1.Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.
Lin CAI ; Jian-Zhong ZHANG ; Xu YAO ; Jun GU ; Quan-Zhong LIU ; Min ZHENG ; Shi-Fa ZHANG ; Jin-Hua XU ; Cheng-Xin LI ; Hao CHENG ; Qing GUO ; Wei-Li PAN ; Shen-Qiu LI ; Ruo-Yu LI ; Zai-Pei GUO ; Zhi-Qi SONG ; Shan-Shan LI ; Xiu-Qin DONG ; Linda WANG ; Rong FU ; Pascaline REGNAULT ; Pascal CHAREF ; Rafal MAZUR ; Manmath PATEKAR
Chinese Medical Journal 2020;133(22):2665-2673
BACKGROUND:
Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.
METHODS:
This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.
RESULTS:
A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
CONCLUSION:
Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
Antibodies, Monoclonal/therapeutic use*
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Antibodies, Monoclonal, Humanized
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China
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Double-Blind Method
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Humans
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Psoriasis/drug therapy*
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Severity of Illness Index
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Treatment Outcome
2.Identification of Chrysanthemum indicum in different geographical populations and Ch. morifolium based on DNA barcodes of psbA-trnH,matK and trnL.
Fu-Rong CHEN ; Tao WANG ; Qiao-Sheng GUO ; Zai-Biao ZHU ; Feng YANG ; Qin-Jun ZOU ; Ya-Jing ZHANG
China Journal of Chinese Materia Medica 2019;44(4):660-665
DNA barcode technology was used to establish a rapid identification method of Chrysanthemum indicum and Ch. morifolium based on psbA-trn H,mat K and trn L sequences. The total DNA was extracted from 21 samples collected,and the psbA-trn H,mat K,trn L sequences were amplified by PCR and sequenced. The information of these sequences were obtained. We aligned all 63 sequences,calculated the intraspecific and interspecific distances,analysed the SNPs distribution of psbA-trn H+mat K+trn L combination sequences and constructed the Neighbor-joining( NJ) Tree,using MEGA 7. 0. The results showed that the genetic distances of Ch. indicum,Ch. indicum( Juhuanao)and Ch. morifolium were overlapped. The SNPs analysis of psbA-trn H+mat K+trn L combination sequences showed that there were 19 nucleotide polymorphism loci( SNPs) and nine parsim-informative sites in the combination sequences. In addition,Ch. indicum showed more obvious sequence polymorphism than those of Ch. indicum( Juhuanao) and Ch. morifolium. The psbA-trn H sequences showed obvious length variation.The NJ Tree showed that Ch. morifolium numbered C2-C5 were clustered into a single subbranch with a bootstrap value of 62%,and Ch.morifolium could be distinguished from Ch. indicum and Ch. indicum( Juhuanao). Moreover,Ch. indicum numbered Z9 and Z10 collected from Gansu province were singly clustered into one branch with a bootstrap value of 77%. It was also found that the changes of psbA-trn H and trn L sequences information of Ch. indicum samples from the northwest were obviously related to the geography and environment. Moreover,Ch.indicum and Ch. indicum( Juhuanao) had obvious differentiation,were also regarded as the evolutionary sources of Ch. morifolium. Therefore,psbA-trn H+mat K+trn L combination sequences as DNA barcode can identify Ch. indicum and Ch. morifolium accurately and rapidly,which provides an important basis for germplasm resources identification and species identification.
Chrysanthemum
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DNA Barcoding, Taxonomic
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DNA, Plant
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Phylogeny
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Trees
4.Effects of light intensity on growth, quality and antioxidant activities of Sedum sarmentosum.
