To introduce the approaches and procedures of neurologic erectile dysfunction (ED ) assessm ent in our institute, and evaluate the neurologic investigation by m aking an analysis of 58 cases. D iagnostic criteria of neurologic ED: nervous system injuries or diseases, abnorm al clinical sym ptom s and signs, electrophysiological abnorm alities of nervous system , abnorm al results of nocturnal penile tum escence and rigidity (N PTR ) (penis rigidity <60% and lasting tim e <10 m inutes). In the group of 20 patients w ith the injuries of the brain, spinal cord or spinal root nerves, pudendal cortical som atic evoked potential (PCSEP), sacral reflex latency (SRL),pudendal-to-corticalm otorevoked potential (PCM EP), penile sym-pathetic skin responses (PSSR ) and N PTR show ed abnorm ality by 45%, 20%, 20%, 85% and 85%, re-spectively. In 38 patients w ith the injuries of pelvic fracture w ith urethra break, PCSEP, SRL, PCM EP, PSSR and N PTR show ed abnorm ality by 24% , 5% , 20% , 92% and 66% , respectively. In the form er, 35% w ere identified to have severe ED , and 50%, m oderate ED;in the latter, 21%, to have severe ED , 13%, m edium ED , and 37%, light ED . The approaches and procedures w ere proved to possess excellent specificity and reliability in the assessm ent of neurological ED .

BACKGROUND: There are few studies conceming morphological charactedstics, space-time distribution and differentiation of hepatic stem cells during embryo liver development.OBJECTIVE: To understand the action of alpha fetoprotein, cytokeratin-19 (CK19) and c-Met in the liver through observing the expression of them.DESIGN, TIME AND SETTING: The in vitro cytological observational study was performed at the Central Laboratory of Weifang Medical College from June 2005 to December 2006.MATERIALS: A total of 40 embryo samples were obtained from 3-rnonth aborted fetus, which were supplied by Hospital Affiliated to Weifang Medical College.METHODS: Aborted embryo was collected and made into sections within 30 minutes. Fetal age was defined according to embryonic layer formation, somite number and organ development under a microscope. Sample sections with fetal age of 3-12weeks were selected. One was collected from every eleven sections and underwent immunohistochemical staining.MAIN OUTCOME MEASURES: Expression of alpha fetoprotein, CK19 and c-Met was measured in embryo hepatic stem cells aged 3-12 weeks.RESULTS: At 3-5 weeks, samples were positive for alpha fetoprotein and c-Met, which were indicated as hepatic stem ceils. At 10-12 weeks, alpha fetoprotein- and c-Met-positive cells were mainly distributed surrounding the header, which suggested that hepatic stem cells were mainly located at hepatic cord of the header. This had similar distribution as adult hepatic oval cells (adult hepatic stem cells). CK19-positive reaction was found at week 7, and mainly at hepatic cord cells, bile duct sheet cells and bile duct epithelial cells at 10-11 weeks. CKlg-positive reaction was only seen at the bile duct sheet and bile duct epithelial cells at week 12. At this time, all bile duct sheet cells and bile duct epithelial cells were positive for alpha fetoprotein, c-Met and CK19.CONCLUSION: CK19-positive reaction was not found in hepatic stem cells, but only detected in bile duct epithelial cells and progenitor calls. CK19 may be not fit for a marker of hepatic stem cells. All bile duct sheet and bile duct epithelial cells are positive for alpha fetoprotein, c-Met and CK19. It is assumed that alpha fetoprotein+/c-Met+/CK19+ may be bile duct progenitor calls.

