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Objective:To deliver understanding of the latest research progress on clinical trials and approval of dermatological drugs in China in 2020.Methods:A registration and information disclosure platform for drug clinical studies and a query system for domestic and imported drugs in the National Medical Products Administration of China were searched for registered clinical trials and approved dermatological drugs, respectively. The number and stages of clinical trials, indications and classification of involved products, and listed dermatological drugs in 2020 were summarized and depicted.Results:There were 157 dermatological drug trials registered in China in 2020, accounting for 6.16% of all the 2 548 clinical drug trials, including 127 (80.9%) initiated by Chinese pharmaceutical enterprises and 25 (15.9%) international multicenter trials. Among the 127 drug trials initiated by Chinese pharmaceutical enterprises, bioequivalence trials were mostly common, accounting for 55.9% (71/127) . Compared with global pharmaceutical enterprises, domestic pharmaceutical companies initiated significantly decreased proportions of international multicenter trials (1.9% [3/157] vs. 14.0% [22/157], P < 0.001) , but significantly increased proportions of phaseⅠclinical trials and bioequivalence trials (24.4% [31/127] vs. 10.0% [3/30], 55.9% [71/127] vs. 0, respectively, both P < 0.001) . Totally, 90 kinds of dermatological drug were involved in all the trials, psoriasis, atopic dermatitis and melanoma were the most common indications, and innovative drugs accounted for 53.3% (48/90) ; the proportion of innovative drugs was significantly lower in domestic pharmaceutical companies than in global pharmaceutical companies (43.2% [32/74] vs. 16/16, P < 0.001) . In addition, 28 dermatological drugs developed by 22 pharmaceutical companies were approved in China in 2020, of which 21 drugs were developed by domestic pharmaceutical companies. Conclusion:Clinical drug trials carried out by domestic pharmaceutical companies mostly focus on generic drugs, and it is still necessary for domestic pharmaceutical companies to further improve the innovation ability.
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Objective@#This study aimed to measure the basal energy expenditure (BEE) of Chinese healthy adults and establish an accurate predictive equation for this population.@*Methods@#In total, 470 Chinese healthy adults had their BEE measured using the Cosmed K4b portable metabolic system. Multiple linear regression analysis was applied to develop new optimal equations for predicting BEE. The bias, accuracy rate, concordance correlation coefficient (CCC), and root mean square error (RMSE) were used to evaluate the accuracy of the predictive equations.@*Results@#There was a significant difference in BEE between males and females, with 5,954 kJ/d and 5,089 kJ/d, respectively. People living in rural areas expended significantly higher BEE (5,885 kJ/d) than those in urban areas (5,279 kJ/d). Previous equations developed by Henry, Schofield, Harris-Benedict (H-B), and Liu overestimated the BEE of Chinese healthy adults. The new equations derived from the present study displayed the smallest average bias and RMSE from the measured basal energy expenditure (mBEE). The CCC of the new equations was higher than other predictive equations, but it was lower than 0.8. There was no significant difference in the accuracy rate among all predictive equations.@*Conclusions@#Sex and regional differences in BEE were observed in Chinese healthy adults. Neither the widely used previous predictive equations nor the one derived in the present study were accurate enough for estimating the BEE of Chinese healthy adults. Further study is required to develop more accurate equations for predicting the BEE of Chinese healthy adults aged between 20-45 years.
