杜墨益肾化浊通络方治疗原发性骨质疏松症临床研究

Clinical Study of Dumo Yishen Huazhuo Tongluo Prescription for Primary Osteoporosis

目的:观察杜墨益肾化浊通络方治疗原发性骨质疏松症的临床疗效。方法:将94例原发性骨质疏松症患者按随机数字表法分为研究组与对照组各47例。所有患者均接受活性维生素D3、钙剂等常规治疗,对照组加用阿仑膦酸钠治疗,研究组加用杜墨化浊益肾通络方治疗。治疗2个月后,比较2组临床疗效及不良反应,比较2组治疗前后骨密度(骨颈、腰椎、大粗隆)水平、骨代谢指标[碱性磷酸酶(ALP)、Ⅰ型胶原交联氨基末端肽(NTX)、骨钙素(BGP)]水平及中医证候评分。结果:研究组总有效率为91.49%,对照组为74.47%,2组比较,差异有统计学意义(P<0.05)。治疗前,2组股骨颈、腰椎、大粗隆的骨密度水平比较,差异均无统计学意义(P>0.05);治疗后,研究组上述各项骨密度水平均高于对照组,差异均有统计学意义(P<0.05)。治疗前,2组骨代谢指标ALP、NTX、BGP水平比较,差异均无统计学意义(P>0.05);治疗后,研究组ALP、NTX水平低于对照组,BGP水平高于对照组,差异均有统计学意义(P<0.05)。治疗前,2组中医证候腰背疼痛、腰膝酸软、神疲肢倦、失眠多梦、头晕耳鸣评分比较,差异无统计学意义(P>0.05);治疗后,研究组上述中医证候评分均低于对照组,差异均有统计学意义(P<0.05)。研究组不良反应发生率为2.13%,对照组为14.89%,2组比较,差异有统计学意义(P<0.05)。结论:杜墨益肾化浊通络方治疗原发性骨质疏松症,可有效提高患者骨密度水平,促进骨代谢改善,且不良反应发生率较低。

Objective:To observe the clinical effect of Dumo Yishen Huazhuo Tongluo prescription for primary osteoporosis.Methods:A total of 94 cases of patients with primary osteoporosis were divided into the study group and the control group according to the random number table method,with 47 cases in each group.All patients were given routine treatment including activated vitamin D3 and calcium agent;the control group was additionally treated with alendronate sodium,and the study group was additionally treated with Dumo Yishen Huazhuo Tongluo prescription.After two months of treatment,the clinical effects and adverse reations in the two groups were compared;the levels of bone mineral density(bone neck,lumbar vertebra,greater trochanter),the bone metabolism indexes including alkaline phosphatase(ALP),Ntelopeptide of type I collagen(NTX)and bone gla protein(BGP)as well as the Chinese medicine syndrome scores before and after treatment in the two groups were compared.Results:The total effective rate was 91.49%in the study group and74.47%in the control group,the difference being significant(P<0.05).Before treatment,there was no significant difference being found in the comparison of the levels of bone mineral density in femur neck,lumbar vertebra and greater trochanter between the two groups(P>0.05).After treatment,the above levels of bone mineral density in the study group were higher than those in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparison of the levels of bone metabolism indexes including ALP,NTX and BGP between the two groups(P>0.05).After treatment,the levels of ALP and NTX in the study group were lower than those in the control group,and BGP level was higher(P<0.05).Before treatment,there was no significant difference being found in the comparison of the scores of the clinical symptoms including lumbar and back pain,soreness and weakness of waist and knees,mental and physical lassitude,insomnia and dreaminess,dizziness and tinnitus between the two groups(P>0.05).After treatment,the above scores of Chinese medicine syndromes in the study group were lower than those in the control group(P<0.05).The incidence of adverse reactions was 2.13%in the study group and 14.89%in the control group,the difference being significant(P<0.05).Conclusion:The application of Dumo Yishen Huazhuo Tongluo prescription for primary osteoporosis can effectively improve the levels of bone mineral density and promote the improvement of bone metabolism,with low incidence of adverse reactions.