Efficacy of Zhumian Tang formula granules combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial.

OBJECTIVE: To evaluate the efficacy and safety of Zhumian Tang formula granules combined with eszopiclone for treating poor sleep quality. METHODS: This multi-center, dynamic block-randomized, parallel-group superiority clinical trial included 130 patients. The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment, and the control group received eszopiclone treatment only. The group allocation ratio was 1∶1. The duration of treatment was 2 weeks. Participants were asked to complete questionnaires before treatment, after 1 week of the intervention, after 2 weeks of the intervention, and at the follow-up on week 3. The primary outcomes were the Pittsburgh Sleep Quality Index (PSQI) score and the total effective rate of treatment. The secondary outcome was the rate of adverse effects. RESULTS: Compared with the eszopiclone treatment group, the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention (6.98 vs 8.26, P < 0.05). However, there was no significant difference in the mean PSQI score after 1 week of the intervention (9.89 vs 9.15, P = 0.124). After the follow-up on week 3, the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group (6.12 vs 8.31, P < 0.001). The total effective rates of treatment of the combined group and the eszopiclone group were 36.92% vs 35.38% (Z = 0.033, P = 0.855) after 1 week of the intervention, 83.08% vs 58.46% (Z = 9.519, P < 0.05) after 2 weeks of the intervention, and 83.08% vs 61.54% (Z = 7.530, P < 0.05) and after the follow-up on week 3, respectively. There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups (21.53% vs 31.8%, P = 0.318). CONCLUSION: The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone. Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.

Clinical course and risk factors for mortality of COVID-19 patients with pre-existing cirrhosis: A multicenter cohort study

BackgroundPatients with pre-existing cirrhosis are considered at increased risk of severe coronavirus disease 2019 (COVID-19) but the clinical course in these patients has not yet been reported. This study aimed to provide a detailed report of the clinical characteristics and outcomes among COVID-19 patients with pre-existing cirrhosis. MethodsIn this retrospective, multicenter cohort study, we consecutively included all adult inpatients with laboratory-confirmed COVID-19 and pre-existing cirrhosis that had been discharged or had died by 24 March 2020 from 16 designated hospitals in China. Demographic, clinical, laboratory and radiographic findings on admission, treatment, complications during hospitalization and clinical outcomes were collected and compared between survivors and non-survivors. FindingsTwenty-one patients were included consecutively in this study, of whom 16 were cured and 5 died in hospital. Seventeen patients had compensated cirrhosis and hepatitis B virus infection was the most common etiology. Lymphocyte and platelet counts were lower, and direct bilirubin levels were higher in patients who died than those who survived (p= 0{middle dot}040, 0{middle dot}032, and 0{middle dot}006, respectively). Acute respiratory distress syndrome and secondary infection were both the most frequently observed complications. Only one patient developed acute on chronic liver failure. Of the 5 non-survivors, all patients developed acute respiratory distress syndrome and 2 patients progressed to multiple organ dysfunction syndrome. InterpretationLower lymphocyte and platelet counts, and higher direct bilirubin level might represent poor prognostic indicators in SARS-CoV-2-infected patients with pre-existing cirrhosis.

Hydroxychloroquine in patients with COVID-19: an open-label, randomized, controlled trial

