Early Death and Survival of Patients With Acute Promyelocytic Leukemia in ATRA Plus Arsenic Era: A Population-Based Study.

Most randomized trials for acute promyelocytic leukemia (APL) have investigated highly selected patients under idealized conditions, and the findings need to be validated in the real world. We conducted a population-based study of all APL patients in Zhejiang Province, China, with a total population of 82 million people, to assess the generalization of all-trans retinoic acid (ATRA) and arsenic as front-line treatment. The outcomes of APL patients were also analyzed. Between January 2015 and December 2019, 1,233 eligible patients were included in the final analysis. The rate of ATRA and arsenic as front-line treatment increased steadily from 66.2% in 2015 to 83.3% in 2019, with no difference among the size of the center (≥5 or <5 patients per year, p = 0.12) or age (≥60 or <60 years, p = 0.35). The early death (ED) rate, defined as death within 30 days after diagnosis, was 8.2%, and the 3-year overall survival (OS) was 87.9% in the whole patient population. Age (≥60 years) and white blood cell count (>10 × 109/L) were independent risk factors for ED and OS in the multivariate analysis. This population-based study showed that ATRA and arsenic as front-line treatment are widely used under real-world conditions and yield a low ED rate and a high survival rate, which mimic the results from clinical trials, thereby supporting the wider application of APL guidelines in the future.

Chronic Progression of Lung Cancer Recurrence After Surgery: Warning Role of Postoperative Pneumonia.

PURPOSE: The association between the process of postoperative pneumonia and lung cancer recurrence remains elusive in lung cancer surgery. Herein, the association between postoperative pneumonia and lung cancer recurrence was investigated, emphasizing the warning role of postoperative specific pneumonia in primary lung cancer resection patients. METHODS: The occurrence of postoperative pneumonia was assessed in 4-6 months (PPFS), 7-12 months (PPST), and lung cancer recurrence within 1 year (LRO) in 332 patients. The primary outcome was the development of PPST and LRO according to PPFS occurrence. The relevant risk factors of PPFS, PPST, and LRO were identified through multivariable regression analysis. RESULTS: During follow-up, 151 (45.48%) participants experienced PPFS. Irrespective of the existing postoperative pneumonia in 1-3 months (PPOT), PPFS significantly increased the risk of PPST (P < 0.01) and LRO (P < 0.01), and persistent PPST further increased the risk of LRO (P < 0.001). The generalized estimating equation identified chemotherapy as an independent risk factor for PPFS and PPST. CONCLUSION: PPFS was associated with the increased risk of PPST and LRO. Postoperative pulmonary inflammation assessed 4 months post-surgery also significantly influenced LRO development, indicating a need for close follow-up of lung inflammatory conditions to improve patient outcomes.

Identification of a nine-gene prognostic signature for gastric carcinoma using integrated bioinformatics analyses.

BACKGROUND: Gastric carcinoma (GC) is one of the most aggressive primary digestive cancers. It has unsatisfactory therapeutic outcomes and is difficult to diagnose early. AIM: To identify prognostic biomarkers for GC patients using comprehensive bioinformatics analyses. METHODS: Differentially expressed genes (DEGs) were screened using gene expression data from The Cancer Genome Atlas and Gene Expression Omnibus databases for GC. Overlapping DEGs were analyzed using univariate and multivariate Cox regression analyses. A risk score model was then constructed and its prognostic value was validated utilizing an independent Gene Expression Omnibus dataset (GSE15459). Multiple databases were used to analyze each gene in the risk score model. High-risk score-associated pathways and therapeutic small molecule drugs were analyzed and predicted, respectively. RESULTS: A total of 95 overlapping DEGs were found and a nine-gene signature (COL8A1, CTHRC1, COL5A2, AADAC, MAMDC2, SERPINE1, MAOA, COL1A2, and FNDC1) was constructed for the GC prognosis prediction. Receiver operating characteristic curve performance in the training dataset (The Cancer Genome Atlas-stomach adenocarcinoma) and validation dataset (GSE15459) demonstrated a robust prognostic value of the risk score model. Multiple database analyses for each gene provided evidence to further understand the nine-gene signature. Gene set enrichment analysis showed that the high-risk group was enriched in multiple cancer-related pathways. Moreover, several new small molecule drugs for potential treatment of GC were identified. CONCLUSION: The nine-gene signature-derived risk score allows to predict GC prognosis and might prove useful for guiding therapeutic strategies for GC patients.

