[1]何帮剑,毛强,华江,等.恒古骨伤愈合剂在胫骨中下段骨折术后的应用及作用机制[J].中医正骨,2020,32(05):15-18.
　HE Bangjian,MAO Qiang,HUA Jiang,et al.Application of Osteoking to patients who received surgery for treatment of middle-lower tibial fractures and its mechanism of action[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(05):15-18.
点击复制

恒古骨伤愈合剂在胫骨中下段骨折术后的应用及作用机制()
分享到：

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期数:
2020年05期
页码:
15-18
栏目:
临床研究
出版日期:
2020-05-20

文章信息/Info

Title:
Application of Osteoking to patients who received surgery for treatment of middle-lower tibial fractures and its mechanism of action
作者:
何帮剑; 毛强; 华江; 童培建
(浙江省中医院,浙江 杭州 310006)
Author(s):
HE Bangjian; MAO Qiang; HUA Jiang; TONG Peijian
Zhejiang Provincial Hospital of Traditional Chinese Medicine,Hangzhou 310006,Zhejiang,China
关键词:
胫骨骨折;  恒古骨伤愈合剂;  桃红四物汤;  骨折愈合;  手术后并发症;  碱性磷酸酶;  骨钙素;  Ⅰ型前胶原羧基末端前肽
摘要:
目的:探讨恒古骨伤愈合剂在胫骨中下段骨折术后的应用价值及作用机制。方法:胫骨中下段骨折患者65例,随机分为2组,恒古骨伤愈合剂组32例、桃红四物汤组33例。2组患者均采用微创经皮锁定加压钢板内固定手术治疗,手术均由同一组医生完成。术后第1天开始,恒古骨伤愈合剂组患者予以恒古骨伤愈合剂口服,每次25 mL,每2日1次; 桃红四物汤组患者予以桃红四物汤口服,每日1剂,每日早晚各1次; 共服用4周。记录术后患肢肿胀消退时间、瘀斑消失时间及骨折愈合时间。分别于服药前和服药4周后,采用疼痛视觉模拟量表(visual analogue scale,VAS)对患肢疼痛情况进行评分; 检测患者血清中碱性磷酸酶(alkaline phosphatase,ALP)、骨钙素(bone gla-protein,BGP)及Ⅰ型前胶原羧基末端前肽(carboxy terminal propeptide of typeⅠprocollagen,PⅠCP)含量。术后12个月,参照Johner-Wruhs胫骨骨折疗效评价标准评价综合疗效。结果:65例患者均顺利完成手术和术后治疗; 均获随访,随访时间12～26个月,中位数18个月。恒古骨伤愈合剂组,术后患肢肿胀消退时间、瘀斑消失时间及骨折愈合时间均短于桃红四物汤组[(15.03±2.29)d,(18.52±3.51)d,t=-4.722,P=0.000;(19.09±2.96)d,(24.09±3.23)d,t=-6.497,P=0.000;(22.47±3.32)周,(26.79±2.89)周,t=-5.597,P=0.000]。服药前,2组患者患肢疼痛VAS评分比较,差异无统计学意义(t=0.995,P=0.324); 服药4周后,2组患者患肢疼痛VAS评分均较服药前降低[(7.28±0.77)分,(2.75±0.76)分,t=26.070,P=0.000;(7.06±0.99)分,(3.18±0.85)分,t=17.913,P=0.000],且恒古骨伤愈合剂组患肢疼痛VAS评分低于桃红四物汤组(t=-2.160,P=0.035)。服药前,2组患者血清ALP、BGP、PⅠCP含量比较,组间差异均无统计学意义(t=-0.344,P=0.732; t=0.653,P=0.561; t=0.283,P=0.778); 服药4周后,2组患者血清ALP、BGP含量较服药前增加、PⅠCP含量较服药前降低[恒古骨伤愈合剂组:(74.88±6.43)单位·L-1,(128.91±10.10)单位·L-1,t=-26.581,P=0.000;(2.26±0.39)μg·L-1,(3.76±0.50)μg·L-1,t=-11.789,P=0.000;(121.06±10.49)μg·L-1,(67.13±6.23)μg·L-1,t=23.366,P=0.000; 桃红四物汤组:(75.45±7.12)单位·L-1,(112.33±7.86)单位·L-1,t=-20.542,P=0.000;(2.20±0.37)μg·L-1,(3.15±0.49)μg·L-1,t=-9.010,P=0.000;(120.27±11.90)μg·L-1,(77.33±7.74)μg·L-1,t=16.951,P=0.000],且恒古骨伤愈合剂组血清ALP、BGP含量高于桃红四物汤组(t=7.395,P=0.000; t=4.987,P=0.000)、PⅠCP含量低于桃红四物汤组(t=-5.844,P=0.000)。术后12个月参照上述疗效评价标准,恒古骨伤愈合剂组优19例、良11例、可2例,桃红四物汤组优16例、良9例、可8例,恒古骨伤愈合剂组的综合疗效优于桃红四物汤组(Z=-6.377,P=0.000)。结论:恒古骨伤愈合剂用于胫骨中下段骨折的术后治疗,可缓解患肢疼痛,促进术后患肢肿胀消退、瘀斑消失及骨折愈合,综合疗效优于桃红四物汤; 其作用机制可能与提高患者血清中ALP、BGP含量、降低血清中PⅠCP含量,调节骨代谢有关。
Abstract:
Objective:To explore the applied values and mechanism of action of Osteoking(OK)in patients who recevied surgery for treatment of middle-lower tibial fractures.Methods:Sixty-five patients with middle-lower tibial fractures were selected and randomly divided into OK group(32 cases)and Taohong Siwu Tang(桃红四物汤,THSWT)group(33 cases).The patients in the 2 groups were treated with minimally invasive percutaneous locking compression plate internal fixation by the same group of surgeons.From postoperative day 1,the patients in OK group were treated with oral application of OK,once every 2 days for consecutive 4 weeks,25 mL at a time; while the patients in THSWT group