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OBJECTIVE To establish a method for concentration determination of caffeine and its three metabolites， theophylline， paraxanthine and theobromine in urine， and apply it in clinical practice. METHODS Using caffeine-13C3-d3 as internal standard （IS）， and the urine samples were protein precipitated with acetonitrile； HPLC-MS/MS method was adopted to determine the concentrations of caffeine and its three metabolites. The determination was performed on Waters ACQUITY UPLC® BEH HILIC column with mobile phase consisting of 60 mmol/L ammonium acetate （A）-acetonitrile （B） （gradient elution） at the flow rate of 0.5 mL/min. The column temperature was set at 38 ℃ ， and the sample size was 2 μL. The electrospray ionization detection was operated in a positive mode by multiple reaction monitoring. The detection ions for quantitative analysis were m/z 195.1→110.0 for caffeine， m/z 181.1→124.0 for theophylline， m/z 181.1→124.0 for paraxanthine， m/z 181.1→138.0 for theobromine， and m/z 198.1→ 140.1 for IS. The above method was used to determine the concentrations of caffeine and its three metabolites in the urine of 19 infants with apnea of prematurity （AOP）. RESULTS The linear ranges of mass concentration of caffeine， theophylline， paraxanthin and theobromine were 0.200-200， 0.050-50.0，0.050 0-50.0， and 0.100-100 μg/mL， respectively. The lower limits of quantification were 0.200， 0.050， 0.050 and 0.100 μg/mL （r＞0.990）， respectively. RSDs of intra-day and intra- day precision were not above 10.37%， and matrix factors were 85.68%-109.90%； extraction recoveries were 93.53%-109.40% （RSD≤15%）， and RSDs of stability tests were all lower than 15%. The concentrations of caffeine and its three metabolites in the urine of 19 cases were （27.346±7.951）， （0.351±0.223）， （0.428±0.395） and （0.472±0.374） μg/mL， respectively. CONCLUSIONS The established HPLC-MS/MS method is simple， sensitive and can be used for the determination of caffeine and its three metabolites in urine samples of AOP.
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Objective:To evaluate the effect of femoral stable interlocking intramedullary nail (FSIIN) and proximal femoral nail anti-rotation (PFNA) in the treatment of anterograde intertrochanteric fractures.Methods:From June 2015 to December 2020, 68 cases with surgically treated of femoral intertrochanteric fractures were included. Among them, there were 37 cases (17 males and 20 females) in proximal femoral nail antirotation (PFNA) group, and the age ranged from 48 to 78 years (62.9±7.1 years); 18 cases were on the left and 19 cases on the right; AO/OTA classification: 16 cases of A1 type and 21 cases of A2 type. And there were 31 cases (18 males and 13 females) in FSIIN group without distal locking, the age ranged from 47 to 84 years (62.4±8.6 years); 15 cases were on the left and 16 cases on the right; AO/OTA classification: 11 cases of A1 type and 20 cases of A2 type. Fracture fixation time, incision length and number, intraoperative blood loss, fracture healing time, visual analogue scale (VAS) and Harris scores at the last follow-up were compared between the two fixation methods.Results:Both groups were followed up, and the follow-up time was 15.3±3.9 months in the FSIIN group and 15.7±3.9 months in the PFNA group, and the difference was not statistically significant ( t=0.42, P=0.675). In FSIIN group, the fracture fixation time was 26.6±11.5 min, the total incision length was 7.6±1.8 cm, the intraoperative blood loss was 107.6±42.8 ml and the fracture healing time was 10.1±1.3 weeks. In PFNA group, the fracture fixation time was 40.3±10.8 min, the total incision length was 12.2±1.8 cm, the intraoperative blood loss was 209.4±52.0 ml and the fracture healing time was 16.3±1.6 weeks. In FSIIN group, the fracture fixation time ( t=3.46, P<0.001), total incision length ( t=2.39, P=0.020), intraoperative blood loss ( t=3.16, P<0.001), fracture healing time ( t=2.80, P<0.001) were all less than those in PFNA group, and the difference was statistically significant. The VAS score of FSIIN group was 1.4±0.5 points, and that of PFNA group was 1.6±0.6 points, and the difference was not statistically significant ( t=0.68, P=0.503). The Harris score was 84.5±2.2 in FSIIN group and 83.3±2.5 in PFNA group, and the difference was not statistically significant ( t=0.63, P=0.530). At the last follow-up, 29 patients in the FSIIN group were very satisfied with the operation, and 2 patients were satisfied with the operation, with a satisfaction rate of 100%. In PFNA group, 30 patients were very satisfied with the operation, 7 patients were satisfied with the operation, and the satisfaction rate was 100%. Conclusion:Compared with PFNA, micro-invasive and micro-stress shielding methodes of FSIIN in the fixation of anterograde intertrochanteric fractures is more minimally invasive, simple, time-saving, less bleeding, less risk, less pain, minimal stress shilding and enhanced recovery after surgery. The effect of treatment is similar in FSIIN and PFNA group.
