1.Introduction of the main addition and revision of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅱ)
ZHOU Yi ; WANG Zhijun ; YUE Zhihua ; CHENG Qilei ; YUE Ruiqi ; YANG Xi ; GUO Wei ; MA Shuangcheng
Drug Standards of China 2025;26(1):023-027
The Pharmacopeia of the People’s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025 Edition, ChP 2025) will be promulgated and implemented. This article introduces the process of development of ChP 2025 Edition (Volume Ⅱ), including the selection, the revision of general notices,the addition and revision of drug monographs, etc., and provides some analysis and examples to illustrate,which can facilitate the readers to understand and implement the ChP 2025 Edition (Volume Ⅱ).
2.Application of early screening scale and evaluation of behavioral intervention effect in children with autism spectrum disorder
Bin ZHANG ; Chunwei HU ; Zhihua LIU ; Huiting YANG ; Canjun WANG ; Xineng FENG
Journal of Public Health and Preventive Medicine 2025;36(4):77-80
Objective To understand the application effect of early screening scale and behavioral intervention effect in children with autism spectrum disorder (ASD). Methods A total of 348 children with suspected ASD were selected and evaluated using the Modified Checklist for Autism in Toddlers (M-CHAT) and Autism Behavior Checklist (ABC). The evaluation results were compared with those from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Children enrolled were given Early start Denver model (ESDM) intervention. The evaluation results of Gesell Developmental Scale and Autism Treatment Evaluation Checklist (ATEC) scores were compared before and after intervention. Results The sensitivity, specificity, accuracy and Kappa value of M-CHAT for evaluating ASD in children aged 1-3 years were 89.53%, 90.70%, 89.92% and 0.78. The corresponding values of ABC were 78.49%, 81.40%, 79.46% and 0.56. The sensitivity, specificity, accuracy and Kappa value of M-CHAT for evaluating children aged >3-6 years were 87.30%, 77.78%, 84.44% and 0.64. The corresponding values of ABC were 85.71%, 77.78%, 83.33% and 0.62. The sensitivity and accuracy of M-CHAT were higher than ABC for evaluating ASD in children aged 1-3 years (P<0.05). There were no significant differences in sensitivity, specificity and accuracy between M-CHAT and ABC for evaluating ASD in children aged 3-6 years (P>0.05). After intervention, development quotients (DQ) of personal-social aspects, adaptability, language, gross motor, and fine motor of children with ASD were higher than those before intervention (P<0.05). ATEC scores for language, behavior, sensation, and social contact of children with ASD were lower than those before intervention (P<0.05). Conclusion M-CHAT and ABC both can be used for early screening of ASD in children, especially M-CHAT. Early behavioral intervention can effectively improve the condition and developmental level of children with ASD.
3.Analysis of changes in cerebral blood flow during maintenance hemodialysis in middle-aged and elderly patients
Yidan GUO ; Wei CUI ; Pengpeng YE ; Zhihua SHI ; Meng JIA ; Xiaoling ZHOU ; Yang LUO
Chinese Journal of Nephrology 2024;40(10):792-797
Objective:To investigate the changes and associated factors of cerebral blood flow in middle-aged and elderly patients undergoing maintenance hemodialysis (MHD).Methods:This was a prospective observational study. End-stage renal disease (ESRD) patients undergoing MHD aged over 50 years at Beijing Shijitan Hospital, Capital Medical University from January 2023 to June 2023 were included. General clinical data of the selected individuals were collected, and dialysis related indicators were recorded and calculated. Mean flow velocity (MFV) of the middle cerebral arterial was measured by transcranial Doppler sonography (TCD) to represent cerebral blood flow throughout dialysis. Hemodialysis-related variables were collected. The MFV values of bilateral middle cerebral artery were measured through temporal windows at 7 time points: 15 minutes before dialysis (T1), 15 minutes (T2), 30 minutes (T3), 60 