止痛健骨方治疗骨性关节炎60例临床研究
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摘要
目的初步评价止痛健骨方治疗骨性关节炎的疗效和安全性。方法采用完全随机分组、阳性药物平行对照、双盲观察设计方案,纳入符合痰瘀阻络兼肝肾亏虚型骨性关节炎病例90例,按治疗组∶对照组2∶1比例分为两组。治疗组服止痛健骨丸,对照组服抗骨质增生丸,疗程4周。以病证主要症状分级计分变化、疼痛开始缓解及消失时间、不良反应及血、尿、便常规、心电图、肝肾功能为观察指标。结果治疗组骨性关节炎总显效率63.3%;对照组总显效率13.3%。治疗组与对照组证候总显效率分别为80.0%、43.3%。组间差异均有统计学意义(P<0.01)。治疗组对关节疼痛开始缓解与消失时间优于对照(P<0.01),研究过程中没有发现治疗组有明显不良反应和对安全性指标的影响。结论止痛健骨方治疗痰瘀阻络兼肝肾亏虚型骨性关节炎病有较好疗效,临床用药较为安全。
Objective To evaluate the efficacy and safety of ZhitongJianGu Decoction on patients with osteoarthritis.Methods According to the design scheme of complete random group, parallel control of positive drugs and double-blind observation,randomly divided 90 patients who meet up with the case inclusion criteria into the treatment group(60 cases) and the control group(30 cases).The design scheme was designed with complete random group, parallel control of positive drugs and double-blind observation.The control group attended anti-hyperosteogeny pill,while the treatment group had ZhitongJianGu pill for 4 weeks.Then observed the major symptom score, time when pain anesis and disappeared,adverse reactions and blood, urine, stool routine, electrocardiogram, liver and kidney function of two groups. Results The total apparent efficiency of the treatment group was 63.3%,while the total apparent efficiency of the control group was 13.3%.The total symptomatic efficiency of the treatment group and the control group was 80.0% and 43.3% respectively. Compared with the control group,the difference between groups was statistically significant(P<0.01).The time when pain anesis and disappeared of the treatment group were better than that in the control group(P<0.01).There was no obvious adverse reactions and the effect on safety indicators during the study. Conclusion ZhitongJianGu Decoction has good curative effect on osteoarthritis patients with phlegm-stasis blocking collateral combined with efficiency of liver and kidney type,and with safer clinical use.
Objective To evaluate the efficacy and safety of ZhitongJianGu Decoction on patients with osteoarthritis.Methods According to the design scheme of complete random group, parallel control of positive drugs and double-blind observation,randomly divided 90 patients who meet up with the case inclusion criteria into the treatment group(60 cases) and the control group(30 cases).The design scheme was designed with complete random group, parallel control of positive drugs and double-blind observation.The control group attended anti-hyperosteogeny pill,while the treatment group had ZhitongJianGu pill for 4 weeks.Then observed the major symptom score, time when pain anesis and disappeared,adverse reactions and blood, urine, stool routine, electrocardiogram, liver and kidney function of two groups. Results The total apparent efficiency of the treatment group was 63.3%,while the total apparent efficiency of the control group was 13.3%.The total symptomatic efficiency of the treatment group and the control group was 80.0% and 43.3% respectively. Compared with the control group,the difference between groups was statistically significant(P<0.01).The time when pain anesis and disappeared of the treatment group were better than that in the control group(P<0.01).There was no obvious adverse reactions and the effect on safety indicators during the study. Conclusion ZhitongJianGu Decoction has good curative effect on osteoarthritis patients with phlegm-stasis blocking collateral combined with efficiency of liver and kidney type,and with safer clinical use.
引文
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[6] 苏新平,朱克俭,谭旭仪,等.止痛健骨方对膝骨关节炎兔软骨TNF-α的影响及TNF-α与软骨评分的相关性分析[J].中医药导报,2017,23(14):23.
[7] 苏新平,朱克俭,谭旭仪,等.止痛健骨方对兔膝骨关节炎软骨MMP-1的影响及与MRI 分级的相关性分析[J].时珍国医国药,2017,28(4):812.
[8] 苏新平,朱克俭,谭旭仪,等. 止痛健骨方对兔膝骨关节炎软骨IKKα及NF-κB mRNA的影响[J].中国中医骨伤科杂志,2017,25(10):1.
[9] 张堃,朱克俭,谭旭仪,等. MRT2mapping成像评估止痛健骨方治疗膝骨性关节炎关节软骨损伤疗效的实验研究[J].中国介入影像与治疗学,2017,14(11):695.
[2] Liu Y,Zhang H,Liang N,et al.Prevalence and associated factors of knee osteoarthritis in a rural Chinese adult population:an epidemiological survey[J].BMC Public Health,2016,16(1):94.
[3] 中华医学会骨科学会分会.骨关节炎诊治指南[M].北京: 人民卫生出版社,2007:19.
[4] 郑筱萸.中药新药临床研究指导原则( 试行)[M].北京: 中国医药科技出版社,2002: 32.
[5] 苏新平,朱克俭,谭旭仪.止痛健骨方对兔膝骨关节炎模型滑膜及软骨修复的影响[J].湖南中医药大学学报,2016,26(4):11.
[6] 苏新平,朱克俭,谭旭仪,等.止痛健骨方对膝骨关节炎兔软骨TNF-α的影响及TNF-α与软骨评分的相关性分析[J].中医药导报,2017,23(14):23.
[7] 苏新平,朱克俭,谭旭仪,等.止痛健骨方对兔膝骨关节炎软骨MMP-1的影响及与MRI 分级的相关性分析[J].时珍国医国药,2017,28(4):812.
[8] 苏新平,朱克俭,谭旭仪,等. 止痛健骨方对兔膝骨关节炎软骨IKKα及NF-κB mRNA的影响[J].中国中医骨伤科杂志,2017,25(10):1.
[9] 张堃,朱克俭,谭旭仪,等. MRT2mapping成像评估止痛健骨方治疗膝骨性关节炎关节软骨损伤疗效的实验研究[J].中国介入影像与治疗学,2017,14(11):695.