Background This study aims to assess the efficacy and safety of Qingpeng ointment (QPO), a Tibetan medicine for alleviating symptoms in individuals with acute gouty arthritis (AGA). Methods This study was a randomized, double-blind, placebo-controlled trial that involved individuals with AGA whose joint pain, as measured on a visual analog scale (VAS) from 0 to 10, was equal to or greater than 3. The participants were randomly assigned to either the QPO or the placebo group and received their respective treatments twice daily for seven consecutive days. In case of intolerable pain, the participants were allowed to use diclofenac sodium sustained-release tablets as a rescue medicine. The primary outcomes measured were joint pain and swelling, while the secondary outcomes included joint mobility, redness, serum uric acid levels, C-reactive protein levels, and the amount of remaining rescue medicine. Any adverse events that occurred during the trial were also recorded. Results A total of 203 cases were divided into two groups, with balanced baselines: 102 in the QPO group and 101 in the placebo group. For joint pain, differences between the groups were notable in the VAS scores [1.75 (0, 3.00) versus 2.00 (1.00, 3.50); P = 0.038], changes in VAS [5.00 (3.00, 6.00) versus 4.00 (2.00, 6.00); P = 0.036], and disappearance rate [26.47% compared to 15.84%; P = 0.046] after treatment. Concerning joint swelling, significant between-group differences were observed in the VAS scores [1.00 (0, 2.30) versus 2.00 (0.70, 3.00); P = 0.032] and disappearance rate [33.33% compared to 21.78%; P = 0.046] at treatment completion. The QPO group exhibited a statistically significant mobility improvement compared to the placebo group ( P = 0.004). No significant differences were found in other secondary outcomes. Five patients, four from the QPO group and one from the other, encountered mild adverse events, primarily skin irritation. All of these cases were resolved after dosage reduction or discontinuation of the medication. Conclusions Compared to the placebo, QPO exhibits positive effects on AGA by alleviating pain, reducing swelling, and enhancing joint mobility, without causing significant adverse effects. Trial Registration ISRCTN34355813. Registered on 25/01/2021.
目的 探讨"六君子汤加味"健脾泄浊治疗脾虚湿阻型高尿酸血症的疗效.方法 将2018年8月~2020年1月共226例某院门诊收治的脾虚湿阻型高尿酸血症患者随机分为试验组(生活干预+常规西药治疗+口服中药颗粒"六君子汤加味",每日1剂,2次分服,n=111例)和对照组(生活干预+常规西药治疗,n=115例),治疗周期为12周,观察两组治疗前后中医临床症状、血尿酸、甘油三酯、血清炎症因子水平的变化,比较两组患者生活质量水平和痛风发生情况.结果 试验组总有效率明显高于对照组(81.08%vs.65.22%,P<0.01).治疗后两组血尿酸、甘油三酯、超敏C反应蛋白(hs-CRP)水平较治疗前均明显下降,差异有统计学意义(P<0.01),治疗后两组血尿酸、甘油三酯比较差异无统计学意义(P>0.05),但hs-CRP水平比较差异有统计学意义(P<0.05).试验组治疗后中医临床症状(脘腹痞闷、腹满、头身困重、口淡不渴、口腻、大便不爽)较治疗前明显下降,差异有统计学意义(P<0.01);对照组治疗后中医临床症状较治疗前均无明显下降,差异无统计学意义(P>0.05).治疗后两组中医临床症状改善差异有统计学意义(P<0.01).治疗后试验组患者生活质量综合问卷(GQOLI-74)各维度评分较对照组均明显升高,差异有统计学意义(P<0.05).治疗结束后1年内,试验组患者痛风发生率较对照组明显降低,差异有统计学意义(14.41%vs.40.87%,P<0.01).结论 "六君子汤加味"口服联合常规生活方式干预治疗可明显降低脾虚湿阻型高尿酸血症患者的血尿酸及甘油三酯水平,相比单纯生活方式干预其能进一步改善脾虚湿阻患者的中医临床症状和生活质量水平,同时降低患者血清炎症细胞因子水平,从而减少痛风的发生.
