OBJECTIVE To conduct a comprehensive clinical evaluation of four nucleoside （acid） analogues that have been approved and marketed in China， such as entecavir， tenofovir disoproxil fumarate， tenofovir alafenamide fumarate， and tenofovir amibufenamide. METHODS According to the Guideline for the Administration of Clinical Comprehensive Evaluation of Drugs （2021 edition， trial implementation）， a comprehensive search was conducted across databases including CNKI， Wanfang Data， VIP， PubMed， the Cochrane Library， Embase， as well as relevant official websites. Drug package inserts， guidelines， consensus statements， and relevant literature for the four drugs were collected and subjected to a comprehensive evaluation across six dimensions： safety， efficacy， cost-effectiveness， innovativeness， suitability， and accessibility. RESULTS The scores for entecavir in terms of safety， efficacy， cost-effectiveness， innovativeness， suitability， and accessibility-along with its comprehensive score-were 13， 14， 13， 10， 18， and 6， totaling 74 points. For tenofovir disoproxil fumarate， the respective scores were 13， 17， 18， 8， 18， and 7， totaling 81 points. For tenofovir alafenamide fumarate， the scores were 14， 20， 12， 8， 18， and 5， totaling 77 points. Finally， for tenofovir amibufenamide， the scores were 10.5， 17， 10， 6， 15， and 4， totaling 62.5 points. CONCLUSIONS Tenofovir disoproxil fumarate， with the highest score， is recommended as the first-line option， suitable for adults， children， and pregnant women. However， caution is warranted for potential renal impairment. Tenofovir alafenamide fumarate is recommended as a second-line alternative， particularly for individuals at high risk for bone and renal damage. Entecavir has a score similar to tenofovir alafenamide fumarate but requires dosing on an empty stomach and dose adjustment based on renal function of patients. Tenofovir amibufenamide received the lowest score and is considered a weak recommendation. The clinical application of these nucleoside （acid） analogues should be individualized based on the patient’s age， physiological status， and risk factors.

The clinical practice guidelines for Chinese patent medicines （CPM） provide reference for the selection of national drug catalogs， the formulation of prescription collections in medical institutions， and the clinical use of CPM， constituting an important part of traditional Chinese medicine （TCM） guidelines. As a crucial part of Chinese drug supply guarantee system， CPM plays an important role in the treatment， prevention， and healthcare of many disease categories， whereas the application of CPM has problems of misuse and even abuse. To standardize the application of CPM， a research team at Zhejiang Chinese Medical University developed the Reporting Items for Practice Guidelines in Healthcare for Chinese Patent Medicines （RIGHT for CPM） based on the RIGHT checklist framework. The RIGHT for CPM checklist gathers key information from published CPM guidelines， existing TCM reporting checklists， and the RIGHT checklist and its extensions to form an initial pool of reporting items. Seventeen experts from different disciplines were invited to conduct two rounds of Delphi surveys， and the final checklist was reviewed and approved for publication by 18 leading experts in TCM research and guideline reporting from China and abroad. The RIGHT for CPM checklist adds 16 sub-items and revises 2 sub-items on the basis of the RIGHT checklist， highlighting the characteristics of CPM guideline reporting. It considers CPM selection and inclusion criteria， policy access， indications and symptoms， drug combination instructions， drug use in special populations， precautions， and recommendations of Western medical physicians， among others. This can further improve the quality and transparency of CPM guideline reporting， promote standardized reporting of CPM guidelines， and facilitate the rational clinical use of CPM. This article interprets the development process of the RIGHT for CPM checklist and the items that highlight the characteristics of CPM guidelines， with a view to promoting the application of the RIGHT for CPM checklist.

ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines （CPMs）， aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs （Angong Niuhuang Wan， Jufang Zhibao Wan， Suhexiang Wan， Pien Tze Huang， Niuhuang Qingxin Wan， Qinggong Shoutao Wan， Compound Realgar Natural Indigo Tablets， Xihuang Wan， Dingkun Wan， Babao Wan， and Guilingji Capsules） were selected. A total of 365 related studies were included in this review， comprising 331 clinical studies （of which 291 were randomized controlled trials）， 30 systematic reviews and Meta-analyses， 3 expert consensus， and 1 rapid health technology assessment. Among the 11 CPMs， 2（Angong Niuhuang Wan and Jufang Zhibao Wan） had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus （frequency of 7）， Bovisc Alculus （7）， and Borneol （5）. The dosage forms included pills， capsules， oral liquid， tablets， and lozenges. The diseases treated by these CPMs mainly included malignant tumors， cerebrovascular diseases， gynecological diseases， and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases， and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred， of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies， incomplete information on medicine package， and non-standard clinical research designs remain to be addressed in the future.

Preclinical studies include pharmacology， toxicology， pharmacokinetics research of animal experiments and in vitro experiments， which are crucial steps in the pre-marketing drugs and medical products， and are essential for exploring the mechanisms of traditional Chinese Medicine （TCM） therapeutic mechanism and promoting clinical translation. Systematic reviews and meta-analyses of preclinical studies in the field of TCM can comprehensively integrate preclinical evidence， consolidate research findings， assess the quality and risk of bias of included studies， enhance the utilization of research results， reduce resource waste， and promote the iterative optimization of TCM research models and evaluation indicators. This article introduced the process and methodology of conducting systematic review and meta-analyses of preclinical studies in TCM from nine steps， defining the research question， forming a research team， writing and registering a study protocol， conducting a comprehensive search， screening literature， evaluating included studies， extracting data， synthesizing data （meta-analysis）， and reporting systematic reviews. It aims to provide methodological references for conducting systematic reviews and meta-analyses of preclinical studies in TCM and to promote the establishment and improvement of the evidence system in the field of TCM.

Objective:To evaluate the efficacy of an etoposide (Vp16) -intensified conditioning regimen in allogeneic hematopoietic stem cell transplantation (allo-HSCT) for the treatment of relapsed/refractory acute myeloid leukemia (AML).Method:A retrospective analysis was conducted on the clinical data of 27 recipients with relapsed/refractory AML who underwent allo-HSCT using a Vp16-intensified conditioning regimen at Aerospace Center Hospital from January 2019 to January 2022. Transplantation-related complications and treatment outcomes were observed. Kaplan-Meier survival analysis was used to assess the overall survival (OS) and disease-free survival (DFS) rates.Result:Among the 27 recipients, there were 14 males and 13 females, with a median age of 41 years (range: 12~55 years). Except for one recipient who experienced primary graft failure, the remaining 26 recipients achieved hematopoietic reconstitution. The median neutrophil and platelet engraftment times were 13 days (range: 9~20 days) and 13.5 days (range: 11~33 days), respectively. Regimen-related toxicity (RRT) was mainly gastrointestinal toxicity and oral mucositis, and no deaths were attributed to RRT. A total of 12 recipients (44.44%) developed acute graft-versus-host disease (aGVHD), of whom 3 cases (11.11%) had grade III~IV aGVHD. Chronic GVHD (cGVHD) occurred in 13 recipients (48.15%), including 8 cases (29.63%) of extensive cGVHD. The median follow-up time after transplantation was 17 months (range: 1~48 months). Fifteen recipients (55.56%) survived without disease, while 12 recipients (44.44%) died— 9 due to relapse and 3 due to transplant-related complications. The 1-year overall survival and DFS rates were 74.07% and 59.26%, respectively; the 2-year overall survival and DFS rates were 59.26% and 55.56%, respectively. The 2-year relapse rate and transplant-related mortality (TRM) were 33.33% and 11.11%, respectively.Conclusion:The Vp16-intensified conditioning regimen in allo-HSCT appears to be a viable treatment option for patients with relapsed/refractory AML, offering favorable efficacy and manageable safety.

