Objective To evaluate the outcome indicators in clinical research on TCM treatment for polycystic ovary syndrome(PCOS);To provide a theoretical basis for establishing the PCOS clinical core outcome indicator set.Methods Relevant clinical research about TCM treatment for PCOS was retrieved from CNKI,Wanfang Data,VIP,CBM,Embase,PubMed,Web of Science and Cochrane Library from 1st,Jan.2019 to 15th,Nov.2023.Research articles were screened based on predefined inclusion and exclusion criteria,and a comprehensive analysis was conducted on the extracted data.Results A total of 951 clinical studies were included(915 in Chinese and 36 in English),involving 86 369 patients,with 221 outcome indicators identified,and a total frequency of 8 991 occurrences.Analysis revealed that commonly used outcome indicators included hormone levels(such as luteinizing hormone,follicle-stimulating hormone,testosterone),overall efficacy rate,ovulation rate,pregnancy rate,TCM syndrome score,ovarian volume and insulin resistance index.However,there was considerable variation in the choice of indicators across different studies,and some indicators were misaligned with clinical needs,lacking a focus on long-term prognosis and safety.Conclusion Clinical research on TCM treatments for PCOS often demonstrates significant variability in outcome indicators,lack of clarity between primary and secondary indicators,disorganized description of indicators,diversity in the choice of measurement tools,and a lack of indicators for specific populations.These problems lead to difficulties in combining similar studies for meta-analysis and fail to provide high-level evidence-based clinical guidance.There is an urgent need to establish a core set of outcome indicators for clinical research on TCM treatment for PCOS.

Objective: To understand the current status of diagnosis and treatment of chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) among hematologists, oncologists, and lymphoma physicians from hospitals of different levels in China. Methods: This multicenter questionnaire survey was conducted from March 2021 to July 2021 and included 1,000 eligible physicians. A combination of face-to-face interviews and online questionnaire surveys was used. A standardized questionnaire regarding the composition of patients treated for CLL/SLL, disease diagnosis and prognosis evaluation, concomitant diseases, organ function evaluation, treatment selection, and Bruton tyrosine kinase (BTK) inhibitor was used. Results: ①The interviewed physicians stated that the proportion of male patients treated for CLL/SLL is higher than that of females, and the age is mainly concentrated in 61-70 years old. ②Most of the interviewed physicians conducted tests, such as bone marrow biopsies and immunohistochemistry, for patient diagnosis, in addition to the blood test. ③Only 13.7% of the interviewed physicians fully grasped the initial treatment indications recommended by the existing guidelines. ④In terms of cognition of high-risk prognostic factors, physicians' knowledge of unmutated immunoglobulin heavy-chain variable and 11q- is far inferior to that of TP53 mutation and complex karyotype, which are two high-risk prognostic factors, and only 17.1% of the interviewed physicians fully mastered CLL International Prognostic Index scoring system. ⑤Among the first-line treatment strategy, BTK inhibitors are used for different types of patients, and physicians have formed a certain understanding that BTK inhibitors should be preferentially used in patients with high-risk factors and elderly patients, but the actual use of BTK inhibitors in different types of patients is not high (31.6%-46.0%). ⑥BTK inhibitors at a reduced dose in actual clinical treatment were used by 69.0% of the physicians, and 66.8% of the physicians had interrupted the BTK inhibitor for >12 days in actual clinical treatment. The use of BTK inhibitors is reduced or interrupted mainly because of adverse reactions, such as atrial fibrillation, severe bone marrow suppression, hemorrhage, and pulmonary infection, as well as patients' payment capacity and effective disease progression control. ⑦Some differences were found in the perceptions and behaviors of hematologists and oncologists regarding the prognostic assessment of CLL/SLL, the choice of treatment options, the clinical use of BTK inhibitors, etc. Conclusion: At present, a gap remains between the diagnosis and treatment of CLL/SLL among Chinese physicians compared with the recommendations in the guidelines regarding the diagnostic criteria, treatment indications, prognosis assessment, accompanying disease assessment, treatment strategy selection, and rational BTK inhibitor use, especially the proportion of dose reduction or BTK inhibitor discontinuation due to high adverse events.
Female ; Humans ; Male ; Aged ; Middle Aged ; Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy* ; Prognosis ; Lymphoma, B-Cell ; Immunohistochemistry ; Immunoglobulin Heavy Chains/therapeutic use*

