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 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.
3.Risk factors of incidental prostate cancer in patients undergoing radical cystoprostatectomy
Abuduaini KAIERMAIDING ; Mulati NAYILA ; Qianjin LI ; Kamili AIKEBAIERJIANG ; Rexiati MULATI
Journal of Modern Urology 2023;28(6):469-473
【Objective】 To investigate the risk factors and clinical significance of incidental prostate cancer (IPCa) in patients undergoing radical cystoprostatectomy (PCR). 【Methods】 The clinicopathological data of 260 patients undergoing RCP in our hospital during Jan. 2010 and Jan. 2022 were retrospectively analyzed, including 39 cases of IPCa detected with postoperative pathology, and 221 non-IPCa cases. 【Results】 The detection rate of IPCa was 15%. Univariate logistic regression analysis showed age (P<0.001), smoking (P<0.05), T stage (P<0.05), number of tumors (P<0.05), involvement of trigone (P<0.05), prostate volume (P<0.05), and preoperative total prostate-specific antigen (tPSA) (P<0.05) were influencing factors of prostate cancer. Multivariate logistic regression analysis showed that age (OR=1.061, 95%CI: 1.021-1.107, P=0.004), smoking (OR=2.852, 95%CI: 1.296-6.677, P=0.012), involvement of trigone(OR=2.967, 95%CI: 2.365-3.657, P=0.019) and preoperative tPSA (OR=1.109, 95%CI: 1.011-1.223, P=0.030) were independent risk factors of IPCa. 【Conclusion】 Advanced age, smoking, bladder tumor in trigone and preoperative PSA abnormality are risk factors for incidental prostate cancer in bladder cancer patients.
4.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*
;
Rhizome/chemistry*
;
Plant Roots/chemistry*
;
Plants, Medicinal
;
Quality Control
5.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.
6.Reprt of the short-term efficacy of a new type of ileal orthotopic cystectomy
Jixing WANG ; Shenshen YAN ; Hongwen SONG ; Qianjin LI ; Qiang LIU ; Jun MA ; Yujie WANG ; ·Rexiati MULATI ; Wenguang WANG
Chinese Journal of Urology 2022;43(4):291-293
In this study, a new ileal orthotopic bladder (Urumqi Bladder) modified by our center based on the ileal "W" type orthotopic bladder and Studer bladder was used on 8 patients with invasive bladder cancer. All of patients were male and aged between 54 and 66 years. The history of disease ranged from 1 month to 3 years, including 5 patients with initial onset, 3 patients with ≥2 TURBT history. 6 patients had multiple tumors, tumor size from 0.5 cm to 2.5cm. There were 2 patients with single tumor. Preoperative PET-CT examination showed no distant metastasis and pelvic lymph node enlargement, no urinary tract hydronephrosis, and cystoscopy showed no suspected tumor in the urethra. Preoperative pathological results: high-grade invasive urothelial carcinoma was found in 6 cases and muscular invasive urothelial carcinoma in 2 cases. In 8 patients, 50cm ileum was taken from 15cm away from ileocecum after radical cystectomy, which was crimped clockwise inward from the right end into a nearly circular shape, with 10cm left at the left end. The remaining 40cm ileum was formed into 3 sections of about 13cm each, which were decanted to form a storage capsule. The last 10cm intestinal tube was crossed from the front of sigmoid colon. The end of intestine was anastomosed with the left ureter. The right ureter was anastomosed with the top of the right intestine pouch, and the urethra was anastomosed with the pouch to complete the diversion of urine flow. During 3-12 months of postoperative follow-up, 4 patients had short-term mild urinary incontinence. All had complete urinary control at 12 months. 1 patient still had mild left ureter reflux 12 months after surgery, and the other 7 patients had no ureter reflux. In this group of 8 patients, postoperative excretory cystography showed satisfactory effect of bladder voiding, residual, and bladder capacity. Follow-up review of chest CT, urinary CT and abdominal ultrasound showed no hydronephrosis, and no tumor recurrence or distant metastasis.
7.Correlation between gross motor function and spinal range of motion for children with bilateral spastic cerebral palsy
Sijia LI ; Qi ZHANG ; Yan HE ; Qianjin LIU ; Yanqing ZHANG ; Tiantian ZHOU
Chinese Journal of Rehabilitation Theory and Practice 2022;28(10):1211-1216
ObjectiveTo explore the correlation between gross motor function and spinal range of motion (ROM) in children with bilateral spastic cerebral palsy. MethodsA total of 33 children with bilateral spastic cerebral palsy in Beijing Bo'ai Hospital from December, 2019 to March, 2022 were selected and divided into group 1 (grade Ⅰ, n = 12), group 2 (grade Ⅱ, n = 11) and group 3 (grade Ⅲ, n = 10) according to Gross Motor Function Classification System (GMFCS). SpinalMouse (spine morphometric machine) was used to measure the ROM of forward and backward flexion, and left and right lateral flexion of trunk, respectively, in sitting. Their gross motor ability was then further tested using the Gross Motor Function Measure (GMFM) 88 item. ResultsThe ROM of backward flexion, the left and right lateral flexion, and the total ROM of sagittal and coronal plane were positively correlated with the scores of GMFM88 (r > 0.424, P < 0.05), and were negatively correlated with the grade of GMFCS (|r| > 0.424, P < 0.05). ConclusionSpinal ROM correlates with gross motor function in children with bilateral spastic cerebral palsy.
8.Investigation on in Vitro Antioxidant Activity and Chemical Composition of Different Polar Parts of Extract of Rosa cymosa Roots
Xuan-xuan ZHU ; Xiao-qian LIU ; Yao-hua LIANG ; Li-mei LIN ; Lu BAI ; Wei-hong FENG ; Zhi-min WANG ; Chun LI ; Duan-fang LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(8):117-125
Objective:To investigate the antioxidant activity and chemical composition of 75% ethanol extract of
9.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.
10.Clinical analysis of 1 057 patients with critical illnesses in a dermatological ward
Hai LONG ; Li JIANG ; Yueqi QIU ; Nan YAO ; Licong LIU ; Yuming XIE ; Feng XIONG ; Siqi TAN ; Qiqi KUANG ; Ruixuan YOU ; Ke CHAI ; Xin LUO ; Haojun LONG ; Yue XIN ; Ziyu GUO ; Jiaqi WANG ; Yixin TAN ; Qing ZHANG ; Guiying ZHANG ; Yaping LI ; Yuwen SU ; Rong XIAO ; Qianjin LU
Chinese Journal of Dermatology 2021;54(9):790-797
Objective:To summarize clinical characteristics of and treatment experience with patients with critical illnesses in a dermatological ward.Methods:All patients with serious or life-threatening conditions, who were hospitalized at the dermatological ward of the Second Xiangya Hospital of Central South University from July 9, 2011 to December 31, 2020, were collected, and their clinical data were retrospectively analyzed. Demographic characteristics, disease types and proportions, main complications, causes of serious or life-threatening conditions, important treatment measures and outcomes were summarized, and causes of death were also analyzed and discussed.Results:A total of 1 057 patients with critical illnesses were collected, with a male-to-female ratio of 1∶1.11, and 64.81% of them aged 18 to 65 years. The types of diseases mainly included drug eruptions (332 cases) , connective tissue diseases (226 cases) , bullous skin diseases (104 cases) , psoriasis (57 cases) , erythroderma (45 cases) , infectious skin diseases (67 cases) , etc. Among them, psoriasis (39 cases) and erythroderma (32 cases) mostly occurred in males, and connective tissue diseases (168 cases) mostly occurred in females. Common complications mainly involved infections, important organ damage or dysfunction, hypoalbuminemia, and fluid, electrolyte and acid-base imbalances. A total of 94 patients were diagnosed with life-threatening conditions, which were found to be mainly caused by primary skin diseases, hematologic abnormalities, respiratory failure, nervous system abnormalities, renal failure, sepsis, fluid, electrolyte and acid-base imbalances, etc. During the management of critical illnesses, 43 patients were treated with high-dose glucocorticoid pulse therapy, 264 were treated with gamma-globulin pulse therapy, 355 were transfused with other blood products, and 34 received special therapies such as hemoperfusion/immunoadsorption therapy, plasma exchange, dialysis, artificial liver support therapy; 42 patients were transferred to the intensive care unit (ICU) , 12 were transferred to the department of surgery for operations, and 12 were transferred to the department of obstetrics and gynecology for delivery or induction of labor. After treatment, 989 patients (93.57%) achieved improvement and were discharged. A total of 14 patients (1.32%) died, of whom 7 died of secondary sepsis, 2 died of severe pulmonary infections, 2 died of asphyxia caused by respiratory mucosa shedding-induced airway obstruction, the other 3 died of gastrointestinal hemorrhage, cerebral hemorrhage and neuropsychiatric systemic lupus erythematosus, respectively.Conclusions:Critical cases in the dermatological ward mainly suffered from serious skin diseases such as severe drug eruptions, connective tissue diseases and bullous skin diseases, as well as complications such as severe underlying diseases, severe organ dysfunction, sepsis or severe fluid, electrolyte and acid-base imbalances. In terms of treatment, it is of critical significance to make a clear diagnosis and assess the severity of disease as early as possible, monitor and prevent possible complications, and to consult with specialists in relevant disciplines in time.

Result Analysis
Print
Save
E-mail