Objective:To observe the TCM(Traditonal Chinese Medcine)syndromes effect and safety of Shujinjianyao Pill in the treatment of LSS(Lumbar Spinal Stenosis)(Ganshenbuzu and Fengshiyuzu Syndrome).Methods:120 LSS patients ...Objective:To observe the TCM(Traditonal Chinese Medcine)syndromes effect and safety of Shujinjianyao Pill in the treatment of LSS(Lumbar Spinal Stenosis)(Ganshenbuzu and Fengshiyuzu Syndrome).Methods:120 LSS patients fit the inclusion criteria were separated into two groups,90 in the experimental group and 30 in the control group.No significant difference was existed in the basic data between the two groups.The experimental group was given Shujinjianyao Pill and Danlutongdu Tablet Simulator orally,while the control group was given Shujinjianyao Pill Simulator and Danlutongdu Tablet orally for 4 weeks.The VAS score,total TCM(Traditonal Chinese Medcine)syndrome score and single TCM symptom score on day 0,14 and 28 were observed,and adverse reactions were recorded.Result:There were significant differences in total TCM syndrome score between the two groups at baseline,14 day and 28 day(P<0.01).There was a significant difference in total TCM syndrome score between the two groups at 28 day(P<0.05).Significant differences were existed between this two groups in total effective rate of total TCM syndromes and waist-knee pain-weak in single TCM syndromes on the 28 day(P<0.05).There was no significant difference in the incidence of adverse events and serious adverse events between the two groups(P>0.05).Conclusion:Shujinjianyao Pill is effective on TCM syndromes in the treatment of Ganshenbuzu and fengshiyuzu syndrome LSS,especially in improving the score of total TCM syndromes and waist-knee pain-weak of single TCM syndrome,and has high safety.展开更多
目的观察补肾健脾通络方治疗老年衰弱综合征临床疗效及安全性。方法研究纳入2021年1月—2022年6月收治的老年衰弱综合征患者共计102例,以随机数字表法将患者分为对照组与观察组,每组51例,对照组患者采取临床常规治疗,观察组患者采取常...目的观察补肾健脾通络方治疗老年衰弱综合征临床疗效及安全性。方法研究纳入2021年1月—2022年6月收治的老年衰弱综合征患者共计102例,以随机数字表法将患者分为对照组与观察组,每组51例,对照组患者采取临床常规治疗,观察组患者采取常规治疗结合补肾健脾通络方治疗。观察各组数据:治疗总有效率、治疗前后患者中医证候总积分变化及Fried表型衰弱量表(frailty phenotype,FP)评分变化及白介素-6(interleukin 6,IL-6)、超敏C反应蛋白(C-ReactiveProtein,hs-CRP)水平变化、握力变化及起立-行走计时测试(Timed Up and Go test,TUG)变化、5次坐立试验(five-times-sit-to-stand test,FTSST)变化、步速变化、体质指数(Body Mass Index,BMI)变化及四肢骨骼肌质量指数(appendicular skeletal muscle mass index,ASMI)变化、简易精神状态评分(Mini-mental State Examination,MMSE)变化、匹兹堡睡眠指数(Pittsburgh sleep quality index,PSQI)评分变化、日常生活能力(Activity of Daily Living,ADL)评分变化、微型营养评估(mini nutritionaal assessment,MNA)评分变化、患者治疗满意度、不良反应。结果观察组患者治疗总有效率比对照组高[96.08%(49/51)vs84.31%(43/51)],P<0.05;治疗前,各组患者中医证候总积分、FP评分、IL-6、hs-CRP水平、握力、TUG测试结果及FTSST测试结果、步速、BMI、ASMI、MMSE评分、PSQI评分、ADL评分、MNA评分比较,P>0.05,治疗后各组患者中医证候总积分、FP评分、IL-6、hs-CRP水平、握力、TUG测试结果及FTSST测试结果、步速、BMI、ASMI、MMSE评分、PSQI评分、ADL评分、MNA评分均改善,观察组患者治疗后中医证候总积分、FP评分、IL-6、hs-CRP水平、握力、TUG测试结果及FTSST测试结果、步速、BMI、ASMI、MMSE评分、PSQI评分、ADL评分、MNA评分均优于对照组患者,P<0.05;观察组患者治疗满意度高于对照组[98.04%(50/51)vs84.31%(43/51)],P<0.05;观察组与对照组不良反应率均较低,且可自行缓解,P>0.05。结论补肾健脾通络方治疗老年衰弱综合征临床疗效显著,能缓解衰弱综合征患者的临床症状,抑制患者机体炎性反应,增加肌肉质量,改善睡眠,提高生活质量,且无不良反应,较为安全可靠,值得应用。展开更多
