补骨颗粒配合小夹板治疗骨质疏松性Colles骨折

发布时间：2018-08-02 10:13

【摘要】：目的:运用"补骨颗粒"对老年骨质疏松性colles骨折进行叠加治疗,观察其治疗效果,验证其有效性,为骨质疏松性colles骨折患者提供一个便捷安全的有效防治方法,为其临床推广提供有效依据。方法:在2015年5月至2016年11月期间纳入67例在广州中医药大学附属湛江市第二中医医院治疗的骨质疏松性colles骨折患者,将这67例患者按随机数字表法分为两组,治疗组34例,对照组33例,治疗期间,治疗组4例患者脱落,对照组3例脱落。治疗前,两组患者在性别、年龄、骨密度基线资料经统计学比较,P0.05,无统计比较意义。对照组B组采用三联抗骨质疏松用药治疗:口服碳酸钙D3,每日一次,一次一片;口服骨化三醇片,每日一次,一次一片;鲑鱼降钙素注射液,50IU/d,肌肉注射2周后改为每周1次。治疗组A患者在对照组的基础上于骨折1周后加服用本院中药配方补骨颗粒,方药组成:骨碎补1包(10g)、三七2包(3g)、鹿角霜1包(10g)、黄芪1包(10g)、肉苁蓉1包(10g)、千斤拔1包(10g)、熟地1包(10g)、当归1包(10g)、白芍1包(10g),(中药颗粒为广东一方制药有限公司生产)水冲服,每日1剂,分2次服。两组中患者无移位骨折或不完全骨折不需要整复,仅用小夹板固定2-4周即可。有移位的骨折均采用手法复位,拍片检查,如骨折对位欠佳或棉垫位置不当,及时纠正,前臂保持中立位挂于胸前。坚持握拳锻炼。视患者骨折愈合情况,一般4周后拆除夹板。各组患者治疗期均为3个月,临床追踪调查期为3个月,按照要求在相应时间点即治疗期间1月、2月、3月如实记录两组患者相关评分数据:疼痛、功能状态、握力、主观感受、客观评价、并发症、骨折愈合情况。禁止所有患者在治疗期间使用除了试验药物之外的药物。运用SPSS18.0统计软件对取得的临床数据进行统计分析,数据以均数土标准差用(x±s)表示,用t检验分析计量资料,X2检验分析计数资料,秩和检验分析等级资料,重复测量设计采用方差分析,当P0.05时认为两组数据之间存在显著性差异,当P0.05时两组数据之间无显著性差异。结果:①治疗组中采用"补骨颗粒"叠加治疗,临床疗效及患者临床症状的改善比对照组明显,且不良反应事件发生率较对照组低,无明显毒副作用。②治疗组30例患者中15例患者痊愈,13例患者好转,总有效率为93.33%,对照组中9例痊愈,15例好转,总有效率为86.66%。经统计学分析比较,P0.05,两组在疗效方面比较存在统计学比较意义。经过治疗后两组患者在Green O'Brien腕关节评分、BMD值与治疗前比较都有积分有较明显提高,肿胀评分较治疗前有明显降低,合并症发生方面,对照组明显较对照组高。两组患者临床症状经治疗后均有改善,且两组治疗后各种指标评分治疗组优于对照组,经过统计学比较P0.05,存在显著性差异。③两组患者在治疗后均有不良反应事件发生,治疗组发生率为13%,对照组为40%。治疗过程中均为未发现肝肾功能损害事件,治疗组中仅有4例对中药产生了胃肠道反应,而对照组有5位患者出现胃肠道反应、1例过敏反应、6例便秘,经停药后症状可消失。经X2检验两组不良反应事件发生率有统计学意义。结论:"补骨颗粒"在治疗骨质疏松性colles骨折(肝肾亏虚夹瘀型或气血亏虚夹淤型)临床试验中能取得较好的临床效果,并且安全有效,能有效地缓解患者临床症状,值得在临床中推广。
[Abstract]:Objective: to apply the "Bu Gu Granule" to the elderly osteoporotic Colles fractures, to observe the therapeutic effect, to verify its effectiveness, to provide a convenient and safe effective prevention and control method for the patients with osteoporotic Colles fracture, and to provide effective basis for its clinical application. Methods: 67 cases were included in the period from May 2015 to November 2016. The patients with osteoporotic Colles fracture treated by Guangzhou University of Chinese Medicine affiliated Zhanjiang second Chinese medicine hospital were divided into two groups according to the random digital table method, 34 cases in the treatment group and 33 in the control group. During the treatment, 4 cases in the treatment group fell off and 3 cases in the control group fell off. Before treatment, the baseline data of sex, age and bone mineral density were in the two groups. Statistical comparison, P0.05, no statistical significance. The control group B group of anti osteoporosis drug treatment: oral calcium carbonate D3, once a day, once a tablet, oral ossification three alcohol tablets, once a day, a tablet, Salcatonin Injection, 50IU/d, muscle injection 2 weeks after 1 times a week. The treatment group of A patients in the control group basis. 1 weeks after the fracture, add the traditional Chinese medicine formula supplementing bone granules, prescription: 1 packages (10g), 37 2 packets (3G), 1 packs of staghorn cream (10g), 1 bags of astragalus (10g), 1 packs (10g), 1 packets of Angelica (10g), 1 (10g) of Radix Paeoniae (10g), and daily 1 The two groups were divided into 2 times. No displaced fracture or incomplete fracture in the two groups did not need to be restored, only a small splint was fixed for 2-4 weeks. The displaced fractures were treated by manipulative reduction and flaps, such as the improper position of the fracture and the improper position of the cotton pad, the forearm kept on the neutral position in the chest. 