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Adult , Female , Humans , Male , Young Adult , Basal Metabolism , Calorimetry , Methods , ChinaABSTRACT
Objective To investigate the clinical effect of platelet-rich plasma combined with flap transplantation in treatment of refractory wounds.Methods Sixty patients of refractory wounds who were admitted into our hospital from April 2016 to February 2017 were enrolled in the observation group,and another sixty patients with refractory wounds who had been discharged from the hospital before April 2016 were trea-ted as the control group.All the patients accepted debridement and disinfection.Then the observation group were managed with PRP and flap transplantation,while the control group were treated with flap transplantation directly without PRP.Observed the frequency of dressing changes, rate of wound infection,healing time and recovering rate of the two groups.Measurement data were analyzed with t inspection and analysis of va-riance,and count data were compared by χ2test,and repeat data was analyzed with repeat data variance analysis.Results After one weeks' treatment,the number of wet gauze layers were(20.5 ±1.6)in the observation group,which was less than(23.3 ±6.1)in the control group with statistically significant difference(t=-3.439,P=0.001).The healing time of the observation group was(25 ±2)d,which was shorter than(43 ±5)d in the control group(t=-25.891,P=0.000).The frequency of dressing changes was(7.1 ±1.0)times in observation group, which was less than(9.3 ±1.4)times in the control group(t=-9.905,P=0.000).There were 5 cases of inflammation reaction in the obser-vation group,which was less than 18 cases in the control group(χ2=9.090,P=0.003).The cases of the skin flap survival in the observation group was 55,which was more than 41 cases in the control group,and the difference of the two groups was statistically significant(χ2=10.208, P=0.001).The average healing rate of the two groups both increased at different time points.And the average healing rate of the observation group was higher than that in the control group at different time points,and the difference was statistically significant(P<0.05).Conclusion Platelet-rich plasma can remarkably shorten the healing time,improve healing rate,reduce frequency of dressing change and promote wound healing for refractory wound.
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Objective To investigate the effect of platelet-rich plasma (PRP) combined with negative pressure wound therapy (NPWT) on orthopedic refractory wound.Methods A total of 84 patients with chronic refractory wound were selected from January 2014 to December 2016 in Department of Osteology,Jizhong Energy Xingtai Mining Group General Hospital.The patients were divided into control group and observation group according to the admission time,42 cases in each group.The patients in the control group were treated with NPWT,and the patients in the observation group were treated with PRP and NPWT.The power of hydrogen (pH) of wound exudate,wound temperature and wound pressure ulcer scale for healing (PUSH) were compared between the two groups before and after treatment.The bacterial cuhure result was compared between the two groups after two weeks of treatment.The change of serum erythropoietin (EPO) level were observed before and four weeks after treatment,and the suitable skingrafting time,wound healing time and cure rate were observed in the two groups.Results After two weeks of treatment,the positive rate of bacterial culture in the observation group was significantly lower than that in the control group (x2 =4.850,P ＜ 0.05).The pH value of wound exudate and the wound PUSH score in the observation group were significantly lower than those in the control group(P ＜0.05),but the wound temperature in the observation group was higher than that in the control group after two weeks of treatment (P ＜ 0.05).The results of intra group comparison showed that the serum EPO level showed an upward trend within four weeks of treatment,and the difference was statistically significant at different time points in the two groups (F =7.356,8.264;P ＜ 0.05).The level of serum EPO in the observation group was significantly higher than that in the control group at the treatment of 1,2,3 and 4 weeks (P ＜ 0.05).Compared with the control group,the suitable skingrafting time was early (P ＜ 0.05),the wound healing was fast (P ＜ 0.05),and the cure rate was high in the observation group (x2 =4.720,P ＜ 0.05).Conclusion The combination of PRP and NPWT has good antibacterial effect,and can promote the EPO level and wound healing.