报道1例在北京市房山区中医医院诊治的肥胖2型糖尿病合并蛋白尿患者使用利拉鲁肽联合达格列净及二甲双胍治疗后,血糖、体重、尿蛋白等改善的过程。患者为34岁女性,主因糖尿病半年,腰部酸痛1个月就诊。结合既往史及检查结果,诊断为:2型糖尿病,肥胖,高血压2级(很高危组),高脂血症,胆囊结石术后,血尿及蛋白尿原因待查。患者体重指数28.86 kg/m 2,糖化血红蛋白8.1%,尿微量白蛋白231.7 mg/L。患者减重意愿强烈,予口服二甲双胍缓释片(1 000 mg,2次/d)及达格列净(10 mg、1次/d)联合利拉鲁肽皮下注射(0.6 mg,1次/d起始,逐渐加量至1.8 mg,1次/d)治疗,治疗约30个月,其糖化血红蛋白、尿微量蛋白、体重、血压均明显改善,患者满意。
目的 探讨针刺联合蚕沙外熨治疗中老年糖尿病周围神经病变的疗效.方法 选取北京市房山区中医医院2019年1月—2020年6月收治的60例中老年糖尿病周围神经病变患者,随机分为对照组30例和治疗组30例,2组均给于糖尿病基础治疗,其中对照组口服甲钴胺治疗,治疗组在口服甲钴胺的基础上,加用针刺联合蚕沙外熨进行治疗,2组均连续治疗4周.观察对比2组患者的中医证候评分、足部震动感觉阈值以及运动传导速度、感觉传导速度、神经体征评分、生活质量评分等.结果 治疗组患者中医证候评分、足部震动感觉阈值以及运动传导速度、感觉传导速度、神经体征及生活质量评分均优于对照组(P<0.05).结论 在临床上使用针刺联合蚕沙外熨治疗糖尿病周围神经病的中老年患者的效果较好,在临床上有较高的应用价值,值得临床推广.
Acute gouty arthritis (AGA) is an inflammatory arthritis clinically characterized by severe pain, swelling, and restricted movement of joints, which may cause physical disability and decrease quality of life. The use of recommended first-line treatment agents for AGA may be limited by adverse events. There has been a traditional use of alternative therapies for AGA. Tibetan medicine Qingpeng ointment is one of the on-market herbal products used for symptom relief of AGA. Previous clinical studies indicated that Qingpeng ointment can relieve pain, swelling, redness, and dysfunction of joints in patients with AGA. However, there is no rigorous randomized trial to demonstrate its benefit for AGA. In order to evaluate the efficacy and safety of Qingpeng ointment for AGA, we designed a randomized controlled trial. This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Two hundred and six adults with acute flare of gout, and visual analogue scale (VAS) score of joint pain ≥ 3 points will be recruited. Participants will be randomly assigned to herbal treatment or placebo group at a ratio of 1:1. Qingpeng ointment, or equal placebo ointment, will be applied topically at involved joints twice a day for consecutive 7 days. Patients in both groups would be allowed giving diclofenac sodium sustained-release tablets as rescue therapy when VAS score of joint pain ≥ 7 points during the treatment. The primary outcomes will be joint pain measured by VAS score, and joint swelling measured using width and thickness of affected joints and VAS score. Other outcome measures will be joint mobility, joint redness, C-reactive protein, serum uric acid, and the use of rescue medicine as well as adverse effect. To the best of our knowledge, this study is the first multi-center, randomized, double-blind, and placebo-controlled clinical trial to assess the efficacy of Tibetan medicine Qingpeng ointment for AGA. The findings of this study would provide evidence for its use to relieve symptoms of AGA. ISRCTN ISRCTN34355813 . Registered on 25 January 2021
Background: Chinese medicine (CM) has become a popular interventional treatment for rheumatoid arthritis (RA). However, limited knowledge about general characteristics and long-term clinical outcomes hampers the development of CM for RA. Purpose: The main objectives of the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) were to describe the population of RA patients receiving CM treatment in multiple centers in China using different variables and compare these findings with internationally reported data. Study design: The CERTAIN is a prospective, multicenter, observational disease registry. Methods: Adult RA patients who fulfilled the 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria for RA and received CM treatment were recruited into the CERTAIN by rheumatologists from 145 hospitals across 30 provinces in China. Data on demographics, disease characteristics, comorbidities, treatments, and adverse events, with a 2-year follow-up, were collected and documented using a predefined protocol. Results: In the 2 years since the study began in September 2019, 11,764 patients have been enrolled (enrolment is ongoing), and 13.10% of participants have completed the 6-month follow-up. We present the baseline charac-teristics of the first 11,764 enrollees. Conclusions: The CERTAIN is the first nationwide registry to document comprehensive data on CM treatment in patients with RA. The development of the CERTAIN resource is a significant step forward for Chinese RA pa-tients, herbal medicine users, and research communities and will deepen our understanding of CM for RA. Registration: The study was registered at ClinicalTrials.gov (NCT05219214).