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OBJECTIVE To establish a method for the determination of plasma protein binding rate of imatinib and its metabolite（N-desmethyl imatinib ）and apply it to patients with gastrointestinal stromal tumor （GIST）.METHODS Using imatinib - d8 as the internal standard ，after being deproteinized methanol ，the sample was determined by equilibrium dialysis combined with liquid chromatography -tandem mass spectrometry . The free concentrations of imatinib and its metabolites in plasma of GIST patients were detected by the same method . RESULTS The protein binding rates of imatinib with albumin ，α1-acid glycoprotein and globulin at 120 ng/mL and 4 000 ng/mL were （92.5±1.0）% and（91.7±0.4）%，（56.6±2.0）% and（62.6±2.6）%，（56.3±3.1）% and （68.0±8.6）% ，respectively. The protein binding rates of N-desmethyl imatinib with albumin ，α1-acid glycoprotein and globulin at 60 ng/mL and 2 000 ng/mL were （90.6±3.5）% and（91.3±1.5）%，（54.1±5.1）% and（63.7±1.3）%，（56.2±7.6）% and（67.5±7.3）%，respectively. Compared with the low concentration group of imatinib （120 ng/mL）and its metabolite （60 ng/mL），the plasma protein binding rate of high concentration of imatinib （4 000 ng/mL）and its metabolite （2 000 ng/mL）with α1-acid glycoprotein and globulin was significantly increased （P＜ Δ基金项目 国家自然科学基金资助项目（No.81503160）；江苏省 0.05），but there was no signifi -cant difference with albumin 卫生健康发展研究中心 2021年度开放课题（No.JSHD2021004）；江苏 （P＞0.05）. In blank plasma ，the protein binding rates of imatinib（4 000 ng/mL）at high concentration and its metabolites（2 000 ng/mL）were significantly lower than those of low （120， 60 ng/mL） and medium （750， 375 ng/mL）concentration （P＜0.01）. Average protein binding rates of imatinib and its metabolite in plasma of GIST patients were （99.0±0.3）% and（99.2±0.3）%，respectively；the correlation coefficients between the concentrations of imatinib and its metabolites and the protein binding rates were －0.298 5 and －3.332 3，respectively（all P＜0.05）. CONCLUSIONS The method for determining the plasma protein binding rates of imatinib and its metabolites is successfully established . The plasma protein binding rates of imatinib and its metabolites in patients with GIST are negatively correlated with drug concentration .
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Objective:To compare the efficacy of double thread elastic locking intramedullary nail (ELIN) and threaded elastic intramedullary nail (TEIN) in the treatment of mid-shaft clavicular fracture.Methods:From August 2017 to September 2020, 33 patients with mid-shaft clavicular fractures were treated with ELIN (double threaded nail group), including 14 males and 19 females, age 52.09±16.32 years old; Robinson classification: 20 cases of type 2A2, 6 cases of type 2B1, and 7 cases of type 2B2. Thirty-two patients were selected as the control group with TEIN fixation (single threaded nail group) during the same period, including 13 males and 19 females; age 43.25±15.03 years old; Robinson classification: 19 cases of type 2A2 and 5 cases of type 2B1, 8 cases of 2B2 type. The operation time, intraoperative incision length, fracture healing time, internal fixation removal time, Constant-Murley shoulder joint score, disabilities of the arm, shoulder, and hand (DASH) score, fracture reduction and postoperative complications were compared between the two groups.Results:The patients in both groups were followed up after operation, the double-threaded screw group was followed up for 16-48 weeks (average, 23.7 weeks), and the single threaded nail group was followed up for 15-51 weeks (average, 22.9 weeks). The operation time of the double threaded nail group and the single threaded nail group were 19.45±6.74 min and 19.59±4.98 min, and the length of the incision was 1.70±0.79 cm and 1.73±0.84 cm. The fracture healing time were 12.12±1.29 weeks and 13.88±1.84 weeks. The internal fixation removal time was 13.09±1.31 weeks and 15.69±1.94 weeks. The Constant-Murley shoulder score was 93.18±3.78 points and 90.09±4.03 points, and the DASH scores were 1.49± 0.49 points and 3.85±1.13 points; There was no significant difference in operation time and incision length between the two groups ( t=0.01, 0.19; P>0.05), while fracture healing ( t=3.70, P<0.001), internal fixation removal time ( t=6.34, P<0.001), Constant-Murley shoulder score ( t=3.19, P<0.001), DASH score ( t=10.95, P<0.001) differences were statistically significant. The length of the clavicle on the healthy side was 16.38±1.09 cm in the double threaded nail group, and the length of the clavicle on the affected side after internal fixation removal was 16.33±1.12 cm. There was no obvious shortening deformity on the affected side, and there was no significant difference in the length of the clavicle between the two sides ( t=1.57, P=0.127). The clavicle lengths of the healthy side and the affected side after internal fixation removal in the single threaded nail group were 16.55±1.12 cm and 15.12±1.18 cm, and the difference was statistically significant ( t=8.02, P<0.001). The postoperative shortening values of the double-threaded screw group and the single-threaded screw group were 9.47±2.12 mm and 17.41±2.42 mm, and the difference was statistically significant ( t=14.07, P<0.001). Postoperatively, 5 cases of bursitis and 2 cases of skin irritation occurred in the double threaded nail group; While 6 cases of bursitis, 3 cases of skin irritation, 4 cases of shortening malunion, and 1 case of broken nail occurred in the single threaded nail group (fracture delayed union after replacement of internal fixation); the other patients did not experience screw retraction, wound infection, delayed fracture union or nonunion, neurovascular injury, and achieved osseous union. Conclusion:Both elastic intramedullary nails are effective surgical methods for the treatment of middle clavicle fractures, and the operation time is short and minimally invasive. However, compared with the TEIN, the fracture healing time of the double-threaded ELIN is shorter, the internal fixation removal time is earlier, the shoulder joint and upper limb function is better, and the shortening deformity is less likely to occur.