The Effects of Once-Weekly Dulaglutide and Insulin Glargine on Glucose Fluctuation in Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus.

Aim. To compare the effects of once-weekly Dulaglutide with once-daily glargine in poorly oral-antidiabetic controlled patients with type 2 diabetes mellitus (T2DM). Method. A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group (n = 16) and glargine group (n = 9). All patients received either Dulaglutide or glargine treatments for 52 weeks. Continuous glucose monitoring systems (CGMS) were applied to them for two 72 h periods at before and after the treatment each. Patient general clinical data were collected and analyzed. Result. Fast blood glucose (FBG) of the glargine group declined more significantly than the Dulaglutide group after treatment (p < 0.05). The mean blood glucose (MBG), standard deviation of blood glucose (SDBG), mean amplitude of glycemic excursion (MAGE) within a day, the largest amplitude of glycemic excursion (LAGE), M-value, absolute means of daily difference (MODD) of glycemic excursion, the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups (p > 0.05). The incidence of hypoglycemia was also similar between the two groups (p > 0.05). Though serum levels of TNF-α, IL-6, and 8-PGF2α all decreased, significant reduction was found in TNF-α and 8-PGF2α. TNF-α was only significantly reduced in the Dulaglutide group, while 8-PGF2α was seen in both groups. Conclusion. For T2DM patients with poorly controlled oral antidiabetic drugs, once-weekly Dulaglutide not only has the same effect on glucose fluctuation as once-daily glargine but also significantly reduced TNF-α and 8-PGF2α after a 52 week treatment protocol. This trial is registered with ClinicalTrials.gov NCT01648582.

Analysis of the add-on effect of α-glucosidase inhibitor, acarbose in insulin therapy: A pilot study.

The aim of the present study was to evaluate the add-on effect of acarbose therapy in oxidative stress, and the lipid and inflammatory profiles of patients with type 2 diabetes mellitus (T2DM) treated with insulin. This was an open and unblended study. Patients (n=134) with T2DM (haemoglobin A1c range, 9.0-12.0%) were recruited. After continuous subcutaneous insulin infusion for 7 days for initial rapid correction of hyperglycaemia, a premixed insulin titration period (duration, 4-6 days) subsequently followed. Patients were then randomized (1:1) into two groups as follows: An acarbose plus pre-mixed 30/70 insulin group or a pre-mixed 30/70 insulin only group; each group received treatment for 2 weeks. Plasma high-sensitivity C-reactive protein (Hs-CRP), 8-iso-prostaglandin F2α (8-iso PGF2α), tumor necrosis factor-α (TNF-α), interleukin (IL)-1ß, and IL-6 levels were measured before and after therapy. Patients that received acarbose plus insulin demonstrated greater reduction in 8-iso PGF2α, Hs-CRP, TNF-α, IL-1ß and IL-6 levels when compared with the insulin only patients. Thus, acarbose add-on insulin therapy was identified to be associated with greater improvements in oxidative stress and inflammation in patients with T2DM when compared with those that received insulin only therapy.

Iridium-catalyzed asymmetric hydrogenation of 2-pyridyl cyclic imines: a highly enantioselective approach to nicotine derivatives.

A highly efficient asymmetric hydrogenation of cyclic imines containing a pyridyl moiety was established by using iridium catalysts with chiral spiro phosphine-oxazoline ligands. This process will facilitate the development of new nicotine-related pharmaceuticals. The introduction of a substituent at the ortho position of the pyridyl ring to reduce its coordinating ability ensures the success of the hydrogenation and excellent enantioselectivity.

