Reference materials play a significant role in enhancing the comparability and accuracy of clinical immunogenicity test results for vaccines. The World Health Organization(WHO) and China have issued many antibody reference standards for evaluating antibody induced by vaccines in clinical phase and infectious disease pathogen infections, which provide a critical material basis for the quantitative detection of antibodies induced by vaccines in clinical phase and serological surveillance. In 2022, the WHO published manuals for the preparation of reference materials, such as “WHO manual for the preparation of reference materials for use as secondary standards in antibody testing”, to improve the development level of antibody reference materials. Recently, the General Chapter 0237 the Preparation and Establishment of National Biological Reference Standards in Chinese Pharmacopoeia 2025 Volume Ⅲ has been revised referring to the WHO manuals mentioned above, and puts forward relevant requirements for the key points of the development of biological reference materials including antibody reference materials, emphasizing the preset criterion, statistical models and uncertainty. It calls for attention to commutability and stability studies and monitoring based on the lifecycle of reference materials. This paper summarizes relevant guidelines and pharmacopoeia requirements, and proposes suggestions for the establishment and application of antibody reference materials in clinical trials for human vaccines in China.

The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.

Shengjiangsan is a classic formula for treating warm diseases with wide clinical application and accurate efficacy. There are different opinions on the origin of this formula and lacks key information research on this formula. Therefore， in this study， we conducted systematic research into the historic origin， composition， and other key information of this Shengjiangsan. Results showed that Shengjiangsan has different versions， with "Neixian Fufang"， "Jiawei Jianghuangwan"， "Peizhensan"， and "Taijiwan" being the same formula with different names. Shengjiangsan was first recorded as "Neixian Fufang" in Wanbing Huichun written by GONG Tingxian from the Ming dynasty， inherited and developed by YANG Lishan from Qing dynasty， and has been passed down to modern times. Pills and powder are two main forms of Shengjiangsan， and powder has become more popular nowadays. According to the measurement system of Ming and Qing dynasties， the recommended dosage and usage of Shengjiangsan are as follows. For the pill version of Shengjiangsan， Bombyx Batryticatus of 74.6 g， Curcumae Longae Rhizoma of 9.325 g， Cicadae Periostracum of 9.325 g， and Rhei Radix et Rhizoma of 149.2 g were processed into pills for preparation. Single dosage is Bombyx Batryticatus of 1.15 g， Curcumae Longae Rhizoma of 0.14 g， Cicadae Periostracum of 0.14 g， and Rhei Radix et Rhizoma of 2.3 g， with halved dosage applied for children. For the powder version of Shengjiangsan， the dosage varied in accordance with the severity of the disease. Bombyx Batryticatus of 1.84 g， Curcumae Longae Rhizoma of 0.28 g， Cicadae Periostracum of 0.92 g， and Rhei Radix et Rhizoma of 3.68 g were processed into powder for patients with mild symptoms. Bombyx Batryticatus of 2.48 g， Curcumae Longae Rhizoma of 0.37 g， Cicadae Periostracum of 1.23 g， and Rhei Radix et Rhizoma of 4.91 g were processed into powder for patients with severe symptoms. Bombyx Batryticatus of 3.68 g， Curcumae Longae Rhizoma of 1.84 g， Cicadae Periostracum of 0.55 g， and Rhei Radix et Rhizoma of 7.36 g were processed into powder for patients with critical conditions. In this formula， four herbs were ground to fine powder. For patients with mild symptoms， the whole formula was divided into four dosages， and each dosage weighed 6.71 g. The 200 mL yellow rice wine and 18.65 g honey were added， and the solution was stirred and taken cold till full recovery. For patients with severe symptoms， the whole formula was divided into three dosages， and each weighed 8.95 g. 300 mL yellow rice wine and 27.98 g honey were added， and the solution was stirred and taken cold. For patients with critical conditions， the whole formula was divided into two dosages， and each weighed 13.43 g. 400 mL yellow rice wine and 37.3 g honey were added， and the solution was stirred and taken cold. Shengjiangsan has the effect of ascending lucidity and descending turbidity， dissipating wind， and clearing heat. It is specialized in treating severe heat in exterior， interior， and triple energizers in warm diseases and has a wide modern clinical application. In this study， the historic evolution and key information of Shengjiangsan were reviewed and analyzed， and the key information table of Shengjiangsan was attached， serving as a reference for scholars' research and a theoretical basis for its market transformation.

