This article discusses the revision background and core content of 9621 General Requirements for Phar-maceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition.In combination with the requirements of bundling review of pharmaceutical packaging and drug products,as well as harmonization of inter-national standards,it analyzed the revision philosophy of the new guideline and the impact to industry.The new edition of the guideline 9621 introduces the concept of "pharmaceutical packaging system" for the first time,constructing four suitability evaluation dimensions covering protection,compatibility,safety,and functionality,it also introduces the requirements for the self-stability evaluation of plastic and rubber pharmaceutical packaging materials,and strengthening the concept of full lifecycle management and risk management.Through the"1+4+58" standard system,the basis for determining the key quality attributes of packaging materials for phar-maceutical use and the optimization path of dynamic inspection rules have been clarified.This revision has resolved the contradiction between the old version of standards and current regulatory requirements through a systematic upgrade,promoting the transformation of pharmaceutical packaging materials and containers quality control towards a scientific,international,and full lifecycle management model,proving technical supports in ensuring the safety,effectiveness of drug products from standard perspective,including advancing the industry high-quality development.

This article discusses the revision background and core content of 9621 General Requirements for Phar-maceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition.In combination with the requirements of bundling review of pharmaceutical packaging and drug products,as well as harmonization of inter-national standards,it analyzed the revision philosophy of the new guideline and the impact to industry.The new edition of the guideline 9621 introduces the concept of "pharmaceutical packaging system" for the first time,constructing four suitability evaluation dimensions covering protection,compatibility,safety,and functionality,it also introduces the requirements for the self-stability evaluation of plastic and rubber pharmaceutical packaging materials,and strengthening the concept of full lifecycle management and risk management.Through the"1+4+58" standard system,the basis for determining the key quality attributes of packaging materials for phar-maceutical use and the optimization path of dynamic inspection rules have been clarified.This revision has resolved the contradiction between the old version of standards and current regulatory requirements through a systematic upgrade,promoting the transformation of pharmaceutical packaging materials and containers quality control towards a scientific,international,and full lifecycle management model,proving technical supports in ensuring the safety,effectiveness of drug products from standard perspective,including advancing the industry high-quality development.

Objective:To investigate the endoscopic characteristics in patients with active ulcerative colitis (UC) affect the endoscopic remission after treatment.Methods:A retrospective case-control study was conductd. The clinical and endoscopic data of 79 cases who underwent colonoscopy in Nanjing Drum Tower Hospital from January 2014 to September 2020 were collected. Mayo endoscopic score (MES) ≤1 was defined as endoscopic remission. Patients were divided into remission and non-remission groups based on the endoscopic remission after treatment achieved or not. Univariate and multivariate analyses were performed to screen the factors affecting endoscopic remission in UC patients by Cox regression.Results:Among the 79 UC patients, 33 were male and 46 were female, with a median age of 42.0 (27.0) years and a median disease course of 30.0 (63.0) months. There were 33 cases in remission group and 46 cases in non-remission group. The composition proportion of the two groups was significantly different in the choice of therapeutic drugs in the treatment of patients ( P<0.05), and there were no statistically significant differences in other clinical data (all P>0.05). Univariate analysis suggested that the complete disappearance of vascular texture (39.4% vs. 76.1%, HR=0.303, 95% CI: 0.146-0.626, P=0.001) and inflammatory hyperplastic polyps (27.3% vs. 67.4%, HR=0.264, 95% CI: 0.118-0.588, P=0.001) were less in the remission group than those in the non-remission group.Multivariate analysis after correction for confounding factors indicated that complete disappearance of vascular texture ( HR=0.455, 95% CI: 0.208- 0.995, P=0.048) and inflammatory hyperplastic polyps ( HR=0.364, 95% CI: 0.153-0.868, P=0.023) were still independent risk factors affecting endoscopic remission. Active UC patients with inflammatory polyps and complete disappearance of vascular texture are difficult to achieve endoscopic remission, with the risk increasing by 63.6% and 54.5% respectively. Conclusions:Inflammatory hyperplastic polyps and complete loss of vascular texture are independent risk factors for endoscopic remission in patients with active UC.

