Objective To observe the clinical efficacy and safety of Yishen Huoxue Decoction combined with low-frequency pulse magnetic fields (PEMFs) for treatment of hemiplegia with osteoporosis (OP). Methods Totally 144 patients were divided into TCM group and control group with randomized parallel controlled method, with 72 cases in each group. Patients in control group were treated with Western routine therapy, rehabilitation training, PEMFs (putting the magnetic head on the back, five times every week, 20-30 minutes each time). On the basis of control group,TCM group received Yishen Huoxue Decoction,one dosage per day,twice a day,orally.The therapeutic course for both groups was 6 weeks. The Fugl-Meyer assessment (FMA), Barthel index (MBI), NIH stroke scale (NIHSS), and visual analogue scale (VAS) before and after treatment were observed in the two groups of patients. Bone mineral density (BMD) was measured. Blood calcium, serum phosphorus, osteocalcin (BGP) content, type 1 procollagen amino-terminal peptide (P1NP), alkaline phosphatase (BALP) were tested. Safety was tested and adverse reactions were observed. Results Compared with before treatment, the scores of FMA, MBI, NIHSS and VAS improved in both groups (P<0.05); the scores of FMA, NIHSS and VAS in the TCM group were significantly improved than the control group after treatment (P<0.05). Compared with before treatment, the levels of BMD, bone metabolic index were improved in both groups (P<0.05). The levels of BMD, BGP, BALP in the TCM group were better than the control group (P<0.05). There was no abnormality in blood routine, liver and kidney function in the 2 groups after treatment, and no obvious adverse reactions were observed. Conclusion Yishen Huoxue Decoction combined with PEMFs can enhance the motor function, improve the neurological deficit symptoms and decrease the pain in hemiplegia patients with OP, and the bone metabolism.%目的 观察益肾活血汤联合低频脉冲电磁场(PEMFs)治疗脑卒中后偏瘫合并骨质疏松症(OP)的临床疗效及安全性.方法 采用随机对照试验设计将144例脑卒中后偏瘫合并OP患者分为对照组和中药组各72例.对照组予西医常规治疗、康复运动训练,并行PEMFs(将磁头置于腰背部,每次20~30 min,每周5次).中药组在对照组基础上予益肾活血汤,每日1剂,每日2次,口服.2组均连续治疗6周.观察2组治疗前后Fugl-Meyer运动功能评分(FMA)、Barthel指数评分(MBI)、美国国立卫生研究院卒中量表评分(NIHSS)及视觉模拟评分(VAS),检测骨密度及骨生化与代谢指标[血钙、血磷、骨钙素(BGP)、1型前胶原氨基端前肽(P1NP)、碱性磷酸酶(BALP)],进行安全性检测并观察不良反应.结果 与本组治疗前比较,2组FMA、MBI、NIHSS、VAS显著改善(P<0.05),中药组治疗后FMA、NIHSS、VAS明显优于对照组(P<0.05).与本组治疗前比较,2组治疗后骨密度、血清骨生化与代谢指标明显改善(P<0.05),中药组治疗后骨密度、BGP、BALP明显优于对照组(P<0.05).治疗后2组血、尿常规及肝、肾功能未见异常,无明显不良反应.结论 益肾活血汤联合 PEMFs 治疗脑卒中偏瘫合并 OP,可明显改善患者的运动功能与神经损伤,减缓疼痛,有效改善骨代谢水平.
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