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<p><b>OBJECTIVE</b>To assess the efficacy of family intervention in management of schizophrenic patients in China.</p><p><b>METHODS</b>Chinese databases CNKI, VIP, WANFANG, CBM and English databases OVID Medline, Science Direct, Web of science, EBSCO were searched systematically from inception to January 2015. Quantitative and empirical studies on the outcomes of social disability screening scale (SDSS), brief psychiatric rating scale (BPRS) and positive and negative syndrome scale (PANSS) of family intervention for Chinese schizophrenic patients were selected. The effect size was derived from the standardized mean difference (SMD), and meta-analysis was conducted to compare effects of family intervention by intervention types, time of intervention, durations of illness and severity of schizophrenia.</p><p><b>RESULTS</b>The study included 57 articles that met inclusion criteria. SDSS and PANSS scores revealed that the effect was positively associated with the length of intervention time (P<0.0001, P=0.0025); the effect of single family intervention was better than that of combined single and multiple family intervention (P<0.0001, P=0.0131); the effect was better for patients with severe conditions than those with less severe conditions (P<0.0001, P=0.0280). The SDSS showed that the effect was better for patients with shorter disease duration (P<0.0001).</p><p><b>CONCLUSION</b>The results suggest that the long single family intervention would benefit to schizophrenic patients, particularly for severe patients with short disease duration.</p>
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Humans , Asian People , Brief Psychiatric Rating Scale , China , Family , Psychiatric Status Rating Scales , Schizophrenia , TherapeuticsABSTRACT
<p><b>OBJECTIVE</b>To study the detection method of coccoid helicobacter pylori (HP) and to investigate the significance of pure coccoid HP infection of gastric mucous membrane.</p><p><b>METHODS</b>A total of 171 gastric biopsy specimens were reviewed by HE stain, and the presence, density and tissue distribution of HP were investigated by sliver stain and immunohistochemistry(S-P method).</p><p><b>RESULTS</b>The rates of mucosal erosion and active inflammation with the presence of pure coccoid HP infection were 36.0% (9/25) and 44.0% (11/25), respectively, both higher than those without HP infection (13.5%, 10/74; 24.3%, 18/74), while lower than those infected with spiral HP (72.1%, 49/68; 79.4%, 54/68). The quantity of interstitial lymphocyte and inflammation severity were also higher than those without HP infection, while lower than those with spiral HP infection.</p><p><b>CONCLUSIONS</b>Pure coccoid HP causes human gastritis, similar to that of spiral HP infection but at a lesser degree. Further studies are important to confirm its clinical significance.</p>
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Adult , Aged , Female , Humans , Male , Middle Aged , Gastritis , Microbiology , Pathology , Gastritis, Atrophic , Microbiology , Pathology , Helicobacter Infections , Microbiology , Helicobacter pylori , Classification , Lymphocyte CountABSTRACT
<p><b>OBJECTIVE</b>To investigate the anti-cancer efficacy and mechanism of sorafenib and 5-fluorouracil (5-FU) therapy in vitro using the HCC cell line MHCCLM3.</p><p><b>METHODS</b>The effects of sorafenib and 5-FU, alone or in combination, on the proliferation of MHCCLM3 cells were evaluated by cell viability assays. Combined-effects analyses were conducted according to the median-effect principle established by Chou and Talalay. Effects on cell cycle distributions were tested by flow cytometry and expression of proteins related to the RAF/MEK/ERK and STAT3 signaling pathways and cyclinD1 were tested by western blotting.</p><p><b>RESULTS</b>Sorafenib and 5-FU alone or in combination displayed significant efficacy in inhibiting proliferation of the MHCCLM3 cells, with the following inhibition rates: sorafenib: 46.16% +/- 2.52%, 5-FU: 28.67% +/- 6.16%, and sorafenib + 5-FU: 22.59% +/- 6.89%. The sorafenib + 5-FU combination did not provide better results than treatment with either drug alone. The combination index values of the sorafenib and 5-FU treatments were mainly greater than 1, indicating that the two agents induced antagonistic, instead of synergistic, effects on the MHCCLM3 cells. In addition, the MHCCLM3 cells were less sensitive to 5-FU when administrated in combination with sorafenib, as evidenced by the half inhibitory concentration (IC50) significantly increasing from (102.86 +/- 27.84) mg/L to (178.61 +/- 20.73) mg/L (P = 0.003). Sorafenib alone induced G1 phase arrest (increasing from 44.73% +/- 1.63% to 65.80% +/- 0.56%; P less than 0.001) and significantly decreased the proportion of cells in S phase (decreasing from 46.63% +/- 0.65% to 22.83% +/- 1.75%; P less than 0.01), as well as down-regulated cyclinD1 expression (0.57 +/- 0.03-fold change vs. untreated control group; P less than 0.01). 