中国医药
中國醫藥
중국의약
CHINA MEDICINE
2014年
8期
1170-1173
,共4页
徐宁%刘蕊%臧嘉捷%刘湘源
徐寧%劉蕊%臧嘉捷%劉湘源
서저%류예%장가첩%류상원
骨关节炎%草乌甲素片%视觉模拟量表评分%美国西部安大略和麦克马斯特大学骨关节炎指数评分
骨關節炎%草烏甲素片%視覺模擬量錶評分%美國西部安大略和麥剋馬斯特大學骨關節炎指數評分
골관절염%초오갑소편%시각모의량표평분%미국서부안대략화맥극마사특대학골관절염지수평분
Osteoarthritis%Bulleyaconitine A%Visual analogue scale score%Western Ontario and Mcmaster Universities Score
目的 观察草乌甲素片治疗骨关节炎的临床疗效和安全性.方法 本研究采用开放式对照法,将114例骨关节炎患者分为2组:试验组57例,口服草乌甲素片0.4 mg,3次/d;对照组57例,口服双氯芬酸钠片25 mg,3次/d.2组疗程均为2周.疗效判断指标为服药前后患者对自己的总体评价变化、医生对患者总体情况的评价变化、患者关节压痛数变化、关节肿胀数变化以及美国西部安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分变化,同时观察不良反应发生情况.结果 用药后2周,对照组自评视觉模拟评分(VAS)试验前为(66±13),试验后为(33±13),差异有统计学意义(P＜0.01);试验组患者自评VAS评分试验前为(67±15),试验后为(39 ± 13),差异有统计学意义(P＜0.01);医生VAS评分均有明显改善[对照组试验前为(66±12),试验后为(33±12),试验组试验前为(67±15),试验后为(39±12)](P＜0.01);且试验组不劣于对照组.对照组关节压痛数试验前为2.0(1.0,4.0),试验后为0.0(0.0,1.0);试验组关节压痛数试验前为2.0(0.0,3.0),试验后为0.0(0.0,1.0);对照组关节肿胀数试验前为8.0(5.0,10.0),试验后为2.0(1.0,3.0);试验组关节肿胀数试验前为7.0(5.0,10.0),试验后为2.0(1.0,4.0);对照组WOMAC评分试验前为(31±13),试验后为(14±7);试验组WOMAC评分试验前为(33±17),试验后为(14±8).2组患者关节压痛数、关节肿胀数以及WOMAC评分均有明显改善(P＜0.01),2组间差异无统计学意义(P＞0.05).结论 草乌甲素片治疗骨关节炎疗效确切,不劣于双氯芬酸钠片.
目的 觀察草烏甲素片治療骨關節炎的臨床療效和安全性.方法 本研究採用開放式對照法,將114例骨關節炎患者分為2組:試驗組57例,口服草烏甲素片0.4 mg,3次/d;對照組57例,口服雙氯芬痠鈉片25 mg,3次/d.2組療程均為2週.療效判斷指標為服藥前後患者對自己的總體評價變化、醫生對患者總體情況的評價變化、患者關節壓痛數變化、關節腫脹數變化以及美國西部安大略和麥剋馬斯特大學骨關節炎指數(WOMAC)評分變化,同時觀察不良反應髮生情況.結果 用藥後2週,對照組自評視覺模擬評分(VAS)試驗前為(66±13),試驗後為(33±13),差異有統計學意義(P＜0.01);試驗組患者自評VAS評分試驗前為(67±15),試驗後為(39 ± 13),差異有統計學意義(P＜0.01);醫生VAS評分均有明顯改善[對照組試驗前為(66±12),試驗後為(33±12),試驗組試驗前為(67±15),試驗後為(39±12)](P＜0.01);且試驗組不劣于對照組.對照組關節壓痛數試驗前為2.0(1.0,4.0),試驗後為0.0(0.0,1.0);試驗組關節壓痛數試驗前為2.0(0.0,3.0),試驗後為0.0(0.0,1.0);對照組關節腫脹數試驗前為8.0(5.0,10.0),試驗後為2.0(1.0,3.0);試驗組關節腫脹數試驗前為7.0(5.0,10.0),試驗後為2.0(1.0,4.0);對照組WOMAC評分試驗前為(31±13),試驗後為(14±7);試驗組WOMAC評分試驗前為(33±17),試驗後為(14±8).2組患者關節壓痛數、關節腫脹數以及WOMAC評分均有明顯改善(P＜0.01),2組間差異無統計學意義(P＞0.05).結論 草烏甲素片治療骨關節炎療效確切,不劣于雙氯芬痠鈉片.
