Albumin is widely used in clinical practice， and the rationality of trial design directly affects the reliability of research findings and clinical application value. This article reviews the key statistical considerations in the design of albumin clinical trials， including the selection of primary endpoints， the establishment of statistical hypotheses and non-inferiority margins， clinical evaluation criteria for ascites improvement， sample size， and interim analyses， in order to provide methodological guidance for clinical researchers to optimize clinical trial design and enhance its scientific rigor and feasibility.

Chaihu Guizhitang is one of the classical formulas in the Catalogue of Ancient Classical Formulas （the second batch）. Through extensive searching and systematic review of ancient medical books on Chaihu Guizhitang， this study summarized the key information of this formula， which encompassed the origin and development， medicinal composition， original plants and processing， dosage， preparation method， usage， compatibility， and indications. A total of 173 valid data entries were obtained， involving a total of 97 ancient books of traditional Chinese medicine. Chaihu Guizhitang is first recorded in ZHANG Zhongjing's Treatise on Cold Damage and consists of nine herbs： Bupleuri Radix， Scutellariae Radix， Cinnamomi Ramulus， Paeoniae Alba Radix， Ginseng Radix et Rhizoma， Pinelliae Rhizoma， Glycyrrhizae Radix et Rhizoma， Rhizoma Zingiberis Recens， and Jujubae Fructus. In ancient medical books， this formula has synonyms such as Chaihu Jia Gui Tang， Chaihu Jia Guizhitang， and Guizhi Chaihu Ge Ban Tang. The medicinal composition of this formula recorded in ancient medical books is basically consistent with that of the original formula， and it is thus recommended that the composition of the original formula should be followed in the current clinical application. The original plants of the herbal medicines in this formula are in accordance with those in the Pharmacopoeia of the People's Republic of China （2020 edition）. In terms of processing methods， Pinelliae Rhizoma processed with ginger， and Glycyrrhizae Radix et Rhizoma is stir-fried. Other herbal medicines in this formula are used with the raw materials. According to the record in the Treatise on Cold Damage， Chaihu Guizhitang is mainly used to treat diseases involving Greater Yang and Lesser Yang. Ancient medical books record that this formula can treat sudden pain in the heart and abdomen， cold abdominal colic， delirium， malaria， thermal imbalance of kidney Qi， and motive Qi. Considering modern medication practice， it is recommended that Chaihu Guizhitang is composed of 14.92 g Bupleuri Radix， 5.60 g Scutellariae Radix， 5.60 g Cinnamomi Ramulus， 5.60 g Paeoniae Alba Radix， 5.60 g Ginseng Radix et Rhizoma， 5.60 g Rhizoma Zingiberis Recens， 4.66 g Pinelliae Rhizoma， 3.73 g Glycyrrhizae Radix et Rhizoma， and 4.30 g Jujubae Fructus， which should be decocted with 1 400 mL water to reach a volume of 600 mL. The decoction should be taken warm after meals， 200 mL each time， three times a day.

Over the past three decades， China has made significant progress in the prevention and control of viral hepatitis， and the incidence rates of new-onset pediatric hepatitis B virus infections and acute viral hepatitis in the population have reduced to a relatively low level； however， there is still a heavy disease burden of chronic viral hepatitis in China， which severely affects the health status of the population. This study systematically summarizes the achievements of viral hepatitis prevention and control in China， analyzes existing problems and challenges， and proposes comprehensive prevention and control strategies and measures to eliminate viral hepatitis as a public health threat based on the national conditions of China， in order to provide a reference for related departments in China on how to achieve the action targets for eliminating viral hepatitis as a public health threat by 2030.