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Objective:To investigate the efficacy of elastic locking intramedullary nail (ELIN) in the treatment of mid clavicle fractures.Methods:From January 2014 to December 2020, the data of 61 patients with mid-clavicle fracture treated with ELIN were retrospectively analyzed. Among them, 38 patients were from the Fourth Central Hospital Affiliated to Nankai University and 23 were from the Second People's Hospital of Hulunbuir City. There were 36 males and 25 females, aged from 19 to 85 years (average, 54.5 years), 39 cases on the left side and 22 cases on the right side. According to Robinson's classification, there were 20 cases of type 2A2, 29 cases of type 2B1 and 12 cases of type 2B2. There was no nerve or vascular injury before operation. The postoperative evaluation measures included incision length, operation time, blood loss, fracture reduction, fracture healing time, ELIN removal time, shoulder Constant-Murley score, disabilities of the arm, shoulder, and hand (DASH) score, and related complications.Results:All patients were followed up for 13-51 weeks (average, 21.8 weeks). There were 34 cases of closed reduction and 27 cases of mini-open reduction, and the length of incision was 2.04±1.08 cm. The closed reduction operation time was 20.32±7.11 min, and the mini-open reduction operation time was 20.30±5.37 min. The intraoperative blood loss was 6.47±2.31 ml in the closed reduction group and 27.41±11.55 ml in the mini-open reduction group. Compared with the healthy side, the clavicle length of the affected side was shortened by 7.74%±3.51% of pre-operation and 0.71%±1.00% of post-operation, there was statistically significant difference in the length of clavicle shortening of pre- and post-operation ( t=3.84, P<0.001). The fracture healing time was 10.48±2.39 weeks. The removal time of ELIN was 13.39±2.69 weeks. At the last follow-up, the Constant-Murley score of shoulder joint was 98.87±1.74. The average of DASH score was 1.13 (range, 0-10). There were 18 cases of skin irritation after operation, of which 13 cases formed pressure sores at the tail end 3-6 weeks after the operation, and were treated with dressing change and keeping clean; 4 cases of skin irritation at the tail end formed bursitis, which disappeared after removal of the internal fixation. In 1 case, the tip of ELIN penetrated the anterior cortex from the proximal clavicle and stimulated the skin. Radiograms showed continuous callus at 4 weeks after operation, and there was no local tenderness on the physical examination, which reached the clinical healing standard, and the symptoms were relieved after the nail was removed. No serious complications such as neural and vascular injury, nail breaking, delayed healing, infection, numbness or discomfort in the subclavian area occurred in all cases, and all patients were satisfied or basically satisfied with the aesthetic of the skin appearance. Conclusion:Minimally invasive and microstress shielding fixation of mid-clavicle fracture with ELIN have the advantages of simple operation, minimally invasive, beautiful appearance, anti-short-shrinkage and rapid fracture healing etc. It is an effective surgical method for the treatment of mid-clavicle fractures.
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This article combines the joint review of combination products in recent years, sorts out the links and common problems in the joint review process, introduces the work carried out to optimize the joint review process of combination products, and puts forward relevant suggestions for improvement, aim to improving the work of joint review and providing reference for relevant product declaration.
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Based on the research situation of the regulatory scientific research project of combination products technical evaluation in recent years, this study introduces the relevant research on how to optimize the supervision of combination products, summarizes the research progress and research results of the project, in order to promote the development of related industries.
