Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Curettage is the main treatment method for oral maxillofacial cystic lesions,but simple curettage may easily damage surrounding structures such as adjacent teeth and nerves,leading to incomplete removal of the cyst and large jaw defects.The curettage assisted by endoscopy can provide a good surgical field for the surgeons,can clearly identify the important anatomical structure during the operation and can remove the cyst wall tissue as much as possible,thereby reducing the damage and reducing the recurrence rate of the lesion.This article combines the characteristics of maxillofacial surgery with clinical treatment experience,summarizes relevant literature from both domestic and international sources,and engages in discussions with experts in order to provide reference for the clinical treatment of jaw cystic lesions with endo-scope assisted curettage.

Objective:To explore the strategy of prostate biopsy in patients with prostate specific antigen(PSA)gray zone based on prostate imaging reporting and data system (PI-RADS).Methods:The clinical data of 427 patients who underwent transperineal prostate biopsy in the First Affiliated Hospital of Nanjing Medical University from January 2020 to December 2022 were retrospectively analyzed. The median age was 66 (61, 72) years old. The median PSA was 6.62 (5.46, 8.19) ng/ml. The median PSA density (PSAD) was 0.15 (0.11, 0.21) ng/ml 2. The median prostate volume (PV) was 43.68 (31.12, 56.82) ml. PSA velocity (PSAV) data were available in 65 patients with negative MRI examination(PI-RADS <3), and the median PSAV was 1.40 (0.69, 2.89) ng/(ml· year). Among the patients with positive MRI(PI-RADS≥3), there were 174 patients with only 1 lesion and 83 patients with ≥2 lesions. A total of 170 patients with negative MRI underwent systematic biopsy, and 257 patients with positive MRI underwent systematic combined targeted biopsy. The PI-RADS score, regions of interest(ROI), PSAD, f/tPSA and PSAV were analyzed to explore the biopsy strategy for patients with PSA gray area based on bpMRI imaging. Results:Of the 427 patients included in the study, 194 were positive and 233 were negative. Among the patients with positive biopsy pathology, 140 cases were clinically significant prostate cancer (CsPCa). Among the MRI-negative patients, there were 33 cases with PSAV ≥1.4 ng/(ml·year), and 10 cases of prostate cancer and 6 cases of CsPCa were detected by systematic biopsy.In 32 cases with PSAV <1.4 ng/(ml·year), 3 cases of prostate cancer and 0 case of CsPCa were detected by systematic biopsy. The sensitivity of systematic biopsy for the diagnosis of prostate cancer and CsPCa in patients with PSAV≥1.4 ng/(ml·year) were 76.9% (10/13) and 100.0% (6/6) respectively, the specificity were 55.8% (29/52) and 54.2% (32/59) respectively, the negative predictive value were 90.6% (29/32) and 100.0% (32/32) respectively, and the positive predictive value were 30.3% (10/33) and 18.2% (6/33) respectively. In MRI-positive patients with PI-RADS 3, the prostate cancer detection rates of targeted biopsy combined with systematic biopsy, systematic biopsy and targeted biopsy were 41.7% (45/108), 32.4% (35/108) and 35.2% (38/108), respectively ( P=0.349). The detection rates of CsPCa were 27.8% (30/108), 21.3% (23/108) and 25.0% (27/108), respectively ( P=0.541). In patients with PI-RADS 4-5 and PSAD > 0.15 ng/ml 2, the detection rates of CsPCa in targeted biopsy combined with systematic biopsy, systematic biopsy and targeted biopsy were 67.8% (61/90), 58.9% (53/90) and 67.8% (61/90), respectively ( P=0.354). Conclusions:For MRI-negative patients, all CsPCa could be detected by perineal systematic biopsy when PSAV ≥1.4 ng/(ml·year), and active observation could be performed when PSAV <1.4 ng/(ml·year). For MRI-positive patients, targeted combined systemic biopsy was required when PI-RADS score was 3, and targeted biopsy only could be performed when PI-RADS score ≥4 and PSAD >0.15 ng/ml 2, otherwise targeted combined systemic biopsy was required.

