小夹板治疗老年桡骨远端骨折中夹板束缚力的量化研究
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摘要
背景
     小夹板外固定曾经一直是桡骨远端骨折治疗的标准方法。随着腕部生物力学及显微解剖学的发展,桡骨远端骨折的治疗观念不断更新。临床上对于桡骨远端骨折治疗方式的选择一直存在争议。有学者认为,对于桡骨远端骨折的治疗方法的选择取决于是否存在潜在的不稳定。对于不稳定骨折,有学者认为无论石膏、夹板外固定技术多高,也都不能维持复位后的位置;但对于无移位的稳定骨折或有移位但复位后可维持稳定的骨折,宜采用闭合复位夹板外固定。
     扎带的约束力是夹板固定骨折的动力来源和外载荷,其松紧合适程度关系到治疗效果的成败,是临床治疗的生物力学首要环节和敏感参数。在普通高等教育“十五”国家级规划教材《中医伤科学》也仅仅描述为:捆扎后要求能提起扎带在夹板上下移动1cm,即扎带的拉力为800(g)左右。描述太过模糊,临床操作难标准化。以这样的不确定的标准,在临床实践中会成为不确定因素,使小夹板治疗不能成为一种科学的、量化的治疗方法。
     国内外有测量夹板治疗扎带下压力值的相关研究,但未见有夹板治疗有效固定压力值范围及压力随时间变化的相关临床文献相关报道。正是由于中医小夹板治疗不能量化及标准化治疗,从而使治疗有相当大的差异性,从而影响了疗效,以及小夹板治疗的推广
     目的
     本研究,首先系统地回顾及研究桡骨远端骨折现代中西医文献及古代中医文献。在此基础上,再通过健康自愿者的临床实验研究,在专家组的指导下初步确定扎带维持有效固定的压力值范围,对桡骨远端骨折小夹板治疗进行量化及标准化设定。接着,通过随机对照的临床实验研究,来验证夹板束缚力的量化对桡骨远端骨折(伸直型)临床疗效的影响。最终为小夹板治疗桡骨远端骨折,提供可靠的临床依据及实验基础。
     方法
     实验研究部分:选取健康自愿者10名,在专家组的指导下,模拟桡骨远端骨折(伸直型)行小夹板固定,测定不同条件下束缚力的时间衰减情况;接着测定不同条件下压力值的变化情况;然后对测出数值分析,确定维持有效固定的扎带压力范围值,对治疗进行量化及标准化设定。
     临床研究部分:对符合纳入条件的66名广东省中医院桡骨远端骨折(伸直型)患者分组,均随访3个月,并在12,30,60,90天时行X射线检查,复位后1、2、3月进解剖评分标准评分、Dienst功能评估标准评分,并进行统计学分析。安全性指标为不良反应,包括压疮、指端感觉、血运。
     结果
     实验研究部分:对不同专家完成小夹板固定测定压力进行组间比较,P<0.05,有差异有显著性意义;再分别进行静态组(不功能锻炼)和动态组(功能锻炼)测定,组间比较P<0.05,差异有统计学意义,动态组压力值衰减较静态组早,固定中期衰减较静态组大,后期两者压力相当。通过实验,还证实压力受随体位、肢体变化情况影响。根据研究,初步确定扎带有效固定的压力值范围为600±100(g),绑扎的初始压力值应在600±50(g)。根据压力衰减情况,建议病人早期需要每天换药;初步确定了量化方案。
     临床研究部分:测量组、对照组两组间性别、年龄、解剖评估标准评分、Dienst功能评估标准评分,情况均衡,具有可比性。治疗1、2、3月后,测量组与治疗组比较,解剖评估差异有显著性意义(P<0.01、P<0.01、P<0.01),测量组的解剖改善明显优于对照组;疗效评分差异有显著性意义(P<0.05、P<0.01、P<0.01),测量组的疗效优于对照组。
     结论
     1.桡骨远端骨折通过手法复位,多数可以使骨折得到良好的复位,恢复相对正常的解剖,而这种解剖关系在骨折愈合过程中能否得到保持,会影响疗效。
     2.临床研究,我们认为固定的有效性是影响骨折稳定性的重要的影响因素,特别是对于不稳定骨折意义更大。而固定的有效性,受扎带束缚力的影响,而扎带束缚力的影响因素包括肢体周径(肿胀)的变化、肢体的活动(包括功能锻炼等)、肢体的位置的影响。
     3.小夹板外固定量化治疗非常必要。从材料上讲,夹板局部外固定系统性质不稳定,具有明显的黏弹性特性和各向异性。多种因素会给骨折的临床治疗效果带来不确定性影响疗效。通过量化能维持小夹板有效固定,能够减少骨折再移位的发生,提高疗效;对于不稳定骨折,也能较好维持复位后的位置;同时减少并发症的发生
     4.解剖估标准评与Dienst功能评估标准评分正相关,但并非简单的正相关,功能的改善除了与复位相关,还与软组织情况相关,也体现了中医“筋骨并重”的理念。
     5.结合专家指导意见,我们的量化意见如下:老年患者维持有效固定的压力在600±100g左右,绑扎的初始压力值应在600±50g左右;固定在前臂中立位为宜;早期需每日调整扎带,骨折初步愈合后隔日调整;行功能锻炼。临床研究证实,量化方案可以提高疗效。
Objectives
     The present study was aimed at providing reliable basis for treatment of distal radial fractures with small splints by both clinical and experimental investigations. Firstly, through the study of clinical trials in healthy volunteers under the guidance of expert group, we measured and analyzed the decay time of binding force, to further quantify and standardize the treatment of distal radial fracture by small splints, which helps initially determine the effective range of pressure to fix the fracture. Then, randomized controlled clinical study was performed to verify the clinical efficacy of the quantitative binding force on the splints for the treatment of distal radial fracture (Straight Type).
