摘要
目的:观察鸡胚地龙接骨膏治疗骨折的临床疗效及安全性。方法:采用前瞻性、多中心、双盲双模拟、随机对照设计方案将240例骨折患者随机分成治疗组150例,对照组90例,另外将骨折手法复位后于患处使用无药物之纱布治疗的患者设为开放组。治疗组待骨折手法复位后于患处外贴鸡胚地龙接骨膏,对照组待骨折手法复位后,口服伤科接骨片。开放组不使用任何药物,3组均行小夹板外固定,治疗8周。分别于治疗前、治疗后7天、治疗后14天、治疗后21天、治疗后28天计算中医证候疗效评分、X线骨痂质量评分、碱性磷酸酶(AKP)活性变化以及评价临床疗效。结果:中医证候疗效治疗组临床痊愈48例(32.00%),显效68例(45.30%),有效31例(20.67%),无效3例(2.00%),总有效率98.00%;对照组临床痊愈25例(27.78%),显效24例(26.67%),有效35例(38.89%),无效6例(6.67%),总有效率93.33%;开放组临床痊愈0例(0.00%),显效4例(13.33%),有效20例(66.67%),无效5例(16.67%),总有效率83.33%;治疗组疗效优于开放组(P<0.05)。治疗14天后治疗组的疼痛、肿胀、压痛情况,X线骨痂质量评分以及碱性磷酸酶(AKP)活性变化明显优于对照组和开放组。3组均未见不良反应。结论:鸡胚地龙接骨膏对骨折治疗有明显的临床疗效,能加速促进骨折的愈合,是一种治疗骨折较好的外用药物。
Objective：To evaluate the effect and safety of JiPeijiegu ointment on the fracture. Methods：Adopting prospective,multicentered,double-blinded,double-dummy,randomized,controlled trial design,Totally 240 fracture patients were randomized into a treatment group（ n = 150） ,and a control group（ n = 90） ,and other 30 fracture patients who didn＇t regularly drugs were set as opening group. The treatment group was administered JiPeijiegu ointment,while the control group was shangkejiegu tabella,and the opening group hadn＇t given medicine. The patients were treated for 8 weeks,the integral of injury extent on patients recorded repectively pre and post treatment for 7. 14,21 and 28 days,and scores of TCM syndromes symptoms,and integrate intensity of callus by X-ray film,and the activity of serum alkaline phosphatase（ AKP） were observed to evaluate the therapeutic effect. Results：After treatment,in the treatment group 48 patients （ 32. 00% ） were clinically cured,treatment was markedly effective in 68 patients（ 45. 30% ） ,effective in 31（ 20. 67% ） and ineffective in 3（ 2. 00% ） ,and in the control group were 25（ 27. 78% ） ,24 （ 26. 67%） ,35（ 38. 89%） and 6 （ 6. 67%） ,while the opening group were 0 （ 0. 00%） ,4 （ 13. 33%） ,20 （ 66. 67%） and 5 （ 16. 67%） respectively,the clinical effect in treatment group was superior to that in the opening group （ P 0. 05） ,After treatment for 14 day,JiPeijiegu ointment had better efficacy local pain,swelling,trenderness,integrate intensity of callus by x-ray film and the activity of serum AKP than those with shangkejiegu tabella and had n＇t given medicine ,the three group it has no harmful effects on the human body. Conclusion：JiPeijiegu ointment is promoting fracture healing and relieving the symptoms of fracture.
出处
《辽宁中医杂志》
CAS
北大核心
2010年第11期2190-2193,共4页
Liaoning Journal of Traditional Chinese Medicine
基金
国家中医药管理局"十一五"中医能力重点建设项目(24JZX1L116K110)
