[1]龚志兵,徐福东,黄淑霞,等.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[J].中医正骨,2020,32(04):9-14.
　GONG Zhibing,XU Fudong,HUANG Shuxia,et al.A clinical study of external application of Gushu(骨舒)cream in removing ecchymoses in affected limbs after total knee arthroplasty[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(04):9-14.
点击复制

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()
分享到：

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期数:
2020年04期
页码:
9-14
栏目:
临床研究
出版日期:
2020-04-20

文章信息/Info

Title:
A clinical study of external application of Gushu(骨舒)cream in removing ecchymoses in affected limbs after total knee arthroplasty
作者:
龚志兵; 徐福东; 黄淑霞; 庄至坤; 张前进
(泉州市正骨医院,福建 泉州 362000)
Author(s):
GONG Zhibing; XU Fudong; HUANG Shuxia; ZHUANG Zhikun; ZHANG Qianjin Quanzhou Orthopedic Hospital; Quanzhou 362000; Fujian; China
Quanzhou Orthopedic Hospital,Quanzhou 362000,Fujian,China
关键词:
关节成形术; 置换; 膝;  瘀斑;  骨舒乳膏;  临床试验
Keywords:
arthroplasty; replacement; knee;  ecchymosis;  Gushu cream;  clinical trial
摘要:
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 cm2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)cm2,(35.73±11.31)cm2,(51.89±11.90)cm2,(32.42±10.85)cm2,(10.39±5.25)cm2,F=179.628,P=0.000;(3.00±2.00)cm2,(36.33±11.13)cm2,(51.96±16.75)cm2,(40.74±12.72)cm2,(25.33±8.19)cm2,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((-overR)骨舒乳膏组=22.13,(-overR)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((-overR)骨舒乳膏组=22.38,(-overR)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。
Abstract:
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((-overR)GS cream group=22.13,(-overR)conventional 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((-overR)GS cream group=22.38,(-overR)conventional 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.

参考文献/References:

