Objective:To evaluate the efficacy and safety of Jiawei Simiao powder(JWSMP)combined with celecoxib for the treatment of acute gouty arthritis by conducting a meta-analysis of randomized controlled trials(RCTs).Method...Objective:To evaluate the efficacy and safety of Jiawei Simiao powder(JWSMP)combined with celecoxib for the treatment of acute gouty arthritis by conducting a meta-analysis of randomized controlled trials(RCTs).Methods: The Chinese National Knowledge Infrastructure Databases,Chinese Scientific Journal Database,Wanfang,Cochrane Library,EMBASE,PubMed,and Web of Science databases were searched from inception until December 2023.Continuous variables were analyzed using the mean difference(MD)for analysis,and dichotomous variables were used as risk ratios.Data with similar characteristics were pooled for meta-analysis,and heterogeneity was assessed using I2.The Cochrane Handbook was used to assess the risk of bias and quality.RevMan 5.3 software was used to perform the meta-analysis.Results: Thirteen RCTs involving 1007 patients were included in the study.The quality of the included studies was low(unclear randomization processes and insufficient blinding reporting).The group receiving JWSMP combined with celecoxib showed significantly lower levels of serum uric acid(SUA,MD=−66.32,95%confidence interval(CI):−80.97 to−51.67,P<.001),erythrocyte sedimentation rate(ESR,MD=−6.05,95%CI:−8.29 to−3.82,P<.001),C-reactive protein(CRP,MD=−7.39,95%CI:−11.15,−3.63,P<.001),and joint pain score(VAS score,MD=−2.14,95%CI:−2.4 to−1.88,P<.001)compared to celecoxib alone.Additionally,the JWSMP combined group had a higher total effective rate(risk ratio=1.22,95%CI:1.14 to 1.29,P<.001)and fewer adverse compared to celecoxib alone.Conclusions: JWSMP combined with celecoxib is more effective than celecoxib alone in improving the total efficacy rate,alleviating joint pain,and improving SUA,ESR,and CRP levels.JWSMP also reduced the occurrence of adverse events caused by celecoxib.However,the quality of the included studies was low,highlighting the need for further high-quality research with larger sample sizes and robust methodologies,such as double-blind randomization,to confirm these findings.展开更多
Objective: To observe the clinical effect of Rebixiao granule (热痹消颗粒剂, RBXG) in treating repeatedly attacking acute gouty arthritis and through experimental study on blood uric acid to explore RBXG's therape...Objective: To observe the clinical effect of Rebixiao granule (热痹消颗粒剂, RBXG) in treating repeatedly attacking acute gouty arthritis and through experimental study on blood uric acid to explore RBXG's therapeutic mechanism. Methods: Ninety repeatedly attacking acute gouty arthritis patients were divided into the treated group ( n =60) and control group ( n =30). The treated group was treated with RBXG, and the control group was treated with Futalin tablets (diclofenac sodium). The baseline treatment including good rest, low purine diet, sufficient water drinking and urine alkalization, etc. was then given to both groups. Hypoxanthine 600 mg/kg and niacin 100 mg/kg was applied to hyperuricemic mice by gastrogavage to establish the animal models. Results: The clinical effective rate of the treated group was 95.0% and that of the control 90.0%. Good therapeutic effects were won, insignificant difference ( P >0.05)was shown between the two groups. However, the cure rate of the treated group was 26.7% while that of the control group was 10.0%, with significant difference ( P <0.01) shown between them. The treated group had its blood uric acid lowered, which was significantly different ( P <0.05) from that of the control group. The animal experiment indicated that all the three groups treated with different dosages of RBXG, as well as the Ash bark and Smilax glabra rhizome groups had their blood uric acid content reduced in the hyperuricemic mice. Conclusion: RBXG has a quicker initiation and better treatment effects than sole anti-inflammatory and analgesic agents on the treatment of repeatedly attacking acute gouty arthritis, showing no obvious toxic or adverse reactions and therefore good for long-term administration and likely to be a safe TCM preparation to control the symptoms and reduce the onsets of repeatedly attacking of acute gouty arthritis. The animal experiment shows that both the compound preparation and part of the single ingredients in the recipe have the function of reducing blood uric acid. However, the compound recipe has better therapeutic effects, proving to be superior to single drugs.展开更多
