ObjectiveTo observe the effectiveness and safety of Xingeng No.Ⅱ Granules （心梗2号颗粒剂） in preventing and treating left ventricular remodeling in patients with qi deficiency and blood stasis syndrome following percutaneous coronary intervention （PCI） for ST-segment elevation myocardial infarction （STEMI）. MethodsIn this randomized controlled trial， patients with qi deficiency and blood stasis syndrome after PCI for STEMI were randomly assigned to treatment group and control group at a 1∶1 ratio， with 66 patients in each group. In the control group， patients only received conventional western medicine after surgery， while the treatment group additionally received the granules （8 g per dose， twice daily）， for a treatment duration of 8 weeks in both groups. The primary outcome was the incidence of left ventricular remodeling within 6 months after surgery. The secondary outcomes were the incidence of major adverse cardiovascular and cerebrovascular events （MACCE） within 6 months， all-cause mortality， stent thrombosis， BARC Ⅲ and V bleeding events， rehospitalization due to acute heart failure， and severe complications of STEMI. Traditional Chinese medicine （TCM） syndrome scores at 1 day and 1， 2， and 6 months after surgery was evaluated. Adverse events during the study were recorded to evaluate safety. ResultsSix cases dropped out from both the treatment group and the control group. The full analysis set （FAS） analysis showed that the incidence of left ventricular remodeling in the treatment group was 16.67% （11/66）， significantly lower than 40.91% （27/66） in the control group （P=0.004）. The per protocol set （PPS） analysis also showed lower incidence of left ventricular remodeling in the treatment group （20.37%， 11/54） than in the control group （49.09%， 27/55） with significant difference （P=0.002）. Within 6 month after surgery， 0 patients in the treatment group and 4 out of 60 patients （6.67%） in the control group were readmitted to hospital for acute heart failure， with significantly higher rate in the control group （P=0.042）. Neither group of patients experienced recurrent myocardial infarction， target vessel revascularization， in-stent thrombosis， or severe complications of STEMI. There was no statistically significant difference between groups in the incidence of stroke， cardiovascular mortality， all-cause mortality， BARC Ⅲ and V bleeding events （P＞0.05）. At 1 day after surgery， there was no statistically significant difference in TCM syndrome score between the groups （P＞0.05）； while 1， 2 and 6 months after surgery， TCM syndrome score in the treatment group was significantly lower than that in the control group （P＜0.05）. Analysis of the safety dataset （SS） showed that the incidence of adverse events in the treatment group was 7.41% （4/60）， while in the control group it was 16.36% （9/57）， showing no statistically significant difference （P = 0.117）. ConclusionIn addition to conventional western medicine， Xingeng No.Ⅱ Granules can reduce the incidence of left ventricular remodeling and the incidence of rehospitalization due to acute heart failure in STEMI patients with qi deficiency and blood stasis syndrome after PCI， with good safety profile.

