Bone Transplantation/adverse effects* ; Transplantation, Autologous/adverse effects*

BACKGROUND: Red-cell transfusion is critical for surgery during the peri-operative period; however, the transfusion threshold remains controversial mainly owing to the diversity among patients. The patient's medical status should be evaluated before making a transfusion decision. Herein, we developed an individualized transfusion strategy using the West-China-Liu's Score based on the physiology of oxygen delivery/consumption balance and designed an open-label, multicenter, randomized clinical trial to verify whether it reduced red cell requirement as compared with that associated with restrictive and liberal strategies safely and effectively, providing valid evidence for peri-operative transfusion. METHODS: Patients aged >14 years undergoing elective non-cardiac surgery with estimated blood loss > 1000 mL or 20% blood volume and hemoglobin concentration <10 g/dL were randomly assigned to an individualized strategy, a restrictive strategy following China's guideline or a liberal strategy with a transfusion threshold of hemoglobin concentration <9.5 g/dL. We evaluated two primary outcomes: the proportion of patients who received red blood cells (superiority test) and a composite of in-hospital complications and all-cause mortality by day 30 (non-inferiority test). RESULTS: We enrolled 1182 patients: 379, 419, and 384 received individualized, restrictive, and liberal strategies, respectively. Approximately 30.6% (116/379) of patients in the individualized strategy received a red-cell transfusion, less than 62.5% (262/419) in the restrictive strategy (absolute risk difference, 31.92%; 97.5% confidence interval [CI]: 24.42-39.42%; odds ratio, 3.78%; 97.5% CI: 2.70-5.30%; P <0.001), and 89.8% (345/384) in the liberal strategy (absolute risk difference, 59.24%; 97.5% CI: 52.91-65.57%; odds ratio, 20.06; 97.5% CI: 12.74-31.57; P <0.001). No statistically significant differences were found in the composite of in-hospital complications and mortality by day 30 among the three strategies. CONCLUSION: The individualized red-cell transfusion strategy using the West-China-Liu's Score reduced red-cell transfusion without increasing in-hospital complications and mortality by day 30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries. TRIAL REGISTRATION ClinicalTrials.gov, NCT01597232.
Humans ; Adult ; Postoperative Complications ; Erythrocyte Transfusion/adverse effects* ; Blood Transfusion ; Hospitals ; Hemoglobins/analysis*

Objective:To evaluate the efficacy and safety of belimumab combined with standard regimen in the treatment of active lupus nephritis (LN).Methods:It was a single-center, pre - and post-control retrospective study. The Data of active LN patients treated with belimumab combined with standard regimen in the Department of Nephrology, the First Affiliated Hospital of Sun Yat-sen University from June 1, 2020 to June 30, 2022 were collected for analyzing the renal response rate and adverse reactions after belimumab treatment.Results:A total of 17 patients were included, including 14 females (82.35%). The age of the first medication was (26.06±2.64) years old, the median time of illness before the use of belimumab was 24.00 (8.50, 48.50) months, and the recurrence times before the use of belimumab was (1.24±1.03) times. All the 17 patients underwent renal biopsy. The main pathological types were type IV in 11 cases (11/17), type Ⅲ+V in 2 cases (2/17), type IV+V in 3 cases (3/17), and type V in 1 case (1/17). The dose of glucocorticoids was (22.95±8.30) mg/d in 1 year before belimumab administration. In 12 patients with LN who completed 24 weeks of belimumab treatment plan, the 24-hour urinary protein showed a downward trend, and there was a statistically significant difference compared with the baseline at 24 week [0.49 (0.15, 2.19) g vs. 2.83 (1.14, 4.11) g, Z=-2.100, P=0.036]. Compared with the baseline, serum albumin at 24 week increased by 29.36%, with statistically significant difference [(34.50±3.34) g/L vs. (26.67±5.75) g/L, t=-3.840, P=0.030]. The systemic lupus erythematosus disease activity index-2K score continued to decline, with statistically significant difference compared with baseline at 24 week (5.00±3.02 vs. 12.00±2.82, t=6.163, P<0.001). The lymphocyte count increased, and the difference was statistically significant compared with the baseline at 24 week [0.72(0.28, 2.39)×10 9/L vs. 0.30(0.19,0.34)×10 9/L, Z=-2.073, P=0.038]. There was a statistically significant difference between the glucocorticoids dosage at 24 week and the average glucocorticoids dosage 1 year before treatment [(11.25±6.35) mg/d vs. (22.60±9.75) mg/d, t=4.225, P=0.003]. After observation of belimumab for (38.13±22.93) weeks, patients had a complete response rate of 64.71% (11/17), a partial response rate of 17.65% (3/17), and an overall response rate of 82.35% (14/17). Relapse occurred in 1 case.No infusion-related reactions occurred in 17 patients. During the treatment, a total of 5 adverse events occurred, including 2 cases of pulmonary infection, 1 case each of sepsis, upper respiratory tract infection, and cytomegalovirus infection, which all improved after treatment and the subsequent treatment was not affected. Conclusion:Belimumab combined with standard regimen can improve the response rate of LN, reduce the recurrence rate, reduce the dosage of glucocorticoids, and control the overall adverse events with good prognosis.

