Background: Osteoarthritis (OA) is imposing substantial burdens on individuals and society with the aging population. Cortex Daphnes patch is widely used for symptomatic knee OA in China with a satisfying clinical efficacy; however, there is scant clinical evidence supporting its use. To evaluate its efficacy, we conducted a multicenter, non-inferiority, randomized, parallel-group study comparing Cortex Daphnes patch with topical nonsteroidal anti-inflammatory drugs in patients with knee OA (NCT02770950).Methods: A total of 264 symptomatic knee OA patients were treated with Cortex Daphnes or indomethacin cataplasms applied to affected sites once daily for 2 weeks. The primary outcome was improvement in knee pain on walking as assessed using a visual analog scale (VAS). The non-inferiority margin based on the full analysis population was set as –5 mm on the pain VAS. The secondary outcomes were changes of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, WOMAC scores for pain, function and stiffness, the 36-item Short Form Health Survey (SF-36), and global assessment of knees by the patients. Responder rates for pain VAS, WOMAC total score, and WOMAC pain were also included in the secondary outcomes.Results: The Cortex Daphnes patch was non-inferior to indomethacin cataplasms for the primary outcome with a group difference (Cortex Daphnes patch–indomethacin cataplasm) of 2.1 mm (95% confidence interval: 2.1–6.4); similar results were found in the per-protocol population. For all other outcomes, no significant differences were found in the full analysis set or in the per-protocol analysis set, except the responder rates for WOMAC pain was higher in the Cortex Daphnes patch group than in the indomethacin cataplasm group (78.4 vs. 64.7%, p = 0.022) in the per-protocol analysis set. Overall, 28.8% patients in the Cortex Daphnes patch group and 9.8% in the indomethacin cataplasm group reported treatment-related adverse events, the vast majority of which were mild-to-moderate skin irritation, resulting in only 3.8 and 0.8% of patients dropping out, respectively.Conclusion: The Cortex Daphnes patch, which provides satisfactory analgesic efficacy and enhances the physical function of the knee, as well as improving quality of life, may be a promising alternative to knee OA.
目的 评价团体认知行为治疗对强直性脊柱炎(AS)伴焦虑抑郁患者的效果.方法 采用病例对照研究,将107例经足量非甾体抗炎药物治疗12周后AS病情活动且伴焦虑抑郁的患者,随机数表法分为观察组及对照组,两组均给予非甾体类抗炎药及TNF-α拮抗剂治疗,对照组行常规治疗,观察组同时给予团体认知行为治疗,于基线期、治疗4及12周末进行汉密尔顿抑郁量表(HAMD)、焦虑自评量表(SAS)、Bath强直性脊柱炎疾病活动指数(BASDAI)及功能指数(BASFI)评估.结果 治疗4周后,观察组AS患者BASDAI、BASFI评分均低于对照组,差异有统计学意义(P<0.05);治疗12周后,观察组AS患者HAMD、SAS、BASDAI、BASFI评分均较对照组降低,差异有统计学意义(P<0.05).观察组AS患者临床缓解率及焦虑抑郁状态改善率均高于对照组,差异有统计学意义(P<0.05).结论 团体认知行为治疗在改善AS患者焦虑抑郁症状的同时,还可以降低AS患者疾病活动度.
目的:探讨艾拉莫德治疗中轴型脊柱关节炎(SpA)的临床效果和安全性.方法:选取2017年1月-2020年1月本院收治的中轴型SpA患者共86例,按照随机数字表法将其分为治疗组和对照组,每组43例.治疗组给予艾拉莫德和塞来昔布治疗,对照组给予柳氮磺吡啶肠溶片和塞来昔布治疗,两组疗程均为12周.比较两组治疗前后的疼痛程度、病情严重程度、炎症指标、骶髂关节骨髓水肿情况及不良反应发生情况.结果:治疗后,两组视觉模拟评分法(visual analogue score,VAS)评分、Bath强直性脊柱炎活动指数(BASDAI)、红细胞沉降率(ESR)、C反应蛋白(CRP)及加拿大脊柱关节研究协会(spondyloarthritis research consortium of canada,SPARCC)评分均低于治疗前,且治疗组均低于对照组(P<0.05).两组不良反应发生率比较,差异无统计学意义(P>0.05).结论:艾拉莫德对中轴型SpA的疗效良好,可缓解关节疼痛,改善病情、减轻炎症反应及骶髂关节骨髓水肿,安全性较好,值得临床推广.
