By reviewing the research history on quality comparison between wild and cultivated Chinese crude drugs， this paper systematically combed the relevant research reports since the 1950s， and summarized and analyzed the results of existing comparative studies， and found that the existing comparative research on the quality of wild and cultivated Chinese crude drugs were mainly focused on several aspects， including characteristics， microstructures， chemical compositions， pharmacodynamic effects， and genetic diversity. Among these， comparative studies of chemical compositions have been the dominant approach， with a particular emphasis on comparing the contents of index components. However， research on pharmacodynamic effects remained relatively limited. Due to various factors such as sample quantity， sample origin， growth period and cultivation methods， the differences in quality between wild and cultivated Chinese crude drugs vary significantly. In general， most wild Chinese crude drugs exhibited higher quality than cultivated products， with significant differences in their characteristics. The contents and proportions of some chemical components underwent noticeable changes， particularly with a marked increase in the proportion of primary metabolites after cultivation. The quality of cultivated Chinese crude drugs is closely related to the cultivation practices employed. Chinese crude drugs produced through wild nurturing， simulated wild planting， ecological cultivation， and other similar methods demonstrate quality levels comparable to those of wild Chinese crude drugs. Based on the analysis results， it is recommended to explicitly specify the cultivation practices and cultivation period of cultivated Chinese crude drugs in comparative studies of the quality between wild and cultivated Chinese crude drugs. Multiple technical approaches， including characteristics， microscopy， non-targeted metabolomics combined with quantitative analysis of differential components， and bioefficacy evaluation， should be employed to comprehensively assess the quality disparities between wild and cultivated Chinese crude drugs. Moreover， research efforts should be intensified to investigate the changes in pharmacodynamic effects resulting from differences in plant cell wall composition， primary metabolites， and secondary metabolites， in order to guide the production of high-quality Chinese crude drugs.

ObjectiveBased on the quality evaluation experience of "it is better to have a fragrant and strong aroma" summarized by materia medica of past dynasties， the chemical components of Sojae Semen Nigrum（SSN） and Sojae Semen Praeparatum（SSP） were systematically compared and analyzed， and the main fermentation products in different fermentation time were quantitatively analyzed， so as to clarify the transformation law of internal components in the processing process and provide scientific basis for the modern quality control of SSP. MethodUltra performance liquid chromatography-quadrupole tandem time-of-flight mass spectrometry（UPLC-Q-TOF-MS） was used for the structural identification of the chemical constituents of SSN and SSP， and with the aid of Progenesis QI v2.3 software， the negative ion mode was employed for principal component analysis（PCA） pattern recognition， and the data were analyzed with the aid of orthogonal partial least squares-discriminant analysis（OPLS-DA） for two-dimensional data to obtain S-plot， and components with |P|>0.1 were selected as the differential constituents. The contents of isoflavonoids in SSP during fermentation was determined by UPLC， and the samples were taken every 8 h in the pre-fermentation period and every 2 d in the post-fermentation period， and the dynamic changes of isoflavonoid contents in different fermentation stages were analyzed. The contents of amino acids and nucleosides in SSP and SSN from different fermentation stages were quantitatively analyzed by phenyl isothiocyanate（PITC） pre-column derivatization and high performance liquid chromatography（HPLC） gradient elution， and the contribution of flavor substances to the "delicious" taste of SSP was discussed by taste intensity value（TAV）. ResultA total of 19 kinds of differential components were screened out， mainly soybean saponins and isoflavones， and their contents decreased significantly or even disappeared after fermentation. In the pre-fermentation process of SSP， glycoside bond hydrolysis mainly occurred， and isoflavone glycosides in SSN were degraded and converted into the corresponding aglycones， the content of flavor substances such as amino acids increased gradually. In the post-fermentation process， protein degradation mainly occurred， after 8 d of post-fermentation， the content of isoflavones was basically stable， while the total content of amino acids increased by 8-40 times on average. Different amino acids form the special flavor of SSP， such as the TAV of glutamate is always ahead of other flavor substances， and sweet substances such as alanine and valine have made relatively great contributions to SSP. ConclusionBased on the law of constituent transformation， combined with the traditional evaluation index of "fragrant and strong"， it is difficult to control the fermentation degree of SSP by the existing standards in the 2020 edition of Chinese Pharmacopoeia. It is suggested that description of the characteristics of SSP be refined and changed to "fragrant， delicious and slightly sweet"， and at the same time， the post-fermentation index compounds such as glutamic acid， alanine and valine should be added as the quality control indicators of SSP， so as to standardize the production process and improve the quality of SSP.

