中华风湿病学杂志
中華風濕病學雜誌
중화풍습병학잡지
CHINESE JOURNAL OF RHEUMATOLOGY
2012年
6期
393-397
,共5页
郭军华%黄烽%张江林%伍沪生%宋慧%徐沪济%刘彧%古洁若%黄建林%方勇飞%张荣华
郭軍華%黃烽%張江林%伍滬生%宋慧%徐滬濟%劉彧%古潔若%黃建林%方勇飛%張榮華
곽군화%황봉%장강림%오호생%송혜%서호제%류욱%고길약%황건림%방용비%장영화
关节炎,类风湿%地塞米松%随机对照试验
關節炎,類風濕%地塞米鬆%隨機對照試驗
관절염,류풍습%지새미송%수궤대조시험
Arthritis,rheumatoid%Dexamethasone%Randomized controlled trials
目的 依据药品临床试验管理规范(GCP)观察评价国产与进口地塞米松棕榈酸酯注射液治疗类风湿关节炎(RA)膝关节受累是否具有相同的临床疗效及安全性.方法 采用多中心、双盲、随机、平行对照研究,237例有膝关节轻、中度肿胀的RA患者入组观察,随机分为治疗组(国产)118例和对照组(进口)119例,分别应用2种地塞米松棕榈酸酯注射液8 mg关节腔注射1次,1周后回访.主要疗效指标为进行关节腔药物注射的膝关节上、下缘周径,次要疗效指标包括关节压痛指数和受试者自我评价,并对不良事件进行统计记录.采用协方差分析、t检验或Wilcoxon秩和检验、x2检验或Fisher精确概率法进行统计分析.结果 治疗组与对照组治疗后上缘周径分别为(37.2±3.3)cm和(36.4±3.9)cm,下缘周径分别为(34.4±2.9)cm和(33.9±3.4)cm,比治疗前的上缘周径[(38.1±3.3)cm和(37.3±4.0)cm],以及下缘周径[(35.1±3.0)cm和(34.6±3.6)cm]明显缩小(P＜0.01).治疗后2组关节压痛指数也有显著改善(P＜0.01).治疗组和对照组在受试者自我评价方面为很大好转和好转的比例分别是67.5％(79/117)和74.8％( 86/115).全部主要和次要疗效指标之间差异无统计学意义(P＞0.05).试验过程中相关不良事件发生率在治疗组和对照组分别为6.8％(8/118)和4.2％(5/119),差异无统计学意义(P＞05).结论 国产地塞米松棕榈酸酯注射液与进口同类产品在治疗RA上具有相同的临床疗效及安全性.接受注射的膝关节上、下缘周径可能成为用于评估关节炎局部注射治疗效果的参考指标之一.
目的 依據藥品臨床試驗管理規範(GCP)觀察評價國產與進口地塞米鬆棕櫚痠酯註射液治療類風濕關節炎(RA)膝關節受纍是否具有相同的臨床療效及安全性.方法 採用多中心、雙盲、隨機、平行對照研究,237例有膝關節輕、中度腫脹的RA患者入組觀察,隨機分為治療組(國產)118例和對照組(進口)119例,分彆應用2種地塞米鬆棕櫚痠酯註射液8 mg關節腔註射1次,1週後迴訪.主要療效指標為進行關節腔藥物註射的膝關節上、下緣週徑,次要療效指標包括關節壓痛指數和受試者自我評價,併對不良事件進行統計記錄.採用協方差分析、t檢驗或Wilcoxon秩和檢驗、x2檢驗或Fisher精確概率法進行統計分析.結果 治療組與對照組治療後上緣週徑分彆為(37.2±3.3)cm和(36.4±3.9)cm,下緣週徑分彆為(34.4±2.9)cm和(33.9±3.4)cm,比治療前的上緣週徑[(38.1±3.3)cm和(37.3±4.0)cm],以及下緣週徑[(35.1±3.0)cm和(34.6±3.6)cm]明顯縮小(P＜0.01).治療後2組關節壓痛指數也有顯著改善(P＜0.01).治療組和對照組在受試者自我評價方麵為很大好轉和好轉的比例分彆是67.5％(79/117)和74.8％( 86/115).全部主要和次要療效指標之間差異無統計學意義(P＞0.05).試驗過程中相關不良事件髮生率在治療組和對照組分彆為6.8％(8/118)和4.2％(5/119),差異無統計學意義(P＞05).結論 國產地塞米鬆棕櫚痠酯註射液與進口同類產品在治療RA上具有相同的臨床療效及安全性.接受註射的膝關節上、下緣週徑可能成為用于評估關節炎跼部註射治療效果的參攷指標之一.