Zai-Biao ZHU ; Jin-Feng YANG ; Qiao-Sheng GUO ; Fan LIU ; Rong WANG ; Wen-Xia ZHANG
China Journal of Chinese Materia Medica 2018;43(22):4404-4409
The present study was conducted to explore the effect of light intensity on growth, bioactivity compounds accumulation and anti-oxidative activity of Sedum sarmentosum. The growth, yield, contents of total flavonoids, total phenolic, quercetin, kaempferol and isorhamnetin, and antioxidant activities were assessed in S. sarmentosum under five light intensities, namely 100% full sunlight (G1), 77% full sunlight (G2), 60% full sunlight (G3), 38% full sunlight (G4), and 16% full sunlight (G5). The results showed that light intensity significantly affected the growth and the chemical compounds accumulation. With the decrease of light intensity, the maximum branch length and the average internode distance increased. G2 treatment greatly promoted the numbers of leaf layers and branches, and G3 treatment remarkably improved the yield. The highest total flavonoids and phenolic contents were obtained in G3 treatment. Meanwhile, the highest quercetin and isorhamnetin contents were obtained in G1 treatment. The difference of kaempferol content was not significant. In addition, based on DPPH, FTC and FRAP methods, the antioxidant activities of the aqueous extracts under G1 treatment were superior to the others. The results indicated that more than 60% full sunlight was the optimum light intensity condition to achieve high yield and quality of S. sarmentosum.
Antioxidants
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Flavonoids
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Phenols
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Plant Extracts
;
Sedum
5.Clinical Features of Adult/Adolescent Atopic Dermatitis and Chinese Criteria for Atopic Dermatitis.
Ping LIU ; Yan ZHAO ; Zhang-Lei MU ; Qian-Jin LU ; Li ZHANG ; Xu YAO ; Min ZHENG ; Yi-Wen TANG ; Xin-Xiang LU ; Xiu-Juan XIA ; You-Kun LIN ; Yu-Zhen LI ; Cai-Xia TU ; Zhi-Rong YAO ; Jin-Hua XU ; Wei LI ; Wei LAI ; Hui-Min YANG ; Hong-Fu XIE ; Xiu-Ping HAN ; Zhi-Qiang XIE ; Xiang NONG ; Zai-Pei GUO ; Dan-Qi DENG ; Tong-Xin SHI ; Jian-Zhong ZHANG
Chinese Medical Journal 2016;129(7):757-762
BACKGROUNDAtopic dermatitis (AD) is an inflammatory skin disease characterized by chronic recurrent dermatitis with profound itching. Most patients have personal and/or family history of atopic diseases. Several criteria have been proposed for the diagnosis of AD. Although the clinical features of childhood AD have been widely studied, there has been less large-scale study on adult/adolescent AD. The aim of this study was to investigate the clinical features of adult/adolescent patients with chronic symmetrical eczema/AD and to propose Chinese diagnostic criteria for adult/adolescent AD.
METHODSA hospital-based study was performed. Forty-two dermatological centers participated in this study. Adult and adolescent patients (12 years and over) with chronic symmetrical eczema or AD were included in this study. Questionnaires were completed by both patients and investigators. The valid questionnaires were analyzed using EpiData 3.1 and SPSS 17.0 software.
RESULTSA total of 2662 valid questionnaires were collected (1369 male and 1293 female). Of all 2662 patients, 2062 (77.5%) patients had the disease after 12 years old, while only 600 (22.5%) patients had the disease before 12 years old, suggesting late-onset eczema/AD is common. Two thousand one hundred and thirty-nine (80.4%) patients had the disease for more than 6 months. One thousand one hundred and forty-four (43.0%) patients had a personal and/or family history of atopic diseases. One thousand five hundred and forty-eight (58.2%) patients had an elevated total serum IgE and/or eosinophilia and/or positive allergen-specific IgE. Based on these clinical and laboratory features, we proposed Chinese criteria for adult/adolescent AD. Of all 2662 patients, 60.3% were satisfied with our criteria, while only 48.2% satisfied with Hanifin Rajka criteria and 32.7% satisfied with Williams criteria, suggesting a good sensitivity of our criteria in adult/adolescent AD patients.
CONCLUSIONLate-onset of eczema or AD is common. The clinical manifestations of AD are heterogeneous. We have proposed Chinese diagnostic criteria for adolescent and adult AD, which are simple and sensitive for diagnosis of adult/adolescent AD.
Adolescent ; Adult ; Dermatitis, Atopic ; diagnosis ; immunology ; Eczema ; diagnosis ; Female ; Humans ; Immunoglobulin E ; blood ; Male ; Middle Aged ; Retrospective Studies ; Surveys and Questionnaires
6.Relationship between Helicobacter pylori infection and histopathological features of nodular gastritis in children.