Objective:The drug-resistant genes carried by carbapenem-resistant Klebsiella pneumoniae(CRKP)limit clinical treatment options,and its virulence genes severely affect patient prognosis.This study aims to investigate the distribution of virulence genes,capsular serotypes,and molecular epidemiological characteristics of CRKP in ICU,to understand the characteristics of CRKP infections in ICU,and to provide a scientific basis for effective monitoring and control of CRKP infections in ICU. Methods:A total of 40 non-duplicate strains of CRKP isolated from the ICU of Guangdong Provincial People's Hospital between January 2021 and December 2022 were collected and analyzed.Whole-genome sequencing was used to analyze the distribution of resistance genes,virulence genes,and capsular serotypes of the strains.The sequences of 7 housekeeping genes of CRKP genome were uploaded to the Klebsiella pneumoniae(KPN)multilocus sequence typing(MLST)database to determine the sequence types(STs)of the strains. Results:The age of the 40 ICU CRKP-infected patients was(69.03±17.82)years old,with various underlying diseases,and there were 20 patients with improved clinical outcome and 20 patients with death.The isolated strains primarily originated from mid-stream urine and bronchoalveolar lavage fluid.Whole-genome sequencing results revealed that the strains predominantly carried blaKPC-1(29 strains,72.5%)and blaNDM-1(6 strains,15.0%),with 5 strains carrying both blaKPC-1 and blaNDM-1.Various virulence genes were detected,among which the carriage rates of genes such as entA,entB,entE,entS,fepA,fepC,fepG,yag/ecp,and ompA reached 100%,while the carriage rates of genes such as entD,fimB,iroB,iroD,fes,and pla were low.The CRKP strains isolated from ICU were predominantly ST11(27 cases,67.5%),with KL64 being the main capsular serotype(29 cases,72.5%).A total of 23 ST11-KL64 CRKP strains were detected,accounting for 57.5%. Conclusion:The main type of ICU CRKP is ST11-KL64,carrying various virulence genes,primarily those related to iron absorption.Furthermore,blaKPC has shifted from blaKPC-2 to blaKPC-1.Therefore,close monitoring of the molecular epidemiological changes of CRKP is necessary,and strict control measures should be implemented to effectively curb the occurrence of CRKP infections.

