Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.

Objective To evaluate the clinical efficacy and safety of percutaneous vertebroplasty and percutaneous kyphoplasty in the treatment of Kummell'disease.Methods Databases of Cochrane Library,PubMed,Medline,Embase,Web of Science,CNKI,VIP,Wanfang Data and CBM were used to search clinical studies on percutaneous kyphoplasty virus percutaneous vertebroplasty in the treatment of Kummell's disease from database inception until June 1st,2022.Literature screening was performed according to the speci-fied inclusion and exclusion criteria.In strict compliance with Cochrane's systematic evaluation principle,authors reasonably screened,e-valuated and analyzed the quality of the retrieved papers and then the evaluating indicator of postoperative ODI,JOA,VAS,operation time and intraoperative complications in each included study was evaluated in Review Manager 5.4software.Results Nine papers were included,involving 243 patients in the percutaneous vertebroplasty group and 222 patients in the percutaneous kyphoplasty group.Percu-taneous kyphoplasty had advantages in postoperative ODI score,cement leakage,and postoperative Cobb's angle,which was statistically significant(P＜0.05),but the operation time was longer and the postoperative VAS score improved poorly.There was no significant difference in intraoperative bleeding and height of the postoperative vertebral margin(P＞0.05).Conclusion In the surgical treatment of Kummell's disease,percutaneous vertebral kyphoplasty can more effectively improve the postoperative ODI score,and reduce the post-operative Cobb's angle and the risk of cement leakage compared to the traditional percutaneous vertebroplasty.It has more advantages in improving the clinical efficacy and reducing the postoperative risk.However,the conclusions of this study require more high-quality,multi-angle and large-sample studies in the future.

In response to the Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance， Innovation， and Development of traditional Chinese medicine（TCM） and the spirit of the National Conference on TCM， Chinese Association of Chinese Medicine organized experts in Otorhinolaryngology Head and Neck Surgery of traditional Chinese and western medicine to discuss the clinical advantages of TCM and integrated traditional Chinese and western medicine in the treatment of allergic rhinitis （AR） and they reached a basic consensus. In recent years， the prevalence of AR has been on the rise， threatening the quality of life of patients and giving rise to a heavy burden to both the patients and the society. AR is resulted from immune imbalance rather than reduced immunity or hyperimmunity， and the imbalance is similar to the Yin-yang disharmony in TCM. In the treatment of this disease， western medicine features rapid onset. However， it is cost-intensive and causes severe surgical trauma， and the recurrence is common. TCM boasts diverse methods for AR， which can be used in all stages of this disease. It has advantages in controlling symptoms such as nasal congestion， runny nose， or dysosmia in the attack stage， preventing recurrence in the remission stage， and treating refractory AR or steroid-resistant AR. In particular， acupuncture enjoys a reputation in treatment of AR， which has been supported by evidence-based medicine and recommended by guidelines. While treating local symptoms of AR， TCM regulates the psychosomatic conditions， which facilitates chronic disease management and long-term follow-up. We should integrate the advantages of TCM and western medicine， give full play to the unique nonnegligible and irreplaceable advantages of TCM， formulate a comprehensive diagnosis and treatment scheme for learning and promotion， and summarize the research outcomes to promote the theoretical innovation of TCM on AR from the perspective of integrated traditional Chinese and western medicine.

The Xidu Community Health Service Center has become the first general practice outskirt teaching site of Shanghai Zhongshan Hospital since May 2015; the Fudan University Shanghai Medical College Xidu General Practice Clinical Teaching and Training Base was formally established in May 2018. For last 6 years, with the cooperation with Zhongshan Hospital the Xidu Community Health Service Center has participated in teaching and training of general practice residents and general practitioners, which also greatly promoted the development of clinical service, disease prevention and scientific research of the center itself. This article introduces the "Fudan-Xidu" integrated model and its experiences in general practice teaching, focusing on the background, the organization, teaching implementation, achievements and future prospects, to provide a reference for talent training of general practice in grassroots institutions.