minutes (T4), 120 minutes (T5), 180 minutes (T6) during dialysis, and the endpoint of dialysis (T7), and the average values were recorded. The ΔMFV was calculated as pre-minus endpoint values of MFV. The Spearman rank correlation method was used to analyze the correlations between ΔMFV and dialysis-related variables, and multiple linear regression method was used to analyze the related factors of the changes in MFV.Results:This study included a total of 123 patients undergoing MHD, aged (63.63±8.44) years (range 50-85 years), including 99 males (80.5%). TCD examination demonstrated a decline trend in MFV throughout dialysis. The MFV at T7 was significantly lower than that at T1 ( Z=-7.650, P<0.001). The Spearman correlation analysis showed that the decline in MFV was correlated with ultrafiltration volume ( r=0.356), ultrafiltration rate ( r=0.371), the difference in systolic pressure (pre-analysis minus post-dialysis, r=0.251), the difference in mean arterial pressure (pre-dialysis minus post-dialysis, r=0.194), combined diabetes ( r=0.293), dialysis vintage ( r=0.220), Kt/V ( r=0.287), and serum albumin ( r=-0.295). Multiple linear regression analysis showed that combined with diabetes ( B=3.889, 95% CI 1.373-6.405, P=0.003), decreased serum albumin ( B=-0.456, 95% CI -0.877--0.036, P=0.034), increased ultrafiltration rate ( B=11.099, 95% CI 6.402-15.797, P<0.001) and the decline in systolic pressure ( B=0.062, 95% CI 0.008-0.116, P=0.026) were significantly associated with the decline in MFV throughout dialysis. Conclusions:In middle and elderly patients with ESRD undergoing hemodialysis, there is a decline trend in cerebral blood flow during hemodialysis. The combination of diabetes, lower serum albumin, higher ultrafiltration rate, and intradialytic systolic pressure decline are the risk factors influencing the intradialytic decline of cerebral blood flow.
4.Respiratory virus infection and its influence on outcome in children with septic shock
Gang LIU ; Chenmei ZHANG ; Ying LI ; Junyi SUN ; Yibing CHENG ; Yuping CHEN ; Zhihua WANG ; Hong REN ; Chunfeng LIU ; Youpeng JIN ; Sen CHEN ; Xiaomin WANG ; Feng XU ; Xiangzhi XU ; Qiujiao ZHU ; Xiangdie WANG ; Xinhui LIU ; Yue LIU ; Yang HU ; Wei WANG ; Qi AI ; Hongxing DANG ; Hengmiao GAO ; Chaonan FAN ; Suyun QIAN
Chinese Journal of Pediatrics 2024;62(3):211-217
Objective:To investigate respiratory virus infection in children with septic shock in pediatric care units (PICU) in China and its influence on clinical outcomes.Methods:The clinical data of children with septic shock in children′s PICU from January 2018 to December 2019 in 10 Chinese hospitals were retrospectively collected. They were divided into the pre-COVID-19 and post-COVID-19 groups according to the onset of disease, and the characteristics and composition of respiratory virus in the 2 groups were compared. Matching age, malignant underlying diseases, bacteria, fungi and other viruses, a new database was generated using 1∶1 propensity score matching method. The children were divided into the respiratory virus group and non-respiratory virus group according to the presence or absence of respiratory virus infection; their clinical characteristics, diagnosis, and treatment were compared by t-test, rank sum test and Chi-square test. The correlation between respiratory virus infection and the clinical outcomes was analyzed by logistic regression. Results:A total of 1 247 children with septic shock were included in the study, of them 748 were male; the age was 37 (11, 105) months. In the pre-and post-COVID-19 groups, there were 530 and 717 cases of septic shock, respectively; the positive rate of respiratory virus was 14.9% (79 cases) and 9.8% (70 cases); the seasonal distribution of septic shock was 28.9% (153/530) and 25.9% (185/717) in autumn, and 30.3% (161/530) and 28.3% (203/717) in winter, respectively, and the corresponding positive rates of respiratory viruses were 19.6% (30/153) and 15.7% (29/185) in autumn, and 21.1% (34/161) and 15.3% (31/203) in winter, respectively. The positive rates of influenza virus and