Tetrandrine citrate eliminates imatinib-resistant chronic myeloid leukemia cells in vitro and in vivo by inhibiting Bcr-Abl/ß-catenin axis.

OBJECTIVE: To evaluate the effects of tetrandrine citrate, a novel tetrandrine salt with high water solubility, on the growth of imatinib (IM)-resistant chronic myeloid leukemia (CML) in vitro and in vivo, and reveal action molecular mechanisms. METHODS: Cell viability in vitro was measured using methyl thiazolyl tetrazolium (MTT) assay. CML cell growth in vivo was assessed using a xenograft model in nude mice. Bcr-Abl and ß-catenin protein levels were determined using Western blotting. Bcr-Abl messenger RNA (mRNA) was measured by reverse transcription polymerase chain reaction (RT-PCR). Flow cytometry (FCM) was used to determine cell cycle status. RESULTS: Tetrandrine citrate inhibited the growth of IM-resistant K562 cells, primary leukemia cells, and primitive CD34(+) leukemia cells, and their inhibition concentration that inhibited 50% of target cells (IC(50)) ranged from 1.20 to 2.97 µg/ml. In contrast, tetrandrine citrate did not affect normal blood cells under the same conditions, and IC(50) values were about 10.12-13.11 µg/ml. Oral administration of tetrandrine citrate caused complete regression of IM-resistant K562 xenografts in nude mice without overt toxicity. Western blot results revealed that treatment of IM-resistant K562 cells with tetrandrine citrate resulted in a significant decrease of both p210(Bcr-Abl) and ß-catenin proteins, but IM did not affect the Bcr-Abl protein levels. Proteasome inhibitor, MG132, did not prevent tetrandrine-mediated decrease of the p210(Bcr-Abl) protein. RT-PCR results showed that tetrandrine treatment caused a decrease of Bcr-Abl mRNA. FCM analysis indicated that tetrandrine induced gap 1 (G(1)) arrest in CML cells. CONCLUSIONS: Tetrandrine citrate is a novel orally active tetrandrine salt with potent anti-tumor activity against IM-resistant K562 cells and CML cells. Tetrandrine citrate-induced growth inhibition of leukemia cells may be involved in the depletion of p210(Bcr-Abl) mRNA and ß-catenin protein.

Neoadjuvant chemotherapy for resectable esophageal carcinoma: a meta-analysis of randomized clinical trials.

Neoadjuvant chemotherapy for resectable esophageal carcinoma has been a focus of study, but no agreement has been reached on clinical randomized controlled trials and relevant systematic evaluation. The purpose of this study was to perform a meta-analysis on published randomized controlled trials (RCTs) that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Medline and manual searches was conducted in PubMed, ASCO (American Society of Clinical Oncology) meeting summary, Embase, the Cochrane Library (up to October 2010), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database. The selection contents were to identify all published and unpublished RCTs that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Sixteen RCTs which included 2,594 patients were selected. The risk ratio (RR) (95% confidence interval [CI]; P value), expressed as neoadjuvant chemotherapy and surgery versus surgery alone (treatment versus control), was 1.02 (0.95, 1.10; P=0.54) for 1-year survival, 1.29 (1.13, 1.47; P=0.0001) for 3-year survival, 1.31 (1.13, 1.51; P=0.0003) for 5-year survival, 1.00 (0.95, 1.04; P= 0.85) for rate of resection and 0.89 (0.64, 1.23; P=0.48) for operative mortality. The results showed that neoadjuvant chemotherapy for resectable esophageal carcinoma can raise the overall survival rate of patients with esophageal carcinoma, but it does not affect treatment-related mortality.

[Inhibitory effect of 4-chlorobenzoyl berbamine on imatinib-resistant K562 cells in vitro and in vivo].