目的:观察中西医结合治疗腹膜后纤维化的临床疗效和安全性.方法:选取接受活血化痰中药联合糖皮质激素和环磷酰胺治疗的腹膜后纤维化患者16例,分析治疗12周后的临床疗效和不良反应发生情况.结果:16例患者主要临床症状为腰痛、腹痛和乏力,治疗12周后患者腹痛、腰痛、乏力等症状均明显缓解,红细胞沉降率、C-反应蛋白均明显下降(P<0.05);治疗后影像学临床控制3例(18.75%),显效8例(50.00%),有效4例(25.00%),无效1例(6.25%),总有效率为93.75%;治疗前后影像学分期比较,差异无统计学意义(P>0.05);治疗过程中无严重不良反应发生.结论:活血化痰中药联合糖皮质激素及环磷酰胺治疗腹膜后纤维化疗效显著,安全性较好,具有增效减毒的作用,值得临床进一步推广应用.治疗前后影像学分期比较无明显变化,说明影像学分期不适合作为疗效评价指标判断短期病情活动情况.
目的 观察联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗活动性强直性脊柱炎(an-kylosing spondylitis,AS)继发骨质疏松症(osteoporosis,OP)的临床效果.方法 选取活动性AS继发OP 68例,采用随机数字表法随机将其分为观察组和对照组两组各34例,研究过程中对照组脱落1例.观察组在常规治疗基础上给予注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白,对照组给予常规治疗,疗程均为24周.比较两组治疗前和治疗24周后炎性指标和Bath AS疾病活动性指数(BASDAI)评分,治疗24周后AS 20%改善程度(ASAS 20)达标率,治疗前和治疗24周后骨代谢标志物和双侧股骨颈、腰1~腰4骨密度(BMD),以及治疗期间不良反应发生情况.结果 治疗前,两组炎性指标及BASDAI评分、骨代谢标志物、双侧股骨颈和腰1~腰4 BMD比较差异均无统计学意义(P>0.05).治疗24周后,两组炎性指标和BASDAI评分、Ⅰ型胶原交联C末端肽(CTX-Ⅰ)低于治疗前,观察组血清碱性磷酸酶(ALP)和两组双侧股骨颈、腰1~腰4 BMD高于治疗前;观察组炎性指标和BASDAI评分、CTX-Ⅰ低于对照组,ASAS 20达标率和双侧股骨颈、腰1~腰4 BMD高于对照组,差异均有统计学意义(P<0.05或P<0.01).治疗期间,两组均未发生明显不良反应.结论 联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗活动性AS继发OP可控制炎症,抑制破骨细胞活性,提升BMD,显著改善AS继发OP.
BACKGROUND Adult-onset still disease (AOSD) and hemophagocytic syndrome (HPS) are two inflammatory diseases with very similar clinical manifestations. HPS is one of the most serious complications of AOSD and its risk of death is very high. It is difficult to identify HPS early in patients with AOSD, but early identification and proper treatment directly affects the prognosis. CASE SUMMARY A 39-year-old male showed a high spiking fever and myalgia. Laboratory data revealed elevated white blood cell, serum ferritin, and neutrophil percentage. However, his fever failed to relieve after a clear diagnosis of AOSD caused by pulmonary infection and treatment by antibiotics and corticosteroids; further laboratory data showed elevated serum ferritin, C-reactive protein, erythrocyte sedimentation rate and triglyceride, as well as liver abnormalities. Bone marrow smear showed hemophagocytosis. Secondary HPS was definitely diagnosed. The high fever disappeared and the laboratory findings returned to normal values after treatment by high-dose intravenous methylprednisolone and methotrexate. CONCLUSION For AOSD patients with high suspicion of HPS, active examination needs to be considered for early diagnosis, and timely using of adequate amount of corticosteroids is the key to reducing risk of HPS death.
