[Regularity of prescription and medication of Jiang Quan in treating rheumatoid arthritis].

The data mining method was used to analyze and summarize the prescription and medicate regularities of chief physician Jiang Quan in the treatment of rheumatoid arthritis,in order to provide references for the clinical treatment of rheumatoid arthritis. Totally 121 prescriptions of rheumatoid arthritis treated by chief physician Jiang Quan from 2007 to 2017 were collected and input into the Chinese medicine inheritance auxiliary system. The " prescription statistics" function of the software " statistical report" system,and the " prescription analysis" function of the " data analysis" system,the data mining methods such as rule analysis,integration correlation,complex system entropy clustering,and unsupervised entropy hierarchical clustering,were used to analyze the prescription regularity of chief physician Jiang Quan. A total of 121 prescriptions were included,involving 144 herbs,in which 30 herbs had a higher frequency of more than 20 times,20 two-herb combinations had a frequency of more than 59 times; after evolution,14 core combinations and 7 new prescriptions were obtained. Among the prescriptions in the treatment of rheumatoid arthritis,those for clearing heat and dampness,promoting blood circulation and removing blood stasis had a higher frequency,and the core prescriptions were modified " Qingre Huoxue Decoction" and modified " Ermiao Pills". The newly evolved prescriptions not only reflected director Jiang Quan' s method of treating rheumatoid arthritis by clearing away heat and dampness and promoting blood circulation by the,but also included the treatment methods of removing wind and removing dampness,dredging collaterals and removing phlegm,nourishing Yin and clearing heat,nourishing Yin and nourishing kidney,nourishing blood and nourishing Qi. The method can be used to analyze the pathogenetic changes of the mutual knot of phlegm and blood stasis,injury of Qi and blood,long-term implication on liver and kidney. At the same time,it also reflects the treatment principles of treating phlegm and strengthening the evil.

[Study advances in regulation effect of Tripterygium wilfordii and its extracts on innate immune system in rheumatoid arthritis cases].

Rheumatoid arthritis( RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The innate immunity mechanism plays a key role in the pathogenesis of RA. Tripterygium wilfordii and its extracts have regulatory effects on innate immune cells including macrophages,dendritic cells,neutrophils,mast cells,NK cells,NKT cells,etc.,as well as a variety of innate immune molecules including cytokines,adhesion molecules,patterns recognition receptor( PRR) and the complement molecules,showing a regulatory effect in the pathogenesis of RA innate immunity. In this paper,the recent domestic and foreign researches on the pathogenesis of RA with innate immunity involved were reviewed and the research status of T. wilfordii and its extracts on the regulation of innate immunity involved in RA was summarized.

Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial.

BACKGROUND: Chinese external therapy (CET) is a topical application with mainly Chinese herb medicine therapy with thousands of years of historical implications and is a clinical routine that is commonly used for relieving joint-related symptoms in patients with arthritis in Chinese hospitals. However, there is a paucity of modern medical evidence to support its effectiveness and safety. Thus, we propose to implement a randomized, double-blinded, placebo-controlled clinical trial in patients with rheumatoid arthritis (RA) using, as the experimental intervention, topical application of a hospital-compounded gel preparation of Tripterygium wilfordii Hook F (TwHF). METHODS: This study will be an 8-week double-blinded, randomized, placebo-controlled clinical trial conducted at Guang'anmen Hospital in Beijing, China, and 168 patients with moderately active RA will be randomly assigned with a 1:1 ratio to apply a topical gel preparation containing TwHF or placebo. The primary outcome variable will be the proportion of subjects, by study group, to achieve a 20% improvement in the American College of Rheumatology criteria (ACR20) by week 8. Secondary outcome measures to be assessed at weeks 4 or 8 will include: measurement of ACR20 response rate at week 4, ACR50 response rate, the changes in DAS28 score, and joint synovitis classification assessment monitored by musculoskeletal ultrasound. Safety evaluations conducted at weeks 4, 8 and 12 will be based on spontaneous complaints by the study subjects, but special emphasis will be focused on cutaneous allergy and alterations of menstruation in premenopausal female participants. Statistical analyses will be performed using the intention to treat analysis data set. DISCUSSION: This proposed clinical trail is designed to evaluate the efficacy and safety of CET based on a single topically-applied agent in a relatively large patient population with RA. This study protocol gives a detailed description of the usage and dosage of the topical compound TwHF gel and the methodology of this study. In addition, it is hoped that the outcomes of this study will be viewed as supporting the generalizability of CET in the setting of inflammatory rheumatic diseases. The results of this study are expected to have important public health implications for Asian RA patients that currently utilize CET as a complimentary treatment. TRIAL REGISTRATION: Clinical trial gov Identifier: NCT02818361 . Registrated on Jun. 15, 2016.