Abstract OBJECTIVE To analyze the prescription of potential drug-drug interactions(pDDIS) between colchicine and statins, carry out risk assessment and formulate preventive measures. METHODS The case and research reports of adverse reactions caused by the interaction between colchicine and statins were retrieved from the databases of CNKI, VIP, Wanfang, PubMed and Elsevier, and the literature was analyzed; all outpatient prescriptions of colchicine combined with statins from January 2020 to October 2022 were extracted through hospital rational drug use software to identify potential drug interactions and grade the severity. RESULTS Twenty two cases of adverse drug reactions caused by drug interaction were retrieved, including 1 case control study and 2 observational cohort studies; the majority of adverse reactions were in the elderly, male were more than female; the time of occurrence was concentrated in 21 d of combined medication, and 3 patients died; high dose, old age, male and liver/kidney dysfunction might increase the risk of this pDDIS; a total of 72 prescriptions of colchicine and statins were collected, including 65 atorvastatin prescriptions, 6 rosuvastatin prescriptions, and 1 simvastatin prescription. The risk levels were all serious; one patient developed myopathy after 4 months of colchicine combined with atorvastatin, and improved after 1 month; seven preventive measures had been formulated by clinical pharmacists. CONCLUSION There is pDDIS in colchicine and statin prescriptions in the Affiliated Hospital of Zunyi Medical University. It is necessary to actively implement preventive measures and strengthen monitoring, especially for elderly men and patients with liver/kidney dysfunction in the early stage of combined use.

Objective:To investigate the feasibility of the surgical mode of immediate implant-based breast reconstruction (IIBR) with silicone implants under subcutaneous tissue directly after the total mastectomy in breast cancer.Methods:Data of 53 patients who underwent (skin-sparing mastectomy, SSM) or (nipple-areola-complex-sparing mastectomy, NSM) combined with IIBR in Department of Breast Surgery, Maoming People’s Hospital were retrospectively analyzed. Patients were divided into two groups, 31 cases with the silicone implant placed in different anatomical locations of the chest wall, including subcutaneous tissue, and 22 cases with subpectoral space implantation followed NSM or SSM. The two groups were compared in terms of the short-term and long-term complications, as well as the aesthetic outcome. Within 12 months the local recurrence rate was collected to evaluate the treatment safety of the two groups preserving the thickness of subcutaneous adipose after NSM or SSM.Results:There was no nipple-areola-complex (NAC) or skin flap for both groups, and the time of removing the drainage tube had no significant difference ( P>0.05) . There was no significant difference between the two groups in terms of the short-term complications within 6 months (repeated local infection and unknown effusion occurrence) , the long-term complications after 6 months (local skin with wrinkles sign, prosthesis displacement, and grade III-IV capsular contracture ( P>0.05) . However, the subcutaneous tissue implant group were superior ( P<0.05) in cosmetic outcome because of the breast had better symmetry. What’s more, no local tumor recurrence occurred in either group within 12 months. Conclusions:IIBR of subcutaneous tissue implantation (without patches) is an economical, novel, safe, and effective surgical mode for breast reconstruction, and the key to this operation mode depends on quality control of surgical procedures and the thickness of skin flap ≥ 1cm covering silicone implants. However, due to the cases enrolled in this study is not enough and short follow-up time, further clinical studies are still needed.

