Objective To evaluate the efficacy and safety of 450 nm blue laser vaporization enucleation of the prostate in the treatment of benign prostatic hyperplasia(BPH)complicated with urinary retention, so as to promote its clinical application. Methods A retrospective analysis was conducted on the clinical data of 60 patients with BPH and urinary retention who underwent 450 nm blue laser vaporization enucleation of the prostate in our hospital during Feb. 2023 and Apr. 2024. All patients had urinary catheters indwelt preoperatively due to urinary retention. The perioperative indicators and complications were recorded. The maximum urinary flow rate(Qmax), postvoid residual(PVR), international prostate symptom score(IPSS), and quality of life score(QoL)were compared before surgery and 3 months after surgery. Results All procedures were completed successfully without conversion to transurethral resection of the prostate(TURP). No cases of severe intraoperative bleeding or transfusion were reported. The average operation time was(60.5±21.5)min, postoperative hemoglobin reduction(3.2±0.8)g/L, catheterization time(3.1±0.4)days, and hospital stay(3.2±0.4)days. No bladder perforation or urethral injury occurred. At 3 months postoperatively, Qmax [(19.2±4.9)mL/s vs.(3.5±2.3)mL/s], PVR [(50.8±20.1)mL vs.(369.2±163.2)mL], IPSS [(9.7±0.9)vs.(21.8±3.2)], and QoL [(1.4±0.5)vs.(4.9±0.1)]were significantly improved compared with preoperative values(P＜0.001). Urinary retention occurred in 2 patients after catheter removal on postoperative day 3, which was resolved one week after re-catheterization. Conclusion The 450 nm blue laser vaporization enucleation of the prostate is a safe and effective treatment for BPH complicated with urinary retention. It can significantly improve the short-term voiding function and quality of life with a low incidence of postoperative complications, demonstrating promising potential for clinical adoption.

Objective: To analyze the disease burden and trends of oral diseases among China’s elderly population (1990-2021) and provide evidence for developing targeted intervention strategies Methods : Using data from the Global Burden of Disease (GBD) 2021 study, we extracted prevalence, incidence, and disability-adjusted life years (DALYs) for oral conditions (permanent dental caries, edentulism, periodontal diseases, and other oral disorders) in individuals aged ≥60 years in China. Due to data limitations, other oral diseases only included DALYs and prevalence. Age-standardized rates (ASR)—including age-standardized prevalence rate (ASPR), age-standardized incidence rate (ASIR), and age-standardized DALYs rate (ASDR)--were calculated. Trends were assessed via Joinpoint regression using average annual percentage change (AAPC), stratified by sex and age groups (60-64, 65-69, 70-74, 75-79, 80-84, 85-89, 90-94, 95+ years). Results: From 1990 to 2021, China’s elderly population exhibited distinct trends in oral disease burden. Overall oral diseases showed declining ASDR and ASPR, yet ASIR slightly increased. Permanent dental caries demonstrated significant rises across ASDR, ASIR, and ASPR. Edentulism showed declining ASDR and ASPR alongside stable ASIR. 95+ age group saw rising rates. Periodontal diseases remained largely stable in ASDR and ASPR but experienced a slight ASIR decline. Other oral disorders showed mild ASDR decline and stable ASPR. Notably, sex and age disparities persisted. Women consistently bore higher burdens for overall oral diseases, caries, edentulism, and other oral diseases but lower periodontal disease rates compared to men. 85-89, 90-95, 95+ age group faced rising DALYs and prevalence for overall oral diseases, while all other age groups demonstrated declining trends in both DALYs and prevalence; for permanent caries, the 60-64 age group showed the largest increases in DALY rate, incidence, and prevalence; edentulism demonstrated the most pronounced and sustained rises in DALY rate and prevalence in the 95+ group, while declining most rapidly in the 60-64 age group; for periodontal disease, both DALY rates and prevalence declined in the 90-94 and 95+ age groups, but increased across all measures (DALY rate, incidence, and prevalence) in the 70-74 and 75-79 age group; other oral conditions exhibited relatively stable burden distributions or minor changes, with no significant age-specific shifting trends observed. Conclusion From 1990 to 2021, China’s elderly oral disease burden declined overall, but caries surged, edentulism improved, periodontal diseases stabilized, and other oral diseases slightly declined. Prioritizing older women and the adults aged 85+ is critical to addressing evolving oral health needs.