[Effect of External Applying Compound Tripterygium wilfordii Hook F. on Joint Pain of Rheumatoid Arthritis Patients].

OBJECTIVE: To observe the effectiveness and safety of external applying Compound Tripterygium wilfordii Hook F. (TwHF) in relieving joint pain in rheumatoid arthritis (RA) patients. METHODS: In this double-blinded, randomized multicenter trial, a total of 174 moderately active RA patients were enrolled and randomly assigned to the treatment group (treated with Compound TwHF, 87 cases) and the placebo control group (87 cases). Compound TwHF or placebo was externally applied in painful joints, 20 g each time, once per day for 8 weeks. Self-reported joint pain relief was taken as a primary effective indicator. Visual analogue scale for pain (VAS), disease activity score of 28 joints (DAS28), VAS for general health (GH) were evaluated before treatment, at week 4 and after treatment. Erythrocyte sedimentation rate (ESR) and hypersensitive C reactive protein (hs-CRP) were tested before and after treatment. Menstrual changes in females were observed during treatment. Skin irritation occurred during the recording process was assessed using skin irritation strength. Intention to treat (ITT) was statistically analyzed. RESULTS: The joint pain relief rate in the treatment group was 90.8% (79/87 cases), higher than that in the placebo control group (69.0%, 60/87 cases; P = 0.001). VAS pain score, DAS28, VAS for GH score were significantly improved in the two groups at week 4 of treatment and after treatment, as compared with before treatment (P < 0.01). ESR and hs-CRP levels significantly decreased in the treatment group after treatment (P < 0.05, P < 0.01). No difference was found in post-treatment VAS pain score, DAS28, VAS for GH score, ESR, or hs-CRP between the two groups (P > 0.05). Eight adverse events occurred in the treatment group (5 skin allergy, 1 intolerance of medical odor, and 2 mild liver injury), while 3 adverse events occurred in the placebo control group (2 skin allergy, 1 mild liver injury). There was no statistical difference in adverse event between the two groups (P > 0.05). No menstrual change occurred in the treatment group. CONCLUSION: External applying Compound TwHF was an effective and safe way to relieve-joint pain of RA patients, which could be taken as an adjuvant therapy.

[Clinical effect analysis of ankylosing spondylitis treated by Chinese medical syndrome differentiation].

OBJECTIVE: To evaluate the curative effect and safety of Bushen Qiangji Decoction (BQD) and Qingre Qiangji Decoction (QQD) in treating ankylosing spondylitis (AS) patients, and to verify the clinical utility of AS syndrome differentiation and treatment scheme [Shen-deficiency induced stasis obstruction syndrome (SDISOS) and dampness-heat obstruction syndrome (DHOS) being two basic syndrome types, Shen invigorating blood activating method (SIBAM) and heat clearing dampness resolving method (HCDRM) being two basic treatment methods]. METHODS: Totally 354 AS patients of SDISOS and DHOS were randomly assigned to the treatment group and the control group using a multi-center randomized, positive drug parallel-controlled clinical trail. Patients in treatment group were treated by BQD or QQD according to syndrome typing, while those in the control group took Sulfasalazine enteric-coated tablet (SECT), 24 weeks as one therapeutic course. After treatment, the clinical efficacy was evaluated by using ASAS20 standard (set by Asessment in Ankylosing Spondylitis working group), Chinese medical efficacy evaluation standards, and BASDAI, BASFI, BASMI, night-pain index, spinal pain index, PGA, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). RESULTS: After 24 weeks of treatment by BQD or QQD, ASAS20 standard rate was 86.75% in the treatment group, and the total effective rate of Chinese medical syndrome was 85.47%. They could significantly reduce patients' integrals of Chinese medical syndrome, BASDAI, BASFI, BASMI, night-pain index, spinal pain index, and PGA (all P < 0.01). CONCLUSIONS: QQD and BQD got confirmable clinical effects in treating AS, providing strong evidence of evidence-based medicine for syndrome differentiation and treatment of AS.

The Impact of Traditional Chinese Medicine QingreHuoxue Treatment and the Combination of Methotrexate and Hydroxychloroquine on the Radiological Progression of Active Rheumatoid Arthritis: A 52-Week Follow-Up of a Randomized Controlled Clinical Study.