Objective:To construct a risk scoring system for predicting the risk of postoperative urosepsis by analyzing the perioperative risk factors of retrograde intrarenal surgery (RIRS).Methods:A retrospective study was conducted on 180 patients with renal calculi admitted to the Guangyuan Central Hospital from January 2019 to December 2020. Among them, 30 patients who developed urosepsis after RIRS were included in the observation group. Using a nested case-control study design, 150 patients without urosepsis during the same period were selected as the control group at a 1∶5 matching ratio. Logistic regression analysis was used to screen the independent risk factors for postoperative urosepsis after RIRS, and a risk scoring system for postoperative urosepsis after RIRS was established based on the logical scoring method. Fifty percent of the cases (90 cases in total) from the above model were selected as validation samples. The model performance was evaluated using discrimination and calibration indicators. The receiver operating characteristic (ROC) curve was used to assess the discriminative ability of the scoring system, and the goodness-of-fit test was used to measure its calibration ability. High-risk patients were identified according to the optimal cut-off value of the ROC curve.Results:Multivariate logistic regression analysis showed that female gender ( β=1.575, P=0.003), positive urine nitrite (NIT) ( β=2.019, P<0.001), peripheral blood neutrophil-to-lymphocyte ratio (NLR)≥2.5 ( β=1.491, P=0.005), operation time>90 minutes ( β=1.716, P=0.005), and procalcitonin (PCT)>0.5 ng/ml ( β=1.347, P=0.011) were independent risk factors for postoperative urosepsis after RIRS. Using the above 5 factors, a risk scoring system for postoperative urosepsis after RIRS (referred to as the " WNNOP Scoring System" ) was constructed based on the logical scoring method: 1 point for female gender, 1 point for positive urine NIT, 1 point for peripheral blood NLR≥2.5, 1 point for operation time>90 minutes, and 1 point for PCT>0.5 ng/ml, with a total score of 5 points; a score≥3 points indicated a high-risk population. The area under the ROC curve (AUC) of the WNNOP Scoring System for predicting postoperative urosepsis after RIRS was 0.893(95% CI: 0.835-0.952, P<0.001). The goodness-of-fit test showed no statistically significant difference between the predicted and actual values of the model (χ 2=2.229, P=0.898). Fifty percent of the cases (90 cases in total) were randomly selected from the model samples for internal validation. The results showed that the AUC of the ROC curve of the scoring system was 0.877(95% CI: 0.786-0.968, P<0.001), and the goodness-of-fit test showed no statistically significant difference between the predicted and actual values of the model (χ 2=10.040, P=0.186), indicating that the risk scoring system had good performance in terms of discrimination and calibration. Conclusions:The WNNOP Scoring System developed in this study can initially assess the risk of postoperative urosepsis in patients undergoing RIRS. If the score is ≥3 points, close attention should be paid during the perioperative period and relevant preventive measures should be taken.

Objective:To evaluate the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the treatment of severe acute pancreatitis (SAP) with infected pancreatic necrosis (IPN).Methods:A retrospective analysis was conducted on the clinical data of 113 patients with SAP and IPN admitted to Qingdao Municipal Hospital between January 2018 and June 2023. The cohort included 66 males and 47 females, aged (46.2±13.6) years. Based on the treatment approach, patients were divided into two groups: those who underwent percutaneous catheter drainage (PCD) alone were assigned to the PCD group ( n=60), and those who received PCNL were assigned to the PCNL group ( n=53). Clinical parameters such as age, sex, number of debridement procedures, and postoperative complications were recorded. Results:Compared with the PCD group, the PCNL group had a higher CT severity index [8(6, 9) vs. 7(6, 8)], a greater proportion of patients with multiloculated abscesses [71.7%(38/53) vs. 41.7%(25/60)], and a higher percentage of patients with IPN involving >50% necrosis [56.6%(30/53) vs. 33.3%(20/60)]. These differences were statistically significant (all P<0.05). The PCNL group also showed a higher proportion of patients with post-treatment IPN necrosis involving <30% [91.4%(49/53) vs. 70.8%(42/60)], a lower rate of requiring step-up laparoscopic or open surgery [3.8%(2/53) vs. 10.0%(6/60)], fewer debridement sessions [2(1, 4) vs. 4(2, 6)], and a shorter total hospital stay [45(35, 58) d vs. 54(23, 72) d]. These differences were statistically significant (all P<0.05). Additionally, the PCNL group had lower rates of postoperative complications, including enteric fistula [3.8%(2/53) vs. 11.7%(7/60)], intra-abdominal bleeding [5.7%(3/53) vs. 13.3%(8/60)], and pancreatic fistula [15.1%(8/53) vs. 20.0% (12/60)]. These differences were also statistically significant (all P<0.05). The recurrence rate of abscesses was significantly lower in the PCNL group [11.3%(6/53) vs. 16.7%(10/60), χ2=4.14, P=0.042]. Conclusion:PCNL is an effective treatment for SAP complicated by IPN. Compared with PCD, it improves the clearance of necrotic tissue, reduces the number of debridement procedures, shortens the total hospital stay, and lowers the risk of postoperative complications.