were treated with oral application of THSWT,one dose a day in the morning and evening respectively for consecutive 4 weeks.The postoperative swelling subsidence time,ecchymoses extinction time and fracture healing time of affected limbs were recorded.The affected limb pain was evaluated by using visual analogue scale(VAS)and the serum contents of alkaline phosphatase(ALP),bone gla-protein(BGP)and carboxy terminal propeptide of typeⅠprocollagen(PⅠCP)were detected before medication and after 4-week medication respectively.The total clinical curative effects were evaluated according to Johner-Wruhs therapeutic effect evaluation standard of tibial fracture at 12 months after surgery.Results:The surgeries and postoperative treatments were finished successfully in all patients,and all patients in the 2 groups were followed up for 12-26 months with a median of 18 months.The postoperative swelling subsidence time,ecchymoses extinction time and fracture healing time of affected limbs were shorter in OK group compared to THSWT group(15.03+/-2.29 vs 18.52+/-3.51 days,t=-4.722,P=0.000; 19.09+/-2.96 vs 24.09+/-3.23 days,t=-6.497,P=0.000; 22.47+/-3.32 vs 26.79+/-2.89 weeks,t=-5.597,P=0.000).There was no statistical difference in pain VAS scores between the 2 groups before medication(t=0.995,P=0.324).The pain VAS scores decreased after 4-week medication compared to pre-medication in the 2 groups(7.28+/-0.77 vs 2.75+/-0.76 points,t=26.070,P=0.000; 7.06+/-0.99 vs 3.18+/-0.85 points,t=17.913,P=0.000),and was lower in OK group compared to THSWT group(t=-2.160,P=0.035).There was no statistical difference in serum contents of ALP,BGP and PⅠCP between the 2 groups before medication(t=-0.344,P=0.732; t=0.653,P=0.561; t=0.283,P=0.778).The serum contents of ALP and BGP increased,while the serum content of PⅠCP decreased after 4-week medication compared to pre-medication(OK group:74.88+/-6.43 vs 128.91+/-10.10 unit/L,t=-26.581,P=0.000; 2.26+/-0.39 vs 3.76+/-0.50 μg/L,t=-11.789,P=0.000; 121.06+/-10.49 vs 67.13+/-6.23 μg/L,t=23.366,P=0.000; THSWT group:75.45+/-7.12 vs 112.33+/-7.86 unit/L,t=-20.542,P=0.000; 2.20+/-0.37 vs 3.15+/-0.49 μg/L,t=-9.010,P=0.000; 120.27+/-11.90 vs 77.33+/-7.74 μg/L,t=16.951,P=0.000),and the serum contents of ALP and BGP were higher and the serum content of PⅠCP was lower in OK group compared to THSWT group(t=7.395,P=0.000; t=4.987,P=0.000; t=-5.844,P=0.000).The total clinical curative effects were evaluated according to Johner-Wruhs therapeutic effect evaluation standard of tibial fracture at 12 months after surgery.Nineteen patients obtained an excellent result,11 good and 2 fair in OK group; while 16 patients obtained an excellent result,9 good and 8 fair in THSWT group.The OK group surpassed the THSWT group in total clinical curative effects(Z=-6.377,P=0.000).Conclusion:OK can relieve the pain and promote swelling subsidence,ecchymoses extinction and fracture healing in patients who recevied surgery for treatment of middle-lower tibial fractures,and its clinical curative effects is better than that of THSWT.Its mechanisms of action may be that it can regulate the bone metabolism through increasing the serum contents of ALP and BGP and decreasing the serum content of PⅠCP.