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). QingreHuoxue treatment (QingreHuoxue decoction [QRHXD]/QingreHuoxue external preparation [QRHXEP]) is a Chinese medicine treatment for RA. To date, very few studies have compared the long-term effects of QRHXD with those of conventional disease-modifying antirheumatic drugs on RA disease activity and radiological progression. QRHXD delayed the radiological progression and showed long-term clinical efficacy of RA. In clinical experiments, the clinical evidence of delaying the radiological progression of RA patients was obtained. A portion of the patients who participated in the "Traditional Chinese Medicine QingreHuoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis" study were followed up for 52 weeks, and intention-to-treat (ITT) and compliance protocol (PP) analyses were used to collect and compare the clinical indicators and imaging data between baseline and week 52. Two radiologists who were blind to treatment scored the images independently. Of the 468 subjects, 141 completed the 52-week follow-up. There were no significant differences among the three groups: the traditional Chinese medicine comprehensive treatment group, the Western medicine treatment group, and the integrated traditional Chinese and Western medicine treatment group. There were no differences in the total Sharp score, joint space stenosis score, and joint erosion score at baseline or 52 weeks. In the comparison of the estimated annual radiographic progression (EARP) and the actual annual Sharp total score changes among the three groups, the actual changes were much lower than the EARP at baseline. The radiological progress in all three groups was well controlled. Results of the ITT and PP data sets showed that the disease activity score 28 level of the three groups at 52 weeks was significantly lower than that at baseline. During the 52-week treatment period, the clearance of heat and promotion of blood circulation controlled disease activity and delayed the radiological progress of active RA.

China rheumatoid arthritis registry of patients with Chinese medicine (CERTAIN): Rationale, design, and baseline characteristics of the first 11,764 enrollees.

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 characteristics 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 patients, herbal medicine users, and research communities and will deepen our understanding of CM for RA. REGISTRATION: The study was registered at ClinicalTrials.gov (NCT05219214).

Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial.

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). Qingre Huoxue treatment (Qingre Huoxue decoction (QRHXD)/Qingre Huoxue external preparation (QRHXEP)) is a therapeutic scheme of TCM for RA. To date, there have been few studies comparing the efficacy and safety of QRHXD and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of active RA. This was investigated in a multicenter, double-blind, randomized controlled trial involving 468 Chinese patients with active RA [disease activity score (DAS)-28 > 3.2] treated with QRHXD/QRHXEP (TCM group), methotrexate plus hydroxychloroquine [Western medicine (WM) group], or both [integrative medicine (IM) group]. Patients were followed up for 24 weeks. The primary outcome measure was the change in DAS-28 from baseline to 24 weeks. The secondary outcome measures were treatment response rate according to American College of Rheumatology 20, 50, and 70% improvement criteria (ACR-20/50/70) and the rate of treatment-related adverse events (TRAEs). The trial was registered at ClinicalTrials.gov (NCT02551575). DAS-28 decreased in all three groups after treatment (p < 0.0001); the score was lowest in the TCM group (p < 0.05), while no difference was observed between the WM and IM groups (p > 0.05). At week 24, ACR-20 response was 73.04% with TCM, 80.17% with WM, and 73.95% with IM (based on the full analysis set [FAS], p > 0.05); ACR-50 responses were 40.87, 47.93, and 51.26%, respectively, (FAS, p > 0.05); and ACR-70 responses were 20.87, 22.31, and 25.21%, respectively, (FAS, p > 0.05). Thus, treatment efficacy was similar across groups based on ACR criteria. On the other hand, the rate of TRAEs was significantly lower in the TCM group compared to the other groups (p < 0.05). Thus, QRHXD/QRHXEP was effective in alleviating the symptoms of active RA-albeit to a lesser degree than csDMARDs-with fewer side effects. Importantly, combination with QRHXD enhanced the efficacy of csDMARDs. These results provide evidence that QRHXD can be used as an adjunct to csDMARDs for the management of RA, especially in patients who experience TRAEs with standard drugs. Clinical Trial Registration: ClinicalTrials.gov, identifier NCTNCT025515.

[Effects of Jianpi Yishen Recipe on recurrence, metastasis and life span of mice transplanted with proventriculus squamous carcinoma after tumorectomy].