adenovirus in the post-COVID-19 group were lower than those in the pre-COVID-19 group (2.1% (15/717) vs. 7.5% (40/530), and 0.7% (5/717) vs. 3.2% (17/530), χ2=21.51 and 11.08, respectively; all P<0.05). Rhinovirus virus were higher than those in the pre-Covid-19 group (1.7% (12/717) vs. 0.2% (1/530), χ2=6.51, P=0.011). After propensity score matching, there were 147 cases in both the respiratory virus group and the non-respiratory virus group. Rate of respiratory failure, acute respiratory distress, rate of disseminated coagulation dysfunction, and immunoglobulin usage of the respiratory virus group were higher than those of non-respiratory virus group (77.6% (114/147) vs. 59.2% (87/147), 17.7% (26/147) vs. 4.1% (6/147), 15.6% (25/147) vs. 4.1% (7/147), and 35.4% (52/147) vs. 21.4% (32/147); χ2=11.07, 14.02, 11.06 and 6.67, all P<0.05); and PICU hospitalization of the former was longer than that of the later (7 (3, 16) vs. 3 (1, 7)d, Z=5.01, P<0.001). Univariate logistic regression analysis showed that the presence of respiratory viral infection was associated with respiratory failure, disseminated coagulation dysfunction, the use of mechanical ventilation, and the use of immunoglobulin and anti-respiratory viral drugs ( OR=2.42, 0.22, 0.25, 0.56 and 1.12, all P<0.05). Conclusions:The composition of respiratory virus infection in children with septic shock is different between pre and post-COVID-19. Respiratory viral infection is associated with organ dysfunction in children with septic shock. Decreasing respiratory viral infection through respiratory protection may improve the clinical outcome of these children.
5.Clinical research of the correlation between hyperkalemia and adverse outcome events in elderly patients with maintenance hemodialysis
Xiyou ZHANG ; Yidan GUO ; Chunxia ZHANG ; Xiaoling ZHOU ; Meng JIA ; Zhihua SHI ; Yang LUO
Tianjin Medical Journal 2024;52(8):840-844
Objective To explore the relationship between hyperkalemia and adverse outcomes in elderly maintenance hemodialysis(MHD)patients.Methods A retrospective cohort trial was conducted on 177 MHD patients aged≥60 years in the hemodialysis center of Beijing Shijitan Hospital,Capital Medical University.Baseline data were collected.The mean age was(77.28±14.25)years,among them 109 cases were males(61.6%).According to the peak serum potassium within 4 months,patients were divided into the K+<5.0 mmol/L group(38 cases,21.5%),the 5.0-5.5 mmol/L group(42 cases,23.7%)and the K+≥5.5 mmol/L group(97 cases,54.8%).Based on the frequency of hyperkalemia within 4 months,patients were divided into the 0,1-2 and 3-4 frequency groups.All of patients were followed up for 1 year.The end point events were all-cause mortality and cardiovascular disease(CVD)mortality.Kaplan-Meier survival analysis was used to compare the cumulative survival rate between the 3 groups.A multivariate Cox regression model was employed to analyze the relationship between the degree and frequency of hyperkalemia with all-cause and CVD mortality.Results The mean follow-up time of 177 patients was 12(1-12)months,20(11.3%)patients died of all-cause death and 14(7.9%)of CVD death.Kaplan Meier survival curve showed cardiovascular mortality rate and all-cause mortality were significantly increased in the K+5.0-5.5 mmol/L group and the K+≥5.5 mmol/L group(both P<0.05).Multivariate Cox regression analysis indicated that,as a continuous variable,peak potassium levels were independently associated with an increased risk of all-cause death and CVD death(P<0.001).As a categorical variable,the all-cause mortality risk and CVD mortality risk were significantly higher in both the K+5.0-5.5 mmol/L group and the K+≥5.5 mmol/L group than those in the K+<5.0 mmol/L group(P<0.05),and those were significantly higher in the 1-2 and 3-4 frequency groups than those in the 0 frequency group of hyperkalemia(P<0.05).Conclusion Serum potassium>5.0 mmol/L in elderly MHD patients is an independent risk factor for all-cause and CVD mortality.It is recommended to adjust the upper limit of the normal range of serum potassium to 5.0 mmol/L.