参考文献/References:

[1] WENNERGREN D,BERGDAHL C,EKELUND J.Epidemiology and incidence of tibia fractures in the Swedish Fracture Register[J].Injury,2018,49(11):2068-2074.
[2] HU L C,XIONG Y,MI B B,et al Comparison of intramedullary nailing and plate fixation in distal tibial fractures with metaphyseal damage:a meta-analysis of randomized controlled trials[J].J Orthop Surg Res,2019,14(1):30.
[3] 袁鑫,武羽洁,角建林,等.彝药恒古骨伤愈合剂的药理作用和临床应用[J].中国现代应用药学,2019,36(3):372-376.
[4] RüEDI T P,BUCKLEY R E,MORAN C G.骨折治疗的AO原则[M].危杰,刘璠,吴新宝,等译.2版.上海:上海科学技术出版社,2010:5.
[5] 黄桂成,王拥军.中医骨伤科学(新世纪第四版)[M].北京:中国中医药出版社,2016:7.
[6] JOHNER R,WRUHS O.Classification of tibial shaft fractures and correlation with results after rigid internal fixation[J].Clin Orthop Relat Res,1983,(178):7-25.
[7] 常文利,张英泽,陈伟.胫骨中下段骨折不愈合原因的研究进展[J].中国骨与关节杂志,2017,6(9):713-716.
[8] ANDALIB A,SHEIKHBAHAEI E,ANDALIB Z,et al.Effectiveness of minimally invasive plate osteosynthesis(MIPO)on comminuted tibial or femoral fractures[J].Arch Bone Jt Surg,2017,5(5):290-295.
[9] 魏英俊,徐克武,蒋宜伟,等.胫骨骨折内固定术后感染的相关危险因素[J].中医正骨,2018,30(5):37-39.
[10] 朱小龙,徐卫星,盛红枫,等.微创锁定加压钢板内固定治疗胫骨中下段骨折[J].中医正骨,2019,31(3):60-62.
[11] 殷兵,张奇,张英泽.胫骨骨不连的手术治疗进展[J].中国矫形外科杂志,2010,18(20):1701-1703.
[12] LI J L.Effect of ossotide injection on the bone metabolism and bone mineral density in patients with femoral intertrochanteric fracture[J].J Hainan Med Univers,2016,22(20):70-73.
[13] 钱雪丰,曹平,刘拴,等.仙灵骨葆辅助外科治疗老年妇女Colles骨折的愈合时间、钙磷含量及骨代谢的评估[J].海南医学院学报,2017,23(2):281-284.
[14] 任保红,张志忠,谢鹏.骨康胶囊对老年桡骨远端骨折患者术后愈合的影响[J].中南医学科学杂志,2018,46(2):183-185.
[15] VAN BAARDEWIJK L J,VAN DER ENDE J,LISSENBERG-THUNNISSEN S,et al.Circulating bone morphogenetic protein levels and delayed fracture healing[J].Int Orthop,2013,37(3):523-527.
[16] 王建年.骨康胶囊辅助外科治疗后老年桡骨远端骨折患者的骨折愈合、微循环状态以及骨代谢的评估[J].海南医学院学报,2016,22(19):2294-2297.
[17] 赵超,张本政,冯和林.中医药干预骨折愈合过程的机制及实验研究进展[J].河北中医,2017,39(12):1904-1907.
[18] 陈弘林,涂来勇,赵疆,等.用于骨折延迟愈合和骨折不愈合的中药汤剂的用药规律研究[J].中医正骨,2018,30(12):37-39.
[19] 高淑兰,周芳,亢孝弟,等.化瘀止痛散在桡骨远端骨折治疗中的疗效观察[J].中国医院药学杂志,2014,34(3):224-226.
[20] 李秀秀,金中义,金福厚.桃红四物汤促进骨折愈合的实验研究进展[J].云南中医中药杂志,2015,36(10):79-81.