Reference material is a kind of criteria“ruler”for the quality control and evaluation of biological products. WorldHealth Organization(WHO) technical reports and guidelines, China's management regulations about biological referencematerials and Chinese Pharmacopoeia play an important guiding role in the development,distribution and use of standards. Inorder to meet the needs of the development of the biological product industry, WHO guidelines and Chinese national manage-ment regulations about biological reference materials have been revised for several times. This paper summarizes the evolu-tion and current situation of the definition, classification and technical requirements for WHO international biological stan-dards and national biological standards in China, aiming to further improve the preparation and application of national biologi-cal reference materials in China.

OBJECTIVE To investigate the effects of alirocumab combined with atorvastatin on clinical efficacy and safety of patients with acute coronary syndrome （ACS） who underwent percutaneous coronary intervention （PCI）. METHODS A total of 207 patients with ACS who underwent PCI in our hospital from January 2021 to December 2023 were randomly divided into alirocumab group， ezetimibe group and control group， with 69 cases in each group. All patients received routine thrombosis prevention and antihypertensive treatment after PCI. On this basis， patients in the control group were treated with atorvastatin （20 mg/time， once a day）； patients in the ezetimibe group were treated with ezetimibe （10 mg/time， once a day） + atorvastatin （20 mg/time， once a day）； patients in the alirocumab group were treated with alirocumab （75 mg/time， once every 2 weeks） + atorvastatin （20 mg/time， once a day）. All patients in the three groups were treated for 8 weeks and followed up for another 6 months after treatment. The levels of cardiac function and lipid metabolism indices before and after treatment， as well as the occurrence of major adverse cardiovascular event （MACE） and other adverse drug reaction （ADR） during the follow-up period were compared among the three groups. RESULTS After treatment for 8 weeks， the levels of cardiac function and lipid metabolism indices in the three groups were significantly improved compared with those before treatment （P＜0.05）. Compared with the control group and ezetimibe group， the left ventricular ejection fraction in the alirocumab group was significantly increased， and the left ventricular end-diastolic diameter （LVEDD） was significantly shortened （P＜0.05）. Compared with control group， LVEDD of ezetimibe group was significantly shortened （P＜0.05）， the levels of total cholesterol， triglyceride and low-density lipoprotein cholesterol in the alirocumab group and ezetimibe group were significantly decreased （P＜0.05）. During the follow-up period， there was no significant difference in the total incidence of MACE and the total incidence of other ADR such as headache and abdominal pain among the three groups （P＞0.05）. CONCLUSIONS Alirocumab combined with atorvastatin can significantly improve cardiac function and regulate lipid metabolism indices in patients with ACS after PCI without increasing the risk of MACE or other ADR.

BACKGROUND: Whether adherence to a healthy lifestyle is associated with a lower risk of developing pneumonia and a better long-term prognosis remains unclear. This study aimed to investigate associations of individual and combined lifestyle factors (LFs) with the incidence risk and long-term prognosis of pneumonia hospitalization. METHODS: Using data from the China Kadoorie Biobank study, we used the multistate models to investigate the role of five high-risk LFs, including smoking, excessive alcohol drinking, unhealthy dietary habits, physical inactivity, and unhealthy body shape, alone or in combination in the transitions from a generally healthy state at baseline to pneumonia hospitalization or cardiovascular disease (CVD, regarded as a reference outcome), and subsequently to mortality. RESULTS: Most of the five high-risk LFs were associated with increased risks of transitions from baseline to pneumonia and from pneumonia to death, but with different risk estimates. The greater the number of high-risk LFs, the higher the risk of developing pneumonia and long-term mortality risk after pneumonia, with the strength of associations comparable to that of LFs and CVD. Compared to participants with 0-1 high-risk LF, the adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for transitions from baseline to pneumonia and from pneumonia to death in those with five high-risk LFs were 1.43 (1.28-1.60) and 1.98 (1.61-2.42), respectively. Correspondingly, the respective HRs (95% CIs) for transitions from baseline to CVD and from CVD to death were 2.00 (1.89-2.11) and 1.44 (1.30-1.59), respectively. The risk estimates changed slightly when further adjusting for the presence of major chronic diseases. CONCLUSION In this Chinese population, unhealthy LFs were associated with an increased incidence and long-term mortality risk of pneumonia.
Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Cardiovascular Diseases/etiology* ; China/epidemiology* ; Life Style ; Pneumonia/etiology* ; Prognosis ; Risk Factors ; Smoking

