中国临床康复
中國臨床康複
중국림상강복
CHINESE JOURNAL OF CLINICAL REHABILITATION
2005年
27期
236-238
,共3页
邓兆智%叶雪英%钟秋生%吴月芹%王维华%王宝爱
鄧兆智%葉雪英%鐘鞦生%吳月芹%王維華%王寶愛
산조지%협설영%종추생%오월근%왕유화%왕보애
脊柱炎,强直性%白芍%甲氨蝶呤%柳氮磺胺吡啶
脊柱炎,彊直性%白芍%甲氨蝶呤%柳氮磺胺吡啶
척주염,강직성%백작%갑안접령%류담광알필정
背景:白芍总苷为白芍中提取的有效成分,具有较好的抗炎和镇痛作用.
目的:观察白芍总苷联合甲氨蝶呤和柳氮磺胺吡啶治疗强直性脊柱炎的协同疗效作用及其毒副作用.
设计:随机对照观察.
单位:广州省中医院风湿科.
对象:选择2003-06/2004-04广东省中医院风湿科门诊收治强直性脊柱炎患者80例.随机分为2组,每组各40例.签书面知情同意书.
方法:治疗组:口服白芍总苷胶囊2粒,3次/d;甲氨蝶呤10 mg/次,1次/周;柳氮磺胺吡啶0.5g/次,3次/d.对照组:口服甲氨蝶呤和柳氮磺胺吡啶,剂量和方法同治疗组.两组均用尼美舒利,0.1g/次,2次/d.疗程均为3个月.于治疗前及治疗4,8,12周进行脊柱功能评价和实验室检查.
主要观察指标:主要结局:Bath强直性脊柱炎活动指数、Bath强直性脊柱炎功能指数,晨僵时间,全身和脊柱疼痛Likert 4级积分以及患者和医生的总体评价积分.次要结局:①血沉、C反应蛋白、Schober实验、扩胸度、枕墙距和指地距.②不良事件和副反应.
结果:治疗组完成了38例和对照组完成了37例患者的观察.①两组患者主要疗效指标中Bath强直性脊柱炎活动指数和功能指数、晨僵时间、全身疼痛积分、脊柱疼痛积分、患者的总体评价积分、医生的总体评价积分结果:两组治疗4,8和12周与各自0周比较均明显下降(P＜0.05);治疗组4周时Bath强直性脊柱炎活动指数、全身和脊柱疼痛Likert4级积分、患者和医生的总体评价积分及8周和12周各指标均较对照组有显著下降(P＜0.05).②两组患者次要疗效指标中血沉、C反应蛋白、Schober试验、扩胸度、枕墙距、指地距的评估结果:治疗组4,8和12周各指标较治疗前显著下降(P＜0.05);对照组4周时Schober试验、扩胸度、指地距及8和12周较治疗前显著下降(P＜0.05).治疗组12周时血沉、C反应蛋白、扩胸度、指地距较对照组显著下降.③不良事件和副反应:两组治疗中均有出现短暂转氨酶升高和白细胞下降,未处理或保肝后恢复正常,无一例停药.治疗组不良反应发生率较对照组低[10%(3/30),57%(17/30),P＜0.05].
结论:白芍总苷联合甲氨蝶呤和柳氮磺胺吡啶治疗强直性脊柱炎具有增效作用,且未出现特殊不良反应,安全性高.
揹景:白芍總苷為白芍中提取的有效成分,具有較好的抗炎和鎮痛作用.
目的:觀察白芍總苷聯閤甲氨蝶呤和柳氮磺胺吡啶治療彊直性脊柱炎的協同療效作用及其毒副作用.
設計:隨機對照觀察.
單位:廣州省中醫院風濕科.
對象:選擇2003-06/2004-04廣東省中醫院風濕科門診收治彊直性脊柱炎患者80例.隨機分為2組,每組各40例.籤書麵知情同意書.