Objective:To explore the value of jellyfish sign, an abnormal ultrasonographic sign, in predicting adverse perinatal outcomes of women with complete placenta previa combined with placenta accreta spectrum disorders (PAS).Methods:This retrospective study analyzed the ultrasound images of 72 singleton gravidas, diagnosed with complete placenta previa combined with PAS, who underwent cesarean section at the First Affiliated Hospital of Nanjing Medical University between January 2020 and February 2023. Based on the presence and absence of the jellyfish sign in ultrasound images, these gravidas were divided into the jellyfish-sign group (15 cases, 20.8%) and the non-jellyfish-sign group (57 cases, 79.2%). The clinical data and perinatal outcomes of the two groups were analyzed. The adverse perinatal outcomes encompassed conditions such as abdominal aorta balloon block, uterine artery embolism, hysterectomy, postpartum hemorrhage, and neonatal intensive care unit (NICU) admission of their neonates. Statistical analysis was performed using two independent samples t-test, the Mann-Whitney U test and the Chi-square (or Fisher's exact) test. Results:(1) The jellyfish-sign group exhibited a higher parity [(1.6±0.7) times vs (1.2±0.6) times, t=2.01] and higher prenatal scores of placenta accreta [(12.3±1.5) scores vs (8.6±2.9) scores, t=6.59] than those in the non-jellyfish-sign group (both P<0.05). Among the 57 cases in the non-jellyfish-sign group, there were 14 cases of placenta creta (24.6%), 40 cases of placenta increta (70.2%), and three cases of placenta percreta (5.3%). Among the 15 cases in the jellyfish-sign group, nine cases were diagnosed with placenta increta, six with placenta percreta, and none with placenta creta. The difference in distribution between the two groups was statistically significant (Fisher's exact test, P<0.001). (2) Intraoperative blood loss [(for those who accepted abdominal aorta balloon block, 1 973±1 057) ml vs (1 211±576) ml, t=2.55], red blood cells transfused [4.0 U (2.0-23.0 U) vs 2.5 U (0.0-11.0 U), Z=－2.53], postoperative hospitalization time [(9.7±2.4) vs (7.5±2.2) d, t=3.36], the incidence of abdominal aorta balloon block [15/15 vs 38.6% (22/57), χ2=17.92], uterine artery embolism [for those who accepted abdominal aorta balloon block, 3/15 vs 1.8% (1/57), Fisher's exact test], and requiring blood transfusion [15/15 vs 63.2% (36/57), Fisher's exact test] were higher in the jellyfish-sign group than those in the non-jellyfish-sign group. However, the non-jellyfish-sign group had lower gestational age at delivery [(33.6±1.5) weeks vs (35.2±1.8) weeks, t=－3.24], and lower neonatal Apgar score at 1 min and 5 min [1 min: 8 scores (3-10 scores) vs 9 scores (4-10 scores), Z=－2.46; 5 min: 9 scores (7-10 scores) vs 10 scores (6-10 scores), Z=－2.02] (all P<0.05). There were no significant differences in emergency surgery rate, 24 h postoperative blood loss, neonatal birth weight, and proportion of NICU admission between the two groups. Additionally, no cases of hysterectomy or death were observed in the two groups. Conclusions:Ultrasound examination revealing jellyfish signs in patients with complete placenta previa and PAS is associated with an increased likelihood of adverse perinatal outcomes. Consequently, the management of these patients should be given greater attention.

Anticoagulation drugs should be used for patients with mechanical heart valve (MHV) in case of potential risk of thrombosis. Pregnant women with MHV have to change therapies due to teratogenic effect of some anti-coagulation drugs. European Society of Cardiology clinical guidelines for the management of cardiovascular diseases during pregnancy gives specific suggestions for anticoagulation therapy.We have treated 2 patients with mechanical heart valve thrombosis (MVT) during pregnancy: One received low molecular weight heparin (LMWH) throughout the pregnancy and developed MVT at the third trimester of pregnancy; one developed MVT at the first trimester when replacing vitamin K antagonists (VKA) with LMWH. These patients raised secondary reflection on the balance between clinical guideline and personalized medicine. During LMWH therapy, we should dynamically monitor patients' anti-activated factor X (anti-Xa) level to evaluate coagulation function during pregnancy. When a pregnant woman with MHV develops symptoms of acute heart failure, stuck mechanical valve should be paid attention to and surgery should be promptly performed if necessary.
Anticoagulants/adverse effects* ; Female ; Heart Valve Prosthesis/adverse effects* ; Heart Valves ; Heparin, Low-Molecular-Weight/adverse effects* ; Humans ; Pregnancy ; Pregnancy Complications, Cardiovascular/drug therapy* ; Thrombosis/drug therapy*

Review the literature on the economic evaluation of PCV-10, PCV-13 and PPSV-23 for providing references for decision-making and research in China. A total of 17 literatures were included, and the basic information to descriptive characteristics, methodology, modeling and the results were extracted. The 14 studies adopted Markov model, 2 studies adopted decision tree model and 1 study adopted probabilistic model. The cost including vaccine price and administration costs, direct medical expenses and indirect lost. All the 17 studies use QALY as the outcome, some studies also use LYG as the outcome. 9 of 13 studies (69.2%) involving people over the age of 50 concluded that pneumococcal vaccination was cost-effective. To provide effective references for decision-makers, China should collect the relevant epidemiological parameters, vaccine effect of pneumococcal disease in the Chinese population and carry out the economic evaluation of pneumococcal vaccination.