相似文献/References:

[1]肖善富,张喜善,于凤珍.髌下小切口钢丝纽扣式内固定治疗胫骨髁间隆突骨折[J].中医正骨,2015,27(11):34.
[2]葛波涌,王玉波,王明太,等.交锁髓内钉内固定治疗胫骨干骨折的临床研究[J].中医正骨,2015,27(10):8.
　GE Boyong,WANG Yubo,WANG Mingtai,et al.Clinical study on the internal fixation with interlocking intramedullary nail for the treatment of tibial shaft fractures[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(05):8.
[3]全先辉,万春友,刘磊,等.Taylor空间支架外固定治疗胫腓骨开放性骨折[J].中医正骨,2015,27(10):30.
[4]何 涛.有限切开植骨钢板内固定治疗 SchatzkerⅡ、Ⅲ型胫骨平台骨折[J].中医正骨,2015,27(09):22.
[5]何忠,黄宗权,王强,等.胫骨中下段螺旋形骨折合并后踝裂纹骨折的诊治体会[J].中医正骨,2015,27(09):28.
[6]王庆东,李付彬,徐向峰,等.关节镜下可吸收螺钉内固定治疗儿童胫骨髁间嵴骨折[J].中医正骨,2015,27(12):52.
[7]李楠,李锋.胫骨平台骨折的手术治疗进展[J].中医正骨,2015,27(12):78.
[8]张一鸣,张学民,陆洲.经皮解剖型锁定钢板固定治疗胫骨远端骨折[J].中医正骨,2015,27(02):47.
[9]陈利军,田野,刘文刚,等.非典型膝关节外伤后胫骨近端隐匿性骨折的影像诊断[J].中医正骨,2015,27(06):26.
[10]徐俊峰,王翔宇.切开复位锁定加压钢板内固定治疗高能量损伤Pilon骨折[J].中医正骨,2015,27(06):54.

备注/Memo

备注/Memo:
(收稿日期:2019-11-06 本文编辑:杨雅)通讯作者:华江 E-mail:185179655@qq.com
更新日期/Last Update: 2020-08-15