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Original Article Thalidomide Plus Leflunomide for Rheumatoid Arthritis and Its Impacts on D-Dimer Expression

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Original Article Thalidomide Plus Leflunomide for Rheumatoid Arthritis and Its Impacts on D-Dimer Expression Int J Clin Exp Med 2018;11(9):9835-9842 www.ijcem.com /ISSN:1940-5901/IJCEM0077261 Original Article Thalidomide plus leflunomide for rheumatoid arthritis and its impacts on D-dimer expression Jinmei Zhao, Yuling Zhang, Bin Zhang, Yuhua Yan, Jingjing Ma, Yun Zhu, Ming Li Department of Rheumatism and Immunity, Weifang People’s Hospital, Weifang City, Shandong Province, P.R. China Received April 3, 2018; Accepted May 2, 2018; Epub September 15, 2018; Published September 30, 2018 Abstract: Objective: To elucidate the clinical efficacy of thalidomide plus leflunomide in the management of rheu- matoid arthritis (RA) and its impacts on D-dimer expression. Methods: One hundred and fifty RA patients admitted to Weifang People’s Hospital were randomly subdivided into the observation group (n=75) and the control group (n=75). The patients in the control group were treated with thalidomide, and those in the observation group received additional leflunomide based on the regimen of the control group. The clinical response of the two groups was compared, and D-dimer expression in each group was examined. Results: The total response rate was 90.67% in the observation group and 78.67% in the control group. The clinical response to treatment was worse in the control group than that in the observation group (P<0.05). Twelve weeks after treatment, the score for disease activity in 28 joints (DAS28), erythrocyte sedimentation rates (ESR), C-reactive protein (CRP), joint function scores, the number of swollen joints, the number of tender joints, and the duration of morning stiffness of patients were improved in both groups compared to those before treatment, with greater improvements in the observation group (all P<0.05). However, no difference was seen in the total incidence of adverse events (P>0.05). Detection of D-dimer expression indicated the D-dimer expression in the observation group was considerably decreased when compared with the control group (P<0.05). Conclusion: Thalidomide-leflunomide medication contributes to improvements in disease, joint functions, and the microcirculation, and a decrease in D-dimer expression in RA patients. Keywords: Thalidomide, leflunomide, rheumatoid arthritis, D-dimer, clinical response Introduction acts as an anti-inflammation and anti-angio- genesis agent by inhibiting secretion of inflam- Rheumatoid arthritis (RA) is common in both matory cytokines (such as IL-6, vascular endo- the young and middle-aged populations, and is thelial growth factor (VEGF), and TNF-α) [6]. Le- more prevalent in females than in males. It is flunomide is an isoxazole derivative that exerts an autoimmune disease present with joint sy- an anti-inflammatory effect by inhibiting expres- novial inflammation and extra-articular lesions sion of cytokines (nuclear factor-κB) and adhe- [1]. RA is an important factor leading to the sion molecules, and suppressing the prolifera- loss of labor force or even disability of young tion of lymphocytes and B-cells [7]. Both tha- and middle-aged patients. It severely affects lidomide and leflunomide are used for the treat- the lives of patients and imposes huge eco- ment of RA, but few studies involve in the com- nomic pressure on both families and the soci- bination of the two agents [8, 9]. Efficacy and ety. It is one of the dominant disability-induc- safety of thalidomide-leflunomide medication ed diseases in humans, hence effective treat- in treating RA warrant further validation. In re- ment regimens are urgent [2-4]. Therefore, de- cent decades, some studies have reported the veloping better treatment protocols to reduce hypercoagulable state is present in RA patients, the incidence of RA is a major issue faced by clinicians. and that the concentration of D-dimer is close- ly related to the disease activity of RA patients Currently, RA is primarily treated by glucocor- [10]. However, few studies are involved in ex- ticoids, non-steroidal anti-inflammatory drugs, ploring the impacts of thalidomide and lefluno- and anti-rheumatic drugs [5]. Thalidomide is mide on the D-dimer expression in the treat- a newly-developed glutamate derivative that ment of RA. Thalidomide plus leflunomide for rheumatoid arthritis and D-dimer expression Therefore, this study aimed to investigate the Outcome measures efficacy and safety of the combination of tha- lidomide with leflunomide in treatment of RA, After completion of treatment, the efficacy (cov- and the impact of the combined regimen on ering the score for disease activity in 28 jo- D-dimer expression, in hope of providing refer- ints (DAS28), erythrocyte sedimentation rates ence for clinical treatment of RA. (ESR), C-reactive protein (CRP)), joint