4 weeks later, the splints were removed. The treatment period of each group was 3 months, and the clinical follow-up period was 3 months. In accordance with the requirements at the corresponding time point, January, February, March, two groups of patients were recorded: pain, functional state, grip strength, subjective feeling, objective evaluation, complications and fracture healing. During the treatment, the drugs were used in addition to the experimental drugs. The statistical analysis of the acquired clinical data was carried out using the SPSS18.0 statistical software. The data were represented by the standard deviation of the average number of soil (x + s), the measurement data were analyzed by the t test, the X2 test and analysis count data, the rank sum test analysis grade data, the repeated measurement design using variance analysis, when P0.05 There was a significant difference between the two groups of data. There was no significant difference between the two groups of data when P0.05. Results: (1) the treatment group was treated with the superposition of "bone filling Granule", the clinical effect and the improvement of the clinical symptoms of the patients were more obvious than the control group, and the incidence of adverse events was lower than the control group, and there was no obvious side effect in the treatment group. 30 cases in the treatment group. Of the patients, 15 patients recovered, 13 patients improved, the total effective rate was 93.33%, 9 cases in the control group were cured, 15 cases improved, the total effective rate was compared with 86.66%., P0.05, two groups in the curative effect comparison of statistical significance. After treatment, two groups of patients in the Green O'Brien wrist joint score, BMD value compared with before treatment before the treatment compared to all The scores were significantly improved, the swelling score was significantly lower than before the treatment, the incidence of complications, the control group was significantly higher than the control group. The two groups of clinical symptoms were improved after treatment, and the two groups after treatment of various indicators in the treatment group were better than the control group, after statistical comparison P0.05, there were significant differences. (3) the two groups of patients were treated. The incidence of adverse reaction occurred after treatment, the rate of treatment group was 13%, the control group was not found liver and kidney function damage during 40%. treatment, only 4 cases in the treatment group had gastrointestinal reaction to Chinese medicine, while 5 patients in the control group had gastrointestinal reaction, 1 cases of hypersensitivity, 6 cases of constipation, and the symptoms could disappear after the drug withdrawal. X2 The incidence of two groups of adverse events was statistically significant. Conclusion: "Bu Gu Granule" can achieve good clinical effect in the treatment of osteoporotic Colles fracture (liver kidney deficiency deficiency and stasis type or qi blood deficiency syndrome type). It is safe and effective and can effectively relieve the clinical symptoms of patients. It is worth popularizing in clinical practice.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R274.1

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