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Volume 41 Issue 7
Jul.  2023
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PAN Yuqiang, MA Minghua, ZHANG Ruoxi, ZHANG Yijun, XU Lingling, NIAN Hua. Curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture after PVP[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(7): 437-442. doi: 10.12206/j.issn.2097-2024.202108038
Citation: PAN Yuqiang, MA Minghua, ZHANG Ruoxi, ZHANG Yijun, XU Lingling, NIAN Hua. Curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture after PVP[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(7): 437-442. doi: 10.12206/j.issn.2097-2024.202108038

Curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture after PVP

doi: 10.12206/j.issn.2097-2024.202108038
  • Received Date: 2021-08-10
  • Rev Recd Date: 2022-01-17
  • Available Online: 2023-07-14
  • Publish Date: 2023-07-25
  •   Objective  To study the curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture (OVCF) after percutaneous vertebroplasty (PVP).   Methods  120 OVCF patients treated with PVP in our hospital from January 2016 to September 2017 were divided into the observation group (60 cases) and the control group (60 cases) according to the random number table method. The control group was given calcium carbonate D3 chewable tablets orally with routine guidance. In addition to the same treatment as the control group, the observation group received the traditional Chinese medicine paste orally with Baduanjin exercise. Both groups were treated for 6 months and followed-up for 3 years. The curative effects in the two groups after 6 months treatment and the low back pain after 1, 3 and 6 months of treatment were recorded. The changes of bone mineral density (BMD), kyphosis angle (Cobb angle), anterior wall height of vertebral body (AVBH) and level of bone metabolism indexes in the two groups were compared before and after treatment for 6 months. The follow-up times and the incidences of push-back fracture after PVP during follow-up were recorded.   Results  After 6 months of treatment, the clinical cure rate of the observation group was 73.33%, which was higher than 53.33% of the control group(P<0.05). Compared with pretreatment, the scores of visual analogue scale (VAS) in the two groups gradually decreased after 3 and 6 months of treatment, and the observation group had a lower scores than the control group (P<0.05). After 6 months treatment, BMD and AVBH of lumbar vertebrae and femoral neck in both groups increased, and the observation group was higher than that in the control group. The Cobb angle and serum levels of Type I procollagen degradation products (β-Cross I), the n-terminal middle osteocalcin (N-MID Ost) and parathyroid hormone (PTH) decreased in both groups, and the observation group was lower than those in the control group (P<0.05). There was no significant difference in fracture incidence after PVP in the year 1, year 1 to 3 follow up between the two groups (P>0.05). During the 3 years follow-up, the incidence of push-body fracture after PVP in the observation group was 3.33%, which was lower than that in the control group 20.00%( P<0.05).   Conclusion  Traditional Chinese medicine paste combined with Baduanjin reduced the serum levels of β-Cross I, N-MID Ost and PTH, regulated bone metabolism, improved BMD and AVBH of lumbar vertebrae and femoral neck, reduced Cobb angle, promoted the recovery of lumbar function, alleviated patients' back pain, lowered the incidence of push-body fracture after PVP. The curative effects were remarkable.
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Curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture after PVP

doi: 10.12206/j.issn.2097-2024.202108038

Abstract:   Objective  To study the curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture (OVCF) after percutaneous vertebroplasty (PVP).   Methods  120 OVCF patients treated with PVP in our hospital from January 2016 to September 2017 were divided into the observation group (60 cases) and the control group (60 cases) according to the random number table method. The control group was given calcium carbonate D3 chewable tablets orally with routine guidance. In addition to the same treatment as the control group, the observation group received the traditional Chinese medicine paste orally with Baduanjin exercise. Both groups were treated for 6 months and followed-up for 3 years. The curative effects in the two groups after 6 months treatment and the low back pain after 1, 3 and 6 months of treatment were recorded. The changes of bone mineral density (BMD), kyphosis angle (Cobb angle), anterior wall height of vertebral body (AVBH) and level of bone metabolism indexes in the two groups were compared before and after treatment for 6 months. The follow-up times and the incidences of push-back fracture after PVP during follow-up were recorded.   Results  After 6 months of treatment, the clinical cure rate of the observation group was 73.33%, which was higher than 53.33% of the control group(P<0.05). Compared with pretreatment, the scores of visual analogue scale (VAS) in the two groups gradually decreased after 3 and 6 months of treatment, and the observation group had a lower scores than the control group (P<0.05). After 6 months treatment, BMD and AVBH of lumbar vertebrae and femoral neck in both groups increased, and the observation group was higher than that in the control group. The Cobb angle and serum levels of Type I procollagen degradation products (β-Cross I), the n-terminal middle osteocalcin (N-MID Ost) and parathyroid hormone (PTH) decreased in both groups, and the observation group was lower than those in the control group (P<0.05). There was no significant difference in fracture incidence after PVP in the year 1, year 1 to 3 follow up between the two groups (P>0.05). During the 3 years follow-up, the incidence of push-body fracture after PVP in the observation group was 3.33%, which was lower than that in the control group 20.00%( P<0.05).   Conclusion  Traditional Chinese medicine paste combined with Baduanjin reduced the serum levels of β-Cross I, N-MID Ost and PTH, regulated bone metabolism, improved BMD and AVBH of lumbar vertebrae and femoral neck, reduced Cobb angle, promoted the recovery of lumbar function, alleviated patients' back pain, lowered the incidence of push-body fracture after PVP. The curative effects were remarkable.