External application of traditional Chinese medicine has a long history and definite curative effect on gout.By searching the latest literature on the treatment of acute gouty arthritis by external treatment of tradit...External application of traditional Chinese medicine has a long history and definite curative effect on gout.By searching the latest literature on the treatment of acute gouty arthritis by external treatment of traditional Chinese medicine,the research progress of external treatment of acute gouty arthritis in recent years was summarized.According to the existing research results,the external treatment of Chinese medicine in the treatment of acute gout has better efficacy and higher safety,and has a broad application prospect.展开更多
[Objectives]To study the anti-inflammatory effect of Simiao Liangxue granule on the rats with acute gouty arthritis(AGA).[Methods]A total of 60 male SD rats were randomly divided into 6 groups with 10 rats in each gro...[Objectives]To study the anti-inflammatory effect of Simiao Liangxue granule on the rats with acute gouty arthritis(AGA).[Methods]A total of 60 male SD rats were randomly divided into 6 groups with 10 rats in each group.The rats in the colchicine group were intragastrically administered with 0.65 mg/kg colchicine,and the rats in low,medium and high dose groups of Simiao Liangxue granule were intragastrically administered with Simiao Liangxue granule with mass concentration of 0.4,0.8 and 1.6 g/kg,respectively.The rats in the normal control group and the model group were given the same amount of normal saline for 7 d,and the acute gouty arthritis model was prepared 1 h after administration on the 5th d.At the end of the experiment,the degree of joint swelling and joint inflammation index,the content of interleukin-1β,tumor necrosis factor-a and cyclooxygenase-2 in articular cartilage,and the content of interleukin-8,NO and UA in serum of rats were measured,and the histomorphological observation was performed.[Results]Compared with the normal control group,the joints of rats were swollen to different degrees,the inflammation score was significantly increased,and the content of IL-1β,TNF-αand COX-2 in the soft tissue of the joints was significantly increased in each group(P<0.05);compared with the model group,the joint swelling degree and inflammation score of rats in the colchicine group and Simiao Liangxue granule group were significantly decreased,the content of IL-1β,TNF-αand COX-2 in the joint soft tissue was also significantly decreased(P<0.05),and the indexes of each dose group of Simiao Liangxue granule were similar to those of the colchicine group;compared with the normal control group,the content of IL-8,NO and UA in the joint soft tissue of rats was significantly increased in each group(P<0.05);compared with the model group,the content of all indexes in joint soft tissue of rats in normal control group,colchicine group and Simiao Liangxue granule group were significantly decreased(P<0.05);the content of various indexes in the joint soft tissue of rats in the low and medium dose groups of Simiao Liangxue granule was higher than that in the colchicine group,and decreased significantly with the increase of the dose of Simiao Liangxue granule(P<0.05);the inflammatory index decreased significantly with the increase of the dose of Simiao Liangxue granule(P<0.05);the inflammation and degeneration in each dose group of Simiao Liangxue granule were milder than those in the model group,and the symptoms were relieved to some extent with the increase of dose(P<0.05).[Conclusions]Simiao Liangxue granule has the effect of anti-inflammation and detumescence,and its mechanism may be related to the content of factors that reduce inflammation including IL-1β,TNF-α,C0X-2,IL-8,NO and UA.展开更多
Objective:To Find the core targets and drug action mechanism of Si Miao decoction for the treatment of acute gouty arthritis.Methods:Through the TCMSP database,the chemical composition of all the drugs in Si Miao deco...Objective:To Find the core targets and drug action mechanism of Si Miao decoction for the treatment of acute gouty arthritis.Methods:Through the TCMSP database,the chemical composition of all the drugs in Si Miao decoction was obtained.The Perl script was compiled and the UniProt database was searched to determine the corresponding target of the chemical composition.Then,the disease databases such as OMIM,DisGeNET,and GeneCards were searched in order to determine acute gouty arthritis Related targets.Finally,screen common targets for drugs and diseases,use the STRING database and Cytoscape software to build a network control map of drugs-chemical components-targets-disease.Use R language software to screen common targets and find the four best The core targets of San for the treatment of acute gouty arthritis.The GO and KEGG analysis of the core targets were performed to clarify the core targets and mechanism of Si Miao decoction for the treatment of gout.Results:There are 64 effective chemical components