Traditional Chinese Medicine (TCM) has become an important part of the health system in the Sultanate of Oman. Although there is no independent law, the local health department has implemented the administrative measures such as the admittance assessment system of TCM doctors and the standardized examination and approval of TCM clinics. The development of TCM in the Sultanate of Oman is supported by the policies of the two governments, with the characteristics likemedical cooperation starting with high-level personnel, the cooperation in economy, trade and medical treatment, TCM and local traditional medicine showing inclusive with good base, and the advantages of TCM theory and treatment meeting the needs of the local medical market. The prospect of cooperation in TCM market is broad. It is suggested that the local government should promote the legislation of traditional medicine and improve the admittance system of practitioners. China needs to promote the formulation of international standards of TCM and optimize the cooperation platform of TCM by using Internet and other technologies. The practitioners in China need to carry out medical activities on the premise of understanding and respecting the local cultural background.In order to promote the development of TCM in Arab countries, the Sultanate of Oman will radiate the whole Middle East through the above strategies.

BACKGROUND: Perioperative treatment has become an increasingly important aspect of the management of patients with non-small cell lung cancer (NSCLC). Small-scale clinical studies performed in recent years have shown improvements in the major pathological remission rate after neoadjuvant therapy, suggesting that it will soon become an important part of NSCLC treatment. Nevertheless, neoadjuvant immunotherapy may be accompanied by serious adverse reactions that lead to delay or cancelation of surgery, additional illness, and even death, and have therefore attracted much attention. The purpose of the clinical recommendations is to form a diagnosis and treatment plan suitable for the current domestic medical situation for the immune-related adverse event (irAE). METHODS: This recommendation is composed of experts in thoracic surgery, oncologists, thoracic medicine and irAE related departments (gastroenterology, respirology, cardiology, infectious medicine, hematology, endocrinology, rheumatology, neurology, dermatology, emergency section) to jointly complete the formulation. Experts make full reference to the irAE guidelines, large-scale clinical research data published by thoracic surgery, and the clinical experience of domestic doctors and publicly published cases, and repeated discussions in multiple disciplines to form this recommendation for perioperative irAE. RESULTS: This clinical recommendation covers the whole process of prevention, evaluation, examination, treatment and monitoring related to irAE, so as to guide the clinical work comprehensively and effectively. CONCLUSIONS Perioperative irAE management is an important part of immune perioperative treatment of lung cancer. With the continuous development of immune perioperative treatment, more research is needed in the future to optimize the diagnosis and treatment of perioperative irAE.

Objective:To evaluate the operating performance, effectiveness and safety of a new portable endoscopic system for upper gastrointestinal endoscopy in an animal model.Methods:A parallel control, non-inferiority study was designed. Ten healthy Bana pigs were selected as the study subjects, and underwent upper gastrointestinal endoscopy using portable endoscope followed by Olympus GIF-Q260 endoscope. The instrument quality, image quality and safety of the new system were evaluated by means of quantitative scores.Results:The time for deployment and installing of the new portable endoscopic system during single operation was 110.24±8.93 s and 91.33±11.59 s, respectively, and the time for the endoscope with disposable protective cover was 233.48±17.06 s. The time of attracting 400 mL normal saline of the portable endoscope and Olympus endoscope was 56.44±5.18 s and 33.71±3.56 s, respectively. The water vapor attraction performance of the portable endoscope was not as good as the Olympus endoscope, but still met the technical requirements of medical devices (attraction capacity >400 mL/min). While in terms of the seal property, biopsy channel, softness and curvature of gastroscopy body, knob operation, and field of view, the two endoscopic systems were equivalent. In terms of image quality evaluation, including clarity, distortion, color resolution, illumination and quality comprehensive evaluation, the performance of the new portable endoscopic system was similar to that of the Olympus endoscopic system. One pig developed nausea during operation with the Olympus endoscope. No adverse events occurred during operation with the new portable endoscope.Conclusion:The new portable endoscopic system is easy to assemble. In terms of device quality, image quality and safety, the new portable endoscopic system is similar to the clinically used Olympus endoscopic system. Therefore, the new portable endoscope system is safe and effective for upper gastrointestinal endoscopy.