Juan ZHANG ; Zai-Ling LI ; Jing SUI ; Rong-Li CUI ; Zhu JIN ; Li-Ya ZHOU
Chinese Journal of Contemporary Pediatrics 2014;16(3):225-229
OBJECTIVETo study the relationship between Helicobacter pylori (Hp) infection and histopathological features of nodular gastritis (NG) in children.
METHODSA total of 213 children who had undergone gastroscopy due to upper gastrointestinal symptoms were enrolled and were divided into NG and non-NG groups according to endoscopic appearance. The histopathological features of gastric mucosa were evaluated using the updated Sydney System. The rates of Hp infection, moderate to severe inflammation and lymphoid follicles formation of gastric mucosa were compared between the two groups.
RESULTSThirty-eight (17.8%) of the subjects were diagnosed with NG. The NG group had significantly increased rates of Hp infection (86.8% vs 14.3%; P<0.01), moderate to severe inflammation (81.6% vs 15.4%; P<0.01) and lymphoid follicles formation of gastric mucosa (52.6% vs 10.3%; P<0.01) compared with the non-NG group. NG had a high specificity (96.8%) and a positive predictive value (86.8%) for the diagnosis of Hp infection. NG was observed in 33 (56.9%) of 58 Hp-positive children and in 5 (3.2%) of 155 Hp-negative children (P<0.01). Hp-positive children had higher rates of moderate to severe inflammation (86.2% vs 5.2%, P<0.01) and lymphoid follicles formation of gastric mucosa (84.2% vs 14.9% P<0.01) compared with Hp-negative children. There were significant differences in Hp colonization, degree of inflammation and inflammation activity in gastric tissues between the NG and non-NG groups (P<0.01).
CONCLUSIONSNG is a special sign of Hp infection in children, which mostly shows moderate to severe inflammation of gastric mucosa, and can be used as an endoscopic indicator of Hp infection. Hp eradication therapy should be considered in the treatment of NG.
Adolescent ; Child ; Child, Preschool ; Female ; Gastric Mucosa ; pathology ; Gastritis ; pathology ; Helicobacter Infections ; pathology ; Helicobacter pylori ; Humans ; Male
7.Impact of the reconstruction of the scrotum with third-degree burns on spermatogenic function: experimental study of three different methods.
Xiu-Jun TANG ; Zai-Rong WEI ; Guang-Feng SUN ; Bin ZHANG ; Jing-Jing ZHU ; Cheng-Liang DENG ; Da-Li WANG
National Journal of Andrology 2012;18(4):318-322
OBJECTIVETo explore the effects of different methods of scrotal reconstruction on the apoptosis of spermatogenic cells and expression of the bcl-2 protein in patients with third-degree scrotal burns.
METHODSForty male and 24 female 2-month-old Guizhou mini-pigs were used in this study, the former equally randomized to groups I (normal control), II (natural healing), III (skin grafting) and IV (skin flap grafting). Ten months after the establishment of the model of third-degree burns, 6 male pigs from each group were paired with the female pigs and fed for 3 weeks. Then the female pigs were fed for another 4 months, followed by observation of their reproductivity. At 12 months, the bilateral testes were taken from the male pigs for detection of the apoptosis index of spermatogenic cells by TUNEL and determination of the expression of the bcl-2 protein by immunohistochemistry. The data obtained were subjected to single factor analysis of variance.
RESULTSThe apoptosis indexes of spermatogenic cells were (7.07 +/- 3.5), (40.34 +/- 4.85), (15.14 +/- 1.36) and (39.29 +/- 5.73)% in groups I , II, III and IV, respectively, significantly higher in groups II , III and IV than in I (P<0.05), with statistically significant differences between group III and groups II and IV (P<0.05) but not between II and IV (P>0.05). The expression rates of the bcl-2 protein were (75.07 +/- 3.74), (54.93 +/- 4.03), (66.85 +/- 3.06) and (53.33 +/- 5.22)% in groups I, II, III, and IV, respectively, remarkably higher in I than in the other three (P<0.05), with significant differences between group III and groups II and IV (P<0.05) but not between II and IV (P>0.05). Pregnancies were found in all the female pigs of group I with 10.0 +/- 1.18 newborns and in 4 of group III with 9.92 +/- 1.31 newborns, but in none of groups II and IV, with significant differences between group I and the other three (P<0.05) as well as between group III and groups II and IV (P<0.05), but not between II and IV (P>0.05).