Objective:To explore the clinical features and diagnosis of coexistence of ankylosing spondylitis (AS) and Beh?et's disease associated with antiphospholipid syndrome (APS).Methods:We analyzed a case of coexistence of ankylosing spondylitis and Beh?et's disease associated with APS in Seventh Medical Center of Chinese PLA General Hospital in 2016, and the related literature were reviewed.Results:A 26-year-old male patient suffered from inflammatory low back pain, arthralgia and iritis. A His CT imaging revealed bilateral grade Ⅱ of bilateral sacroiliac arthritis. He was diagnosed as AS. He also had recurrent oral ulceration, iritis, vascular disorders and positive acupuncture pathergy test. He was diagnosed as Beh?et's disease. He suffered from recurrentpeated venous thrombosis. Laboratory tests revealed positive antiphospholipid antibodies. He was diagnosed as secondary APS complicated with Beh?et's disease. After he was treated with of glucocorticosteroid, cyclophosphamide, adalimumab and dabigatran, his condition improved significantly.Conclusion:There are some cases reported of AS with Beh?et's disease, or Beh?et's disease with APS, or AS with APS. The relationship between them is complex. The possibility of coexistence of AS and Beh?et's disease and APS should not be ignored, in order to avoid misdiagnosis.
Lupus enteritis and Crohn's disease are two common immune diseases involving the gastrointestinal tract. There are many similar clinical manifestations, therefore it is very difficult to distinguish between them. The digestive system is involved anywhere from 8 to 40% of patients with systemic lupus erythematosus (SLE) and up to 53% of these go on to develop lupus enteritis. In patients with Crohn's disease, 6-40% were presented with oral mucosa ulceration, nodular erythema of skin, arthritis, eye disease and other extraintestinal manifestations. The concomitant of Crohn's disease and SLE is extremely rare; however, here we described a case of concomitant Crohn's disease and SLE characterized by recurrent intestinal obstruction. A systematic literature review of lupus concomitant with Crohn's disease was then conducted.
目的 验证祖师麻膏药治疗膝骨关节炎的有效性和安全性.方法 采用多中心随机对照临床试验设计,于2016年5月至2017年4月纳人中国中医科学院广安门医院、首都医科大学附属北京中医医院、上海市中医医院、卫生部北京医院、北京积水潭医院、首都医科大学世纪坛医院、北京军区总医院、甘肃省中医院门诊确诊的396例膝关节炎患者,参照美国风湿病学会1995年膝骨关节炎分类标准,将患者以1∶1∶1的比例随机分为祖师麻膏药12 h贴敷组、祖师麻膏药24 h贴敷组和吲哚美辛巴布膏24 h贴敷组并干预2周.主要疗效指标为膝关节疼痛视觉模拟评分(PVAS),次要疗效指标为西安大略和麦克马斯特骨关节炎指数(WOMAC)评分,采用皮肤刺激性强度评价标准对试验过程中出现的皮肤刺激症状进行安全性评价.采用符合方案数据集进行统计分析.结果 3组患者治疗2周后PVAS和WOMAC评分较治疗前均有明显改善(P<0.001).3组间WOMAC评分中疼痛维度的“平地走路时”和生理功能维度的“上楼”、“平地走路”和“繁重家务劳动”条目评分差异有统计学意义(P<0.022),其中祖师麻膏药24 h贴敷组“平地走路时”、“上楼”和“繁重家务劳动”条目评分低于吲哚美辛巴布膏24 h贴敷组,差异有统计学意义(P<0.006);祖师麻膏药24 h贴敷组的“平地走路”条目评分低于祖师麻膏药12h贴敷组,差异有统计学意义(P=0.006).祖师麻膏药12h和24 h贴敷组患者局部皮肤红斑、水肿、瘙痒症状分别为23、7、22和32、13、34例次,多于吲哚美辛巴布膏24 h贴敷组的8、2、8例次,差异均有统计学意义(P<0.005),但皮肤刺激症状轻微,不影响药物使用.结论 祖师麻膏药短期应用与吲哚美辛巴布膏止痛疗效相当;祖师麻膏药贴敷24 h可明显改善患者平地走路时疼痛和上楼、繁重家务劳动的关节功能,其作用优于吲哚美辛巴布膏.祖师麻膏药应用后局部皮肤刺激但症状轻微.