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Anthocyanins are widely distributed water-soluble pigments that not only give the fruit colorful appearances, but also are important sources of natural edible pigments. In recent years, the interest on anthocyanins of solanaceous vegetables is increasing. This paper summarized the structure of anthocyanins and its biosynthetic pathway, the structural genes and regulatory genes involved in the biosynthesis of anthocyanins in solanaceous vegetables, as well as the environmental factors affecting the biosynthesis. This review may help clarify the synthesis and regulation mechanism of anthocyanins in solanaceous vegetables and make better use of anthocyanins for quality breeding of fruit colors.
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Anthocyanins/metabolism , Fruit/genetics , Gene Expression Regulation, Plant , Plant Breeding , Vegetables/geneticsABSTRACT
Objective:To evaluate the efficacy of femoral stable interlocking intramedullary nail (FSIIN) in the treatment of anterograde intertrochanteric fractures.Methods:FSIIN was invented to treat femoral intertrochanteric fractures. From January 2005 to February 2019, 36 cases of anterograde intertrochanteric fractures were retrospectively analyzed. Among them, 29 cases were from the Fourth Central Hospital Affiliated to Nankai University and 7 cases were from the Second People's Hospital of Hulunbuir City. 15 cases (6 males and 9 females) were treated with FSIIN distal locking fixation(distal locking group). The average age was 68.53±10.82 years (range, 48-80 years old); According to AO/OTA classification, there were 7 cases of 31-A1 type and 8 cases of 31-A2 type. 21 cases (12 males and 9 females) were treated by FSIIN distal fixation non-locking (distal unlocking group). The average age was 67.86±11.70 years (range, 46-85 years). there were 9 cases of 31-A1 type and 12 cases of 31-A2 type. The operation time, intraoperative blood loss, fracture healing time, visual analogue scale (VAS) and Harris scores at the last follow-up were compared between the two fixation methods.Results:Both groups were followed up for 10-24 months, and the mean time in the lock group was 16.73±3.41 months. The mean time in the non-locking group was 16.10±3.36 months. In the locked group, the operation time was 43.47±2.39 min, the intraoperative blood loss was 149.33±44.96 ml, and the fracture healing time was 14.57±1.50 weeks. In the non-locking group, the operation time was 33.29±5.30 min, intraoperative blood loss was 97.62±38.46 ml, and fracture healing time was 10.16±1.20 weeks. The operation time of the non-locking group was shorter than the locking group ( t=6.930, P<0.001), intraoperative blood loss was decreased than the locking group ( t=3.708, P<0.001), fracture healing time was reduced than the locking group ( t=9.818, P<0.001). At the last follow-up, the VAS score of the locked group was 1.60±0.63 and the non-locked group was 1.81±1.08, which showed no significant difference( t=0.673, P=0.506). There was no significant difference in Harris score between the locked group 84.33±2.53 and the non-locked group 84.90±2.19( t=0.724, P=0.474). Eight weeks after the operation, the proximal inferior locking nail was withdrawn 1 cm in 1 case. The fracture healed without treatment. Conclusion:Both FSIIN distal locking and non-locking are effective methods for the treatment of femoral intertrochanteric fractures. Compared with the distal locking group, the non-locking group had more simpler operation, more minimally invasive, and enhanced recovery after surgery.
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Objective:To compare the clinical characteristics of critically ill pregnant women admitted to the intensive care unit (ICU) with different admission methods, in order to make more effective and rational use of ICU resources.Methods:A retrospective study was conducted. The clinical data of critically ill pregnant women admitted to ICU of Peking University Third Hospital from January 2006 to July 2019 were analyzed. According to the admission mode to ICU, the pregnant women were divided into emergency admission group (transferred to ICU on the same day or the next day due to critical illness) and planned admission group (transferred to ICU 2 days after admitting in obstetric ward). The clinical characteristics of ICU critical pregnant women, such as the incidence, causes of admission, severity of the disease, main treatment measures, mortality, and medical expenses were collected, and a comparative analysis between the two groups was performed.Results:During the nearly 14 years, a total of 576 critical pregnant women in ICU were enrolled, accounting for 0.8% (576/71 790) of the total number of obstetric inpatients and 4.6% (576/12 412) of the total number of ICU inpatients. Seven maternal deaths accounted for 1.2% of all critically pregnant women transferred to ICU, and the overall mortality of pregnant women was 10/100 thousand. Of the 576 critically pregnant women, there were 327 patients (56.8%) in the emergency admission group and 249 patients (43.2%) in the planned admission group. Compared with the planned admission group, the proportion of elective cesarean section in the emergency admission group was significantly lower (17.7% vs. 94.0%, P < 0.01), and the proportion of emergency cesarean section was