OBJECTIVE: To observe the inhibitory effect of 4-chlorobenzoyl berbamine (BBD9) on imatinib-resistant cell line K562 (K562/IR) in vitro and in vivo and explore the mechanisms. METHODS: The IC50 of BBD9 and berbamine (BBM) was determined by MTT assay. The expressions of p210(Bcr-Abl), IKKa, cytoplasmic and nuclear NF-κBp65 were determined using Western blotting in K562/IR cells following a 48-h exposure to 0.5 µg/ml BBD9 or 8 µg/ml BBM. Flow cytometry was used to analyze the cell viability, apoptosis and necrosis; Western blotting was employed to determine the expressions of PARP, caspase-3, caspase-9 and LC3II in K562/IR cells exposed to different concentrations of BBD9 for 48 h. In nude mouse models bearing K562/IR cell xenograft, the tumor weight, tumor regression, and body weight changes of the mice were measured after treatments with 15 mg/kg and 30 mg/kg BBD9 and 100 mg/kg imatinib. RESULTS: The IC50 of BBD9 and BBM was 0.73 µg/ml and 5.43 µg/ml, respectively. In K562/IR cell cultures, the expressions of p210(Bcr-Abl), IKKa and nuclear NF-κB p65 were all decreased following BBD9 and BBM treatments, but BBD9 produced more potent effect; cytoplasmic NF-κB p65 showed no obvious changes after the treatments. The cell apoptosis and necrosis increased with the concentrations of BBD9, which also dose-dependently increased the levels of cleaved caspase-3, csapase-9, PARP, and LC3II expression. In the tumor-bearing mouse model, BBD9 showed stronger effects than imatinib in reducing the tumor weight, promoting tumor regression, and increasing the body weight. CONCLUSION: BBD9 can effectively inhibit the growth of K562/IR cells in vitro and in vivo by activating cell apoptosis, necrosis and autophage pathways, down-regulating expressions of p210(Bcr-Abl) and IKKa and suppressing the cytoplasm-to- nucleus translocation of NF-κBp65.

Effect of exenatide on inflammatory and oxidative stress markers in patients with type 2 diabetes mellitus.

AIM: This study was designed to determine the effect of exenatide on inflammatory and oxidative stress markers in type 2 diabetes mellitus (T2DM) patients who were suboptimally controlled with metformin and/or sulfonylurea. SUBJECTS AND METHODS: Twenty-three patients with T2DM with inadequate glucose control were randomly divided into two groups: exenatide group (E group) (12 patients, 5 µg b.d. × 4 weeks followed by 10 µg b.d. × 12 weeks) and placebo group (P group) (11 patients). Glycosylated hemoglobin (HbA1c), the seven-point glucose profile, daily mean glucose, and glycemic excursion were determined. The effects of exenatide on 8-iso-prostaglandin F2α (PGF2α), monocyte chemoattractant protein-1 (MCP-1), and high-sensitivity C-reactive protein (hs-CRP) were investigated. RESULTS: Exenatide treatment reduced body weight and body mass index (BMI) and improved HbA1c, the seven-point glucose profile, and daily mean glucose compared with placebo (P < 0.05). Limited glycemic excursion was found in the E group compared with the P group (P < 0.05), including a smaller SD and postprandial glucose excursion. In addition, the oxidative stress maker PGF2α was significantly reduced by exenatide treatment (P < 0.05). The inflammatory markers hs-CRP and MCP-1 were also significantly reduced in the E group compared with the P group (P < 0.05). PGF2α was significantly correlated with glycemic excursion (P < 0.05), whereas MCP-1 was significantly correlated with body weight, BMI, glycemic excursion, and HbA1c (P < 0.05 for all). CONCLUSIONS: Exenatide treatment reduced patient body weight and BMI, improved HbA1c and the seven-point glucose profile, reduced daily mean glucose, limited glycemic excursion, and reduced oxidative stress and inflammatory markers in patients of T2DM having inadequate glucose control.

[Correlation of cyclooxygenase 2 expression with microlymphatic density and its clinical significance].