Objective: To evaluate the consistency on the determination of target heart rate by simple calculation method based on resting heart rate and by anaerobic threshold method in cardiopulmonary exercise test (CPET) for patients with coronary artery disease after percutaneous coronary intervention (PCI). Methods: This study was a diagnostic test. Patients with coronary artery disease who underwent the first PCI in the Department of Cardiology of Peking University People's Hospital from October 2011 to April 2021 were enrolled. Patients were further divided into subgroups according to gender, age (<60 years group and ≥60 years group), with or without myocardial infarction history (myocardial infarction group and angina pectoris group) and whether β blockers were applied. The general clinical data of patients, resting heart rate (RHR) and anaerobic threshold heart rate in CPET were collected through the electronic medical record system. The simple target rate (RHR plus 20 or 30 bpm) and the target rate calculated by anaerobic threshold (anaerobic threshold heart rate minus 10 bpm) were both calculated in each patient. Consistency test of target heart rate derived by above the two methods was shown by intra-class correlation (ICC) and Bland-Altman plots. Results: A total of 439 patients were included, age was (56.2±8.8) years, body mass index was (25.77±2.34) kg/m², there were 382 males (87.0%). The target heart rate determined by anaerobic threshold method was (90.0±11.8)bpm, and the simple target heart rate determined by RHR plus 20 bpm was (91.0±8.4)bpm. There was no significant difference on the target heart rate derived from the two calculation methods (P=0.091). The simple target heart rate determined by RHR plus 30 bpm was (101.0±8.4)bpm, which was significant higher than that determined by anaerobic threshold method (P<0.001). In the following analysis, RHR plus 20 bpm was defined as the simple target heart rate. The ICC value of target heart rate determined by anaerobic threshold and resting rate plus 20 bpm was 0.529(95%CI 0.458-0.593, P<0.001). Bland-Altman plots analysis showed that the ratio of the simple target heart rate and the target heart rate determined by anaerobic threshold method was 1.03±0.11 and the 95% limits of agreement (LOA) were 0.812-1.245. In the subgroup of patients aged<60 years (n=247), the ICC value was 0.492, the ratio by Bland-Altman plots analysis was 1.02±0.11 and LOA was 0.814-1.234; in the subgroup of patients aged ≥60 years (n=192), the ICC value was 0.566, the ratio by Bland-Altman plots analysis was 1.03±0.11 and LOA was 0.810-1.260. In male subgroup(n=382), the ICC value was 0.540, the ratio by Bland-Altman plots analysis was 1.03±0.11 and LOA was 0.813-1.246; in female subgroup(n=57), the ICC value was 0.445, the ratio by Bland-Altman plots analysis was 1.03±0.11 and LOA was 0.810-1.240.In myocardial infarction subgroup (n=186), the ICC value was 0.568, the ratio by Bland-Altman plots analysis was 1.02±0.11 and LOA was 0.810-1.227; in angina pectoris subgroup (n=253), the ICC value was 0.495, the ratio by Bland-Altman plots analysis was 1.04±0.11 and LOA was 0.813-1.260. In the subgroup of patients with β blockers (n=353), the ICC value was 0.520, the ratio by Bland-Altman plots analysis was 1.03±0.11 and LOA was 0.810-1.252; in the subgroup of patients without β blockers (n=86), the ICC value was 0.570, the ratio by Bland-Altman plots analysis was 1.02±0.10 and LOA was 0.821-1.219. Conclusions: The simple target heart rate determined by RHR plus 20 bpm is consistent with the target heart rate determined by anaerobic threshold in patients with coronary artery disease after PCI. But the simple target heart rate determined by RHR plus 20 bpm can't replace the target heart rate determined by anaerobic threshold in this patient cohort.
Adrenergic beta-Antagonists ; Anaerobic Threshold ; Angina Pectoris ; Coronary Artery Disease ; Female ; Heart Rate/physiology* ; Humans ; Male ; Myocardial Infarction ; Percutaneous Coronary Intervention