OBJECTIVE: To explore the clinical phenotype and genetic characteristics of a patient with Progressive pseudorheumatoid dysplasia (PPRD) due to compound heterozygous variants of CCN6 gene. METHODS: A patient who was admitted to Qilu Hospital of Shandong University due to "bilateral finger joint deformity, bilateral hip and knee joint movement limitation for 19 years" was selected as the study subject. Clinical data of the patient were retrospectively collected. Peripheral blood samples were collected from the patient and her parents and subjected to whole exome sequencing (WES). Long-read sequencing (LRS) and Sanger sequencing were used to verify the candidate variants. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), the pathogenicity of candidate variants was classified. This study was approved by the Medical Ethics Committee of Qilu Hospital of Shandong University (Ethics No.: KYLL-202502 061). RESULTS: The patient, a 23-year-old female, presented with progressive polyarticular deformity, limited movement and abnormal growth and development since childhood. She was initially misdiagnosed as Ankylosing spondylitis and had poor response to sulphasalazine and etoricoxib treatment. WES revealed that she has harbored two heterozygous variants of the CCN6 gene (NM_198239.2), namely c.348C>A and c.676G>C. LRS confirmed that the two variants are located on two homologous chromosomes and constitute compound heterozygous variants. Based on the ACMG guidelines, both variants were rated as pathogenic (PVS1+PM2_Supporting+PM3; PM1+PM2_Supporting+PM3_Supporting+PM5+PP3_Strong). The c.676G>C variant has not been recorded by the HGMD and ClinVar databases. CONCLUSION The c.348C>A and c.676G>C compound heterozygous variants of the CCN6 gene probably underlay the pathogenesis of PPRD in this patient. Above finding has enriched the mutational spectrum of PPRD and provided a basis for the clinical diagnosis and genetic counseling.
Humans ; Female ; CCN Intercellular Signaling Proteins/genetics* ; Phenotype ; Heterozygote ; Young Adult ; Mutation ; Exome Sequencing ; Joint Diseases/congenital*

Objective To analyze the medication pattern of national patents for the prevention and treatment of Hashimoto thyroiditis by means of data mining technology,so as to provide reference for clinical diagnosis and treatment and new drug development.Methods To summarize the Chinese medicine compound patents for the prevention and treatment of Hashimoto thyroiditis in the patent database of the China National Intellectual Property Administration and the patent database of China Knowledge Network,with the search time from the establishment of the database to December 31,2024,with the help of Excel 2019,the Ancient and Modern Medical Case Cloud Platform,and other data mining software,to analyzed the frequency of use of the patented compound Chinese medicines,the properties,taste and meridian,the rules of association,the clustering of medicines,and the complex networks,and so on.Results Through screening,there were 57 patented compounds that met the inclusion criteria,involving 215 herbs,and the top 6 herbs used more frequently were Huangqi,Chaihu,Xiakucao,Baishao,Gancao and Fuling.The medicinal properties were considered to be cold,flat and warm,and the medicinal tastes were mainly bitter,sweet and pungent;the liver meridian was the most common meridian,followed by the spleen meridian and lung meridian.The cluster analysis identified a total of 4 high-frequency herb combinations,including 3 strongly associated herb pairs and 1 three-herb combination.Conclusion The basic pathogenesis of Hashimoto thyroiditis is mainly based on deficiency of vital Qi,Qi stagnation,blood stasis and phlegm coagulation at the gall,which belongs to the syndrome of deficiency of vital qi and deficiency of vital Qi.Clinically,tonifying deficiency medicines such as Huangqi,Gancao,Dangshen and Baizhu are often used to consolidate the foundation,liver-soothing and Qi-regulating medicines like Chaihu and Xiangfu,phlegm-resolving and nodule-dispersing medicines such as Xiakucao and Zhebeimu,and blood-activating and stasis-resolving medicines like Danggui,Chuanxiong and Danshen are employed to address the symptoms.This combined treatment of root and branch aims to prevent the progression of disease.

[Objective] To compare the clinical efficacy of super pulse thulium laser enucleation of the prostate (SPThuLEP) with "open tunnel" and transurethral holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic hyperplasia (BPH), in order to provide reference for the treatment options of BPH. [Methods] The clinical data of 112 BPH patients treated in our hospital during Jan.2023 and Jul.2023 were retrospectively analyzed, including 65 treated with SPThuLEP with "open tunnel" and 57 with HoLEP.The operation time, postoperative hemoglobin decrease, postoperative bladder irrigation, catheter indwelling time, hospitalization time and complications were compared between the two groups.The changes of maximum urine flow rate (Qmax), international prostate symptom score (IPSS), quality of life score (QoL), postvoid residual (PVR) and prostate-specific antigen (PSA) were compared between the two groups before operation and one month after operation. [Results] All operations were successful without conversion to open or transurethral plasmakinetic resection.The postoperative decrease of hemoglobin in SPThuLEP group was lower than that in HoLEP group [(13.12±6.72) g/L vs. (21.02±6.51) g/L], with statistical difference (P<0.05). There were no significant differences in the operation time [(63.35±15.73) min vs.(61.02±17.55) min], postoperative bladder irrigation time [(1.07±0.45) d vs. (1.06±0.36) d], catheter indwelling time [(2.98±0.56) d vs. (3.01±0.63) d] and hospitalization time [(3.63±0.61) d vs.(3.79±0.76) d] between the two groups (P>0.05). No blood transfusion, secondary bleeding or unplanned hospitalization occurred, and there were no serious complications such as transurethral electroresection syndrome (TURS), urethral stricture and urinary incontinence.One month after operation, the Qmax, IPSS, QoL, PVR and PSA of the two groups were significantly improved compared with those before operation (P<0.05), but with no statistical difference between the two groups (P>0.05). [Conclusion] SPThuLEP with "open tunnel" has comparable efficacy as HoLEP in the treatment of BPH.With advantages of small amount of bleeding and high safety, this minimally invasive technique can be widely popularized in clinical practice.

