| Objective: The first aim of this study is to perform a meta-analysis of randomized controlled trials(RCTs) in multiple sclerosis(MS) patients to evaluate the efficacy and safety of vitamin D as add-on therapy.The second aim of this study is to perform a meta-analysis of randomized controlled trials(RCTs) in multiple sclerosis(MS) patients to evaluate the efficacy and safety of alemtuzumab.Methods: Study I. We searched Pub Med, EMbase, the Cochrane Library, CNKI, VIP Database CBM and so on up to January 2016 using the keywords: ‘multiple sclerosis’ or‘disseminated sclerosis’ or ‘MS’ and the drug names: ‘vitamin D’ or ‘Cholecalciferol’ or‘calcitriol’ or ‘1, 25-dehdroxyvitamin D3’ or ‘Dekristol’. According to the inclusion criteria, two authors independently selected the articles and extracted the data. We performed meta-analysis using Review Manager(Rev Man) version 5.3 software.Study II. We searched Pub Med, EMBASE, the Cochrane Library and so on up to February2015 using the keywords: ‘multiple sclerosis’ or ‘MS’ and the drug names: alemtuzumab. Two authors independently selected the articles and extracted the data. We performed meta-analysis using Review Manager(Rev Man) version 5.3 software.Results: Study I. Four RCTs with a total of 247 patients were selected.(1)efficacy evaluation: Compared to the placebo, the annual relapse rate(MD=-0.08, 95% CI =[-0.37,0.21], P=0.60), the EDSS score(MD=-0.33, 95% Confidence interval(CI)=[-0.68, 0.01], P=0.05) and the number of gadolinium-enhancing lesions(MD=-0.16, 95%CI=[-0.57,0.25], P=0.45) showed no significant difference at 12 months, meanwhile the EDSS score(MD=-0.48,95%CI=[-0.87,-0.09], P=0.02) and the annual relapse rate(MD=-0.27, 95%CI=[-0.52,-0.02],P=0.03) were significantly less in the vitamin D group at 24 months,(2)safety evaluation:There was no hypercalcaemia in vitamin D treated patients in each studies, main adverseevents reported were diarrhoea, fever, constipation, dyspepsia, headache and so on. Thesesymptoms are mild, after stopping drug can relieve the general.Study II. Three RCTs with a total of 1695 patients were selected. Compared to the interferon beta, the number of gadolinium-enhancing lesions(odds ratio(OR)=0.33, 95% Confidenceinterval(CI)=[0.23, 0.48], P < 0.00001), the cumulative probability of sustained disability(OR=0.51, 95% CI =[0.38, 0.69], P<0.0001) and the proportion of patients who had at least one relapse of MS(OR=0.42, 95% CI =[0.34, 0.52], P < 0.0001) were significantly less in the alemtuzumab group, meanwhile the number of new T2-hyperintense lesions(OR=0.10,95%CI=[0.01, 1.75], P=0.11) showed no significant difference. Comparing adverse events between two groups, alemtuzumab treatment did not increase the frequency of serious adverse events(OR=1.00, 95% CI =[0.80, 1.26], P=0.99) but increase the frequency of any adverse events(OR=2.29, 95% CI =[1.40, 3.75], P=0.001).Conclusions: The result of Study I show that vitamin D as an added in the treatment of MS showed as same as the placebo in some clinical indicators. However, after a longer treatment,the clinical indicators were significantly lower in the vitamin D group,meanwhile, the safety of Vitamin D is accepted. The result of Study II show that alemtuzumab is a relatively effective and safe treatment for MS. |
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