[1] 程开源,翁习生.2017膝关节重建术新进展[J].中华骨与关节外科杂志,2017,10(6):530-535.
[2] SEHAT K R,EVANS R L,NEWMAN J H.Hidden blood loss following hip and knee arthroplasty.Correct management of blood loss should take hidden loss into account[J].J Bone Joint Surg Br,2004,86(4):561-565.
[3] LI N,LIU M,WANG D,et al.Comparison of complications in one-stage bilateral total knee arthroplasty with and without drainage[J].J Orthop Surg Res,2015,10:3.
[4] 李雳.TKA术后早期局部症状群规律探究[D].广州:广州中医药大学,2015.
[5] WANG J,ZHU H L,SHI Z J,et al.The application of thromboelastography in understanding and management of ecchymosis after total knee arthroplasty[J].J Arthroplasty,2018,33(12):3754-3758.
[6] KANG Y,ZHANG Z J,FU M,et al.Blood transfusion and drainage catheter clamping are associated with ecchymosis formation at the surgical site after total knee arthroplasty:an analysis of 102 unilateral cases[J].Eur J Orthop Surg Traumatol,2013,23(2):219-224.
[7] ZHU S,QIAN W,JIANG C,et al.Enhanced recovery after surgery for hip and knee arthroplasty:a systematic review and meta-analysis[J].Postgrad Med J,2017,93(1106):736-742.
[8] 龚志兵,庄至坤,张焕堂,等.骨散外敷治疗急性踝关节扭伤气滞血瘀证的临床研究[J].中医正骨,2018,30(12):13-17.
[9] 郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002.
[10] 王李娜,程晋兰,周晓兰,等.正交设计法优选骨舒乳膏基质成分的配比[J].中国现代药物应用,2009,3(20):38-40.
[11] ELIZAVETA K,GIULIO A,GIUSEPPE F,et al.Knee scoring systems[M].Springer Berlin Heidelberg,2014:3373-3374.
[12] LEUNG K H,CHIU K Y,YAN C H,et al.Review article:venous thromboembolismafter total joint replacement[J].J Orthop Surg(Hong Kong),2013,21(3):351-360.
[13] 张华芳,陈梅,李成太.充气止血带个体化压力值在膝关节置换手术中的应用效果[J].安徽医学,2016,37(10):1292-1293.
[14] 任中华,李江涛,郑志永.人工膝关节置换术后皮下瘀血形成与隐性失血量的相关性[J].广东医学,2017,38(10):1558-1560.
[15] JUNG Y B,LEE Y S,LEE E Y,et al.Comparison of the modified subvastus and medial parapatellar approaches in total knee arthroplasty[J].Int Orthop,2009,33(2):419-423.
[16] 卿忠,刘淼.全膝关节置换术出血量分析及控制出血对策[J].中国骨与关节损伤杂志,2008,23(3):232-233.
[17] LI B,WEN Y,WU H,et al.The effect of tourniquet use on hidden blood loss in total knee arthroplasty[J].Int Orthop,2009,33(5):1263-1268.
[18] 于召龙.全膝关节置换术中有限使用止血带的临床效果观察[D].济南:山东大学,2017.
[19] 康焱,傅明,盛璞义,等.人工全膝关节置换术后伤口周围瘀斑形成的危险因素分析[J].中华创伤骨科杂志,2010,12(12):1135-1138.
[20] DEMIRKALE I,TECIMEL O,SESEN H,et al.Nondrainage decreases blood transfusion need and infection rate in bilateral total knee arthroplasty[J].J Arthroplasty,2014,29(5):993-997.
[21] 袁义,章海均,张波,等.早期间断夹闭引流管对全膝关节置换术后出血量影响的病例对照研究[J].中国骨伤,2019,32(1):60-63.
[22] WANG Z, SHEN X.The efficacy of combined intra-articular and intravenous tranexamic acid for blood loss in primary total knee arthroplasty:a meta-analysis[J].Medicine(Baltimore),2017,96(42):e8123.
[23] ZHANG L K,MA J X,KUANG M J,et al.The efficacy of tranexamic acid using oral administration in total knee arthroplasty:a systematic review and meta-analysis[J].J Orthop Surg Res,2017,12(1):159.
[24] ZHANG P,LI J F,WANG X.Combined versus single application of tranexamic acid in total knee and hip arthroplasty:a meta-analysis of randomized controlled trials[J].Int J Surg,2017,43:171-180.
[25] 国家卫生计生委公益性行业科研专项《关节置换术安全性与效果评价》项目组,中华医学会骨科学分会关节外科学组,中国医疗保健国际交流促进会骨科分会关节外科委员会,等.中国髋、膝关节置换术加速康复——围术期管理策略专家共识[J].中华骨与关节外科杂志,2016,9(1):1-9.
[26] 国家卫生计生委公益性行业科研专项《关节置换术安全性与效果评价》项目组.中国髋、膝关节置换术围术期抗纤溶药序贯抗凝血药应用方案的专家共识[J].中华骨与关节外科杂志,2015,8(4):281-285.
[27] 高乐才,吴文元,魏金栋,等.术后抗凝对膝关节置换术后隐性失血影响的临床观察[J].河北医药,2013,35(6):880-882.
[28] ERSKINE J G,FRASER C,SIMPSON R,et al.Blood loss with knee joint replacement[J]. J R Coll Surg Edinb,1981,26(5):295-297.
[29] 陶坤,吴海山,李晓华,等.闭式引流在全膝关节置换术中的作用评价[J].中华外科杂志,2006,44(16):1111-1114.
[30] 郑婧,张贵君,韦敏,等.五加皮药材基原、化学成分及药理作用研究进展[J].辽宁中医药大学学报,2015,17(8):104-107.
[31] 傅兴圣,陈菲,刘训红,等.大黄化学成分与药理作用研究新进展[J].中国新药杂志,2011,20(16):1534-1538.
[32] 郑勇凤,王佳婧,傅超美,等.黄芩的化学成分与药理作用研究进展[J].中成药,2016,38(1):141- 147.
[33] CHINNAM N,DADI P K,SABRI S A,et al.Dietary bioflavonoids inhibit escherichia coli ATP synthase in differential manner[J].Int J Biolo Macromol,2010,46(5):478-486.
[34] DAI B D,CAO Y Y,HUANG S,et al.Baicalein induces programmed cell death in Candida albicans[J].J Microbiol Biotechnol,2009,19(8):803-809.
[35] 邝枣园,符林春,罗海燕,等.从受体角度探讨黄芩苷对肺炎衣原体感染细胞的干预作用[J].广州中医药大学学报,2005,22(3):210-212.
[36] 孟祥乐,李红伟,李颜,等.栀子化学成分及其药理作用研究进展[J].中国新药杂志,2011,20(11): 959-967.
[37] 那莎,龙子江,王宗殿,等.栀子总皂苷对肝郁脾虚型慢性肝炎大鼠血液流变学的影响[J].江苏中医药,2005,26(1):52-54.
[38] 林清,张建军,李伟,等.五倍子与黄柏外用治疗急性湿疹的配伍合理性研究[J].中华中医药杂志,2011,26(9):2126-2129.
[39] 李燕妮,徐东红,代科科,等.复方黄柏液外用治疗新生儿脓疱疹34例[J].河南中医,2014,34(10):1993.
[40] 张亚范,崔桂香,李辉.石膏黄柏外用治疗关节扭伤106例疗效观察[J].青岛医药卫生,2004,36(3):208.
[41] 蒋燕萍,甘彦雄,严鑫,等.自然铜的研究进展[J].中药与临床,2016,7(1):62-64.
[42] 檀龙颜,马洪娜.骨碎补药理作用的研究进展[J].中国民族民间医药,2017,26(11):66-70.
[43] 蒋海峰,宿树兰,欧阳臻,等.乳香、没药提取物及其配伍对血小板聚集与抗凝血酶活性的影响[J].中国实验方剂学杂志,2011,17(19):160-165.
[44] 李东晓,邓文龙.冰片促透作用研究进展[J].中药药理与临床,2007,23(1):87-88.