functions (including joint function score, the number of Materials and methods swollen joints, the number of tender joints, the duration of morning stiffness, D-dimer levels Study participants and the incidence of adverse events were ob- served among patients in the two groups. Joint From January 2013 to January 2016, 150 RA function scores were evaluated in reference patients were randomly arranged to receive th- to the revised criteria for the classification of alidomide (control group, n=75) or the combina- global functional status in rheumatoid arthritis tion of leflunomide and thalidomide (observa- released by the American College of Rheuma- tion group, n=75). There were 58 male patients tology in 1991 [12]. ESR was detected by Wei’s and 92 female patients, with a mean age of method, and the levels of D-dimer and CRP 42.7±6.4 years (range, 18-70 years). Patients were examined by enzyme-linked immunosor- were eligible for enrolment if they had confirm- bent assay (ELISA). The ELISA kits were bought ed symptoms of RA meeting the diagnostic cri- from Shanghai Jingkang Biological Engineering, teria for RA which were specified in the 1987 China. revised criteria of the American Rheumatism Association. This included affected knees that Clinical response evaluation had not been treated with thalidomide and le- flunomide within the previous three months or The clinical response to medication was evalu- they had voluntarily participated in the experi- ated by the following three diagnostic criteria: ment in the study [11]. Patients were excluded good response, moderate response, and non- if they had other systemic inflammatory res- response [13]. ponse syndrome (SIRS); if they were pregnant; it they had cardiovascular or hepatorenal disor- The patient was classified as a good responder der, a history of mental and neurological ill- if a difference in the DAS28 was less than 1.2 ness, or a chronic pain syndrome. If they were than that of a non-responder or the DAS28 was difficult to communicate with verbally and did less than 3.2, the ESR was less than or equal not comply with the treatment, if they were to 15 mm/h in male, less than or equal to 20 allergic to thalidomide and leflunomide, if they mm/h in female, or the CRP was less than or had joint bone tumors, had bone metastases equal to 8 mg/L. from various cancers or if they had recent acu- te stroke were further exclusion criteria. This The patient was classified as a moderate res- study was approved from the Medical Ethics ponder if improvement in DAS28 was between Committee of Weifang People’s Hospital and 0.6 and 1.2 than before treatment, or the patients or their families submitted written in- DAS28 was greater than or equal to 3.2 but formed consent. less than 5.1. Treatment protocols The patient was classified as a non-responder if improvement in DAS28 was less than 0.6 The patients in the control group were adminis- than before treatment or the DAS28 was great- tered with thalidomide alone at a dose of 50 er than or equal to 5.1. mg per day for 12 weeks. Thalidomide (Nation- al drug code No., H20103705) was purchased Statistical analysis from Shanghai Guang Rui Biological Techno- logy, China. In contrast, those in the observa- Statistical analyses were done using SPSS soft- tion group were treated with thalidomide plus ware, version 22.0 (Asia Analytics Formerly, leflunomide 20 mg twice daily for 12 weeks. SPSS, China). Count data were presented as Teflunomide (National drug code No., H2000- percentages (n, %) and processed by the Chi- 0550) was purchased from Shanghai Shifeng square tests. Measurement data are described Biotechnology, China. as mean ± sd; data without normal distribution 9836 Int J Clin Exp Med 2018;11(9):9835-9842 Thalidomide plus leflunomide for rheumatoid arthritis and D-dimer expression Table 1. Baseline patient data inter-group comparisons at Control group Observation P the same time point was Statistics (n=75) group (n=75) value conducted by the indepen- Sex (n, %) 0.167 0.867 dent samples t-tests wh- ereas intra-group compari- Male 30 (40.00) 29 (38.67) sons before and after tr- Female 45 (60.00) 46 (61.33) eatment were performed Mean age (year) 42.5±6.1 42.9±6.7 0.382 0.703 with the paired t-tests. Sig- Course of disease (year) 6.77±3.59 7.12±3.48 0.606 0.545 nificance was set at P val- RA affected site (n, %) 0.091 0.955 ues <0.05. Upper extremity 35 (46.67) 34 (45.33) Lower extremity 34 (45.33) 34 (45.33) Results Other 6 (8) 7 (9.34) Baseline data Smoking (n, %) 0.568 0.570 Yes 55 (78.57) 58 (77.33) A total of 150 RA patients No 20 (21.43) 17 (22.67) were enrolled in this stu- Anti-CCP antibody (n, %) 0.272 0.786 dy, with an average age Negative 68 (90.67) 67 (89.33) of 42.7±6.4 years. Of th- Positive 7 (9.33) 8 (10.67) em, 75 were assigned to Rheumatoid factor (U/mL) 217.36±18.44 222.88±17.28 1.892 0.060 the control group, includ- ing 30 male patients and 45 female patients, with Table 2.
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