ObjectivesTo assess the efficacy and safety of hydroxychloroquine (HCQ) plus standard-of-care (SOC) compared with SOC alone in adult patients with COVID-19. DesignMulticenter, open-label, randomized controlled trial. Setting16 government-designated COVID-19 treatment centers in China through 11 to 29 in February 2020. Participants150 patients hospitalized with laboratory confirmed COVID-19 were included in the intention to treat analysis. 75 patients were assigned to HCQ plus SOC and 75 to SOC alone. InterventionsHCQ was administrated with a loading dose of 1, 200 mg daily for three days followed by a maintained dose of 800 mg daily for the remaining days (total treatment duration: 2 or 3 weeks for mild/moderate or severe patients, respectively). Main outcome measuresThe primary outcome was whether participants had a negative conversion of SARS-CoV-2 by 28 days, and was analyzed according to the intention-to-treat principle. Adverse events were analyzed in the safety population in which HCQ recipients were participants who actually received at least one dose of HCQ and HCQ non-recipients were those actually managed with SOC alone. ResultsAmong 150 patients, 148 were with mild to moderate disease and 2 were with severe disease. The mean days ({+/-} standard deviation, min to max) from symptoms onset to randomization was 16.6 ({+/-}10.5 days, 3 to 41 days). The negative conversion probability by 28 days in SOC plus HCQ group was 85.4% (95% confidence interval (CI) 73.8% to 93.8%), similar to that in the SOC group 81.3% (95%CI 71.2% to 89.6%). Between-group difference was 4.1% (95%CI -10.3% to 18.5%). In the safety population, adverse events were recorded in 7 (8.8%) HCQ non-recipients (N=80) and in 21 (30%) HCQ recipients (N=70). The most common adverse event in the HCQ recipients was diarrhea, reported in 7 (10%) patients. Two HCQ recipients reported serious adverse events. ConclusionsThe administration of HCQ did not result in a significantly higher negative conversion probability than SOC alone in patients mainly hospitalized with persistent mild to moderate COVID-19. Adverse events were higher in HCQ recipients than in HCQ non-recipients. Trial registrationChiCTR2000029868 What is already known on this topic-- The pandemic of coronavirus disease 2019 (COVID-19) imposes substantial burdens on individuals, communities, health-care facilities, markets, governments, etc. globally. -- There is no specific treatment approved for COVID-19 or vaccine to prevent infection with the novel coronavirus. -- During the urgent pandemic, media headlines the utility of drugs without solid evidence but buries the side-effects of these drugs. What this study adds-- In this randomized clinical trial of patients mainly with persistent mild to moderate COVID-19, exposure to hydroxychloroquine led to a similar probability of virus elimination comparing to the current standard-of-care. -- Adverse events, mostly gastrointestinal related, were significantly increased in patients who received hydroxychloroquine. -- Overall, the results from our trial do not support the use of hydroxychloroquine in patients with persistent mild to moderate COVID-19. Print abstractO_ST_ABSStudy questionC_ST_ABSTo assess the efficacy and safety of hydroxychloroquine (HCQ) plus standard-of-care (SOC) compared with SOC alone in adult patients with COVID-19. MethodsThis is a multicenter, open-label, randomized controlled trial conducted in 16 government-designated COVID-19 treatment centers in China through 11 to 29 in February 2020. A total of 150 patients hospitalized with laboratory confirmed COVID-19 were included in the intention to treat analysis. Among them, 75 patients were assigned to HCQ plus SOC and 75 to SOC alone. HCQ was administrated with a loading dose of 1, 200 mg daily for three days followed by a maintained dose of 800 mg daily for the remaining days (total treatment duration: 2 or 3 weeks for mild/moderate or severe patients, respectively). The primary outcome was whether participants had a negative conversion of SARS-CoV-2 by 28 days, and was analyzed according to the intention to treat principle. Adverse events were analyzed in the safety population in which HCQ recipients were participants who actually received at least one dose of HCQ and HCQ non-recipients were those actually managed with SOC alone. Study answer and limitationsAmong 150 patients, 148 were with mild to moderate disease and 2 were with severe disease. The mean days ({+/-} standard deviation, min to max) from symptoms onset to randomization was 16.6 ({+/-}10.5 days, 3 to 41 days). The negative conversion probability by 28 days in SOC plus HCQ group was 85.4% (95% confidence interval (CI) 73.8% to 93.8%), similar to that in the SOC group 81.3% (95%CI 71.2% to 89.6%). Between-group difference was 4.1% (95%CI -10.3% to 18.5%). In the safety population, adverse events were recorded in 7 (8.8%) HCQ non-recipients (N=80) and in 21 (30%) HCQ recipients (N=70) with two serious adverse events. The most common adverse event in the HCQ recipients was diarrhea, reported in 7 (10%) patients. Two HCQ recipients reported serious adverse events. What this study addsOur trial does not support the use of hydroxychloroquine in patients with persistent mild to moderate COVID-19 due to limited effects on virus eliminating and significantly increased adverse events. Funding, competing interests, data sharingThis work was supported by the Emergent Projects of National Science and Technology (2020YFC0844500), National Natural Science Foundation of China (81970020, 81770025), National Key Research and Development Program of China (2016YFC0901104), Shanghai Municipal Key Clinical Specialty (shslczdzk02202, shslczdzk01103), National Innovative Research Team of High-level Local Universities in Shanghai, Shanghai Key Discipline for Respiratory Diseases (2017ZZ02014), National Major Scientific and Technological Special Project for Significant New Drugs Development (2017ZX09304007), Key Projects in the National Science and Technology Pillar Program during the Thirteenth Five-year Plan Period (2018ZX09206005-004, 2017ZX10202202-005-004, 2017ZX10203201-008). All authors declared no competing interests. Anonymized datasets can be made available on reasonable request after approval from the trial management committee. Study registrationChiCTR2000029868