significantly higher (65.1% vs. 2.4%, P < 0.01), the acute physiology and chronic health evaluation (APACHE Ⅱ, APACHE Ⅲ) scores, simplified acute physiology score Ⅱ (SAPS Ⅱ) and Marshall score were significantly higher [APACHE Ⅱ score: 6.0 (4.0, 9.8) vs. 4.0 (3.0, 7.0), APACHE Ⅲ score: 14.0 (11.0, 20.3) vs. 12.0 (9.0, 16.0), SAPS Ⅱ score: 8 (0, 12) vs. 3 (0, 8), Marshall score: 2 (1, 4) vs. 1 (1, 3), all P < 0.01]. The length of ICU stay in the emergency admission group was significantly longer than that in the planned admission group [days: 2 (1, 5) vs. 2 (1, 3), P < 0.01], and the total length of hospital stay was significantly shorter [days: 9 (7, 13) vs. 13 (10, 18), P < 0.01]. Both in the emergency admission group and the planned admission group, obstetric factors were the main reason for admission, 60.9% (199/327) and 70.3% (175/249), respectively. The proportion of postpartum hemorrhage was the highest [35.2% (115/327) and 57.0% (142/249)], followed by preeclampsia/eclampsia [7.0% (23/327) and 7.6% (19/249)]. Only 7 of the 19 critically pregnant women with puerperal infection were planned admission. All 21 patients with acute fatty liver of pregnancy (AFLP) during pregnancy were emergency admission. Among the emergency and planned admission patients, 73 patients (22.3%) and 42 patients (16.9%) required mechanical ventilation (duration of mechanical ventilation > 24 hours), 99 patients (30.3%) and 35 patients (14.1%) needed vasoactive agents, 67 patients (20.5%) and 20 patients (8.0%) received hemodynamic monitoring, and 123 patients (37.6%) and 154 patients (61.8%) were given anticoagulation therapy, respectively. In terms of severity score of critical pregnant women, there were significant differences in APACHE Ⅱ, APACHE Ⅲ, SAPS Ⅱ and Marshall scores of pregnant women with different diseases. Among them, the APACHE Ⅲ, SAPS Ⅱ and Marshall scores of AFLP were the highest [21.0 (15.0, 32.5), 12.0 (6.0, 16.5) and 6.0 (3.5, 8.0), respectively]. The APACHE Ⅱ and APACHE Ⅲ scores of postpartum hemorrhage were the lowest [4.0 (3.0, 7.0), 12.0 (10.0, 16.0)]. The SAPS Ⅱ score of pneumonia was the lowest [2.0 (0, 14.0)]. The Marshall score for puerperal infection was the lowest [1.0 (0, 3.0)]. In terms of the total medical expenses, the cost in the emergency admission group was significantly lower than that in the planned admission group [10 thousand Yuan: 3.1 (2.0, 4.7) vs. 4.1 (2.9, 5.8), P < 0.05]. Conclusions:Compared with the critically ill pregnant women who planned to be admitted to ICU, the patients emergency admitted to ICU were more complicated and urgent, and the severity of the condition was scored higher. At present, the severity scoring system commonly used in ICU can only partly evaluate the severity of critically ill pregnant women, therefore, it is necessary to design the specific severity scoring system for critically ill pregnant women to effectively and rationally use the precious ICU resources.
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The safety of leachable substances in medical devices is an important guarantee of the safety of medical devices, and is also the focus of attention in the review of medical devices in recent years. Combined with the difficult issues in the study of leachable substances, the challenges in the study of leachable substances in medical devices were briefly described, and the counter-measures were briefly described for reference by relevant institutions and researchers.
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Based on observing the cytological characteristics of the flower buds of the functional male sterile line (S13) and the fertile line (F142) in eggplant, it was found that the disintegration period of the annular cell clusters in S13 anther was 2 days later than that of F142, and the cells of stomiun tissue and tapetum in F142 disintegrated on the blooming day, while it did not happen in S13. The comparative transcriptomic analysis showed that there were 1 436 differential expression genes (DEGs) (651 up-regulated and 785 down-regulated) in anthers of F142 and S13 at 8, 5 days before flowering and flowering day. The significance analysis of GO enrichment indicated that there were more unigene clusters involved in single cell biological process, metabolism process and cell process, and more catalytic activity and binding function were involved in molecular functions. Through KEGG annotation we found that the common DEGs were mainly enriched in the biosynthesis of secondary metabolites, metabolic pathway, protein processing in endoplasmic reticulum, biosynthesis of amino acids, carbon metabolism and plant hormone signal transduction. The fifteen genes co-expression modules were identified from 16 465 selected genes by weighted gene co-expression network analysis (WGCNA), three of which (Plum2, Royalblue and Bisque4 modules) were highly related to S13 during flower development. KEGG enrichment showed that the specific modules could be enriched in phenylpropanoid biosynthesis, photosynthesis, porphyrin and chlorophyll metabolism, α-linolenic acid metabolism, polysaccharide biosynthesis and metabolism, fatty acid degradation and the mutual transformation of pentose and glucuronic acid. These genes might play important roles during flower development of S13. It provided a reference for further study on the mechanism of anther dehiscence in eggplant.