OBJECTIVE: To study the expression of cyclooxygenase-2 (COX-2) in esophageal carcinoma and its correlation with microlymphatic density (MLD), and to investigate the clinicopathological and prognostic significance of COX-2 and MLD in patients with esophageal cancer. METHODS: COX-2 expression and MLD were detected by immunohistochemistry in 100 cases of esophageal squamous cell carcinoma. Follow up was available in 76 patients. Multivariable Cox regression was used to analyze the association between the laboratory indices and overall survival of patients with esophageal carcinoma. RESULTS: COX-2 expression was present in 73% of patients. MLD in patients with high COX-2 expression (99.71±39.62) was significantly higher than that in those with low or no COX-2 expression (80.22±30.36) (P<0.05). No correlations were observed between the over expression of COX-2 and clinicopathologic parameters including tumor size and lymphatic metastasis (P<0.05). However, MLD was associated with lymphatic metastasis and the depth of invasion (P<0.05, P<0.01). In the 76 patients with followed up, the median survival was 25.5 months. Cox regression showed that the COX-2 expression, histological grade of the tumor and MLD were risk factors of overall survival of esophageal carcinoma. CONCLUSIONS: COX-2 may contribute to the lymphangiogenesis in the tumor. COX-2 may be a new target point for the treatment of esophageal carcinoma. COX-2 expression and microlymphatic vessel density are of significant prognostic value for esophageal carcinoma.

Papillary thyroid carcinoma on sonography.

OBJECTIVE: The purpose of this study is to investigate the characteristics of papillary thyroid carcinomas (PTCs) on color duplex sonography (CDUS). METHODS: We retrospectively reviewed 115 nodules (104 patients) with PTC confirmed by pathology from February 1, 2005, to August 31, 2008. The size, border, calcification, echotexture, hemodynamics (peak systolic velocity and resistance index) of the thyroid nodules and cervical lymph nodes on CDUS were analyzed. RESULTS: There was a close relationship between the size of the nodule and the vascularity of the thyroid carcinoma (P=.000). Microcalcification increased the suspicion for malignancy of the thyroid nodule. A hypoechoic thyroid nodule with abundant internal vascularity, ill-defined border and microcalcification was highly suggested PTC. CONCLUSION: CDUS plays an important role in the early detection of PTC and cervical lymph node metastasis, which would provide surgeons with valuable information for planning surgical intervention. Mastering manifestations of PTC on CDUS will improve the accuracy in the diagnosis of PTC. CDUS-guided fine needle aspiration of the thyroid nodule is the standard in the diagnosis of thyroid carcinoma and metastasis pre- and postthyroidectomy.

[Case-control studies on external fixator for the treatment of comminuted distal radius fractures in senile].

OBJECTIVE: To compare and analyze the clinical effects of external fixator and small splint fixator in the treatment of comminuted distal radius fracture in senile. METHODS: From 2005.6 to 2008.6, 74 senile patients (82 sides) with comminuted distal radius fractures were divided into external fixation group (34 cases 38 sides, 27 males and 7 females, with an average of 70.05 +/- 3.70 years) and small splint fixation group (40 cases 44 sides, 29 males and 11 females, with an average of 70.30 +/- 3.48 years). The loss of volar tilting angle and ulnar inclination angle after reduction and the function scores of carpal joint after removing the fixators were compared. RESULTS: One week after surgery, there was loss of volar tilting angle and ulnar inclination in small splint fixation (P < 0.01), and one month after removing the external fixator, the loss of angle was more obvious (P < 0.01); while the loss of angle in external fixation group was not significant (P > 0.05). After one month of removing the fixation, the functional score of wrist joint in external fixation group was obviously higher than that of the small splint fixation group (P < 0.05). CONCLUSION: The external fixator can be adopted to treat comminuted distal radius fractures in senile, which is able to decrease the reduction loss and helpful to functional recovery.

Berbamine exhibits potent antitumor effects on imatinib-resistant CML cells in vitro and in vivo.