Objective To investigate the effects of Fuzheng Touxie Prescription on pulmonary injury of Pseudomonas aeruginosa pneumonia(PAP)in rats;To discuss its possible mechanism.Methods A total of 36 SD rats were divided into blank group,model group,piperacillin group and Fuzheng Touxie Prescription low-,medium-and high-dosage groups according to random number table method,with 6 rats in each group.Except for the blank group,0.1 mL of Pseudomonas aeruginosa suspension with a concentration of 3×109 CFU/mL was injected through oral catheterization.In the blank group,0.1 mL sterile saline was injected by oral catheterization.Fuzheng Touxie Prescription low-,medium-and high-dosage groups were gavaged 1.6 mL of Fuzheng Touxie Prescription solution with the concentration of 0.43,0.86 and 1.73 g/mL respectively,the blank group and model group were gavaged equal volume of distilled water,piperacillin group was intraperitoneal injected 0.53 mL piperacillin tazobactam sodium solution with a concentration of 0.11 g/mL,once a day,for consecutive 3 days.HE staining was used to observe the pathological changes of lung tissue,lung injury score was performed and bronchial wall thickness was measured,flow cytometry was used to detect Th17/Treg ratio in peripheral blood,the serum contents of RORγt,FoxP3,TGF-β and inflammatory factors TNF-α,IL-6 and IL-10 were detected by ELISA,the mRNA expression of RORγt,FoxP3 and inflammatory factors in lung tissue were detected by RT-qPCR,the protein expressions of RORγt,FoxP3 and inflammatory factors in lung tissue were detected by Western blot.Results Compared with the blank group,a large amount of inflammatory cell infiltration was observed in lung tissue of the model group rats,accompanied by bronchial wall hyperplasia,alveolar dilation,interstitial edema,and a significant increase in lung injury score and bronchial wall thickness(P<0.01),the proportion of Th17 in peripheral blood increased(P<0.01),the proportion of Treg decreased(P<0.01),and the Th17/Treg ratio increased(P<0.05),the contents of serum RORγt,TNF-α,TGF-β and IL-6 significantly increased(P<0.01),the contents of FoxP3 and IL-10 significantly decreased(P<0.01),the mRNA and protein expressions of RORγt,TNF-α,TGF-β and IL-6 in lung tissue significantly increased(P<0.01),while the mRNA and protein expressions of FoxP3 and IL-10 significantly decreased(P<0.01).Compared with the model group,the alveoli of rats in each treatment group were relatively intact and the structure was clearer,inflammatory cell infiltration,pulmonary interstitial edema and congestion were reduced,and lung injury scores and bronchial wall thickness were reduced(P<0.05,P<0.01),the proportion of Th17 in peripheral blood decreased(P<0.05),the proportion of Treg increased(P<0.05),and the Th17/Treg ratio decreased(P<0.05)in Fuzheng Touxie Prescription high-dosage group and piperacillin group,the contents of serum RORγt,TNF-α,TGF-β and IL-6 significantly decreased in Fuzheng Touxie Prescription medium-and high-dosage groups and piperacillin group(P<0.05,P<0.01),the contents of FoxP3 and IL-10 significantly increased(P<0.05,P<0.01),the mRNA and protein expressions of RORγt,TNF-α,TGF-β and IL-6 in lung tissue significantly decreased(P<0.05,P<0.01),the mRNA and protein expressions of FoxP3 and IL-10 significantly increased(P<0.05,P<0.01).Conclusion Fuzheng Touxie Prescription can improve pulmonary inflammatory symptoms,reduce the level of inflammatory factors and increase the level of anti-inflammatory factors in PAP rats.The mechanism may be through the TGF-β/RORγt/FoxP3 pathway to regulate immune balance.

Objective:To evaluate the early and mid-term efficacy of physician-modified fenestrated endovascular repair combined with inner branch techniques for aortic pathologies complicated by aberrant subclavian artery (ASA).Methods:A retrospective case series was conducted, including 24 patients with ASA-associated aortic pathologies who underwent thoracic endovascular aortic repair (TEVAR) with physician-modified fenestration and inner branch reconstruction at 7 centers in China from February 2021 to March 2025. The cohort comprised 18 males and 6 females, with an age of (54.4±11.7) years (range:37 to 80 years). Pathological diagnoses included aortic aneurysm in 7 patients (29.2%), aortic dissection in 11 (45.8%; 6 chronic, 4 subacute, 1 acute), and penetrating aortic ulcer in 6 (25.0%; 3 with concomitant intramural hematoma). Preoperative planning was performed using three-dimensional CT angiographic reconstruction, incorporating both the greater-curvature hemodynamic length and the centerline wall-adherent length. Fenestration sites were verified on three-dimensional printed models, and precise fenestrations were created at the covered stent-graft locations corresponding to the subclavian artery and ASA anatomy. Patients subsequently underwent TEVAR combined with supra-aortic revascularization as indicated, followed by completion ascending aortography to evaluate the sealing of the main stent-graft and the patency of fenestrated or branched stents. Perioperative outcomes, complications, and early-to mid-term clinical efficacy were analyzed.Results:All procedures were technically successful. Immediate angiography identified one case of minor type Ⅳ endoleak that resolved spontaneously on 3-month follow-up CT angiography, and one case of mild type Ⅱ endoleak that was left untreated with a stable false lumen during follow-up. One patient died on postoperative day 7 of an undetermined cause. The mean follow-up period was (23.1±11.3)months (range:3 to 37 months). During follow-up, one patient developed mild bilateral lower-limb weakness 1 month after surgery. Vascular occlusion and spinal cord infarction were excluded, and the symptoms were considered related to postoperative spinal hemodynamic changes; the weakness resolved after blood pressure adjustment without recurrence. No other complications, including upper limb ischemia, spinal cord ischemia, or posterior circulation ischemia, were observed. Throughout follow-up, all branch and main stents remained patent with good structural integrity, without migration or device-related complications.Conclusions:Physician-modified fenestration combined with inner branch techniques for ASA-associated aortic pathologies is technically feasible and yields satisfactory early and mid-term results. Long-term outcomes require further follow-up.