Stability represents a critical quality attribute of reference materials. To ensure the stability of biological reference standards, World Health Organization(WHO) has continuously refined and elaborated the stability requirements in guidelines for both international(primary) and national(secondary) biological reference materials, aiming to enhance the scientificity and operability of stability studies and monitoring. Based on a summarization of the WHO guidelines on stability studies for biological reference standards and case studies of international reference standards development documented in the literature, this paper proposes considerations and recommendations for improving stability studies and stability monitoring of national biological reference standards in China.

First recorded in an official medical book from the Northern Song Dynasty called Taiping Huimin Heji Ju Fang （Prescriptions of the Bureau of Taiping People's Welfare Pharmacy）， Xiaoyaosan has been developed and refined over generations and is preserved to this day. It specializes in soothing the liver，resolving stagnation，fortifying the spleen，and nourishing blood. In this study，ancient traditional Chinese medicine （TCM） books and contemporary studies were reviewed to obtain information on Xiaoyaosan using bibliometrics，including its historical development，dosage，origin，processing methods，decoction dosage，and ancient and modern indications. Furthermore，a question regarding the presence of Zingiberis Rhizoma Recens and Menthae Haplocalycis Herba in Xiaoyaosan was investigated，and a table of key information on Xiaoyaosan was compiled，providing references for developing Xiaoyaosan preparations. According to the weight and measurement system of the Song dynasty，the contemporary equivalent formulation of the decocted Xiaoyaosan consists of 20.65 g of Glycyrrhizae Radix et Rhizoma and 41.3 g of Angelica Sinensis Radix，Poria，Paeoniae Radix Alba，Atractylodis Macrocephalae Rhizoma，and Bupleuri Radix. The formulation is processed to obtain a mixed powder with a particle size of 10 mesh. For each dose，8.25 g of the mixed powder is combined with 1 g of unprocessed Zingiberis Rhizoma Recens and 0.62 g of Menthae Haplocalycis Herba in 300 mL of water. The mixture is decocted until the volume reaches 210 mL，and the residue is then removed，with no specific timing required for administration. After the processing，each dose consists of approximately 0.75 g of Glycyrrhizae Radix et Rhizoma and 1.50 g of Radix Angelica Sinensis，Poria，Paeoniae Radix Alba，Atractylodis Macrocephalae Rhizoma，and Bupleuri Radix. Ancient medical literature shows that Xiaoyaosan primarily treats blood deficiency and overstrain，specifically for symptoms including heat caused by blood deficiency and fatigue，irregular menstruation，headache，eye soreness，pain in the ribs and limbs，and emaciation and bone steaming. In the Qing Dynasty，ZHANG Lu clearly proposed the pathogenesis of liver depression，and since then，the use of Xiaoyaosan in treating various syndromes associated with liver depression has been highly praised by physicians in the Qing dynasty and modern times. Xiaoyaosan has a wide application in modern clinical practices，involving digestive diseases，gynecological diseases，psychological diseases，nervous system diseases，and otorhinolaryngologic diseases. Moreover，it is most commonly used to treat depression and other diseases complicated with depression，hyperplasia of the mammary gland，etc. The key information on Xiaoyaosan and its clinical applications in ancient and modern times investigated in the study could serve as a scientific reference for in-depth research and extended clinical applications of the prescription.

