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 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.

PURPOSE: A large number of studies have suggested the practicability and predictability of immediate implant function, but few studies have reported marginal bone level changes during sequential loading periods. The purpose of this study was to evaluate the marginal bone remodeling of immediately loaded self-tapping implants both at each time point and during each loading period between two time points. MATERIALS AND METHODS: The patients included in this retrospective study were treated with immediately loaded NobelSpeedy Replace implants between August 2008 and July 2009. Differences in the marginal bone level (MBL) at each time point and the marginal bone level change (ΔMBL) between two time points were analyzed with Bonferroni correction (P < .05). RESULTS: Overall, 24 patients (mean age, 47.3 ± 12.8 years) with 42 immediately loaded implants and a median follow-up of 6.5 years (IQR, 67.8 months) were included. The cumulative survival rate after 10 - 12 years was 95.2%. Continuous but slow marginal bone loss was observed during long-term follow-up. MBL at both 7.5 years and 11 years was significantly lower than that at loading, 6 months, 2 years and 4 years (P < .05). No bone loss difference was found in any period before 4 years of follow up (P > .05). The loading period of 4 years to 7.5 years showed the largest ΔMBL compared to those of other time periods (P < .05). CONCLUSION Slight bone loss occurred continuously, and more radical changes of marginal bone can be observed during the period of 4-7.5 years. Thus, long-term effective follow-up of immediately loaded implants is needed.

Objective:To analyze and discuss the psychological needs of family members of critically ill burn inpatients in semi-closed wards and their related influence factors.Methods:A cross-sectional survey was conducted among the 82 burn patients, who met the inclusion criteria and were admitted to the Department of Burns and Plastic Surgery of Ruijin Hospital of Shanghai Jiao Tong University School of Medicine from October 2018 to April 2019, and their family members. A general condition questionnaire of 15 indexes was applied to investigate the general data of burn patients and their family members including cause of burn, gender, age, total burn area, burn depth, burn severity, burn site, and type of medical insurance of patients, kinship with the patients, gender, age, experience of accompanying in intensive care isolation wards, occupation, education level, and monthly income of their family members. The Critical Care Family Needs Inventory (CCFNI) was used to assess each item, each factor, and total scores of the family members of patients including 5 factors and 45 items such as support scale (SS), comfort scale (CS), information scale (IS), proximity scale (PS), assurance scale (AS). CCFNI was used to assess the total scores of patients and their family members after classification according to the general data, the data were statistically analyzed with one-way analysis of variance or independent sample t test. Indicators with statistical significance in the above analysis were selected for multiple linear regression analysis to screen the independent influence factors of psychological needs of patients' family members. CCFNI was used to assess each dimension scores of patients and their family members after classification according to the aforementioned selected independent influence factors including age and burn area of patients, gender, educational level, and experience of accompanying in intensive care isolation wards of their family members, and the data were statistically analyzed with one-way analysis of variance or independent sample t test. Results:A total of 82 questionnaires were sent out in this study, and 80 were effectively received, with s a recovery rate of 97.6%. In 80 patients, there were 45 males and 35 females; 35 cases (43.75%) were ≤14 years; most of the patients had flame and thermal burns; 33 patients (41.25%), 21 patients (26.25%), and 26 patients (32.50%) had moderate, severe, and extremely severe burns, respectively; and only 3 patients (3.75%) had no health insurance. In 80 family members of patients, 34 (42.50%) were males and 46 (57.50%) were females; 62.50% in the family members of patients were concentrated between 18 and 45 years old; and 12 family members of patients had experience of accompanying in intensive care isolation wards, accounting for 15.00%. The total CCFNI score of the family members was (141±14) points, and the scores of AS, PS, IS, CS, and SS were (3.77±0.23), (3.43±0.37), (3.53±0.34), (2.50±0.59), and (2.69±0.45) points, respectively. The top five items of the psychological needs of family members of patients were concentrated in three factors (AS, PS, and IS), and the item "ensuring that patients receive the best treatment" ranked the first, with a score of (3.99±0.11) points. There were significant differences on the CCFNI total scores of patients with different age, total burns area, and severity of burns and of their family members with different gender, education level, and whether or not experience of accompanying in intensive care isolation unit ( F=4.378, 5.481, 5.913, t=4.027, 14.339, 7.265, P<0.05 or P<0.01). Multiple linear regression analysis showed that the patient's age (≤14, 15-45 years) and total burn area (11%-30%, 31%-49%, ≥50% TBSA) and the patient's family members' gender, educational level, experience of accompanying in intensive care isolation unit could affect the psychological needs of family members of patients ( t=3.133, 2.260, 2.297, 2.433, 3.015, 2.200, 2.102, 2.463, P<0.05 or P<0.01). There was statistically significant difference in AS score of the patients' family members with different age ( F=4.390, P<0.05). There were significant differences in both IS and AS scores of the patients' family members of patients with different burn area ( F=5.042, 3.131, P<0.05 or P<0.01). The AS score of the patients' family members with experience of accompanying in intensive care isolation unit was significantly lower than those without ( t=-1.040, P<0.05). The SS score of the patients' family members with college education or above was significantly higher than those with high school (technical secondary school) or below ( t=0.657, P<0.05). The IS score of the patients' family members with college education or above was significantly lower than those with high school (technical secondary school) or below ( t=-1.438, P<0.05). The SS score of male family members of patients was significantly lower than those of female patients ( t=4.149, P<0.05). Conclusions:The family members of burn patients in semi-closed ward have the most urgent need to ensure the patients receive the best treatment. Patients' age, total burn area, and their family members' gender, education level, experience of accompanying in intensive care isolation unit are the main factors affecting the psychological needs of family members of patients.