6.Robot-assisted laparoscopic ureteroplasty with buccal mucosa graft for complex ureteral stricture
Yicen YING ; Yicong DU ; Zhihua LI ; Yiming ZHANG ; Xinfei LI ; Bing WANG ; Peng ZHANG ; Hongjian ZHU ; Liqun ZHOU ; Kunlin YANG ; Xuesong LI
Journal of Peking University(Health Sciences) 2024;56(4):640-645
Objective:To investigate the feasibility,safety and effectiveness of robot-assisted laparo-scopic buccal mucosa graft ureteroplasty in the treatment of complex long proximal ureteral stricture.Methods:The clinical data of 20 patients with proximal ureteral stricture undergoing robot-assisted lapa-roscopic buccal mucosa graft ureteroplasty admitted to the Department of Urology,Peking University First Hospital and Beijing Jiangong Hospital from July 2022 to January 2023 were prospectively collected and analyzed.Intraoperative conditions,postoperative complications and follow-up data were also recorded and analyzed.Results:The operations under robot-assisted laparoscopy were performed successfully in all the 20 patients without conversion to traditional laparoscopic surgery or open surgery.The study in-cluded 14 males and 6 females with a mean age of(41±11)years(range:19 to 60 years)and a mean body mass index of(24.3±3.6)kg/m2(range:18.2 to 31.8 kg/m2).There were 9 cases on the left side and 11 cases on the right side.The strictures of all the patients were located in the proximal segment of the ureter(including the ureteropelvic junction).The mean preoperative serum creatinine was(92.2±23.3)μmol/L(range:49.2 to 138.9 μmol/L),and the mean length of ureteral stricture was(2.8±0.9)cm(range:1.0 to 4.0 cm).Ten patients had previously undergone unsuccessful reconstructive surgery.During the operation,12 patients received posteriorly augmented anastomosis with ventral onlay.The mean length of the buccal mucosa graft harvested during the operation was(3.1±0.6)cm(range:2.0 to 4.3 cm),and the median width was 1.5 cm(range:1.0 to 2.0 cm).The omentum flap was used to wrap the reconstructed ureteral segment in all the 20 cases.The median operative time was 154 min(range:113 to 300 min),and the median estimated blood loss was 45 mL(range:0 to 100 mL).The median postoperative hospital stay was 4 d(range:4 to 14 d).The mean postoperative follow-up time was(15.0±1.7)months(range:12.5 to 17.9 months),and the surgical success rate was 100.0%in this study.After surgery,11 patients reported mild discomfort at the oral donor site,2 patients deve-loped urinary tract infection,and no postoperative complications were reported in the other 7 patients.The mean serum creatinine was(90.9±23.9)μmol/L(range:60.0 to 153.0 μmol/L)six months after surgery.Conclusion:Robot-assisted laparoscopic buccal mucosa graft ureteroplasty for the treatment of complex long proximal ureteral stricture has satisfactory efficacy without severe complications,which has shown good feasibility,safety and effectiveness.However,large sample studies and long-term follow-up are still needed to evaluate its long-term efficacy.
7.Analysis of perioperative complications of flow-diverter devices in the treatment of unruptured intracranial aneurysms
Xiaohui WANG ; Rongju ZHANG ; Nan TIAN ; Zhihua DU ; Xinfeng LIU ; Bin LYU ; Yang BIAN ; Xiangyu CAO ; Jun WANG
Chinese Journal of Surgery 2024;62(12):1094-1103
Objective:To investigate the perioperative adverse events and complications of flow-diverter devices in the treatment of unruptured intracranial aneurysms.Methods:This is a retrospective case series study. The clinical and imaging data of 174 patients with unruptured intracranial aneurysms treated with flow-diverter devices in the Department of Neurointervention, Department of Neurology, the First Medical Center of Chinese People′s Liberation Army General Hospital from January 2020 to January 2024 were retrospectively analyzed. There were 63 males and 111 females, with an age of (53.9±11.4) years (range:23 to 76 years).The occurrence, development and outcome of perioperative complications and related adverse events during treatment were collected and analyzed. The degree of aneurysm embolization was evaluated using the O′Kelly-Marotta (OKM) grading system,with OKM grade C and D as successful occlusion.Results:A total of 187 flow-diverter devices (from 7 different brands) were implanted in 174 patients (with 294 aneurysms). Of these, 151 cases involved standalone stent embolization, 26 cases involved stent embolization combined with coil assistance, and 5 cases involved the use of two flow-diverter devices simultaneously. Twenty-nine cases (16.7%,29/174) suffered intraoperative adverse events, including 10 cases of poor stents deployment, 3 cases of stents migration into the aneurysm sac, 1 cases of abnormal guidewire movement, 4 cases of ischemic events. Complications occurred in 10 patients (5.7%, 10/174), and neurological deficits occurred in 5 patients (2.9%, 5/174). A total of 129 patients completed follow-up for more than 12 months after surgery. There were 117 aneurysms with OKM grade D and 22 with OKM grade C, showing a satisfactory healing rate of 77.7% (139/179).Conclusion:The effect of flow-diverter devices in the treatment of intracranial aneurysms is satisfactory, but complications and adverse events cannot be ignored, especially the relatively high incidence of perioperative adverse events, which requires neurointerventional physicians to be vigilant.
