骨舒乳膏外用促进全膝关节置换术后患肢瘀斑消退的临床研究

A clinical study of external application of Gushu(骨舒)cream in removing ecchymoses in affected limbs after total knee arthroplasty

目的:观察骨舒乳膏外用促进全膝关节置换术(total knee arthroplasty,TKA)后患肢瘀斑消退的临床疗效和安全性。方法:选择因膝关节非化脓性关节炎初次接受单侧TKA,术后第3天患肢瘀斑面积>10 cm^2的患者为研究对象。共纳入60例患者,随机分为2组,每组30例。常规治疗组不针对瘀斑进行干预,骨舒乳膏组自术后第3天开始采用骨舒乳膏外用,每日2次,连续使用至术后第14天。选择瘀斑面积和美国特种外科医院(Hospital for Special Surgery,HSS)膝关节评分进行疗效评价,同时观察治疗期间不良反应的发生情况。结果:①一般情况。骨舒乳膏组1例患者治疗3 d后出现皮肤过敏反应退出试验,2例患者未严格遵医嘱使用骨舒乳膏退出试验,1例患者资料记录不完整予以剔除;常规治疗组1例患者术后第3天发生小腿肌间血栓,退出试验,加大抗凝药物剂量,治疗1周后血栓消失;2例患者资料记录不完整予以剔除。②患肢瘀斑面积。时间因素和分组因素存在交互效应(F=8.400,P=0.010)。2组患者瘀斑面积总体比较,组间差异有统计学意义,即存在分组效应(F=6.180,P=0.020)。术后不同时间点瘀斑面积的差异有统计学意义,即存在时间效应(F=271.790,P=0.000);2组患者的瘀斑面积随时间变化均呈先升高后降低的趋势,但变化趋势不完全一致[(3.00±2.00)cm^2,(35.73±11.31)cm^2,(51.89±11.90)cm^2,(32.42±10.85)cm^2,(10.39±5.25)cm^2,F=179.628,P=0.000;(3.00±2.00)cm^2,(36.33±11.13)cm^2,(51.96±16.75)cm^2,(40.74±12.72)cm^2,(25.33±8.19)cm^2,F=113.157,P=0.000];术后第1天、第3天、第5天,2组患者瘀斑面积的组间差异均无统计学意义(Z=-0.400,P=0.690;t=-0.190,P=0.850;t=-0.020,P=0.980);术后第7天、第14天,骨舒乳膏组的瘀斑面积均小于常规治疗组(t=-2.560,P=0.010;t=-7.880,P=0.000)。术后第14天时,按照瘀斑面积减少情况,骨舒乳膏组的疗效优于常规治疗组(R骨舒乳膏组=22.13,R常规治疗组=31.69,Z=-2.665,P=0.008)。③HSS膝关节评分。时间因素和分组因素存在交互效应(F=10.530,P=0.000)。2组患者HSS膝关节评分总体比较,组间差异有统计学意义,即存在分组效应(F=5.520,P=0.020)。手术前后不同时间点HSS膝关节评分的差异有统计学意义,即存在时间效应(F=372.220,P=0.000);2组患者HSS膝关节评分随时间变化均呈上升趋势,但2组的上升趋势不完全一致[(45.07±6.36)分,(57.08±4.02)分,(67.58±2.89)分,(76.00±4.08)分,F=254.592,P=0.000;(46.74±5.48)分,(58.70±4.69)分,(63.07±3.26)分,(70.37±5.12)分,F=129.816,P=0.000];术前及术后第3天,2组的HSS膝关节评分比较,组间差异均无统计学意义(t=-1.020,P=0.310;t=-1.350,P=0.180);术后第7天和第14天,骨舒乳膏组的HSS膝关节评分均高于常规治疗组(t=5.240,P=0.000;t=4.420,P=0.000)。术后第14天时,依据HSS膝关节评分进行疗效评定,骨舒乳膏组优于常规治疗组(R骨舒乳膏组=22.38,R常规治疗组=31.44,Z=-2.658,P=0.008)。④不良反应。骨舒乳膏组1例患者因涂药部位皮肤过敏退出试验,停止用药并以温水擦洗处理后症状消失。常规治疗组未出现不良反应。2组患者的并发症发生率比较,差异无统计学意义(P=0.491)。结论:TKA术后外用骨舒乳膏,可促进患肢瘀斑消退,加速术后康复,安全性高。