Objective:To investigate the effects of modified TROPIS surgery, incorporating both open and hanging stitches on the treatment of elevated anal fistula.Methods:For our study, 92 patients with high anal fistula, admitted between Jan. 2023 and Jun. 2024, were selected. They were divided into two categories: the observation group (45 modified TROPIS surgery) and the control group (47 cuts) ,to observe the clinical efficacy, postoperative recovery, quality of life and complications of the two groups.Results:Compared with the control group, the operation time, intraoperative blood loss and postoperative hospitalization time decreased in the observation group ( P<0.05) . Compared with the control group, the healing time of anal fistula in the observation group was (28.01±5.02) d, shorter than that in the control group (35.05±7.09) d, the healing rate was 97.78%, higher than that in the control group (80.85%) , and the recurrence rate was 4.44%, lower than that in the control group (19.14%) ( P<0.05) . The degree of postoperative pain and Wexner anal incontinence score in the observation group were lower than those in the control group ( P<0.05) . The life quality score of the observation group was higher than that of the control group ( P<0.05) . The complication rate of observation group was lower than that of control group ( P<0.05) . Conclusions:The modified TROPIS surgical method evidently provides advantages in anal fistula treatment. It can not only efficiently eliminate infections but also reduce anal movements and decrease the chances of post-surgical injuries and complications, presenting enhanced clinical options and suggesting a promising outlook for traditional anal fistula surgery.

Objective To provide valuable references and insights for improving the excipient standard system of the Chinese Pharmacopeia and promoting its harmonization with ICH Q3D.By analyzing the harmonization strategies and implementation of excipient standards in the pharmacopoeias of Europe,the United States,and Japan.Methods Through a combination of literature review and case study analysis,this paper introduces the policies and strategies adopted by the pharmacopoeias of three major regions(Europe,the United States,and Japan)in implementing the ICH Q3D guidelines in the field of pharmaceutical excipients.Additionally,it reviews the updates on excipient standards in these regions and analyzes the characteristics of their alignment with ICH Q3D.Results The strategies for implementing ICH Q3D in pharmacopeial excipient standards vary across different regions,with each following distinct approaches and progressing at different rates.Notably,there are significant differences in the establishment of standards for elemental impurities.Conclusion Promoting the harmonization of pharmacopeial excipient standards with ICH Q3D is a challenging and long-term endeavor.It is essential to develop a harmonization strategy that is tailored to China's national context.

Objective:To investigate the effects of modified TROPIS surgery, incorporating both open and hanging stitches on the treatment of elevated anal fistula.Methods:For our study, 92 patients with high anal fistula, admitted between Jan. 2023 and Jun. 2024, were selected. They were divided into two categories: the observation group (45 modified TROPIS surgery) and the control group (47 cuts) ,to observe the clinical efficacy, postoperative recovery, quality of life and complications of the two groups.Results:Compared with the control group, the operation time, intraoperative blood loss and postoperative hospitalization time decreased in the observation group ( P<0.05) . Compared with the control group, the healing time of anal fistula in the observation group was (28.01±5.02) d, shorter than that in the control group (35.05±7.09) d, the healing rate was 97.78%, higher than that in the control group (80.85%) , and the recurrence rate was 4.44%, lower than that in the control group (19.14%) ( P<0.05) . The degree of postoperative pain and Wexner anal incontinence score in the observation group were lower than those in the control group ( P<0.05) . The life quality score of the observation group was higher than that of the control group ( P<0.05) . The complication rate of observation group was lower than that of control group ( P<0.05) . Conclusions:The modified TROPIS surgical method evidently provides advantages in anal fistula treatment. It can not only efficiently eliminate infections but also reduce anal movements and decrease the chances of post-surgical injuries and complications, presenting enhanced clinical options and suggesting a promising outlook for traditional anal fistula surgery.

Objective To analyze and evaluate the differences between the standards for elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"and ICH Q3D,and to explore strategies for harmonization between them.Methods This study summarizes and reviews the main differences between the general chapters and specific monographs of pharmaceutical excipients in the 2020 edition of the"Chinese Pharmacopoeia"and its first supplement,compared with ICH Q3D.Results By integrating the harmonization strategies for elemental impurities in foreign pharmacopoeias and the risk assessment results for pharmaceutical excipients,this study proposes harmonization strategies and pathways for the standards of pharmaceutical excipients in the"Chinese Pharmacopoeia."Conclusions A systematic risk assessment of elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"should be conducted based on their risk levels.The revision methods should be determined and continuously updated according to the assessment results.