基金Guangdong science and technology plan project(No.2013A032500020)
文摘Objective:To observe the TCM(Traditonal Chinese Medcine)syndromes effect and safety of Shujinjianyao Pill in the treatment of LSS(Lumbar Spinal Stenosis)(Ganshenbuzu and Fengshiyuzu Syndrome).Methods:120 LSS patients fit the inclusion criteria were separated into two groups,90 in the experimental group and 30 in the control group.No significant difference was existed in the basic data between the two groups.The experimental group was given Shujinjianyao Pill and Danlutongdu Tablet Simulator orally,while the control group was given Shujinjianyao Pill Simulator and Danlutongdu Tablet orally for 4 weeks.The VAS score,total TCM(Traditonal Chinese Medcine)syndrome score and single TCM symptom score on day 0,14 and 28 were observed,and adverse reactions were recorded.Result:There were significant differences in total TCM syndrome score between the two groups at baseline,14 day and 28 day(P<0.01).There was a significant difference in total TCM syndrome score between the two groups at 28 day(P<0.05).Significant differences were existed between this two groups in total effective rate of total TCM syndromes and waist-knee pain-weak in single TCM syndromes on the 28 day(P<0.05).There was no significant difference in the incidence of adverse events and serious adverse events between the two groups(P>0.05).Conclusion:Shujinjianyao Pill is effective on TCM syndromes in the treatment of Ganshenbuzu and fengshiyuzu syndrome LSS,especially in improving the score of total TCM syndromes and waist-knee pain-weak of single TCM syndrome,and has high safety.
文摘目的观察补肾健脾通络方治疗老年衰弱综合征临床疗效及安全性。方法研究纳入2021年1月—2022年6月收治的老年衰弱综合征患者共计102例,以随机数字表法将患者分为对照组与观察组,每组51例,对照组患者采取临床常规治疗,观察组患者采取常规治疗结合补肾健脾通络方治疗。观察各组数据:治疗总有效率、治疗前后患者中医证候总积分变化及Fried表型衰弱量表(frailty phenotype,FP)评分变化及白介素-6(interleukin 6,IL-6)、超敏C反应蛋白(C-ReactiveProtein,hs-CRP)水平变化、握力变化及起立-行走计时测试(Timed Up and Go test,TUG)变化、5次坐立试验(five-times-sit-to-stand test,FTSST)变化、步速变化、体质指数(Body Mass Index,BMI)变化及四肢骨骼肌质量指数(appendicular skeletal muscle mass index,ASMI)变化、简易精神状态评分(Mini-mental State Examination,MMSE)变化、匹兹堡睡眠指数(Pittsburgh sleep quality index,PSQI)评分变化、日常生活能力(Activity of Daily Living,ADL)评分变化、微型营养评估(mini nutritionaal assessment,MNA)评分变化、患者治疗满意度、不良反应。结果观察组患者治疗总有效率比对照组高[96.08%(49/51)vs84.31%(43/51)],P<0.05;治疗前,各组患者中医证候总积分、FP评分、IL-6、hs-CRP水平、握力、TUG测试结果及FTSST测试结果、步速、BMI、ASMI、MMSE评分、PSQI评分、ADL评分、MNA评分比较,P>0.05,治疗后各组患者中医证候总积分、FP评分、IL-6、hs-CRP水平、握力、TUG测试结果及FTSST测试结果、步速、BMI、ASMI、MMSE评分、PSQI评分、ADL评分、MNA评分均改善,观察组患者治疗后中医证候总积分、FP评分、IL-6、hs-CRP水平、握力、TUG测试结果及FTSST测试结果、步速、BMI、ASMI、MMSE评分、PSQI评分、ADL评分、MNA评分均优于对照组患者,P<0.05;观察组患者治疗满意度高于对照组[98.04%(50/51)vs84.31%(43/51)],P<0.05;观察组与对照组不良反应率均较低,且可自行缓解,P>0.05。结论补肾健脾通络方治疗老年衰弱综合征临床疗效显著,能缓解衰弱综合征患者的临床症状,抑制患者机体炎性反应,增加肌肉质量,改善睡眠,提高生活质量,且无不良反应,较为安全可靠,值得应用。
