| Background and objective:Systemic sclerosis(SSc)is a systemic autoimmune disease featuring extensive vascular dysfunction and progressive fibrosis of skin and internal organs.Over 90%of the SSc patients present with Raynaud’s phenomenon(RP)and often accompanied by ischemic disorders,such as pain,digital ulcers,and can even lead to amputation.It is necessary for those who have RP secondary to SSc to be managed in a proper way.Current conservative therapy,medical or surgical treatments are not fully effective while causing side effects,so we need to find a new method to treat these patients.Not only can botulinum toxin A(BTX-A)inhibit muscle contraction,but also it can dilate blood vessels,inhibit pain-related neurons and prevent intravascular thrombosis,which have been supported by many studies.It is reported that BTX-A have function of relieving pain,reducing symptoms of RP,promoting ulcer healing and improving blood supply of limbs.However,there still lacks randomized controlled trials in a large sample and there doesn’ t exsit a method to evaluate treatment outcomes objectively and conveniently.Our study aims to recruit as many samples as we can to conduct a randomized controlled trial,to use a variety of evaluation methods to further study the effectiveness and safty of BTX-A in the treatment of SSc with RP,and to explore the role of dermatoscopy in evaluating diease conditions and treatment outcomes.Materials and methods:We recruited SSc patients with RP in dermatology clinics of PUMCH from October 2016 to March 2017.The study included those who were>18 years old and>0.5 year disease duration,who experienced invalid medical therapy and voluntarily accepted the treatment.Patients who were allergic to botulinum toxin,had proximal vascular occlusive disease,had infection in injection site,were pregnancy or lactation,suffered myasthenia gravis or clotting disorders were all excluded.A total of 47 patients met the criteria were evaluated as the baseline group.They were divided into lcSSc and dcSSc subgroups.We collected their basic information,assessed and recorded the results of their Raynaud’ s score,VAS pain scale,Quick-DASH,modified Rodnan skin scale(mRSS),baseline skin temperature of digits,recovery skin temperature after cold water stimulation,digital ulcer and dermotoscopy appearance(qualitative classification and semi-quantitative classification).20 patients agreed to proceed(called intervention group).They were randomly injected with BTX-A in one of their hands,in the level of metacarpophalangeal joint with dose of 10U in each injection site.The follow-up for patients was 4 weeks,evaluating items the same as what was done before the injection.Also,we recorded adverse reactions.We used SPSS Statistics 17.0 to analyze data,and set p(bilateral)<0.05 as the definition of statistically significance.We analyzed clinical characteristics of baseline group,comparing the difference of the results of various evaluation methods between the two subgroups.We analyzed the results of all evaluation methods before and after the injection treatment between the two subgroups in the intervention group.We also analyzed the correlation of qualitative classification and semi-quantitative classification of dermatoscopy,and their correlations to skin temperature and digital ulcer.Results:1.In baseline group,dcSSc subgroup had statistically significant higher score of Quick-DASH(p=0.000)and mRSS(p=0.000)than lcSSc subgroup.While Raynaud’ s score,VAS pain scale,baseline skin temperature of digits,recovery skin temperature after cold water stimulation,digital ulcer and dermotoscopy appearance had no statistically significant improvement.2.After receiving injection treatment,patients of two subgroups both had statistically significant improvement of RS(p=0.000,0.042)and recovery skin temperature after cold water stimulation(p=0.012,0.012).Baseline skin temperature of digits(p = 0.002)improved significantly in dcSSc subgroup.Quick-DASH in lcSSc group decreased significantly(p=0.028).Qualitative classification of dermatoscopy(p=0.031)in lcSSc subgroup decreased significantly.Semi-quantitative classification of dermatoscopy of two subgroups both had statistically significant reduction(p=0.034,0.010).We had not seen any obvious adverse reactions in all patients so far.3.Qualitative classification of dermatoscopy was siganificantly correlated to loss of capillaries(r=0.834,p=0.000),disorganization of capilary architecture(r=0.436,p=0.002),ramified bushy capillaries(r=0.332,p=0.021)and sum of the semi-quantitative classification(r=0.447,p=0.001).It also had positive relation to ulcer scores(r=0.474,p=0.001).Conclusions:1.In baseline group,dcSSc subgroup has higher modified Rodnan skin scale and Quick-DASH score than lcSSc group.2.Injection of BTX-A can reduce activity of RP,improve digital blood supply,improve hand function,relieve pain and improve NCPs under dermatoscopy,especially for the lcSSc subgroup patients.There is efficacy and safety to use BTX-A to treat RP secondary to SSc.3.The dermatoscopy can reflect change of NCPs before and after treating by BTX-A.It has higher diagnostic sensitivity for late pattern NCPs in SSc patients. |
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