Objective To analyze the historical and current inclusion of heavy metals and specific elemental impurity tests in the monographs of pharmaceutical excipients in the Pharmacopeias of the US(USP),Europe(EP)and Japan(JP)pharmacopeias.By examining the characteristics and trends in these pharmacopeias,the study seeks to provide insights that can inform the strategy for incorporating elemental impurity tests in the Chinese Pharmacopoeia and offer guidance for the industry to enhance control over elemental impurities in drugs and excipients.Methods The study reviews the inclusion and revision processes of heavy metals and specific elemental impurity tests in the pharmacopeias of the US,Europe and Japan,focusing on aspects such as the number of excipient monographs,the proportion of heavy metal tests,professional categories,and treatment methods.A comparative analysis with the Chinese Pharmacopoeia was conducted to explore the reasons behind the observed differences and to identify potential future developments.Results The USP contains the largest number of excipient monographs,the EP has the fastest progress in the evaluation of elemental impurities in excipients,the JP relies most heavily on wet chemical methods for testing.Conclusion The strategies of the US,European,and Japanese pharmacopeias can serve as valuable references for the development of elemental impurity testing strategies in the Chinese Pharmacopoeia.It is recommended to classify pharmaceutical excipients by risk level,removing heavy metal tests for low-risk categories and conducting elemental impurity risk assessments for higher-risk mineral-based excipients.The inclusion of specific elemental impurity tests should be determined based on these risk assessments,with specific limits or methods established as needed according to excipient category or individual monographs.

Objective To provide valuable references and insights for improving the excipient standard system of the Chinese Pharmacopeia and promoting its harmonization with ICH Q3D.By analyzing the harmonization strategies and implementation of excipient standards in the pharmacopoeias of Europe,the United States,and Japan.Methods Through a combination of literature review and case study analysis,this paper introduces the policies and strategies adopted by the pharmacopoeias of three major regions(Europe,the United States,and Japan)in implementing the ICH Q3D guidelines in the field of pharmaceutical excipients.Additionally,it reviews the updates on excipient standards in these regions and analyzes the characteristics of their alignment with ICH Q3D.Results The strategies for implementing ICH Q3D in pharmacopeial excipient standards vary across different regions,with each following distinct approaches and progressing at different rates.Notably,there are significant differences in the establishment of standards for elemental impurities.Conclusion Promoting the harmonization of pharmacopeial excipient standards with ICH Q3D is a challenging and long-term endeavor.It is essential to develop a harmonization strategy that is tailored to China's national context.

Objective To analyze and evaluate the differences between the standards for elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"and ICH Q3D,and to explore strategies for harmonization between them.Methods This study summarizes and reviews the main differences between the general chapters and specific monographs of pharmaceutical excipients in the 2020 edition of the"Chinese Pharmacopoeia"and its first supplement,compared with ICH Q3D.Results By integrating the harmonization strategies for elemental impurities in foreign pharmacopoeias and the risk assessment results for pharmaceutical excipients,this study proposes harmonization strategies and pathways for the standards of pharmaceutical excipients in the"Chinese Pharmacopoeia."Conclusions A systematic risk assessment of elemental impurities in pharmaceutical excipients in the"Chinese Pharmacopoeia"should be conducted based on their risk levels.The revision methods should be determined and continuously updated according to the assessment results.

Objective To analyze the historical and current inclusion of heavy metals and specific elemental impurity tests in the monographs of pharmaceutical excipients in the Pharmacopeias of the US(USP),Europe(EP)and Japan(JP)pharmacopeias.By examining the characteristics and trends in these pharmacopeias,the study seeks to provide insights that can inform the strategy for incorporating elemental impurity tests in the Chinese Pharmacopoeia and offer guidance for the industry to enhance control over elemental impurities in drugs and excipients.Methods The study reviews the inclusion and revision processes of heavy metals and specific elemental impurity tests in the pharmacopeias of the US,Europe and Japan,focusing on aspects such as the number of excipient monographs,the proportion of heavy metal tests,professional categories,and treatment methods.A comparative analysis with the Chinese Pharmacopoeia was conducted to explore the reasons behind the observed differences and to identify potential future developments.Results The USP contains the largest number of excipient monographs,the EP has the fastest progress in the evaluation of elemental impurities in excipients,the JP relies most heavily on wet chemical methods for testing.Conclusion The strategies of the US,European,and Japanese pharmacopeias can serve as valuable references for the development of elemental impurity testing strategies in the Chinese Pharmacopoeia.It is recommended to classify pharmaceutical excipients by risk level,removing heavy metal tests for low-risk categories and conducting elemental impurity risk assessments for higher-risk mineral-based excipients.The inclusion of specific elemental impurity tests should be determined based on these risk assessments,with specific limits or methods established as needed according to excipient category or individual monographs.