Abstract: Objective　To analyze the laboratory indexes of patients infected with malaria patients and COVID-19, so as to provide reliable evidence for the diagnosis of mixed infection of both. Methods　The routine clinical laboratory items such as routine blood, biochemistry and lymphocyte subsets were tested in three cases of COVID-19 complicated with falciparum malaria who admitted to Guangzhou Eighth People's Hospital Affiliated to Guangzhou Medical University from July to December 2020 were tested. Laboratory data were stage-wise analyzed in conjunction with changes in the course of disease. Results　Three patients confirmed COVID-19 infection recruited all had malaria infection history. Fever, headache, and other symptoms emerged on the 4rd to 11th day after admission. Malaria parasite was detected by malaria parasite antigen testing and blood smear testing, and all three patients had re-ignition of malaria after being confirmed COVID-19 infection. In the early stage of malaria relapse, lymphocytes decreased, CRP and SAA increased, and gradually returned to normal level after antimalarial treatment. Interestingly, we only found one patient at the initial stage of malaria detection showed PLT decreased, no other unnormal changes in other routine blood results (WBC, ESO) and liver function results (ALT, AST, GGT, TBIL, DBIL, CG) were found from the beginning to end course of the disease. Conclusion　COVID-19 infection may promote the resurgence of malaria, so the relapse of malaria should be monitored especially for the patient with malaria infection history who begin to develop fever and other symptoms a few days after the diagnosis of COVID-19. The inflammatory indicators would be worth able as an auxiliary judgment basis for the effective treatment of the two combined infection.

Objective To evaluate the contribution of gyrA and parE detection in Ureaplasma genotyping.Methods Sixty Ureaplasma isolates were selected with the Mycoplasma IST kit.The gyrA and parE were amplified by PCR.The DNA was sequenced and compared with the corresponding sequences in GenBank.Results The nucleotide sequence of gyrA had 100% identity in serovar 1,3,6,14 and 100%identity in serovar 2,4,5,7～13,too.But the sequence had 91%identity between the two groups.The nucleotide sequence of parE had 98%～99% identity in serovar 1,3,6,14.And it had 100% identity in erovar 2,5,7,8,11 and 100% identity in serovar4,12,13.But it had only 90% identity between the two groups.Ureaplasma parvum(Up),Ureaplasma urealyticum(Uu)and Up+Uu infection were found 68.3%(41/60),21.7%(13/60)and 10%(6/60) of clinical specimens,respectively.In Up isolates,serovar 3 was 48.8%(20/41).Conclusion Ureaplasma can be divided into two genotypes(Up and Uu)by gyrA analysis.And Up can be divided into four subtypes which correspond to serovar 1,3,6,14,respectively.Serovar 3 is the main isolate in our research.

Objective To investigate the life quality in infants with food allergy before and after treatment by using of Food Allergy Quality of Life Questionnaire - Parent Form(FAQLQ - PF). Methods The severity of eczema in 46 children with food allergy was determined by eczema area and severity index(EASI). The life quality of such infants was assessed by the FAQLQ - PF after 2 - months treatment. Results (1)Among the 50 subjects,46(92% )respon-ded to the tests;the average age was(4. 78 ± 1. 48)months. Twenty - nine(63. 04% )subjects had family history of allergic disease. Egg(73. 91% )was the most common allergen,followed by cow milk(43. 48% ),fish and shrimp (8. 70% ),and carrot(4. 35% ).(2)The scores of EASI,FAQLQ - PF in children with food allergy before treatment were 13. 20 ± 12. 86 and 2. 12 ± 1. 33,respectively,the scores after treatment declined(2. 02 ± 4. 40 and 1. 33 ± 1. 08, respectively),there was a statistical significance(t = 28. 070,4. 014,all P ﹤ 0. 05).(3)Compared with pre - treat-ment,the scores of emotional impact subscale and food anxiety subscale declined,from 2. 10 ± 1. 47 and 2. 63 ± 1. 83 to 1. 30 ± 1. 09 and 1. 68 ± 1. 37,respectively,and there were statistically significant differences(t = 5. 204,8. 818,all P ﹤ 0. 05).(4)There was a positive correlation between the EASI and FAQLQ - PF scores(ρ = 0. 205,P ﹤ 0. 05). Conclusions Food allergy adversely affects the quality of life in infants. The poor life quality is associated with more severe symptoms. The life quality in infants and parents can be improved by standardized treatment.