Objective:To investigate the construction and existing problems of radiotherapy departments in non-public hospitals in Beijing, and to propose improvement suggestions.Methods:An electronic questionnaire survey of 2023 medical education and research situation of the radiotherapy departments of 8 non-public hospitals in Beijing was conducted from March 2024 to June 2024, and on-site quality control supervision and inspection were conducted. The survey covered the equipment allocation, the educational background, professional title, age, working experience of radiotherapy-related personnel, and the operation of the hospital, etc. The questionable questionnaires were reviewed by telephone. The quality control method of entry was double entry and cross-checking. Frequency and composition ratio were used for statistical description. Results:The radiation oncology departments of 8 non-public hospitals in Beijing were mainly located in the main urban areas and suburbs. There were 105 radiotherapy practitioners, including 37 radiation oncologists, 19 medical physicists (14 with intermediate titles) and 49 radiotherapists (42 with junior titles, accounting for 86%). The medical teams of 5 hospitals lacked of a 3-level professional title echelon. A total of 67% (33/49) of radiotherapists had ≤ 5 years of working experience. There were 10 medical linear accelerators, 2 sets of after-loading radiotherapy equipment, 8 sets of CT simulation positioning equipment, 1 X-ray simulation positioning machine, and 35 sets of radiotherapy quality control instruments. Conformal intensity-modulated radiotherapy and volumetric arc-modulated radiotherapy could be simultaneously carried out in 8 hospitals. In 2023, 5010 patients were treated with medical linear accelerators and 171 patients were treated with after-loading radiotherapy. Two hospitals carried out scientific research, 1 hospital accepted trainees, and 2 hospitals provided teaching for interns. The results of quality control supervision and inspection showed that the equipment from 8 non-public hospitals could basically meet the needs of radiotherapy and daily equipment quality control.Conclusions:The organizational structure of radiotherapy departments in non-public hospitals in Beijing are generally reasonable, with relatively complete equipment and personnel configurations. However, multiple issues such as an insufficient number of personnel, unbalanced personnel structures, lack of work experience, low professional titles, and inadequate research and teaching capabilities still exist, which require further improvements.

Objective:To investigate the clinical application of internal mammary perforator (IMP) as recipient vessels in immediate breast reconstruction using deep inferior epigastric perforator (DIEP) flap.Methods:The clinical data of 10 patients with early breast cancer who underwent DIEP for immediate breast reconstruction using IMP as the recipient vessels from January 2022 to December 2023 were analyzed. The number, position, and diameter of IMP, diameter of DIEP, the size of the flap, the operation time, surgical complications, cosmetic effect of breast, and patients' satisfaction were summarized and analyzed.Results:The number of IMPs was 2-3, and they were distributed in the second to the fourth ribs. The diameter of the IMP artery was (1.15±0.22) mm, and the diameter of the vein was (1.35±0.19) mm. The diameter of the DIEP was (1.55±0.28) mm, and that of its accompanying vein was (1.50±0.23) mm. The sizes of the flaps ranged from 10.0 cm×8.0 cm×3.0 cm to 12.0 cm×22.0 cm×4.0 cm, with an average of 20.5 cm×11.2 cm×2.8 cm. The weight of the flap was (389.1±51.5) g. The operation time was (574.8±68.1) min. All 10 cases of flaps survived. The reconstructed breasts were natural, soft, and symmetrical to the healthy side breasts. There was no obvious operative complication. The average BREAST-Q score of the patients was 93.5. No recurrence or metastasis was found during follow-up.Conclusions:Although technically difficult, using IMP as recipient vessels in DIEP flats for immediate breast reconstruction results in a low complication rate of the injuries in the internal mammary region. Under the premise of strictly adhering to the surgical indications, satisfactory results can be achieved, and it is safe and reliable.

