1.Mechanism of Yishen Jiangtang Decoction in regulating endoplasmic reticulum stress-mediated NLRP3 inflammasome to improve renal damage in diabetic nephropathy db/db mice.
Yun-Jie YANG ; Bin-Hua YE ; Chen QIU ; Han-Qing WU ; Bo-Wei HUANG ; Tong WANG ; Shi-Wei RUAN ; Fang GUO ; Jian-Ting WANG ; Ming-Qian JIANG
China Journal of Chinese Materia Medica 2025;50(10):2740-2749
This study aims to explore the mechanism through which Yishen Jiangtang Decoction(YSJTD) regulates endoplasmic reticulum stress(ERS)-mediated NOD-like receptor thermal protein domain associated protein 3(NLRP3) inflammasome to improve diabetic nephropathy(DN) in db/db mice. Thirty db/db mice were randomly divided into the model group, YSJTD group, ERS inhibitor 4-phenylbutyric acid(4-PBA) group, with 10 mice in each group. Additionally, 10 db/m mice were selected as the control group. The YSJTD group was orally administered YSJTD at a dose of 0.01 mL·g~(-1), the 4-PBA group was orally administered 4-PBA at a dose of 0.5 mg·g~(-1), and the control and model groups were given an equal volume of carboxylmethyl cellulose sodium. The treatments were administered once daily for 8 weeks. Food intake, water consumption, and body weight were recorded every 2 weeks. After the intervention, fasting blood glucose(FBG), glycosylated hemoglobin(HbA1c), urine microalbumin(U-mALB), 24-hour urine volume, serum creatinine(Scr), and blood urea nitrogen(BUN) were measured. Inflammatory markers interleukin-1β(IL-1β) and interleukin-18(IL-18) were detected using the enzyme-linked immunosorbent assay(ELISA). Renal pathology was assessed through hematoxylin-eosin(HE), periodic acid-Schiff(PAS), and Masson staining, and transmission electron microscopy(TEM). Western blot was used to detect the expression levels of glucose-regulated protein 78(GRP78), C/EBP homologous protein(CHOP), NLRP3, apoptosis-associated speck-like protein containing CARD(ASC), cysteinyl aspartate-specific proteinase(caspase-1), and gasdermin D(GSDMD) in kidney tissues. The results showed that compared to the control group, the model group exhibited poor general condition, increased weight and food and water intake, and significantly higher levels of FBG, HbA1c, U-mALB, kidney index, 24-hour urine volume, IL-1β, and IL-18. Compared to the model group, the YSJTD and 4-PBA groups showed improved general condition, increased body weight, decreased food intake, and lower levels of FBG, U-mALB, kidney index, 24-hour urine volume, and IL-1β. Specifically, the YSJTD group showed a significant reduction in IL-18 levels compared to the model group, while the 4-PBA group exhibited decreased water intake and HbA1c levels compared to the model group. Although there was a decreasing trend in water intake and HbA1c in the YSJTD group, the differences were not statistically significant. No significant differences were observed in BUN, Scr, and kidney weight among the groups. Renal pathology revealed that the model group exhibited more severe renal damage compared to the control group. Kidney sections from the model group showed diffuse mesangial proliferation in the glomeruli, tubular edema, tubular dilation, significant inflammatory cell infiltration in the interstitium, and increased glycogen staining and blue collagen deposition in the basement membrane. In contrast, the YSJTD and 4-PBA groups showed varying degrees of improvement in renal damage, glycogen staining, and collagen deposition, with the YSJTD group showing more significant improvements. TEM analysis indicated that the model group had extensive cytoplasmic edema, homogeneous thickening of the basement membrane, fewer foot processes, and widening of fused foot processes. In the YSJTD and 4-PBA groups, cytoplasmic swelling of renal tissues was reduced, the basement membrane remained intact and uniform, and foot process fusion improved.Western blot results indicated that compared to the control group, the model group showed upregulation of GRP78, CHOP, GSDMD, NLRP3, ASC, and caspase-1 expression. In contrast, both the YSJTD and 4-PBA groups showed downregulation of these markers compared to the model group. These findings suggest that YSJTD exerts a protective effect against DN by alleviating NLRP3 inflammasome activation through the inhibition of ERS, thereby improving the inflammatory response in db/db DN mice.
