The expanded clinical trial system is designed to provide clinical trial drugs for patients suffering from serious or life-threatening diseases for which there is no effective treatment， essentially seeking a balance between the accessibility of drugs to patients and the soundness of the development of the pharmaceutical industry， as well as between the risk of expanding the use of clinical trial drugs and the need to safeguard the rights and interests of patients’ lives and health. Article 23 of China's Drug Administration Law provides only a principled description of the applicable standards and operating procedures for this system， with no implementing regulations， making it difficult for the system to function effectively in practice. The United States， Japan， and Canada have made detailed provisions on the conditions of application， applicants， review subjects and contents， and safeguards of the system through laws， regulations， and guidelines. Based on China's legislative environment and regulatory reality， and considering that the system is still in the initial stage in China， it is recommended that appropriate reference be made to the beneficial experience of foreign countries and that regulations and normative documents be promulgated as soon as possible to clarify the types of expanded clinical trials， applicants， review subjects etc.， and to determine the responsibilities of all the parties involved， to promote the standardization of China’s expanded clinical trial system， to promote the availability of medicines to patients， and to effectively safeguard the rights and interests of patients’ lives and health， and the soundness and safety of the development of the pharmaceutical industry.

Objective:To discuss the changes of serum levels of Klotho and fibroblast growth factor 23(FGF23)in the small for gestational age(SGA)infants after birth,and to clarify their relationships with growth and development.Methods:A total of 35 SGA and 53 appropriate for the gestational age(AGA)infants were selected and divided into SGA group(n=35)and AGA group(n=53),including 51 infants in premature group,among them 20 infants in preterm SGA group and 31 infants in preterm AGA group;among them 37 infants in full-term group,15 infants in full-term SGA group and 22 infants in full-term AGA group.The clinical materials of the infants in various groups were collected.The levels of Klotho and FGF23 in serum and clinical biochemical markers of the infants on the 7th and 14th days after birth were detected.The relationships between the levels of Klotho and FGF23 in serum on the 7th and 14th days postnatally and newborn growth indicators such as body weight,body length,head circumference,chest circumference,and Kopu index,as well as their correlations with calcium and phosphorus metabolism were analyzed.Results:Compared with AGA group,the body weight,body length,head circumference,chest circumference,and Kopu index of the infants in SGA group were decreased(P<0.05).On the 7th and 14th days after birth,compared with preterm group,the serum levels of Klotho and FGF23 of the infants in full-term group were significantly increased(P<0.01).Compared with the 7th day after birth,the levels of serum Klotho of the infants in preterm and full-term groups on the 14th day were significantly increased(P<0.01),and the levels of FGF23 in serum were decreased(P<0.01).Compared with AGA group,the levels of serum Klotho and FGF23 of the infants in SGA group on the 7th and 14th days after birth were significantly decreased(P<0.05 or P<0.01).Compared with the 7th day after birth,the levels of serum Klotho of the infants in both AGA and SGA groups on the 14th days after birth were significantly increased(P<0.01),and the FGF23 levels were decreased(P<0.05 or P<0.01).Compared with preterm AGA group,the levels of Klotho and FGF23 in serum of the infants in preterm SGA group on the 7th and 14th days after birth were significantly decreased(P<0.05 or P<0.01).Compared with full-term AGA group,the levels of Klotho and FGF23 in serum of the infants in full-term SGA group on the 7th and 14th days after birth were significantly decreased(P<0.05 or P<0.01).In SGA group,the serum levels of Klotho and FGF23 on the 7th day after birth were positively correlated with the gestational age,body weight,body length,head circumference,chest circumference,and Kopu index(P<0.05 or P<0.01);there was a positive correlation between the serum level of Klotho and the serum level of FGF23(P<0.05).In terms of calcium-phosphorus metabolism,in SGA group,the serum level of Klotho on the 7th day after birth was positively correlated with serum phosphorus level(P<0.01),and the level of serum FGF23 on the 7th day after birth was positively correlated with serum calcium and phosphorus levels(P<0.05 or P<0.01).Conclusion:Klotho and FGF23 proteins are closely associated with growth and development and phosphate metabolism of the infants.The expression levels of Klotho and FGF23 in serum of the SGA infants postnatally are lower,but the secretion of Klotho is increased with the gradul improvement of each organ,and the decrease of FGF23 may be the adaptive response.