Review the literature on the economic evaluation of PCV-10, PCV-13 and PPSV-23 for providing references for decision-making and research in China. A total of 17 literatures were included, and the basic information to descriptive characteristics, methodology, modeling and the results were extracted. The 14 studies adopted Markov model, 2 studies adopted decision tree model and 1 study adopted probabilistic model. The cost including vaccine price and administration costs, direct medical expenses and indirect lost. All the 17 studies use QALY as the outcome, some studies also use LYG as the outcome. 9 of 13 studies (69.2%) involving people over the age of 50 concluded that pneumococcal vaccination was cost-effective. To provide effective references for decision-makers, China should collect the relevant epidemiological parameters, vaccine effect of pneumococcal disease in the Chinese population and carry out the economic evaluation of pneumococcal vaccination.

On March 11, 2020, WHO officially declared that COVID-19 had become Pandemic. As of March 31, the epidemic had affected more than 178 countries and regions, with more than 780 000 confirmed cases. The Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits (the 'PIP Framework’ or 'Framework’) is an international arrangement adopted by the World Health Assembly (WHA) in May 2011 to improve global pandemic influenza preparedness and response. Since the transmission route and transmission capacity of COVID-19 are similar to that of influenza A (H1N1) in 2009, which conforms to the basic elements of 'human pandemic', and the epidemic scale has exceeded that of influenza A (H1N1). It is probable to incorporate COVID-19 epidemic response into PIPF, and at the same time to verify and improve PIPF in practice. It is recommended that WHO, other international organizations and relevant countries make full use of the PIPF system to respond to the epidemic and better coordinate national actions at the global level. At the same time, China should also make the planning and deploy of domestic epidemic prevention and control and international epidemic cooperation under the framework.

Objective:To evalute the accuracy and clinical outcome of a real-time navigation system for the placement of quad zygomatic implants.Methods:Twenty-four patients [9 males and 15 females, mean age was (50.8±14.7) years old], from January 2015 to December 2019, with 96 zygomatic implants placed under a real-time navigation system in Department of Second Dental Center and Department of Oral Implantology of Ninth People′s Hospital, Shanghai Jiaotong University School of Medicine were included in the study. The preoperative and the postoperative multislice CT or cone-beam CT were fused to measure and record the entry, exit and angle deviation between the planned and placed implants. The implants were divided into groups according to implant insertion approach (real-time navigation and free-hand), implant length (<47.5 mm and ≥47.5 mm) and implant position (proximal and distal implant). And the differences of implant accuracy were analyzed. The intraoperative and postoperative complications were also recorded. The implant survival rate was evaluated after 6 months follow-up. A P value<0.05 indicates statistical significance. Results:The mean entry, exit and angle deviation of zygomatic implants were (1.49±0.64) mm, [2.03(1.58, 2.40)] mm and (2.49°±1.12°), respectively. The average entry, exit and angle deviation of the navigation guided implant insertion group were (1.45±0.60) mm, (1.96±0.44) mm and (2.66±1.13°) respectively, while those of the free-hand group were (1.50±0.64) mm, (2.04±0.79) mm and (2.50°±1.13°) respectively. There was no significant difference between the two groups ( P>0.05). The average entry, exit and angle deviation of the group with length<47.5 mm were (1.42±0.60) mm, (2.13±0.60) mm and (2.61°±1.08°) respectively and those of the group with length ≥ 47.5 mm were (1.52±0.65) mm, (1.98±0.82) mm and (2.43°±1.14°) respectively. No significant difference was found between the two groups ( P>0.05). In proximal implant group, the average entry, exit and angle deviation were (1.55±0.69) mm, (2.05±0.92) mm and (2.48°±1.16 °) respectively while those of distal implant group were (1.43±0.57) mm, (2.01±0.57) mm and (2.49°±1.10°), respectively. No significant difference was detected between the two groups ( P>0.05). All zygomatic implants were placed uneventfully. There were no intra-operative complications, and post-operative reversible complications developed in 3 patients. Two zygomatic implants were lost and the overall zygomatic implant survival rate was 97.9% (94/96) within a follow-up of 6 months. Conclusions:Quad zygomatic implant placement can be achieved with high accuracy and predictable clinical outcome under guidance of a real-time navigation system.

In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.
Device Approval ; Industry ; Licensure ; Registries