Animals
;
Endoplasmic Reticulum Stress/drug effects*
;
Diabetic Nephropathies/metabolism*
;
NLR Family, Pyrin Domain-Containing 3 Protein/genetics*
;
Drugs, Chinese Herbal/administration & dosage*
;
Mice
;
Inflammasomes/drug effects*
;
Male
;
Kidney/pathology*
;
Endoplasmic Reticulum Chaperone BiP
;
Humans
;
Interleukin-18/genetics*
;
Mice, Inbred C57BL
2.Identification of tissue distribution components and mechanism of antipyretic effect of famous classical formula Dayuanyin.
Yu-Jie HOU ; Kang-Ning XIAO ; Jian-Yun BI ; Xin-Rui LI ; Ming SU ; Li-Jie WANG ; Yu-Qing WANG ; Dan-Dan SUN ; Hui ZHANG ; Xin-Jun ZHANG ; Shan-Xin LIU
China Journal of Chinese Materia Medica 2025;50(10):2810-2824
Based on the ultra performance liquid chromatography-quadrupole Exactive Orbitrap mass spectrometry(UPLC-Q-Exactive Orbitrap-MS) technology, combined with related literature, databases, and reference material information, this study qualitatively analyzed the components of Dayuanyin in the tissue of rats after gavage and employed molecular docking technology to predict the rationality of the mechanism behind the antipyretic effect of the in vivo components in Dayuanyin. A total of 21, 26, 20, 21, 14, and 31 prototype components and 3, 16, 3, 7, 5, and 24 metabolites were identified from the heart, liver, spleen, lung, kidney, and hypothalamus of the rats, respectively, and the binding ability of key components and targets was further verified by molecular docking. The results showed that all components had good binding ability with targets. The established UPLC-Q-Exactive Orbitrap-MS could effectively and quickly identify the Dayuanyin components distributed in tissue and preliminarily identify their metabolites. Many components were identified in the hypothalamus, which suggested that the components delivered to the brain should be focused on in the study on Dayuanyin in the treatment of febrile diseases. The molecular docking technology was used to predict the rationality of the mechanism behind its antipyretic effect, which lays the foundation for the clarification of the material basis and action mechanism of Dayuanyin, the development of new preparations, and the prediction of quality markers.
Animals
;
Drugs, Chinese Herbal/administration & dosage*
;
Rats
;
Molecular Docking Simulation
;
Male
;
Antipyretics/metabolism*
;
Rats, Sprague-Dawley
;
Tissue Distribution
;
Mass Spectrometry
;
Chromatography, High Pressure Liquid
;
Hypothalamus/metabolism*
3.Rapid characterization and identification of non-volatile components in Rhododendron tomentosum by UHPLC-Q-TOF-MS method.
Su-Ping XIAO ; Long-Mei LI ; Bin XIE ; Hong LIANG ; Qiong YIN ; Jian-Hui LI ; Jie DU ; Ji-Yong WANG ; Run-Huai ZHAO ; Yan-Qin XU ; Yun-Bo SUN ; Zong-Yuan LU ; Peng-Fei TU
China Journal of Chinese Materia Medica 2025;50(11):3054-3069
This study aimed to characterize and identify the non-volatile components in aqueous and ethanolic extracts of the stems and leaves of Rhododendron tomentosum by using sensitive and efficient ultra-performance liquid chromatography-quadrupole-time of flight mass spectrometry(UHPLC-Q-TOF-MS) combined with a self-built information database. By comparing with reference compounds, analyzing fragment ion information, searching relevant literature, and using a self-built information database, 118 compounds were identified from the aqueous and ethanolic extracts of R. tomentosum, including 35 flavonoid glycosides, 15 phenolic glycosides, 12 flavonoids, 7 phenolic acids, 7 phenylethanol glycosides, 6 tannins, 6 phospholipids, 5 coumarins, 5 monoterpene glycosides, 6 triterpenes, 3 fatty acids, and 11 other types of compounds. Among them, 102 compounds were reported in R. tomentosum for the first time, and 36 compounds were identified by comparing them with reference compounds. The chemical components in the ethanolic and aqueous extracts of R. tomentosum leaves and stems showed slight differences, with 84 common chemical components accounting for 71.2% of the total 118 compounds. This study systematically characterized and identified the non-volatile chemical components in the ethanolic and aqueous extracts of R. tomentosum for the first time. The findings provide a reference for active ingredient research, quality control, and product development of R. tomentosum.