Cleft lip and palate (CLP) are common congenital craniofacial developmental disorders with a high incidence rate among newborns. Due to the influence of the cleft, an increased frequency of anomalies occurs in cleft-adjacent teeth. This review summarizes the abnormality of tooth development and malposition characteristics of the central incisors, lateral incisors, and canines adjacent to the alveolar cleft in CLP patients and treatment progress in order to provide information for related clinical treatment and research. The literature reveals that central incisors, lateral incisors, and canines adjacent to the alveolar cleft exhibit various types and degrees of abnormalities. The alveolar cleft-adjacent central incisors show significantly smaller mesiodistal diameters, root lengths, and root volumes compared to the non-alveolar cleft side, while the crown-to-root ratio is larger. Further, they are inclined distally and lingually compared to the non-alveolar cleft side. The alveolar cleft-adjacent lateral incisor is the most common missing or impacted tooth and is often affected by microdontia. The total length and root length of the alveolar cleft-adjacent canines are significantly smaller, while the crown-to-root ratio is larger on the alveolar cleft side. In addition, they are inclined mesially and buccally compared to the non-alveolar cleft side. Further, they are higher positioned and located closer to the midline. For developmental anomalies, impacted central incisors can be addressed by orthodontic space preparation to facilitate eruption or surgical crown exposure and orthodontic traction. Treatment of missing lateral incisors can involve orthodontic closure of the gap or preservation of the space for subsequent prosthetic restoration. When lateral incisors present with developmental defects, such as microdontia, peg-shaped teeth, or invaginated teeth, a comprehensive decision is necessary to determine whether to retain and restore or extract the malformed lateral incisors. Treatment of impacted canines after bone grafting involves either extraction or traction to facilitate the eruption of the impacted tooth. For malposition, presurgical orthodontic treatment can correct teeth with excessive inclination or rotation on the cleft side to improve the effectiveness of bone grafting surgery. Postsurgical orthodontic treatment can enhance the stability of bone grafting surgery. Although numerous studies have explored the dental characteristics of patients with CLP, the lack of applicability and specificity still need to be elucidated, thus indicating the need for further research.

Qingfeitang， specialized in resolving phlegm to stop cough and producing fluid to moisten dryness， is a classic prescription inherited and developed by physicians of successive generations and has been included in the Catalogue of Ancient Classic Prescriptions （First Batch） published by the National Administration of Traditional Chinese Medicine （TCM） in 2018. Relevant ancient books data and modern literature were collected by bibliometrics to analyze the historic origin， formula composition， herb origin， preparation methods， processing methods， clinical effect， and indications of Qingfeitang. The key information of Qingfeitang was summarized to provide reference for the clinical application of the decoction. In this study， a total of 43 pieces of effective data on relevant ancient literature， including 35 ancient TCM books， were collected based on a systematic collation of relevant historic and modern literature. Results showed that "Qingfeitang" was originated from the "Renshen Qingfeitang" recorded in the Taiping Holy Prescriptions for Universal Relief from the Qing dynasty. The name of "Qinfeitang" was first recorded in the Yeshi Luyanfang written by YE Dalian in the Song dynasty. We suggested the modern dosage and usage of Qingfeitang as follows： "Scutellariae Radix of 5.60 g， Platycodon grandiflora， Poria， Tangerine， Fritillaria， and Cortex Mori of 3.73 g respectively， Angelicae Sinensis Radix， Asparagi Radix， Gardeniae Fructus， Armeniacae Semen Amarum， and Ophiopogonis Radix of 2.61 g respectively， Schisandra of 1 g， and Glycyrrhizae Radix et Rhizoma of 1.12 g， and they were taken 3 times daily. The above formula is recommended to be decocted with 400 mL of water， with 3.37 g ginger and 6 g jujubae fructus， to 320 mL， and taken after a meal， three times per day". Qingfeitang has the effect of resolving phlegm to stop cough and producing fluid to moisten dryness， specialized in treating cough， asthma， rash， and other symptoms in ancient times. Modern applications are mainly focused on the respiratory system， used for treating diseases such as bronchopneumonia and cough. The above research results provide a reference basis for the later development and research of Qingfeitang.