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

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。

Application of Osteoking to patients who received surgery for treatment of middle-lower tibial fractures and its mechanism of action

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+/-0.50μg/L,t=-11.789,P=0.000;121.06+/-10.49 vs 67.13+/-6.23μg/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+/-0.49μg/L,t=-9.010,P=0.000;120.27+/-11.90 vs 77.33+/-7.74μg/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.