1.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.
2.A multi-constraint optimal puncture path planning algorithm for percutaneous interventional radiofrequency thermal fusion of the L5/S1 segments
Hu LIU ; Zhihai SU ; Chengjie HUANG ; Lei ZHAO ; Yangfan CHEN ; Yujia ZHOU ; Hai LÜ ; Qianjin FENG
Journal of Southern Medical University 2024;44(9):1783-1795
Objective To minimize variations in treatment outcomes of L5/S1 percutaneous intervertebral radiofrequency thermocoagulation(PIRFT)arising from physician proficiency and achieve precise quantitative risk assessment of the puncture paths.Methods We used a self-developed deep neural network DWT-UNet for automatic segmentation of the magnetic resonance(MR)images of the L5/S1 segments into 7 key structures:L5,S1,Ilium,Disc,N5,Dura mater,and Skin,based on which a needle insertion path planning environment was modeled.Six hard constraints and 6 soft constraints were proposed based on clinical criteria for needle insertion,and the physician's experience was quantified into weights using the analytic hierarchy process and incorporated into the risk function for needle insertion paths to enhance individual case adaptability.By leveraging the proposed skin entry point sampling sub-algorithm and Kambin's triangle projection area sub-algorithm in conjunction with the analytic hierarchy process,and employing various technologies such as ray tracing,CPU multi-threading,and GPU parallel computing,a puncture path was calculated that not only met clinical hard constraints but also optimized the overall soft constraints.Results A surgical team conducted a subjective evaluation of the 21 needle puncture paths planned by the algorithm,and all the paths met the clinical requirements,with 95.24%of them rated excellent or good.Compared with the physician's planning results,the plans generated by the algorithm showed inferior DIlium,DS1,and Depth(P<0.05)but much better DDura,DL5,DN5,and AKambin(P<0.05).In the 21 cases,the planning time of the algorithm averaged 7.97±3.73 s,much shorter than that by the physicians(typically beyond 10 min).Conclusion The multi-constraint optimal puncture path planning algorithm offers an efficient automated solution for PIRFT of the L5/S1 segments with great potentials for clinical application.
3.A Review of Theoretical Research on Interpretation of Scientific Connotation of Compatibility of Traditional Chinese Medicine Compounds
Shiyun GUO ; Zhihao DENG ; Yan LI ; Yuxuan GUO ; Xiaoxin ZHU ; Yujie LI ; Ying CHEN ; Qing YANG ; Yi SUN ; Yajie WANG ; Qi LI ; Weiyan CAI ; Xiaogang WENG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(23):338-344
Traditional Chinese medicine (TCM) has a long history of application in China and has consistently played a vital role in treating diseases and saving lives. TCM prescriptions (compounds) constitute the primary form of clinical TCM treatment and significantly differ from western medicine (chemicals) due to the diverse composition and chemical constituents of TCM (compounds). Nevertheless, the potential multi-component, multi-target, and multi-pathway action characteristics of TCM prescriptions also demonstrate their possible (complementary) therapeutic advantages when compared with single-component chemical drugs. Therefore, driven by the development of modern science and technology and the demands of the modernization and internationalization of TCM, modern theories regarding the complexity of TCM prescription effects have been continuously proposed: Different from the abstract language of traditional prescription theory, the modern TCM prescription theory is more inclined to illustrate the connotation of prescription compatibility concretely and vividly from an experimental and scientific perspective. In this paper, new theories on the complexity of TCM prescriptions proposed in recent years are summarized to provide research references and ideas for the greater role of TCM prescriptions and a better scientific understanding.
4.A multi-constraint optimal puncture path planning algorithm for percutaneous interventional radiofrequency thermal fusion of the L5/S1 segments
Hu LIU ; Zhihai SU ; Chengjie HUANG ; Lei ZHAO ; Yangfan CHEN ; Yujia ZHOU ; Hai LÜ ; Qianjin FENG
Journal of Southern Medical University 2024;44(9):1783-1795
Objective To minimize variations in treatment outcomes of L5/S1 percutaneous intervertebral radiofrequency thermocoagulation(PIRFT)arising from physician proficiency and achieve precise quantitative risk assessment of the puncture paths.Methods We used a self-developed deep neural network DWT-UNet for automatic segmentation of the magnetic resonance(MR)images of the L5/S1 segments into 7 key structures:L5,S1,Ilium,Disc,N5,Dura mater,and Skin,based on which a needle insertion path planning environment was modeled.Six hard constraints and 6 soft constraints were proposed based on clinical criteria for needle insertion,and the physician's experience was quantified into weights using the analytic hierarchy process and incorporated into the risk function for needle insertion paths to enhance individual case adaptability.By leveraging the proposed skin entry point sampling sub-algorithm and Kambin's triangle projection area sub-algorithm in conjunction with the analytic hierarchy process,and employing various technologies such as ray tracing,CPU multi-threading,and GPU parallel computing,a puncture path was calculated that not only met clinical hard constraints but also optimized the overall soft constraints.Results A surgical team conducted a subjective evaluation of the 21 needle puncture paths planned by the algorithm,and all the paths met the clinical requirements,with 95.24%of them rated excellent or good.Compared with the physician's planning results,the plans generated by the algorithm showed inferior DIlium,DS1,and Depth(P<0.05)but much better DDura,DL5,DN5,and AKambin(P<0.05).In the 21 cases,the planning time of the algorithm averaged 7.97±3.73 s,much shorter than that by the physicians(typically beyond 10 min).Conclusion The multi-constraint optimal puncture path planning algorithm offers an efficient automated solution for PIRFT of the L5/S1 segments with great potentials for clinical application.
