补肾中药靶向经穴给药对骨质疏松患者的归经调节

Channel tropism of the prescription for kidney tonifying by target-oriented administration for osteoporosis

目的:通过临床实验观察补肾方药靶向经穴位给药治疗骨质疏松症的疗效,分析靶向给药与药物归经的相关性。方法:①观察对象:选择2004-08/2006-12河北医科大学骨质疏松专科门诊和石家庄市桥东区医院门诊骨质疏松患者180例(患者知情同意,并经单位伦理委员会批准)。②实验分组:采用随机数字表法将180例患者分为6组:补肾方药口服组,外贴肾经组,外贴膀胱经组,依普拉封组,骨疏康组,非经非穴位组,每组30例,平均年龄(60.5±6.0)岁,平均病程(6.32±2.03)年。6组一般资料差异无显著性(P>0.05),具有可比性。补肾方药由地黄、淫羊藿、山药、丹参、骨碎补、独活等药物组成,每5丸含原药材3g;抗骨松贴剂:由地黄、淫羊藿、山药、丹参、骨碎补、独活等药物组成);依普拉封为正大青春宝药业有限公司产品;骨疏康颗粒由熟地黄、淫羊藿、黄芪、丹参、骨碎补、木耳、黄瓜子组成。③实验干预:补肾方药口服组:口服补肾方药10丸/次,3次/d,连续服用6个月。外贴肾经穴位组:选择足少阴肾经原穴太溪和络穴大钟;外贴膀胱经穴位组:选择足太阳膀胱经背部肾俞穴和络穴飞扬;外贴非经非穴位组:选择大腿外侧和后背部较广阔没有经络循行的区域;外贴组每个穴位贴2g生药量,每2天1次,左右交替进行。依普拉封组:口服依普拉封200mg/次,3次/d。骨疏康组:口服骨疏康颗粒10g/次,2次/d,各组均以6个月为1疗程,用药期间不进行任何其他中西医抗骨质疏松治疗。④实验评估:比较6组的骨痛症状与骨密度、血清Ca、P、碱性磷酸酶、尿羟脯氨酸,甲状旁腺素、降钙素、雌二醇、睾酮等指标的变化情况。进行综合疗效评价,评估标准分为显效、有效、无效。结果:180例患者全部进入结果分析。①补肾方药口服组、外贴肾经组、外贴膀胱经组、依普拉封组、骨疏康组治疗后,升高骨密度、雌二醇、睾酮、降钙素;降低甲状旁腺素;总有效率分别为90.0%,83.33%,83.33%,83.33%,83.33%。②非经非穴位组治疗后,骨密度、雌二醇、睾酮、降钙素、甲状旁腺素与治疗前比较差异无显著性(P>0.05);总有效率为46.67%。结论:靶向经穴给药可明显提高补肾方药的归经调节作用,至少在骨和性腺两个靶点起作用。

AIM： To investigate the correlation between target-oriented administration and drug channel tropism by observing the curative effect of the channel tropism of prescription for kidney tonifying on primary osteoporosis. METHODS： （1）180 patients with osteoporosis, average age of （60.5±6.0） years, and disease history of （6.32±2.03） years were selected from the Outpatient Department of Osteoporosis of Hebei Medical University and Qiaodong District Hospital of Shijiazhuang between August 2004 and December 2006. The informed consent and approval was obtained from the patients, and the Ethics Committee, respectively. （2）The patients were randomly divided into 6 groups： prescription for tonifying kidney group, kidney meridian sticking group, urinary bladder meridian sticking group, Iprifiavone group, Gushukang group, and non-meridian or acupoint sticking group with 30 cases in each group. Their general data had no obvious difference （P 〉 0.05）. The prescription for tonifying kidney was composed of rehmannia, epimedium herb, batatatis, rhizoma drynariae, danshen root, and doubleteeth pubescent angelica root, with 3 g crude drug in every 5 pills; the anti-osteoporosis sticking was composed of rehmannia, epimedium herb, batatatis, rhizoma drynariae, danshen root, and doubleteeth pubescent angelica root; Ipriflavone was provided by Chiatai Qingchun Bao Pharmaceutical Co., Ltd.; Gushukang Granules were composed of rehmannia, epimedium herb, membranous milkvetch root, danshen root, rhizoma dryniadae, jelly fungi, and cucumber seeds. （3）The prescription for tonifying kidney group took the medicine orally, 10 pills every time, three times daily for successive 6 months; the kidney meridian sticking group was acupunctured Kidney Median of Foot-Shaoyin Taixi, and collateral point Dazhong; urinary bladder meridian sticking group was stuck at Urinary Bladder Meridian of Foot-Taiyang through Shenshu acupoint and Feiyang; non-meridian or acupoint sticking group was stuck at the lateral thigh and back with no meridian; all the sticking groups were given 2 g crude drug to each acupoint, once every two days. Iprifiavone group took 200 mg drug orally, 3 times daily; Gushukang group was given 10 g medicine every time, twice daily, six months as one course of treatment, and no other anti-osteoporosis treatment was performed during administration. （4）The curative effect was evaluated by bone ache symptoms and changes in bone mineral density （BMD）, serum Ca, P, alkaline phosphatase （ALP）, urinary hydroxyproline, parathyroid hormone （PTH）, calcitonin （CT）, estradiol （E2）, testosterone （T）, and classified into favorite efficacy, effective, and ineffective. RESULTS： All 180 patients were involved in the result analysis. （1）Compared with that before treatment, the BMD, E2, T, and CT of the prescription for kidney tonifying group, kidney meridian sticking group, urinary bladder meridian sticking group, Iprifiavone group, and non-meridian or acupoint sticking group were obviously increased （P 〈 0.05）, while the PTH of those groups was decreased （P 〈 0.05）; the total clinical effective rates were 90.0%, 83.33%, 83.33%, 83.33%, and 83.33%. （2）Compared with that before treatment, the BMD, E2, T, CT, and PTH of the non-meridian or acupoint sticking group had no significant changes （P 〉 0.05）, and the total clinical effective rate was 46.67%. CONCLUSION： The prescription for kidney tonifying displays ＂channel tropism＂ by two approaches, at least at bone and sexual gland.