The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

Tuberous sclerosis complex (TSC) is an autosomal dominant genetic disorder primarily caused by pathogenic variants in the TSC1 or TSC2 genes. It is characterized by multisystem hamartomatous lesions and neuropsychiatric manifestations. Here we report a young male patient with TSC involving multiple organs, caused by a heterozygous frameshift mutation in TSC2 (c.2071delC, p.Arg691Alafs^*7). The patient initially presented with classic facial angiofibromas and hypomelanotic macules, and subsequently developed psychiatric and behavioral disturbances with auditory hallucinations. Neuroimaging revealed an intracranial mass lesion, which was confirmed as a subependymal giant cell astrocytoma on postoperative histopathology following surgery performed at an outside institution. After admission, the patient underwent a comprehensive diagnostic workup, and multidisciplinary treatment evaluation revealed extensive multisystem involve-ment, including the nervous system, skin, kidneys, lungs, heart, eyes, pancreas, liver and bones. Combined with relevant literature, this article discusses the molecular mechanisms, clinical phenotypes, and comprehensive management of TSC, in order to provide a reference for the standardized and individualized management of this disease.

Objective:To explore the safety and feasibility of laparoscopic pancreaticoduodenectomy (LPD) combined with portal vein system resection and reconstruction.Methods:The clinical data of 26 patients with pancreatic head cancer or distal bile duct malignant tumors who underwent reconstructive LPD combined with portal vein resection in the Department of Hepatobiliary Surgery of the Second Hospital of Hebei Medical University from January 2016 to December 2023 were retrospectively analyzed, including 13 males and 13 females, aged 63.0 (57.2, 66.0) years. The clinical data of the patients, including the operation time, intraoperative blood loss and blood transfusion, blood flow interruption time, postoperative complications, intensive care unit (ICU) admission time, and hospital stay were recorded.Results:All 26 patients had completed the operation successfully. The operation time was (483.65±118.00) min, the intraoperative blood loss was 1 100 (625, 2 750) ml, the intraoperative blood transfusion was 600 (438, 1 050) ml, and the portal vein system blockade time was (35.00±6.00) min. There were 5 cases (19.2%, 5/26) with laparotomy, 5 cases (19.2%%, 5/26) with repair after partial resection of the portal vein system, 12 cases (46.1%, 12/26) with end-to-end anastomosis of the portal venous system, and 9 cases (34.6%, 9/26) with artificial vascular replacement. There was 1 case of grade B pancreatic fistula (3.8%, 1/26), 3 cases of bile leakage (11.5%, 3/26), 1 case of gastric paralysis (3.8%, 1/26), 3 cases of intestinal obstruction (11.5%, 3/26), 2 cases of abdominal infection (7.7%, 2/26), 2 cases of postoperative bleeding (7.7%, 2/26), 1 case of secondary surgery (3.8%, 1/26), and 1 case of perioperative death (3.8%, 1/26). The postoperative hospital stay was 14.00 (12.00, 20.75) d, the ICU length of stay was 3.0 (1.0, 6.5) d, the tumor length diameter was 4.00 (3.00, 5.38) cm, and the number of positive lymph nodes was 1.0(0.5, 3.5).Conclusion:LPD reconstructed with portal system resection is a safe and effective treatment of patients with pancreatic head cancer or distal bile duct malignancy.

Objective To investigate the role of JAK2/STAT3 signaling pathway mediated Treg/Th17 imbalance in children with cow's milk protein allergy and the effect of dietary avoidance on the imbalance.Methods A total of 103 children with cow's milk protein allergy in the hospital were enrolled and divided in-to the IgE-mediated group(n=38)and the non-IgE-mediated group(n=65).All patients underwent a 3-month strict dietary avoidance intervention.A total of 100 healthy children who underwent health checkups at the hospital's physical examination center during the same period,with no history of food allergy or other im-mune-related diseases,were selected as the healthy control group.The percentages of Treg and Th17 cells were measured by flow cytometry.The mRNA expression levels of JAK2,STAT3,SOCS1,and SOCS3 were determined by qPCR.Differences between groups,changes before and after dietary avoidance,and correlations between these indicators and clinical symptoms were analyzed using Pearson's test.Results At baseline,both the IgE-mediated group and the non-IgE-mediated group had significantly lower Treg percentages and SOCS1/SOCS3 mRNA levels,and higher Th17 percentages and JAK2/STAT3 mRNA levels compared to the healthy control group(P＜0.05).After dietary avoidance,Treg percentages and SOCS1/SOCS3 mRNA levels in-creased,while Th17 percentages and JAK2/STAT3 mRNA levels decreased in the IgE-mediated group and the non-IgE-mediated group(P＜0.05).The increase of Treg percentage and the decrease of Th17 percentage in the non-IgE-mediated group were greater than in the IgE-mediated group,whereas the increases of SOCS1 and SOCS3 mRNA levels were smaller in the non-IgE-mediated group(P＜0.05).Logistic regression identified JAK2,STAT3,SOCS1,and SOCS3 mRNA levels as factors influencing Treg and Th17 percentages(P＜0.05).Pearson correlation analysis revealed that allergic symptom scores and serum milk-specific IgE levels were positively correlated with JAK2/STAT3 mRNA levels and Th17 percentage,and negatively correlated with SOCS1/SOCS3 mRNA levels,Treg percentage,and the Treg/Th17 ratio(P＜0.05).Conclusion Dieta-ry avoidance can modulate the activity of JAK2/STAT3 signaling pathway,with a more pronounced improve-ment in non-IgE-mediated cow's milk protein allergy.

