痹祺胶囊联合氨基葡萄糖胶囊和玻璃酸钠治疗膝骨关节炎的临床研究
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摘要
目的探讨痹祺胶囊联合氨基葡萄糖胶囊和玻璃酸钠治疗膝骨关节炎的临床疗效。方法选取2016年2月—2018年10月中国人民武装警察部队特色医学中心收治的82例膝骨关节炎患者,随机分为对照组和治疗组,每组各41例。对照组膝关节腔注射玻璃酸钠注射液,2.5 mL/次,1次/周,连续注射5周为1个疗程,并口服盐酸氨基葡萄糖胶囊,0.75 g/次,2次/d,连续服用6周为一个疗程。治疗组在对照组治疗基础上口服痹祺胶囊,1.2g/次,3次/d。两组患者均连续治疗6周后进行疗效评价。观察两组的临床疗效,比较两组治疗前后WOMAC评分、VAS评分和血清学指标的变化情况。结果治疗后,对照组和治疗组的总有效率分别为80.49%、95.12%,两组总有效率比较差异有统计学意义(P<0.05)。治疗后,两组WOMAC各项评分、总分、VAS评分均较同组治疗前显著降低,同组治疗前后评分比较差异有统计学意义(P<0.05);治疗后治疗组这些评分显著低于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组血清白细胞介素-1(IL-1)、肿瘤坏死因子-α(TNF-α)、基质金属蛋白酶-3(MMP-3)、软骨寡聚基质蛋白(COMP)水平较同组治疗前均显著降低,同组治疗前后比较差异有统计学意义(P<0.05);治疗后治疗组这些血清学指标显著低于对照组,两组比较差异有统计学意义(P<0.05)。结论痹祺胶囊联合氨基葡萄糖胶囊和玻璃酸钠治疗膝骨关节炎具有较好的临床疗效,能有效降低患者膝关节炎性反应,缓解患肢症状,改善患者膝关节功能,具有一定的临床推广应用价值。
Objective To investigate the clinical efficacies of Biqi Capsules combined with sodium hyaluronate and Glucosamine Capsules in treatment of knee osteoarthritis. Methods Patients(82 cases) with knee osteoarthritis in Characteristic Medical Center of Chinese PAP from February 2016 to October 2018 were randomly divided into control(41 cases) and treatment(41 cases) groups.Patients in the control group were intra-articular injection of Sodium Hyaluronate Injection, 2.5 mL/time, once weekly, for 5 weeks.And they were po administered with Glucosamine Hydrochloride Capsules, 0.75 g/time, twice daily, for 6 weeks. Patients in the treatment group were po administered with Biqi Capsules on the basis of the control group, 1.2 g/time, three times daily. Patients in two groups were treated for 6 weeks. After treatment, the clinical efficacy was evaluated, and the changes of WOMAC score, VAS score,and serum markers in two groups before and after treatment were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 80.49% and 95.12%, respectively, and there were differences between two groups(P < 0.05). After treatment, the WOMAC scores, total scores and VAS scores in two groups were significantly lower than those in the same group before treatment, and there were differences in the same group(P < 0.05). After treatment, these scores in the treatment group were lower than those in the control group, and there were differences between two groups(P < 0.05). After treatment, IL-1, TNF-α,MMP-3, and COMP in two groups were significantly lower than those in the same group before treatment, and there were differences in the same group(P < 0.05). After treatment, the serological indicators in the treatment group were lower than those in the control group, and there were differences between two groups(P < 0.05). Conclusion Biqi Capsules combined with Glucosamine Capsules and sodium hyaluronate has significant effect in treatment of knee osteoarthritis, and can effectively reduce the inflammatory reaction of knee joints, and also can relieve the symptoms of affected limbs, and improve the function of knee joints, which has a certain clinical application value.
Objective To investigate the clinical efficacies of Biqi Capsules combined with sodium hyaluronate and Glucosamine Capsules in treatment of knee osteoarthritis. Methods Patients(82 cases) with knee osteoarthritis in Characteristic Medical Center of Chinese PAP from February 2016 to October 2018 were randomly divided into control(41 cases) and treatment(41 cases) groups.Patients in the control group were intra-articular injection of Sodium Hyaluronate Injection, 2.5 mL/time, once weekly, for 5 weeks.And they were po administered with Glucosamine Hydrochloride Capsules, 0.75 g/time, twice daily, for 6 weeks. Patients in the treatment group were po administered with Biqi Capsules on the basis of the control group, 1.2 g/time, three times daily. Patients in two groups were treated for 6 weeks. After treatment, the clinical efficacy was evaluated, and the changes of WOMAC score, VAS score,and serum markers in two groups before and after treatment were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 80.49% and 95.12%, respectively, and there were differences between two groups(P < 0.05). After treatment, the WOMAC scores, total scores and VAS scores in two groups were significantly lower than those in the same group before treatment, and there were differences in the same group(P < 0.05). After treatment, these scores in the treatment group were lower than those in the control group, and there were differences between two groups(P < 0.05). After treatment, IL-1, TNF-α,MMP-3, and COMP in two groups were significantly lower than those in the same group before treatment, and there were differences in the same group(P < 0.05). After treatment, the serological indicators in the treatment group were lower than those in the control group, and there were differences between two groups(P < 0.05). Conclusion Biqi Capsules combined with Glucosamine Capsules and sodium hyaluronate has significant effect in treatment of knee osteoarthritis, and can effectively reduce the inflammatory reaction of knee joints, and also can relieve the symptoms of affected limbs, and improve the function of knee joints, which has a certain clinical application value.