Objective:Primary sclerosing cholangitis (PSC) is a rare autoimmune disease. This study aims to describe the baseline characteristics and clinical outcomes of Chinese PSC patients and explore risk factors associated with prognosis, addressing the lack of long-term prognostic analysis in China.Methods:Clinical data of PSC patients were retrospectively collected from May 2009 to June 2023 in Beijing Friendship Hospital Affiliated to Capital Medical University, and patient follow-up was conducted through outpatient visits, telephone calls, and medical record reviews. The Cox proportional hazards model and the Kaplan-Meier method were employed to identify risk factors and estimate transplant-free survival.Results:A total of 65 PSC patients were enrolled, with male patients accounting for 50.8% and an average age of onset of 44 years. The disease types primarily included large duct PSC (57.9%) and whole duct PSC (22.8%). Most patients (78.5%) sought medical attention due to symptoms, with common clinical manifestations including jaundice (32.3%), fatigue (23.1%), abdominal discomfort (21.5%), pruritus (16.9%), and fever (10.8%). A total of 19 patients (29.2%) had concomitant ulcerative colitis. Compared to large duct PSC or whole duct PSC, small duct PSC showed a lower proportion of concomitant ulcerative colitis ( P<0.001) and milder baseline disease severity. After a median follow-up of 29 months (interquartile range: 11,53), 19 patients experienced liver transplantations and/or liver disease-related deaths. The overall 2-year and 5-year transplant-free survival rates for PSC patients were 76.0% and 59.5%, respectively. Elevated bile acid levels were identified as an independent risk factor for poor outcomes in PSC patients. Conclusion:The study population of Chinese PSC patients predominantly consisted of middle-aged males, characterized by a low ratio of asymptomatic cases, a low incidence of associated inflammatory bowel disease, and a low rate of transplant-free survival. Elevated bile acid level was identified as an independent risk factor for poor outcomes in PSC patients.

Objective:To explore the distribution characteristics of HBsAg levels in treatment-na?ve and treatment-experienced patients with chronic hepatitis B (CHB) in China.Methods:Data were obtained from the China Registry of Hepatitis B (CR-HepB) platform from the establishment of the platform to April 11, 2024. Patients with CHB who were treatment-na?ve and treatment-experienced with nucleos(t)ide analogs (NAs) were included. Relevant clinical data were collected. The distribution of hepatitis B surface antigen (HBsAg) status, as well as the levels in populations of different age groups after different antiviral treatment durations, were retrospectively analyzed. Normally and non-normally distributed measured data were represented by Mean± SD, and M( Q1, Q3). Results:A total of 13 505 treatment-na?ve patients and 6 390 treatment-experienced patients were included in the analysis. The proportions of treatment-na?ve patients with HBsAg<100, <500, and <1 500 IU/mL were 10.51%, 28.47%, and 46.85%, and the corresponding proportions of treatment-experienced patients were 12.88%, 29.84%, and 52.07%. The proportions of treatment-na?ve patients with HBsAg levels≥1 500, ≥3 000, and≥8 000 IU/mL were 53.15%, 38.17%, and 15.62%, and the corresponding proportions of treatment-experienced patients were 47.93%, 31.77%, and 10.39%. HBsAg level showed a trend of gradual decrease with the increase of antiviral treatment time. The proportion of treatment-experienced patients with HBsAg<100 IU/mL increased from 12.73% when the treatment duration was less than three years to 26.92% when the treatment duration was≥10 years, while the proportion of patients with HBsAg levels≥3 000 IU/mL or≥8 000 IU/mL decreased from 34.66% to 23.08% and from 12.19% to 5.77%, respectively. The proportion of patients with HBsAg<100, <500, and<1 500 IU/mL increased with age, while the proportion of patients with HBsAg≥1 500, ≥3 000, and ≥8 000 IU/mL decreased sequentially.Conclusions:The CR-HepB platform provides a basis for clarifying the serum HBsAg levels in treatment-na?ve and treatment-experienced CHB patients in China. The HBsAg status indicates that with a prolonged antiviral treatment duration, there is a gradual decline trend in HBsAg level.