Process analytical technology(PAT) is a key means for digital transformation and upgrading of the traditional Chinese medicine(TCM) manufacturing process, serving as an important guarantee for consistent and controllable TCM product quality. Near-infrared(NIR) spectroscopy has become the core technology for measuring the TCM manufacturing process. By incorporating NIR spectroscopy into PAT and starting from the construction of a smart platform for the TCM manufacturing process, this paper systematically described the development history and innovative application of the combination of NIR spectroscopy with chemometrics in measuring the TCM manufacturing process by the research team over the past two decades. Additionally, it explored the application of a validation method based on accuracy profile(AP) in the practice of NIR spectroscopy. Furthermore, the software development progress driven by NIR spectroscopy supported by modeling technology was analyzed, and the prospect of integrating NIR spectroscopy in smart factory control platforms was exemplified with the construction practices of related platforms. By integrating with the smart platform, NIR spectroscopy could improve production efficiency and guarantee product quality. Finally, the prospect of the smart platform application in measuring the TCM manufacturing process was projected. It is believed that the software development for NIR spectroscopy and the smart manufacturing platform will provide strong technical support for TCM digitalization and industrialization.
Spectroscopy, Near-Infrared/methods* ; Drugs, Chinese Herbal/analysis* ; Software ; Medicine, Chinese Traditional ; Quality Control

This study primarily aimed to investigate the prevalence of human papillomavirus (HPV) and other common pathogens of sexually transmitted infections (STIs) in spermatozoa of infertile men and their effects on semen parameters. These pathogens included Ureaplasma urealyticum, Ureaplasma parvum, Chlamydia trachomatis, Mycoplasma genitalium , herpes simplex virus 2, Neisseria gonorrhoeae, Enterococcus faecalis, Streptococcus agalactiae, Pseudomonas aeruginosa , and Staphylococcus aureus . A total of 1951 men of infertile couples were recruited between 23 March 2023, and 17 May 2023, at the Department of Reproductive Medicine of The First People's Hospital of Yunnan Province (Kunming, China). Multiplex polymerase chain reaction and capillary electrophoresis were used for HPV genotyping. Polymerase chain reaction and electrophoresis were also used to detect the presence of other STIs. The overall prevalence of HPV infection was 12.4%. The top five prevalent HPV subtypes were types 56, 52, 43, 16, and 53 among those tested positive for HPV. Other common infections with high prevalence rates were Ureaplasma urealyticum (28.3%), Ureaplasma parvum (20.4%), and Enterococcus faecalis (9.5%). The prevalence rates of HPV coinfection with Ureaplasma urealyticum, Ureaplasma parvum, Chlamydia trachomatis, Mycoplasma genitalium , herpes simplex virus 2, Neisseria gonorrhoeae, Enterococcus faecalis, Streptococcus agalactiae , and Staphylococcus aureus were 24.8%, 25.4%, 10.6%, 6.4%, 2.4%, 7.9%, 5.9%, 0.9%, and 1.3%, respectively. The semen volume and total sperm count were greatly decreased by HPV infection alone. Coinfection with HPV and Ureaplasma urealyticum significantly reduced sperm motility and viability. Our study shows that coinfection with STIs is highly prevalent in the semen of infertile men and that coinfection with pathogens can seriously affect semen parameters, emphasizing the necessity of semen screening for STIs.
Humans ; Male ; Infertility, Male/epidemiology* ; Coinfection/microbiology* ; Papillomavirus Infections/virology* ; Adult ; Sexually Transmitted Diseases/complications* ; China/epidemiology* ; Staphylococcus aureus/isolation & purification* ; Chlamydia trachomatis/isolation & purification* ; Prevalence ; Mycoplasma genitalium/isolation & purification* ; Ureaplasma urealyticum/isolation & purification* ; Neisseria gonorrhoeae/isolation & purification* ; Enterococcus faecalis/isolation & purification* ; Streptococcus agalactiae/isolation & purification* ; Herpesvirus 2, Human/genetics* ; Pseudomonas aeruginosa/isolation & purification* ; Semen/virology* ; Sperm Motility ; Spermatozoa/microbiology* ; Human Papillomavirus Viruses