in Si Miao decoction,197 genetic targets,600 disease targets,and 58 common targets.It is predicted that IL6,VEGFA,IL1B,JUN,PTGS2,and CCL2 may be treated by Si Miao decoction for gout The core target of arthritis.GO enrichment analysis identified 85 entries,of which biological processes mainly included the regulation of cytokine activity,protease activation,nucleic acid expression,etc.;KEGG pathway enrichment analysis identified 135 signaling pathways,of which signaling pathways involved the IL-17 signaling pathway,TNF signaling pathway,Th17 cell differentiation and other pathways.Conclusion:Si Miao decoction acts on acute gouty arthritis by regulating the occurrence of inflammation,and has significant anti-inflammatory and immune effects.The formula is rigorous and scientific,and it is worthy of clinical application.展开更多
Objective:To investigate the effect and anti-inflammatory mechanism the effect of Flemingia Roxb.exAit extract on acute gouty arthritis.Methods:Sixty SD rats were randomly divided into 6 groups by weight,control and m...Objective:To investigate the effect and anti-inflammatory mechanism the effect of Flemingia Roxb.exAit extract on acute gouty arthritis.Methods:Sixty SD rats were randomly divided into 6 groups by weight,control and model group,(100、150、200 mg/kg)of Flemingia Roxb.exAit extract group and colchicine group.The rats of each group were given by intragastric for 7 days of continuous administration,meanwhile,there were given 0.9%NaCl solution instead as control and model group.The acute gouty arthritis model was constructed through right ankle joint cavity injection of sodium urate crystal solutionon day 5 after 1 h,but rats in the negative control group were injected with 0.9%NaCl solution into the articular cavity of the right foot.The general condition of rats and the degree of joint swelling,and the gait was observed after constructed model.To detected the joint fluid IL-1β、TNF-α、IL-6 indicators,and the expression of NLRP3,Caspase-1 protein in ankle joint tissue for 2 hours after the last administration.Results:Groups of Flemingia Roxb.exAit extract could markedly reduce the joint swelling on acute gouty arthritis rat model,improve gait in a dose-dependent manner,high dose group of Flemingia Roxb.exAit extract did particularly well(Pjoint swelling<0.01;Pgait<0.05),close to the therapeutic effect colchicine group.Further mechanism studies show that the joint fluid IL-1β、TNF-α、IL-6 level was reduced by Flemingia Roxb.exAit extract group,the expressions of NLRP3、Caspase-1 protein of Flemingia Roxb.exAit extract group was decreased observbly than model group,but the most obvious is that high dose group as well as colchicine group(PNALP3<0.01;PCaspase-1<0.01).Conclusion:Flemingia Roxb.exAit extract has the effect of treating acute gouty arthritis and its mechanism may be related toinhibiting NLRP3 inflammasome activation and inhibiting inflammatory response.展开更多
Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious...Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious adverse reactions.Huzhang Granule(HZG),a compound Chinese herbal medicine,has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions.However,the efficacy and safety of HZG in AGA patients remains unknown.Objective:The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.Design,setting,participants and interventions:The current study was conducted as a noninferiority,randomized controlled clinical trial on 180 eligible enrolled participants.Participants were randomly assigned into the HZG and etoricoxib groups.Treatments were administered for 5 d,during which the HZG group received HZG and placebo etoricoxib,while the etoricoxib group received etoricoxib and placebo HZG in the same ratio(1:1).Main outcome measures:The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window.The pain level was measured via a visual analogue scale,ranging from 0 mm to 100 mm.The secondary outcomes comprised joint tenderness and swelling,reduction of inflammatory biomarkers,and the patient’s and investigator’s global evaluations of therapeutic response.Results:The mean reduction in pain was-51.22 mm(95%confidence interval[CI],[-53.42,-49.03]mm)for the HZG and-52.00 mm(95%CI,[-54.06,-49.94]mm)for the etoricoxib groups.The mean difference between the two groups was 0.78 mm(95%CI,[-2.25,3.81]mm).All additional efficacy endpoints,covering decreased inflammation and pain relief,yielded compelling proof of noninferiority.Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group(4.44%vs 13.33%;P≤0.05).Conclusion:HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness.The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.展开更多
基金supported by the National Administration of Traditional Chinese Medicine Young Qi Huang Scholars support project.