5.Quality analysis of Rosae Radix et Rhizoma.
Hai-Hui LIU ; Chen-Na LU ; Xuan-Xuan ZHU ; Lu BAI ; Li-Mei LIN ; Qian-Wen CHEN ; Wei-Hong FENG ; Duan-Fang LIAO ; Chun LI
China Journal of Chinese Materia Medica 2023;48(10):2781-2791
Rosae Radix et Rhizoma is a herbal medicine in a variety of famous Chinese patent medicines, while the quality standard for this medicine remains to be developed due to the insufficient research on the quality of Rosae Radix et Rhizoma from different sources. Therefore, this study comprehensively analyzed the components in Rosae Radix et Rhizoma of different sources from the aspects of extract, component category content, identification based on thin-lay chromatography, active component content determination, and fingerprint, so as to improve the quality control. The results showed that the content of chemical components varied in the samples of different sources, while there was little difference in the chemical composition among the samples. The content of components in the roots of Rosa laevigata was higher than that in the other two species, and the content of components in the roots was higher than that in the stems. The fingerprints of triterpenoids and non-triterpenoids were established, and the content of five main triterpenoids including multiflorin, rosamultin, myrianthic acid, rosolic acid, and tormentic acid in Rosae Radix et Rhizoma was determined. The results were consistent with those of major component categories. In conclusion, the quality of Rosae Radix et Rhizoma is associated with the plant species, producing area, and medicinal parts. The method established in this study lays a foundation for improving the quality standard of Rosae Radix et Rhizoma and provides data support for the rational use of the stem.
Drugs, Chinese Herbal/chemistry*
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Rhizome/chemistry*
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Plant Roots/chemistry*
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Plants, Medicinal
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Quality Control
6.Clinical treatment guideline for pulmonary blast injury (version 2023)
Zhiming SONG ; Junhua GUO ; Jianming CHEN ; Jing ZHONG ; Yan DOU ; Jiarong MENG ; Guomin ZHANG ; Guodong LIU ; Huaping LIANG ; Hezhong CHEN ; Shuogui XU ; Yufeng ZHANG ; Zhinong WANG ; Daixing ZHONG ; Tao JIANG ; Zhiqiang XUE ; Feihu ZHOU ; Zhixin LIANG ; Yang LIU ; Xu WU ; Kaican CAI ; Yi SHEN ; Yong SONG ; Xiaoli YUAN ; Enwu XU ; Yifeng ZHENG ; Shumin WANG ; Erping XI ; Shengsheng YANG ; Wenke CAI ; Yu CHEN ; Qingxin LI ; Zhiqiang ZOU ; Chang SU ; Hongwei SHANG ; Jiangxing XU ; Yongjing LIU ; Qianjin WANG ; Xiaodong WEI ; Guoan XU ; Gaofeng LIU ; Junhui LUO ; Qinghua LI ; Bin SONG ; Ming GUO ; Chen HUANG ; Xunyu XU ; Yuanrong TU ; Liling ZHENG ; Mingke DUAN ; Renping WAN ; Tengbo YU ; Hai YU ; Yanmei ZHAO ; Yuping WEI ; Jin ZHANG ; Hua GUO ; Jianxin JIANG ; Lianyang ZHANG ; Yunfeng YI
Chinese Journal of Trauma 2023;39(12):1057-1069
Pulmonary blast injury has become the main type of trauma in modern warfare, characterized by externally mild injuries but internally severe injuries, rapid disease progression, and a high rate of early death. The injury is complicated in clinical practice, often with multiple and compound injuries. Currently, there is a lack of effective protective materials, accurate injury detection instrument and portable monitoring and transportation equipment, standardized clinical treatment guidelines in various medical centers, and evidence-based guidelines at home and abroad, resulting in a high mortality in clinlcal practice. Therefore, the Trauma Branch of Chinese Medical Association and the Editorial Committee of Chinese Journal of Trauma organized military and civilian experts in related fields such as thoracic surgery and traumatic surgery to jointly develop the Clinical treatment guideline for pulmonary blast injury ( version 2023) by combining evidence for effectiveness and clinical first-line treatment experience. This guideline provided 16 recommended opinions surrounding definition, characteristics, pre-hospital diagnosis and treatment, and in-hospital treatment of pulmonary blast injury, hoping to provide a basis for the clinical treatment in hospitals at different levels.