引文
[1]骨关节炎诊疗指南(2018年版)[J].中华骨科杂志,2018,38(12):705-715.
[2]Huang Z,Chen J,Ma J,et al.Effectiveness of low-level laser therapy in patients with knee osteoarthritis:a systematic review and meta-analysis[J].Osteoarthritis Cartilage,2015;23(9):1437-1444.
[3]McAlindon T E,Bannuru R R,Sullivan M C,et al.OARSI guidelines for the non-surgical management of knee osteoarthritis[J].Osteoarthritis Cartilage,2014:22(3):363-88.
[4]Pascal Richette,Xavier Chevalier,Hang Korng Ea,et al.Hyaluronan for knee osteoarthritis:an updated meta-analysis of trials with low risk of bias[J].RMDOpen,2015:1(1):e000071.
[5]Nelson A E,Allen K D,Golightly Y M,et a1.A systematic review of recommendations and guidelines for the management of osteoarthritis:The chronic osteoarthritis management initiative of the U.S.bone and joint initiative[J].Semin Arthritis Rheum,2014,43(61):701-712.
[6]Kongtharvonskul J,Anothaisintawee T,McEvoy M,et al.Efficacy and safety of glucosamine diacerein and NSAIDs in osteoarthritis knee:a systematic review and network nmta-analysis[J].Eur J Med Res,2015(20):24.
[7]牟明威.痹祺胶囊治疗膝骨关节炎临床观察[J].中华中医药杂志,2013,28(4):1151-1152.
[8]中华医学会骨科学分会.骨关节炎诊治指南[J].中华骨科杂志,2007,27(10):793-796.
[9]Kellgren J H,Lawrence J S.Radiological assessment of osteoarthritis[J].Ann Rheum Dis,1957,16(4):494.
[10]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:353.
[11]Dawes P,Haslock I.Visual analogue scales[J].Ann Rheum Dis,1982,41(4):434-435.
[12]Bellamy N,Buchanan W W,Goldsmith C H,et al.Validation study of WOMAC:a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee[J].J Rheumatol,1988,15(12):1833-1840.
[13]陈付艳,周鑫.痹祺胶囊联合塞来昔布治疗膝骨性关节炎的临床研究[J].现代药物与临床,2017,32(7):1341-1344.
[14]李芳,姚建华,郑桂敏,等.痹祺胶囊对骨性关节炎患者血清IL-1、MMP-3、TIMP-1表达的影响[J].中华中医药杂志,2016,31(1):300-302.
[15]高晶,曾勇,于飞,等.痹祺胶囊全方及拆方抗炎镇痛作用研究[J].中草药,2009,40(1):93-96.
[16]韦健,周建飞,洪定钢.氨基葡萄糖硫酸盐对兔膝关节骨关节炎的保护作用研究[J].现代药物与临床,2016,31(8):1129-1134.
[17]胡天鑫,周游,熊靓,等.盐酸氨基葡萄糖胶囊联合复方骨肽注射液治疗膝骨关节炎的临床研究[J].现代药物与临床,2018,33(7):1793-1797.
[18]Nguyen C,LefèvreColau M M,Poiraudeau S,et al.Evidence and recommendations for use of intra-articular injections for knee osteoarthritis.Annals of Physical and Rehabilitation[J].Med,2016,59(3):184-189.
[19]Conrozier T,Monfort J,Chevalier X,et al.EUROVISCORecommendations for optimizing the clinical results of viscosupplementation in osteoarthritis.[J].Cartilage,2018.doi:10.1177/1947603518783455.
[20]Jotanovic Z,Etokebe J,Mihelic R,et al.Hip osteoarthritis susceptibility is associated with IL1B(G>A)and IL1 RN(VNTR)genotypic polymorphisms in Croatian Caucasian population[J].J Orthop Res,2011,29(8):1137-1144.
[21]Joos H,Hogrefe C,Rieger L,et al.Single impact trauma in human early-stage osteoarthritic cartilage:implication of prostaglandin D2 but no additive effect of IL-1βon cell survival[J].Int J Mol Med,2011,28(2):271-277.
[22]陈巍,李彬,唐中尧,等.膝骨性关节炎患者关节滑液IL-1β和TNF-α的表达及临床意义[J].广东医学,2010,31(15):1998-2000.
[23]张金山,程园园,刘健.膝骨关节炎患者血清MMP-3、TIMP-1水平变化及相关性研究[J].安徽医科大学学报,2012,47(9):1066-1069.