Rhododendron/chemistry*
;
Chromatography, High Pressure Liquid/methods*
;
Drugs, Chinese Herbal/chemistry*
;
Mass Spectrometry/methods*
;
Plant Leaves/chemistry*
4.Spatiotemporal characteristics of diesel exhaust particle pollution in confined space and impacts of ventilation and airflow: A laboratory simulation study
Zheyu HUANG ; Jian ZHANG ; Lihua HE ; Wenchu HUANG ; Zihui LI ; Bilige HASEN ; Hongbo WANG ; Yun WANG
Journal of Environmental and Occupational Medicine 2025;42(7):814-821
Background Diesel engines are widely used in transportation, agriculture, construction, industry, and other fields. Diesel exhaust, classified as a Group 1 carcinogen, emits particles (DEP) that can penetrate deep into the respiratory tract, posing significant health risks. DEP pollution is particularly severe in confined environments, necessitating effective control measures. Objective Under laboratory simulation conditions, to explore the spatiotemporal distribution characteristics of the mass and number concentrations of DEP as it diffuses indoors and to reveal the effects of ventilation and additional airflow on indoor DEP pollution levels. Methods A diesel engine was placed in a laboratory (length 3.39 m × width 2.85 m × height 2.4 m) with its exhaust emitted from east to west. An air purifier was installed 1 m south of the engine. Eight measurement points (1 m horizontal distance from the exhaust outlet, height: 1 m/1.5 m) were setup to monitor DEP concentrations using portable laser particle sizers. The effects of engine power (4.05 kW vs. 5.15 kW), ventilation (maximum airflow: 600 m3·h−1), additional airflow intensity (low and high), and direction (forward/reverse) on DEP pollution were analyzed. DEP levels of 5 diesel vehicle models were also compared. Results The mass and number concentrations of DEP indoors increased immediately after the diesel engine started. The peak mass concentration time at the eastern measurement point (−1, 0) m opposite to the exhaust direction (17.70 min) was significantly longer than that at the western (1, 0) m (16.20 min), southern (0, -1) m (14.45 min), and northern (0, 1) m (12.70 min) points (P<0.05), with no significant differences between the other points (western, southern, and northern) (P>0.05). The northern point (0, 1) m exhibited the highest DEP mass and number concentration peaks (174.62 μg·m−3,
5.Effectiveness analysis of basal osteotomy of first metatarsal combined with first metatarsophalangeal joint replacement for treatment of hallux valgus combined with hallux rigidus.
Yanqing WANG ; Jian WANG ; Siyuan LI ; Yun LU
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(10):1240-1245
OBJECTIVE:
To investigate the effectiveness of basal osteotomy of the first metatarsal combined with first metatarsophalangeal joint replacement for the treatment of hallux valgus combined with hallux rigidus.