     Methods
     Experimental research:10 healthy volunteers were selected, and simulated distal radial fracture (Straight Type) line splintage. Under the guidance of the expert group, we measured the force provided by splints under different conditions and how it decayed over time. Then by statistical analysis, we determined the appropriate range of pressure to maintain the effective fix of fracture, set the treatment to a quantified and standardized model.
     clinical research:66 eligible patients of distal radial fracture (Straight Type) from Guangdong Provincial Hospital of Chinese Medicine were included, grouped as Experimental Group and Controlled Group randomly, and followed up for 3 months. At 12,30,60,90 days, the patients had X-ray examination of the injured forearm. And anatomy of Grading, Dienst functional assessment criteria were applied to assess the treatment effect at 1,2,3 months after reset. These data, as well as safety indicators, including pressure sores, fingers feeling, and blood supply were statistically analyzed.
     Results
     Experimental research:different experts have completed a small splint and measured the pressure. Pressures between groups were statistically significant (P<0.05). The measured pressures between static group (no functional exercise) and dynamic group (functional exercise) were statistically significant (P<0.05). The pressure of the dynamic group decays earlier than that of static group. At the midterm the pressure of the dynamic group is less than the other group. At the advanced stage the pressure of the two groups were similar. We also found that the position of limbs, swelling of limbs also effect the pressure. According to the study, the initial pressure to determine the value of the fixed tie the effective range of 600±100g, based on the pressure decay, suggesting that patients require daily dressing changes early. Initially set the quantization scheme.
     Clinical research:Basic characteristics of gender, age, anatomical evaluation criteria score, Dienst functional evaluation criteria score, were balanced between the two groups of measured and controlled groups.1,2,3 months after treatment, anatomical assessment of the two groups was significantly different (P<0.01, P<0.01, P<0.01), with better improvement achieved by measured group than the controlled group. Efficacy scores between groups were significantly different (P<0.05, P<0.01, P<0.01), measured group has superior clinical effect to controlled group.
     Conclusions
     1. The majority of distal radical fractures through the gimmick reset can be well reseted, restore relatively normal anatomy, and this anatomical relationship in the fracture healing process can be maintained, whether the shift will happen again, that can affect the efficacy.
     2. In addition to the factors that affect the stability of the fracture energy and the injured degree of metaphyseal comminution, bone quality, through clinical research, we believe that the effectiveness of the fixed factors are also important, especially for unstable fractures more meaningful. And fixed by the binding force of the impact of cable ties, cable ties binding force of the impact of factors.Such as, the material mechanics factors with karzai, changes in body weeks diameter, physical activity (Including functional training, etc.), and location of body.
     3. Quantitative treatment of small splints is necessary. From the materials perspective, local external splint fixation system unstable, with a clear viscoelastic properties and anisotropy. Will fracture a variety of factors cause the uncertainty of treatment efficacy? By maintaining a small splint to quantify the effective fixed, and then shift to reduce the incidence of fractures, improve the efficacy; for unstable fractures, can also better maintain the reset position; while reducing complications.
     4. Dienst anatomical assessment and functional assessment standard evaluation criteria score is related to, but not simple correlation, functional improvement in addition to associated with the reduction, but also relevant in the case of soft tissue, also reflects the traditional Chinese medicine "bones and muscles are both important" concept.
     5. With expert guidance, we quantified the following views:elderly patients to maintain an effective constant pressure of about 600±100g, the initial lashing pressure should be around 600±50g; fixed the forearm in neutral position is appropriate; early to be adjusted daily cable ties, fracture healing after the initial adjustment the next day; line functional exercise. Clinical studies to quantify the program could improve the outcome.
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