BACKGROUND: Focal cerebral ischemia model in rats should be established under drugged state by surgery operation, but anaesthetic drug may influence the outcome of focal cerebral ischemia.OBJECTIVE: To observe the effects of ketamine anesthesia on the pathological outcome of focal cerebral ischemia model in rats, and perform control with pentobarbital.DESIGN: Randomized controlled animal experiment.SETTING: Center of Experimental Animal and Department of Pathology of Second Affiliated Hospital, School of Medicine, Xi'an Jiaotong University.MATERIALS: The experiment was performed in the Center of Experimental Animal and Department of Pathology of Second Affiliated Hospital,School of Medicine, Xi'an Jiaotong University from May 2004 to March 2005. Thirty male SD rats were randomly assigned into pentobarbital group and ketamine group with 15 rats in each group.METHODS: The rats in the pentobarbital group and ketamine group were subjected to 40 mg/kg pentobarbital and 60 mg/kg ketamine by abdominal anaesthesia, respectively. The permanent middle cerebral artery occlusion (MCAO) was performed in rats by thread embolism in cavity in order to induce cerebral ischemia after abolition of righting reflex.MAIN OUTCOME MEASURES: ①A modified Bederson's scoring system was adopted to determine the neurological functional deficit at hour 4 after the MCAO. ②Five rats from each group were selected at hour 24 after MCAO. They were killed and their brain was stained with 20 g/L 2,-3,-5-triphenyltetrazolium hydrochloride (TTC). The infarct volume was determined. ③ MCAO was performed for 72 hours and mortality rate of two groups were recorded. Four rats in each group were re-anesthetized. They were killed and their brain was gained. Survival neurons were detected with toluidine blue staining.RESULTS: Totally 30 rats were involved in the result analysis. ①There was no significant difference in neurological score 4 hours after MCAO between pentobarbital group and ketamine group (1.46±0.98,1.38±0.68 ,P＞0.05). ②The infarct volume in the ketamine group was less than that in the pentobarbital group at hour 24 after MCAO [(28.1±4.11)%,37.8±4.95]%, P＜0.05]. ③The mortality rate 72 hours after ischemia was not significantly different between pentobarbital group and ketamine group (42% vs 33%,P＞0.05). But neuron density in penumbra in the ketamine group was higher than that in the pentobarbital group [(836±15),(740±24) numbers/mm2, P＜0.05].CONCLUSION: ①The ketamine anesthesia induces minor brain injury in setting of the focal cerebral ischemia model in rats. ②When neuroprotective effects of procedures or drugs being studied are evaluated in this focal cerebral ischemia model, they might provide no additional advantage to cerebral ischemia.