Objective:To establish diagnostic system of TCM syndrome of rheumatoid arthritis (RA).Methods:A total of 1,000 RA patients′ diagnostic information of TCM syndrome was collected for multi-variate analysisthe syndrome information was collected to establish the diagnostic system of TCM syndrome of RA.Results:RA syndrome diagnostic criteria were establishedafter the 1,000 RA patients with 179 diagnostic elements were screenedincluding 10 basic syndromes and 56 diagnostic optimization indexes.Conclusion:RA mainly comprises 10 basic syndromes,and the diagnosis system has significant diagnostic value.It is effective to use multi-variate statistical analysis combined application in the study of diagnostic criteria of TCM syndrome screeningand it is worthy of further promotion.
Objective To investigate the value of T cell spot test (T-SPOT.TB) in thc diagnosis of the infection of tuberculosis in patients with rheumatic diseases.Methods From July 2010 to July 2014,266 patients screened for tuberculosis using T-SPOT.TB and examine the sputum in Department of Rheumatology,PLA Army General Hospital were selected.Among the patients,132 cases were diagnosed with rheumatic diseases (rheumatic diseases group),and 134 cases were non-rheumatic immunity (non-rheumatic immunity group).The results of T-SPOT.TB,sputum culture and anti-acid staining of patients were collected.The positive rate of tuberculosis diagnosed by T-SPOT.TB between the two groups.Results The positive rate of tuberculosis diagnosed by T-SPOT.TB in the rheumatic diseases group was 39.39% (52/132),and the positive rate in the non-rheumatic diseases group was 46.53% (67/134).There was no statistical significance difference (P > 0.05).Conclusion T-SPOT.TB has certain diagnostic value for the screening of mycobacterium tuberculosis in patients with rheumatoid immunity.
Objective To observe the effect of tetrandrine in treating connective tissue disease caused interstitial lung disease (CTD-ILD). Method 32 case of CTD-ILD were randomly divided into two groups, each group 16 cases.Corticosteroids and immunosuppressive therapy were given to the control group. The treatment group on the basis of the above treatment with tetrandrine 40mg, 3 times a day orally, the course of treatment was three months for both groups. Result After treatment, the effective rate in the control group was 53.33%, in the treatment group was 87.50%, and there was significant difference between the two groups (P<0.05). After the treatment, the arterial partial pressure of oxygen and forced vital capacity, total lung capacity, diffusion capacity for carbon monoxide of lung were significantly improved than before(P<0.01), while the treatment group the various indicators improved significantly better than those of control group (P<0.05). Conclusion Tetrandrine has good clinical curative effect in treating connective tissue disease related interstitial lung disease, it can significantly improve the patient's lung function.
Objective:To observe the clinical effects of removing both phlegm and blood stasis therapy in treating connective tissue disease related interstitial lung disease (CTD-ILD);Methods:A total of 52 patients with CTD-ILD were randomly divided into treatment group and control group,with 26 cases in each group.The control group received glucocorticoid and immunosuppressive therapy,and the treatment group was added treatment with drugs of removing both phlegm and blood stasis on the basis of the above treatment for 3 months.The effective rate,he 6-minute walk distance,the arterial partial pressure of oxygen (PaO2),forced vital capacity (FVC),total lung capacity (TLC),and diffusion capacity for carbon monoxide of lung (DLCO) of two groups were evaluated.Results:After treatment,the effective rates in treatment group and control group were 88.46% and 64.0% respectively,and the difference between the two groups was statistically significant (P < 0.05);After the treatment,the 6-minute walk distance,PaO2,FVC,TLC and DLCO were significantly improved than that before treatment (P < 0.05),while the improvement of these indicators in the treatment group was significantly better than those of control group (P < 0.05).The number of patients with adverse reactions in the control group was significantly larger than that in the treatment group (P < 0.05).Conclusion:Removing both phlegm and blood stasis therapy has better clinical efficacy in treatment of CTD-ILD,which can significantly improve thepulmonary function of patients,as well as reduce the glucocorticoid and immunosuppressive drug toxicity,so it can be further applied and promoted in clinical practice.