목적 관찰초오갑소편치료골관절염적림상료효화안전성.방법 본연구채용개방식대조법,장114례골관절염환자분위2조:시험조57례,구복초오갑소편0.4 mg,3차/d;대조조57례,구복쌍록분산납편25 mg,3차/d.2조료정균위2주.료효판단지표위복약전후환자대자기적총체평개변화、의생대환자총체정황적평개변화、환자관절압통수변화、관절종창수변화이급미국서부안대략화맥극마사특대학골관절염지수(WOMAC)평분변화,동시관찰불량반응발생정황.결과 용약후2주,대조조자평시각모의평분(VAS)시험전위(66±13),시험후위(33±13),차이유통계학의의(P＜0.01);시험조환자자평VAS평분시험전위(67±15),시험후위(39 ± 13),차이유통계학의의(P＜0.01);의생VAS평분균유명현개선[대조조시험전위(66±12),시험후위(33±12),시험조시험전위(67±15),시험후위(39±12)](P＜0.01);차시험조불렬우대조조.대조조관절압통수시험전위2.0(1.0,4.0),시험후위0.0(0.0,1.0);시험조관절압통수시험전위2.0(0.0,3.0),시험후위0.0(0.0,1.0);대조조관절종창수시험전위8.0(5.0,10.0),시험후위2.0(1.0,3.0);시험조관절종창수시험전위7.0(5.0,10.0),시험후위2.0(1.0,4.0);대조조WOMAC평분시험전위(31±13),시험후위(14±7);시험조WOMAC평분시험전위(33±17),시험후위(14±8).2조환자관절압통수、관절종창수이급WOMAC평분균유명현개선(P＜0.01),2조간차이무통계학의의(P＞0.05).결론 초오갑소편치료골관절염료효학절,불렬우쌍록분산납편.
Objective To assess the efficacy and safety of bulleyaconitine A on patients with osteoarthritis.Methods In this open-controlled trial,a total of 114 patients with osteoarthritis were assigned to bulleyaconitine A (n =57,at dose of 0.4 mg,three daily) or diclofenac (n =57,at dose of 25 mg,three daily) for two weeks.Total patient-self assay,total doctor assay,number of tenderness for joins,number of edeme for joins and the western ontario and McMaster universities osteoarthritis index (WOMAC) score were assessed.Results In diclofenac group,VAS score for patient was (33 ± 13) after two weeks of treatment and it was (66 ± 13) before drug use(P ＜ 0.01) in bulleyaconitine A group.VAS score for patient was (39 ± 13) after two weeks and it was (67 ± 15) before treatment(P ＜0.01).There was significant improvement of VAS score in both groups (P ＜ 0.01).Bulleyaconitine A showed noninferiority to diclofenac.Before drug use,the number of tenderness for joins was 2.0 (1.0,4.0) ; after drug use it was 0.0 (0.0,1.0) in diclofenac group.Before drug use,the number of tenderness for joins was 2.0(0.0,3.0) ; after drug use it was 0.0(0.0,1.0) in Bulleyaconitine A group.Before drug use,the number of edeme for joins was 8.0(5.0,10.0) ; after drug use,it was 2.0 (1.0,3.0) in diclofenac groups.Before drug use,the number of edeme for joins was 7.0 (5.0,10.0) ;after drug use,it was 2.0 (1.0,4.0) in bulleyaconitine A group.Before drug use,WOMAC score was (31 ± 13) ; after drug use,it was (14 ±7) in diclofenac group.Before drug use,WOMAC score was (33 ± 17) ; after drug use,it was (14 ± 8) in bulleyaconitine A group.There was improvement of tenderness and edema of joins and WOMAC score in both groups(P ＜ 0.01).Conclusion Bulleyaconitine A has confirmed efficacy and is non-inferior to diclofenac.