Objective:To investigate the clinical characteristics and prognosis of Philadelphia (Ph) chromosome-positive chronic myeloid leukemia (CML) patients with additional chromosomal abnormalities.Methods:The data of 351 CML patients with Ph-positive in the Affiliated Hospital of Qingdao University from January 2009 to January 2019 were retrospectively analyzed. The bone marrow chromosomal karyotype analysis of all patients was performed by using R-banding technique. The clinical characteristics and karyotype of Ph-positive CML patients with additional chromosomal abnormalities at initial diagnosis were summarized, and Kaplan-Meier was used to analyze the differences in overall survival (OS) of patients with different karyotypes.Results:Among 351 patients with Ph-positive CML, 32 (9.1%) cases had variant translocation. At initial diagnosis, 47 cases had additional chromosomal abnormalities including 29 cases in chronic phase accounting for 9.15% (29/317) of all patients in chronic phase, 3 cases in accelerated phase accounting for 25.00% (3/12) of all patients in accelerated phase, 15 cases in blast crisis accounting for 68.18% (15/22) of all patients in blast crisis; there was a statistically significant difference in the chromosomal abnormalities rate of all different phases ( χ2=50.799, P<0.05). Among 47 Ph-positive CML patients with additional chromosomal abnormalities, 13 patients had complex karyotypes with more than 3 additional chromosomal abnormalities, the proportion of complex karyotypes in chronic phase, accelerated phase and blast crisis was 13.79% (4/29), 33.33% (1/3) and 53.33% (8/15), respectively, and the difference was statistically significant ( χ2=9.26, P<0.05). The study showed that the most common additional chromosomal abnormalities in chronic phase were double Ph (48.28%, 14/29) and -Y (10.34%, 3/29), while the most common chromosomal abnormalities in the blast crisis were +8 (26.67%, 4/15) and double Ph (26.67%, 4/15). Kaplan-Meier survival analysis showed that at initial diagnosis the OS time of patients with additional chromosomal abnormalities was worse than that of those with the non-additional chromosomal abnormalities group ( χ2 = 61.138, P<0.05). The OS of patients with complex karyotypes for Ph - positive CML patients with additional chromosomal abnormalities at initial diagnosis was worse than that of patients with non-complex karyotypes, and the difference was significant ( χ2 = 4.945, P < 0.05). Conclusions:The additional chromosomal abnormalities is closely related to the progression of CML, and the prognosis of CML patients with additional chromosomal abnormalities is poorer than that of patients with only Ph translocation. Moreover, the more complex the additional chromosomes are, the more likely blastic changes are, and the poorer prognosis. And additional chromosomeal abnormalities during the treatment of CML patients may also lead to the progression of blastic changes.

Objective: To evaluate the effect of Tai Chi and Qigong on patients with lumbar disc herniation (LDH). Methods: Relevant data were retrieved from nine English and Chinese databases, including Cochrane Library, PubMed, and Wanfang Data, etc. from inception to June 2024. All published randomized controlled trials assessing the effect of Tai Chi and Qigong on visual analog scale (VAS), Japanese Orthopedic Association (JOA) score, and other health indicators in participants with LDH compared to usual medical care or other treatments were included. Grey literature, trials involving the pushing of hands (Tui Shou) or Tai Chi with weapons, and trials with co-interventions (Tai Chi/Qigong plus another treatment) were excluded. Methodological quality was analyzed using the Cochrane risk of bias tool, and evidence quality was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) tool. Results: Fourteen trials (954 patients) were included in this study. Tai Chi and Qigong were associated with lower VAS pain scores (standardized mean difference −0.55, 95% confidence interval [CI] −0.95 to −0.15, P = .01), higher JOA scores (mean difference [MD] 4.40, 95% CI 2.62 to 6.18, P < .001) and straight leg raise test results (MD 9.40°, 95% CI 7.64 to 11.15, P < .001) in patients with LDH. Furthermore, compared with usual care, Tai Chi and Qigong showed enhanced effects on pain and JOA scores. When compared to other exercises or massage, the effect on pain scores was similar but that on JOA scores was significant. Conclusions Tai Chi and Qigong may have favorable effects on VAS pain and JOA scores compared with usual care, and on JOA scores compared with other exercises or massage in patients with LDH. Given the overall poor quality of the evidence, the results of current study should be interpreted cautiously.

