中药补肾法改善原发性骨质疏松症临床症状的研究

A study on the improvement of clinical symptoms of primary osteoporosis with tonifying kidney method by traditional Chinese medicine

目的评价中药补肾法治疗原发性骨质疏松症的临床疗效。方法从河南中医药大学第三附属医院门诊选取确诊为原发性骨质疏松症的患者100例,按随机分组法分为治疗组和对照组,对照组给予钙尔奇1次1片,阿法迪三骨化醇1次2片,1日1次口服,1个月为1疗程;治疗组在对照组治疗基础上,给予河南中医药大学第三附属医院协定方所制蜜丸口服,每次1丸、每日两次,1个月为1疗程。每个疗程间隔2 d,观察6个疗程后判定疗效,采用中医症候评分、VAS评分,以及检测骨密度值进行疗效评价。结果共100例患者纳入本研究,治疗组50例,脱落1例,完成49例;对照组50例,脱落2例,完成48例。(2)临床总有效率,治疗组为96.5%,对照组为84.2%;治疗组明显优于对照组(P<0.05)。(3)治疗后比较,治疗组在改善中医症候、降低VAS评分等方面明显优于对照组,但在骨密度改善情况差异无显著差异(P>0.05)。随访6个月疗效稳定。(4)两组患者出现的不良反应差异无统计学意义(P>0.05)。结论研究证明,该治疗方案对改善骨质疏松临床症候,缓解疼痛疗效显著,且药物副作用小,便于临床推广。

Objective To evaluate the curative effect of tonifying kidney method by traditional Chinese medicine in the treatment of primary osteoporosis. Methods One hundred patients diagnosed with primary osteoporosis were selected from the third affiliated hospital of Henan university of TCM. They were randomly divided into the treatment group and control group. Patients in the control group received one tablet of Caltrate and two tablets of Alpha D3 Calciferol daily for one month. Patients in the treatment group received additional honey pill made by agreement prescription of our hospital,one pill each time,twice a day,for one month.There was 2-day interval between the course of treatment. TCM symptom score,VAS score,and bone mineral density value were used to evaluate the curative effect after six courses. Results 1） A total of 100 patients were enrolled in this study. Fifty cases were treated in the treatment group,with 1 case lost and 49 cases completed. Fifty cases in the control group,with 2 cases lost and48 cases completed.（2） The total clinical efficacy was 96. 5% in the treatment group and 84. 2% in the control group. It was significantly better in the treatment group than in the control group（P〈0. 05）.（3） The treatment group was significantly better than the control group in improving the symptoms of TCM and reducing the VAS score. There was no significant difference in the improvement of bone mineral density（P〉0. 05）. The result were stable in 6 months follow-up.（4） There was no significant difference in adverse reaction between the two groups（P〉0. 05）. Conclusion The research proves that the therapeutic schedule is beneficial for the clinical symptoms of osteoporosis and the pain. The side effect of drug is not obvious. It is easy to apply.