Resistance of adult Culex pipiens quinquefasciatus to four common insecticides in Guiyang City / 中华地方病学杂志

Objective To investigate the insecticide resistance levels of adult Culex pipiens quinquefasciatus to four common insecticides in Guiyang City.Methods Larvae of Culex pipiens quinquefasciatus were collected from 8 areas of Guiyang City by larval scoop method from August to September 2015,and raised in the laboratory to adult Culex pipiens quinquefasciatus.Contact tube method was used to determine the insecticide resistance levels of adult Culex pipiens quinquefasciatus to four common insecticides,and knockdown rate of 1 h and mortality rate of 24 h recovery were calculated.The resistance level was judged according to the mortality rate:＜ 90％ was in the resistant group (R);90％-＜ 98％ was in the potential resistant group (M);and ≥98％ was in the sensitive group (S).Results The adult Culex pipiens quinquefasciatus were exposed to 7.70 g/L dichlorvos,3.30 g/L propoxur,0.25 g/L beta-cypermethrin and 0.20 g/L dehamethrin,knockdown rates of 1 h were 57.78％ (52/90)-91.11％ (82/90),86.67％ (78/90)-100.00％ (90/90),23.33％ (21/90)-77.78％ (70/90) and 27.78％ (25/90)-88.89％ (80/90),respectively;and mortality rates of 24 h recovery were 61.11％ (55/90)-94.44％ (85/90),90.00％ (81/90)-97.78％ (88/90),23.33％ (21/90)-73.33％ (66/90) and 21.11％ (19/90)-72.22％ (65/90),respectively.Conclusion Adult Culex pipiens quinquefasciatus in Guiyang City have developed some resistance to four common insecticides,in which the mosquito has a higher resistance to pyrethroid insecticides such as beta-cypermethrin and deltamethrin.

Surgical treatment for diabetic foot ulcers / 中华内分泌外科杂志

Objective To get the experience of surgical treatment for diabetic foot (DF) ulcer.Methods Clinical data of 85 patiems (108 limbs in total) admitted in Department of Bum and Plastic Surgery in The First Affiliated Hospital of Chongqing Medical University from Jan 2010 to Dec 2012 were retrospectively analyzed.Results Wound culture results of the 85 patients were:bacteria in 142 limbs,and fungi in 7 limbs.The main bacteria cultured were staphylococcus aureus,escherichia coli,coagulase negative staphylococcus,enterococcus,pseudomonas aeruginosa,and acinetobacter baumannii.DF healing and Wagner classification was negatively correlated:the higher the class,the less the primary healing rate.The higher amputation rate were found in the higher class patients.The more delayed healing,and the longer the healing time and average hospital stay were also found in the higher class patients.85 patients underwent surgery:skin grafting in 45 cases (52.9％),flap in 8 cases (9.4％),skin repair + flap grafting in 7 cases,toe (limb) amputation in 28 cases,2 cases were sutured after debridement.All cases were cured after one or multiple surgeries.No recurrence was found during the follow-up of 10 days to 2 months.No delayed infection occurred to the repairments.The shape and weight bearing walking function were good.Conclusions The treatment of DF need to follow the principle of multidisciplinary cooperation,professional treatmem,systemic and local treatment.We need to pay attention to the etiology and prevention of the disease,focus on wound bed preparation,choose the best treatment.Early operation can significandy fascilitate wound healing.

The effects of CD4~+ CD25~+ regulatory T cells on the airway inflammation of asthmatic rats / 中国医师杂志

Objective To observe the effects of CD4~+ CD25~+ regulatory T cells ( CD4~+ CD25~+ Treg) on the airway inflammation of asthmatic rats. Methods CD4~+ CD25~+ Treg of OVA- immune tolerance rats were transferred to asthmatic rats. Then bronchoalveolar lavage fluid (BALF) was collected, and cytology study was conducted. The IL-4, IL-5, IFN-γ and OVA-specific serum IgE level in BALF were determined by ELISA. The lung tissue was obtained, and histologieal analysis was done through H. E. Results Total cells number, the percentage of lymphocytes and neutrophils in BALF, the IL-4 and IL-5 BALF levels and the OVA-specific serum IgE level of adoptive transfer group were decreased ( P < 0.05 ) , and the percentage of eosinophils ( Eos) was significantly lower than that of asthma group ( P < 0.01) , while its BALF IFN-γ level was higher than that of asthma group( P <0. 05). Compared with that of asthma group, peribronchiole inflammatory of treated group was alleviated. Conclusion CD4 ~+ CD25~+ Treg of OVA- immune tolerance rats transferred to asthmatic rats can significantly alleviate the airway inflammation of asthmatic rats.