목적 의거약품림상시험관리규범(GCP)관찰평개국산여진구지새미송종려산지주사액치료류풍습관절염(RA)슬관절수루시부구유상동적림상료효급안전성.방법 채용다중심、쌍맹、수궤、평행대조연구,237례유슬관절경、중도종창적RA환자입조관찰,수궤분위치료조(국산)118례화대조조(진구)119례,분별응용2충지새미송종려산지주사액8 mg관절강주사1차,1주후회방.주요료효지표위진행관절강약물주사적슬관절상、하연주경,차요료효지표포괄관절압통지수화수시자자아평개,병대불량사건진행통계기록.채용협방차분석、t검험혹Wilcoxon질화검험、x2검험혹Fisher정학개솔법진행통계분석.결과 치료조여대조조치료후상연주경분별위(37.2±3.3)cm화(36.4±3.9)cm,하연주경분별위(34.4±2.9)cm화(33.9±3.4)cm,비치료전적상연주경[(38.1±3.3)cm화(37.3±4.0)cm],이급하연주경[(35.1±3.0)cm화(34.6±3.6)cm]명현축소(P＜0.01).치료후2조관절압통지수야유현저개선(P＜0.01).치료조화대조조재수시자자아평개방면위흔대호전화호전적비례분별시67.5％(79/117)화74.8％( 86/115).전부주요화차요료효지표지간차이무통계학의의(P＞0.05).시험과정중상관불량사건발생솔재치료조화대조조분별위6.8％(8/118)화4.2％(5/119),차이무통계학의의(P＞05).결론 국산지새미송종려산지주사액여진구동류산품재치료RA상구유상동적림상료효급안전성.접수주사적슬관절상、하연주경가능성위용우평고관절염국부주사치료효과적삼고지표지일.
Objective To evaluate the efficacy and safety of two forms of preparations of dexamethasone palmitate in the treatment of rheumatoid arthritis (RA).Methods A multicenter,double-blind,randomized,parallel-group clinical trial was carried out according to good clinical practice (GCP).A total of 237cases of RA patients with mild to moderate knee swelling were randomly divided into the treatment group (n=118 ) or the control group (n=119) and were treated with two kinds of dexamethasone palmitate 8 mg injection respectively.The primary efficacy endpoints were the circumference of the knee joint at the upper and the lower edge after the intra-articular injection.The secondary efficacy endpoints were joint tenderness index and patients general assessment.The adveme events were recorded.Analysis of covariance,t test or Wilcoxon test,x2 test or Fisher exact test were used for statistical analysis.Results The upper edges of the treatment group and the control group after treatment were (37.2±3.3) cm and (36.4±3.9) cm respectively,and the lower edges of the two groups were (34.4±2.9) cm and (33.9±3.4) cm respectively.They were all significantly smaller than the edges before treatment [(38.1± 3.3) cm and (37.3±4.0) cm of the upper edges,(35.1±3.0)cm and (34.6±3.6) cm of the lower edges respectively ) (P＜0.O1)].After treatment,the joint tenderness index were improved (P＜0.01).A total ratio of great improvement and improvement of patients general assessment of the two group patients were 67.5％ (79/117) and 74.8％ (86/115) respectively.No statistical significant difference was found in all primary and secondary efficacy endpoints between the two groups (P＞0.05).During the clinical trial,the incidence of adverse events related to the treatment of two groups were 4.2％ and 6.8％,without any significant difference (P＞0.05).Conclusion New preparation of dexamethasone palmitate has the same efficacy and safety as the imported producted in the treatment of RA.The circumference of the knee joints at the upper and the lower edge may be used to assess the effects of intra-articular injections.