OBJECTIVE: To observe the effects of Jianpi Yishen Recipe (JPYSR), a compound Chinese herbal medicine, on recurrence, metastasis and life span of mice transplanted with proventriculus squamous carcinoma cells after tumorectomy. METHODS: JPYSR was orally administered to 615 mice transplanted with proventriculus squamous carcinoma cells in the palma of left hind limb after tumorectomy. The local tumor recurrence, lung metastasis and life span of the mice were evaluated and compared with those of the 5-FU-treated mice and untreated mice. RESULTS: The pulmonary metastasis rate was 94.4% and the recurrence rate was 94.44% in untreated group. The pulmonary metastasis rate was 68.4%, the inhibition rate of pulmonary metastasis was 27.5%, the recurrence rate was 78.95%, and the inhibition rate of tumor recurrence was 65.35% in JPYSR-treated group. The average and median life spans were obviously prolonged in JPYSR-treated group, as compared with those in untreated group. The life-prolonging rate was 100%. CONCLUSION: JPYSR can effectively inhibit the local recurrence and pulmonary metastasis of the transplanted proventriculus squamous carcinoma in mice after tumorectomy, and prolong the life span.

A one-year evaluation of radiographic progression in patients with rheumatoid arthritis treated by Qingre Huoxue Decoction ().

OBJECTIVE: To investigate the effects of Qingre Huoxue Decoction , clearing heat and promoting blood flow; QRHXD), on the radiographic progression in patients with rheumatoid arthritis (RA) by X-ray imaging. METHODS: Eighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were randomized into a QRHXD group and a QRHXD plus methotrexate (MTX) group, with 43 cases in each group. After one-year of treatment, 21 cases in each group (42 in total) were evaluated. Radiographs of hands were obtained at the baseline and after 12 months of treatment. Images were evaluated by investigators blinded to chronology and clinical data, and assessed according to the Sharp/Van der Heijde methods. RESULTS: High intrareader agreements were reached (mean intraobserver intraclass coefficients: 0.95). No significant change in any imaging parameters of joint destruction was observed at 12 months in either group; and the differences between the two groups were not significant (P>0.05). The mean of the changing score in the QRHXD group was 3.5 ± 4.1, and 2.4 ± 3.5 in the QRHXD+MTX group, while the baseline radiographic score of patients in the QRHXD group was relatively higher (18.9 ± 19.1 vs. 14.0 ± 14.0). The mean rates of the changing scores of the two groups were similar (0.24 ± 0.28 vs. 0.25 ± 0.44, P=0.40). The severity of progression in the two groups was also similar (P=0.46), 7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group, 3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group. CONCLUSION: Radiographic progression of RA patients in both groups is similar, indicating that the QRHXD Decoction has a potential role in preventing bone destruction.

[One-year evaluation of radiographic progress in patients with rheumatoid arthritis treated by Qingre Huoxue decoction].

OBJECTIVE: To investigate the effect of Qingre Huoxue decoction, (QRHX) on radiographic progression in patients with rheumatoid arthritis (RA) with X-ray imaging. METHODS: From July 2007 to March 2009, 86 patients with active RA who were diagnosed as damp-heat and blood stasis syndrome were randomly divided into QRHX group and QRHX plus methotrexate (MTX) group, 43 cases in each group. Patients in the QRHX group were treated with QRHX decoction [composed of Huangbai, Chishao, Bixie, Danshen, Ezhu, Qingfengteng, raw Huangqi, Jinyinhua, Tufuling, Wugong, Fengfang, raw Yiyiren, which was cooked with water as 400 ml liquid); while patients in the other group were treated with QRHX decoction plus MTX. After one-year observation, 21 patients in each group (42 in total) were evaluated,with 19 females in QRHX group, average age of (43.0 +/- 11.3) years, and the course of the disease was 2 (1,3) years; and 18 females in QRHX+MTX group, average age of (44.5 +/- 14.0) years, and the course of the disease was 3 (1.7, 5) years. Radiographs of hands were obtained at baseline and 12 months after treatment. Images were evaluated by investigators blinded to chronology and clinical data, and assessed according to Sharp/van der Heijde methods. RESULTS: High intrareader agreements were reached (mean intraobserver intraclass coefficients: 0.95). No significant change in any imaging parameters of joint destruction was observed at 12 months after treatment in both groups; and there were no statistical differences between the two groups (P > 0.05). The severity of progress in two groups was also similar (P = 0.46), 7 patients without radiographic progress in QRHX group and 8 patients in QRHX+MTX group,3 patients with obvious radiographic progress in QRHX group and 1 patient in QRHX+MTX group. CONCLUSION: Radiographic progress of RA patients in two groups is similar, indicating QRHX decoction has a potential role in preventing bone destruction.