METHODS:
A retrospective analysis was conducted on the medical records of 15 patients (16 feet) with hallux valgus combined with hallux rigidus who underwent first metatarsal basal osteotomy combined with first metatarsophalangeal joint replacement between May 2019 and December 2024. The patients included 1 male and 14 females, aged 60-80 years, with an average age of 68.5 years. According to the Mann classification of hallux valgus, 2 feet were moderate and 14 feet were severe. According to the Hallux Rigidus Coughlin grading, 12 feet were grade 3 and 4 feet were grade 4. The evaluation indicators included hallux valgus angle (HVA) and intermetatarsal angle (IMA) measured on weight-bearing X-ray film at preoperation and last follow-up; the American Orthopaedic Foot and Ankle Society (AOFAS) score and visual analogue scale (VAS) score were used to evaluate the improvement of walking function, metatarsophalangeal joint function, and pain relief in patients.
RESULTS:
All patients underwent surgery successfully without complications such as vascular or nerve injury during operation. One foot developed a superficial incisional infection postoperatively, which healed after dressing changes; the remaining 15 feet had primary incision healing. All patients were followed up 5-55 months, with an average of 17.5 months. All osteotomies achieved bony union, with a union time ranging from 8 to 13 weeks, averaging 11.8 weeks; no elevation of the first metatarsal was observed. At last follow-up, no complications such as prosthesis loosening, dislocation, fracture, toe shortening, bone dissolution, synovial reaction, or metatarsalgia was found. The appearance and function of the affected feet significantly improved, and the pain significantly relieved. At last follow-up, the HVA, IMA, AOFAS score, and VAS score showed significant differences when compared with preoperative values ( P<0.05).
CONCLUSION
Basal osteotomy of the first metatarsal combined with first metatarsophalangeal joint replacement for the treatment of hallux valgus with hallux rigidus can correct deformities through osteotomy, restore the normal flexion-extension axis of the metatarsophalangeal joint, relieve pain, and preserve a certain degree of mobility, achieving good short- and mid-term effectiveness.
Humans
;
Male
;
Female
;
Hallux Valgus/diagnostic imaging*
;
Osteotomy/methods*
;
Aged
;
Middle Aged
;
Metatarsophalangeal Joint/surgery*
;
Retrospective Studies
;
Hallux Rigidus/diagnostic imaging*
;
Aged, 80 and over
;
Metatarsal Bones/surgery*
;
Treatment Outcome
;
Arthroplasty, Replacement/methods*
6.Application of 3D-printed auxiliary guides in adolescent scoliosis surgery.
Dong HOU ; Jian-Tao WEN ; Chen ZHANG ; Jin HUANG ; Chang-Quan DAI ; Kai LI ; Han LENG ; Jing ZHANG ; Shao-Bo YANG ; Xiao-Juan CUI ; Juan WANG ; Xiao-Yun YUAN
China Journal of Orthopaedics and Traumatology 2025;38(11):1119-1125
OBJECTIVE:
To investigate the accuracy and safety of pedicle screw placement using 3D-printed auxiliary guides in scoliosis correction surgery for adolescents.
METHODS:
A retrospective analysis was conducted on the clinical data of 51 patients who underwent posterior scoliosis correction surgery from January 2020 to March 2023. Among them, there were 35 cases of adolescent idiopathic scoliosis and 16 cases of congenital scoliosis. The patients were divided into two groups based on the auxiliary tool used:the 3D-printed auxiliary guide screw placement group (3D printing group) and the free-hand screw placement group (free-hand group, without auxiliary tools). The 3D printing group included 32 patients (12 males and 20 females) with an average age of (12.59±2.60) years;the free-hand group included 19 patients (7 males and 12 females) with an average age of (14.58±3.53) years. The two groups were compared in terms of screw placement accuracy and safety, spinal correction rate, intraoperative blood loss, number of intraoperative fluoroscopies, operation time, hospital stay, and preoperative and last follow-up scores of the Scoliosis Research Society-22 (SRS-22) questionnaire.