AIM: The aim of this study was to explore the effects and mechanism of berbamine on imatinib-resistant BCR-ABL-positive human leukemia K562 (K562-r) cells in vitro and in vivo. METHODS: Cell viability was measured by MTT assay, and apoptotic morphology changes were detected by fluorescence microscopy. The apoptosis rate was measured by flow cytometric assay. mdr-1 mRNA levels were determined by RT-PCR. Bcl-2 family proteins, cytochrome c(cyt C), poly (ADP-ribose) polymerase (PARP), and P-glycoprotein were detected by Western blot. BALB/c nu/nu mice were injected with K562-r cells subcutaneously. Tumor-bearing mice were treated intravenously with berbamine. RESULTS: MTT tests revealed that berbamine significantly inhibited K562-r cell proliferation and increased the chemo-sensitivity of K562-r cells to imatinib. The apoptosis rate was significantly increased following treatment with 21.2 micromol/L berbamine; formation of typical apoptotic blebs was apparent, as observed by fluorescence microscopy. Expression levels of mdr-1 mRNA and P-gp protein were high in untreated K562-r cells and significantly down-regulated by berbamine treatment. Berbamine-treated K562-r cells also exhibited down-regulated expression of the anti-apoptotic proteins Bcl-2 and Bcl-x(L), up-regulated expression of the apoptotic proteins Bax and cytoplasmic cyt C, and stimulated proteolytic cleavage of PARP. In addition, berbamine also suppressed the growth of K562-r xenotransplanted tumors in vivo. CONCLUSION: Berbamine inhibited proliferation of K562-r cells both in vitro and in vivo. Berbamine-induced apoptosis in K562-r cells appeared to occur through a mechanism involving Bcl-2 family proteins, as well as mdr-1 mRNA and P-gp protein. Berbamine in combination with imatinib restored the chemo-sensitivity of K562-r cells to imatinib. Our findings suggest that berbamine may be useful in treating imatinib-resistant CML patients.

[A case-control study on green tea consumption and the risk of adult leukemia].

OBJECTIVE: To investigate whether green tea consumption can reduce the risk of adult leukemia. METHODS: A hospital-based matched case-control study was conducted in 2005 - 2006. We recruited 107 confirmed leukemia cases and 110 inpatient controls with orthopedic disease without leukemia or other malignancy matched on gender, age and hospitals that patients stayed. Related information were gathered on quantity, duration and frequency of tea consumption, demographic characteristics, exposure to radiation and occupational hazards, medications, using a validated questionnaire by face-to-face interview. Univariate and multivariate unconditional logistic regression analysis were used to estimate odds ratios (ORs) and associated 95% confidence intervals (CIs) with SPSS 11.5 software. RESULTS: Compared with non-tea-drinkers, the OR of those who consumed green tea was 0.58 (95% CI:0.34-1.00, P< 0.05) under univariate statistical analysis. The OR was 0.52 ( 95% CI: 0.28- 0.98, P = 0.04), using logistic regression to count for age, gender, residential area, smoking, level of education, exposure to radiation, benzene and organo-phosphorus. Compared with non-drinkers, the risk of adult leukemia declined with increasing quantity, duration, and frequency of green tea consumption. Tests for trend on dose-response was statistically significant (P < 0.01). CONCLUSION: A higher consumption of green tea seemed to be associated with a declined risk of adult leukemia. Tea consumption might be of help to human health planning projects.

[A isolation and identification of an antioxidant from Monochoria vaginalis].

With solvent extraction, a total of four fractions were separated from 75% alcohol extract of Monochoria vaginalis, and their antioxidative activities were measured by iodine method. The results showed that among the fractions, n-butanol fraction exhibited the highest antioxidative activity, which was not only significantly higher than CK (water), but also equivalent to the natural antioxidant tea polyphenols and synthetic antioxidant butylated hydroxyl toluene (BHT). A compound was isolated from the n-butanol fraction by using column chromatography, and identified as stigmasterol 3-O-beta-D-glucopyranoside. Its antioxidative activity estimated by the determination of the percentage of scavenged free radicals indicated that this compound exhibited a higher activity than BHT in scavenging free radicals.

[Application of bone marrow biopsy imprint in evaluating cellularity].