Objective:To compare the efficacy of endoscopic retrograde appendicitis therapy (ERAT) and sub-endoscopic retrograde appendicitis therapy (SERAT) for the treatment of acute appendicitis.Methods:The retrospective study was performed on consecutive patients who underwent SERAT (21 cases) and ERAT (30 cases) for acute appendicitis in Shandong Provincial Third Hospital from November 2021 to April 2023. Patient baseline information, clinical treatment, hospitalization costs, and hospital stay were analyzed, and complications and recurrence were followed up.Results:There was no significant difference between the two groups regarding age, gender, clinical manifestation, laboratory and imaging data, or Alvrrado score ( P>0.05). Compared with the ERAT group, the operation time was shorter in the SERAT group (23.6±10.1 min VS 44.8±18.8 min, t=4.679, P<0.001). There were no significant differences between the two groups in stent implantation rate [61.9% (13/21) VS 70.0% (21/30), χ2=0.364, P=0.546], fecalith removal rate [38.1% (8/21) VS 33.3% (10/30), χ2=0.123, P=0.726], postoperative time for temperature (19, 2, 0 and 26, 3, 1 cases after 0 to 1 day, >1 to 3 days and >3 days, respectively, χ2=0.723, P=0.697) and white blood cell count normalization (20, 1, 0 and 27, 2, 1 cases after 0 to 1 day, >1 to 3 days and >3 days, respectively, χ2=0.813, P=0.666), proportion of visual analogue scale scores<3 at 6 hours after treatment [100.0% (21/21) VS 90.0% (27/30), χ2=2.231, P=0.135], length of hospital stay (3.4±1.2 days VS 4.5±2.9 days, t=1.579, P=0.121), hospitalization cost (15 393.0±4 352.5 yuan VS 17 836.0±5 134.6 yuan, t=1.777, P=0.082), or incidence of complications [0.0% (0/21) VS 0.0% (0/30), χ2=0.000, P=1.000]. The recurrence rate in SERAT group (0.0%, 0/21) was significantly lower than that in ERAT group (23.3%, 7/30) ( P=0.017). Conclusion:SERAT is a safe and effective minimally invasive approach for managing acute appendicitis, characterized by a shorter operation duration and a lower recurrence rate compared to ERAT.

Klotho protein is an anti-aging gene product, which is involved in the regulation of calcium, phosphate and vitamin D metabolism together with fibroblast growth factor 23 (FGF23). In recent years, studies have found that Klotho/FGF23 is closely related to the growth and development of children and newborns. This paper summarizes the role of Klotho/FGF23 in the occurrence and development of infants small for gestational age, in order to provide further understanding and inspiration for the prevention and treatment of SGA complications.

Objective:To explore the module of the construction and application of medical first-aid at the door of the space capsule and the air evacuation.Methods:According to the purpose, principle, and method set by the module, it was divided into two sub-modules: medical first-aid at the door of the space capsule and the air evacuation. During the comprehensive first-aid training, independent training and combined training were carried out respectively according to different mission stages of launch and recovery and different recovery terrain. Meanwhile, research was performed to ensure that medical carrying equipment was lightweight, modular, and portable, and the efficiency of modularization construction was tested in the comprehensive training.Results:The module of medical first-aid at the door of the space capsule and the air evacuation obviously shortened the rescuing time during the comprehensive training, the saving effect was remarkable, and the overall saving efficiency was significantly improved.Conclusions:The module of medical first-aid at the door of the space capsule and the air evacuation meet the requirements that the emergency support system of aerospace medicine should function on an immediate basis, ensuring accurate treatment and air evacuation without any delay, so that to achieve the aim of aerospace medicare.

Objective:To study the application of scenario simulation teaching combined with modular training in nursing education of medical rescue in manned space flight.Methods:Twenty nurses from the medical rescue team of Strategic Support Force Characteristic Medical Center were selected as the research objects. The research objects were randomly divided into the scenario simulation combined with practical training group (practical training group, n=10) and traditional teaching group (control group, n=10). Scenario simulation teaching combined with modular training and traditional teaching were used to carry out nursing training. After the training, theoretical assessment, operation assessment and satisfaction survey were organized. Results:The scenario simulation teaching combined with modular training group was significantly better than the traditional training group in theory assessment, operation assessment and satisfaction survey of nursing staff (all P<0.05). Conclusions:Scenario simulation teaching combined with modular training has obvious teaching effect, which can improve the ability and quality of nursing staff, and help to complete the manned space medical rescue mission efficiently.