OBJECTIVE To establish a quantitative analysis method for the quality control components in Tenghuang jiangu capsules， and predict the possible action mechanism of the quality control components. METHODS Seven key quality control components in Tenghuang jiangu capsules were quantitatively analyzed by UHPLC-Q-Orbitrap HRMS. The “component-target” network was constructed based on network pharmacology， and the Kyoto Encyclopedia of Genes and Genomes （KEGG） pathway enrichment analysis and gene ontology （GO） function enrichment analysis were further conducted to find the key signaling pathways. RESULTS The average contents of succinic acid， hyperoside， gallic acid， kaempferol， naringin， naringenin and protocatechuic acid in 20 batches of Tenghuang jiangu capsules were 520.92， 67.67， 129.48， 4.74， 397.45， 5.66 and 376.62 μg/g， respectively. The results of network pharmacology showed that the 62 key target genes of the quality control components of the drug included AKT1， TNF， VEGFA， MMP9， PTGS2， etc. They were mainly enriched in cytokine receptor interaction， nuclear factor， tumor necrosis factor， interleukin 17， rheumatoid arthritis， Toll-like receptor and other signal pathways， involving inflammatory reaction， signal transduction， protein phosphorylation and other biological processes， kytoplasm， cell membrane and other cell components， as well as enzyme activity， energy activity and other molecular functions. CONCLUSIONS The established UHPLC- Q-Orbitrap HRMS method can be used for the quantitative analysis of the quality control components of Tenghuang jiangu capsule. Its quality control components may be mapped to inflammatory pathways related to bone diseases such as rheumatoid arthritis and Toll-like receptors through AKT1， TNF， VEGFA and other key targets， so as to play a therapeutic role.

Objective:To evaluate the clinical outcome of 3D printing titanium cage combined with Masquelet technology for the treatment of calcaneus infective defect.Methods:Data of 5 cases with chronic calcaneus infectivedefect treated with regional flap, 3D printing titanium cage combined with Masquelet technology with rib autograft from January 2017 to January 2019 were retrospectively analyzed. There were 3 males and 2 females, with an average age of 37 years old (range, 17-52 years). The mechanism of the five patients included two motor vehicle incidents, two high fall injuries and one rolling compaction. All patients were treated by two-stage procedures. First stage included debridement, polymethyl methacrylate (PMMA) filling and regional flap coverage. The soft tissue defect of the 5 cases included 10 cm×8 cm in 2 cases, 8 cm×7 cm, 8 cm×5 cm, and 5 cm×3 cm each in one case. Bone defect included 4 cm×3 cm×2 cm in two cases, 3 cm×3 cm× 2 cm in two cases and 3 cm×1 cm×1 cm in one case. Second stage was 3D printing titanium cage combined with masquelet technology of rib autograft. Time of bone union, morphology of calcaneus, position of implant, Maryland score and AOFAS hind foot score were recorded to evaluate the clinical outcome.Results:All five patients were followed up for an average time of 18.2 months (range, 12-30 months). Infection happened in one patient 2 months after first stage operation and successfully treated by debridement and PMMA replacement. Incision of the rest 4 cases all healed successfully. Germiculture of the five cases included Methicillin-resistant Staphylococcus aureus (MRSA) in three cases, Staphylococcus epidermidis in one case and Bacterium coli in one case. All five patients got calcaneus bone union after second stage operation. The average time for bone union was 4.32 (range, 3-8) month. Bone trabecular were observed in CT scan 13 (range, 10-22) month post-operation. Average Maryland score in 12 months post-operation was 92 (range, 86-98) and average AOFAS ankle hind foot score was 89.8 (range, 83-100).Conclusion:3D printing titanium cage and Masquelet technology maybe an effective treatment for calcaneus infective defect.

