1.Clinical effect of total hip arthroplasty in treatment of patients with ankylosing spondylitis and bilateral hip bony ankylosis
Guoli CHEN ; Xianwei WU ; Haibin LIN ; Furen FU ; Wei ZHANG ; Xuanhuang CHEN ; Jianhui DAI
Chinese Journal of Primary Medicine and Pharmacy 2011;18(1):16-17
Objective To investigate the effect of total hip arthroplasty in treatment of patients with ankylosing spondylitis and bilateral hip bony ankylosis. Methods 43 patients with ankylosing spondylitis and bilateral hip bony ankylosis were randomly divided into observation group (23 cases) and control group (20 cases) in accordance with the principle of informed consent, individually treated by total hip arthroplasty and conservative treatment, the effect of two groups were compared and analyzed. Results In the observation group, the postoperative Harris hip score and the VAS pain score of patients were significantly better than the control group,the differences were all statistically significant between two groups( all P < 0.05 ). Excellent rate of the two groups were 91.3% and 60.0% respectively, and the difference was statistically significant ( x2 = 4.328, P < 0.05 ). Conclusion Total hip arthroplasty in treatment of patients with ankylosing spondylitis and bilateral hip bony ankylosis has better clinical effect, and could improve the quality of life of patients, so it was worthy of clinical application.
2.Effect of Astragalus Injection as an Adjunctive Therapy on the Biology in Patients with Schizophrenia and Its Clinical Efficacy
Ruiguo QUAN ; Bingquan LI ; Liqin LI ; Dongming WANG ; Peiyi SONG ; Furen CHEN
China Pharmacy 2001;0(09):-
OBJECTIVE:To observe the effect of Astragalus injection as an adjunctive therapy on the biology in patients with schizophrenia and its clinical efficacy. METHODS: A total of 100 patients with schizophrenia were randomly assigned to trial group(n=50) or control group(n=50). The trial group received routine antipsychotic drugs plus Astragalus injection (40 mL?d-1, iv gtt) for 7 days, and the control group received antipsychotic drugs alone without addition of traditional Chinese medicine for 7 days. All the patients received for a total of 4 courses of treatment. Besides, both groups received additional benzodiazepine but not other hipnotics. RESULTS: After treatment, there were significant differences between the trial group and the control group in ECG QTc duration, sugar level, therapeutic efficacy, PANSS scores (total score and the sub-item scores) and adverse reactions etc(P
3.Clinical observation of arrhythmia after treatment with recombinant human interleukin 11 in elderly patients with myelodysplastic syndromes
Zhao CHEN ; Ming ZHOU ; Jianying CHEN ; Xianqing LIU ; Furen ZENG
Journal of Leukemia & Lymphoma 2017;26(12):752-755
Objective To analyze the arrhythmia after treatment with recombinant human interleukin 11 (rhIL-11) because of down-regulating platelet in elderly patients with myelodysplastic syndromes (MDS), and to investigate the possible mechanism of arrhythmia induced by in MDS patients. Methods The data of 2 MDS patients with arrhythmia after rhIL-11 therapy were analyzed retrospectively. The patients'hemoglobin, electrocardiogram (ECG), myocardial enzymes, cardiac troponin Ⅰ (cTnⅠ), N-terminal pro brain natriuretic peptide (NT-proBNP) changes, as well as cardiac ultrasonography and Holter monitoring during arrhythmia were dynamically observed before and after use of rhIL-11, at the time of arrhythmia and restoring sinus rhythm after the withdrawal of rhIL-11. Results Before the use of rhIL-11, blood platelet count of patient 1 and patient 2 was 2×109/L and 3×109/L respectively. Arrhythmias occurred in the two patients at 11st and 14th days respectively. ECG showed atrial fibrillation with rapid ventricular rate, and dynamic ECG monitoring showed that syncope was caused by sinus arrest due to cardiac cardiogenic syncope. Heart ultrasound prompted ejection fraction (EF) values in the normal range. Creatine kinase, creatine kinase isoenzymes, aspartate transaminase, lactate dehydrogenase, and cTnⅠ had no obvious increase or decrease after rhIL-11 treatment, but NT-proBNP was increased significantly. After discontinuation of rhIL-11 and diuretic treatment, no syncope occurred. ECG restored sinus rhythm, and NT-proBNP was decreased significantly. Conclusion rhIL-11 in elderly MDS patients may induce arrhythmia, which can be restored after drug withdrawal, limited sodium diet and diuretic treatment, but much attention should be paid to the heart-related symptoms and signs, dynamic monitoring of NT-proBNP and timely treatment.