Objective:To explore the relationship of glutathione S-transferase P1(GSTP1)and X-ray repair cross-complemen-tation group 1(XRCC1)gene polymorphisms with chemotherapy sensitivity and prognosis in patients with prostate cancer(PCa).Methods:A total of 103 PCa patients underwent androgen-deprivation therapy+double-agent chemotherapy from May 2018 to May 2021.We collected the clinical data from the patients,determined their genotypes using the PCR-PFLP method,analyzed the associa-tion of the locus polymorphisms of GSTP1-rs1695 and XRCC1-rs25487 with chemotherapy sensitivity,and investigated the correlation of GSTP1 and XRCC1 gene polymorphisms with the 3-year survival rate of the patients.Results:The distribution of GSTP1-rs1695 and XRCC1-rs25487 loci in the 103 PCa patients receiving chemotherapy was consistent with the Hardy-Weinberg equilibrium(x2=9.794,P＞0.05).At the GSTP1-rs1695 locus,the AA genotype accounted for 65.05％(67/103),the AG genotype 23.30％(24/103)and the GG genotype 11.65％(12/103);at the XRCC1-rs25487 locus,the A A genotype accounted for 29.13％(30/103),the AG genotype 50.49％(52/103)and the GG genotype 20.39％(21/103).Chemotherapy sensitivity was significantly lower in the patients with the GSTP1-rs1695 AA type than in those with the AG/GG types(35.82％vs 58.33％,P＜0.05),but showed no statistically significant difference between the XRCC1-rs25487 AA and AG/GG types(40.00％vs 45.21％,P＞0.05).There was no statistically significant difference in the 3-year progression-free survival rate between the patients with different GSTP1-rs1695 and XRCC1-rs25487 phenotypes(P＞0.05).The 3-year overall survival rate was lower in the patients with the GSTP1-rs1695 AA type than in those with the AG/GG types,and so was it in those with the XRCC1-rs25487 AA type than in those with the AG/GG types(P＜0.05).Multivariate COX regression analysis showed that the GSTP1-rs1695 AA and XRCC1-rs25487 AA types were inde-pendent factors affecting the 3-year overall survival of the patients after chemotherapy.Conclusion:Both GSTP1-rs1695 and XRCC1-rs25487 gene polymorphisms have some influence on chemotherapy sensitivity and prognosis in PCa patients.The A allele mu-tations of GSTP1-rs1695 and XRCC1-rs25487 can decrease the 3-year survival rate,while their G allele mutations may help improve chemotherapy sensitivity and survival.

Objective: The characteristics and differences of the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia were investigated to provide references and suggestions for the compilation of the Chinese Pharmacopoeia.
Methods: From the perspective of frame structure and main contents, the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia was compared.
Results: Each volume of the Chinese Pharmacopoeia had its general notice, including 34 to 48 items and 10 to 12 chapters based on different varieties collected in each volume. The Japanese Pharmacopoeia had 49 items not arranged by chapters. There are many differences on the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia, such as the definitions and expressions of names, determination of appearance, revision rules, risk assessment and quality control conception. The framework of the general notice in the Chinese Pharmacopoeia was clear, the content was specific and the operation was friendly. The term description of the general notice in the Japanese Pharmacopoeia was concise, and some terms need to be implemented under the guidance of professional knowledge.
Conclusion: In light of comparative study, every volume’s general notice of the Chinese Pharmacopoeia has its own characteristics. By integrating advanced analytical technique, combining the requirements with laws and regulations, and optimizing content and terms, all volume’s general notice could be explored to be coordinated and unified.

