[1]徐涛涛 郑凌歆 孙岩 张煊 潘晓豪 项周益 金红婷 童培建△.恒古骨伤愈合剂治疗膝骨性关节炎的临床疗效及安全性评价[J].中国中医骨伤科杂志,2022,30(02):8-12.
　XU Taotao ZHENG Lingxin SUN Yan ZHANG Xuan PAN XiaohaoXIANG Zhouyi JIN Hongting TONG Peijian.Clinical Efficacy and Safety Evaluation of Henggu Bone Wound Healing Agent on the Treatment of Knee Osteoarthritis[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2022,30(02):8-12.
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恒古骨伤愈合剂治疗膝骨性关节炎的临床疗效及安全性评价()
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《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第30卷
期数:
2022年02期
页码:
8-12
栏目:
临床研究
出版日期:
2022-02-15

文章信息/Info

Title:
Clinical Efficacy and Safety Evaluation of Henggu Bone Wound Healing Agent on the Treatment of Knee Osteoarthritis
文章编号:
1005-0205(2022)02-0008-05
作者:
徐涛涛1 郑凌歆2 孙岩2 张煊2 潘晓豪2 项周益3 金红婷1 童培建1△
1浙江中医药大学附属第一医院(杭州,310006)2浙江中医药大学第一临床医学院3杭州市上城区清波街道社区卫生服务中心
Author(s):
XU Taotao1 ZHENG Lingxin2 SUN Yan2 ZHANG Xuan2 PAN Xiaohao2XIANG Zhouyi3 JIN Hongting1 TONG Peijian1△
1The First Affiliated Hospital of Zhejiang Chinese Medical University,Hangzhou 310006,China; 2Zhejiang Chinese Medical University,Hangzhou 310053,China; 3Qingbo Street Community Health Service Center,Hangzhou 310002,China.
关键词:
恒古骨伤愈合剂;  膝骨关节炎;  临床疗效;  安全性评价
Keywords:
osteoking;  knee osteoarthritis;  clinical efficacy;  safety evaluation
分类号:
R684.3
文献标志码:
A
摘要:
目的:观察恒古骨伤愈合剂治疗膝骨性关节炎(Knee Osteoarthritis,KOA)的临床疗效及安全性。方法:纳入KOA患者128例,其中气滞血瘀型64例,肝肾亏虚型64例。采用SPSS 25.0统计软件生成随机数序列,分别将两种证型的患者随机分为2组,其中气滞血瘀型对照组和治疗组各32例; 肝肾亏虚型对照组和治疗组各32例。对照组口服塞来昔布胶囊200 mg/次,1次/d; 治疗组给予恒古骨伤愈合剂,25 mL/次,1次/2 d,治疗6周后采用WOMAC评分及疗效评定标准评定患者的临床疗效,并记录治疗过程中不良反应情况。结果:剔除脱落病例后,最后共纳入病例121例,气滞血瘀型62例,其中对照组30例,治疗组32例; 肝肾亏虚型59例,其中对照组28例,治疗组31例。对照组和治疗组患者治疗后WOMAC各项评分较治疗前均明显下降,差异有统计学意义(P< 0.05)。气滞血瘀型患者中,治疗组的疼痛评分及总评分较对照组下降,差异有统计学意义(P<0.05); 肝肾亏虚型患者中,治疗组的僵硬、功能评分以及总评分较对照组下降,差异有统计学意义(P<0.05)。对照组和治疗组的总有效率相比,差异无统计学意义(P>0.05); 但肝肾亏虚型中治疗组的显效率明显高于对照组,差异有统计学意义(P<0.05)。总体而言,治疗组不良反应发生率较对照组降低,差异有统计学意义(P<0.05)。此外,血常规、肝肾功能及尿常规结果显示两组患者在治疗前至治疗后6周时以上实验室指标均未见明显异常,且较治疗前无明显波动。结论:恒古骨伤愈合剂具有活血益气、补益肝肾的作用,临床上治疗气滞血瘀、肝肾亏虚证型的KOA患者,可以缓解膝关节疼痛、僵硬,改善膝关节功能,其疗效优于口服塞来昔布胶囊,且不良反应相对较少,值得临床推广应用。
Abstract:
To study on the efficacy of Henggu bone wound healing agent on knee osteoarthritis(KOA). Methods:128 patients with KOA were selected, including 64 cases Qi-stagnation and blood-stasis type and 64 cases of liver and kidney deficiency type. SPSS 25.0 statistical software was used to generate random number sequence, and patients with two syndrome types were randomly divided into two groups.Qi-stagnation and blood-stasis type: 32 cases in the control group and 32 cases in the treatment group.Liver and kidney deficiency type: 32 cases in the control group and 32 cases in the treatment group. The control group were treated with Celebrex(200 mg, oral administration, once a day for 6 weeks)and the treatment group were treated with osteoking(25 mL, oral administration, once two days for 6 weeks). WOMAC score and efficacy evaluation standard were used to evaluate the improvement of clinical symptoms of KOA patients. The adverse events during the treatment were recorded. Results:A total of 121 effective cases were included after removing the lost to follow-up cases. There were 62 KOA patients with Qi-stagnation and blood-stasis, including 30 cases in the control group and 32 cases in the treatment group. There were 59 cases of KOA with liver and kidney deficiency, including 28 cases in the control group and 31 cases in the treatment group. After 6 weeks of treatment, WOMAC scores of the two groups significantly decreased than those before treatment(P<0.05). Compared with the control group, the scores of the treatment group with Qi-stagnation and blood-stasis were lower in pain score and total score, and the difference was statistically significant(P<0.05). Compared with the control group, the scores of the treatment group with liver and kidney deficiency were lower in stiffness score, function score and total score, and the difference was statistically significant(P<0.05). There was no significant difference in the total effective rate between the control group and the treatment group(P>0.05). The effective rate of the treatment group of liver and kidney deficiency type was higher than that of the control group, and the difference was statistically significant(P<0.05). The incidence of adverse reactions in the treatment group was lower than that in the control group, and the difference was statistically significant(P<0.05). In addition, the results of blood, liver and kidney function and urine routine examination showed no significant abnormality in the above laboratory indicators between the two groups before treatment and 6 weeks after treatment, and no significant fluctuation compared to the previous treatment. Conclusion:Henggu bone wound healing agent can effectively relieve pain and improve the clinical symptom of KOA, especially for the patients whose blood starched due to Qi-stagnation and liver and kidney were asthenic. In addition, the adverse reactions are relatively less. Therefore,Henggu bone wound healing agent is worthy of further clinical application for KOA.

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备注/Memo

备注/Memo:
基金项目:浙江省医药卫生科技计划项目(面上项目)
(2020KY659)
白求恩公益基金会(G-X-2020-1107-17)
浙江省科协“育才工程”项目(CTZB-2020080127)
浙江中医药大学中青年科研创新基金(KC201933)
浙江中医药大学校级科研基金(2019ZR01)
△通信作者 E-mail:peijiantongzjtcm@163.com
更新日期/Last Update: 1900-01-01