The number of investor initiated trial(IIT)in the field of traditional Chinese medicine(TCM)in China has been increasing year by year,but there are still many problems about their scientific validity.Scientific review is the top priority of IIT management,which is of great significance to improve the quality of IIT.Considering the characteristics of IIT in the field of TCM,randomized controlled trials and discuss common methodological problems in the scientific review process of IIT are focused on,such as non-standard placebo setting,unclear research hypothesis or improper selection of hypothesis test type,inappropriate sample size estimation methods,insufficient characteristics of TCM in outcome measures,unreasonable statistical analysis methods,etc.At the same time,corresponding solutions are proposed to increase the scientific and credibility of IIT,thus improving the research quality of IIT in TCM.

Objective:To investigate the effects of anisodamine hydrobromide (654-1), 654-1+ norepinephrine and norepinephrine on early hemodynamic indexes of piglets with septic shock.Methods:A total of 38 healthy Bama pigs were selected as the study subjects, 32 of which were treated with lipopolysaccharide to create septic shock piglet model, and the other 6 were sham operation group. The animals were randomly divided into control group ( n=8), drug treatment group [654-1 group ( n=8), 654-1+ norepinephrine group ( n=8), norepinephrine group ( n=8)]. Hemodynamic parameters were recorded at T 0 (basic state), T 1 (successful shock modeling), T 2 (1 h after successful modeling), T 3 (2 h after successful modeling), T 4 (4 h after successful modeling), T 5 (6 h after successful modeling) and T 6 (8 h after successful modeling) respectively, including: Mean arterial pressure (MAP), cardiac index (CI), whole-heart end-diastolic volume index (GEDI), lactic acid (LAC). Results:Except for the sham operation group, MAP of all treatment groups at T 1 was significantly lower than that at T 0 (all P<0.05). MAP of all treatment groups at T 2-T 6 was significantly higher than that at T 1 (all P<0.05). T 1 MAP of all treatment groups was significantly lower than that of the sham operation group (all P<0.05). MAP at T 2-T 6 in the norepinephrine group and the 654-1+ norepinephrine group was higher than that in the control group (all P<0.05), and MAP at T 2-T 4 in the 654-1 group was significantly lower than that in the 654-1+ norepinephrine group (all P<0.05). LAC of all treatment groups at T 1-T 3 was significantly higher than that at T 0 (all P<0.05) except the sham operation group. LAC in the group 654-1 at T 4 to T 6 was significantly lower than that at T 1 (all P<0.05). LAC in the group 654-1 at T 4-T 6 was significantly lower than that in the norepinephrine group and the control group (all P<0.05). The CI of norepinephrine group at T 2, T 5 and T 6 was lower than that at T 0 (all P<0.05). There was no significant difference in CI between T 2 and T 6 compared with T 1 (all P>0.05). CI of the 654-1+ norepinephrine group at T 4 was significantly lower than that of T 0 ( P<0.05); The CI of the 654-1 group at T 2 was significantly higher than that of T 1 ( P<0.05). CI at T 1 in the 654-1+ norepinephrine group was significantly lower than that in the sham operation group (all P<0.05). The GEDI at T 1 to T 5 in the 654-1 group was significantly lower than that at T 0 in the 6541+ norepinephrine group (all P<0.05), and the GEDI at T 1 to T 2 was significantly lower than that at T 0 in the 6541+ norepinephrine group (all P<0.05), while the GEDI at T 2 and T 4 was higher than that at T 1 (all P<0.05). Conclusions:MAP decreased significantly in septic shock, LAC increased significantly in the early stage of shock. 654-1 can improve MAP in early stage of septic shock, and significantly reduce LAC level in early stage of septic shock.