This study design of specific identification primers for the ITS2 sequence of F. ussuriensis. The reaction system and conditions were optimized, and PCR-nucleic acid test strips were constructed to realize the visual detection of F. ussuriensis Bark. Through molecular cloning and sequencing technology, we constructed a positive control for F. ussuriensis DNA and formulated quality standards. The established method was evaluated for sensitivity, specificity and reproducibility, and the authenticity of the commercially available samples was identified. Results demonstrated that based on the ITS2 sequences, F. ussuriensis and its mixed forgeries could be distinguished. The PCR products of the authentic F. ussuriensis on test strips showed two bands in the T and C lines, while the pseudo products and negative control showed only one band in the C line, which was consistent with the results of agarose gel electrophoresis. The specificity was 100%, and the sensitivity of the PCR-nucleic acid test strip was up to 0.1 ng·μL^-1, which was 10 times higher than that of the gel electrophoresis assay. 11 out of 16 commercially available samples of F. ussuriensis were qualified, and 5 were unqualified. Collectively, the PCR-nucleic acid test strip method established in this study is specific, rapid, accurate and visualized, which can provide a new technical idea for the detection of F. ussuriensis.

BACKGROUND: Sarcoplasmic reticulum calcium ATPase 2a (SERCA2a) is a key protein that maintains myocardial Ca 2+ homeostasis. The present study aimed to investigate the mechanism underlying the SERCA2a-SUMOylation (small ubiquitin-like modifier) process after ischemia/reperfusion injury (I/RI) in vitro and in vivo . METHODS: Calcium transient and systolic/diastolic function of cardiomyocytes isolated from Serca2a knockout (KO) and wild-type mice with I/RI were compared. SUMO-relevant protein expression and localization were detected by quantitative real-time PCR (RT-qPCR), Western blotting, and immunofluorescence in vitro and in vivo . Serca2a-SUMOylation, infarct size, and cardiac function of Senp1 or Senp2 overexpressed/suppressed adenovirus infected cardiomyocytes, were detected by immunoprecipitation, triphenyltetrazolium chloride (TTC)-Evans blue staining, and echocardiography respectively. RESULTS: The results showed that the changes of Fura-2 fluorescence intensity and contraction amplitude of cardiomyocytes decreased in the I/RI groups and were further reduced in the Serca2a KO + I/RI groups. Senp1 and Senp2 messenger ribose nucleic acid (mRNA) and protein expression levels in vivo and in cardiomyocytes were highest at 6 h and declined at 12 h after I/RI. However, the highest levels in HL-1 cells were recorded at 12 h. Senp2 expression increased in the cytoplasm, unlike that of Senp1. Inhibition of Senp2 protein reversed the I/RI-induced Serca2a-SUMOylation decline, reduced the infarction area, and improved cardiac function, while inhibition of Senp1 protein could not restore the above indicators. CONCLUSION I/RI activated Senp1 and Senp2 protein expression, which promoted Serca2a-deSUMOylation, while inhibition of Senp2 expression reversed Serca2a-SUMOylation and improved cardiac function.
Animals ; Mice ; Calcium/metabolism* ; Cysteine Endopeptidases/metabolism* ; Myocardial Reperfusion Injury/metabolism* ; Myocardium/metabolism* ; Myocytes, Cardiac/metabolism* ; Proteins/metabolism* ; Sarcoplasmic Reticulum Calcium-Transporting ATPases/genetics*

Objective: To explore the stem cell collection rate and efficacy and safety of patients aged 70 and below with newly diagnosed multiple myeloma (MM) treated with the VRD (bortezomib, lenalidomide and dexamethasone) regimen followed by autologous stem cell transplantation (ASCT). Methods: Retrospective case series study. The clinical data of 123 patients with newly diagnosed MM from August 1, 2018, to June 30, 2020, at the First Affiliated Hospital of Soochow University and Suzhou Hopes Hematology Hospital, who were eligible for VRD regimen sequential ASCT, were collected. The clinical characteristics, efficacy after induction therapy, mobilization