7.Study on mechanism of action of Fuke duanhongyin capsule on the improvement of dysfunctional uterine bleeding in rats
Ying HE ; Yonggen LING ; Hongqing ZHAO ; Mengyao WU ; Lu BAI ; Qian CHEN ; Haohan ZHOU ; Yuhong WANG
China Pharmacy 2022;33(23):2840-2844
OBJECTIVE To investigate the mechanism of Fuke duanhongyin capsule in improving dysfunctional uterine bleeding (DUB) in rats. METHODS Pregnant SD rats were randomly divided into blank control group (distilled water), model control group (distilled water) and Fuke duanghongyin capsule group (1.296 g/kg), with 6 rats in each group. Except for blank control group, DUB model was established in other groups. After modeling, they were given relevant medicine/distilled water 10 mL/kg intragastrically, once a day, for consecutive 14 d. After medication, uterine index, ovary index and hemorheology indexes (whole blood high shear relative index, whole blood low shear relative index, erythrocyte aggregation index, Carson viscosity) of rats were all determined. The pathological changes of uterus and ovary tissues were observed; mRNA relative expression levels of epidermal growth factor (EGF), hypoxia-inducible factor 1α (HIF-1α), epidermal growth factor receptor (EGFR) and serine/ threonine-protein kinase 1(AKT1), and protein relative expression levels of EGF and EGFR in uterine tissue were all measured. RESULTS Compared with model control group, the uterine index, ovary index, erythrocyte aggregation index were all decreased significantly in Fuke duanghongyin capsule group (P<0.05 or P<0.01); whole blood high shear relative indexes, mRNA relative expression levels of EGF, HIF-1α and EGFR and protein relative expression levels of EGF and EGFR in uterine tissue were all increased significantly (P<0.05 or P<0.01). The pathological changes of ovary and uterus were improved. CONCLUSIONS Fuke duanhongyin capsule can improve DUB in rat, the mechanism of which may be related to the activation of EGF-EGFR signaling pathway.
8.Value of contrast-enhanced ultrasound combined with serum CXCL8 and CXCR2 in the evaluation of postoperative efficacy of transcatheter arterial chemoembolization for primary liver cancer
Yumin ZHANG ; Xianwei ZHAO ; Qianjin HE ; Jieneng CHEN
Journal of International Oncology 2022;49(10):592-596
Objective:To investigate the application value of contrast-enhanced ultrasound combined with serum CXC chemokine ligand 8 (CXCL8) and CXC chemokine receptor 2 (CXCR2) levels detection in the efficacy evaluation of patients with primary liver cancer after transcatheter arterial chemoembolization (TACE) .Methods:A total of 80 patients with primary liver cancer who were diagnosed and treated in Huanggang Central Hospital of Hubei Province from June 2019 to January 2022 were selected as the research objects. The therapeutic efficacy was evaluated 2 months after TACE treatment. According to the pathological diagnosis, the patients were divided into complete inactivation group ( n=30) and residual lesion group ( n=50) . The levels of serum CXCL8 and CXCR2 were measured by enzyme linked immunosorbent assay (ELISA) double antibody sandwich method, and contrast-enhanced ultrasonography was performed on the patients. Receiver operating characteristic (ROC) curve was applied to analyze the value of serum CXCL8 and CXCR2 in evaluating the efficacy of TACE in patients with primary liver cancer. Kappa test was applied to test the consistency of contrast-enhanced ultrasound and contrast-enhanced ultrasound combined with serum CXCL8 and CXCR2 in evaluating the efficacy of TACE in patients with primary liver cancer and the results of pathological diagnosis. Results:Compared with the complete inactivation group, the levels of serum CXCL8 [ (7.12±1.68) ng/ml vs. (5.07±1.25) ng/ml] and CXCR2 [ (3.62±0.79) ng/ml vs. (2.43±0.67) ng/ml] in the residual lesion group were obviously higher ( t=5.79, P<0.001; t=6.89, P<0.001) . The areas under the curve of CXCL8 and CXCR2 in evaluating the efficacy of TACE in patients with primary liver cancer were 0.827 and 0.801 respectively, the specificities were 73.3% and 76.7%, and the sensitivities were 70.0% and 72.0% respectively. The concordance between contrast-enhanced ultrasound and pathological diagnosis was moderate, and the Kappa value was 0.49 ( P<0.001) . The concordance between contrast-enhanced ultrasound combined with serum CXCL8 and CXCR2 and pathological diagnosis was high, and the Kappa value was 0.62 ( P<0.001) . The sensitivity of contrast-enhanced ultrasound combined with serum CXCL8 and CXCR2 in evaluating the efficacy of TACE in patients with primary liver cancer was 90.0%, which was higher than the sensitivity of contrast-enhanced ultrasound (72.0%, χ2=5.26, P=0.022) , CXCL8 (70.0%, χ2=6.25, P=0.012) and CXCR2 (72.0%, χ2=5.26, P=0.022) . Conclusion:Contrast-enhanced ultrasound can detect residual lesions after TACE in patients with primary liver cancer to a certain extent, and its combination with serum CXCL8 and CXCR2 can effectively improve the evaluation efficiency of the efficacy of TACE treatment in patients with primary liver cancer.