Objective:To explore the efficacy of percutaneous osteoplasty (POP) combined with 131I therapy in patients with bone metastases from differentiated thyroid carcinoma (DTC) and assess the survival. Methods:From Januray 2008 to January 2020, 29 DTC patients with bone metastases (16 males, 13 females, age range: 24-64 years) who received POP combined with 131I therapy in Shanghai Sixth People′s Hospital were retrospectively analyzed. Clinical data and characteristics of patients were analyzed. The efficacy and prognosis were evaluated based on the changes of serum thyroglobulin (Tg) and relieving condition of bone pain after the combined treatment. χ2 test was used to determine the association between clinical characteristics and efficacy, and Kaplan-Meier analysis was used to estimate the overall survival (OS) rate. Results:The biochemical response rate of serum Tg was 68.97% (20/29) after the combined treatment. For the influence on changes of serum Tg, whether or not combined with non-osseous distant metastasis, and cumulative dose of 131I treatment(≥22.2 vs <22.2 GBq) were statistically significant ( χ2 values: 5.448 and 4.371, both P<0.05). The rate of bone pain relief was 65.52%(19/29). Age (≥55 vs <55 years) and the cumulative dose of 131I treatment had statistically influences on bone relief ( χ2 values: 7.486 and 5.154, both P<0.05). The 5-years OS rate of patients was 87.68%, while the 10-years OS rate was 65.76%. Conclusion:POP combined with 131I therapy is effective on relieving the pain, reducing the serum Tg to some extent, and improving the long-term survival of DTC patients with bone metastasis.

Objective To summarize the medical security experience in first-aid and resuscitation for astronauts at the exit of capsule after the spacecraft returns to the main landing site in the process of human spaceflight in China,and thus to provide a powerful security measures for Chinese aerospace medicine.Methods The medical support experiences were summarized in human spaceflight from "Shenzhou V" to "Shenzhou X",relevant reports on emergency rescue and resuscitation were consulted in in-orbit process and after emergency return and landing for domestic and foreign astronauts,astronauts' physiological changes in cardiopulmonary resuscitation were analyzed during emergency return,and then,corresponding strategies were proposed and tested in practice (actual combat) by combining with the flight characteristics of the spacecraft "Shenzhou XI".Results On the basis of the original emergency treatment,the countermeasures for the cardiopulmonary resuscitation were proposed after the spacecraft returned to the main landing site in human spaceflight,the emergency equipment was adjusted,the emergency procedures were optimized,and anti-fog glidescopes were added,laryngeal masks were introduced to perform supraglottic ventilation as the quickest and most effective airway opening measure on site.In addition,ultrasound examination was applied in practice as an important treatment and assessment method for basic life support and advanced life support.All these could ensure the rescuing ability on cardiopulmonary resuscitation during their stay in space for the medium-term and after their return to the main landing site.Conclusions During the return of the astronauts of the spacecraft "Shenzhou XI" to the main landing site,the first aid and support program had been improved specifically and the process had been optimized to ensure the successful completion of medical security mission of China's human spaceflight.

OBJECTIVE: To establish a method for the simultaneous determination of shikonin, acetylshikonin and β, β-dimethylacrylshikonin in Arnebia euchroma. METHODS: RP-HPLC method was adopted. The determination was performed on Kromasil 100-5 C18 column with mobile phase consisted of acetonitrile-0. 1％ formic acid solution (80: 20, V/V) at the flow rate of 1. 0 mL/min. The detection wavelength was set at 516 nm, column temperature was 25 ℃, and sample size was 10 μL. RESULTS: The linear ranges of shikonin, acetylshikonin and β, β-dimethylacrylshikonin were 0. 404-10. 100 μg/mL(r=0. 999 8), 5. 350-107. 000 μg/mL(r=0. 999 6), 2. 035-40. 700 μg/mL(r=0. 999 8), respectively. The limit of quantitation was 0. 40, 2. 91, 1. 34 μg/mL, and the limit of detection was 0. 12, 0. 87, 0. 40 μg/mL. RSDs of precision, stability and reproducibility tests were all lower than 2. 0％ (n=6). The recovery rate were 99. 12％-104. 18％ (RSD=1. 85％, n=6), 96. 51％-100. 21％ (RSD=1. 43％, n=6), 98. 11％-102. 51％ (RSD=1. 42％, n=6), respectively. CONCLUSIONS: The method is simple, precise, stable and reproducible. It can be used for simultaneous determination of shikonin, acetylshikonin and β, β-dimethylacrylshikonin in A. euchroma.