Objective:To review the characteristics and coping strategies of the rescue and landing medical support mission of Shenzhou-14 manned spacecraft.Methods:The characteristics of rescue and landing medical support mission of Shenzhou-14 manned spacecraft was analyzed, and the coping strategies and experience were discussed.Results:(1) The characteristics of rescue and landing medical support mission of Shenzhou-14 manned spacecraft included: long time in space station and high-intensity space missions; high-density space medical support mission in short term; special environmental factors in severe cold night; complex terrain of landing site; and the young medical support team. (2) The main coping strategies of rescue and landing medical support mission of Shenzhou-14 manned spacecraft included: strengthened the organization and leadership and improved the training model; reinforcement learning the medical treatment plan and strengthened the medical rescue skills training; optimized the carrying equipment and added the heat preservation and lighting measures; improved the medical rescue process and perfected the emergency plan; emphasized on the scientific research as important as mission; and strengthened the physical exercise and cold resistance exercise.Conclusions:The characteristics and coping strategies of rescue and landing medical support mission of Shenzhou-14 manned spacecraft are summarized to provide the experience for space medical rescue and offer the support for China's manned space industry.

Objective:To understand the current status of nursing for chronic constipation patients accepted fecal microbiota transplantation and provide reference basis for constructing clinical nursing plan.Methods:From April to August 2021, a field research was conducted in the Tenth People′s Hospital of Tongji University. Data was collected by field observation and informal interview for 13 nurses and analyzed by three-level coding method of qualitative research.Results:The work content of the observation subjects could be divided into 3 items including entrance health education, donor management, bacterial fluid management and clinical nursing. It still needed being improved in donor management, health education, nursing of naso-jejunal tube, intestinal preparation, infusion of bacterial fluid, observation of complications and follow-up.Conclusions:It still needs further development in nursing for chronic constipation with fecal microbiota transplantation. It is urgent to establish donor follow-up team, conduct professional training for nurses, rely on mobile medical platform to improve quality of fecal microbiota transplantation, so as to promote the recovery of patients.

Objective:To summarize the relevant evidence of motor rehabilitation of stroke at home and abroad, so as to provide reference for medical staff to carry out motor rehabilitation.Methods:The related evidence on exercise management for patients with stroke in BMJ Best practice, UpToDate, Joanna Briggs Institute (JBI) Evidence-Based Health Care Center Database, National Guideline, American Heart Association/American Stroke Association, European Stroke Organization, National Institute for Health and Care Excellence, Registered Nurses Association of Ontario, Canadian Medical Association, American Association of Critical Care Nurses, National Stroke Foundation, Chinese Stroke Association, Medlive, Cochrane library, PubMed, Web of Science, Embase, OVID, Medline, China National Knowledge Infrastructure, Wanfang, VIP, SinoMed were searched by computer. The retrieval time limit was from 2012 to June 30, 2022. Two to four investigators independently assessed the quality of the included article, and extracted and summarized the evidence that met the quality standards.Results:A total of 22 articles were included, including 5 guidelines, 2 summary of evidence, 2 expert consensus, and 13 systematic evaluations. A total of 42 pieces of evidence related to exercise rehabilitation were extracted and integrated, including 11 aspects such as multidisciplinary teams, exercise goals, exercise timing, exercise evaluation, exercise venue, exercise style, exercise intensity, exercise time and frequency, safety monitoring, exercise behavior maintenance, and health education.Conclusions:The best evidence summarized in this study can provide a reference for clinical medical staff to implement exercise rehabilitation, but in clinical practice, it is necessary to select and apply evidence in a targeted manner in combination with specific circumstances, so as to improve the safety and effect of exercise rehabilitation.

Objective:To investigate the clinical and genetic characteristics of Prader-Willi syndrome (PWS).Methods:The clinical data and genetic characteristics of 2 children with PWS diagnosed in Hebei Provincial People's Hospital were retrospectively analyzed, and the relevant literature was reviewed.Results:Case 1, male, aged 6 years and 3 months, was presented to the hospital because of short stature, mild mental retardation, dysarthria, scoliosis, cryptorchidism, micropenis, long skull, narrow face, almond eyes, small mouth, thin upper lip, downward corners of the mouth, fair skin. He had hypotonia and feeding difficulties in infancy, and gradually became hyperappetitive. Bilateral cryptorchidism surgery was performed at 1.5 years old, but the effect was not good. Case 2, male, aged 4 years, presented to the hospital mainly due to obesity, hyperappetite, excessive weight gain, backward language and cognitive function, dysarthria, and scoliosis.The infant had feeding difficulties in the early stage, and bilateral cryptorchidism surgery at the age of 2 was not effective.Methylation specific polymerase chain reaction and methylation specific multilink probe amplification were used to detect the loss of the parent fragment in the key region (15q11-13) of PWS, which confirmed Prader-Willi syndrome.Conclusion:PWS is a rare hereditary disease with complex and diverse clinical manifestations and different characteristics in different age groups. It is highly susceptible to unexplained hypotonia and feeding difficulties in infancy. Children with short stature and obesity should be alert to the disease, which can be clearly diagnosed by molecular genetic techniques.