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目的观察青娥丸加味治疗非创伤性股骨头缺血性坏死的有效性与安全性,为缺血性股骨头坏死提供一种可行且有效的治疗方法。方法本试验采用随机方式分为实验组与对照组,试验组试验药为青娥丸加味,对照药为钙剂(钙尔奇D 600mg qd)。将纳入试验的40例患者随机分为试验组与对照组,以影像学检查疗效、Harris评分作为疗效评价指标,以血常规、肝功能、肾功能、凝血功能作为安全性评价指标。治疗进行24周,分析统计随访结果。结果治疗组影像学CT有效率为73.33%,对照组为42.30%(t﹤0.05)。治疗组Harris评分为70.75高于对照组57.43。治疗过程中安全指标未出现明显异常。结论对于非创伤性股骨头坏死患者,青娥丸加味是明显有效和安全的。
Objective To observe the efficacy and safety of Qing’e pill in treating non-traumatic avascular necrosis of the femoral head and to provide a feasible and effective treatment for ischemic necrosis of the femoral head. Methods The experiment was divided into experimental group and control group by random method. The experimental group was treated with Qing’e Wan and the control drug was calcium (Calcium D 600mg qd). The 40 patients included in the trial were randomly divided into test group and control group. Harris score was used as evaluation index of curative effect, and blood routine, liver function, renal function and coagulation function were used as safety evaluation indexes. Treatment for 24 weeks, analysis of statistical follow-up results. Results The effective rate of imaging CT was 73.33% in the treatment group and 42.30% in the control group (t <0.05). The Harris score of the treatment group was 70.75 higher than that of the control group 57.43. Safety indicators during treatment did not appear obvious abnormalities. Conclusion For patients with non-traumatic avascular necrosis, Qing-e-Wan flavored is significantly effective and safe.