冯新送教授论治骨质疏松症的经验总结及补肾健脾活血思想的临床研究
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摘要
目的
     该课题遵循导师冯新送教授治疗骨质疏松症的学术思想,通过观察补肾健脾活血中药对绝经后骨质疏松症患者的疗效临床,和治疗前后患者骨密度、血清E2、骨保护素(OPG)和胰岛素样生长因子Ⅰ (IGF-Ⅰ)的变化情况,以期从临床疗效及细胞分子学两方面印证补肾健脾活血思想的科学性,同时探讨补肾健脾活血中药防治骨质疏松症的科学依据及其作用机理,从而为中医药防治骨质疏松症提供可靠的科学依据。
     方法
     采用随机对照法,进行前瞻性临床试验研究,选取符合纳入标准的绝经后骨质疏松症患者53例,随机分为治疗组和对照组两组,治疗时间为6个月。治疗组服用中药骨康煎剂和钙尔奇D,对照组服用仙灵骨葆胶囊和钙尔奇D,观察治疗前后中医证候计分、骨密度、血清E2、OPG、IGF-Ⅰ水平的变化,并用统计学方法进行统计分析。
     结果
     本组共有53例绝经后骨质疏松症患者完成治疗和随访。结果显示:在同时补钙的情况下,治疗6个月后,两组治疗前后腰椎(L2-L4)侧位BMD比较虽无显著性差异(P>0.05),但治疗后L2-L4骨密度均有升高。两组血清E2、IGF-Ⅰ含量均显著升高(P<0.01),但两组血清OPG含量显著降低(P<0.01)。两组治疗后比较,治疗组E2、IGF-Ⅰ水平明显高于对照组(P<0.01)。治疗后治疗组OPG水平稍高于对照组,但二者比较无显著性差异(P>0.05)。
     本组病例治疗前,初始中医证候计分无显著性差异。治疗组治疗2个月后分值开始显著下降(P<0.01),并逐月降低;对照组治疗4个月和6个月后较治疗前显著下降(P<0.01),但均较同期治疗组分值有显著性差异(P<0.01);两组间比较从治疗第2个月时起三次计分均明显低于对照组(P<0.01)。结果表明,两种药物均能改善绝经后骨质疏松症患者的中医症候,但中药骨康煎剂治疗效果好、显效快。从综合疗效来看,治疗组显效率(29%)和总有效率(86%)均高于对照组显效率(24%)和总有效率(80%),但两组相比,统计学无显著性差异(P>0.05)。
     结论
     雌激素缺乏是绝经后骨质疏松症发生的重要原因,血清OPG和IGF-Ⅰ含量的改变在骨质疏松症的发生中起着重要作用。补肾中药骨康煎剂和仙灵骨葆胶囊均可抑制绝经后骨质疏松症患者的骨吸收,提高患者的骨密度,骨康煎剂作用较强,但两者统计学比较无显著性差异。骨康煎剂和仙灵骨葆胶囊对血清E2、OPG、IGF-Ⅰ均有调节作用,骨康调节E2、IGF-Ⅰ作用较强。骨康煎剂治疗肾阳虚证型绝经后骨质疏松症的临床疗效,与仙灵骨葆胶囊比较无显著性差异,但在改善患者全身状态方面优于仙灵骨葆胶囊。
     综上,中药骨康煎剂能够有效改善绝经后骨质疏松症患者临床症状,提高腰椎骨密度,可以升高血清E2和IGF-Ⅰ水平,降低血清OPG水平。由此可见,补肾健脾活血治则的代表方中药骨康煎剂治疗绝经后骨质疏松症的机理是一种对机体的整体调治过程。
Objective
     Following the academic thinking of professor Feng Xinsong treatmenting osteoporosis, to evaluate the effect of the Methods about invigorate kidney, support Splen and activating blood on the E2、OPG and IGF-Ⅰ cytokine axis and clinical therapeutic effect in the post-menopause osteoporosis through the clinical research.
     Method
     By the random and prospective clinical research,53post-menopause osteoporosis patients were randomly divided into treatment group and control group. Treatment group were given Gu kang and calcium tablets, control group were given Xianlinggubao capsule and calcium tablets. Both groups take medicines for6months. After six months treatment, we will observe the count-scores of clinical symptom, BMD, E2, OPG and IGF-Ⅰ in the serum,and statistical analysis of the results
     Results
     There were53post-menopause osteoporosis patients completed the follow-up and treatment. The results indicate:First, the excellence rate in treatment group (29%) was higher than in control group (24%), and the total efficient rate in treatment group (86%) was higher than in control group (80%), there were no significant statistical differences in the two groups(P>0.05). Second, BMD and E2of post-menopause osteoporosis patients were lower than healthy women. Under the same circumstances, E2in the serum and BMD in the from2to4lumbar vertebrae were higher than before treatment. E2had a significant statistical difference (P<0.01), but BMD had no significant statistical difference (P>0.05) in the two groups. Third, OPG and IGF-Ⅰ of post-menopause osteoporosis patients were higher than healthy women. After six months treatment, OPG in the serum were significant lower, but IGF-Ⅰ in the serum was higher than before. There were no significant statistical difference (P>0.05) in both groups.
     Conclusion
     Hormonoprivia is a important reason for post-menopause osteoporosis. The change of level OPG, IGF-Ⅰ in the serum have important role in post-menopause osteoporosis. To sum up, Gu kang improve clinical therapeutic effect, increase the level of BMD、E2、and IGF-Ⅰ, and decrease the level of OPG. So, it can be seen that the therapy of the chinese herbal drugs Gu kang regarding the Methods about invigorate kidney, support Splen and activating blood is a total mode of regulation on the body through the clinical research.
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