Micro/nanoplastics (MNPs), recognized as emerging environmental pollutants, are widely distributed in natural environments. Due to their small particle size and significant migratory capacity, MNPs can infiltrate diverse environmental matrices, then invade and accumulate in the organism via the skin, respiration, and digestion. Recently, concerns have grown over the detrimental effects and potential toxicity of MNPs on reproductive health. This review summarized published epidemiological and toxicological studies related to MNPs exposure and their effects on reproductive health. Firstly, this review critically examined the current landscape of epidemiological evidence and found that MNPs (e.g., polystyrene, polypropylene, polyvinyl chloride, polyethylene, etc.) are present in various biological specimens from both males and females, and their presence may be associated with an increased risk of reproductive disorders. Secondly, extensive toxicological studies revealed that MNPs exposure induces reproductive health damage through mechanisms such as disrupting the microstructure of reproductive organs and altering molecular-level expressions. Oxidative stress, inflammatory responses, and apoptosis are identified as potential links between MNPs exposure and reproductive damage. Finally, this review addressed the prevalent shortcomings in existing studies and proposed future directions to tackle the challenges posed by MNPs-induced reproductive harm. These insights aim to inform strategies for safeguarding public reproductive health and ecological security, providing a scientific foundation for mitigating risks associated with MNPs pollution.

Objective To analyze the structural and phylogenetic characteristics of the mitochondrial genome from Bulinus globosus, so as to provide a theoretical basis for classification and identification of species within the Bulinus genus, and to provide insights into understanding of Bulinus-schistosomes interactions and the mechanisms of parasite transmission. Methods B. globosus samples were collected from the Ruya River basin in Zimbabwe. Mitochondrial DNA was extracted from B. globosus samples and the corresponding libraries were constructed for high-throughput sequencing on the Illumina NovaSeq 6000 platform. After raw sequencing data were subjected to quality control using the fastp software, genome assembly was performed using the A5-miseq and SPAdes tools, and genome annotation was conducted using the MITOS online server. Circular maps and sequence plots of the mitochondrial genome were generated using the CGView and OGDRAW software, and the protein conservation motifs and structures were analyzed using the TBtools software. Base composition and codon usage bias were analyzed and visualized using the software MEGA X and the ggplot2 package in the R software. In addition, a phylogenetic tree was created in the software MEGA X after sequence alignment with the software MAFFT 7, and visualized using the software iTOL. Results The mitochondrial genome of B. globosus was a 13 730 bp double-stranded circular molecule, containing 2 ribosomal RNA (rRNA) genes, 22 transfer RNA (tRNA) genes, and 13 protein-coding genes, with a marked AT preference. The mitochondrial genome composition of B. globosus was similar to that of other species within the Bulinus genus. Phylogenetic analysis revealed that the complete mitochondrial genome sequence of B. globosus was clustered with B. truncatus, B. nasutus, and B. ugandae into the same evolutionary clade, and gene superfamily analysis showed that the metabolism-related proteins of B. globosus were highly conserved, notably the cytochrome c oxidase family, which showed a significant consistency. Conclusions This is the first whole mitochondrial genome sequencing to decode the compositional features of the mitochondrial genome of B. globosus from Zimbabwe and its evolutionary relationship within the Bulinus genus, which provides important insights for further understanding of the phylogeny and mitochondrial genome characteristics of the Bulinus genus.