The number of investor initiated trial(IIT)in the field of traditional Chinese medicine(TCM)in China has been increasing year by year,but there are still many problems about their scientific validity.Scientific review is the top priority of IIT management,which is of great significance to improve the quality of IIT.Considering the characteristics of IIT in the field of TCM,randomized controlled trials and discuss common methodological problems in the scientific review process of IIT are focused on,such as non-standard placebo setting,unclear research hypothesis or improper selection of hypothesis test type,inappropriate sample size estimation methods,insufficient characteristics of TCM in outcome measures,unreasonable statistical analysis methods,etc.At the same time,corresponding solutions are proposed to increase the scientific and credibility of IIT,thus improving the research quality of IIT in TCM.

Objective:To investigate the effects of anisodamine hydrobromide (654-1), 654-1+ norepinephrine and norepinephrine on early hemodynamic indexes of piglets with septic shock.Methods:A total of 38 healthy Bama pigs were selected as the study subjects, 32 of which were treated with lipopolysaccharide to create septic shock piglet model, and the other 6 were sham operation group. The animals were randomly divided into control group ( n=8), drug treatment group [654-1 group ( n=8), 654-1+ norepinephrine group ( n=8), norepinephrine group ( n=8)]. Hemodynamic parameters were recorded at T 0 (basic state), T 1 (successful shock modeling), T 2 (1 h after successful modeling), T 3 (2 h after successful modeling), T 4 (4 h after successful modeling), T 5 (6 h after successful modeling) and T 6 (8 h after successful modeling) respectively, including: Mean arterial pressure (MAP), cardiac index (CI), whole-heart end-diastolic volume index (GEDI), lactic acid (LAC). Results:Except for the sham operation group, MAP of all treatment groups at T 1 was significantly lower than that at T 0 (all P<0.05). MAP of all treatment groups at T 2-T 6 was significantly higher than that at T 1 (all P<0.05). T 1 MAP of all treatment groups was significantly lower than that of the sham operation group (all P<0.05). MAP at T 2-T 6 in the norepinephrine group and the 654-1+ norepinephrine group was higher than that in the control group (all P<0.05), and MAP at T 2-T 4 in the 654-1 group was significantly lower than that in the 654-1+ norepinephrine group (all P<0.05). LAC of all treatment groups at T 1-T 3 was significantly higher than that at T 0 (all P<0.05) except the sham operation group. LAC in the group 654-1 at T 4 to T 6 was significantly lower than that at T 1 (all P<0.05). LAC in the group 654-1 at T 4-T 6 was significantly lower than that in the norepinephrine group and the control group (all P<0.05). The CI of norepinephrine group at T 2, T 5 and T 6 was lower than that at T 0 (all P<0.05). There was no significant difference in CI between T 2 and T 6 compared with T 1 (all P>0.05). CI of the 654-1+ norepinephrine group at T 4 was significantly lower than that of T 0 ( P<0.05); The CI of the 654-1 group at T 2 was significantly higher than that of T 1 ( P<0.05). CI at T 1 in the 654-1+ norepinephrine group was significantly lower than that in the sham operation group (all P<0.05). The GEDI at T 1 to T 5 in the 654-1 group was significantly lower than that at T 0 in the 6541+ norepinephrine group (all P<0.05), and the GEDI at T 1 to T 2 was significantly lower than that at T 0 in the 6541+ norepinephrine group (all P<0.05), while the GEDI at T 2 and T 4 was higher than that at T 1 (all P<0.05). Conclusions:MAP decreased significantly in septic shock, LAC increased significantly in the early stage of shock. 654-1 can improve MAP in early stage of septic shock, and significantly reduce LAC level in early stage of septic shock.

