补肾活血胶囊治疗高龄男性骨质疏松症疼痛的临床观察

Clinical Effect of Busheng-Huoxue Capsules in Treatment of Osteoporosis Pain of Aged Males

目的:评价补肾活血胶囊治疗高龄男性骨质疏松症疼痛的临床疗效和安全性。方法:将入选高龄男性骨质疏松症患者随机分为试验组[年龄75～91岁,平均(82.15±8.2)岁]和对照组[年龄75～90岁,平均(83.61±7.9)岁],每组33例。试验组和对照组分别以补肾活血胶囊和阿仑膦酸钠(福善美)治疗,两组同时补充钙尔奇D,服药1年。观察疼痛强度、疼痛缓解度,计算镇痛有效率,并测定腰椎2～4和股骨颈骨密度以及骨钙素(BGP)、吡啶酚/肌苷(PYD/Cr)水平,同时监测血、尿常规及肝、肾功能。结果:治疗后,两组腰背及下肢疼痛强度均明显改善(P<0.05,P<0.01),试验组疗效更佳(P<0.05);两组疼痛缓解总有效率相近,分别为84·8%和84·4%(P>0.05),但试验组镇痛显效率明显高于对照组(P<0.05);两组腰椎2～4、股骨颈骨密度均较治疗前明显提高(P<0.05),且两组间无明显差异(P>0.05);试验组BGP水平明显提高(P<0.05),与对照组比较有显著差异(P<0·05);两组PYD/Cr均明显下降(P<0.01),且两组间无明显差异(P>0.05)。治疗中未出现明显不良反应。结论:补肾活血胶囊能稳定地改善老年男性骨质疏松症患者骨痛症状,疼痛缓解有效率与阿仑膦酸钠组相当,显效率更佳;同时能促进骨形成,抑制骨吸收,明显提高骨密度,安全、有效,无不良反应。

Objective： To investigate the therapeutic effect and safety of Busheng-Huoxue capsules （capsules with the effect of nourishing kidney and invigorating blood circulation according to TCM theory—editor＇s note） on osteoporosis pain of aged male patients. Methods： The diagnosed osteoporosis patients were randomly divided into two groups： 33 patients in the control group[mean age （83.61±7.9） years], and 33 patients in the test group[mean age（82.15±8.2）years]. The patients in the test group took Busheng-Huoxue capsules plus caltrate-D （600 mg·d^-1）, and the patients in the control group took alend-ronate（70 mg per week） plus caltrate-D （600 mg·d^-1） for 12 months. Before treatment and every month after treatment, the pain intensity （0-10） and release degree of pain grades （0-4） were recorded and the efficiency rate of analgesia was calculated. The bone mineral density （BMD） of lumbarvertebra （L2-4） and femoral neck was determined respectively. Serum osteocalcin （BGP） and urine pyridinoline （PYD） were measured. And blood routine, urine routine, hepatic and renal function were also examined. Results： After the treatment, pain intensity of osteoporosis in two groups was obviously lower than that before treatment （P 〈0. 05, P 〈0. 01）, and compared with the control group, that of the test group has significant statistical differences （P〈0.05）. The total efficiency （obvious efficacy and efficacy） rate of the two groups was similar （84.8% vs 84.4%, P 〉 0.05）, but the obvious efficacy （ obvious remission and complete remission） rate in the test group was obviously higher than that in the control group（ P〈0.05）. After the treatment, the BMD of two groups, serum BGP of the test group was significantly increased（ P 〈 0.05）, and PYD/Cr was significantly decreased in two groups （P 〈0. 01）. No obvious adverse events were observed in two groups. Conclusion： Busheng-Huoxue capsules can effectively alleviate the osteoporosis ache of aged male patients, which is similar to the effect of alendronate, and elevate the bone mineral density thus promoting the quality of life.