Objective:To evaluate the efficacy, safety, and pharmacokinetics of the generic azacitidine in Chinese patients with higher-risk myelodysplastic syndromes(MDS).Methods:Between October 2013 and 2016, 72 patients were eligible for enrollment at 9 sites from China received generic subcutaneous azacitidine 75 mg·m -2·d -1 for 7 days per 28-day cycle, for ≥6 cycles. Pharmacokinetic blood samples were collected on day 1 of a single-dose. Results:For each patient at cycle 6 or at the time of study discontinuation, whichever came first, the overall response rate, which included complete remission (CR)and partial remission(PR), was 6.9%(5/72), the rate of patients who had the best effect with CR or PR during the treatment was 12.5%(9/72). Patients who were dependent on red-blood-cell transfusions and platelet transfusions at baseline became transfusion independent were 46.3%(19/41)and 41.2% (7/17), respectively. The median time of treatment was 6 cycles, and the median OS was 16.1 months (95% CI 10.9-20.6 months). For 36 patients(50%)received treatment at ≥6 cycles, and the median OS was 22.3 months(95% CI 16.1- not evaluative). Most common grade Ⅲ-Ⅳ hematologic treatment-emergent adverse events were neutropenia(55%), leukopenia(47%), and thrombocytopenia(61%). Pharmacokinetic profiles were similar for generic and original azacitidine in Chinese patients. Conclusion:Generic azacitidine treatment was favorable and safe and can be used as a standard treatment for patients with higher-risk MDS.

Philadelphia chromosome-positive acute myeloid leukemia is controversial and difficult to distinguish from the blast phase of chronic myeloid leukemia.As a myeloid neoplasm,rare cases of this leukemia manifest multiple soft-tissue tumors or bone lytic lesions.In this paper,we describe a 49-year-old male patient who had an abrupt onset with sharp chest pain,fever,fatigue,emaciation,and splenomegaly.18F-fluoro-deoxy-glucose positron emission tomography/computed tomography (18F-FDG PET/CT) result showed diffuse and uneven hypermetabolic lesions in the bone marrow with peripheral bone marrow expansion,multiple soft tissue neoplasms with high 18F-FDG uptake,and lytic bone lesions.Bone marrow smear and biopsy detected aberrant blast cells expressing myeloid rather than lymphoid immunophenotype marker.For the existence of Philadelphia chromosome and BCR-ABL1 fusion gene together with complex chromosome abnormalities,a diagnosis of Philadelphia-positive acute myeloid leukemia was made,although the type (de novo or blast crisis) remained unclear.

OBJECTIVETo compare the efficacy and toxicity of the chemotherapeutic regimen containing pirarubicin and mitoxantrone on the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults.

METHODSIn this open prospective multicentre study, we randomly assigned patients with relapsed or refractory AML to receive TAE regimen (pirarubicin+cytarabine+etoposide) versus MAE regimen (mitoxantrone + cytarabine + etoposide). The efficacy and toxicity were compared between the two groups.

RESULTS56 patients entered this clinical trial. The complete remission (CR) rate on TAE arm was 79.0% versus 55.6% on MAE arm with the overall response (OR) rates of 86.8% versus 88.9%, respectively. The CR was higher on TAE arm (P=0.035) but with no significant difference between the two groups regarding the overall response (OR) rate. The regimens were well tolerated in both groups. Hematologic and non-hematologic toxicity were similar except relatively lower the mean dosage of G-CSF, red blood cells and platelets transfusion on TAE arm. No significant differences were seen between the two groups regarding the overall survival and relapse free survival rates.

CONCLUSIONTAE regimen might be an effective salvage therapy in patients with relapsed or refractory AML.

Adult ; Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; therapeutic use ; Dactinomycin ; administration & dosage ; Doxorubicin ; administration & dosage ; analogs & derivatives ; Etoposide ; administration & dosage ; Granulocyte Colony-Stimulating Factor ; administration & dosage ; Humans ; Leukemia, Myeloid, Acute ; drug therapy ; Methotrexate ; administration & dosage ; Prospective Studies ; Recurrence ; Remission Induction

ObjectiveTo evaluate the methodological quality of traditional Chinese medicine （TCM） diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ）tool， and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI，VIP，Wanfang Data，SinoMed，PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then，the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare （RIGHT） Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included，involving 794 experts. The scores of AGREE II were clarity of presentation（59.0%），scope and purpose（44.0%），stakeholder involvement（23.1%），rigor of development （12.1%），applicability （11.1%），and editorial independence （8.3%） from high to low. Five articles were recommended at B level（recommended after revision） and 8 articles were at C level （not recommended）. The average scores of RIGHT Statement were as follows：basic information （93.59%），background （57.69%），evidence （18.46%），recommendations （20.88%），review and quality assurance （19.23%），funding，declaration and management of interests （0.00%）， and other information （0.00%）. The included guidelines/consensus recommended a total of 27 Chinese patent medicines，among which 20 were included in the National Reimbursement Drug List，with 4 species of Class A and 16 species of Class B， accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus，accounting for 50% of all purgative drugs， and 8 were not recommended. There were prescriptions for purgation， for promoting digestion and removing food stagnation， for clearing heat and purging fire，and for warming the middle and dissipating cold，Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment，the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover，the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However， the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.

