补肾壮骨片治疗早期非创伤性股骨头坏死的临床研究

发布时间：2019-02-18 18:42

【摘要】：目的:观察补肾壮骨片治疗早期非创伤性股骨头坏死的临床疗效。方法:将早期非创伤性股骨头坏死患者随机分为两组,口服补肾壮骨片治疗的患者作为治疗组共40例,口服仙灵骨葆胶囊治疗的患者作为对照组共40例。观察患者年龄、性别、ARCO分期、舌质、舌苔及脉象;以影像稳定率、Harris评分、SF-36评分作为疗效评价指标,并观察治疗前后的肝肾功能,作为药物的安全性指标。结果:在Harris评分结果显示:治疗3个月后,两组患者相比Harris总分、疼痛程度、功能、下肢畸形、髋关节活动范围比较均P0.05,说明两组患者治疗3个月后无明显差异;治疗6个月后,两组患者Harris总分、疼痛程度、功能、髋关节活动范围比较均P0.05,差异存在,有统计学意义。影像学稳定率结果显示:I期患者治疗组稳定率为100%,对照组为83.3%,II期患者治疗组稳定率为82.35%,对照组稳定率为73.53%。生存质量评价(SF-36评分)显示:治疗3个月的两组患者在生理功能、生理职能、躯体疼痛、总体健康、活力、社会功能、情感职能、精神健康八个维度中两组P0.05,两组无明显差异。治疗6个月后,在躯体疼痛、活力、情感职能、精神健康4个维度中P0.05,有统计学意义。治疗前后肝肾功比较均P0.05,说明对肝肾功无影响。结论:补肾壮骨片可明显改善早期非创伤性股骨头坏死出现的疼痛、功能障碍、髋关节活动受限等临床症状,能提高影像学稳定率,并提高患者的生存质量。治疗6个月临床效果明显优于仙灵骨葆胶囊,该药物安全、有效、副作用小。
[Abstract]:Objective: to observe the clinical effect of Bushen Zhuanggu tablet on early nontraumatic necrosis of femoral head. Methods: patients with early non-traumatic femoral head necrosis were randomly divided into two groups. 40 patients were treated with Bushen Zhuanggu tablet and 40 patients were treated with Xianling Gubao capsule. The age, sex, ARCO stage, tongue quality, tongue coating and pulse were observed, and the imaging stability rate, Harris score and SF-36 score were used as the therapeutic evaluation index, and the liver and kidney function before and after treatment were observed as the safety index of the drug. Results: after 3 months of treatment, there was no significant difference between the two groups in the total score of Harris, pain degree, function, deformity of lower extremity and the range of hip joint movement (P0.05), which indicated that there was no significant difference between the two groups after 3 months of treatment. After 6 months of treatment, the total score of Harris, the degree of pain, the function and the range of hip joint activity in the two groups were all P 0.05, the difference was statistically significant. The results of imaging stability showed that the stability rate of stage I group was 100, that of control group was 83.3% and that of control group was 82.35%, and that of control group was 73.53%. The quality of life (SF-36) score showed that the two groups had two groups in the eight dimensions of physical function, physical pain, general health, vitality, social function, emotional function and mental health (P0.05). There was no significant difference between the two groups. After 6 months of treatment, there were significant differences in physical pain, vitality, emotional function and mental health (P 0.05). The comparison of liver and kidney function before and after treatment was P 0.05, indicating that there was no effect on liver and kidney function. Conclusion: Bushen Zhuanggu tablet can obviously improve the clinical symptoms of early non-traumatic necrosis of femoral head, such as pain, dysfunction and limited motion of hip joint, can improve the imaging stability rate and improve the quality of life of the patients. The clinical effect of treatment for 6 months was better than Xianling Gubao capsule, the drug was safe, effective and had little side effect.
【学位授予单位】：山东中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R274.9

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