Chronic atrophic gastritis(CAG)is a common intractable gastric disease in clinic,which belongs to the gastric precancerous lesions.Professor LIU Feng-Bin and his team have performed the exploration and practice in the field of CAG for more than 30 years,and they proposed that the evolution of the traditional Chinse medicine(TCM)pathogenesis of inflammation-to-tumor transition(ITT)in CAG was characterized by spleen deficiency being the root cause,qi stagnation,blood stasis and dampness retention being the branch cause,and stasis and toxin being the aggravating factors.Deificiency of the spleen and stomach is the initial factor of CAG,which influences the whole process of the disease.Qi stagnation,blood stasis and dampness retention are the triggering and aggravating factors for the ITT in CAG.The formation of blood stasis and toxin is the key to the progression and transition of CAG.Treatment of ITT in CAG should be based on the results of syndrome differentiation and gastroscopic findings by staging therapy.Before treatment,disease dianosis and syndrome differentiation should be made,and macro and micro syndrome differentiation should be carried out for assistance.Therapy of strengthening the spleen and supporting healthy qi should be implemented throughout the whole process of the disease.The early stage of CAG has the features of gastric mucosa with mild to moderate atrophy and with or without mild intestinal epithelial hyperplasia,the pathogenesis of early CAG is characterized by weakness of the spleen and stomach and is accompanied with the pathological factors of qi stagnation,damp-retention and blood stasis,and the basic treatment should adopt the therapies of strengthening the spleen and clearing heat,regulating qi and activating blood stasis.The advanced stage of CAG has the features of severe atrophic gastric mucosa with or without moderate to severe intestinal epithelial and/or mild to moderate intraepithelial neoplasia,the pathogenesis is characterized by weakness of the spleen and stomach,phlegm blended with blood stasis,and stasis-toxin in the gastric collaterals,and the basic treatment should adopt the therapies of supporting healthy qi and dissipating masses,and unblocking the collaterals and removing toxin,so as to construct an intact line to blocking the ITT in CAG with traditional Chinese medicine.

Objectives:To evaluate the safety and efficacy of implantation of subcutaneous implantable cardioverter defibrillator(S-ICD)after transvenous lead extraction(TLE)in ICD patients without pacing indications. Methods:All patients who underwent TLE at Peking University People's Hospital from June 2018 to October 2023 were consecutively included.TLE indication,S-ICD implantation indication,defibrillation threshold(DFT)test,complications and postoperative follow-up were collected and analyzed. Results:A total of 11 patients with TV-ICD underwent S-ICD implantation after TLE,eight patients were males and median age were 56(44,65)years.The indications for TLE were infection and lead dysfunction.Nine patients were implanted with S-ICD for secondary prevention,and the most common cause of implantation was ion channelopathies(5 cases).The operative time for S-ICD was 51(48,58)minutes and no perioperative complications were noted.Eight patients underwent DFT testing,and 100%were successful.During a median follow up of 30(9,39)months,a total of six appropriate treatments occurred in two patients,and no complications occurred,including inappropriate treatment,ineffective treatment,infection,lead malfunction and death. Conclusions:Our study provides evidence for S-ICD implantation as a replacement after TV-ICD removal.The S-ICD implantation after TLE is safe and effective.

Objectives:To assess the clinical characteristics and lead extraction in patients with venous occlusion related to infection of cardiovascular implantable electronic devices. Methods:Clinical data of 405 patients(147 men,mean age[62.4±13.2]years)who underwent lead extraction from January 2020 to January 2024 in Peking University People's Hospital were reviewed.Contrast venography of the access vein was retrospectively analyzed.The patients were divided into venous occlusion group(n=119)and non-venous occlusion group(n=286)according to the presence or absence of venous occlusion.The clinical characteristics and lead extraction of patients in two groups were analyzed. Results:Occlusion of the access vein occurred in 119 patients(29.4%).The subclavian vein was occluded in 48 cases(40.3%),brachiocephalic vein was occluded in 37 cases(31.1%),axillary vein was occluded in 30 cases(25.2%),superior vena cava was occluded in 4 cases(3.4%).There were no significant differences between venous occlusion group and non-venous occlusion group in terms of age,sex,device type,number of leads,or anticoagulation therapy(all P>0.05).Time from implant of the initial leads was significantly longer in the venous occlusion group than in the non-venous occlusion group([10.4±3.8]years vs.[5.9±4.1]years,P=0.042).Clinical extraction success rate and complications were similar between the venous occlusion group and the non-venous occlusion group(both P>0.05).Procedural duration and fluoroscopy exposure time were significantly lower in non-venous occlusion group than in the venous occlusion group(both P<0.05).Patients in the venous occlusion group required more advanced tools(such as laser sheaths,evolution sheaths,and needle's eye snares)for lead extraction compared to patients in the non-venous occlusion group(84.0%vs.67.1%,P=0.001). Conclusions:The incidence of venous occlusion related to infection of cardiovascular implantable electronic devices is 29.4%.Time from implant of the initial leads is significantly longer and lead extraction is more difficult in patients with venous occlusion,and requires more advanced tools and more time to achieve the successful lead extraction.