目的 探究六君子汤加味治疗脾虚湿阻型高尿酸血症(hyperuricemia,HUA)对患者生活质量的影响.方法 选取2018年7月至2020年6月本院收治的252例高尿酸血症患者作为研究对象,随机分为治疗组和对照组,每组126例.对照组给予常规生活干预,治疗组在对照组基础上加服汤剂六君子汤加味治疗.比较两组治疗前后BMI、腰腹围、生活质量评分及急性痛风性关节炎复发率.结果 治疗前,两组BMI、腰腹围比较差异无统计学意义;治疗后,治疗组BMI、腰腹围均明显低于对照组,差异有统计学意义(P<0.05).治疗前,两组SF-36评分比较差异无统计学意义;治疗后,两组SF-36评分均高于治疗前,且治疗组高于对照组,差异有统计学意义(P<0.05).治疗组急性痛风性关节炎发生率为11.90%,明显低于对照组的23.02%,差异有统计学意义(P<0.05).结论 六君子汤加味治疗脾虚湿阻型高尿酸血症效果显著,在改善尿酸水平的同时能降低患者BMI、腰腹围,提高患者生活质量,值得临床推广应用.
目的 探讨晚蚕沙外熨联合甲钴胺对寒凝血瘀型糖尿病周围神经病变患者临床疗效.方法 将2017年3月 ~2019年5月231例北京中医药大学房山医院门诊收治的寒凝血瘀型糖尿病周围神经病变患者随机分为实验组(甲钴胺500μg,3次/天,口服+晚蚕沙外熨肢体麻凉痛部位,n=121例)和对照组(甲钴胺500μg,3次/天,口服,n=110例),治疗周期为4周,观察两组治疗前后临床有效率、临床症状积分、肢运动神经传导速度(MNCV)以及感觉神经传导速度(SNCV)、多伦多(Toronto)临床神经病变评分的差异.结果 实验组总有效率明显高于对照组(P<0.05).治疗后两组临床症状积分及Toronto临床评分较治疗前均明显下降,MNCV与SNCV较治疗前均明显升高,差异有统计学意义(P<0.05);治疗后,实验组临床症状积分较对照组下降更加明显(P<0.05)、MNCV与SNCV较对照组提升更加明显(P<0.05).结论 晚蚕沙外熨联合甲钴胺口服可有效改善寒凝血瘀型糖尿病周围神经病变患者的临床症状及多伦多临床神经病变评分,较单纯甲钴胺口服临床疗效更好,值得临床推广.
目的 探讨传统门诊教学与病房案例教学结合的中医诊断学课间见习模式的效果.方法 将287名北京中医药大学课间见习学生按照专业、班级不同分为试验组和对照组,其中对照组145人,试验组142人,对照组采用传统门诊见习模式,试验组在门诊见习的基础上,结合病房案例式教学,在见习始、末学生通过问卷进行见习自我评价.结果 见习后学生自我评价项目"新知识、新事物与自身知识体系链接能力"、"运用四诊收集病人病情资料与要领掌握情况"、"对生命意义和人生价值,尊重生命、敬畏生命、关爱生命的理解"有明显差异,且具有统计学意义(P<0.05).结论 门诊与病房案例式教学结合的教学模式,能够使学生体会中医四诊的采集过程,初步建立临床思维,培养了医学生人文关怀精神,切实提高了医学人才培养质量.
目的:分析益气化瘀通痹方治疗气阴两虚夹瘀型糖尿病周围神经病变疗效及对患者血流动力学的影响.方法:将106例气阴两虚夹瘀型糖尿病患者,随机分为对照组和观察组,每组各53例,对照组在糖尿病基础治疗基础上给予西药治疗,观察组给予益气化瘀通痹方治疗.比较治疗前后血清炎症因子水平、神经传导速度及血流动力学指标,观察治疗前后中医症候积分及NSS、NDS评分.结果:治疗后观察组IL-6、TNF-α、hs-CRP水平均低于对照组(P<0.05),观察组感觉神经及运动神经等各项神经传导速度均高于对照组(P<0.05),观察组血浆比黏度、全血黏度及纤维蛋白原指数均高于对照组(P<0.05).结论:益气化瘀通痹方可减轻气阴两虚夹瘀型糖尿病患者周围神经病变的神经症状及神经缺陷,降低炎性因子,增加神经传导速度,有效改善血液流变性,改善临床症状.