RESULTS:
A total of 707 pedicle screws were placed in the two groups, with 441 screws in the 3D printing group and 266 screws in the free-hand group. All patients in both groups successfully completed the surgery. There was a statistically significant difference in operation time between the two groups (P<0.05). The screw placement accuracy rate of the 3D printing group was 95.46% (421/441), among which the Grade A placement rate was 89.34% (394/441);the screw placement accuracy rate of the free-hand group was 86.47% (230/266), with a Grade A placement rate of 73.31% (195/266). There were statistically significant differences in the accuracy of Grade A, B, and C screw placements between the two groups (P<0.05), while no statistically significant differences were observed in intraoperative blood loss, number of fluoroscopies, correction rate, or hospital stay (P>0.05). In the SRS-22 questionnaire scores, the scores of functional status and activity ability, self-image, mental status, and pain of patients in each group at the last follow-up were significantly improved compared with those before surgery (P<0.05), but there were no statistically significant differences in all scores between the two groups (P>0.05).
CONCLUSION
In scoliosis correction surgery, compared with traditional free-hand screw placement, the use of 3D-printed auxiliary guides for screw placement significantly improves the accuracy and safety of screw placement and shortens the operation time.
Humans
;
Male
;
Scoliosis/surgery*
;
Female
;
Adolescent
;
Printing, Three-Dimensional
;
Retrospective Studies
;
Pedicle Screws
;
Child
7.Erectile dysfunction with hyperuricemia: Distribution of traditional Chinese medicine syndrome types and influencing factors.
Guo-Wei DU ; Qi ZHAO ; Yun WANG ; Xing-Hao ZHANG ; Jin-Chen HE ; Jian-Huai CHEN ; Yun CHEN
National Journal of Andrology 2025;31(5):449-456
OBJECTIVE:
To investigate the distribution of traditional Chinese medicine (TCM) syndrome types of and influencing factors on ED with hyperuricemia.
METHODS:
Based on the clinical data on 271 cases of ED with hyperuricemia admitted to our Department of Andrology, we studied the characteristics of syndrome elements, summarized the TCM syndrome types, and investigated the influencing factors on the distribution of the syndrome types by factor analysis and cluster analysis.
RESULTS:
By factor analysis of the data collected on TCM symptoms, 12 common factors and 15 syndrome type elements were identified, including disease type syndrome elements dampness, phlegm, heat, qi stagnation, blood stasis, qi deficiency, blood deficiency, yin deficiency, yang deficiency and essence deficiency, and disease-location syndrome elements kidney, liver, spleen, limbs and joints. Common factor cluster analysis revealed the main TCM syndrome types kidney deficiency damp-heat syndrome, spleen and kidney deficiency syndrome, liver depression and kidney deficiency syndrome, kidney deficiency and blood stasis syndrome, and the main influencing factors on the distribution of syndrome types including uric acid, systolic blood pressure, urea, obesity and so on.
CONCLUSION
The main TCM syndrome types of ED with hyperuricemia include kidney deficiency damp-heat syndrome, spleen and kidney deficiency syndrome, liver depression and kidney deficiency syndrome, kidney deficiency and blood stasis syndrome, and the related influencing factors can be used as an objective basis for the differentiation of TCM syndromes.
Humans
;
Medicine, Chinese Traditional
;
Hyperuricemia/complications*
;
Male
;
Cluster Analysis
8.The Valvular Heart Disease-specific Age-adjusted Comorbidity Index (VHD-ACI) score in patients with moderate or severe valvular heart disease.
Mu-Rong XIE ; Bin ZHANG ; Yun-Qing YE ; Zhe LI ; Qing-Rong LIU ; Zhen-Yan ZHAO ; Jun-Xing LV ; De-Jing FENG ; Qing-Hao ZHAO ; Hai-Tong ZHANG ; Zhen-Ya DUAN ; Bin-Cheng WANG ; Shuai GUO ; Yan-Yan ZHAO ; Run-Lin GAO ; Hai-Yan XU ; Yong-Jian WU
Journal of Geriatric Cardiology 2025;22(9):759-774
BACKGROUND:
Based on the China-VHD database, this study sought to develop and validate a Valvular Heart Disease- specific Age-adjusted Comorbidity Index (VHD-ACI) for predicting mortality risk in patients with VHD.