方法:治療組:口服白芍總苷膠囊2粒,3次/d;甲氨蝶呤10 mg/次,1次/週;柳氮磺胺吡啶0.5g/次,3次/d.對照組:口服甲氨蝶呤和柳氮磺胺吡啶,劑量和方法同治療組.兩組均用尼美舒利,0.1g/次,2次/d.療程均為3箇月.于治療前及治療4,8,12週進行脊柱功能評價和實驗室檢查.
主要觀察指標:主要結跼:Bath彊直性脊柱炎活動指數、Bath彊直性脊柱炎功能指數,晨僵時間,全身和脊柱疼痛Likert 4級積分以及患者和醫生的總體評價積分.次要結跼:①血沉、C反應蛋白、Schober實驗、擴胸度、枕牆距和指地距.②不良事件和副反應.
結果:治療組完成瞭38例和對照組完成瞭37例患者的觀察.①兩組患者主要療效指標中Bath彊直性脊柱炎活動指數和功能指數、晨僵時間、全身疼痛積分、脊柱疼痛積分、患者的總體評價積分、醫生的總體評價積分結果:兩組治療4,8和12週與各自0週比較均明顯下降(P＜0.05);治療組4週時Bath彊直性脊柱炎活動指數、全身和脊柱疼痛Likert4級積分、患者和醫生的總體評價積分及8週和12週各指標均較對照組有顯著下降(P＜0.05).②兩組患者次要療效指標中血沉、C反應蛋白、Schober試驗、擴胸度、枕牆距、指地距的評估結果:治療組4,8和12週各指標較治療前顯著下降(P＜0.05);對照組4週時Schober試驗、擴胸度、指地距及8和12週較治療前顯著下降(P＜0.05).治療組12週時血沉、C反應蛋白、擴胸度、指地距較對照組顯著下降.③不良事件和副反應:兩組治療中均有齣現短暫轉氨酶升高和白細胞下降,未處理或保肝後恢複正常,無一例停藥.治療組不良反應髮生率較對照組低[10%(3/30),57%(17/30),P＜0.05].
結論:白芍總苷聯閤甲氨蝶呤和柳氮磺胺吡啶治療彊直性脊柱炎具有增效作用,且未齣現特殊不良反應,安全性高.
배경:백작총감위백작중제취적유효성분,구유교호적항염화진통작용.
목적:관찰백작총감연합갑안접령화류담광알필정치료강직성척주염적협동료효작용급기독부작용.
설계:수궤대조관찰.
단위:엄주성중의원풍습과.
대상:선택2003-06/2004-04광동성중의원풍습과문진수치강직성척주염환자80례.수궤분위2조,매조각40례.첨서면지정동의서.
방법:치료조:구복백작총감효낭2립,3차/d;갑안접령10 mg/차,1차/주;류담광알필정0.5g/차,3차/d.대조조:구복갑안접령화류담광알필정,제량화방법동치료조.량조균용니미서리,0.1g/차,2차/d.료정균위3개월.우치료전급치료4,8,12주진행척주공능평개화실험실검사.
주요관찰지표:주요결국:Bath강직성척주염활동지수、Bath강직성척주염공능지수,신강시간,전신화척주동통Likert 4급적분이급환자화의생적총체평개적분.차요결국:①혈침、C반응단백、Schober실험、확흉도、침장거화지지거.②불량사건화부반응.
결과:치료조완성료38례화대조조완성료37례환자적관찰.①량조환자주요료효지표중Bath강직성척주염활동지수화공능지수、신강시간、전신동통적분、척주동통적분、환자적총체평개적분、의생적총체평개적분결과:량조치료4,8화12주여각자0주비교균명현하강(P＜0.05);치료조4주시Bath강직성척주염활동지수、전신화척주동통Likert4급적분、환자화의생적총체평개적분급8주화12주각지표균교대조조유현저하강(P＜0.05).②량조환자차요료효지표중혈침、C반응단백、Schober시험、확흉도、침장거、지지거적평고결과:치료조4,8화12주각지표교치료전현저하강(P＜0.05);대조조4주시Schober시험、확흉도、지지거급8화12주교치료전현저하강(P＜0.05).치료조12주시혈침、C반응단백、확흉도、지지거교대조조현저하강.③불량사건화부반응:량조치료중균유출현단잠전안매승고화백세포하강,미처리혹보간후회복정상,무일례정약.치료조불량반응발생솔교대조조저[10%(3/30),57%(17/30),P＜0.05].