Objective: To evaluate the long-term prognosis of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) by risk stratification with American College of Cardiology (ACC)/American Heart Association (AHA) classification of coronary lesions. Methods: Data used in this study derived from the I-LOVE-IT 2 trial. I-LOVE-IT 2 trial was a prospective, multicenter, randomized, assessor-blinded, noninferiority study. A total of 1 255 patients in I-LOVE-IT 2 trial with only one lesion and underwent biodegradable polymer drug-eluting stent implantation were included and grouped according to ACC/AHA classification of coronary lesions, namely type A/B1 lesion group (n=184), type B2 lesion group (n=457) and type C lesion group (n=614). The primary endpoint was 48-month patient-oriented composite endpoint (PoCE), a composite of all-cause mortality, all myocardial infarction, stroke, and/or any revascularization. The secondary endpoints were target lesion failure (TLF), components of PoCE, major bleeding (bleeding academic research consortium(BARC) type 3-5) and definite/probable stent thrombosis within 48 months. The incidences of endpoint events were compared in the three groups. The multivariable Cox hazard ratio model was used to analyze the independent predictors of PoCE and TLF at 48 months. Results: Incidences of PoCE at 48 months were significantly higher in patients with type C lesion compared with patients with type A/B1 (24.43%(150/614) vs. 14.13%(26/184), P<0.05) or B2 lesion (24.43%(150/614) vs. 15.97%(73/457), P<0.05). The multivariable Cox hazard ratio model showed that the type C lesion were the independent predictors of 48-month PoCE (HR=1.59, 95%CI 1.21-2.08, P<0.001) and TLF (HR=2.31, 95%CI 1.53-3.49, P<0.001). After multivariable adjustment, the HRs of PoCE for patients with type C lesion versus type A/B1 and type B2 were 1.91 (95%CI 1.25-2.92, P=0.003) and 1.64 (95%CI 1.23-2.20, P<0.001), respectively. Meanwhile, the HRs of TLF for patients with type C lesion versus type A/B1 and type B2 were 2.45 (95%CI 1.29-4.64, P=0.006) and 2.55 (95%CI 1.62-4.02, P=0.001), respectively. Conclusions: The ACC/AHA classification of coronary lesions has good discrimination with long-term outcomes for CAD patients undergoing PCI. The type C lesion is associated with a worse prognosis, enough attention should be paid in these patients during routine clinical management.
Cardiovascular Agents ; Coronary Artery Disease ; Drug-Eluting Stents ; Humans ; Percutaneous Coronary Intervention ; Prognosis ; Prospective Studies ; Risk Assessment ; Risk Factors ; Sirolimus ; Treatment Outcome

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.
Benchmarking ; Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards ; Quality Control

OBJECTIVETo evaluate the oxidative stress in patients with colorectal cancer and to investigate the relationship between oxidative stress and colorectal cancer.

METHODSSeventy-six subjects were divided into two groups (36 colorectal cancer patients as the study group and 40 normal healthy individuals as the control group). Their protein oxidation, DNA damage, lipid peroxidation and antioxidants, vitamin C, vitamin E, glutathione (GSH), and antioxidative enzymes in serum were detected.

RESULTSThe levels of protein carbonyl and advanced oxidation protein products (AOPP) were significantly higher in the study group than in the control group (P<0.01). Serum 8-OHdG was significantly increased in the study group compared to the control group (P<0.01). However, the mean serum level of MDA and conjugated diene was lower in the study group than in the control group (P<0.01). The activity of antioxidative enzymes was significantly decreased in the study group compared to the control group (P<0.01). Serum vitamins C and E concentrations were significantly reduced in the study group compared to the control group (P<0.01).

CONCLUSIONColorectal cancer is associated with oxidative stress, and assessment of oxidative stress and given antioxidants is important for the treatment and prevention of colorectal cancer.