Objective:To evaluate the clinical effects of external application of late silkworm sand on peripheral neuropathy in diabetic (DPN) patients with cold coagulation blood stasis(CCBS).Methods:Sixty DPN patients with CCBS were randomly divided into the experimental group and the control group(n=30, each group). Both groups were given routine treatment with mecobalamin, while the experimental group was treated with external application of silkworm sand additionally for 4 weeks.Improvements in brachial-ankle index(ABI)and foot vibration perception threshold(VPT)were compared between the two groups before and after treatment.Results:The left and right ABI values were increased and the VPT value was decreased in the two groups after treatment compared with before treatment values.The left and right ABI values were higher( t=6.690 and 8.355, both P=0.000)and the VPT values were lower( t=6.447 and 6.734, both P=0.000)in the experimental group than in the control group after treatment. Conclusions:External application of late silkworm sand can improve ABI and VPT with good safety in treating DPN patients with CCBS and should be promoted in clinical practice.
目的 探讨晚蚕沙外熨联合针对性干预对糖尿病性周围神经病变患者临床疗效及生活质量的影响.方法 将2018年5月—2019年4月本科收治的180例糖尿病性周围神经病变寒凝血瘀型患者根据入院时间分为对照组(90例)与观察组(90例).对照组患者给予口服甲钴胺治疗,观察组患者在对照组治疗基础上联用晚蚕沙外熨及针对性干预治疗.两组患者4周为1个疗程,评估各组治疗前后临床疗效及生活质量量表(SF-36)评分.结果 (1)两组治疗后肢体麻木、肢体疼痛、手足畏寒发凉的症状积分较治疗前均明显好转(P<0.05);(2)两组中医主症总疗效比较:观察组及对照组总有效率分别为81.18%、66.27%,与对照组比较差异有统计学意义(P<0.05);(3)与对照组比,观察组生活质量改善显著,差异有统计学意义(P<0.05).结论 晚蚕沙外熨联合针对性干预可有效改善糖尿病周围神经病变患者症状、提高疗效并且改善患者的生活质量.
Objective To investigate the effects of silkworm excrement ironing on blood levels of glucose,lipids and Hcy in diabetic peripheral neuropathy patients with cold coagulation and blood stasis.Methods A total of 260 diabetic peripheral neuropathy patients with cold coagulation and blood stasis were randomly divided into the control group(n=130)and the observation group(n=130).Both groups were treated with oral methylcobalamin(500 μg,tid),and in addition,the observation group was given silkworm excrement ironing on areas of the limb with numbness and pain.Patients underwent one single course of treatment lasting 4 weeks.Blood levels of glucose,lipids and Hcy preand post treatment were analyzed.Results Blood lipid profiles and hemorheology improved in both groups after treatment,compared with pre-treatment data,and greater improvement was seen in the observation group than in the control group(all P<0.05).Plasma Hcy levels decreased in both groups after treatment,compared with pre-treatment levels,and deeper decline was seen in the observation group than in the control group after treatment(all P<0.05).Conclusions Silkworm excrement ironing can effectively improve the blood glucose profile and lipid metabolism,reduce plasma Hcy levels and may exert beneficial preventive and therapeutic effects on diabetic peripheral neuropathy.
目的 探讨加味六君子汤对降低高尿酸血症患者血尿酸(UA)水平以及安全性的影响.方法 选取2016年12月~2017年12月于北京房山区中医院诊断为脾虚湿阻型高尿酸血症的患者64例,采用随机数字表法分成治疗组和对照组,每组各32例.对照组采用常规生活及饮食指导进行治疗,治疗组在对照组的基础上服用加味六君子汤进行治疗.比较两组患者治疗前后其中医症候改善情况及UA、谷丙转氨酶(ALT)、谷草转氨酶(AST)、尿素氮(BUN)和肌酐(CREA)等水平改善情况以及临床疗效和不良反应情况等.结果 治疗后,两组患者中医症候总积分均降低(P<0.01),治疗组患者中医症候总积分明显低于对照组,差异有高度统计学意义(P< 0.01);两组患者治疗后UA水平较治疗前明显降低,差异有高度统计学意义(P<0.01),且治疗组明显低于对照组,差异有高度统计学意义(P<0.01);两组患者治疗前后ALT、AST、BUN、CREA水平均无明显变化,差异无统计学意义(P>0.05);治疗组临床疗效总有效率明显高于对照组,差异有高度统计学意义(P< 0.05);两组患者不良反应发生率均较低,且差异无统计学意义(P>0.05).结论 采用加味六君子汤治疗高尿酸血症能够较好地降低UA水平,且安全性较高,值得临床推广应用.
