated peptides (anti-CCP) antibody. Finally, we carried out combined analysis of rs548234 association with RA based on the published data.</p><p><b>RESULTS</b>No significant difference in the genotype distribution between RA patients and healthy controls for rs548234 (C/T) polymorphism was found in Chinese Han population, neither in whole data set nor in stratified subsets, e.g. RF and anti-CCP status. Association analysis in different ethnic groups showed that rs548234 at PRDM1-ATG5 region was associated with RA in Caucasian ancestry but not in East Asian population.</p><p><b>CONCLUSIONS</b>Our results showed no involvement of rs548234 at PRDM1-ATG5 region in the susceptibility or clinical relevance of RA in Chinese Han population.</p>
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Adult , Aged , Female , Humans , Male , Middle Aged , Arthritis, Rheumatoid , Epidemiology , Genetics , Asian People , Autophagy-Related Protein 5 , Genetic Predisposition to Disease , Genetics , Genotype , Microtubule-Associated Proteins , Genetics , Polymorphism, Single Nucleotide , Genetics , Positive Regulatory Domain I-Binding Factor 1 , Repressor Proteins , GeneticsABSTRACT
ObjectiveTo investigate the clinical features of patients with primary biliary cirrhosis (PBC) in China. MethodsThe reported articles about clinical analysis of patients with PBC in China were searched. The quality of included studies was critically evaluated. Meta-analysis was performed using RevMan 4.2 software about controlled trials. Results① Ninety-one literatures including 2315 patients wuth PBC were included. ②The common symptoms in PBC were fatigue (54.54%). AMA was found in 74.1%~100% of patients with PBC, as well as the prevalence rate of anti-M2 range from 45% to 83%. ANA antibodies present in 20%~83.78% of patients, the most common antinuclear patterns were nuclear-envelope(38.65%).Increased levels of IgM [(2.8±0.7)~(7.3±5.1) g/L], IgG [(16.5±4.9)~(20.5±5.9) g/L] were found in these patients, and the most common liver histologic classification was type Ⅱ (36.6%). Sjogren's syndrome occured significantly more frequently in PBC (1.96%~34.61%). To the end of follow-up period (five months to nintysix months ), 3.80% of patients were dead. ③ Meta-analysis performed in several case control studies, showed no significant differences was found in liver tests including of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotrans ferase (AST), total bilirubin (TBil), or gamma-glutamyltransferase (GGT), IgG levels between AMA positive groups and AMA negative groups. However, lower levels of IgM presented in the latter. While it also showed that levels of ALP decreased after ursodeoxycholic acid (UDCA)therapy. The levels of TBil were lower in the elderly than in younger group, but the mortality ratio for liver diseases was higher in the former. ConclusionThe clinical characteristics of the present series in China are mostly similar to those reported in other countries. Because of the low quality and the small number of included studies, larger sample-size, randomized, double-blinded controlled trials are needed.
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<p><b>BACKGROUND</b>A novel anti-rheumatic drug, T-614, has been shown to have an anti-inflammatory effect and to improve abnormal immunological findings in rheumatoid arthritis (RA). To assess the safety and efficacy of T-614 versus placebo in patients with active RA we conducted a 24-week clinical study in 280 Chinese patients.</p><p><b>METHODS</b>In a multicenter, randomized, double blind, placebo controlled study, 280 patients were randomly assigned to receive placebo (n = 95) or T-614 at 50 mg (n = 93) or 25 mg (n = 92) daily. Active disease was defined by 4 of the following 5 criteria: >or= 5 tender joints, >or= 3 swollen joints, morning stiffness lasting for >or= 60 minutes, and Westergren erythrocyte sedimentation rate (ESR) >or= 28 mm/h, the assessment of pain at the rest by patient as moderate or severe. Clinical and laboratory parameters were analyzed at baseline, 2, 4, 6, 12, 18 and 24 weeks. The primary efficacy variable at week 24 was the American College of Rheumatology (ACR) response rate using the intent-to-treat population.</p><p><b>RESULTS</b>The ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group within 8 weeks after the initiation of treatment. After 24 weeks, the 25 mg/d and 50 mg/d dosage groups and the placebo group showed 39.13%, 61.29% and 24.21% in ACR20 and 23.91%, 31.18% and 7.37% in ACR50, respectively. A time-response in ACR response was observed, with clear superiority for the 25 mg/d and 50 mg/d dosage groups compared to placebo (P < 0.0001), and the 50 mg/d dose compared to the 25 mg/d dose (P < 0.05) when using the ACR response analyses after 24 weeks. ESR and c-reactive protein (CRP) were significantly different in the treatment groups after 24 weeks. The incidence of adverse events (AEs) was not significantly higher with T-614 than with placebo, but upper abdominal discomfort, leucopenia, elevated serum alanine aminotransferase (sALT), skin rash and/or pruritus were more common in the 50 mg and 25 mg dosage groups.</p><p><b>CONCLUSION</b>T-614, a new slow-acting drug, is effective in treatment of rheumatoid arthritis and is well tolerated.</p>