Based on the current laws and regulations framework of China， combined with practical cases， this paper systematically and comprehensively analyzes the supervision attributes， clinical trial supervision model and existing problems of tumor neoantigen vaccine， aiming to provide reference for the construction of the supervision system of clinical trial of tumor neoantigen vaccine in China. The results showed that， at present， the clinical trials of tumor neoantigen vaccine in China adopt a dual-track supervision model： clinical trials initiated by pharmaceutical enterprises and clinical trials initiated by researchers. This supervision model lags behind the development speed of the industry， mainly in the following aspects： challenges brought by dual- track supervision； the clinical trial data initiated by researchers are not effectively connected with new drug research applications； the guiding principles of clinical trial supervision need to be improved. Relevant medical institutions， regulatory authorities and cooperative enterprises can help the development of the regulatory system for clinical trials of tumor neoantigen vaccine in China from the above aspects.

Objective: To investigate the efficacy and safety of IA regimen which contains idarubicin (IDA) 8 mg/m², 10 mg/m² or 12 mg/m² as induction chemotherapy for adult patients with de-novo acute myeloid leukemia (AML) . Methods: A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China were enrolled in the multicenter, single-blind, non-randomized, clinical controlled study. To compare the response rate of complete remission (CR) , adverse events between different dose idarubicin combined with cytarabine (100 mg/m²) as induction chemotherapy in newly diagnosed patients of adult AML. Results: Of 1 207 evaluable AML patients were assigned to this analysis of CR rate. The CR rates of IDA 8 mg/m² group, IDA 10 mg/m² group and IDA 12 mg/m² group were 73.6% (215/292) , 84.1% (662/787) and 86.7% (111/128) , respectively (P<0.001) . After adjusted for age, blast ratio of bone marrow, FAB classification and risk stratification, the odds ratios (95% CI) of IDA 10 mg/m² group and IDA 12 mg/m² group were 0.49 (0.34-0.70) and 0.36 (0.18-0.71) , as compared with the IDA 8 mg/m² group (P<0.001, P=0.003) . In the intermediate and favorable groups, CR rates was 76.5% (163/213) , 86.9% (506/582) and 86.1% (68/79) in different doses of IDA (P=0.007) . Interestingly, IA regimen with IDA 10 mg/m² was the only beneficial factor affecting CR in this group after adjusted for age, blast ratio of bone marrow and FAB classification[OR=0.47 (95% CI 0.31-0.71) , P<0.001]. CR rates in adverse group was 50.0% (18/36) , 60.6% (43/71) and 81.8% (18/22) respectively (P=0.089) . However, the odds ratios (95% CI) of IDA 12 mg/m² when compared with the IDA 8 mg/m² was 0.22 (0.06-0.80) , after adjusted for age, blast ratio of bone marrow and FAB classification. The median time (days) of neutrophil count less than 0.5×10⁹/L in IDA 8 mg/m² group, IDA 10 mg/m² group and IDA 12 mg/m² group were 14 (11-18) , 15 (11-20) and 18 (14-22) , respectively (P=0.012) and of platelet count lower than 20×10⁹/L were 14 (7-17) , 15 (11-20) and 17 (15-21) , respectively (P=0.001) . The incidences of lung infection in the three groups were 9.8%, 13.5% and 25.2%, respectively (P<0.001) . Conclusions For young adult patients (aged 18-60 years) with AML in China, intensifying induction therapy with idarubicin 10 mg/m² is clinically superior to IDA 8 mg/m² and IDA 12 mg/m² in favorable intermediate AML subgroup. However, idarubicin 12 mg/m² is more suitable to adverse AML subgroup.