目的 观察艾拉莫德联合治疗原发性干燥综合征(primary sjogren's syndrome,pSS)的临床效果和安全性.方法 选取我科2014年7月-2015年5月收治的pSS 60例,随机将其分为观察组和对照组各30例.观察组采用甲泼尼龙联合艾拉莫德治疗,对照组采用甲泼尼龙联合硫酸羟氯喹治疗,均治疗12周.观察比较两组临床疗效和安全性指标.结果 治疗12周后两组血清IgG含量、红细胞沉降率及类风湿因子水平均较治疗前有所改善,差异均有统计学意义(P <0.05);IgG降低到正常值观察组28例(93.3%),对照组22例(73.3%),观察组IgG降低有效率高于对照组,差异有统计学意义(P<0.05).观察组治疗1周后发现1例血白细胞降低,加用利血生口服1周恢复正常;对照组治疗2d后1例出现皮疹、皮肤瘙痒,予以醋酸泼尼松乳膏外用3d症状消失.结论 糖皮质激素联合艾拉莫德能明显降低血清IgG水平,并能抑制相关炎症反应达到治疗pSS的目的,且其治疗pSS的效果优于糖皮质激素联合硫酸羟氯喹.
Objective:To observe the curative effect and safety of integrated traditional Chinese and western medicine in treating systemic lupus erythematosus (SLE)complicated with herpes zoster (HZ).Methods:A total of 56 cases of patients with SLE were randomly divided into treatment group and control group with 28 patients in each.Both groups were treated wiht conventional treatment and acyclovir orally.Additionally,heat-clearing,blood-cooling antitoxicant herbs and helium-neon laser therapy were given to the treatment group.The treatment lasts for 1 4 days.Results:After treatment,the results of medicinal diagnosis in treat-ment group showed better than the control group in the clinical manifestation of total effective rate,pain outcome,the duration of herpes regression,and the duration of crusts form and fall.The results is of statistical significance with P <0.05.Adverse reaction has not been seen in both groups.Conclusion:Integrated traditional Chinese and western medicine is an effective and safe way to treat SLE complicated with HZ,and worth spreading for clinical use.
Objective Exploring the related risk factors in patients with systemic lupus erythematosus complicated with herpes zoster,to prevent and control herpes zoster. Method Enrolled 26 cases of systemic lupus erythematosus patients with herpes zoster as the observation group from inpatients of Department of Rheumatism of General Hospital of Beijing Military Region,35 cases of systemic lupus erythematosus patients hospitalized in the same period as the control group. The clinical data of two groups of successively by single factor analysis and multi factor non condition-al Logistic regression analysis. Result Course of disease,the value of lymphocyte,hormone treatment time,the hor-mone impact cases,immunosuppressive treatment time,whether treated with cyclophosphamide in one month as well as CD+3 ,CD+4 ,CD+8 value,CD+4/CD+8 ratio were significantly correlated with the occurrence of herpes zoster ( all P<0. 05). Multivariate Logistic regression analysis showed that hormone therapy time and number of cases received hor-mone impact treatment were significantly positive correlation with herpes zoster, absolute value of lymphocyte was negatively correlated with herpes zoster (P<0. 05). Conclusion Hormone in patients with systemic lupus erythema-tosus using time prolonged,the hormone impact treatment and reduction in absolute lymphocyte are major risk factors of herpes zoster occurred;while patients with the extension of course,immunosuppressive treatment time prolonged, treated with cyclophosphamide in one month and CD+3 , CD+4 decreased and CD+8 increased,the numerical value of CD+4/CD+8 ratio decreased are secondary risk factors,clinicians should give early attention and positive prevention of herpes zoster.