CONCLUSIONAll the three methods of reconstruction for the scrotum with third-degree burns can suppress spermatogenic function, increase the apoptosis of spermatogenic cells and decrease the expression of the bcl-2 protein, among which, skin grafting least affects spermatogenic function.
Animals ; Apoptosis ; Burns ; surgery ; Disease Models, Animal ; Female ; Male ; Reconstructive Surgical Procedures ; methods ; Scrotum ; injuries ; metabolism ; surgery ; Seminiferous Epithelium ; cytology ; metabolism ; Skin Transplantation ; methods ; Spermatogenesis ; Swine ; Swine, Miniature
8.The cryosurgery of central lung cancer by rigid bronchoscopy.
Yan-chu TIAN ; De-ruo LIU ; Yong-qing GUO ; Zhen-rong ZHANG ; Zai-yong WANG ; Jing-yu CHEN ; Bing-sheng GE
Chinese Journal of Surgery 2009;47(24):1876-1878
OBJECTIVETo evaluate the method and effectiveness of rigid-bronchoscopic cryosurgery for advanced central lung cancer.
METHODSForty-eight patients were enrolled in this study from June 2002 to December 2008, including 33 male and 15 female. The average age was 70 years (ranged from 45 to 83 years old). For the 48 patients, 38 cases were patients with advanced central lung cancer who were not suitable for surgery, and the remaining 10 cases were patients with local recurrence in trachea or main bronchus postoperatively. Cryosurgery was performed 120 times for all patients, 2.5 times per patient on average. The trachea or bronchus station, symptom such as dyspnea, hemoptysis, respiratory function and quality of life were observed.
RESULTSThe unblocked ratio of trachea and bronchi was 97%. All patients got satisfied improvement ratio of symptoms, 87.5% for dyspnea, 72.9% for cough, 93.8% for hemoptysis and 62.5% for chest pain. Respiratory function tests showed that both the mean forced expiratory volume in first second and forced vital capacity got an improvement from (1.03+/-0.05) L to (1.85+/-0.13) L and from (1.69+/-0.18) L to (2.96+/-0.14) L respectively (P<0.01). Karnofsky score also got no less than 20 scores improvement. The Follow-up time was 6 to 62 months. The longest survival was 62 months. The median survival time was 20 months. There was no severe perioperative complications and mortality except for 3 cases of moderate exeduation.
CONCLUSIONSCryosurgery is easy to perform with minimal complications. Not only could it provide an effective and rapid control of symptoms caused by central lung cancer, it could also unobstructed bronchus promptly and improve patients' quality of life.
Aged ; Aged, 80 and over ; Bronchoscopy ; Cryosurgery ; methods ; Female ; Humans ; Lung Neoplasms ; surgery ; Male ; Middle Aged ; Treatment Outcome
9.Feasibility of apoptosis-imaging agent 99mTc-HYNIC-annexin V in early assessment of chemotherapeutic effect on tumor models.
Xiao-li LAN ; Yong-xue ZHANG ; Yong HE ; Xun SUN ; Rui AN ; Zai-rong GAO ; Guo-xiang CAO
Chinese Journal of Oncology 2008;30(10):737-740
OBJECTIVETo evaluate if 99mTc-HYNIC-annexin V may be used to detect the early chemotherapeutic effect and to determine the best timing for detecting apoptosis in vivo.
METHODSAnnexin V was labeled with 99mTc using HYNIC as a bifunctional agent. Normal Kunming mice received inoculation of Ehrlich ascites cells into the right upper limb. After the tumor reached 1 cm in diameter, the mice were randomly divided into saline treatment group as control and cyclophosphamide (150 mg/kg injected intraperitoneally) treatment group. 99mTc-HYNIC-annexin V was injected intravenously at 1 h and 24 h after treatment. Region of interest technique (ROI) from the SPECT images taken at different time was used to get the ratio of tumor/limb in each group. TUNEL staining was used to detect apoptotic cells and the rates of positive stained cells were calculated.