[24]Das E G,Ng W R,Wong S F,et al.Correlation of serum cartilage oligometric matrix protein(COMP)and interleukin-16(IL-16)levels with disease severity in primary knee osteoarthritis:A pilot study in a Malaysian population[J].PLoS One,2017,12(9):e0184802.
[2]Huang Z,Chen J,Ma J,et al.Effectiveness of low-level laser therapy in patients with knee osteoarthritis:a systematic review and meta-analysis[J].Osteoarthritis Cartilage,2015;23(9):1437-1444.
[3]McAlindon T E,Bannuru R R,Sullivan M C,et al.OARSI guidelines for the non-surgical management of knee osteoarthritis[J].Osteoarthritis Cartilage,2014:22(3):363-88.
[4]Pascal Richette,Xavier Chevalier,Hang Korng Ea,et al.Hyaluronan for knee osteoarthritis:an updated meta-analysis of trials with low risk of bias[J].RMDOpen,2015:1(1):e000071.
[5]Nelson A E,Allen K D,Golightly Y M,et a1.A systematic review of recommendations and guidelines for the management of osteoarthritis:The chronic osteoarthritis management initiative of the U.S.bone and joint initiative[J].Semin Arthritis Rheum,2014,43(61):701-712.
[6]Kongtharvonskul J,Anothaisintawee T,McEvoy M,et al.Efficacy and safety of glucosamine diacerein and NSAIDs in osteoarthritis knee:a systematic review and network nmta-analysis[J].Eur J Med Res,2015(20):24.
[7]牟明威.痹祺胶囊治疗膝骨关节炎临床观察[J].中华中医药杂志,2013,28(4):1151-1152.
[8]中华医学会骨科学分会.骨关节炎诊治指南[J].中华骨科杂志,2007,27(10):793-796.
[9]Kellgren J H,Lawrence J S.Radiological assessment of osteoarthritis[J].Ann Rheum Dis,1957,16(4):494.
[10]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:353.
[11]Dawes P,Haslock I.Visual analogue scales[J].Ann Rheum Dis,1982,41(4):434-435.
[12]Bellamy N,Buchanan W W,Goldsmith C H,et al.Validation study of WOMAC:a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee[J].J Rheumatol,1988,15(12):1833-1840.
[13]陈付艳,周鑫.痹祺胶囊联合塞来昔布治疗膝骨性关节炎的临床研究[J].现代药物与临床,2017,32(7):1341-1344.
[14]李芳,姚建华,郑桂敏,等.痹祺胶囊对骨性关节炎患者血清IL-1、MMP-3、TIMP-1表达的影响[J].中华中医药杂志,2016,31(1):300-302.
[15]高晶,曾勇,于飞,等.痹祺胶囊全方及拆方抗炎镇痛作用研究[J].中草药,2009,40(1):93-96.
[16]韦健,周建飞,洪定钢.氨基葡萄糖硫酸盐对兔膝关节骨关节炎的保护作用研究[J].现代药物与临床,2016,31(8):1129-1134.
[17]胡天鑫,周游,熊靓,等.盐酸氨基葡萄糖胶囊联合复方骨肽注射液治疗膝骨关节炎的临床研究[J].现代药物与临床,2018,33(7):1793-1797.
[18]Nguyen C,LefèvreColau M M,Poiraudeau S,et al.Evidence and recommendations for use of intra-articular injections for knee osteoarthritis.Annals of Physical and Rehabilitation[J].Med,2016,59(3):184-189.
[19]Conrozier T,Monfort J,Chevalier X,et al.EUROVISCORecommendations for optimizing the clinical results of viscosupplementation in osteoarthritis.[J].Cartilage,2018.doi:10.1177/1947603518783455.
[20]Jotanovic Z,Etokebe J,Mihelic R,et al.Hip osteoarthritis susceptibility is associated with IL1B(G>A)and IL1 RN(VNTR)genotypic polymorphisms in Croatian Caucasian population[J].J Orthop Res,2011,29(8):1137-1144.
[21]Joos H,Hogrefe C,Rieger L,et al.Single impact trauma in human early-stage osteoarthritic cartilage:implication of prostaglandin D2 but no additive effect of IL-1βon cell survival[J].Int J Mol Med,2011,28(2):271-277.
[22]陈巍,李彬,唐中尧,等.膝骨性关节炎患者关节滑液IL-1β和TNF-α的表达及临床意义[J].广东医学,2010,31(15):1998-2000.
[23]张金山,程园园,刘健.膝骨关节炎患者血清MMP-3、TIMP-1水平变化及相关性研究[J].安徽医科大学学报,2012,47(9):1066-1069.
[24]Das E G,Ng W R,Wong S F,et al.Correlation of serum cartilage oligometric matrix protein(COMP)and interleukin-16(IL-16)levels with disease severity in primary knee osteoarthritis:A pilot study in a Malaysian population[J].PLoS One,2017,12(9):e0184802.