摘要
目的：探讨中医学对绝经后骨质疏松症的认识,采用滋补肝肾壮骨方治疗绝经后骨质疏松症,客观评价滋补肝肾壮骨方对绝经后骨质疏松症肝肾阴虚证患者的治疗效果,尤其是对临床症状、骨密度测定(BMD)、血清钙、磷、雌二醇(E2)、血清睾酮(T),白介素-6(IL-6)等方面所产生的影响,并评价其安全性,为临床应用提供客观依据。
方法：采用随机、对照的研究方法,将符合绝经后骨质疏松症的患者,随机分为对照组和治疗组。在基础治疗和西药常规治疗的基础上,对照组给予口服阿法D3胶丸(阿法骨化醇),0.25ug,每日2次；钙尔奇D,600mg,每日1次；治疗组给予滋补肝肾壮骨方中药水煎剂,每日1剂,分早晚两次服用。以4周为1个疗程,观察3个疗程。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测骨密度、血清钙、磷、雌二醇、睾酮、白介素-6等指标。全部数据以SPSS16.0统计软件进行统计学分析。
结果：绝经后骨质疏松症患者50例随机分为2组,治疗组25例,对照组25例,治疗前两组的年龄、病程、中医症状等基线数据经统计学处理无显着性差异,有可比性。其结果如下：①对症状体征的改善作用：治疗组患者治疗后症状有明显改善,治疗组中医症状改善情况明显优于对照组(P<0.05)。②提高骨密度：治疗后治疗组患者BMD均明显升高,有显著性差异(P<0.01)；对照组较治疗前无明显差异(P>0.05)。治疗组BMD的变化与对照组相比,差异有统计学意义(P<0.05)。③对血钙、磷的影响：治疗后两组患者血钙均升高,但差异无统计学意义(P>0.05)；治疗后两组患者血磷均有所降低,但差异无统计学意义(P>0.05)；治疗组血钙、血磷的变化较对照组无显著性差异(P>0.05)。④调节性激素水平：患者性激素比较,治疗组E2较治疗前明显升高(P<0.01)；T较治疗前明显降低(P<0.01)。组间比较,E2的升高幅度明显大于对照组(P<0.01),T的降低幅度大于对照组,差异有统计学意义(P<0.05)。⑤对IL-6影响：治疗组IL-6较治疗前也有显著性改善(P<0.01),与对照组比较均有差异(P<0.01)。⑥安全性指标：治疗组患者血、尿、粪常规及肝肾功能检查均在正常范围。两组均未见不良反应。
结论：从初步临床研究来看,滋补肝肾壮骨方治疗绝经后骨质疏松症肝肾阴虚证,可明显改善患者的临床症状；在西医学指标方面,可以改善骨密度,调节性激素水平,且无肝肾功能损害,治疗本病安全、有效,有广泛的应用前景。但由于本人为境外学生,能力和条件限制,本研究病例数相对较少,今后需进一步深入研究。
Purpose:To discuss the understanding of traditional Chinese medicine about postmenopausal osteoporosis, using the therapy of renal-vital-reinforce and Bone-vital-strong Prescription to treat postmenopausal osteoporosis.To observe the therapeutic efficacy of this prescription in treating postmenopausal osteoporosis with deficiency of liver-yin and kidney-yin symptoms by the indexes such as clinical symptom, bone mineral density(BMD), serum calcium and phosphorus, estradiol, testoterone, interleukin-6(IL-6).Then evaluating its safety, so as to guide its clinical application.
Methods:A randomized, controlled trial was conducted.The patients of postmenopausal osteoporosis were randomly classified into two groups.On the basic of normal treatment and western medicine, the patients of treated group were treated by Chinese medicine while the patients of controlled group were treated by Alfacalcidol Capsule and Caltrate Vitamin D3Tabletas.,which was observed for3month and four weeks were a course of treatment..The observed indexes included curative effect indexes, such as clinic symptoms, bone mineral density, serum calcium and phosphorus, estradiol, testoterone, interleukin-6and so on. The complete data carries on statistics analysis by the SPSS16.0statistics software.
Results:The diagnosis and included postmenopausal osteoporosis patients with50cases.25cases of treated group,while25cases of controlled group.Prior treatment,age,course of disease of the two groups patients had no differeces.1.Symptoms and signs improvement:the treated group after treatment had a significant improvement. The symptoms improvement of the treated group was better than the controlled group (P<0.05).2. Bone mineral density:After treatment, the BMD of the treated group were significantly higher than controlled group(P<0.01) while the controlled group had no statistical significance(P>0.05).The BMD of the treated group had a difference than controlled group(P<0.05).3. Serum calcium and phosphate:Serum calcium of the two groups were higher, but had no statistical significance(P>0.05).Serum phosphate of the two groups were lower, but had no statistical significance.Serum calcium and phosphate of the controlled group had no statistical significance(P>0.05).4.Hormone:after treatment, the E2of the treated group was visibly higher(P<0.01) while the T was visibly lower(P<0.01).The improvement of E2of the treated group was better than the controlled group(P＜0.01) and the improvement of T of the treated group was better than the controlled group, and had a statistical significance(P<0.05).5.IL-6:After treatment, the IL-6of the treated group were also significantly improved(P＜0.01), and had a significantly difference than controlled group(P<0.01).6.Safety index:The routine blood/urine/feces test, and the liver and kidney function tests of treated group were within the normal range. Two groups had no unhealthy response.
Conclusion:Through the preliminary clinical study,chinese medicine of method has sure curative effected in treating postmenopausal osteoporosis with deficiency of liver-yin and kidney-yin.From the angle of western medicine,it is safe and can improve BMD,adjust hormone,and has no side-effect of liver and kidney. It is worth studying deeply and developing further.
引文
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