regimen of autologous stem cells, autologous stem cell collection rate, and side effects and efficacy of ASCT were retrospectively analyzed. Results: Of the 123 patients, 67 were males. The median patient age was 56 (range: 31-70) years. Patients with IgG, IgA, IgD, and light-chain types accounted for 47.2% (58/123), 23.6% (29/123), 3.2% (4/123), and 26.0% (32/123) of patients, respectively. In addition, 25.2% (31/123) of patients had renal insufficiency (creatinine clearance rate<40 ml/min). Patients with Revised-International Staging System (R-ISS) Ⅲ accounted for 18.2% (22/121) of patients. After induction therapy, the rates of partial response and above, very-good partial response (VGPR) and above, and complete response (CR)+stringent CR were 82.1% (101/123), 75.6% (93/123), and 45.5% (56/123), respectively. Overall, 90.3% (84/93) of patients were mobilized with cyclophosphamide+granulocyte colony-stimulating factor (G-CSF) and 8 patients with G-CSF or G-CSF+plerixafor due to creatinine clearance rate<30 ml/min and one of them was mobilized with DECP (cisplatin, etoposide, cyclophosphamide and dexamethasone)+G-CSF for progressive disease. The rate of autologous stem cell collection (CD34⁺cells≥2×10⁶/kg) after four courses of VRD regimen was 89.1% (82/92), and the rate of collection (CD34⁺cells≥5×10⁶/kg) was 56.5% (52/92). Seventy-seven patients treated with the VRD regimen sequential ASCT. All patients had grade 4 neutropenia and thrombocytopenia. Among the nonhematologic adverse events during ASCT, the highest incidence was observed for gastrointestinal reactions (76.6%, 59/77), followed by oral mucositis (46.8%, 36/77), elevated aminotransferases (44.2%, 34/77), fever (37.7%, 29/77), infection (16.9%, 13/77) and heart-related adverse events (11.7%, 9/77). Among the adverse events, grade 3 adverse events included nausea (6.5%, 5/77), oral mucositis (5.2%, 4/77), vomiting (3.9%, 3/77), infection (2.6%, 2/77), elevated blood pressure after infusion (2.6%, 2/77), elevated alanine transaminase (1.3%, 1/77), and perianal mucositis (1.3%, 1/77); there were no grade 4 or above nonhematologic adverse events. The proportion of patients who achieved VGPR and above after VRD sequential ASCT was 100% (75/75), and the proportion of patients who were minimal residual disease-negative (<10^-4 level) was 82.7% (62/75). Conclusion: In patients aged 70 and below with newly diagnosed MM treated with VRD induction therapy, the collection rate of autologous stem cells was good, and good efficacy and tolerability were noted after follow-up ASCT.
Male ; Humans ; Female ; Multiple Myeloma/diagnosis* ; Hematopoietic Stem Cell Transplantation/adverse effects* ; Retrospective Studies ; Creatinine ; Hematopoietic Stem Cell Mobilization ; Transplantation, Autologous ; Dexamethasone/therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Heterocyclic Compounds/therapeutic use* ; Bortezomib/therapeutic use* ; Cyclophosphamide/therapeutic use* ; Stomatitis/etiology*

ObjectiveTo investigate the association between spontaneous portosystemic shunt （SPSS） and hepatorenal syndrome （HRS） in patients with liver cirrhosis. MethodsA retrospective analysis was performed for 93 patients with SPSS from Dezhou Hospital， Qilu Hospital of Shandong University， from January 2015 to January 2022， and the patients were followed up for 12 months with the onset of HRS as the observation endpoint. According to the presence or absence of HRS， the 93 patients with SPSS were divided into HRS group with 38 patients （40.86%） and non-HRS group with 55 patients （59.14%）， and the two groups were compared in terms of clinical data， laboratory data， complication， and shunt diameter. Based on the maximum shunt vein diameter of 1.5 cm， the 93 patients with SPSS were divided into high shunt group with 52 patients （55.91%） and low shunt group with 41 patients （44.09%）， and with the onset of HRS as the observation endpoint， the two groups were compared in terms of the incidence rate of HRS and survival time curve. The independent-samples t test was used for comparison of normally distributed continuous data with homogeneity of variance