Objectives:To evaluate the strategy and clinical outcomes of reimplanting biventricular cardiac resynchronization therapy (Biv-CRT) devices after transvenous removal of coronary sinus left ventricular leads due to device-related infections. Methods:A retrospective analysis was conducted on the clinical data and surgical outcomes of all patients who underwent transvenous removal of infectious coronary sinus left ventricular leads and subsequent reimplantation of Biv-CRT devices at Peking University People's Hospital from January 2013 to December 2022.Follow-up was performed to assess the incidence of complications and all-cause mortality. Results:A total of 167 patients underwent coronary sinus left ventricular lead removal due to infection,removal was successful in 161 cases (96.4％) and failed in 6 cases (3.6％).Among the patients with successful removal,109 cases (67.7％) were scheduled for Biv-CRT device reimplantation.After a median time of 7 (5,7) days,6 cases (5.5％) of reimplantation failed,while 103 reimplantations (94.5％) were successful.Among these successful reimplantation cases,102 patients (99.0％) were through the right-side approach,and 1 case (1.0％) through the left-side approach due to bilateral pocket infections.Of the 161 patients with successful removal,58 cases (36.0％) did not undergo left ventricular lead reimplantation,including 39 cases (24.2％) where the initial indications for Biv-CRT were questionable or had resolved.During the one-year postoperative follow-up,among the 103 patients who had undergone Biv-CRT device reimplantation,7 patients (6.8％) died,1 patient (1.0％) experienced pocket infection,and 1 patient (1.0％) had right atrial lead dislodgment. Conclusions:Reimplantation of Biv-CRT devices after removal of coronary sinus left ventricular leads due to infections is feasible,with a high success rate,low complication rate,and low mortality rate for right-side approach implantation.Therefore,for patients re-evaluated to have indications for repeated Biv-CRT after lead removal,right-side reimplantation of the coronary sinus left ventricular lead should be recommended.

Objective:To evaluate the safety and efficiency of China-made Toumai Robot-assisted laparoscopic radical prosta-tectomy(LRP).Methods:This study included 40 cases of PCa treated from January 2023 to May 2023 by robot-assisted LRP with preservation of the bladder neck and maximal functional urethral length,15 cases with the assistance of Toumai Robot(the TMR group)and the other 25 with the assistance of da Vinci Robot as controls(the DVR group).We recorded the docking time,laparo-scopic surgery time,vesico-urethral anastomosis time,intraoperative blood loss and postoperative urinary continence,and compared them between the two groups.Results:Operations were successfully completed in all the cases.No statistically significant differ-ences were observed between the TMR and DVR groups in the docking time(6 min vs 5 min,P＞0.05)or intraoperative blood loss(200 ml vs 150 ml,P＞0.05).The TMR group,compared with the DVR group,showed a significantly longer median laparoscopic surgery time(146 min vs 130 min,P＜0.05)and median vesico-urethral anastomosis time(19 min vs 16 min,P＜0.05).There were no statistically significant differences between the TMR and DVR groups in the rates of urinary continence recovery immediately af-ter surgery(60.0％[9/15]vs 64.0％[16/25],P＞0.05)or at 1 month(80.0％[12/15])vs(76.0％[19/25],P＞0.05),3 months(93.3％[14/15])vs(92.0％[23/25],P＞0.05)and 6 months postoperatively(100％[15/15])vs(96％[24/25],P＞0.05).Conclusion:China-made Toumai? Robot surgical system is safe and reliable for laparoscopic radical prosta-tectomy,with satisfactory postoperative recovery of urinary continence.

BACKGROUND: This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability. METHODS: This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability. RESULTS: STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min. CONCLUSION The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.
Reproducibility of Results ; Surveys and Questionnaires ; Practice Guidelines as Topic ; Humans

Objective:To evaluate the safety of leadless pacemaker implantation in super-elderly patients.Methods:Eleven patients with average age of 90 (86, 92) years who underwent leadless pacemaker implantation in the Department of Cardiology, Peking University People′s Hospital from March 2021 to May 2022 were included. The clinical data and implantation information were collected. The complications (cardiac tamponade, myocardial infarction, cerebral infarction, pulmonary embolism, pacemaker reinfection, femoral vein hematoma) and death of patients were documented at 24 h, 3 d, and 1, 3, 6 months after pacemaker implantation.Results:There were 9 males and 2 females with the body mass index of 21(19, 23)kg/m 2. The underlying diseases were hypertension, diabetes, coronary heart disease, chronic kidney disease, chronic obstructive pulmonary disease, previous cerebral infarction and moderate to severe tricuspid regurgitation in 9, 9, 9, 6, 4, 4, 4 patients, respectively. The left ventricular ejection fraction was 49% (45%, 52%), the hemoglobin concentration was 118 (114, 122)g/L, 4 patients were taking anticoagulant drugs, and 6 patients were taking antiplatelet drugs. Eight patients were newly implanted with a leadless pacemaker, 2 patients were implanted after removal the old ones, and 1 case was implanted at the same time as removal. The implantation time was 45(40, 47) minutes, the X-ray exposure time was 14 (13, 15) minutes, the release time was 1 (1, 2), the threshold value was 0.50(0.38, 0.75)V/0.24 ms, the impedance was 730 (700, 770) Ω, and the perceived R-wave amplitude 8.2(6.7, 12.8) mV. During the follow-up period of 8 (6, 10) months, no patient had pacemaker dysfunction; and the threshold, R wave sensing, and impedance were stable and maintained within the normal range. No cardiac tamponade, myocardial infarction, cerebral infarction, pulmonary embolism, pacemaker reinfection or death occurred perioperatively and during the follow-up period; 1 patient had hematoma after femoral vein puncture, which improved after compression treatment. Conclusion:This single-center and small-sample study shows that leadless pacemaker implantation is safe for super-elderly patients.

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal