Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective To evaluate the application value of aspiration catheter and debulking technology in the treatment of patients with intermediate-and high-risk pulmonary thromboembolism(PTE).Methods The clinical data of 28 patients with intermediate-and high-risk PTE were analyzed retrospectively.All subjects received thrombectomy using a 7F JR Guiding catheter.The success rate of surgery and the incidence of complications were counted,and the preoperative and postoperative values in heart rate(HR),systolic blood pressure(SBP),oxygen saturation(SO2),partial pressure of oxygen(PO2),Miller index,and mean pulmonary arterial pressure(MPAP)were compared.Results All patients were successfully treated,of which 26 cases obtained symptomatic relief after surgery.There were 2 cases of death in high-risk patients,of whom one died of myocardial infarction,and the other died of cerebral herniation after the procedure.One case reported the formation of pulmonary artery small dissection which disappeared within 2 months during conservative observation.The postoperative HR,Miller index,and MPAP decreased and SBP,SO2,and P()2 increased significantly than those of preoperative(P＜0.05).The follow-up period for this group ranged from 7 to 29 months,with a median follow-up of 14.6(7,19)months.During the follow-up period,no recurrences were observed.Conclusion The aspiration catheter and debulking technology demonstrate efficacy in treating intermediate-and high-risk PTE,and is associated with favourable success rates and low complication rates.The findings suggest its potential for wider clinical use.

Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective To evaluate the application value of aspiration catheter and debulking technology in the treatment of patients with intermediate-and high-risk pulmonary thromboembolism(PTE).Methods The clinical data of 28 patients with intermediate-and high-risk PTE were analyzed retrospectively.All subjects received thrombectomy using a 7F JR Guiding catheter.The success rate of surgery and the incidence of complications were counted,and the preoperative and postoperative values in heart rate(HR),systolic blood pressure(SBP),oxygen saturation(SO2),partial pressure of oxygen(PO2),Miller index,and mean pulmonary arterial pressure(MPAP)were compared.Results All patients were successfully treated,of which 26 cases obtained symptomatic relief after surgery.There were 2 cases of death in high-risk patients,of whom one died of myocardial infarction,and the other died of cerebral herniation after the procedure.One case reported the formation of pulmonary artery small dissection which disappeared within 2 months during conservative observation.The postoperative HR,Miller index,and MPAP decreased and SBP,SO2,and P()2 increased significantly than those of preoperative(P＜0.05).The follow-up period for this group ranged from 7 to 29 months,with a median follow-up of 14.6(7,19)months.During the follow-up period,no recurrences were observed.Conclusion The aspiration catheter and debulking technology demonstrate efficacy in treating intermediate-and high-risk PTE,and is associated with favourable success rates and low complication rates.The findings suggest its potential for wider clinical use.

Objective To evaluate the efficacy of endovascular treatment for ruptured descending thoracic aortic aneurysm(rDTAA),and to summarize the treatment experience.Methods The clinical data of 8 patients with rDTAA,who were admitted to the Department of Vascular Interventional Surgery,Zhangjiajie Municipal People's Hospital of China to receive treatment between January 2016 and June 2023,were retrospectively analyzed.The patients included 4 males and 4 females,with a median age of 70.5 years(61-78 years).Preoperative computed tomography angiography(CTA)was performed in all the 8 patients,and the diagnosis of rDTAA complicated by hematoma in the thoracic cavity and/or mediastinum was confirmed.Emergency thoracic endovascular aortic repair(TEVAR)was carried out in all the 8 patients.Results Complete isolation of the thoracic descending aortic aneurysm was achieved in 6 patients,and 2 of them received reconstruction of left subclavian artery by using chimney stent technique.The remaining two patients had a small amount of type Ⅰa endoleak,which disappeared after implantation of a cuff stent at the proximal site.During hospitalization,one patient died of septic shock caused by thoracic aortic-esophageal fistula,and 3 patients developed respiratory failure after operation,which was recovered after thoracic drainage,anti-infection medication and ventilator-assisted breathing therapy.Two patients developed postoperative ischemic stroke,one of them presented as grade Ⅲ motor muscle weakness on the affected side accompanied by speech impairment,and the another patient presented as grade Ⅳ motor muscle weakness on the affected side accompanied by speech impairment.During the follow-up period,one patient died of sudden chest pain 7 months after surgery,and another patient who had not received chimney stent implantation developed type Ⅰa endoleak 18 months after operation,which disappeared after implantation of a cuff stent at the proximal site.The remaining 5 patients showed good clinical condition during the follow-up period.Conclusion For the treatment of rDTAA,TEVAR is clinically safe and effective.

OBJECTIVE:To observe the effects and safety of different treatment courses of rivaroxaban in prevention and treatment of deep venous thrombosis(DVT)after total hip replacement. METHODS:The clinical data of 127 patients under-went selective total hip replacement in our hospital during Dec. 2014-Dec. 2015 were selected and analyzed retrospectively. They were divided into group A [83 cases,subdivided into group A1(40 cases)and A2(43 cases)by treatment course] and group B (44 cases) according to anticoagulant duration. Group A was given Rivaroxaban tablet 10 mg,po,qd,6-8 h after surgery;the treatment course of group A1 was 5 weeks(35 d)while that of group A2 was 2 weeks(14 d). Group B was giv-en Enoxaparin sodium injection 5000 AxaIU,sc,qd,12d before surgery;and then given Enoxaparin sodium injection 5000 AxaIU,sc,qd,after surgery;the treatment course lasted for 2 weeks. The incidence of DVT were compared among 3 groups as well as thrombin time(TT),activated partial thromboplastin time(APTT),hemoglobin(Hb)content,whole blood viscos-ity,plasma viscosity,platelet count and anticoagulant safety 3 days before surgery and after treatment. RESULTS:The inci-dence of DVT in group A1 was 0,which was significantly lower than that in group A2 (9.30%) and group B (11.36%), with statistical significance(P<0.05);there was no significant differences between group A2 and group B(P>0.05). Wheth-er 3 d before surgery or after treatment,there was no statistical significance in PT,APTT,Hb content,whole blood viscosi-ty,plasma viscosity and platelet count among 3 groups (P>0.05). No major bleeding events or pulmonary embolism was found in 3 groups. The incidence of mild bleeding events in group A was 5.00%,which was slightly higher than that in group A2 (2.33%) and group B (2.27%),without statistical significance (P>0.05);there was no statistical significance between group A2 and group B(P>0.05). CONCLUSIONS:Rivaroxiban long-term anticoagulation after total hip replacement has no significant effect on coagulation function and platelet,not only decrease the incidence of DVT,but also will not increase no bleeding with good safety.

OBJECTIVETo study the high risk factors of the third level of lymphatic metastasis in breast cancer patients to guide clinical practice.

METHODSThe clinical data of 746 breast cancer patients (all female, aged from 33 to 80 years with a median of 46 years) received radical or modified mastectomy between 2001 and 2011 was analyzed retrospectively. Eleven individual variables were selected to investigate high risk factors of the third level of lymphatic metastasis in different conditions.

RESULTSAxillary nodes metastasis status (OR = 4.541, 95%CI:3.569-5.776), tumor site (OR = 1.437, 95%CI:1.029-2.007), external nodes involved (OR = 3.809, 95%CI:1.683-8.618) and estrogen receptor (OR = 0.740, 95%CI:0.569-0.964) were high risk factors of the third level of lymphatic metastasis. Further analysis found that it is prone to happen a metastasis, especially when the tumor with a size over 5 cm and located at the lateral quadrant. Negative estrogen receptor was a risk factor of the third level lymphatic metastasis along with the tumor stage.

CONCLUSIONFor preoperative tumor biopsy shows Negative estrogen receptor of tumor stage T3 and over stage T3 when considering suspicious lymph node metastasis or external tissues metastasis intraoperatively should take in account into third level axillary lymph node dissection actively.

Adult ; Aged ; Aged, 80 and over ; Axilla ; pathology ; Breast Neoplasms ; pathology ; surgery ; Female ; Humans ; Lymph Node Excision ; Lymph Nodes ; pathology ; Lymphatic Metastasis ; Mastectomy ; methods ; Middle Aged ; Prognosis ; Retrospective Studies ; Risk Factors