相似文献/References:

[1]邢金明.切开复位锁定钢板内固定术和人工半肩关节置换术 治疗老年肱骨近端复杂骨折的对比研究[J].中医正骨,2015,27(08):11.
　XING Jinming.A retrospective trial of open reduction and locking plate internal fixation versus artificial shoulder hemiarthroplasty for complicated proximal humeral fractures in old patients[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(04):11.
[2]赵云昌.人工股骨头置换治疗老年粉碎性股骨转子间骨折[J].中医正骨,2015,27(08):31.
[3]张明强.生物型加长柄半髋关节置换术治疗 高龄不稳定股骨转子间骨折疗效观察[J].中医正骨,2015,27(02):56.
[4]蔡云仙.围手术期耳穴按压联合平衡针疗法 在全膝关节置换术后镇痛中的应用[J].中医正骨,2015,27(06):41.
[5]喻长纯,杨明路,王战朝.不同手术方式治疗胫骨平台骨折畸形愈合的体会[J].中医正骨,2015,27(03):37.
[6]魏瑄,宋树春,王金良.术前精确测量和评估在全髋关节置换治疗 成人发育性髋关节发育不良继发骨关节炎中的价值[J].中医正骨,2015,27(01):30.
[7]鲍荣华,陈晓东,王国平,等.Wagner Cone生物型假体置换结合经股骨转子下横形截骨 治疗CroweⅣ型成人发育性髋关节发育不良[J].中医正骨,2015,27(01):33.
[8]喻长纯,杨明路,王战朝.同期髌骨脱位矫正术联合全膝关节置换术治疗 晚期膝骨关节炎合并习惯性髌骨脱位[J].中医正骨,2015,27(01):41.
[9]武理国,沈军,傅国海,等.人工肱骨头置换治疗老年肱骨近端复杂骨折[J].中医正骨,2013,25(10):70.
[10]李国梁,韩广普,闫国强,等.红花化瘀汤薰蒸联合理筋手法 在膝骨关节炎全膝关节置换术后康复中的应用[J].中医正骨,2013,25(12):31.
　Li Guoliang*,Han Guangpu,Yan Guoqiang,et al.Clinical application of HONGHUAHUAYU decoctions steaming combined with sinew adjusting manipulation in the postoperative rehabilitation of total knee arthroplasty in patients with knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2013,25(04):31.
[11]樊庆阳,任凯晶.定制3D打印切模辅助全膝关节置换术治疗 膝骨关节炎合并股骨干骨折畸形愈合[J].中医正骨,2015,27(11):37.
[12]李翰林,童培建.利福平联合用药配合保留假体清创治疗 人工关节置换术后早期感染及低毒性感染[J].中医正骨,2015,27(09):56.
[13]刘晓雅,孙永强,刘国杰.主动快速康复锻炼对全膝关节置换术后关节活动度的影响[J].中医正骨,2015,27(09):73.
[14]张维平,康两期,陈卫,等.全髋关节置换术围手术期隐性失血的研究进展[J].中医正骨,2015,27(08):61.
[15]宋兵华,孙俊英,倪增良,等.全膝关节置换术前CT测量股骨后髁角的临床意义[J].中医正骨,2015,27(07):38.
[16]王金良,孙京涛,李玲,等.骨水泥联合螺钉修复全膝关节置换术中 胫骨平台内侧骨缺损[J].中医正骨,2015,27(12):55.
[17]徐伟锋,叶健,吴连国.强骨饮对骨质疏松性股骨颈骨折患者全髋关节置换术后 血清骨代谢生化指标和骨密度的影响[J].中医正骨,2015,27(02):12.
　XU Weifeng,YE Jian,WU Lianguo.Effect of Qianggu Yin(强骨饮,QGY)on serum bone metabolism indexes and bone density after total hip arthroplasty in patients with osteoporotic femoral neck fractures[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(04):12.
[18]张荣,王健.人工全膝关节置换术的围手术期心理护理[J].中医正骨,2015,27(05):77.
[19]齐志远,陈秀民,王在斌,等.桃红四物加黄芪汤预防人工髋膝关节置换术后 下肢深静脉血栓形成[J].中医正骨,2015,27(03):71.
[20]陆吴超,季卫锋,马镇川.关节镜下清创后持续灌洗联合中药口服治疗 全膝关节置换术后急性期感染[J].中医正骨,2015,27(01):51.

备注/Memo

备注/Memo:
(收稿日期:2020-01-09 本文编辑:李晓乐)通讯作者:徐福东 E-mail:xfd2004@qq.com
更新日期/Last Update: 2020-07-31