Objective:To develop a simple and effective subretinal injection pipeline system to enhance the accuracy and precision of subretinal injection volume control.Methods:A retrospective case series study. From May to October 2023, 18 patients (18 eyes) with submacular hemorrhage (SMH) who continuously received modified subretinal injection treatment in Department of Ophthalmology of Peking Union Medical College Hospital were included in the study. Among them, there were 10 males and 8 females. The mean age was (60.00±7.41) years. The primary causes included polypoid choroidal vasculopathy (14 cases), retinal macroaneurysm (2 cases), traumatic retinopathy (1 case), and Valsalva retinopathy (1 case). Hemorrhage affected 14 eyes of the fovea centralis. All affected eyes underwent standard three-channel 25G vitrectomy via the flat part of the ciliary body combined with modified subretinal injection of recombinant tissue plasminogen activator. The improved injection system consisted of a 1 ml syringe, a Q-Syte TM connector, a 41G subretinal microinjection needle, a converter and a viscoelastic substance control pipeline. The drug preparation time for subretinal injection (i.e., the time consumed by the system connection step), the injection time, whether bubbles occur during the injection process, and the perioperative complications were recorded and analyzed. Results:The preparation time prior to drug injection ranged from 230 to 335 seconds, while the injection completion time varied between 43 and 75 seconds. Both times decreased progressively as operator proficiency improved. Among the treated eyes, five received a target injection dose of 0.05 ml and thirteen received 0.10 ml, with all eyes achieving the preset dose accurately. No subretinal bubbles were observed during the injection procedure. Additionally, no intraoperative complications such as retinal hemorrhage or tear secondary to mechanical trauma at the injection site were recorded. Postoperatively, one eye developed anterior chamber hemorrhage, which resolved following intraocular pressure-lowering treatment. No other postoperative complications, including hemorrhage, rhegmatogenous retinal detachment, or infection, were observed in the remaining eyes.Conclusion:The retinal drug injection system developed in this study has a simple structure, safe and stable operation, can achieve precise drug injection, and effectively avoid the formation of bubbles.

Objective:To retrospectively analyze the cases of inflammatory myofibroblastic tumor (IMT) involving the sinonasal skull base, and to investigate their clinical characteristics, diagnostic approaches, and treatment outcomes, in order to improve understanding of this rare entity.Methods:Clinical data from five patients with pathologically confirmed sinonasal skull base IMT who underwent surgical treatment at Xiangya Hospital of Central South University between April 2010 and June 2023 were reviewed. Information on clinical presentation, laboratory findings, imaging features, histopathological and immunohistochemical results, treatment strategies, and follow-up outcomes was collected. A comprehensive analysis was performed in combination with a literature review to summarize the clinical features, diagnostic methods, and therapeutic approaches for sinonasal skull base IMT.Results:The five patients (aged 18 to 68 years) were all diagnosed based on histopathological and immunohistochemical examinations. The lesions primarily involved the nasopharynx, clivus, sphenoid sinus, and maxillary sinus. Major clinical symptoms included nasal obstruction, headache, blood-tinged nasal discharge, and facial numbness or pain. All patients underwent surgical resection; two of them also received adjunctive glucocorticoid therapy. During follow-up ranging from 1 to 143 months, two patients experienced tumor recurrence, three patients had no recurrence with significant symptomatic improvement.Conclusions:Histopathology combined with immunohistochemistry is critical for the diagnosis of sinonasal skull base IMT. Complete surgical excision when feasible remains the primary treatment strategy.