8.Surgical techniques for pollybeak deformity correction
Hongli ZHAO ; Xiancheng WANG ; Yang SUN ; Xiang XIONG ; Xianxi MENG ; Wenbo LI ; Zhihua QIAO ; Kai YANG ; Weiliang ZENG ; Yi TIAN
Chinese Journal of Plastic Surgery 2024;40(2):156-162
Objective:To evaluate the effectiveness of surgical methods for correcting pollybeak deformity in Chinese rhinoplasty.Methods:A retrospective chart review was conducted for patients who underwent pollybeak correction between January 2021 and December 2022 at the Department of Plastic and Aesthetic (Burn) Surgery, the Second Xiangya Hospital of Central South University. Individualized correction was tailored based on the etiology and severity of the nasal deformity of each patient, involving techniques such as resection of the anterior part of the nasal septum, reconstruction of nasal tip support, reconstruction of the middle part of the nasal vault, and excision of skin in the upper region of the nasal tip. A modified classification system for pollybeak deformity, the supratip fullness rating scale (SFRS), was developed to evaluate supratip fullness (0-3 points, with higher scores indicating more apparent deformity). The patients aesthetic outcomes were assessed by surgeons using the visual analogue scale (VAS) (0-10 points, with higher scores indicating more apparent deformity), and patient self-assessed using the rhinoplasty outcome evaluation (ROE) questionnaire (0-100 points, with higher scores indicating higher satisfaction). The measurement data of normal distribution was expressed as Mean±SD and analyzed by paired t-test; the measurement data of non-normal distribution was expressed as M( Q1, Q3) and analyzed by Wilcoxon signed rank test. Results:In a cohort study of 53 rhinoplasty patients (7 male, 46 female; age range 19-45 years, mean 29 years), comprising 15 primary and 38 secondary surgeries, nasal tip deformities were evaluated. Deformities were classified as mild (5 cases), moderate (25 cases), and severe (23 cases). Over a follow-up period of 6-17 months (mean 9.5 months), significant aesthetic improvements in the nasal tip region were observed. The SFRS scores decreased from 2(2, 3) preoperatively to 0(0, 0) postoperatively ( Z = -6.58, P < 0.001), and VAS scores decreased from 7.47±1.73 to 1.79±1.67 ( t = -25.61, P < 0.001). High patient satisfaction was indicated by a mean ROE score of 82.45±11.55. No significant complications, such as nasal tip ptosis, skin necrosis, or scar hyperplasia, were reported. Conclusion:Selecting an appropriate surgical method based on the severity and cause of pollybeak deformity can achieve satisfactory outcomes. Post-operative patients exhibit significant aesthetic improvement in the upper nasal tip area, resulting in high patient satisfaction.