Objective:To investigate the endoscopic characteristics in patients with active ulcerative colitis (UC) affect the endoscopic remission after treatment.Methods:A retrospective case-control study was conductd. The clinical and endoscopic data of 79 cases who underwent colonoscopy in Nanjing Drum Tower Hospital from January 2014 to September 2020 were collected. Mayo endoscopic score (MES) ≤1 was defined as endoscopic remission. Patients were divided into remission and non-remission groups based on the endoscopic remission after treatment achieved or not. Univariate and multivariate analyses were performed to screen the factors affecting endoscopic remission in UC patients by Cox regression.Results:Among the 79 UC patients, 33 were male and 46 were female, with a median age of 42.0 (27.0) years and a median disease course of 30.0 (63.0) months. There were 33 cases in remission group and 46 cases in non-remission group. The composition proportion of the two groups was significantly different in the choice of therapeutic drugs in the treatment of patients ( P<0.05), and there were no statistically significant differences in other clinical data (all P>0.05). Univariate analysis suggested that the complete disappearance of vascular texture (39.4% vs. 76.1%, HR=0.303, 95% CI: 0.146-0.626, P=0.001) and inflammatory hyperplastic polyps (27.3% vs. 67.4%, HR=0.264, 95% CI: 0.118-0.588, P=0.001) were less in the remission group than those in the non-remission group.Multivariate analysis after correction for confounding factors indicated that complete disappearance of vascular texture ( HR=0.455, 95% CI: 0.208- 0.995, P=0.048) and inflammatory hyperplastic polyps ( HR=0.364, 95% CI: 0.153-0.868, P=0.023) were still independent risk factors affecting endoscopic remission. Active UC patients with inflammatory polyps and complete disappearance of vascular texture are difficult to achieve endoscopic remission, with the risk increasing by 63.6% and 54.5% respectively. Conclusions:Inflammatory hyperplastic polyps and complete loss of vascular texture are independent risk factors for endoscopic remission in patients with active UC.

Objective:To study the intestinal mucosal state of ulcerative colitis (UC) through UC endoscopic scores and to investigate the correlation between the endoscopic scores and clinical activity and histological scores.Methods:A retrospective analysis was performed on data of 152 patients who underwent colonoscopy or sigmoidoscopy in Nanjing Drum Tower Hospital from January 2014 to September 2019. The results were graded with 7 endoscopic scores, namely, Mayo endoscopic score(MES), modified Baron score(MBS), endoscopic activity index(EAI) , Sutherland index(DAI or UCDAI) , Rachmilewitz endoscopic index(REI), Lemann endoscopic index (LEI), and ulcerative colitis endoscopic index of severity(UCEIS). Spearman correlation coefficients between endoscopic score and partial Mayo scores, Truelove-Witts disease severity score and Nancy index (NI), Robarts index (RHI) and Geboes score (GS) were calculated respectively. Consistency of each endoscopic score among different observers was analyzed.Results:Except for the weak correlation between DAI and Truelove - Witts classification ( r= 0.469, P < 0.001), all other endoscopic scores were moderately positively correlated with clinical activity scores with significance( all P<0.001). However, the correlation between 7 endoscopic scores and histological scores was weak ( P<0.001). Except that the consistency of MBS among observers was medium, those of MES, DAI and LEI among observers were poor, and those of UCEIS, EAI and REI among observers were worse ( P<0.001). Conclusion:Endoscopic scores were moderately correlated with clinical activity indexes and weakly correlated with histological scores. However, patients with endoscopic remission may have histologic inflammatory activity, so attention should be paid to histological mucosal healing after endoscopic remission. The consistency of all 7 endoscopic scoring stystems among observers was low, and the repeatability was poor.