目的 探究黄连温胆汤加味联合耳穴压豆治疗痰热内扰型失眠的临床效果.方法 选取痰热内扰型失眠患者82例,随机分为观察组和对照组,各41例.观察组采用黄连温胆汤配合耳穴压豆治疗,对照组予口服艾司唑仑片治疗,比较两组治疗前后疗效、中医症候积分、睡眠质量及不良反应.结果 观察组总有效率(90.24%)显著高于对照组(70.73%,P<0.05);治疗后,观察组中医证候积分、睡眠质量积分均较对照组降低(P<0.05);观察组不良反应发生少于对照组(P<0.05).结论 黄连温胆汤加味联合耳穴压豆能有效治疗痰热内扰型失眠,改善中医证候及睡眠质量,减少不良反应发生.
目的 观察健脾化湿、泄浊活血法治疗脾虚湿阻型高尿酸血症(HUA)的临床疗效.方法 将60例HUA患者随机分为试验组与对照组各30例,所有患者给予常规治疗,试验组在此基础上加用六君子汤合桃红四物汤加味治疗.两组疗程均为12周,比较治疗前后中医症状改善情况.结果 试验组有效率为100%,对照组为6.67%,组间比较差异有显著性(P<0.05),试验组在改善腹胀、肢体困重、形体肥胖、气短乏力、小便浑浊方面明显优于对照组(P<0.05).治疗期间、治疗后3个月、6个月、1年后,试验组患者痛风发作率均低于对照组(P<0.01).结论 健脾化湿、泄浊活血法治疗脾虚湿阻型高尿酸血症可有效缓解中医症状,通过中医体质辨识指导治疗高尿酸血症临床疗效显著,且具有较好的安全性,值得临床应用.
<正>类风湿关节炎(RA)是一种病因尚未明了的慢性全身性炎症性疾病,以慢性、对称性、多滑膜关节炎和关节外病变为主要临床表现,属于自身免疫炎性疾病。该病好发于手、腕、足等小关节,反复发作,呈对称分布,早期有关节红肿热痛和功能障碍,晚期关节可出现不程度的僵硬畸形,并伴有骨和骨骼肌的萎缩,极易致残,此病是目前世界性的难治性
目的:观察蠲痹汤加味治疗类风湿性关节炎的临床疗效。方法:患者30例予蠲痹汤加味联合西药来氟米特治疗12周后判定疗效。结果:治疗后患者的关节压痛数、关节肿胀数明显减少,晨僵时间明显缩短,双手平均握力增加,疼痛程度明显减轻。血沉、CRP明显降低。结论:蠲痹汤加味联合西医治疗类风湿关节炎有良好疗效。
目的:观察独活寄生汤加减联合针灸治疗类风湿性关节炎的临床疗效。方法:将80例类风湿性关节炎患者随机分为治疗组和对照组各40例。治疗组采用独活寄生汤加减联合针灸治疗,对照组采用美洛昔康片口服治疗,20 d为1疗程,连续2个疗程;观察两组临床症状、体征改善情况及血沉、C反应蛋白、血流变学改变情况,并进行对比分析。结果:治疗组痊愈18例(45.0%),显效16例(40.0%),有效4例(10.0%),无效2例(5.0%);对照组痊愈9例(22.5%),显效14例(35.0%),有效12例(30.0%),无效5例(12.5%),两组临床疗效比较,治疗组优于对照组,差异有统计学意义(P<0.05);两组治疗前各项指标比较,差异无统计学意义(P>0.05),两组组内治疗前后比较,差异均有统计学意义(P<0.05);两组治疗后各项指标比较,治疗组疗效优于对照组,差异有统计学意义(P<0.05)。结论:独活寄生汤加减联合针灸治疗类风湿性关节炎临床疗效良好。