PAN Yuqiang, MA Minghua, ZHANG Ruoxi, ZHANG Yijun, XU Lingling, NIAN Hua. Curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture after PVP[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(7): 437-442. doi: 10.12206/j.issn.2097-2024.202108038
Citation: PAN Yuqiang, MA Minghua, ZHANG Ruoxi, ZHANG Yijun, XU Lingling, NIAN Hua. Curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture after PVP[J]. Journal of Pharmaceutical Practice and Service, 2023, 41(7): 437-442. doi: 10.12206/j.issn.2097-2024.202108038
  • 骨质疏松性椎体压缩骨折(OVCF)属于脊柱骨折,多发于中老年人,为临床最为常见的骨质疏松性骨折之一,严重影响患者脊柱功能、日常活动能力等,且发病率、致残、致死率均较高。现阶段,临床多以经皮椎体成形术(PVP)对OVCF患者进行治疗,临床疗效确切,可迅速缓解骨折引起的疼痛,促进椎体形态和功能恢复,但其对患者骨质疏松程度及骨质疏松引起的疼痛改善效果欠佳,故临床倡导PVP术后予以适当的干预以改善手术效果[1]。西医临床常用药物为碳酸钙D3,但有研究[2]指出其对部分患者的干预效果较差,临床多与中医药物干预、锻炼等相结合对PVP术后OVCF患者进行治疗。中医学认为,OVCF属“骨痿”范畴,主要病机为肾精不足、气滞血瘀所致骨质枯槁,肝肾阴虚证为其主要证型之一,应治以滋补肝肾,填精壮骨[3]。中药膏方含阿胶、枸杞子、鸡血藤、党参等,根据临床中药机制可见其有补肾填精、益气健脾、通络止痛等功效,但其对PVP术后OVCF患者的疗效及机制尚未完全明确[4]。故设立本研究,以120例于我院行PVP治疗的OVCF患者为研究对象进行前瞻性随机对照研究,旨在进一步观察中药膏方联合八段锦治疗PVP术后OVCF患者的疗效,为其临床应用提供参考。

    • 前瞻性选取120例2016年1月至2017年9月于我院行PVP治疗的OVCF患者为研究对象,患者均知情同意,按随机数字表法将其分为观察组(60例),对照组(60例)。本研究经我院医学研究伦理研究委员会审核通过。观察组:男35例,女25例;年龄50~80岁,平均(66.27±2.15)岁;体质量指数(BMI)19~25 kg/m2,平均(22.35±0.41)kg/m2;骨质疏松病程1~5年,平均(2.51±0.22)年;骨折病程1~3周,平均(1.55±0.12)周;骨压缩程度[5]:轻度16例,中度30例,重度14例。对照组:男33例,女27例;年龄51~78岁,平均(66.18±2.20)岁;BMI 19~25 kg/m2,平均(22.41±0.42)kg/m2;骨质疏松病程1~5年,平均(2.48±0.20)年;骨折病程1~3周,平均(1.52±0.13)周;骨压缩程度:轻度15例,中度29例,重度16例。两组性别、年龄、BMI、骨质疏松病程、骨折病程、压缩程度等一般资料比较差异无统计学意义(P>0.05),具有可比性。

