文献类型：期刊文献

中文题名：固本增骨方治疗老年原发性骨质疏松的随机对照临床试验研究

英文题名：Randomized controlled clinical study on the treatment of osteoporosis with consolidating origin and improving bone formula in the elderly

作者：巩彦龙[1];宋敏[1];董万涛[2];董平[1,3];宋志靖[1];黄凯[1];王凯[1]

第一作者：巩彦龙

机构：[1]甘肃中医药大学,甘肃兰州730000;[2]甘肃中医药大学附属医院,甘肃兰州730020;[3]内蒙古医科大学,内蒙古呼和浩特010010

第一机构：甘肃中医药大学

年份：2020

卷号：26

期号：5

起止页码：676

中文期刊名：中国骨质疏松杂志

外文期刊名：Chinese Journal of Osteoporosis

收录：CSTPCD;;北大核心:【北大核心2017】；CSCD:【CSCD2019_2020】；

基金：甘肃省自然科学基金计划(1506RJZA048,17JR5RA056);甘肃省中医药防治慢性疾病重点实验室开放基金项目(GSMBKY2015-07);甘肃省中医药管理局科研课题(GZK-2016-17);甘肃省中药现代制药工程研究院项目(YWW-2015049)。

语种：中文

中文关键词：固本增骨方;原发性骨质疏松;骨密度

外文关键词：consolidating origin and improving bone formula;primary osteoporosis;bone mineral density

摘要：目的观察固本增骨方治疗老年原发性骨质疏松的临床疗效。方法将确诊为老年原发性骨质疏松症的106例患者随机分为固本增骨方组(53例)和骨健康补充剂组(53例),骨健康补充剂组给予碳酸钙D3咀嚼片1片/次,1次/d;骨化三醇胶丸1粒/次,1次/d,1个月为1疗程,共治疗6个疗程,固本增骨方组在骨健康补充剂组治疗基础上,给予固本增骨方,每日1剂,水煎服,早晚各1次分服,1个月为1疗程,观察6个疗程后判定疗效,采用VAS评分、中医症候评分以及检测骨密度值进行疗效评价,并观察不良反应发生情况。结果治疗后固本增骨方组有效率为94.34%,明显高于阳性药物对照组的84.90%(P<0.05);治疗后,两组患者的VAS评分均较治疗前降低(P<0.05),固本增骨方组明显低于骨健康补充剂组(P<0.05);固本增骨方组和骨健康补充剂组治疗后骨密度值均较治疗前升高(P<0.05),治疗组高于骨健康补充剂组(P<0.05);治疗后两组患者的主要症状评分均较治疗前下降(P<0.05),固本增骨方组低于骨健康补充剂组(P<0.05);治疗后,固本增骨方组1例患者出现胃烧灼感;骨健康补充剂组出现2例恶心、纳差,1例患者出现皮肤过敏,停药后不良反应均自行消失,两组患者不良反应的差别无统计学意义(P>0.05)。结论固本增骨方治疗骨质疏松症患者安全有效,能够增加骨密度、缓解疼痛症状以及主要症状,是一种安全、有效、经济的治疗方法。
Objective To observe the clinical efficacy of consolidating origin and improving bone formula on the treatment of primary osteoporosis.Methods One hundred and six patients who diagnosed with primary osteoporosis were randomly divided into consolidating origin and improving bone formula group(53 cases)and bone health supplement group(53 cases).Patients in the bone health supplement group received one calcium carbonate D3 chewable tablet and calcitriol capsules daily for one month.Patients in the consolidating origin and improving bone formula group received consolidating origin and improving bone formula one dose twice a day,for one month in addition of the treatment of the bone health supplement group.The curative effect,VAS score,TCM symptom score,bone mineral density value,and the occurrence of adverse reactions were used for evaluation after six courses.Results The total clinical efficacy was 94.34%in the consolidating origin and improving bone formula group and 84.90%in the bone health supplement group.It was significantly better in the consolidating origin and improving bone formula group than in the bone health supplement group(P<0.05).After the treatment,VAS scores in the two groups were lower than those before treatment(P<0.05),and VAS score in the consolidating origin and improving bone formula group was significantly lower than that in the bone health supplement group(P<0.05).BMD values in two groups after the treatment were higher than those before the treatment(P<0.05).BMD values was higher in the consolidating origin and improving bone formula group than that in the bone health supplement group.After the treatment,the scores of main symptoms in the two groups were lower than those before treatment(all P<0.05),while those in the consolidating origin and improving bone formula group were lower than in the bone health supplement group(all P<0.05).After the treatment,one patient in the consolidating origin and improving bone formula group had a burning sensation of stomach,and two patients had nausea and poor appetite,and one patient had skin allergy in the bone health supplement group.The adverse reactions disappeared spontaneously after drug withdrawal.There was no significant difference in the adverse reactions between the two groups(P>0.05).Conclusion Consolidating origin and improving bone formula is a safe,effective,economical,and reliable treatment for osteoporosis,which can increase bone mineral density,relieve pain symptoms and main symptoms.