Objective To investigate the relationship between stationing years of personnel on an island and their traditional Chinese medicine(TCM)constitution,thus providing a reference for adjusting the health status of stationed personnel,preventing and treating diseases.Methods Based on The Scale of Constitution in Chinese Medicine Questionnaire,TCM constitution of 734 personnel stationed on an island was investigated.Pearson χ2 method was used for data analysis.Results Of the 734 personnel stationed on an island 345(47.0%)were of the balanced constitution type and 389(53.0%)were of the biased constitution types.Among the people with biased constitution types,composite constitution accounted for 80.5%(313 people)and the simple accounted for the rest(19.5%,76 people).The top three types of the biased were dampness heat(15.2%),qi deficiency(14.0%),and yin deficiency(10.7%).The distribution of TCM constitution types was significantly different in terms of stationing years on the island(P<0.05).There was a significant difference in the balanced type and yin deficiency type between people with stationing time≤2 years and>8 years(P<0.05).There was a significant difference in qi deficiency type and qi depression type between people with stationing time≤2 years and>5 years(P<0.05).Compared to people with stationing time≤2 years,significant difference was found in yang deficiency type in people with stationing time ranging from 2 to 5 years and those with>8 years(P<0.05).There were significant differences in the phlegm dampness type,blood stasis type,and specific diathesis type between people with stationing time≤2 years and people with stationing time ranging from>2～5 years and>8 years(P<0.05).There were significant differences in the dampness heat type between people with stationing time≤2 years and people with stationing time ranging from>5～8 years and>8 years,between pepole with stationing time ranging from>2～5 years and people with stationing time>8 years(P<0.05).Conclusion The dampness heat type,qi deficiency type and yin deficiency type are common biased TCM constitution in personnel stationed on islands.The longer the time spent on islands,the greater the possibility of forming biased constitution.

BACKGROUND: While emotional distress, encompassing anxiety and depression, has been associated with negative clinical outcomes, its impact across various clinical departments and general hospitals has been less explored. Previous studies with limited sample sizes have examined the effectiveness of specific treatments (e.g., antidepressants) rather than a systemic management strategy for outcome improvement in non-psychiatric inpatients. To enhance the understanding of the importance of addressing mental health care needs among non-psychiatric patients in general hospitals, this study retrospectively investigated the impacts of emotional distress and the effects of early detection and management of depression and anxiety on hospital length of stay (LOS) and rate of long LOS (LLOS, i.e., LOS >30 days) in a large sample of non-psychiatric inpatients. METHODS: This retrospective cohort study included 487,871 inpatients from 20 non-psychiatric departments of a general hospital. They were divided, according to whether they underwent a novel strategy to manage emotional distress which deployed the Huaxi Emotional Distress Index (HEI) for brief screening with grading psychological services (BS-GPS), into BS-GPS ( n = 178,883) and non-BS-GPS ( n = 308,988) cohorts. The LOS and rate of LLOS between the BS-GPS and non-BS-GPS cohorts and between subcohorts with and without clinically significant anxiety and/or depression (CSAD, i.e., HEI score ≥11 on admission to the hospital) in the BS-GPS cohort were compared using univariable analyses, multilevel analyses, and/or propensity score-matched analyses, respectively. RESULTS: The detection rate of CSAD in the BS-GPS cohort varied from 2.64% (95% confidence interval [CI]: 2.49%-2.81%) to 20.50% (95% CI: 19.43%-21.62%) across the 20 departments, with a average rate of 5.36%. Significant differences were observed in both the LOS and LLOS rates between the subcohorts with CSAD (12.7 days, 535/9590) and without CSAD (9.5 days, 3800/169,293) and between the BS-GPS (9.6 days, 4335/178,883) and non-BS-GPS (10.8 days, 11,483/308,988) cohorts. These differences remained significant after controlling for confounders using propensity score-matched comparisons. A multilevel analysis indicated that BS-GPS was negatively associated with both LOS and LLOS after controlling for sociodemographics and the departments of patient discharge and remained negatively associated with LLOS after controlling additionally for the year of patient discharge. CONCLUSION Emotional distress significantly prolonged the LOS and increased the LLOS of non-psychiatric inpatients across most departments and general hospitals. These impacts were moderated by the implementation of BS-GPS. Thus, BS-GPS has the potential as an effective, resource-saving strategy for enhancing mental health care and optimizing medical resources in general hospitals.
Humans ; Retrospective Studies ; Male ; Length of Stay/statistics & numerical data* ; Female ; Middle Aged ; Adult ; Psychological Distress ; Inpatients/psychology* ; Aged ; Anxiety/diagnosis* ; Depression/diagnosis*