Efficacy And Safety Of⁹⁹Tc–MDP Treatment In Patients With Active Rheumatoid Arthritis

Objective: To evaluate the efficacy and safety of combination therapy with⁹⁹Tc-MDP+MTX+LEF compared to combination therapy of MTX and LEF in patientswith active RA, we collected information and analyzed the data from the Rheumatologyand Immunology department of First Affiliated of Dalian Medical University.Methods: A retrospective analysis of case reports of73patients admitted fromApril2009to March2012in our hospital were reviewed, and was categorized into2groups according to the treatment protocol used: the MDP group （combination MDPgiven11mg/day through intravenous infusion for10days every month-a total courseof3months therapy+MTX10mg qw po+LEF20mg daily po） and the control group（combination MTX10mg qw po+LEF20mg daily po） respectively. Baselineparameters such as clinical symptoms of tenderness joint count, swollen joint count,duration of morning stiffness as well as serological tests, including CRP, ESR, RF andthe CCP were assessed before and after treatment in both the MDP and placebo group.The clinical and serological parameters used to assess efficacy of trial treatmentregimens were repeatedly analyzed after12weeks of therapy. Further assessments, forinstance complete physical and laboratory tests were performed to observe any adversereactions in liver and kidney functions, so as to ensure safety profile of the medications.With the aid of SPSS Statistics11.5software for statistical analysis, Chi-square （χ²ï¼‰ testwas used to compare group result differences, T-test （t） or Wilcoxon rank test was usedto compare the parameters before and after treatment. P <0.05was consideredstatistically significant.Results:1) The MDP group comprised of42patients,11were males and31were females,with median age61years （age range38-85years）. In the control group, out of31patients, there were10males and21females, with a median age58years （age range 19-82years）. The baseline parameters （both clinical and serological） were similar in the2groups, i.e., there was no statistical difference （p>0.05） before the initiation of anytherapy.2)Evaluation of therapeutic response was performed after12weeks, whichindicated that there was significant improvement from baseline parameters in the MDPgroup compared to control group. Overall, in the MDP group, positive result wasobserved in92.9%（39/42） cases. MDP therapy was found to be substantially effectivein16.7%cases （7/42）. Moderate improvement in baseline parameters from MDPtherapy was reported in23.8%（10/42） patients;52.4%（22/42） had mild improvementwhile no improvement was noted in7.1%（3/42） cases. Outcomes in the control groupwere: total positive result71%（22/31）; significant improvement in12.9%（4/31）;moderate improvement in22.6%（7/31）; mild improvement in35.5%（11/31） and noimprovement in29%（9/31）. Comparative analysis in treatment efficacy between theMDP and control groups （p=0.013vs. χ²=6.22respectively） showed statisticallysignificant difference between the2treatment sets3)Safety evaluation: During the treatment period in the MDP group,2cases ofmild transaminase elevation;3cases of gastrointestinal reactions;3cases of patientswith phlebitis were recorded; adverse reaction rate was19%（8/42）. In the control group,1patient had mild transaminase elevation. After three weeks therapy in the controlgroup, we reported2cases of leukopenia,2cases of gastrointestinal reactions,2patientswith oral ulcers; the incidence of adverse reactions was22.4%（7/31）. No patientsdiscontinued treatment due to adverse events. There was not statistically significantdifference in the incidence of adverse events （χ2=0.136, P=0.712） between the twogroups.Conclusions:1) Efficacy of⁹⁹Tc-MDP combined with MTX and LEF in the treatment of RAwassignificantly higher when compared with combined therapy of MTX and LEF andthe clinical parameters improved significantly in the MDP group than in the controltreatment group.2) Both combination treatment groups had comparable minimal adverse events,whichwas not significantly different, hence both treatment sets had good safety profile.Therefore, from this study, we can conclude that use of combined MDP, MTX and LEFin active RA for3months can be considered as an important choice of combinationdrug therapy due to its increased efficacy, tolerability and good safety profile，and may have a synergistic effect in MTX and LEF.