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Humans , Male , Flowers/genetics , Gene Expression Profiling , Gene Expression Regulation, Plant , Infertility, Male , Metabolic Networks and Pathways/genetics , Solanum melongena/genetics , Transcriptome/geneticsABSTRACT
This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.
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European Union , Marketing , United StatesABSTRACT
The number of combination products is increasing, and the cutting-edge and innovative technologies are constantly being used. How to evaluate combination products become difficult points. This study team summarizes the supervision conditions of the combination products and analyzes the common problems of these products application from the perspective of technical review, in order to provide reference for Chinese manufacturers and investigators in these products registration.
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Biomedical TechnologyABSTRACT
Objective@#To compare the curative effect between Elastic Locking Intramedullary Nail (ELIN) and Anatomic Locking Plate (ALP) for the treatment of fracture in the mid-shaft of clavicle (Classification AO/OTA:2A/2B).@*Methods@#Data of 47 cases of 2A/2B clavicular fractures who were treated with operation from January 2014 to December 2016 were retrospectively analyzed. The patients were divided into ELIN group and ALP group according to different fixation methods. There were 23 cases in ELIN group, 14 male and 9 female, aged from 19 to 85 years (average, 55.26 years). 14 cases on the left side and 9 cases on the right side. There were 6 cases of type 2A and 17 cases of type 2B. There were 24 cases in the ALP group, 18 male and 6 female, aged from 15 to 71 years (average, 51.25 years). 16 cases on the left side and 8 cases on the right side. There were 9 cases of type 2A and 15 cases of type 2B. The operation time, intraoperative blood loss, length of skin incision, fracture healing time, extraction time of internal fixation, Constant-Murley score of shoulder joint, disabilities of the arm, shoulder, and hand (DASH) score, and complication incidence were compared between the two groups.@*Results@#All the operations were successfully performed. The mean follow-up for the patients in the ELIN group was 19.35 weeks (range, 14-23 weeks). The mean follow-up for the patients in the ALP group was 53.13 weeks (range, 28-76 weeks). In the ELIN group, the operative time was 20.78 ± 7.71 min, the intraoperative blood loss was 13.26±9.72 ml, the length of incision was 1.57±1.24 cm, the fracture healing time was 10.39±2.39 weeks, the extraction time of internal fixation was 13.17±2.37 weeks, the Constant-Murley score of shoulder joint was 99.09±1.86, and the DASH score was 1.20±2.47. In the ALP group, the operative time was 57.79±11.56 min, the intraoperative blood loss was 69.17±46.24 ml, the length of incision was 9.67±2.90 cm, the fracture healing time was 14.21±4.05 weeks, the extraction time of internal fixation was 47.38±10.46 weeks, the Constant-Murley score of shoulder joint was 98.00±2.17, and the DASH score was 0.89±1.65. The operation time (t=12.856, P=0.000), intraoperative blood loss (t=5.791, P=0.000) in the ELIN group were less than that of ALP group. The length of incision was significantly smaller in ELIN group than that of ALP group (t=12.549, P=0.000). The fracture healing time was earlier in ELIN group than that of ALP group (t=3.566, P=0.002). The extraction time of internal fixation was obviously earlier in ELIN group than that of ALP group (t=15.603, P=0.000). Constant-Murley score of shoulder joint and DASH score showed no significant difference. No delayed healing, no infection was found in the ELIN group, however skin irritation and tail bursitis were found in 6 cases, 3-6 weeks after the operation. The dressing was changed, kept clean. Skin irritation and tail bursitis disappeared, after the extraction of the internal fixation. There were 2 cases of delayed healing in the ALP group. After prolonged observation, the 2 cases healed. The healing time was extended to 24 and 27 weeks, respectively. There was 1 case of infection, 1 case of poor skin healing in the ALP group. The infected patient was treated with debridement and sensitive antibiotics, and the patient with poor skin healing was treated with dressing change. All the patients had wound healing about 4 weeks after surgery. 2 cases of skin irritation in the ALP group disappeared, after the extraction of the internal fixation.@*Conclusion@#Both ALP and ELIN are effective methods for the treatment of mid-shaft clavicular fracture. ELIN group has the advantages of more minimally invasive, faster union, shorter internal fixation time, better appearance, and lower medical cost. However, the ELIN group also had skin irritation and temporary bursitis.
