Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

OBJECTIVETo compare the efficacy difference in treatment of myofasical pain syndrome between sparrow-pecking moxibustion and acupuncture at trigger points so as to provide the reference of the effective therapeutic method for myofascial pain syndrome.

METHODSNinety patients were randomized into a sparrow-pecking moxibustion group and an acupuncture group, 45 cases in each one. The trigger points were selected in pain areas in the two groups. In the sparrow-pecking moxibustion group, the sparrow-pecking moxibustion was applied, 30 min in each time. In the acupuncture group, the filiform needles were inserted obliquely at 45 degrees and retained for 40 min in each treatment. The treatment was given once a day and 10 treatments made one session in the two groups. The short-form McGill pain questionnaire was used as the observation index, and the changes in pain rating index (PRI), present pain intensity (PPI) and visual analogue scale (VAS) before and after treatment were used for efficacy assessment.

RESULTSThe results of PRI, PPI and VAS after treatment were reduced apparently as compared with those before treatment in the sparrow-pecking moxibustion group and the acupuncture group (all P<0.001). The differences in PRI, PPI and VAS after treatment were not significant in comparison of the two groups (both P>0.05). The curative and remarkably effective rate was 80.0% (36/45) in the sparrow-pecking moxibustion group, which was better than 40.0% (18/45, P<0.001) in the acupuncture group.

CONCLUSIONSparrow-pecking moxibustion at trigger points achieves the superior efficacy on myofascial pain syndrome as compared with acupuncture at trigger points. This therapy is simpler in operation additionally.

Acupuncture Points ; Adolescent ; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Moxibustion ; Myofascial Pain Syndromes ; physiopathology ; therapy ; Treatment Outcome ; Trigger Points ; physiopathology ; Young Adult

Adult ; Animals ; Asthma ; epidemiology ; etiology ; Female ; Humans ; Immunoglobulin E ; blood ; Male ; Occupational Diseases ; epidemiology ; etiology ; Pyroglyphidae ; Skin Tests

Abstract: Schistosomiasis, an important zoonotic parasitic disease, is one of the six major tropical diseases identified by WHO, and also one of the most important parasitic diseases for prevention and control in China. After more than 70 years of efforts, the prevention and control of schistosomiasis in China has made great achievements, and the current epidemic of schistosomiasis in China has entered an extremely low epidemic state, but the distribution base of the only intermediate host of schistosomiasis, Oncomelania hupensis, is still large. For now, the techniques used to monitor schistosomiasis have shortcomings such as time-consuming, laborious and low sensitivity, which cannot meet the current needs of China. Environmental DNA (eDNA) refers to DNA that can be extracted from environmental samples (such as soil, water or air) without isolating any target organisms, which is a complex mixture of genomic DNA and its degradation products from different organisms in the same environment. eDNA technology can reflect the community or species composition information in the ecosystem through DNA extraction and detection of environmental samples. Compared with traditional biological monitoring methods, eDNA technology has the advantages of high efficiency, high sensitivity and environmental friendliness. eDNA has been successfully used for the specific detection of Schistosoma mansoni, Schistosoma haematobium and Schistosoma japonicum. This paper reviews the current detection methods of eDNA, the application and technical limitations of eDNA technology in schistosomiasis monitoring, aiming to provide scientific reference for research in the field of schistosomiasis surveillance.

In order to confirm the role that the 49th amino acid residue plays in enzymatic inactivity of Glutamine 49 phospholipase A2(Gln49-PLA2),site-directed mutagenesis of its 49th amino acid gene codon was conducted using PCR.Aspartic acid 49 phospholipase A2(Asp49-PLA2-Q49D-PLA2),the mutant of Gln49-PLA2 was expressed in E.coli with pET32a+ vector.The fusion protein,expressed as inclusion body,after being denatured,was on-column refolded and purified by immobilized metal affinity chromatography(IMAC),and then cleaved by Factor Xa.The mature Q49D-PLA2 mutant was obtained by Hitrap SP cation exchange and Superdex 75 gel filtration chromatography,with the recovery rate of 1.3%,and the specific activity of the mature Q49D-PLA2 mutant was 72 U/mg.It has been demonstrated that the 49th glutamine amino acid residue is the main reason in enzymatic inactivity of Gln49-PLA2 and the results are helpful for denatured protein refolding,especially in rich disulfide bonds conditions.

To evaluate the protective effects of intravitreal injection of cannabinoid HU - 211 for optic nerve in glaucoma rats, providing the experimental evidence in the treatment of glaucoma optic nerve injury.
●METHODS: Glaucoma rats (18 eyes) were modeled by electric coagulation sclera surface vein and randomized into 3 groups, group A received intravitreal injection of 1mg/ 0. 1mL cannabinoid HU - 211 every other day respectively; group B was given intravitreal injection of 0. 1mL water every other day, group C was high intraocular pressure (lOP) group, 6 eyes were randomly selected for blank control group ( group D). lOP was observed every day. The rats were sacrificed after treatment 4wk, froze retina section, HE stain. The density fluctuation of retinal ganglion cell ( RGC ) neurons assessment the optic nerve of rat model with chronic high lOP glaucoma were measured.
●RESULTS: The apoptosis and damage degree of RGC in group B was obviously higher than that in group A, with statistically significant difference (P<0. 05). There was no significant difference in groups B and C (P >0. 05).
●CONCLUSlON: lntravitreal injection of cannabinoid HU-211 shows obvious protective effect on optic nerve in glaucom rat models.