Objective:To investigate the auxiliary diagnostic value of serum midkine (MK) and thyroid stimulating hormone (TSH) for differentiated thyroid cancer (DTC).Methods:Seventy-one postoperative DTC patients (DTC group) treated with 131I were selected, and 143 patients with benign thyroid lesions (benign thyroid disease group) treated with surgery in Center Hospital of Xiaogan from March 2019 to December 2020 at the same period were also selected. Clinical data such as liver and kidney function indexes, positive rate of anti thyroglobulin antibodies (TGAb) and positive rate of thyroid peroxidase antibody (TPOAb) were collected before treatment, and their fasting blood samples were collected before treatment. Fully automated electrochemiluminescence immunoassay was used to measure free thyroxine (FT 4), free triiodothyronine (FT 3), TSH levels in patients′ serum. The serum MK levels were measured by enzyme-linked immunosorbent assay (ELISA). Binary Logistic regression model was used to screen for independent risk factors for the development of DTC. A receiver operating characteristic curve (ROC) was drawn to evaluate the efficacy of MK, TSH and MK combined with TSH, in aiding the diagnosis of DTC and its staging. Results:Serum TSH and MK levels in DTC group were higher than those in benign thyroid disease group: (3.55 ± 0.61) mU/L vs. (2.97 ± 0.46) mU/L, (394.25 ± 63.36) ng/L vs. (311.45 ± 42.66) ng/L, and the differences were statistically significant ( P<0.05). Elevated serum TSH and MK levels were independent risk factors for DTC. When MK combined with TSH was used to diagnose DTC, the area under the curve (AUC), sensitivity and specificity were higher than those of MK and TSH alone (0.925 vs. 0.859 and 0.783, 83.10% vs. 78.87% and 73.24%, 89.51% vs. 85.31% and 79.02%), and the differences were statistically significant ( P<0.05). Serum TSH and MK levels in stage Ⅲ and Ⅳ patients in DTC group were higher than those in stage Ⅰ and Ⅱ patients: (3.79 ± 0.65) mU/L vs. (3.42 ± 0.56) mU/L, (427.88 ± 52.73) ng/L vs. (311.45 ± 42.66) ng/L, and the differences were statistically significant ( P<0.05). The AUC, sensitivity and specificity of MK combined with TSH in the diagnosis of different stages of DTC were higher than those of MK and TSH alone (0.822 vs. 0.657 and 0.666, 73.90% vs. 56.52% and 56.52%, 83.33% vs. 77.08% and 79.17%), and the differences were statistically significant ( P<0.05). Conclusions:Serum TSH and MK levels are independent risk factors for the occurrence of DTC in patients, and the combination of them has certain auxiliary diagnostic value for the identification and staging of DTC.

Lower extremity deep vein thrombosis (DVT) is one of the main complications in patients with traumatic fractures, and for severe patients, the DVT can even affect arterial blood supply, resulting in insufficient limb blood supply. If the thrombus breaks off, pulmonary embolism may occur, with a high mortality. The treatment and rehabilitation strategies of thrombosis in patients with lower extremity fractures have its particularity. DVT in traumatic fractures patients has attracted extensive attention and been largely studied, and the measures for prevention and treatment of DVT are constantly developing. In recent years, a series of thrombosis prevention and treatment guidelines have been updated at home and abroad, but there are still many doubts about the prevention and treatment of DVT in patients with different traumatic fractures. Accordingly, on the basis of summarizing the latest evidence-based medical evidence at home and abroad and the clinical experience of the majority of experts, the authors summarize the clinical treatment and prevention protocols for DVT in patients with traumatic fractures, and make this consensus on the examination and assessment, treatment, prevention and preventive measures for DVT in patients with different fractures so as to provide a practicable approach suitable for China ′s national conditions and improve the prognosis and the life quality of patients.

Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.

Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.