文摘Objective:To evaluate the efficacy and safety of Jiawei Simiao powder(JWSMP)combined with celecoxib for the treatment of acute gouty arthritis by conducting a meta-analysis of randomized controlled trials(RCTs).Methods: The Chinese National Knowledge Infrastructure Databases,Chinese Scientific Journal Database,Wanfang,Cochrane Library,EMBASE,PubMed,and Web of Science databases were searched from inception until December 2023.Continuous variables were analyzed using the mean difference(MD)for analysis,and dichotomous variables were used as risk ratios.Data with similar characteristics were pooled for meta-analysis,and heterogeneity was assessed using I2.The Cochrane Handbook was used to assess the risk of bias and quality.RevMan 5.3 software was used to perform the meta-analysis.Results: Thirteen RCTs involving 1007 patients were included in the study.The quality of the included studies was low(unclear randomization processes and insufficient blinding reporting).The group receiving JWSMP combined with celecoxib showed significantly lower levels of serum uric acid(SUA,MD=−66.32,95%confidence interval(CI):−80.97 to−51.67,P<.001),erythrocyte sedimentation rate(ESR,MD=−6.05,95%CI:−8.29 to−3.82,P<.001),C-reactive protein(CRP,MD=−7.39,95%CI:−11.15,−3.63,P<.001),and joint pain score(VAS score,MD=−2.14,95%CI:−2.4 to−1.88,P<.001)compared to celecoxib alone.Additionally,the JWSMP combined group had a higher total effective rate(risk ratio=1.22,95%CI:1.14 to 1.29,P<.001)and fewer adverse compared to celecoxib alone.Conclusions: JWSMP combined with celecoxib is more effective than celecoxib alone in improving the total efficacy rate,alleviating joint pain,and improving SUA,ESR,and CRP levels.JWSMP also reduced the occurrence of adverse events caused by celecoxib.However,the quality of the included studies was low,highlighting the need for further high-quality research with larger sample sizes and robust methodologies,such as double-blind randomization,to confirm these findings.
基金Supported by Project of Science and Technology Commis sion Foundation of Jiangsu Province in 1998
文摘Objective: To observe the clinical effect of Rebixiao granule (热痹消颗粒剂, RBXG) in treating repeatedly attacking acute gouty arthritis and through experimental study on blood uric acid to explore RBXG's therapeutic mechanism. Methods: Ninety repeatedly attacking acute gouty arthritis patients were divided into the treated group ( n =60) and control group ( n =30). The treated group was treated with RBXG, and the control group was treated with Futalin tablets (diclofenac sodium). The baseline treatment including good rest, low purine diet, sufficient water drinking and urine alkalization, etc. was then given to both groups. Hypoxanthine 600 mg/kg and niacin 100 mg/kg was applied to hyperuricemic mice by gastrogavage to establish the animal models. Results: The clinical effective rate of the treated group was 95.0% and that of the control 90.0%. Good therapeutic effects were won, insignificant difference ( P >0.05)was shown between the two groups. However, the cure rate of the treated group was 26.7% while that of the control group was 10.0%, with significant difference ( P <0.01) shown between them. The treated group had its blood uric acid lowered, which was significantly different ( P <0.05) from that of the control group. The animal experiment indicated that all the three groups treated with different dosages of RBXG, as well as the Ash bark and Smilax glabra rhizome groups had their blood uric acid content reduced in the hyperuricemic mice. Conclusion: RBXG has a quicker initiation and better treatment effects than sole anti-inflammatory and analgesic agents on the treatment of repeatedly attacking acute gouty arthritis, showing no obvious toxic or adverse reactions and therefore good for long-term administration and likely to be a safe TCM preparation to control the symptoms and reduce the onsets of repeatedly attacking of acute gouty arthritis. The animal experiment shows that both the compound preparation and part of the single ingredients in the recipe have the function of reducing blood uric acid. However, the compound recipe has better therapeutic effects, proving to be superior to single drugs.
基金the Subject of Wuxi Health and Family Planning Commission(ZXZL201803)Youth Lift Plan of Wuxi Hospital of Traditional Chinese Medicine(ZYY2017B005).
文摘External application of traditional Chinese medicine has a long history and definite curative effect on gout.By searching the latest literature on the treatment of acute gouty arthritis by external treatment of traditional Chinese medicine,the research progress of external treatment of acute gouty arthritis in recent years was summarized.According to the existing research results,the external treatment of Chinese medicine in the treatment of acute gout has better efficacy and higher safety,and has a broad application prospect.
基金Guangxi Natural Science Foundation(2020GXNSFAA259059)National Training Program for Characteristic Technology Inheritance of Traditional Chinese Medicine(20184828005)In-hospital Preparation Development Project of the First Affiliated Hospital of Guangxi University of Chinese Medicine in 2017(2017ZJ001).