Objective To survey the retraction of dental unit waterlines (DUWLs)in medical institutions,and evaluate the influencing factors for retraction of DUWLs.Methods In May-November 2014,dental chair units (DCUs)in medical institutions in Tianjin City were sampled through systematic random sampling method,retrac-tion volume of DUWLs was detected by independently made detector,the relevant influencing factors were investi-gated.Results A total of 58 DCUs in 30 medical institutions in 10 districts(counties)of Tianjin were investigated, the average retraction volume of DUWLs was (103.60 ±117.85 )mm3 ,the qualified rate of retraction volume of DUWLs was 48.28 %(28/58);length of utilization of DCUs was positively correlated with DUWLs retraction (r=0.52,P <0.001).There were no significant difference in retraction volume of DUWLs among medical institutions in different districts(counties),levels of medical institutions,DUC brands,and modes of DUC water supply(all P >0.05 ).Conclusion The qualified rate of retraction volume of DUWLs is low,routine maintenance of DUCs needs to be intensified,especially the long-term used DUCs,contaminatin of DUWLs due to the invalidity of retraction valve should be prevented.

ObjectlveTo evaluate the role of cannabinoid receptor 2 (CB2 receptor) in microglial injury induced by glutamate.MethodsMicroglia cells were randomly divided into 4 grups:control group (group C),microglial injury group ( group Ⅰ),specific CB2 receptor agonist AM 1241 group ( group AM1241 ) and specific CB2 receptor antagonist AM630 group (group AM630).In group C,the cells were cultured routinely for 26 h.In group Ⅰ,the cells were incubated in the culture medium containing glutamate 10 mmol/L for 24 h.In group AM1241,the cells were incubated in the culture medium containing AM1241 2 μmol/L for 2 h,and then in the culture medium containing glutamate 10 mmol/L for 24 h.In group AM630,the cells were incubated in the culture medium containing AM630 2 μmol/L for 2 h,and then in the culture medium containing glutamate 10 mmol/L for 24 h.The cell viability and release of LDH were measured.Microglial morphology was observed under microscope.Results Compared with group C,the cell viability was significantly decreased,and the release of LDH was significantly increased in groups Ⅰ,AM1241 and AM630 (P ＜ 0.05).Compared with group Ⅰ,the cell viability was significantly increased,and the release of LDH was significantly decreased in group AM1241 ( P ＜ 0.05).There was no significant difference in the cell viability and the release of LDH between groups 1 and AM630 ( P ＞ 0.05).Conclusion Glutamate induces microglial injury through inhibiting the function of CB2 receptor.

Objective To evaluate premature clopidogrel cessation,intraoperative tranexamic acid and their interaction on bleeding and transfusion outcomes in on-pump CABG patients.Methods The current study is a prospective and randomized trial with 2 × 2 factorial design.The first factor is preoperative clopidogrel with 2 levels,clopidogrel ingestion within 7 days preoperatively (group E) and nave to clopidogrel (group B).The second level is antifibrinolytic therapy with 2 level,tranexamic acid (group T) and placebo (group P).A total of 333 patients receiving selective on-pump CABG were recruited.The tranexamic acid regimen was a bolus of 10 mg · kg-1 followed by a maintenance of 10 mg · kg 1 · h-1 throughout the surgery.Results Baseline characteristics were fairly balanced among the groups.Tranexamic acid significantly reduced postoperative blood loss.major bleeding,the volume of erythrocyte and plasma transfused,the exposure of erythrocyte,plasma and any allogeneic products (ET vs EP,P ＜ 0.01 ; BT vs BP,P ＜ 0.01).Clopidogrel within 7 days preoperatively significantly increased blood loss (EP vs BP,P＜0.05),major bleeding,the volume of erythrocyte (EP vs BP,P＜0.01) and the exposure of erythrocyte and plasma (EP vs BP,P ＜ 0.05) and any allogeneic products (EP vs BP,P ＜ 0.01).Under the protection of tranexamic acid,the bleeding and transfusion outcomes were comparable between the patients with premature clopidogrel cessation and those nave to clopidogrel (ET vs BP,P ＞0.05).Perioperative mortality,morbidity and the incidence of adverse events were comparable among the groups except for IABP.Conclusion Comparing with nave to clopidogrel,premature cessation within 7 days preoperatively deteriorated bleeding and transfusion outcomes in on-pump CABG patients.Intraoperative tianexamie acid could reduce the risk.

ObjectiveTo investigate the reliability and validity of Chinese Rehabilitation Research Center Standard Aphasia Examination (CRRCAE) among patients with aphasia after cerebral injury. Methods40 patients were measured using the CRRCAE. For reliability, interclass correlation coefficients were analyzed. For validity, the correlation coefficients of the aphasia quotients and 4 items of CRRCAE and Western Aphasia Battery (WAB) were analyzed.ResultsThe interclass correlation coefficients>0.9, while the Cronbach α of total scale was 0.9411, the scale of the comprehension was 0.8677,the scale of express was 0.8889. CRRCAE had positive relationship with WAB(with the aphasia quotients, r=0.948,P<0.01). The effect size statistics scale was 0.94.ConclusionCRRCAE shows a good retest reliability and good internal consistency. The total scale of CRRCAE can be correlated with serious level of aphasia effectively.