Objective:To observe the clinical curative effects and safety of external application of Gushu(骨舒,GS)cream in removing ecchymoses in affected limbs after total knee arthroplasty(TKA).Methods:Sixty patients received primary unilateral TKA for treatment of knee nonsuppurative arthritis and ecchymoses of>10 cm(2)were found in affected limbs at postoperative day 3.The patients were enrolled in the study and were randomly divided into conventional therapy group and GS cream group,30 cases in each group.The patients in conventional therapy group were not given any intervention in ecchymoses;while the patients in GS cream group were treated with external application of GS cream from postoperative day 3 to postoperative day 14,twice a day.The clinical curative effects were evaluated according to the area of ecchymoses and Hospital for Special Surgery(HSS)knee scores,and the incidence of adverse reactions were observed during the treatment period.Results:After 3-day treatment,four patients in GS cream group dropped out of the trial for allergic reactions in skin(1),failing to use GS cream strictly as required(2)and incomplete information(1)respectively.At postoperative day 3,one patient in conventional therapy group dropped out of the trial for surae intermuscular thrombus,and the thrombus disappeared after 1-week treatment with large doses of anticoagulants,besides,two patients were excluded for incomplete information.There was interaction between time factor and group factor in area of ecchymoses in affected limbs(F=8.400,P=0.010).There was statistical difference in the area of ecchymoses between the 2 groups in general,in other words,there was group effect(F=6.180,P=0.020).There was statistical difference in the area of ecchymoses between different timepoints after the surgery,in other words,there was time effect(F=271.790,P=0.000).The area of ecchymoses presented a time-dependent trend of increasing firstly and decreasing subsequently in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(3.00+/-2.00,35.73+/-11.31,51.89+/-11.90,32.42+/-10.85,10.39+/-5.25 cm(2),F=179.628,P=0.000;3.00+/-2.00,36.33+/-11.13,51.96+/-16.75,40.74+/-12.72,25.33+/-8.19 cm(2),F=113.157,P=0.000).There was no statistical difference in the area of ecchymoses between the 2 groups on postoperative day 1,3 and 5 respectively(Z=-0.400,P=0.690;t=-0.190,P=0.850;t=-0.020,P=0.980).The areas of ecchymoses were less in GS cream group compared to conventional therapy group on postoperative day 7 and 14 respectively(t=-2.560,P=0.010;t=-7.880,P=0.000).On postoperative day 14,the GS cream group surpassed the conventional therapy group in clinical curative effect according to the reduction of ecchymosis area(RGS cream group=22.13,Rconventional therapy group=31.69,Z=-2.665,P=0.008).There was interaction between time factor and group factor in HSS knee scores(F=10.530,P=0.000).There was statistical difference in HSS knee scores between the 2 groups in general,in other words,there was group effect(F=5.520,P=0.020).There was statistical difference in HSS knee scores between different timepoints before and after the surgery,in other words,there was time effect(F=372.220,P=0.000).The HSS knee scores presented a time-dependent increasing trend in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(45.07+/-6.36,57.08+/-4.02,67.58+/-2.89,76.00+/-4.08 points,F=254.592,P=0.000;46.74+/-5.48,58.70+/-4.69,63.07+/-3.26,70.37+/-5.12 points,F=129.816,P=0.000).There was no statistical difference in HSS knee scores between the 2 groups before the surgery and on postoperative day 3(t=-1.020,P=0.310;t=-1.350,P=0.180).The HSS knee scores were higher in GS cream group compared to conventional therapy group on postoperative day 7 and 14 respectively(t=5.240,P=0.000;t=4.420,P=0.000).On postoperative day 14,the GS cream group surpassed conventional therapy group in clinical curative effect according to the HSS knee scores(RGS cream group=22.38,Rconventional therapy group=31.44,Z=-2.658,P=0.008).One patient in GS cream group dropped out of the trial for allergic reactions in skin,and the symptoms disappeared after GS cream was suspended and the skin was swabbed with warm water.No adverse reactions were found in conventional therapy group.There was no statistical difference in complication incidences between the 2 groups(P=0.491).Conclusion:External application of GS cream can promote ecchymoses extinction and accelerate recovery after TKA with high safety.