OBJECTIVE: To study the value of bone marrow biopsy imprint in evaluating cellularity. METHODS: The bone marrow tissues were obtained by trephine biopsy from 272 patients, and then put on the slides to make the imprints. The imprints was stained by Wright-Giemsa method, and the bone marrow smears and imprints were examined simultaneously according to the bone marrow cellularity criteria. RESULT: In bone marrow cellularity, four grades (distinct decrease, extreme decrease, distinct increase, and extreme increase) were significantly higher in bone marrow imprints than those in bone marrow smears (P <0.05), but there was no significantly differences between bone marrow imprints and sections (P >0.05). Using bone marrow sections as standard, in cellularily decreasing samples, the consistent rate of bone marrow imprints and smears were both high (84.4% and 97.9%), in the group of the normal and increased cellularity, the consistent rate of the bone marrow imprints (84.4% and 97.7%) was significantly higher than that in smears (60% and 64%, P<0.01). The sensitivity, specificity, Youden index, positive predictive value and positive likelihood rate of bone marrow imprints were all higher than those of the smears. Using the bone marrow sections as gold standard, in 124 cases with decreased cellularity in smears, the positive diagnosis rate for aplastic anemia and dyshaematopoiesis based on bone marrow imprints was 37.1% with a false positive rate of 7.3% which was lower than that of the bone marrow smears (false positive rate of 29.8%, P<0.01). CONCLUSION: To evaluate bone marrow cellularity, bone marrow imprint is better than bone marrow smear. The combination of the two examinations can make the diagnosis more convenient and quicker.

[Multicenter randomized control trial on safety of domestic idarubicin for acute leukemia].

OBJECTIVE: To evaluate the safety of domestically produced idarubicin in the treatment of acute leukemia by a multicenter randomized control trial. METHODS: This trial was carried out in the hemotologica department of five hospitals throughout China, with hospitalized patients who suffered from acute myelogenous leukemia ( AML except M3 type) , acute lymphocytic leukemia ( ALL) , chronic myelogenous leukemia-blast (CML-blast) , totally 155 patients. Those with severely cardial, hepatic or renal disfunction or those who had ever treated with > or = 200 mg/m(2) idarubicin were excluded from the trial. All patients signed the letter of consent as required by the Ethics Committee of our government. In this study, 155 leukemia patients were randomly grouped into: 1. test group treated using domestic idarubicin, 2. control group using imported idarubicin. The acute myelogenous leukemia regimen included idarubicin 8 mg/m(2), dl -3 plus cytosine arabinoside 100 mg/m(2), dl - 7 for 1-2 cycles. The regimen for acute lymphocytic leukemia was idarubicin 8 mg/m2, dl - 3; vincristine 2 mg/mr, dl; cyclophosphamide 750 mg/m2, dl ; plus prednisone 60 mg/m(2),dl - 14 for 1-2 cycles. RESULTS: Clinical response rate of the tested group treated with domestic idarubicin and control group treated with imported idarubicin was 78. 1% (50/64) vs. 76.9% (50/65) without any statistically significant difference between the two groups(P >0. 05). Grade Ill - IV hematological toxicity rate of the domestic idarubicin group and imported idarubicin group was 74. 0% vs. 73. 1% , respectively (P = 0. 73). Drug-related death was observed in 3 of 77 patients in the domestic idarubicin group (3.9%) due to cerebral hemorrage or septic infection. The incidence of non-hematological toxicities in domestic idarubicin group and imported idarubicin group was 84. 4% vs. 79. 5% for nausea or vomiting, 70. 1% vs. 71. 8% for infection, 42. 9% vs. 41. 0% for mucositis, 33. 8% vs. 33. 3% for alopecia, 28.6% vs. 28. 2% for serum glutamicoxalacetic transaminase abnormalitis, 16. 9% vs. 10. 3% for cardiac toxicity, all without statistically significant differences between these two groups (P > 0. 05). Discontinuation of treatment due to non-hematological toxicity was not neccessary. CONCLUSION: Domestic idarubicin is comparable to imported counterpart in efficiency and safety for the treatment of acute leukemia. The most severe side effects of domestic idarubicin is hematological toxicity, which should be closely observed and treated in time, while its non-hematological toxicity is tolerable.