between two groups， and the chi-square test was used for comparison of categorical data between two groups. The receiver operating characteristic （ROC） curve was used to predict cut-off values， the Kaplan-Meier curve was used for comparison of survival time， and the Log-rank test was used to compare the differences in survival curves. The multivariate Cox regression analysis was used to investigate risk factors. ResultsCompared with the non-HRS group， the HRS group had significant increases in Child-Pugh score， Child-Pugh class， MELD score， serum creatinine， blood urea nitrogen， alanine aminotransferase， aspartate aminotransferase， maximum shunt vein diameter， the incidence rates of hepatic encephalopathy and spontaneous bacterial peritonitis， and the degree of ascites， as well as significant reductions in main portal vein diameter， serum sodium and albumin （all P<0.05）. Compared with the low shunt group， the high shunt group had a significant increase in the incidence rate of HRS （51.92% vs 26.83%， χ²=5.974， P=0.015） and a significant reduction in the time to the onset of HRS （Log-rank P=0.033）. A maximum shunt vein diameter of >1.5 cm （hazard ratio ［HR］=1.123， 95% confidence interval ［CI］： 1.041‍ ‍—‍ ‍1.211， P=0.003）， an increase in MELD score （HR=1.205， 95%CI： 1.076‍ ‍—‍ ‍1.437， P=0.039）， a reduction in serum albumin （HR=0.890， 95%CI： 0.814‍ ‍—‍ ‍0.974， P=0.011）， an increase in the degree of ascites （HR=2.099， 95%CI： 1.066‍ ‍—‍ ‍4.130， P=0.032）， and spontaneous bacterial peritonitis （HR=2.259， 95%CI： 1.020‍ ‍—‍ ‍5.003， P=0.045） were independent risk factors for the onset of HRS in SPSS patients. ConclusionThere is an association between SPSS and HRS， and shunt diameter >1.5 cm was an independent risk factor for HRS in SPSS patients， which should be taken seriously and require early intervention in clinical practice.

Objective:To investigate the risk factors of moderate to severe pain in patients with non-small cell lung cancer within 3 days after lobectomy.Methods:The clinical data of 297 patients with non-small cell lung cancer who underwent lobectomy in the Department of Thoracic Surgery, Sun Yat-sen University Cancer Center from December 2020 to June 2021 were retrospectively analyzed. A numerical rating scale was used to score the most severe pain within 3 days after surgery. Pain score ≥ 4 was defined as moderate to severe pain. The risk factors for moderate to severe pain were analyzed by binary Logistic regression. General linear model repeated measures and linear mixed models were used to analyze the trend of risk factors influencing postoperative pain with time.Results:The incidence of moderate to severe pain was 34.2% (102/297), 59.8% (178/297), 66.4% (198/297), and 28.2% (84/297) on days 0, 1, 2, and 3 after surgery respectively. The risk for moderate to severe pain was significantly higher in patients undergoing thoracotomy than patients undergoing thoracoscopic surgery on days 1 ( OR = 1.99, P = 0.009), 2 ( OR = 3.08, P < 0.001), and 3 ( OR = 3.88, P < 0.001) after surgery. However, the risk for moderate to severe pain in patients undergoing thoracotomy was slightly, but not significantly, higher than that in patients undergoing thoracoscopic surgery ( OR = 1.53, P = 0.087). The risk for moderate to severe pain was higher in female patients than male patients on day 2 ( OR = 1.62, P = 0.077), and in particular on day 3 after surgery ( OR = 2.39, P = 0.002). Prophylactic use of parecoxib significantly reduced the risk of moderate to severe pain on day 0 ( OR = 0.32, P = 0.004), 1 ( OR = 0.20, P < 0.001), 2 ( OR = 0.36, P < 0.001) and 3 ( OR = 0.56, P = 0.047). Conclusion:The incidence of moderate to severe pain on days 1 and 2 after lobectomy was relatively high in patients with non-small cell lung cancer. Patients undergoing thoracotomy have a higher risk of moderate to severe pain than those who underwent thoracoscopic surgery. Female patients have a higher risk for moderate to severe pain on days 2 and 3 after surgery than male patients. Prophylactic use of parecoxib can decrease the risk for moderate to severe pain in patients with non-small cell lung cancer.