METHODS & RESULTS:
The China-VHD study was a nationwide, multi-centre multi-centre cohort study enrolling 13,917 patients with moderate or severe VHD across 46 medical centres in China between April-June 2018. After excluding cases with missing key variables, 11,459 patients were retained for final analysis. The primary endpoint was 2-year all-cause mortality, with 941 deaths (10.0%) observed during follow-up. The VHD-ACI was derived after identifying 13 independent mortality predictors: cardiomyopathy, myocardial infarction, chronic obstructive pulmonary disease, pulmonary artery hypertension, low body weight, anaemia, hypoalbuminaemia, renal insufficiency, moderate/severe hepatic dysfunction, heart failure, cancer, NYHA functional class and age. The index exhibited good discrimination (AUC, 0.79) and calibration (Brier score, 0.062) in the total cohort, outperforming both EuroSCORE II and ACCI (P < 0.001 for comparison). Internal validation through 100 bootstrap iterations yielded a C statistic of 0.694 (95% CI: 0.665-0.723) for 2-year mortality prediction. VHD-ACI scores, as a continuous variable (VHD-ACI score: adjusted HR (95% CI): 1.263 (1.245-1.282), P < 0.001) or categorized using thresholds determined by the Yoden index (VHD-ACI ≥ 9 vs. < 9, adjusted HR (95% CI): 6.216 (5.378-7.184), P < 0.001), were independently associated with mortality. The prognostic performance remained consistent across all VHD subtypes (aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation, tricuspid valve disease, mixed aortic/mitral valve disease and multiple VHD), and clinical subgroups stratified by therapeutic strategy, LVEF status (preserved vs. reduced), disease severity and etiology.
CONCLUSION
The VHD-ACI is a simple 13-comorbidity algorithm for the prediction of mortality in VHD patients and providing a simple and rapid tool for risk stratification.
9.Different Acupuncture Therapies for Postherpetic Neuralgia: An Overview of Systematic Reviews and Meta-analysis.
Yun-Fan XIA ; Ruo-Han SUN ; Shi-Min LI ; Yi-Yi WANG ; Rong-Rong LI ; Jian-Qiao FANG
Chinese journal of integrative medicine 2025;31(1):55-67
BACKGROUND:
Postherpetic neuralgia (PHN) is the most common complication of herpes zoster infection and affects patients' quality of life. Acupuncture therapy is regarded as a competitive method of treatment for analgesia.
OBJECTIVE:
To summarize evidence from systematic reviews (SRs) and evaluate the effectiveness and safety of different acupuncture therapies for treating PHN.
METHODS:
Eight electronic databases were searched from their inception to August 5, 2022, including 4 international electronic databases (PubMed, EMBASE, the Cochrane Library, and Web of Science) and 4 Chinese databases (Chinese Biomedical Database, China National Knowledge Infrastructure, VIP Database and Wanfang Database). Methodological quality was assessed by A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2). The Risk of Bias in Systematic Review (ROBIS) tool was used to assess the risk of bias in SRs. Evidence level was assessed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
RESULTS:
Totally, 7 SRs were included, including 128 studies and 9,792 patients. In AMSTAR 2, most of the SRs were of low or critically low levels since they had more than 1 critical deficiency. In ROBIS, 1 SR (14.29%) was rated as high risk, and the other 6 (85.71%) were rated as low risk. In the GRADE system, 9 outcomes (28.13%) were valued as high level, 5 (15.63%) as moderate level, 1 (3.13%) as low, and 17 (53.13%) as very low. In the effectiveness of acupuncture therapy, the group "moxibustion vs. original medical treatment" [mean difference (MD)=-1.44, 95% confidence interval (CI): -1.80 to -1.08, I2=99%, P<0.00001] was of the highest heterogeneity and the group "bloodletting vs. original medical treatment" (MD=-2.80, 95% CI: -3.14 to -2.46, I2=0, P<0.00001) was of the lowest heterogeneity. Six SRs have reported the safety of their studies and no serious events were shown in the treatment and control groups.