文摘[Objectives]To study the anti-inflammatory effect of Simiao Liangxue granule on the rats with acute gouty arthritis(AGA).[Methods]A total of 60 male SD rats were randomly divided into 6 groups with 10 rats in each group.The rats in the colchicine group were intragastrically administered with 0.65 mg/kg colchicine,and the rats in low,medium and high dose groups of Simiao Liangxue granule were intragastrically administered with Simiao Liangxue granule with mass concentration of 0.4,0.8 and 1.6 g/kg,respectively.The rats in the normal control group and the model group were given the same amount of normal saline for 7 d,and the acute gouty arthritis model was prepared 1 h after administration on the 5th d.At the end of the experiment,the degree of joint swelling and joint inflammation index,the content of interleukin-1β,tumor necrosis factor-a and cyclooxygenase-2 in articular cartilage,and the content of interleukin-8,NO and UA in serum of rats were measured,and the histomorphological observation was performed.[Results]Compared with the normal control group,the joints of rats were swollen to different degrees,the inflammation score was significantly increased,and the content of IL-1β,TNF-αand COX-2 in the soft tissue of the joints was significantly increased in each group(P<0.05);compared with the model group,the joint swelling degree and inflammation score of rats in the colchicine group and Simiao Liangxue granule group were significantly decreased,the content of IL-1β,TNF-αand COX-2 in the joint soft tissue was also significantly decreased(P<0.05),and the indexes of each dose group of Simiao Liangxue granule were similar to those of the colchicine group;compared with the normal control group,the content of IL-8,NO and UA in the joint soft tissue of rats was significantly increased in each group(P<0.05);compared with the model group,the content of all indexes in joint soft tissue of rats in normal control group,colchicine group and Simiao Liangxue granule group were significantly decreased(P<0.05);the content of various indexes in the joint soft tissue of rats in the low and medium dose groups of Simiao Liangxue granule was higher than that in the colchicine group,and decreased significantly with the increase of the dose of Simiao Liangxue granule(P<0.05);the inflammatory index decreased significantly with the increase of the dose of Simiao Liangxue granule(P<0.05);the inflammation and degeneration in each dose group of Simiao Liangxue granule were milder than those in the model group,and the symptoms were relieved to some extent with the increase of dose(P<0.05).[Conclusions]Simiao Liangxue granule has the effect of anti-inflammation and detumescence,and its mechanism may be related to the content of factors that reduce inflammation including IL-1β,TNF-α,C0X-2,IL-8,NO and UA.
基金National Natural Resources Foundation program(No.81373802)Beijing Natural Science Foundation(No.7172244)Beijing Science and Technology Project(No.Z191100006619024)
文摘Objective:To Find the core targets and drug action mechanism of Si Miao decoction for the treatment of acute gouty arthritis.Methods:Through the TCMSP database,the chemical composition of all the drugs in Si Miao decoction was obtained.The Perl script was compiled and the UniProt database was searched to determine the corresponding target of the chemical composition.Then,the disease databases such as OMIM,DisGeNET,and GeneCards were searched in order to determine acute gouty arthritis Related targets.Finally,screen common targets for drugs and diseases,use the STRING database and Cytoscape software to build a network control map of drugs-chemical components-targets-disease.Use R language software to screen common targets and find the four best The core targets of San for the treatment of acute gouty arthritis.The GO and KEGG analysis of the core targets were performed to clarify the core targets and mechanism of Si Miao decoction for the treatment of gout.Results:There are 64 effective chemical components in Si Miao decoction,197 genetic targets,600 disease targets,and 58 common targets.It is predicted that IL6,VEGFA,IL1B,JUN,PTGS2,and CCL2 may be treated by Si Miao decoction for gout The core target of arthritis.GO enrichment analysis identified 85 entries,of which biological processes mainly included the regulation of cytokine activity,protease activation,nucleic acid expression,etc.;KEGG pathway enrichment analysis identified 135 signaling pathways,of which signaling pathways involved the IL-17 signaling pathway,TNF signaling pathway,Th17 cell differentiation and other pathways.Conclusion:Si Miao decoction acts on acute gouty arthritis by regulating the occurrence of inflammation,and has significant anti-inflammatory and immune effects.The formula is rigorous and scientific,and it is worthy of clinical application.