Objective: To investigate the current status and real performance of the detection of RUNX1-RUNX1T1 fusion transcript levels and WT1 transcript levels in China through interlaboratory comparison. Methods: Peking University People's Hospital (PKUPH) prepared the samples for comparison. That is, the fresh RUNX1-RUNX1T1 positive (+) bone morrow nucleated cells were serially diluted with RUNX1-RUNX1T1 negative (-) nucleated cells from different patients. Totally 23 sets with 14 different samples per set were prepared. TRIzol reagent was added in each tube and thoroughly mixed with cells for homogenization. Each laboratory simultaneously tested RUNX1-RUNX1T1 and WT1 transcript levels of one set of samples by real-time quantitative PCR method. All transcript levels were reported as the percentage of RUNX1-RUNX1T1 or WT1 transcript copies/ABL copies. Spearman correlation coefficient between the reported transcript levels of each participated laboratory and those of PKUPH was calculated. Results: ①RUNX1-RUNX1T1 comparison: 9 samples were (+) and 5 were (-) , the false negative and positive rates of the 20 participated laboratories were 0 (0/180) and 5% (5/100) , respectively. The reported transcript levels of all 9 positive samples were different among laboratories. The median reported transcript levels of 9 positive samples were from 0.060% to 176.7%, which covered 3.5-log. The ratios of each sample's highest to the lowest reported transcript levels were from 5.5 to 12.3 (one result which obviously deviated from other laboratories' results was not included) , 85% (17/20) of the laboratories had correlation coefficient ≥0.98. ②WT1 comparison: The median reported transcript levels of all 14 samples were from 0.17% to 67.6%, which covered 2.6-log. The ratios of each sample's highest to the lowest reported transcript levels were from 5.3-13.7, 62% (13/21) of the laboratories had correlation coefficient ≥0.98. ③ The relative relationship of the reported RUNX1-RUNX1T1 transcript levels between the participants and PKUPH was not always consistent with that of WT1 transcript levels. Both RUNX1-RUNX1T1 and WT1 transcript levels from 2 and 7 laboratories were individually lower than and higher than those of PKUPH, whereas for the rest 11 laboratories, one transcript level was higher than and the other was lower than that of PKUPH. Conclusion: The reported RUNX1-RUNX1T1 and WT1 transcript levels were different among laboratories for the same sample. Most of the participated laboratories reported highly consistent result with that of PKUPH. The relationship between laboratories of the different transcript levels may not be the same.
China ; Core Binding Factor Alpha 2 Subunit ; Humans ; Leukemia, Myeloid, Acute ; RUNX1 Translocation Partner 1 Protein ; Real-Time Polymerase Chain Reaction ; Transcription, Genetic ; WT1 Proteins

The integrin is a family of membrane receptor proteins composed of heterologous dimer , it can identify the sequence RGD .Integrin excessive expressed in tumor cells and angiogenesis .Using their special relationship a-mong them, the RGD as the carrier, combined with the radioactive tracer , antineoplastic drugs and other substances,which has tumoraffin imaging ,targeted anticancer therapy ,anti-inflammatory,anti depression effect and bone and nerve repair , and so on .

OBJECTIVETo investigate clinical effect of transverse tibial bone transport micro vessels regeneration technology combined with vacuum drainage in treating diabetic foot ulcer.

METHODSFrom November 2015 and December 2016, clinical data of 19 diabetic foot ulcer patients treated with transverse tibial bone transport micro vessels regeneration technology combined with vacuum drainage were retrospective analyzed, including 15 males and 4 females aged from 42 to 82 years old with an average of (64.57±7.14) years old;the courses of diabetic ranged was (14.62±6.19) years;12 cases on the left side and 7 cases on the right side;the area of ulcer ranged from 2 cm×3 cm to 8 cm×6 cm. All patients were stage D according to Texas classification, 3 cases were grade 2, 10 cases were grade 3 and 6 cases were grade 4. Ankle-brachial index and Michigan Neuropathy Screening Instrument (MNSI) were used to evaluate recovery of peripheral vessel and nerve before and after operation, the result of angiography and vascular ultrasound were also compared after operation.

RESULTSSeventeen of 19 patients were followed up from 3 to 13 months with an average of 6.9 months. Seventeen patients' surface wound were healed. Ankle-brachial index was increased from (0.51±0.20) before operation to (0.93±0.18) at 3 months after operation, and had significant difference(=13.63, =0.000);MNSI was increased from (4.06±1.36) before operation to(5.76±1.44) at 3 months after operation, and differences were statistically significant (=7.31, =0.000). Postoperative angiography and vascular ultrasound showed satisfied regeneration of micro-vessel and affected foot achieved normal movement and daily life.

CONCLUSIONSTransverse tibial bone transport micro vessels regeneration technology could reconstruct micro-vessel under lower affected limb, promote recovery of peripheral vessel and nerve, while with vacuum drainage could promote wound healing, has advantages of simple operation, obvious clinical effect, and high success rate of limb-salvage, and is one of ideal treatment for diabetic foot ulcer.

Adult ; Aged ; Aged, 80 and over ; Angiography ; Ankle Brachial Index ; Diabetic Foot ; surgery ; Drainage ; Female ; Humans ; Male ; Middle Aged ; Regeneration ; Retrospective Studies ; Tibia ; blood supply ; Treatment Outcome ; Ultrasonography ; Vacuum