    • ①中医诊断符合《中医药防治原发性骨质疏松症专家共识(2015)》[6]中肝肾阴虚证相关辩证标准,西医诊断符合《骨质疏松性骨折诊疗指南》[7]中OVCF相关诊断标准,并经临床检查确诊者;②均为胸腰椎骨折,且是首次因OVCF就诊者;③无PVP相关禁忌,手术成功,且术后生命体征平稳者;④近3个月内未行特殊的抗骨质疏松治疗,同期未接受其他治疗者;⑤无脊髓损伤或神经根症状者等。

    • ①椎体爆裂性骨折、陈旧性胸腰椎压缩性骨折或肿瘤、感染等所致病理骨折者;②脊柱结核、骨肿瘤者;③继发性骨质疏松者;④精神障碍、认知能力或沟通能力障碍者;⑤伴严重器官障碍、急性腰扭伤、骨瘤骨转移、强直型脊柱炎、四肢新鲜骨折、软组织损伤者等。

    • 对照组予以碳酸钙D3咀嚼片[重庆海默尼制药有限公司,国药准字H20205039,碳酸钙1.25 g(相当于钙0.50 g)、维生素D3 200 IU]口服,每次1片,每日2次。同时指导患者每天摄入适量豆类、瘦肉、牛奶、鱼类等优质蛋白(1.20~1.40 g/kg),进行适当的日光浴及行走锻炼(30 min以上)。

      观察组在对照组基础上予以中药膏方(将阿胶、枸杞子、鸡血藤、党参各200 g,鹿角胶、茯苓、桑寄生、熟地黄、牛膝、丹参、威灵仙各150 g,龟板胶、白术、骨碎补、神曲各100 g,炙甘草60 g制成膏剂后即得)口服,开水调服,每次10 g,每日2次。同时指导患者进行八段锦锻炼,所用方法为改良八段锦第八式:躯体直立,两足平行分开(与肩同宽),两手臂自然下垂,手指稍并拢,掌指向前,两膝关节屈曲135°~170°;两眼平视前方,微张口,平稳呼吸,全身放松2 min,紧接着保持原来体位尽可能屈膝下蹲,然后在双上臂伸直情况下慢慢上举到水平,慢慢随之站起(保持躯体直立下),至身体直立时顺势将两脚跟向上提起(期间慢慢匀速吸气到最满并憋气),停顿10~15 s;两脚跟下落着地,双手臂随之顺势下落,回到膝关节屈曲位(期间慢慢匀速呼气);每次7个循环,每日3次。两组均治疗6个月,并随访3年。

    • 根据《中药新药临床研究指导原则》[8]可将两组治疗6个月后的疗效分为临床治愈(腰部功能完全恢复,临床症状、体征完全消失,X射线可见压缩椎体恢复正常状态),显效(腰部功能没有完全恢复,临床症状、体征基本消失,X射线可见压缩椎体恢复正常状态),有效(腰部功能没有完全恢复,临床症状、体征减轻,X射线可见大量骨痂形成,但未完全愈合),无效(腰部功能有改善,临床症状、体征有减轻,但X射线可见几乎无骨痂形成)。临床治愈率=临床治愈例数/总例数;显效率=显效例数/总例数;有效率=有效例数/总例数;无效率=无效例数/总例数。总有效率=(临床治愈+显效+有效)例数/总例数。

    • 以疼痛视觉模拟评分法(VAS,0~10分)[9]评估两组治疗1、3、6个月的腰背疼痛情况,得分越高提示患者腰背疼痛程度越严重。

    • 以BMD测定仪(QDR 4500C,美国Hologic公司)检测两组治疗前、治疗6个月后的腰椎、股骨颈BMD;以X射线检查两组治疗前、治疗6个月后的Cobb角、AVBH。

    • 抽取两组治疗前、治疗6个月后的晨起空腹静脉血3 ml,离心机3 000 r/min离心15 min,分离血清,以全自动电化学发光分析仪(罗氏Cobas e601,北京东方迈润医疗器械有限公司)检测血清I型原胶原降解产物(β-Cross I)、N端中段骨钙素(N-MID Ost)、甲状旁腺素(PTH)水平。

    • 记录两组随访时间及随访1年内、1~3年内PVP术后推体再骨折发生率,同1例患者发生多次再骨折仅算1例。

    • 数据采用SPSS 21.0(IBM公司,美国)统计学软件进行分析,计量资料采用($\bar x $±s)表示,组内比较使用配对t检验,治疗前、治疗6个月后的比较使用独立样本t检验,多组间比较采用F检验;计数资料采用[n(%)]表示,使用χ2检验进行比较。