Objective To establish a syndrome diagnostic criterion for rheumatoid arthritis( RA) and validate the diagnostic performance of the criteria. Methods We drew up a RA clinical syndrome questionnaire and applied cross-sectional study method. 700 RA patients were surveyed. Then survey information underwent multivariate statistical analysis,including cluster analysis,logistic stepwise regression analysis,stepwise discriminant analysis,principal component analysis,and factor analysis. The diagnostic performance of RA syndrome diagnostic criteria was validated with discriminant analysis. Results Diagnostic indicators of 700 RA patients were reduced from 179 to 124 after first screening; cluster analysis showed that the basic syndromes were damp-heat stagnation,liver-kidney yin deficiency,stagnation of blood stasis,cold-damp stagnation,blood and qi deficiency,phlegm and blood stasis blocking collaterals,and spleen-kidney yang deficiency. By Logistic stepwise regression analysis,the diagnostic indicators of these 7 syndromes were reduced from 124 to 41. Forty six diagnostic indicators were added after stepwise discriminant analysis. Summing up the indicators above,we confirmed that there were 52 sensitive diagnostic indicators for 7 basic syndromes of RA. And after principal component analysis was applied on these 52 indicators,47 remained. Factor analysis then was done on the 47 indicators. According to contributions of the symptoms to the syndrome,syndrome diagnostic criteria of 7 RA basic syndrome types were developed. It is proved with discriminant analysis that the diagnostic accuracy of the criteria was 83. 39%. Conclusion There are 7 basic TCM syndromes in RA,and TCM syndrome diagnostic criteria of RA have a relatively high diagnostic value.
Objective To investigate the clinical characteristics of lung injury in patients with antineutrophil cytoplasmic antibody associated systemic vasculitis (AASV).Methods The clinical data of 14 cases with lung involvement in patients with AASV were retrospectively analyzed,the characteristics of lung injury were summarized.Results Pulmonary manifestations were cough (92.86%),expectoration (78.57%),chest tightness (64.29%),shortness of breath (50.00%),diffusion ventilation dysfunction (85.71%),pulmonary fibrosis (57.14%).Laboratory examination showed elevated erythrocyte sedimentation rate and C-reactive protein,anemia (57.14 %),pANCA (+) (71.43 %).Extrapulmonary manifestations were fever (78.57%),fatigue (50.00%),renal injury (71.43%),and digestive tract injury (42.86%).11 patients (78.57%) improved after the treatment of corticosteroid and immunosuppressive agent,three cases (21.43%) were invalid,including two cases died,one patient in end-stage renal failure need hemodialysis treatment.Conclusions The clinical manifestation of AASV is complicated with lung injury,mainly including cough and expectoration,interstitial pulmonary fibrosis,and extrapulmonary manifestations with fever and kidney damage,early diagnosis and timely treatment may improve the prognosis.
Objective:To observe efficacy and safety of the traditional Chinese medicine Hulisan Capsule on the treatment of knee osteoarthritis.Methods:64 patients with KOA were randomly divided into two groups,namely control group(32 cases) and treatment group(32 cases),two groups were treated with glucosamine sulfate capsule,on this basis,the treatment group was given Hulisan capsule for external application,the control group was given diclofenac emulsion for external application,the course of treatment was 4 weeks,to observe the changes of symptoms and signs of the two groups of patients before and after treatment.Results:After 4 weeks treatment,VAS score and the score of joint function of two groups were significantly improved(P<0.05) compared with those before treatment,and those of the treatment group were better than control group(P<0.05),the clinical effect of the treatment group was significantly better than that of control group.No obvious adverse reactions were found during treatment.Conclusion:Hulisan Capsule can significantly reduce the joint swelling and pain,improve joint function,has a good clinical effect,and high security,is worthy of clinical application.
Objective: To observe the clinical efficacy and safety of Diyu Huaihua decoction combinde with methotrexate in treating pso- riatic arthritis. Methods: A randomized controlled study was conducted. 51 cases of PSA were randomly divided into two groups,the control group ( 25 cases) was given methotrexate therapy while the treatment group ( 26 cases) was given Diyu Huaihua decoction and methotrexate combination treatment for 12 weeks,observed the changes of clinical and laboratory parameters in the two groups of patients before and after treatment. Results: After 12 weeks of treatment,compared with pre-treatment,the VAS score,duration of morning stiff- ness,swollen joint count,tender joint count,ESR,C-RP and skin lesions PASI score of the two groups showed significant improvement ( P<0.05) ,and compared with the control group,the differences of these index in treatment group before and after treatment were sig- nificant( P < 0. 05) ; the incidence of adverse reactions was significantly higher in control group when compared with treatment group ( P < 0. 05) . Conclusion: Diyu Huaihua decoction combined with methotrexate combination can significantly improve joint symptoms,re- lieve skin lesions and has smaller adverse reactions.