OBJECTIVE:To provide reference for improving the level of rational drug use in public hospitals at county level. METHODS:The relevant indicator data of rational drug use in our hospital was analyzed,and the relevant indicator data of the hos-pitals at county level around it was investigated and analyzed,a total of 36 parts of rational drug use management indicator system was established,including administrative management indicators,outpatient management indicators,hospital management indica-tors,and drug procurement management indicators,and it was constantly improved and optimized. Meanwhile,relevant indicator data of rational drug use from 2010 to 2014 was statistically analyzed to evaluate the effect of the effectiveness of the system. RE-SULTS:In the 5 years,the drug revenues accounted for revenue ratio(the ratio of drug)decreased by 10.3%;the use indicators of antibiotics in clinic showed gradual optimization,the proportion of outpatient antibiotic prescriptions decreased from 57.1% to 19.3%,the use rate of inpatient antibiotic decreased from 90.2% to 56.3%,the proportion of type I incision operation preventive use of antibiotics decreased from 94.6% to 28.6%,and the submission rate of microbiological sample of inpatients before they re-ceived the treatment of antibiotics increased from 8.4% to 32.7%;the proportion of essential medicines increased 25.5%,and pro-portion of use amount increased to 24.1%;the application of the system promoted the improvement of rational drug use and phar-macy management level in our hospital,and also helped the hospital successfully passed the national three class comprehensive hos-pital evaluation. CONCLUSIONS:The established rational drug use management indicator system is comprehensive and feasible, and can provide reference for strengthening rational drug use management and medical and health system decision in China.

Objective To evaluate the technical method,clinical effect,safety and complication of the endovascular interventional therapy of intracranial A1 segment aneurysms of anterior cerebral artery(ACA).Methods The data of 14 cases with ruptured A1 segment aneurysms received interventional therapy were analyzed retrospectively.All patients were admitted with subarachnoid hem-orrhage (SAH)and classified by Hunt-Hess scale.There were 3 cases of Grade Ⅰ,5 cases of Grade Ⅱ,and 6 cases of Grade Ⅲ. One of fourteen patients was treated by stent implantation alone and 10 patients were treated by coiling alone.The other 3 patients were treated by stent-assisted coiling.Results All the cases were embolized successfully and cured.Angiography immediately after procedure showed Raymond Ⅰ in 1 1 patients,RaymondⅡ in 2 patients and Raymond Ⅲ in 1 patient.In one patient a coil loop was partly left in the parent artery.All of them showed excellent outcome without any serious complication except that one patient suf-fered transient left hemiparesis.Conclusion Endovascular interventional therapy is a safe,effective method in the treatment of the intracranial A1 segment ACA aneurysms.

Objective To evaluate the effectives of high-frequency oscillatory ventilation (HFOV)in the treatment of severe NRDS.Methods The severe NRDS who failed to response to conventional mechanical ventilation (CMV) were changed to HFOV treatment.Ventilator parameters and blood gas analysis were compared before and after treatment.Results Among thirty patients,19 cases were significantly improved and 11 cases were failed,the success rate was 63％.Nineteen patients with HFOV,the main ventilator parameters and blood gas results such as FiO2 ( 0 h:0.87 ± 0.09 vs 3 h:0.67 ± 0.10,6 h:0.54 ±0.08,12h:0.44 ±0.08),MAP[0 h:(14.47 ±1.17) mbar vs 3 h:(13.79 ± 1.03) mbar,6 h:(13.26 ±1.05) mbar,12 h:( 12.37 ±0.83) mbar],f[0 h:(7.26 ±0.56) Hz vs 3 h:(7.89 ±0.57) Hz,6 h:(8.42±0.51 ) Hz,12 h:(9.26 ±0.45) Hz] and PaCO2 [0 h:(9.69 ±0.86) kPa vs 3 h:(6.00 ±0.55) kPa,6 h:(5.62 ± 1.03)kPa,12 h:(5.47 ±0.55)kPa] were decreased while pH(0 h:7.21 ±0.06 vs 3 h:7.35 ±0.07,6 h:7.39 ±0.07,12 h:7.40 ±0.06) and PaO2[0 h:(5.46 ±0.82)kPa vs 3 h:(7.92 ± 1.13)kPa,6 h:(9.25 ± 0.99)kPa,12 h:(9.20 ± 0.96)kPa] were significantly increased compared with before treatment ( P ＜ 0.05).Conclusions The patients of severe NRDS who failed to response to CMV were treated with HFOV,some patients received a significant effect with HFOV treatment.