RESULTSAfter treatment with saline, only little amount of the radiolabeled tracer could be seen in the tumor and showed weak image of the tumor. But after 24 h of treatment with cyclophosphamide, clear image on the tumor could be seen. 24 h after the treatment of cyclophosphamide, the ratio of tumor/limb was (6.27 +/- 0.24) which was much higher than that at 24 h after treatment with saline (2.36 +/- 0.18) and that at 1 h after cyclophosphamide treatment (4.00 +/- 0.38). At 24 h after cyclophosphamide treatment, TUNEL staining showed a significantly higher rate of apoptotic cells in the mice.
CONCLUSION99mTc-HYNIC-annexin V can be used as an apoptosis-imaging agent to detect and evaluate the early curative effect after chemotherapy. The effective detection of apoptotic response in tumor with 99mTc-HYNIC-annexin V requires a 24 h interval after chemotherapy. SPECT images can be obtained at 60 min after injection of the imaging agent. It suggests that 99mTc-HYNIC-annexin V may become a promising agent for apoptosis-imaging in clinical application.
Animals ; Annexin A5 ; pharmacokinetics ; Antineoplastic Agents, Alkylating ; therapeutic use ; Apoptosis ; drug effects ; Carcinoma, Ehrlich Tumor ; diagnostic imaging ; drug therapy ; pathology ; Cyclophosphamide ; therapeutic use ; Male ; Mice ; Neoplasm Transplantation ; Organotechnetium Compounds ; pharmacokinetics ; Radiopharmaceuticals ; pharmacokinetics ; Random Allocation ; Tissue Distribution ; Tomography, Emission-Computed, Single-Photon
10.Targeted radionuclide therapy for patients with metastatic medullary thyroid carcinoma.
Zai-rong GAO ; Rui AN ; Yong-xue ZHANG ; Hans J BIERSACK
Chinese Journal of Oncology 2006;28(8):621-624
OBJECTIVETo evaluate the effect of 90Y-DOTATOC and 131I-MIBG in treatment of metastatic medullary thyroid carcinoma (MTC).
METHODSTwelve histologically confirmed patients with metastatic MTC were included. All patients underwent both 111In-DTPA-octreotide imaging and 131I/ 123I-meta-iodobenzylguanidine (MIBG) imaging. According to the results of the combined imaging, positive patients were selected to be treated with 90Y-DOTA-D-Phe1-Tyr3-octreotide (90Y-DOTATOC) or 131I-MIBG, respectively. The therapeutic procedures of targeted internal radiation were performed with 3.33 GBq 90Y-DOTATOC at 6-week intervals, or 11.1 GBq 131I-MIBG with a minimum interval of three months.
RESULTSThe imaging procedure was positive in all 12 patients: 111In-DTPA-octreotide imaging in eight patients, 131I/ 123I-MIBG imaging in six patients. According to the results of combined imaging, we identified four patients to be treated with 90Y-DOTATOC, and five patients with 131 I-MIBG. After three to five sessions of treatment, three patients with partial remission and six with stable disease were observed. The effective rate was 3/9 (33.3%) and the overall tumor response rate was 9/9 (100%). No relevant toxicity was observed.
CONCLUSIONThe combined imaging technique can be used to identify patients for effective radionuclide treatment. The treatment with 90Y-DOTATOC or 131I-MIBG is well tolerated and may improve the fate of patients with metastatic MTC.
3-Iodobenzylguanidine ; therapeutic use ; Adult ; Aged ; Antineoplastic Agents ; therapeutic use ; Carcinoma, Medullary ; metabolism ; radiotherapy ; secondary ; Female ; Follow-Up Studies ; Humans ; Indium Radioisotopes ; Male ; Middle Aged ; Octreotide ; analogs & derivatives ; therapeutic use ; Pentetic Acid ; analogs & derivatives ; Positron-Emission Tomography ; Remission Induction ; Thyroid Gland ; diagnostic imaging ; pathology ; radiation effects ; Thyroid Hormones ; metabolism ; Thyroid Neoplasms ; metabolism ; pathology ; radiotherapy ; Treatment Outcome ; Yttrium Radioisotopes ; therapeutic use

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