Adult ; Aged ; Aged, 80 and over ; Colorectal Neoplasms ; metabolism ; DNA Damage ; Female ; Humans ; Lipid Peroxidation ; Male ; Middle Aged ; Oxidative Stress

Objective: To observe the clinical efficacy of acupuncture plus bloodletting therapy in treating insomnia in people with blood stasis constitution. Methods: Seventy-two patients were randomized into a treatment group and a control group by using the random number table, 36 cases each. The treatment group received acupuncture plus bloodletting therapy, while the control group was intervened by oral administration of estazolam. One-week treatment was taken as a course, for 3 successive courses in total. A follow-up study was conducted 3 months later. The Pittsburgh sleep quality index (PSQI) was evaluated before and after the intervention, as well as in the follow-up. The clinical efficacies were also compared. Results: The total effective rate was 88.9% in the treatment group versus 83.3% in the control group, and the between-group difference was statistically significant (P<0.05). After the intervention, the PSQI scores dropped significantly in both groups (both P<0.05); the between-group difference in PSQI score was statistically significant (P<0.05). The follow-up study showed that the between-group difference in the global score of PSQI was statistically significant (P<0.05). Conclusion: Acupuncture plus bloodletting therapy can produce a more significant efficacy than oral administration of estazolam in treating insomnia in people with blood stasis constitution.

OBJECTIVETo investigate the correlation of gestational age (GA) with carboxyterminal propeptide of type I procollagen (PICP), deoxypyridinoline (DPD), and bone sound of speed (SOS) in appropriate-for-gestational-age (AGA) neonates, as well as the relationship between bone turnover markers and bone SOS.

METHODSSixty-five AGA neonates were included in the study. The neonates were divided into three groups: preterm infant (GA ≤3 4 weeks, 14 cases), late preterm infant (34 weeks

RESULTSThere were significant differences in GA (F=140.199, P<0.001), birth weight (F=47.042, P<0.001), birth length (F=46.877, P<0.001), and PI (F=11.898, P<0.001) between the three groups; the higher the GA, the higher the birth weigh, birth length, and PI. There were significant differences in PICP (F=30.384, P<0.001), DPD/Cr (F=21.761, P<0.001), and SOS (F=20.052, P<0.001) between the three groups; the higher the GA, the lower the PICP and DPD/Cr and the higher the bone SOS. PICP and DPD/Cr were negatively correlated with GA, birth weight and bone SOS (P<0.01), while bone SOS was positively correlated with GA and birth weight (P<0.01), which still held true after adjustment for GA and birth weight.

CONCLUSIONSAmong AGA neonates, bone turnover markers are negatively correlated with GA, birth weight and bone SOS. High bone turnover is bad for bone health in AGA neonates.

Amino Acids ; blood ; Birth Weight ; Bone Density ; Female ; Gestational Age ; Humans ; Infant, Newborn ; Male ; Peptide Fragments ; blood ; Procollagen ; blood ; Tibia ; diagnostic imaging ; Ultrasonography

The study was aimed to investigate the expression of VEGF mRNA and VEGF protein in HL-60 cells treated with diallyl disulfide (DADS), and to explore the antileukemic mechanism of DADS in respect of VEGF production. Semi-quantitative RT-PCR and ELISA were used to detect the expression of VEGF mRNA and secretion of VEGF protein in HL-60 cell lines treated by DADS respectively. The results showed that the expression of VEGF mRNA and secretion of VEGF protein were found in HL-60 cells. The expression of VEGF mRNA and secretion of VEGF protein in HL-60 cells could be down regulated by treatment with 0.625, 1.25, and 2.5 microg/mL DADS for 48 and 72 hours and the effects had a dose dependent relationship (r > 0.9, P < 0.01). The differences between DADS treated HL-60 cell groups and the control group were statistically significant (P < 0.01), there were also statistically significant differences among three DADS-treated HL-60 cell groups (P < 0.05). It is concluded that DADS effectively inhibits the proliferation of human leukemia cell line HL-60 cells; DADS exerts its antileukemic effects by reduction of the expression of VEGF mRNA and VEGF protein secretion.
Allyl Compounds ; pharmacology ; Antineoplastic Agents ; pharmacology ; Cell Proliferation ; drug effects ; Disulfides ; pharmacology ; HL-60 Cells ; Humans ; RNA, Messenger ; biosynthesis ; genetics ; Vascular Endothelial Growth Factor A ; biosynthesis ; genetics

Adenocarcinoma, Mucinous ; metabolism ; pathology ; surgery ; Adult ; Carcinoma ; metabolism ; pathology ; surgery ; Cytokines ; metabolism ; Diagnosis, Differential ; Female ; Follow-Up Studies ; Humans ; Immunohistochemistry ; Kidney ; chemistry ; pathology ; surgery ; Kidney Neoplasms ; metabolism ; pathology ; surgery ; Male ; Middle Aged ; Mucin-1 ; metabolism ; Nephrectomy ; Vimentin ; metabolism