The role of PDK in regulating cytokine secretion by extracellular matrixes / 中华微生物学和免疫学杂志

Objective To investigate the regulatory effects of extracellular matrixes, including fi-bronectin(FN), and collagen Ⅰ (ColⅠ ) on the immunologic function of human airway smooth muscle cells (HASMCs) passively sensitized with asthmatic serum, and the role of phosphoinosifide 3-kinase (PI3K). Methods Primarily cultured HASMCs were inoculated on the blank plates or on the plates coated with difference matrix proteins, added 10% asthmatic serum to passively sensitized non-asthmatic HASMCs and 10% non-asthmatic serum treated HASMCs as control, cell pretreated with PI3K inhibitor LY294002 for 30 min. The expressions of RANTES, Eotaxin, TGF-β1 mRNA were observed by RT-PCR and RANTES, Eotaxin, TGF-β1 protein in the ceil culture supernatunts was detected by enzyme-linked immtmosorbent assay (ELISA). Results Compared with the control serum group, the expressions of RANTES, Eotaxin, TGF-β1 mRNA of HASMCs and those protein in HASMCs culture supematants were significantly increased in the asthmatic serum group and the control serum + FN group and the control serum + Col Ⅰ group ( P < 0.05 ). The expressions of RANTES, Eotaxin, TGF-β1 mRNA of HASMCs and protein in HASMCs culture superna-tants were significantly increased in the asthmatic serum + FN group and the asthmatic serum + Col Ⅰ group. 50 μmoL/L LY294002 could significantly inhibit the expressions of RANTES, Eotaxin, TGF-β1 mRNA of HASMCs and protein in HASMCs culture supematants(P < 0.05). Conclusion These results suggest ex-tracellular matrixe may regulate immunomodulatory function of HASMCs passively sensitized with asthmatic serum and PI3K signaling pathway may play an important role in the process.

Danshen injection decrease interleukin-13 and eotaxin expression in the lung of asthmatic rats / 中国医师杂志

Objective To investigate the molecular mechanism of inhibitory effect of Danshen injection on allergic airway inflamma-tion of asthma. Methods 30 SD rats were random divided into control group, asthma group and Danshen injection group. Bronchoalveolar lavage fluid (BALF) was collected, and cytology study was conducted. The lung tissue was obtained and pathologic analysis was done through HE staining, lnterleukin-13 (IL-13) and Eotaxin in lung tissue were measured by RT - PCR and immunohistochemistry SP method. Results Compared with the asthma group, less infiltration of inflammatory cells in lung tissues was observed in the Danshen injection group. Total cell number, the percentage of lymphocytes, neutrophils and eosinophils (Eos) in BALF of Danshen injection group were lower than that of asthma group (P<0.05, P<0.01). The expression of IL-13 and eotaxin in lung tissue of asthma group was higher than that of control group and Danshen injection group (P<0.05). The expression of IL-13 was negatively correlated with eotaxin (r=0.90, P< 0.05). Conclusion Danshen injection could suppress airway inflammation of asthmatic rats, which probably be through decreasing the ex-pression of IL-13 and eotaxin in the lung tissue of asthmatic rats.

Sexual Behavior of High School Students and Its Relationship with Attachment to Parents and Peers / 中国心理卫生杂志

Objective:To explore the sexual behavior of high school students of Beijing and its relationship to parent and peer attachment.Methods:847 students of two high schools in Beijing were investigated with self-designed inventory on sexual behavior and Inventory of Parental and Peer Attachment.Results:The age of first menstruation among girl was 12.7,that of first semen loss of boys was 13.2.3.3% students had sex intercourse(in boys 16/350,in girls 12/497),the average age of them was 16.0.39.1% students had dating experience.The source of sex information came mainly from friends(38.8%),books and newspaper(24.5%),and school education(15.8%).Boys had more positive attitude to sex behavior of peers than girls.Students with safe attachment to parents were more conservative to sex behavior than those with unsafe attachment to parents.They also had less sexual behaviors.Conclusion:Sex behavior and attitude of high school students in Beijing have week association with attachment pattern.