| 邓敦.行气活血补肾壮骨方在双膦酸盐药物休假期患者的临床观察[J].浙江中西医结合杂志,2023,33(6): |
| 行气活血补肾壮骨方在双膦酸盐药物休假期患者的临床观察 |
| The clinical observation of Xingqihuoxiebushenzhuanggu formula in Osteoporosis? patients’ Bisphosphonate drug holiday periodDeng Dun,Chen Liqiu,Jiang Chang,etal. |
| 投稿时间：2022-05-22 修订日期：2023-03-07 |
| DOI： |
| 中文关键词: 气滞血瘀型 骨质疏松症 双膦酸盐 药物休假期 临床观察 |
| 英文关键词:qi stagnation and blood stasis type osteoporosis Bisphosphonate drug holiday period clinical observation |
| 基金项目:浙江省中医药科研项目(2019ZB144) |
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| 中文摘要: |
| 摘要：目的：观察益气活血补肾壮骨方在骨质疏松症(气滞血瘀型)患者双膦酸盐药物休假期的临床疗效和不良反应等。方法：将本院2019年12月—2021年7月就诊120例气滞血瘀型骨质疏松症双膦酸盐药物休假期患者按照随机数字表均分为两组。对照组予钙片、阿法骨化醇胶囊、金天格治疗，研究组予钙片、阿法骨化醇胶囊加用益气活血补肾壮骨方治疗。治疗6个月后，比较两组患者骨代谢、细胞因子、骨密度、 健康调查简表(SF-36评分)、脆性骨折发生率、骨折风险评估、中医证候积分、疗效和不良反应等。结果：治疗前两组各项指标比较差异无统计学意义(p>0.05)。治疗后研究组骨代谢低于对照组（BGP25.69±4.07vs26.37±4.16ng/mL、PINP35.79±7.38vs37.02±8.12ng/mL、CTX0.85±0.14vs1.26±0.21mmol/L、TRACP8.93±1.26vs13.06±2.59u/L），细胞因子(IL-1:26.36±3.07vs23.75±2.93pg/mL、IL-6:82.71±6.25vs78.62±9.08pg/mL、TNF-α5.03±1.02vs3.81±1.09ng/L)高于对照组，差异有统计学意义（p<0.05）。研究组SF-36评分(87.46±8.32vs70.62±6.59)、西医有效率(86%vs80%)、中医症候积分(23.46±5.32vs21.62±4.59)、中医疗效有效率(84%vs76%)高于对照组，左股骨颈BMD(0.68±0.05vs0.70±0.06g/cm2)，脆性骨折发生率(2%vs8%)、骨折风险评估(1.49±0.32vs2.63±0.47)低于对照组，但差异无统计学意义(p>0.05)。结论：益气活血补肾壮骨方联合钙片、阿法骨化醇胶囊可改善双膦酸盐药物假期患者(气滞血瘀型)骨代谢水平，抑制骨吸收和炎性因子水平、促进骨形成、提高骨密度，降低脆性骨折发生率和骨折风险，提高中医症候积分、生活质量，从而提高疗效，疗效水平与金天格相当。 |
| 英文摘要: |
| Abstract:objective:To observe the clinical effect and adverse reactions of Yiqihuoxiebushenzhuanggu formula in OP patients’ Bisphosphonate drug holiday period.Methods:From December 2019 to July 2021,120 Bisphosphonate drug holiday period OP patients were randomly divided into two groups according to the random number table.The control group were given calcium,vitamin D3,Jin tiange.While the research group were given calcium,vitamin D3Yiqihuoxiebushenzhuanggu formula.After six month treatment,bone metabolism,cytokine,BMD,SF-36score, incidence of brittle fracture,fracture risk assessment,TCM syndrome score,curative effect and adverse reaction were compared between the two groups.Results: Before treatment,there were no statistically significant differences between the two groups.After treatment,bone metabolismin the research group were significantly lower than the control group（BGP25.69±4.07vs26.37±4.16ng/mL、PINP35.79±7.38vs37.02±8.12ng/mL、CTX0.85±0.14vs1.26±0.21mmol/L、TRACP8.93±1.26vs13.06±2.59u/L）,cytokine(IL-1:26.36±3.07vs23.75±2.93pg/mL、IL-6:82.71±6.25vs78.62±9.08pg/mL、TNF-α5.03±1.02vs3.81±1.09ng/L)in the research group were significantly higher than the control group.The differences were statistically significant(P<0.05).The SF-36score(87.46±8.32vs70.62±6.59),curative effect(86%vs80%),TCM syndrome score(23.46±5.32vs21.62±4.59),TCM curative effect(84%vs76%) in the research group were higher than the control group,while the left femoral neck BMD(0.68±0.05vs0.70±0.06g/cm2)、incidence of brittle fracture(2%vs8%)、fracture risk assessment(1.49±0.32vs2.63±0.47) in the research group were lower than the control group,but the differences were not statistically significant(P>0.05).Conclusion:Combing Yiqihuoxiebushenzhuanggu formula with calcium,vitamin D3 can improve bisphosphonate drug holiday period OP patients' s bone metabolism,decreasing the bone resorption and inflammatory factor levels,promoting the bone formation and the BMD,decreasing the incidence of brittle fracture and fracture risk assessment,improving TCM syndrome score,the quality of life and curative effect.It has the similar effect levels with Jin Tiange. |
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