    • 治疗6个月后,观察组临床治愈率为73.33%,高于对照组的53.33%(P<0.05);而两组显效率、有效率、无效率、总有效率比较差异无统计学意义(P>0.05,表1)。

      组别例数临床治愈率显效率有效率无效率总有效率
      观察组6044(73.33)13(21.67)3(5.00)0(0.00)60(100.00)
      对照组6032(53.33)20(33.33)8(13.33)0(0.00)60(100.00)
      χ25.1672.0482.502
      P<0.05>0.05>0.05
    • 治疗前,两组患者VAS评分比较差异无统计学意义(P>0.05)。与治疗前比较,治疗3、6个月后两组VAS评分均降低,且观察组低于对照组(P<0.05);与治疗3个月后比较,治疗6个月后,两组VAS评分均降低(P<0.05,表2)。

      组别例数治疗前治疗3个月后治疗6个月后
      观察组607.55±0.372.47±0.33*1.14±0.23**
      对照组607.52±0.353.51±0.51*2.36±0.42**
      t0.45613.26219.735
      P>0.05<0.05<0.05
      *P<0.05,与治疗前比较;**P<0.05,与治疗3个月后比较
    • 治疗前,两组患者BMD、Cobb角及AVBH比较差异无统计学意义(P>0.05)。与治疗前比较,治疗6个月后两组腰椎、股骨颈BMD及AVBH均升高,且观察组高于对照组(P<0.05);而两组Cobb角均降低,且观察组低于对照组(P<0.05,表3)。

      时间组别例数腰椎BMD(g/cm3)股骨颈BMD(g/cm3)Cobb角(°)AVBH(%)
      治疗前观察组600.70±0.070.68±0.0623.09±2.5153.93±7.26
      对照组600.69±0.080.67±0.0723.11±2.4954.04±7.44
      t0.7290.8400.0440.082
      治疗6个月后观察组600.93±0.08*0.93±0.07*6.47±1.98*96.56±9.41*
      对照组600.84±0.11*0.85±0.08*8.91±2.26*85.73±8.04*
      t5.1255.8296.2906.778
      *P<0.05,与治疗前比较
    • 治疗前,两组患者血清β-Cross I、N-MID Ost、PTH水平比较差异无统计学意义(P>0.05)。与治疗前比较,治疗6个月后,两组血清β-Cross I、N-MID Ost、PTH水平均降低,且观察组低于对照组(P<0.05,表4)。

      时间组别例数β-Cross I(ng/ml)N-MID Ost(ng/ml)PTH(pg/ml)
      治疗前观察组600.79±0.1342.10±9.5362.28±9.42
      对照组600.78±0.1441.98±9.5262.25±9.39
      t0.4050.0690.017
      治疗6个月后观察组600.67±0.10*36.15±5.46*52.47±4.02*
      对照组600.73±0.12*38.93±6.14*57.45±5.72*
      t2.9752.6215.518
      *P<0.05,与治疗前比较
    • 两组患者随访时间、随访1年内、1~3年内PVP术后推体再骨折发生率比较,均无统计学意义(P>0.05);随访3年内,观察组PVP术后推体再骨折发生率为3.33%,低于对照组的20.00%(P<0.05,表5)。

      组别例数随访1年内发生率
      [n(%)]
      随访1~3年内合计
      [n(%)]
      随访时间
      ($\bar x $±s, 年)
      发生率
      [n(%)]
      观察组602(3.33)1.94±0.430(0.00)2(3.33)
      对照组607(11.67)1.86±0.725(8.33)12(20.00)
      t/χ23.0030.7393.3398.086
      P>0.05>0.05>0.05<0.05
    • 骨质疏松为临床常见的慢性骨代谢异常疾病,可见骨钙含量减少、骨量下降,极易出现骨折,OVCF为其临床常见类型。OVCF发病后可致患者出现椎体高度下降、疼痛、功能障碍等,未得到及时有效的治疗,可致残、致死,且其再发骨折风险高[10]。现阶段,微创PVP治疗为大多保守治疗无效的OVCF患者的主要选择,可恢复椎体力学强度、稳定骨折,但骨转换率及骨量流失未能纠正,且手术造成的内外骨膜血管损伤及制动可能会加重骨质疏松而影响患者预后[11]。故PVP术后予以适当的干预治疗至关重要,临床常用药物为碳酸钙D3,其可促进骨质形成而缓解骨质疏松程度,但其多偏重于抑制骨吸收,减轻骨质流失。近年来,越来越多的研究[12-13]发现,中医药治疗PVP术后OVCF有一定成效,其既能抑制流失,又能促进成骨形成,在抗骨质疏松、促进骨折愈合、防治再骨折发生等方面优势明显,现已备受临床医生青睐,但关于何种药物更佳尚无统一定论。