5-FU alone up-regulated cyclinD1 expression (1.45 +/- 0.12-fold change vs. untreated control group; P less than 0.01). Moreover, sorafenib alone significantly inhibited the RAF/MEK/ERK and STAT3 pathways, with the fold-changes of p-C-RAF, p-ERK1/2 and p-STAT3 being 0.56 +/- 0.05, 0.54 +/- 0.02 and 0.36 +/- 0.02, respectively (all P less than 0.01); 5-FU alone produced no significant effects on these pathways.</p><p><b>CONCLUSION</b>Administered alone, both sorafenib and 5-FU exert anti-tumoral activity on in vitro cultured HCC cells. The sorafenib + 5-FU combination treatment produces antagonistic, rather than synergistic, effects. Sorafenib-inhibited RAF/MEK/ERK and STAT3 signaling and cyclinD1 expression may have induced the observed G1phase arrest and S phase reduction, thereby reducing the cells' sensitivity to 5-FU.</p>
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Humans , Cell Line, Tumor , Cell Proliferation , Cyclin D1 , Metabolism , Drug Antagonism , Fluorouracil , Pharmacology , Niacinamide , Pharmacology , Phenylurea Compounds , Pharmacology , STAT3 Transcription Factor , Metabolism , Signal TransductionABSTRACT
<p><b>OBJECTIVE</b>To discuss the influence of reducing buccolingual width of artificial crown on distribution of biting force and masticatory efficiency in unilateral distal-extension implant denture and provide valuable information for the design of buccolingual width. To find a design that the biting force of implant prothesis was less evident than those on the contralateral natural teeth without compromising masticatory efficiency.</p><p><b>METHODS</b>T-Scan II occlusal analyzer and 722 grating spectrophotometer were used to analyze the distribution of biting force and masticatory efficiency in unilateral distal-extension implant denture. Heat-cured resin crowns with three different buccolingual width (group A: standard buccolingual width; group B: the buccolingual width was reduced by 1/4; group C: the buccolingual width was reduced by 1/3) were designed as follow, one was contoured with standard buccolingual width, the other two were made with reducd buccolingual width by 1/4 and 1/3.</p><p><b>RESULTS</b>The ratio of biting force (ROF) of group C was 16.25%, which was significantly lower than group A (27.38%) and B (22.60%) (P < 0.0083). The X axis displacement of center of occlusal force (COF) of group C was 2.0 mm, which was significantly difference with group A (1.5 mm, P = 0.004). The masticatory efficiency absorbance A value (MEA) of group C was 0.217, which was significantly lower than group A (0.345, P = 0.005) and B (0.289, P = 0.004).</p><p><b>CONCLUSIONS</b>According to the study, the buccolingual width of the crown reduced by 1/4 was a more ideal design for unilateral distal-extension implant denture.</p>
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Adult , Aged , Female , Humans , Male , Middle Aged , Bite Force , Crowns , Dental Occlusion , Dental Prosthesis Design , Dental Prosthesis, Implant-Supported , Mastication , SpectrophotometryABSTRACT
<p><b>OBJECTIVE</b>To compare the 2-DE profiles for serum proteins of different pathological stages during hepatocarcinogenesis.</p><p><b>METHODS</b>Sera from hepatocellular carcinoma patients, cirrhosis patients, chronic hepatitis patients and healthy controls were collected. After sonication, albumin and immunoglobulin (IgG) depletion, and desalination, sera were subjected to 2-DE, the differential protein spots were identified by MALDI-TOF-MS. Western blot was used to validate these differentially expressed proteins.</p><p><b>RESULTS</b>2-DE sera protein profiles were obtained from the patient suffering from HCC, liver cirrhosis, chronic hepatitis, healthy controls in each group. From optimized 2-DE gel images of the above groups, 96 protein spots with more than 2-fold difference in intensity between the two groups were selected by image master 6.0 software, differential proteins including haptoglobin, SAA1 and SP40 were identified by MALDI-TOF-MS/MS. 7 different spots within more than 30 protein spots belonged to the same haptoglobin family. The differential expression of haptoglobin was confirmed by western blot.</p><p><b>CONCLUSIONS</b>Four protein expression patterns have been identified during the pathological stages of hepatocarcinogenesis. Haptoglobin is significantly increased from liver cirrhosis to HCC. It implies that haptoglobin might be a potential biomarker in the early diagnosis of liver cancer.</p>