CONCLUSIONS
Acupuncture therapy seems to be effective in treating PHN. Despite the evidence that suggested the advantages of acupuncture therapy in relieving pain and promoting efficacy and safety, the methodological quality was quite low. Further studies should pay more attention to the quality of original studies and evidence for SRs to confirm these findings. (PROSPERO registration No. CRD42022344790).
Humans
;
Neuralgia, Postherpetic/therapy*
;
Acupuncture Therapy/methods*
;
Systematic Reviews as Topic
10.Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial.
Qing-Yun JIA ; Yi-Ru WANG ; Da-Wei SUN ; Jian-Chun MAO ; Luan XUE ; Xiao-Hua GU ; Xiang YU ; Xue-Mei PIAO ; Hao XU ; Qian-Qian LIANG
Chinese journal of integrative medicine 2025;31(2):99-107
OBJECTIVE:
To explore the efficacy and safety of Juan Bi Pill (JBP) in treatment of active rheumatoid arthritis (RA).
METHODS:
From February 2017 to May 2018, 115 participants from 4 centers were randomly divided into JBP group (57 cases) and placebo group (58 cases) in a 1:1 ratio using a random number table method. Participants received a dose of JBP (4 g, twice a day, orally) combined with methotrexate (MTX, 10 mg per week) or placebo (4 g, twice a day, orally) combined with MTX for 12 weeks. Participants were required with follow-up visits at 24 and 48 weeks, attending 7 assessment visits. Participants were undergo disease activity assessment 7 times (at baseline and 2, 4, 8, 12, 24, 48 weeks) and safety assessments 6 times (at baseline and 4, 8, 12, 24, 48 weeks). The primary endpoint was 28-joint Disease Activity Score (DAS28-ESR and DAS28-CRP). The secondary endpoints included American College of Rheumatology (ACR) criteria for 20% and 50% improvement (ACR20/50), Health Assessment Questionnaire Disability Index (HAQ-DI), clinical disease activity index (CDAI), visual analog scale (VAS), Short Form-36 (SF-36) score, Medial Outcomes Study (MOS) sleep scale score, serum erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender joint count, swollen joint count, and morning stiffness. The adverse reactions were observed during the treatment.
RESULTS:
After 12 weeks of treatment, DAS28-ESR and DAS28-CRP scores in both groups were lower than before treatment (both P<0.01), while the remission rate of DAS28-ESR and DAS28-CRP and low disease activity of JBP group were higher than those in the placebo group (both P<0.01). JBP demonstrated better efficacy on ACR20 and ACR50 compliance rate at 12 and 48 weeks comparing to placebo (all P<0.05). The CDAI and HAQ-DI score, pain VAS and global VAS change of RA patients and physicians, the serum ESR and CRP levels, and the number of tenderness and swelling joints were lower than before treatment at 4, 8, 12, 24, 48 weeks in both groups (P<0.05 or P<0.01), while the reduction of above indices in the JBP group was more obvious than those in the placebo group at 12 weeks (ESR and CRP, both P<0.05) or at 12 and 48 weeks (all P<0.01). There was no difference in adverse reactions between the 2 groups during treatment (P=0.75).
CONCLUSION
JBP combined with MTX could effectively reduce disease activity in patients with RA in active stage, reduce the symptoms of arthritis, and improve the quality of life, while ensuring safety, reliability, and fewer adverse effects. (Trial Registration: ClinicalTrials.gov, No. NCT02885597).
Humans
;
Arthritis, Rheumatoid/drug therapy*
;
Methotrexate/adverse effects*
;
Female
;
Double-Blind Method
;
Male
;
Middle Aged
;
Treatment Outcome
;
Drugs, Chinese Herbal/adverse effects*
;
Drug Therapy, Combination
;
Adult
;
Antirheumatic Agents/adverse effects*
;
Aged

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