      中医认为OVCF属“骨枯”、“骨萎”、“痹证”等范畴,肾中精气是骨生长发育的根本,脾胃为后天之本,气血生化之源,故其发病机制主要为肾精亏虚、脾精不足所致骨骼失养;外伤导致筋脉损伤、气血运行不畅,加之患者湿热寒邪侵袭、肾脾虚亏,容易加重气滞血瘀症状,使得骨骼和筋骨失去濡养,导致骨关节萎缩、活动不利等而诱发OVCF,故治疗应补肾壮骨、活血行气、舒经通络、消肿止痛[14]。中药膏方中的阿胶、枸杞子、鹿角胶、龟板胶可补血益气、填精益髓,其中,龟鹿二仙胶中鹿角胶、龟板胶为主方,与党参、枸杞子配伍可增强益气养阴、补肾填精益髓之功;鸡血藤可活血补血、舒筋活络、疏风止痛;党参可补中益气、生血行血;茯苓可利水消肿、益气健脾;桑寄生、熟地黄、骨碎补、牛膝可补肾壮骨;丹参、威灵仙、神曲可健脾和胃、消食调中,进而减轻膏方的厚腻;炙甘草可补脾和胃,益气复脉,同时调和诸药;全方可发挥补肾填精、益气健脾、通络止痛之功效[15-16]。同时八段锦作为一种由八节不同动作组成的一套医疗、康复体操,其通过人体垂直方向的应力刺激成骨、下蹲平衡锻炼、膀胱经的经气疏通等可对OVCF患者产生舒筋活络的良好功效,进而有助于促进患者腰部功能恢复,提高患者临床疗效。本研究显示,治疗6个月后,观察组临床治愈率高于对照组,且治疗3、6个月后VAS评分低于对照组,进一步说明中药膏方联合八段锦治疗PVP术后OVCF可有效缓解患者腰背疼痛,疗效显著。

      OVCF的发生发展与骨代谢及转换密切相关,其中,β-Cross I为骨吸收的重要指标,N-MID Ost为骨形成、骨转换的重要指标,可直接反映成骨细胞的活性与数量变化,PTH则可加速骨代谢活跃,促进骨吸收,血清β-Cross I、N-MID Ost、PTH水平升高提示患者骨转换成程度严重,可促进病情进展,不利于PVP术后腰部功能的恢复[17]。本研究显示,治疗6个月后,观察组腰椎、股骨颈BMD及AVBH高于对照组,Cobb角、血清β-Cross I、N-MID Ost、PTH低于对照组,且随访3年内PVP术后推体再骨折发生率低于对照组,提示中药膏方联合八段锦治疗PVP术后OVCF可调节患者机体骨代谢,提高腰椎、股骨颈BMD及AVBH,降低Cobb角,促进腰部功能的恢复,降低PVP术后推体再骨折发生率。PVP术后OVCF患者骨折愈合的本质为骨重建,该过程涉及局部微环境的构建、成骨细胞的活化、大量血管的生成等,而现代药理学研究[18-20]指出,中药膏方中的骨碎补含双氢黄酮苷、黄酮等成分,可提高BMD,刺激成骨细胞增殖分化,防止骨吸收、促进骨形成,发挥抗骨质疏松、促进骨折愈合等作用,进而促进腰部功能的恢复;牛膝含牛膝竹节参皂苷,可发挥较好的抗炎、止痛、改善微循环作用,有助于促进局部微环境的构建而促进患者骨折愈合,进而降低再骨折发生率。同时联合八段锦进行治疗,可有效疏通OVCF患者经络,促进机体气血运行通畅,进而可增强中药膏方促进患者腰部功能恢复的作用,降低患者PVP术后推体再骨折发生率。而对照组由于仅进行常规对症治疗,而未对患者采取中药膏方联合八段锦等治疗,故患者复发的风险明显增加。

      综上,中药膏方联合八段锦治疗PVP术后OVCF可降低其血清β-Cross I、N-MID Ost、PTH水平,调节机体骨代谢,有助于提高腰椎、股骨颈BMD及AVBH,降低Cobb角,促进腰部功能的恢复,进而缓解患者腰背疼痛,降低PVP术后推体再骨折发生率,疗效显著。

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