1.Efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ IgG:Fc fusion protein for injection in Chinese patients with early rheumatoid arthritis and active spondyloarthritis
Chaofeng LIAN ; Fengchun ZHANG
Chinese Journal of Rheumatology 2016;(2):106-111
Objective To evaluate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ IgG: Fc fusion protein for injection (rhTNFR: Fc) treatment in Chinese patients with early rheumatoid arthritis (ERA) and active spondyloarthritis. Methods This was a large-scale, multicenter, open-label, phase Ⅳclinical observational study. The dosage of rhTNFR: Fc was 50 mg per week, combined or not combined with other drugs. The primary endpoint of efficacy included the proportion of patients with low disease activity [simplified disease activity index (SDAI)≤11] at 3 month and 6 month. Secondary endpoint variables included clinical disease activity index (CDAI), disease activity score 28 based on C-reactive protein (DAS28-CRP) and health assessment questionnaire(HAQ). The primary endpoint of SpA was the ankylosing spondylitis disease activity score (ASDAS-CRP) at month 3. The secondary endpoints were the proportion of subjects achieving ASDAS<1.3 and ASDAS<2.1, Bath AS functional index (BASFI) and CRP. All subjects in the study were evaluated for safety. T test, χ2 test and rank sum test were used for satistical analysis. Results One thousand two hundred and seventy subjects with ERA were studied. The difference between the baseline and month 3 after treatment in SDAI, CDAI, DAS28-CRP were 26 ±16, 23 ±15, 1.86 ± 1.01 respectively (P<0.01). The above parameters 6 months after treatment were similar to those at 3 months after treatment, which demonstrated the persistence of drug efficacy. Two thousand three hundred and twenty eight subjects of SpA were studied. The difference between the baseline and 3 months after treatment in ASDAS, BASFI was 2.6 ±1.7, 3.4 ±3.8 respectively (t=73 .54, t=42 .36, P<0.01). The overall incidence of adverse events was 8.03%(289/3 598), including the common adverse events such as injection site reactions, skin rash and elevated liver enzyme levels. Adverse events were improved after proper treatment, without severe infections and tumor. These data confirmed that the overall safety of rhTNFR: Fc was good. Conclusion The study confirms that rhTNFR: Fc is effective for the treatment of ERA and SpA, and it is safe and well-tolerated.
2.Changes of PGE_2, PGI_2 and TXA_2 concentration in rat traumatic pulpitis
Jianbo PAN ; Shiguang HUANG ; Huadong WANG ; Chaofeng HU ; Lian YAN
Chinese Journal of Pathophysiology 2000;0(11):-
AIM: To study the relationship between prostaglandins and acute pulpitis. METHODS: Rat traumatic pulpitis model was established by pulp exposure. The kinetic pathological changes in dental pulpal tissues and changes of PGE 2?6-Keto-PGF 1? and TXB 2 concentration in dental pulp were observed. RESULTS: After pulpal trauma, the dental pulp showed inflammatory changes and the concentrations of PGE 2?6-Keto-PGF 1? and TXB 2 were increased, which peaked at 6 hour post-trauma. CONCLUSION: Prostaglandins play a significant role in the pathogenesis of pulpitis.
3.Clinical characteristics of patients with antisynthetase syndrome and positive anti-Ro52 antibody
Xin ZHANG ; Xiangmei ZHAO ; Qihua YANG ; Chaofeng LIAN ; Wei LI ; Lu YANG ; Jiameng LU ; Wenjuan GUAN ; Lijuan ZHANG ; Shuhua CHENG ; Hui LI ; Shengyun LIU
Chinese Journal of Internal Medicine 2022;61(2):200-204
To analyze the clinical characteristics of patients with antisynthetase syndrome (ASS) and positive anti-Ro52 antibody. The clinical data of 203 ASS patients admitted to the First Affiliated Hospital of Zhengzhou University from 2017 to 2020 were analyzed retrospectively. Demographics, clinical manifestations, laboratory results, treatment and outcome were collected including data of 18 patients with rapidly progressive interstitial lung disease (RP-ILD). In total, the majority were women (148,72.9%). The average onset age was (51.9±13.3) years. There were 163 (80.3%) patients with positive anti-Ro52 antibody. The positivity in women (77.3% vs. 55.0%, P=0.004) was higher, and the median time from disease onset to diagnosis [4.5 (2.0, 24.0) months vs. 2.0 (1.0, 12.0) months, P=0.024] was longer in patients with positive anti-Ro52 antibody than those negative. Compared with negative patients, patients with positive anti-Ro52 antibody had a higher incidence of interstitial lung disease (ILD) (96.9% vs. 65.0%, P<0.001), arthritis (33.7% vs. 17.5%, P=0.046), and arthralgia (39.3% vs. 20.0%, P=0.022). Higher rate of positve antinuclear antibody (ANA) (85.3% vs. 55.0%, P<0.001), lower rate of positive anti-Jo-1 antibody (32.5% vs. 50.0%, P=0.039), lower albumin level [(34.6±5.2) g/L vs. (37.3±4.7) g/L, P=0.004] and lower lymphocyte counts [(1.4±0.8) ×10 9/L vs. (1.8±0.8) ×10 9/L, P=0.014] were more common in patients with positive anti-Ro52 antibody. The presence of anti-Ro52 antibody is associated with a particular phenotype of ASS, leading to common ILD, involvement of joints, high ANA positivity, low albumin and low lymphocyte counts.