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OBJECTIVE To evaluate the effectiveness， safety， economy， innovation， suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein （EC）， and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin （TB-PPD） were analyzed by the method of systematic review. Cost minimization analysis， cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD， and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation， suitability and accessibility were determined by systematic review and improved Delphi expert consultation， and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness， safety， economy， innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent， while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight， the scores of effectiveness， safety， economy， innovation， suitability， accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD， EC performs better in all dimensions of effectiveness， safety， economy， innovation， suitability and accessibility. However， it is worth noting that EC should further improve its availability in the dimension of accessibility.
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Objective:To explore the influence of early essential newborn care (EENC) on breastfeeding after vaginal delivery.Methods:Women with full-term vaginal delivery at Jiaxing Women and Children's Hospital Affiliated to Wenzhou Medical University from January to June 2019 were enrolled in this prospective randomized controlled trial. These participants and their neonates were assigned randomly to receive early skin-to-skin contact for 90 min after delayed umbilical clamping (EENC group) or routine nursing care after delivery and skin-to-skin contact for 30 min (control group). The main outcomes were successful initiation and duration of first-time breastfeeding, initiation time of second-stage lactation, self-efficacy score of breastfeeding, acceptance and satisfaction score of breastfeeding, and the rate of exclusive breastfeeding at 24, 48, 72 h, and 42 d postpartum. The secondary outcomes included the onset time of first deep sleep of the newborn, the baby's first breast-fed stool, and the neonatal weight within 4 days of birth. Two independent samples t-test and Chi-square test were used for statistical analysis. Results:A total of 200 women with full-term vaginal delivery were recruited and 117 (61 in EENC group and 56 in control group) completed the study. (1)Main outcomes: Compared with the control group, the EENC group had earlier initiation of the first breastfeeding [(25.5±6.9) vs (33.2±7.2) min, t=5.902] and the second stage of lactation [(72.1±3.3) vs (78.6±4.3) h, t=9.504], longer duration of the first breastfeeding [(40.6±5.2) vs (32.6±6.1) min, t=7.806], and higher self-efficacy score [(122.5±2.1) vs (98.2±3.1) scores, t=50.660], acceptance score [(21.8±3.1) vs (15.3±4.3) scores, t=9.444], satisfaction score of breastfeeding [(23.2±2.1) vs (18.8±3.1) scores, t=9.278], and higher rate of exclusive breastfeeding at 24, 48 and 72 h after delivery[43% (26/61) vs 21% (12/56), 59%(36/61) vs 36%(20/56), 89%(54/61) vs 64%(36/56); χ 2 were 5.980, 6.353, and 9.663, respectively], all P<0.05. (2)Secondary outcomes: In the EENC group, the onset time of first deep sleep [(90.1±10.6) vs (118.3±9.9) min, t=7.645] and the the baby's first breast-fed stool [(57.1±6.4) vs (66.4±5.5) h, t=8.435] were earlier; neonatal weight at 3 d [(3 720±329) vs (3 558±412) g, t=2.382] and 4 d after birth [(3 778±289) vs (3 562±315) g, t=3.857] were significantly heavier, comparing with the control group (all P<0.01). Conclusions:EENC can improve multiple short-term breastfeeding indicators and maternal acceptance and satisfaction of breastfeeding in women after full-term vaginal delivery.
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OBJECTIVE：To systematically evaluate the research and development status quo of respiratory inhalation preparations. METHODS ：Related literatures or data about R&D status quo of domestic and foreign respiratory inhalation preparations were retrieved from 5 databases（PubMed，Embase，CNKI，Wanfang database and VIP ），4 clinical trial registration platforms，15 national/regional drug administration platforms and yaozhi.com . The status quo of related studies was analyzed by descriptive analysis. RESULTS & CONCLUSIONS ：A total of 27 second literatures were included. The information of respiratory inhalation preparations approved by European Union ，the United States ，Canada，Japan and China was collected ，and the information of related drugs under registration and approval in China was also collected. The market situation of respiratory inhalation preparations was analyzed from the perspective of dosage form ：powder aerosols accounted for 46％，aerosols account ed for 32％，and atomized inhalation solutions accounted for 22％ in the global consumption sum of each dosage form. From the perspective of market share ，companies such as AstraZeneca in the UK ，Boehringer Ingelheim in Germany and GlaxoSmithKline in the UK had a total market share of about 70％. At present ，there were 39 kinds of respiratory inhalation preparations on the market in European Union ，121 kinds in the United States ，111 kinds in Canada ，37 kinds in Japan ，69 kinds of domestic inhalation preparations and 80 kinds of imported inhalation preparations in China. Respiratory inhalation preparations were undergoing clinical trials with 511 cases abroad and 69 cases in China. The barriers to the imitation of respiratory inhalation preparations mainly included research and development ，clinical trial ，approval and production barriers. At present ，the support is provided for 0035） domestic drug innovation and localization of medical devices in China through a series of policies ，which is helpful to promote the localization research and development of inha led preparations. Future research and development can pay more cn attention to combination ，indication，dosage and device of inhalation preparation.
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To investigate the association of preoperative clinical and sonographic characteristics of clinically node‐negative ( cN0) papillary thyroid carcinoma ( PTC) with central lymph node metastasis ( CLNM ) . Methods A total of 514 patients with PTC confirmed by pathology in our hospital were included in the retrospective analysis . Clinical and sonographic characteristics were assessed including age ,gender ,tumor size ,and the distance between the tumor and the capsule . These cases were all diagnosed as cN0 according to clinical and sonography examinations . And the cases were divided into CLNM ( + ) group and CLNM ( －) group based on the pathological results . T hen statistical analysis was used to evaluate the correlation between CLNM and risk factors of cN 0 PTCs . Results ① Of the 514 cN0 PTC cases ,211 cases ( 41 .1% ) were CLNM ( + ) and 303 cases ( 58 .9% ) were CLNM ( －) . ② With the presence of capsule invasion in the ultrasound examination ,the probability of CLNM ( + ) group was higher than that of CLNM ( －) group ( 62 .1% vs 37 .9% ) . ③ In the 364 cases without capsule invasion ,the probability of CLNM ( + ) was significantly increased when the distance between the tumor and the capsule was ＜ 1 .5 mm ( 88 .8% vs 11 .2% ) . ④ M ultivariate analysis showed that risk factors independently associated with CLNM included age ＜45 years old ,tumor maximum diameter ≥10 mm ,and the distance between the tumor and the capsule ＜ 1 .5 mm ,among w hich the distance between the tumor and the capsule ＜1 .5 mm had the highest OR value . Conclusions In cN0 PTC patients ,CLNM is associated with age ,size and the distance between the tumor and the capsule .
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Objective: to examine the relationship between emotional states and skin conductance response during lie- detection and to provide evidence for improvement of lie- detection technique. Methods: 38 university students participat- ed in the study. They were provided with antisocial behavior materials that elicited different levels of emotional arousal. Results: Significant difference in skin conductance response was observed with the high emotionality items eliciting the highest skin conductance response. Conclusion: Under a certain level of pressure, individuals’emotional state has direct impact on skin conductance. High emotionality questions are better for detecting lies and honesty than low emotionality questions. In addition to lying, the questions themselves have direct impact on subjects’emotional responses, which in turn lead to skin conductance response. When cues for emotionality are obvious, related events tend to receive greater at- tention by subjects and thus lead to special skin conductance response.