9.Analysis of risk factors for arrhythmia in patients after heart valve replacement
Manrong YAN ; Qianjin ZHONG ; Yongchao GOU ; Jianming CHEN ; Yijie HU ; Yi SONG ; Ye YUAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(04):459-466
Objective To explore and analyze the risk factors for arrhythmia in patients after heart valve replacement. Methods A retrospective analysis of 213 patients undergoing cardiac valve replacement surgery under cardiopulmonary bypass in our hospital from August 2017 to August 2019 was performed, including 97 males and 116 females, with an average age of 53.4±10.5 year and cardiac function classification (NYHA) grade of Ⅱ-Ⅳ. According to the occurrence of postoperative arrhythmia, the patients were divided into a non-postoperative arrhythmia group and a postoperative arrhythmia group. The clinical data of the two groups were compared, and the influencing factors for arrhythmia after heart valve replacement were analyzed by logistic regression analysis. Results There were 96 (45%) patients with new arrhythmia after heart valve replacement surgery, and the most common type of arrhythmia was atrial fibrillation (45 patients, 18.44%). Preoperative arrhythmia rate, atrial fibrillation operation rate, postoperative minimum blood potassium value, blood magnesium value in the postoperative arrhythmia group were significantly lower than those in the non-postoperative arrhythmia group (P<0.05); hypoxemia incidence, hyperglycemia incidence, acidosis incidence, fever incidence probability were significantly higher than those in the non-postoperative arrhythmia group (P<0.05). The independent risk factors for postoperative arrhythmia were the lowest postoperative serum potassium value (OR=0.305, 95%CI 0.114-0.817), serum magnesium value (OR=0.021, 95%CI 0.002-0.218), and hypoxemia (OR=2.490, 95%CI 1.045-5.930). Conclusion Taking precautions before surgery, improving hypoxemia after surgery, maintaining electrolyte balance and acid-base balance, monitoring blood sugar, detecting arrhythmia as soon as possible and dealing with it in time can shorten the ICU stay time, reduce the occurrence of complications, and improve the prognosis of patients.
10.Comparison of postoperative analgesic effect of flurbiprofen axetil and parecoxib sodium in patients with humeral shaft fracture in painless ward
Qianjin YU ; Lei HONG ; Meijing DOU ; Guiyou WU ; Guoqiang CHEN ; Lei CHEN ; Wenfeng LI
Chinese Journal of Postgraduates of Medicine 2021;44(4):289-293
Objective:To compare postoperative analgesic effect of flurbiprofen axetil and parecoxib sodium in patients with humeral shaft fracture in painless ward.Methods:All of 200 hospitalized humeral fractures patients were retrospectively studied in the painless ward of the Forth Medical Center of PLA General Hospital from January 2017 to September 2019 , the clinical effects of flurbiprofen axetil and parecoxib were compared.Results:Postoperative visual analogue scale (VAS) scores after 3 d of two groups of patients were significantly lower, compared with preoperative results: (4.26±0.96) scores vs. (6.09±1.38) scores, (4.04±1.19) scores vs. (6.04±1.11) scores, and the differences were statistical significantly ( P<0.01). Postoperative VAS score after 3 d of two groups had no statistical significance ( P>0.05). Two groups had different degree of adverse reactions after operation, and flurbiprofen axetil group had singnificant gastrointestinal adverse reaction: 22 patients vs. 3 patients( P<0.05). The number of patients in the parecoxib group were more than that in the flubiprofen axetil group without troubled sleep: 20 patients vs. 8 patients. Two groups of patients were satisfied with the pain care during hospitalization. Conclusions:Two analgestic drugs can obtain obvious analgesic effect in the treatment of bones surgery. The side effects and sleep disturbance in the flurbiprofen axetil group are higher than those in the parecoxib group. Good pain control can improve patients satisfaction with pain care.

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