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Objective@#To study the effect and mechanism of recombinant human thrombopoietin (rhTPO) on platelet activation and pyroptosis in mice with lipopolysaccharide (LPS)- induced thrombocytopenia, and provide a theoretical basis for the clinical use of rhTPO.@*Methods@#One hundred C57BL/6 mice were randomly(random number) divided into 5 groups: blank control group (sham group), experimental control group (LPS group), low dose (L group, 1.35 ×103U·kg-1·d-1), medium dose (M group, 2.7 ×103U·kg-1·d-1), and high dose (H group, 5.4 ×103U·kg-1·d-1) rhTPO treatment groups. Continuous observation for 72 h. The positive expression rates of CD61/CD62p, Gasdermin D and Caspase-1 in washed platelets were detected by flow cytometry at 72 h, and the levels of IL-1β and IL-18 in plasma were detected by ELISA.@*Results@#Compared with the sham group, the survival rate of the LPS group was significantly lower (P< 0.01). Compared with the LPS group, the survival rates of the L, M and H groups were slightly increased, but the difference was not statistically significant (P>0.05). There was no significant change in platelet count of the sham group before and after the experiment. The platelet count in the LPS group decreased significantly. The platelet count at 72 h in the L group was significantly higher than those in the LPS, M and H groups (P<0.01), and there was no significant difference between the M and H groups and LPS group (P>0.05). Compared with the sham group, CD61/CD62p and Gasdermin-D protein expressions in the LPS group were significantly increased (P<0.01), significantly decreased in the L group (P<0.05), and not significantly changed in the M and H groups (P>0.05). Caspase-1 expression was significantly increased in the LPS group compared with the sham group (P<0.01), significantly decreased in the L and M groups compared with the LPS group (P<0.05), and not significantly changed in the H group compared with the LPS group (P>0.05). The levels of platelet-rich plasma IL-1 beta and IL-18 in the LPS group were significantly higher than those in the sham group (P<0.01), while those in the L group were significantly lower than those in the LPS group (P<0.01), and those in the M and H groups were not significantly changed than those in the LPS group (P>0.05).@*Conclusions@#rhTPO can inhibit platelet activation and pyroptosis in LPS-induced thrombocytopenia mice, which provides basic research basis for the treatment of sepsis thrombocytopenia.
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Objective To study the effect and mechanism of recombinant human thrombopoietin (rhTPO) on platelet activation and pyroptosis in mice with lipopolysaccharide (LPS)-induced thrombocytopenia,and provide a theoretical basis for the clinical use of rhTPO.Methods One hundred C57BL/6 mice were randomly(random number) divided into 5 groups:blank control group (sham group),experimental control group (LPS group),low dose (L group,1.35 ×103U · kg-1 · d-1),medium dose (M group,2.7 ×103U · kg-1 · d-1),and high dose (H group,5.4 ×103U · kg-1 · d-1) rhTPO treatment groups.Continuous observation for 72 h.The positive expression rates of CD61/CD62p,Gasdermin D and Caspase-1 in washed platelets were detected by flow cytometry at 72 h,and the levels of IL-1β and IL-18 in plasma were detected by ELISA.Results Compared with the sham group,the survival rate of the LPS group was significantly lower (P＜ 0.01).Compared with the LPS group,the survival rates of the L,M and H groups were slightly increased,but the difference was not statistically significant (P＞0.05).There was no significant change in platelet count of the sham group before and after the experiment.The platelet count in the LPS group decreased significantly.The platelet count at 72 h in the L group was signiftcantly higher than those in the LPS,M and H groups (P＜0.01),and there was no significant difference between the M and H groups and LPS group (P＞0.05).Compared with the sham group,CD61/CD62p and Gasdermin-D protein expressions in the LPS group were significantly increased (P＜0.01),significantly decreased in the L group (P＜0.05),and not significantly changed in the M and H groups (P＞0.05).Caspase-1 expression was significantly increased in the LPS group compared with the sham group (P＜0.01),significantly decreased in the L and M groups compared with the LPS group (P＜0.05),and not significantly changed in the H group compared with the LPS group (P＞0.05).The levels ofplatelet-rich plasma IL-1 beta and IL-18 in the LPS group were significantly higher than those in the sham group (P＜0.01),while those in the L group were significantly lower than those in the LPS group (P＜0.01),and those in the M and H groups were not significantly changed than those in the LPS group (P＞0.05).Conclusions rhTPO can inhibit platelet activation and pyroptosis in LPS-induced thrombocytopenia mice,which provides basic research basis for the treatment of sepsis thrombocytopenia.
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This article summarizes the attribute conditions to the combination products designation from 2009 to 2018 in China,analyzes the common problems of combination products attribution definition.It is hoped to be helpful for researchers and manufacturers of combination products.
