Clinical And Experimental Study Of Vincristine And Cyclophosphamide In Patients With Systemic Lupus Erythematosus

BackgroundsSystemic lupus erythematosus (SLE) is a kind of severity autoimmune disease.Pressent, there was no effect therapeutic tool. So, it's important to find effectivecombination therapy. For reference successfully combination therapy in leucemia, wefirst based on theory cell proliferation, sequential combined vincristine (VCR) with lowdosage CTX intermittently to treat SLE. CTX is a cell cycle nonspecial stage agent,while VCR as a cell cycle special stage agent. During the last decade, the newcombination therapy has effective and safetive through we carried on clinicl practice.Otherwise, by animal studies, there was no increase of adverse effect in combinationtherapy of VCR and CTX.There is functional disorder in immunoloregulation of SLE. Recently, researchersthink highly of Th17 cell and regulatory T cells.To evaluate the combination therapy's efficacy and safety, to approach the changeof Th17 cell and regulatory T cells, we carry out this study.Objectives1. To evaluate the efficacy of VCR and CTX combination therapy.2. To evaluate the safety of VCR and CTX combination therapy.3. To approach the change of Th17 cell and regulatory T cells.Methods1. To carry out a random contrastive single study about 24 weeks.2. Part of clinical: after 38 actively patients with SLE was chose successfully, theywere randomly divided into CTX pause group and VCR+CTX combination group. Tostudy the change of ESR, SLEDAI and PGA. There are 24 weeks from set up to finish.3. Part of experiment: after 20 actively patients with SLE was chose successfully,they were randomly divided into CTX pause group and VCR+CTX combination group.Meanwhile, choose 10 normal people. To detect the change of Th17 cell and regulatoryT cells. There are 24 weeks from set up to finish. ResultResults1. Evaluation of efficacy: the combination of VCR and CTX could significantlydecrease the numerical value of SLEDAI (P＜0.05).2. Evaluation of safety: there is no difference of adverse effect between VCR+CTXcombination group and CTX pause group (P＜0.05).3. The change of Th17 cell and regulatory T cells: compare to normal people, thereis effective increase in Th17 cell and effective decrease in regulatory T cells (P＜0.05).In 24 weeks, there is effective decrease in Th17 cell and effective increase in regulatoryT cells (P＜0.05). Importantly, VCR+CTX combination group surpass CTX pausegroup in decreasing Th17 cell (P＜0.05).Conclusions1. The combination of VCR and CTX could markedly improve SLE patient'scondition.2. The adverse effect of VCR+CTX combination group was similar to CTX pausegroup.3. The combination of VCR and CTX could effectively decrease the amount ofTh17 cell and increase the amount of regulatory T cells.