9.Analysis of perioperative complications of flow-diverter devices in the treatment of unruptured intracranial aneurysms
Xiaohui WANG ; Rongju ZHANG ; Nan TIAN ; Zhihua DU ; Xinfeng LIU ; Bin LYU ; Yang BIAN ; Xiangyu CAO ; Jun WANG
Chinese Journal of Surgery 2024;62(12):1094-1103
Objective:To investigate the perioperative adverse events and complications of flow-diverter devices in the treatment of unruptured intracranial aneurysms.Methods:This is a retrospective case series study. The clinical and imaging data of 174 patients with unruptured intracranial aneurysms treated with flow-diverter devices in the Department of Neurointervention, Department of Neurology, the First Medical Center of Chinese People′s Liberation Army General Hospital from January 2020 to January 2024 were retrospectively analyzed. There were 63 males and 111 females, with an age of (53.9±11.4) years (range:23 to 76 years).The occurrence, development and outcome of perioperative complications and related adverse events during treatment were collected and analyzed. The degree of aneurysm embolization was evaluated using the O′Kelly-Marotta (OKM) grading system,with OKM grade C and D as successful occlusion.Results:A total of 187 flow-diverter devices (from 7 different brands) were implanted in 174 patients (with 294 aneurysms). Of these, 151 cases involved standalone stent embolization, 26 cases involved stent embolization combined with coil assistance, and 5 cases involved the use of two flow-diverter devices simultaneously. Twenty-nine cases (16.7%,29/174) suffered intraoperative adverse events, including 10 cases of poor stents deployment, 3 cases of stents migration into the aneurysm sac, 1 cases of abnormal guidewire movement, 4 cases of ischemic events. Complications occurred in 10 patients (5.7%, 10/174), and neurological deficits occurred in 5 patients (2.9%, 5/174). A total of 129 patients completed follow-up for more than 12 months after surgery. There were 117 aneurysms with OKM grade D and 22 with OKM grade C, showing a satisfactory healing rate of 77.7% (139/179).Conclusion:The effect of flow-diverter devices in the treatment of intracranial aneurysms is satisfactory, but complications and adverse events cannot be ignored, especially the relatively high incidence of perioperative adverse events, which requires neurointerventional physicians to be vigilant.
10.Surgical techniques for pollybeak deformity correction
Hongli ZHAO ; Xiancheng WANG ; Yang SUN ; Xiang XIONG ; Xianxi MENG ; Wenbo LI ; Zhihua QIAO ; Kai YANG ; Weiliang ZENG ; Yi TIAN
Chinese Journal of Plastic Surgery 2024;40(2):156-162
Objective:To evaluate the effectiveness of surgical methods for correcting pollybeak deformity in Chinese rhinoplasty.Methods:A retrospective chart review was conducted for patients who underwent pollybeak correction between January 2021 and December 2022 at the Department of Plastic and Aesthetic (Burn) Surgery, the Second Xiangya Hospital of Central South University. Individualized correction was tailored based on the etiology and severity of the nasal deformity of each patient, involving techniques such as resection of the anterior part of the nasal septum, reconstruction of nasal tip support, reconstruction of the middle part of the nasal vault, and excision of skin in the upper region of the nasal tip. A modified classification system for pollybeak deformity, the supratip fullness rating scale (SFRS), was developed to evaluate supratip fullness (0-3 points, with higher scores indicating more apparent deformity). The patients aesthetic outcomes were assessed by surgeons using the visual analogue scale (VAS) (0-10 points, with higher scores indicating more apparent deformity), and patient self-assessed using the rhinoplasty outcome evaluation (ROE) questionnaire (0-100 points, with higher scores indicating higher satisfaction). The measurement data of normal distribution was expressed as Mean±SD and analyzed by paired t-test; the measurement data of non-normal distribution was expressed as M( Q1, Q3) and analyzed by Wilcoxon signed rank test. Results:In a cohort study of 53 rhinoplasty patients (7 male, 46 female; age range 19-45 years, mean 29 years), comprising 15 primary and 38 secondary surgeries, nasal tip deformities were evaluated. Deformities were classified as mild (5 cases), moderate (25 cases), and severe (23 cases). Over a follow-up period of 6-17 months (mean 9.5 months), significant aesthetic improvements in the nasal tip region were observed. The SFRS scores decreased from 2(2, 3) preoperatively to 0(0, 0) postoperatively ( Z = -6.58, P < 0.001), and VAS scores decreased from 7.47±1.73 to 1.79±1.67 ( t = -25.61, P < 0.001). High patient satisfaction was indicated by a mean ROE score of 82.45±11.55. No significant complications, such as nasal tip ptosis, skin necrosis, or scar hyperplasia, were reported. Conclusion:Selecting an appropriate surgical method based on the severity and cause of pollybeak deformity can achieve satisfactory outcomes. Post-operative patients exhibit significant aesthetic improvement in the upper nasal tip area, resulting in high patient satisfaction.


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