Objective To investigate the effects of Fuzheng Touxie Prescription on pulmonary injury of Pseudomonas aeruginosa pneumonia(PAP)in rats;To discuss its possible mechanism.Methods A total of 36 SD rats were divided into blank group,model group,piperacillin group and Fuzheng Touxie Prescription low-,medium-and high-dosage groups according to random number table method,with 6 rats in each group.Except for the blank group,0.1 mL of Pseudomonas aeruginosa suspension with a concentration of 3×109 CFU/mL was injected through oral catheterization.In the blank group,0.1 mL sterile saline was injected by oral catheterization.Fuzheng Touxie Prescription low-,medium-and high-dosage groups were gavaged 1.6 mL of Fuzheng Touxie Prescription solution with the concentration of 0.43,0.86 and 1.73 g/mL respectively,the blank group and model group were gavaged equal volume of distilled water,piperacillin group was intraperitoneal injected 0.53 mL piperacillin tazobactam sodium solution with a concentration of 0.11 g/mL,once a day,for consecutive 3 days.HE staining was used to observe the pathological changes of lung tissue,lung injury score was performed and bronchial wall thickness was measured,flow cytometry was used to detect Th17/Treg ratio in peripheral blood,the serum contents of RORγt,FoxP3,TGF-β and inflammatory factors TNF-α,IL-6 and IL-10 were detected by ELISA,the mRNA expression of RORγt,FoxP3 and inflammatory factors in lung tissue were detected by RT-qPCR,the protein expressions of RORγt,FoxP3 and inflammatory factors in lung tissue were detected by Western blot.Results Compared with the blank group,a large amount of inflammatory cell infiltration was observed in lung tissue of the model group rats,accompanied by bronchial wall hyperplasia,alveolar dilation,interstitial edema,and a significant increase in lung injury score and bronchial wall thickness(P<0.01),the proportion of Th17 in peripheral blood increased(P<0.01),the proportion of Treg decreased(P<0.01),and the Th17/Treg ratio increased(P<0.05),the contents of serum RORγt,TNF-α,TGF-β and IL-6 significantly increased(P<0.01),the contents of FoxP3 and IL-10 significantly decreased(P<0.01),the mRNA and protein expressions of RORγt,TNF-α,TGF-β and IL-6 in lung tissue significantly increased(P<0.01),while the mRNA and protein expressions of FoxP3 and IL-10 significantly decreased(P<0.01).Compared with the model group,the alveoli of rats in each treatment group were relatively intact and the structure was clearer,inflammatory cell infiltration,pulmonary interstitial edema and congestion were reduced,and lung injury scores and bronchial wall thickness were reduced(P<0.05,P<0.01),the proportion of Th17 in peripheral blood decreased(P<0.05),the proportion of Treg increased(P<0.05),and the Th17/Treg ratio decreased(P<0.05)in Fuzheng Touxie Prescription high-dosage group and piperacillin group,the contents of serum RORγt,TNF-α,TGF-β and IL-6 significantly decreased in Fuzheng Touxie Prescription medium-and high-dosage groups and piperacillin group(P<0.05,P<0.01),the contents of FoxP3 and IL-10 significantly increased(P<0.05,P<0.01),the mRNA and protein expressions of RORγt,TNF-α,TGF-β and IL-6 in lung tissue significantly decreased(P<0.05,P<0.01),the mRNA and protein expressions of FoxP3 and IL-10 significantly increased(P<0.05,P<0.01).Conclusion Fuzheng Touxie Prescription can improve pulmonary inflammatory symptoms,reduce the level of inflammatory factors and increase the level of anti-inflammatory factors in PAP rats.The mechanism may be through the TGF-β/RORγt/FoxP3 pathway to regulate immune balance.