基金2016 Hainan Medical College Students Innovation and Entrepreneurship Training Program(No.HYCX2016055)2017 Hainan College Students Innovation and Entrepreneurship Training Program Project(No.2017098)。
文摘Objective:To investigate the effect and anti-inflammatory mechanism the effect of Flemingia Roxb.exAit extract on acute gouty arthritis.Methods:Sixty SD rats were randomly divided into 6 groups by weight,control and model group,(100、150、200 mg/kg)of Flemingia Roxb.exAit extract group and colchicine group.The rats of each group were given by intragastric for 7 days of continuous administration,meanwhile,there were given 0.9%NaCl solution instead as control and model group.The acute gouty arthritis model was constructed through right ankle joint cavity injection of sodium urate crystal solutionon day 5 after 1 h,but rats in the negative control group were injected with 0.9%NaCl solution into the articular cavity of the right foot.The general condition of rats and the degree of joint swelling,and the gait was observed after constructed model.To detected the joint fluid IL-1β、TNF-α、IL-6 indicators,and the expression of NLRP3,Caspase-1 protein in ankle joint tissue for 2 hours after the last administration.Results:Groups of Flemingia Roxb.exAit extract could markedly reduce the joint swelling on acute gouty arthritis rat model,improve gait in a dose-dependent manner,high dose group of Flemingia Roxb.exAit extract did particularly well(Pjoint swelling<0.01;Pgait<0.05),close to the therapeutic effect colchicine group.Further mechanism studies show that the joint fluid IL-1β、TNF-α、IL-6 level was reduced by Flemingia Roxb.exAit extract group,the expressions of NLRP3、Caspase-1 protein of Flemingia Roxb.exAit extract group was decreased observbly than model group,but the most obvious is that high dose group as well as colchicine group(PNALP3<0.01;PCaspase-1<0.01).Conclusion:Flemingia Roxb.exAit extract has the effect of treating acute gouty arthritis and its mechanism may be related toinhibiting NLRP3 inflammasome activation and inhibiting inflammatory response.
基金supported by the Clinical Research Plan of SHDC(No.SHDC2020CR4053SHDC2022CRS053)+14 种基金Research Project of Shanghai Municipal Health Care Commission(No.20204Y0312)Shanghai Municipal Health Commission Health Industry Clinical Research Special Project(No.20234Y0075)Health Young Talents of Shanghai Municipal Health Commission(No.2022YQ026)the Clinical Research Program of Shanghai Municipal Health Commission(No.202240371)Shanghai Clinical Key Specialty Construction Project(No.shslczdzk05001)Three-year Action Plan of Shanghai to Further Accelerate the Inheritance and Innovation of Traditional Chinese Medicine(No.ZY[2021-2023]-0302)Jiangxi Provincial Natural Science Foundation(No.20224BAB216096)Shanghai Dermatology Research Center(No.2023ZZ02017)Shanghai Dermatology Hospital Demonstration Research Ward Project(No.SHDC2023CRW009)Xinglin Youth Scholar of Shanghai University of Traditional Chinese Medicine(No.RY411.33.10)Youth Talent Promotion Project of China Association of Traditional Chinese Medicine(2021–2023)Category A(No.CACM-2021-QNRC2-A10)‘‘Chen Guang”project supported by Shanghai Municipal Education Commission and Shanghai Education Development Foundation(No.22CGA50)High-level Chinese Medicine Key Discipline Construction Project(Integrative Chinese and Western Medicine Clinic)of National Administration of TCM(No.zyyzdxk-2023065)Shanghai Talent Development Fund(No.2021073)Shanghai Sailing Program(No.20YF1450500)。
文摘Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious adverse reactions.Huzhang Granule(HZG),a compound Chinese herbal medicine,has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions.However,the efficacy and safety of HZG in AGA patients remains unknown.Objective:The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.Design,setting,participants and interventions:The current study was conducted as a noninferiority,randomized controlled clinical trial on 180 eligible enrolled participants.Participants were randomly assigned into the HZG and etoricoxib groups.Treatments were administered for 5 d,during which the HZG group received HZG and placebo etoricoxib,while the etoricoxib group received etoricoxib and placebo HZG in the same ratio(1:1).Main outcome measures:The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window.The pain level was measured via a visual analogue scale,ranging from 0 mm to 100 mm.The secondary outcomes comprised joint tenderness and swelling,reduction of inflammatory biomarkers,and the patient’s and investigator’s global evaluations of therapeutic response.Results:The mean reduction in pain was-51.22 mm(95%confidence interval[CI],[-53.42,-49.03]mm)for the HZG and-52.00 mm(95%CI,[-54.06,-49.94]mm)for the etoricoxib groups.The mean difference between the two groups was 0.78 mm(95%CI,[-2.25,3.81]mm).All additional efficacy endpoints,covering decreased inflammation and pain relief,yielded compelling proof of noninferiority.Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group(4.44%vs 13.33%;P≤0.05).Conclusion:HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness.The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.