결론:백작총감연합갑안접령화류담광알필정치료강직성척주염구유증효작용,차미출현특수불량반응,안전성고.
BACKGROUND: Total glucosides of paeony, effective component extracted from peony, has good inflammatory and analgesic effect.
OBJECTIVE: To investigate the curative effect and side effect of total glucosides of paeony combined with methotrexate and sulfasalazine in the treatment of ankylosing spondylitis.
DESIGN: Randomized and controlled observation
SETTING: Department of Rheumatology , Guangdong Hospital of Traditional Chinese Medicine
PARTICIPANTS: Totally 80 inpatients with ankylosing spondylitis hospitalized in the Clinic of Department of Rheumatology, Guangdong Hospital of Traditional Chinese Medicine from June 2003 to April 2004 were involved. The patients were randomly divided into 2 groups with 40 patients in each group. Informed consent was obtained.
METHODS: Experimental group: 2 capsules of total glucosides of peony was taken orally, three times per day; methotrexate 10 mg/time, once per week; sulfasalazine 0.5 g/time, three times per day. Control group:methotrexate and sulfasalazine were taken orally and the dosage and method were the same as those in the experimental group. Two groups all used the same NSAID (Nimesulide) , 0.1 g/time, twice per day. The period of the treatment was 3 months. Evaluation of spinal column function and laboratory examination was performed before treatment and 4, 8 and 12 weeks after treatment.
MAIN OUTCOME MEASURES: Primary outcomes: Bath ankylosing spondylitis activity index, Bath ankylosing spondylitis function index [1-2],duration of morning stiffness, systemic pain and spinal pain on a four point Likert scale, overall assessment of patient and physician on a four point scale. Secondary outcomes: ①erythrocyte sedimentation, C-reaction protein,Schober test, chest expansion, Occiput to wall distance and finger to floor distance.② Adverse events and side effects.
RESULTS: The observation of 38 patients in the experiemtnal group and 37 patients in the control group was completed. ①Result of Bath ankylosing spondylitis activity index, Bath ankylosing spondylitis function index,duration of morning stiffness, pain and spinal pain on a four point Likert scale, overall assessment of patient and physician on a four point scale:The indices at week 4, 8 and 12 werevmore significantly decreased than those before treatment in each group (P ＜ 0.05); the Bath ankylosing spondylitis activity index, pain and spinal pain on a four point Likert scale,overall assessment of patient and physician on a four point scale at week 4and all the indices at week 8 and 12 were more significantly decreased than those in the control group (P ＜ 0.05). ② Evaluation result of Erythrocyte sedimentation rate (ESR) and C reaction protein, Schober test, chest expansion , occiput to wall distance and finger to floor distance: Each index at week 4, 8 and 12 in the experimental group were significantly decreased than those before treatment (P ＜ 0.05), those at week 8 and 12 in the control group were more significantly decreased than those before treatment (P ＜ 0.05). ESR , C reactive protein (CRP) , chest expansion and finger to floor distance at week 12 in the control group were more significantly decreased . ③ Adverse events and side effects: All adverse reactions occurred transiently during the course of disease in the two groups. Undisposed or after having taken live-protective medicine, all patients recovered.Drug was not withdrawn in any case.The incidence of adverse reaction in the experimental group was lower than that in the control group [10％ (3/30),57％(17/30) ,P ＜ 0.05].
CONCLUSION: Combination of total glucosides of paeony, methotrexate and sulfasalazine has an enhanced effect and better safety without special adverse reaction in the treatment of ankylosing spondylitis.