Objective:To evaluate the early and mid-term efficacy of physician-modified fenestrated endovascular repair combined with inner branch techniques for aortic pathologies complicated by aberrant subclavian artery (ASA).Methods:A retrospective case series was conducted, including 24 patients with ASA-associated aortic pathologies who underwent thoracic endovascular aortic repair (TEVAR) with physician-modified fenestration and inner branch reconstruction at 7 centers in China from February 2021 to March 2025. The cohort comprised 18 males and 6 females, with an age of (54.4±11.7) years (range:37 to 80 years). Pathological diagnoses included aortic aneurysm in 7 patients (29.2%), aortic dissection in 11 (45.8%; 6 chronic, 4 subacute, 1 acute), and penetrating aortic ulcer in 6 (25.0%; 3 with concomitant intramural hematoma). Preoperative planning was performed using three-dimensional CT angiographic reconstruction, incorporating both the greater-curvature hemodynamic length and the centerline wall-adherent length. Fenestration sites were verified on three-dimensional printed models, and precise fenestrations were created at the covered stent-graft locations corresponding to the subclavian artery and ASA anatomy. Patients subsequently underwent TEVAR combined with supra-aortic revascularization as indicated, followed by completion ascending aortography to evaluate the sealing of the main stent-graft and the patency of fenestrated or branched stents. Perioperative outcomes, complications, and early-to mid-term clinical efficacy were analyzed.Results:All procedures were technically successful. Immediate angiography identified one case of minor type Ⅳ endoleak that resolved spontaneously on 3-month follow-up CT angiography, and one case of mild type Ⅱ endoleak that was left untreated with a stable false lumen during follow-up. One patient died on postoperative day 7 of an undetermined cause. The mean follow-up period was (23.1±11.3)months (range:3 to 37 months). During follow-up, one patient developed mild bilateral lower-limb weakness 1 month after surgery. Vascular occlusion and spinal cord infarction were excluded, and the symptoms were considered related to postoperative spinal hemodynamic changes; the weakness resolved after blood pressure adjustment without recurrence. No other complications, including upper limb ischemia, spinal cord ischemia, or posterior circulation ischemia, were observed. Throughout follow-up, all branch and main stents remained patent with good structural integrity, without migration or device-related complications.Conclusions:Physician-modified fenestration combined with inner branch techniques for ASA-associated aortic pathologies is technically feasible and yields satisfactory early and mid-term results. Long-term outcomes require further follow-up.

Objective To evaluate the dosimetric effect of three-dimensional(3D)printed headrests made of different materials in radiotherapy for head and neck tumor,and to evaluate whether the existence of customized 3D-printed headrest can be neglected during planning phase by comparing differences in target area doses,homogeneity index(HI),conformity index(CI),monitor units(MU),and organ-at-risk(OAR)dose.Methods Ten patients with head and neck tumors,including 5 cases with nasopharyngeal carcinoma and 5 with other head and neck tumors,were enrolled.The headrest contours were outlined using Monaco treatment planning system,and with the same calculation parameters,treatment plans were generated for scenarios without a headrest,with a standard headrest,and with 3D-printed headrests made of 10%filled polylactic acid and thermoplastic polyurethane.The target area doses,OAR dose,MU,and other results were recorded and subjected to statistical analysis.Results No significant differences were observed among the 4 groups(ignoring headrest,standard headrest,3D-printed headrests with 10%filled polylactic acid and thermoplastic polyurethane)in parameters such as D95,D5,Dmean,HI,CI,MU,and OAR dose(the maximum dose to the spinal cord)(P>0.05).Considering the presence of the headrest,significant differences were found in CI for nasopharyngeal carcinoma and other head and neck tumors(P<0.05).Conclusion During the planning phase,the existence of customized 3D-printed headrest can be ignored,but it should be noted that the presence of a headrest may reduce the MU in radiotherapy plans.When considering the headrest,the average CI of patients with other head and neck tumors is significantly higher than that with nasopharyngeal carcinoma.