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China , Equipment and Supplies , Terminology as TopicABSTRACT
Objective To compare the curative effect between Elastic Locking Intramedullary Nail (ELIN) and Anatomic Locking Plate (ALP) for the treatment of fracture in the mid?shaft of clavicle (Classification AO/OTA:2A/2B). Methods Data of 47 cases of 2A/2B clavicular fractures who were treated with operation from January 2014 to December 2016 were retrospectively analyzed. The patients were divided into ELIN group and ALP group according to different fixation methods. There were 23 cases in ELIN group, 14 male and 9 female, aged from 19 to 85 years (average, 55.26 years).14 cases on the left side and 9 cases on the right side. There were 6 cases of type 2A and 17 cases of type 2B. There were 24 cases in the ALP group, 18 male and 6 fe?male, aged from 15 to 71 years (average, 51.25 years). 16 cases on the left side and 8 cases on the right side. There were 9 cases of type 2A and 15 cases of type 2B. The operation time, intraoperative blood loss, length of skin incision, fracture healing time, ex?traction time of internal fixation, Constant?Murley score of shoulder joint, disabilities of the arm, shoulder, and hand (DASH) score, and complication incidence were compared between the two groups. Results All the operations were successfully performed. The mean follow?up for the patients in the ELIN group was 19.35 weeks (range, 14-23 weeks). The mean follow?up for the patients in the ALP group was 53.13 weeks (range, 28-76 weeks). In the ELIN group, the operative time was 20.78 ± 7.71 min, the intraopera? tive blood loss was 13.26±9.72 ml, the length of incision was 1.57±1.24 cm, the fracture healing time was 10.39±2.39 weeks, the extraction time of internal fixation was 13.17±2.37 weeks, the Constant?Murley score of shoulder joint was 99.09±1.86, and the DASH score was 1.20±2.47. In the ALP group, the operative time was 57.79±11.56 min, the intraoperative blood loss was 69.17± 46.24 ml, the length of incision was 9.67±2.90 cm, the fracture healing time was 14.21±4.05 weeks, the extraction time of internal fixation was 47.38±10.46 weeks, the Constant?Murley score of shoulder joint was 98.00±2.17, and the DASH score was 0.89±1.65. The operation time (t=12.856, P=0.000), intraoperative blood loss (t=5.791, P=0.000) in the ELIN group were less than that of ALP group. The length of incision was significantly smaller in ELIN group than that of ALP group (t=12.549, P=0.000). The frac?ture healing time was earlier in ELIN group than that of ALP group (t=3.566, P=0.002). The extraction time of internal fixation was obviously earlier in ELIN group than that of ALP group (t=15.603, P=0.000). Constant?Murley score of shoulder joint and DASH score showed no significant difference. No delayed healing, no infection was found in the ELIN group, however skin irritation and tail bursitis were found in 6 cases, 3-6 weeks after the operation. The dressing was changed, kept clean. Skin irritation and tail bursitis disappeared, after the extraction of the internal fixation. There were 2 cases of delayed healing in the ALP group. After pro?longed observation, the 2 cases healed. The healing time was extended to 24 and 27 weeks, respectively. There was 1 case of infec?tion, 1 case of poor skin healing in the ALP group. The infected patient was treated with debridement and sensitive antibiotics, and the patient with poor skin healing was treated with dressing change. All the patients had wound healing about 4 weeks after sur?gery. 2 cases of skin irritation in the ALP group disappeared, after the extraction of the internal fixation. Conclusion Both ALP and ELIN are effective methods for the treatment of mid?shaft clavicular fracture. ELIN group has the advantages of more minimal?ly invasive, faster union, shorter internal fixation time, better appearance, and lower medical cost. However, the ELIN group also had skin irritation and temporary bursitis.
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OBJECTIVE:To provide reference for improving related policy and list about medical insurance medicines in China. METHODS:The descriptive analysis method was used to compare 2017 and 2009 edition of Medicine List for National Basic Medical Insurance,Employment Injury Insurance and Maternity Insurance in respects of item,medicine classification (including classification code,grading and name),medicine types(including new type,removed type),dosage(including new dosage classification,adjusted dosage form),the limit of payment and use.The trend of its development and the existing problems were discussed. RESULTS:Compared with 2009 edition,2017 edition of medicine list added the item of"drug classification code"and removed the item of"English name". The grading of drug classification code was reduced from six grades to four grades. The code and name of four grades classification were in accordance with the first four grades classification rules of the anatomical-therapeutic-chemistry(ATC). A total of 2 535 types were included in 2017 edition,increasing by 362 types compared to 2009 edition(151 chemical medicines,211 Chinese patent medicines). 15 types of chemical medicines were removed,and 4 types were transferred to Chinese patent medicine list;11 types of Chinese patent medicines were removed,and one type was transferred to chemical medicine list. 2017 edition was actually 20 more dosage forms than 2009 edition,involving 31 types;dosage forms of 231 types were adjusted(143 chemical medicines,88 Chinese patent medicines). Chemical medicines of usage and payment restriction increased from 239 to 302,and Chinese patent medicines increased from 72 to 115,respectively. CONCLUSIONS:2017 edition of list increases the number of medicine,expands the scope of clinical medication and improves the classification structure of the list.The number of medical insurance cost control type shows a growing trend.