4.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
5.Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension
Chen YU ; Songmei GENG ; Bin YANG ; Yunhua DENG ; Fuqiu LI ; Xiaojing KANG ; Mingye BI ; Furen ZHANG ; Yi ZHAO ; Weili PAN ; Zhongwei TIAN ; Jinhua XU ; Zhenghua ZHANG ; Nan YU ; Xinsuo DUAN ; Shuping GUO ; Qing SUN ; Weiquan LI ; Juan TAO ; Zhijun LIU ; Yuanyuan YIN ; Gang WANG
Chinese Medical Journal 2024;137(10):1190-1198
Background::There is a need for effective and safe therapies for psoriasis that provide sustained benefits. The aim of this study was to assess the efficacy and safety of tildrakizumab, an anti-interleukin-23p19 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in Chinese patients.Methods::In this multi-center, double-blind, phase III trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned (1:1) to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and 4. Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12, 16, and every 12 weeks thereafter. Patients in the tildrakizumab group continued with tildrakizumab at week 16, and every 12 weeks until week 52. The primary endpoint was the Psoriasis Area and Severity Index (PASI 75) response rate at week 12.Results::At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) and Physician’s Global Assessment (60.9% [67/110] vs. 10.0% [11/110]; difference, 49.1% [95% CI, 38.64, 59.62]; P <0.001) compared to placebo. PASI 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups, reaching maximal efficacy after 28 weeks (86.8% [92/106] vs. 82.4% [89/108]) and maintained up to 52 weeks (91.3% [95/104] vs. 87.4% [90/103]). Most treatment-emergent adverse events were mild and not related to tildrakizumab. Conclusion::Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.Trial registration::ClinicalTrials.gov, NCT05108766.
6.Clinical characteristics of psoriasis and current status of medical care for patients in county areas of China
Min LI ; Bo ZHANG ; Wenjun WANG ; Yixuan ZHANG ; He HUANG ; Yihe WANG ; Hao JIANG ; Daihua TAN ; Lina CHEN ; Yuxiu JIANG ; Yingyou ZHAO ; Qunli ZHAO ; Xianyong YIN ; Liangdan SUN ; Furen ZHANG ; Xinghua GAO ; Yong CUI ; Xuejun ZHANG
Chinese Journal of General Practitioners 2024;23(11):1155-1161
Objective:To investigate the clinical characteristics of psoriasis and status quo of medical care for patients in county areas of China.Methods:This study was a cross-sectional investigation. Based on the “Qianxian Wuyin” Project (a national project for upgrating ability for psoriasis care at county level), an online questionnaire survey was conducted in the dermatology departments of 459 county hospitals in 404 pilot administrative counties across China from February to June 2023. The questionnaire included demographic information of patients (gender, ethnicity, age, place of residence, education, marital status), and clinical characteristics of psoriasis (disease course, type, comorbidities, body surface area (BSA) and previous treatment. The Dermatology Life Quality Index (DLQI) and Psoriasis Area and Severity Index (PASI) were applied for assessing the quality of life and disease severity, and completed by patients or guardian and doctors, respectively.Results:A total of 16 935 patients completed the questionnaire. The age of patients was 1-102(44.17±11.58)years, and 71.0% (12 036/16 935) were 30-59 years old. The ratio of male to female was 2.21∶1; 24.3%(4 117/16 935) of patients had high school education; there were 9 940 patients(58.7%) with previous or current smoking and/or alcohol use; 42.8%(7 218/16 855) of patients had a disease course of 1-5 years. There were 15 630 patients(92.3%) with DLQI≥10, 8 346 patients(49.7%) with PASI≥10, 15 017 patients(89.2%) with BSA≥10%. The plaque type was the most common disease type ( n=14 965, 88.7%), and spotting type ranked the second ( n=1 141, 6.8%). The most common initial site was the trunk ( n=12 309, 72.9%). Among the comorbidities, hypertension was the most common one ( n=1 681, 10.0%). There were 7 650 reports of treatment response to conventional topical drug therapy and 3 112 reports of treatment response to systemic drug therapy, with 6 269 (81.9%) and 2 493 (80.1%) reporting poor or no response, respectively. Conclusions:The survey shows that in the county areas of China, the majority of psoriasis patients are severe patients with short course of disease, plaque type is the most common type, and hypertension is the most common comorbidity; and the conventional treatment is less effective for most patients.