OBJECTIVE: To explore the genetic basis for a fetus suspected for congenital nephrotic syndrome of Finland (CNF). METHODS: Genomic DNA was extracted from peripheral and umbilical cord blood samples derived from both parents and the fetus. Potential variants were detected by using next-generation sequencing. Suspected variants were confirmed by Sanger sequencing. RESULTS: The fetus was found to carry compound heterozygous variants c.1440+1G>A and c.925G>T of the NPHS1 gene, which were respectively inherited from its mother and father. CONCLUSION Identification of the compound heterozygous NPHS1 variants has enabled diagnosis of CNF in the fetus and genetic counseling for the affected family.
Female ; Fetus ; Finland ; Heterozygote ; Humans ; Membrane Proteins ; genetics ; Nephrotic Syndrome ; congenital ; diagnosis ; Pregnancy ; Prenatal Diagnosis

Objective: To explore the genetic basis for a fetus suspected for congenital nephrotic syndrome of Finland (CNF). Methods: Genomic DNA was extracted from peripheral and umbilical cord blood samples derived from both parents and the fetus. Potential variants were detected by using next-generation sequencing. Suspected variants were confirmed by Sanger sequencing. Results: The fetus was found to carry compound heterozygous variants c. 1440+ 1G>A and c. 925G>T of the NPHS1 gene, which were respectively inherited from its mother and father. Conclusion Identification of the compound heterozygous NPHS1 variants has enabled diagnosis of CNF in the fetus and genetic counseling for the affected family.

Objective To discuss the differences of clinical features and characteristics and features of polysomnography be‐tween elderly patients and middle‐aged patients with obstructive sleep apnea hypopnea syndrome (OSAHS) ,so as to provide refer‐ence for the diagnosis and individualized intervention of elderly OSAHS .Methods Totally 81 aged OSAHS cases and 123 youth OSAHS cases were analyzed in terms of general condition ,clinical manifestations and polysomnographic characteristics ,and the clin‐ical manifestations and polysomnographic difference indicators of the two groups were matched according to body mass index (BMI) .Results Most OSAHS patients were males in both groups ,with BMI and neck waist circumference in the aged group less than those in the middle‐aged group ,and the difference was statistically significant (P<0 .05) ,while the bust was larger than that in the middle‐aged group ,but the difference was not statistically significant (P>0 .05);clinical symptoms of senile groups such as drowsiness ,snoring ,morning headaches ,dry mouth and nighttime awakenings were lower than the middle‐aged group ,the difference was statistically significant (P<0 .05) ,and complications such as hypertension ,diabetes and other risk disease were significantly higher than those in the middle‐aged group ,and the difference was statistically significant (P<0 .05);in the aged group ,the degree of OSAHS was dominated by mild to moderate ,while the middle‐aged group ,was dominated by moderate to severe ,but the differ‐ence was not statistically significant (P>0 .05);REM AHI was more than the middle‐aged group ,the difference was statistically significant (P< 0 .05) ,AHI was less in old age group than in the middle‐aged group ,the difference was statistically significant (P<0 .05);NREMⅠ + Ⅱ stage in the aged group was more than that in the middle‐aged group(P<0 .05) ,and NREM Ⅲ + Ⅳstage ,REM period ,the average SaO2 (% ) ,MAI clear were less than those in the young group;LSAT (% ) was greater than that in the middle‐aged group ,but the difference was not statistically significant (P>0 .05) .Conclusion The incidence of typical clinical manifestations of aged OSAHS patients was lower than that in the middle‐aged group ,but high blood pressure ,diabetes and other complications prevalence were significantly higher than those in the middle‐aged group ,with similar severity of OSAHS in both groups ,there were differences PSG monitoring results with the middle‐aged group ,and the difference of REM AHI was significant .