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Adult , Aged , Female , Humans , Male , Middle Aged , Antirheumatic Agents , Therapeutic Uses , Arthritis, Rheumatoid , Drug Therapy , Benzopyrans , Therapeutic Uses , Double-Blind Method , Sulfonamides , Therapeutic UsesABSTRACT
Objective To investigate the immunoregulatory effect and compare the different regula- tions of bone marrow mescnchymal stem cells(MSCs)derived from both lupus(NZBWF1/J)and normal(BALB/ c)mice on T lymphocytes in vitro.Methods MSCs from NZBWF1/J and BALB/c mice bone marrow were iso- lated and expanded,and identified by the surface phenotypes.CD3~+ T lymphocytes isolated by nylon wool columns were stimulated by phorbol myristate acetate(PMA)and co-cultured with or without the two strains of MSCs for 24 h.Intracellular eytokines of T cell,such as interferon(IFN)-?,interleukin(IL)-4,IL-12,IL-6, were analyzed by flow cytometry and quantification of transcription factors T-box expressed in T cells(T-bet) and GATA-binding protein 3(GATA-3)were detected by reverse transcriptase PCR(RT-PCR).T cell apop- tosis was assessed by flow cytometry using rhodamine123.Results The results showed that a decrease of CD3~+ T cell apoptosis was seen when NZBWF1/J MSCs or BALB/c MSCs were added to T cells stimulated by PMA(P<0.05),and an increase of TH2 cytokines by NZBWF1/J MSCs and TH1 eytokines by BALB/c MSCs were observed in the CD3~+ T cells eo-cuhured with MSCs(P<0.05).Conclusion It is suggested that the al- teration of T subsets caused by MSCs may interfere with the systemic lupus erythematosus(SLE)development and normal MSCs may be effective in the improvement of SLE.NZBWF1/J MSCs have defective immunoregula- tory function when compared with MSCs from healthy mouse strains.
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Objective To study the efficacy and safety of T-614 in treating rheumatoid arthritis(RA). Methods Two hundred and eighty patients with active RA were randomly allocated to 3 groups:T-614 50 mg each day,25 mg each day or placebo.Clinical and laboratory parameters were analyzed at baseline,2,4,6,12, 18 and 24 weeks.Results The ACR response rate was significantly higher in the T-614 treatment group com- pared with the placebo group during the first 6 weeks.After 24 weeks,25 mg/d,50 mg/d dosage group and the placebo group showed 39.1%,61.3% and 24.2% in ACR20,23.9%,31.2% and 7.4% in ACR50 respectively.A time-response in ACR response after 24 weeks was observed,with clear superiority of the 25 mg/d and 50 mg/d dosage groups compared to the placebo,and 50 mg/d dosage group compared to 25 mg/d dosage group(P
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Objective To explore the biological characteristics and karyotype of bone marrow-derived mesenchymal stem cells(MSCs)in patients with systemic lupus erythematosus(SLE)and hematopoietic sup- port of MSCs.Methods MSCs were isolated from bone marrow of 11 SLE patients and 6 healthy controls by density centrifugation and adhesive culture in vitro.The surface markers were detected by flow cytometry (FCM).The morphological changes of MSCs were observed in primary and passage cultures.The growth curves were assayed.The karyotype of MSCs was detected by blocking cellular mitosis with colchicines.The MSCs from SLE patients and healthy controls were infused to ICR mice after high-dose chemotherapy.The changes of peripheral blood counts of the mice were recorded.Results Approximately(6~9)?10~9 MSCs from SLE were obtained after 5 passages and their growth was slower than normal controls(P<0.01).Both groups were positive for CD29,CD44 and CD105,and negative for CD14,CD34,CD45 and HLA-DR.MSCs from SLE had a normal karyotype.MSCs infusions of the two groups were accompanied by no adverse event and the recovery of white blood cell,hemoglobin and platelet count was quicker when compared with the controls(P<0.05).Conclusion MSCs from SLE have demonstrated abnormalities in expansion in vitro.MSCs from SLE have a normal karyotype.Ex vivo MSCs infusion from SLE patients can support hematopoiesis as normal MSCs.
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0.05). In active SLE, the CD3~+HLA-DR~+, CD4~+HLA-DR~+ and CD8~+ HLA-DR~+ cells of BM were all higher than those of peripheral blood in the control group(P
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Objective To explore the biological characteristics and to compare the different regulation mechanisms of bone marrow mesenchymal stem cells(MSCs)derived from both lupus(MRL/Ipr)and normal (C57BL/6)mice on T iymphoeytes in vitro. Methods MSCs from MRL/lpr and C57BL/6 mice bone marrow were isolated and cultured. The surface phenotypes were detected by flow cytometry(FCM). The morphologi- cal changes of MSCs were evaluated in primary and passage cultures. The growth curves were assayed. CD3~+T lymphocytes from spleen of C57BL/6 mice were isolated by nylon wool columns and stimulated by ConA and co-cultured with or without the two strains of MSCs or supernatant for 72 h. The proliferation of T cells stained by CFSE and activation of T cells were detected. The apoptosis was assessed by now cytometry using Annexin V/PI. Results The growth of lupus MSCs was faster than normal controls(P