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@#The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.
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Objective To understand the quality status of salt iodine monitoring results at the county level and checking results at the city level from 2017 to 2021 in Suzhou，and to provide a scientific basis for the development of iodine deficiency disease（IDD）prevention and control strategies and measures. Methods During the past five years, Suzhou CDC randomly selected 15 samples of 300 monitored salt samples from each county/district CDC each year for spot checks. The data were processed by comparative analysis of relative error and grouped data t test. Results In the conformity of iodized salt and non-iodized salt, the sample monitoring results of some counties/districts were non-iodized salt, while the city-level test results were iodized salt. In the conformity of iodized salt and seaweed iodized salt (or enhanced salt), the sample monitoring results of county/district level were iodized salt, while the test results at the city level were seaweed iodized salt (or enhanced salt). The non-conformity was relatively concentrated in some county/district laboratories, and the total amount of non-conformity tended to increase year by year. The total number of samples with relative error of >20% between the county/district and city-level results was the least in 2021, with 6, and the most in 2018, with 25. The number of samples with relative error of >30% between the county/district and city-level results was the least in 2017 being 0, while there were 12 samples in 2018, fluctuating within a small range in the past three years. The t-test results of grouped data showed that the average value of the checking results at the city level was generally higher than the monitoring results at the county level. There were 21 pairs of data with no statistical significance (P>0.05) and 29 pairs of data with statistical significance (P<0.05) between the results at the county/district level and at the city level. Among them, there were 7 counties/districts whose sample monitoring results were not significantly different from the city-level test results in 2020, while there were 9 counties/districts whose monitoring results were statistically different from the city-level test results in 2021. Conclusion The data analysis results show that the monitoring data of iodized salt in Suzhou is basically reliable and accurate, but there still exist some problems. Therefore, in the future work it is necessary to strengthen the monitoring system of IDD, increase training efforts, continuously monitor and check the quality of iodized salt to provide a scientific basis for effective prevention and control of IDD.
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@#Telephone follow-up is one of the important ways to follow up patients. High-quality follow-up can benefit both doctors and patients. However, clinical research-related follow-up is often faced with problems such as time-consuming, laborious and poor patient compliance. The authors belong to a team that has been committed to the study of patient-reported outcomes for a long time. The team has carried out long-term follow-up of symptoms, daily function and postoperative complications of more than 1 000 patients after lung cancer surgery, and accumulated certain experience. In this paper, the experience of telephone follow-up was summarized and discussed with relevant literatures from the aspects of clarifying the purpose of clinical research follow-up, understanding the needs of patients in follow-up, and using follow-up skills.
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OBJECTIVE@#To observe the effect of electroacupuncture (EA) of " acupoint combination" on appetite, body fat, insulin sensitivity and central sensitivity of cholecystokinin (CCK) in obese rats with insulin resistance (IR), and to explore the mechanism of EA on improving obesity with insulin resistance.@*METHODS@#Among the fifty 8-week-old healthy SPF male Wistar rats, 10 rats were randomly selected and fed with normal diet; after 8 weeks, 8 rats were randomly selected as a normal group. The remaining 40 rats were fed with high-fat diet to establish the model of obsesity IR; after 8 weeks, 24 rats with successful model of obsesity IR were randomly divided into a model group, an EA group and a sham EA group, 8 rats in each group. Eight weeks after model establishment, the rats in the EA group were intervened with EA at "Fenglong" (ST 40), "Zhongwan" (CV 12), "Guanyuan" (CV 4) and "Zusanli" (ST 36), with continuous wave, in frequency of 2 Hz, and current intensity of 1 mA, for 10 min each time. The rats in the sham EA group were intervened with EA at the points 5 mm next to the acupoints used in the EA group and no electricity was given; the sham EA was given for 10 min each time. Both the treatments were given once every other day for 8 weeks. The Lee's index and food intake were observed before the intervention as well as 2 weeks, 4 weeks, 6 weeks and 8 weeks into intervention; after the intervention, serum insulin (INS) and glucose infusion rate (GIR) were detected; serum cholecystokinin (CCK) level was detected by ELISA; c-fos expression in the area postrema (AP) and nucleus tractus solitarius (NTS) of medulla oblongata was detected by immunohistochemistry.@*RESULTS@#Before the intervention as well as 2 weeks, 4 weeks, 6 weeks and 8 weeks into intervention, the Lee's index and food intake in the model group were higher than those in normal group (<0.01). The Lee's index (6 weeks and 8 weeks into intervention) and food intake (4 weeks, 6 weeks and 8 weeks into intervention) in the EA group were lower than those in the model group and the sham EA group (<0.05, <0.01). After intervention, compared with the normal group, serum level of INS was increased (<0.01), while GIR, serum CCK level, c-fos expression in AP and NTS in the model group were decreased (<0.01, <0.05). Compared with the model group and the sham EA group, serum level of INS in the EA group was decreased (<0.01), and GIR, serum CCK level, c-fos expression in AP and NTS were increased (<0.01, <0.05).@*CONCLUSION@#EA of " acupoint combination" could effectively reduce appetite, body fat and enhance insulin sensitivity in obese rats with IR. The mechanism may be related to the regulation of central sensitivity of CCK.
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The effect of acupuncture cooperated with low-frequency repetitive transcranial magnetic stimulation (rTMS) on chronic insomnia was explored.Seventy-eight patients with chronic insomnia were randomly allocated into two groups:treatment group and control group.In the treatment group,the patients received acupuncture combined with rTMS treatment,and those in the control group were given acupuncture cooperated with sham rTMS treatment,3 days per week for 4 weeks.Before and after treatment,the primary outcomes including the scores on Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) and the secondary outcomes including total sleep time (TST),sleep onset latency (SOL),wake after sleep onset (WASO),sleep efficiency (SE％) recorded by sleeping diary and actigraphy were observed in both groups.Seventy-five participants finished the study (38 in treatment group and 37 in control group respectively).After treatment,the scores in the two groups were improved significantly,more significantly in the treatment group than in the control group.It can be inferred that acupuncture cooperated with rTMS can effectively improve sleep quality,enhance the quality of life of patients and has less side effects.
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The effect of acupuncture cooperated with low-frequency repetitive transcranial magnetic stimulation (rTMS) on chronic insomnia was explored.Seventy-eight patients with chronic insomnia were randomly allocated into two groups:treatment group and control group.In the treatment group,the patients received acupuncture combined with rTMS treatment,and those in the control group were given acupuncture cooperated with sham rTMS treatment,3 days per week for 4 weeks.Before and after treatment,the primary outcomes including the scores on Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) and the secondary outcomes including total sleep time (TST),sleep onset latency (SOL),wake after sleep onset (WASO),sleep efficiency (SE％) recorded by sleeping diary and actigraphy were observed in both groups.Seventy-five participants finished the study (38 in treatment group and 37 in control group respectively).After treatment,the scores in the two groups were improved significantly,more significantly in the treatment group than in the control group.It can be inferred that acupuncture cooperated with rTMS can effectively improve sleep quality,enhance the quality of life of patients and has less side effects.
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Risk management is derived from industry.In recent years,risk management is introduced by many medical laboratories their process management abroad.However,the concept of risk management is still very new for laboratories in China.Therefore,the establishment of the project for risk detection,classification,correction,prevention and supervision could help medical laboratories improve their service quality.
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<p><b>BACKGROUND</b>Accumulating evidence demonstrates that the microenvironment of the host has an important effect on the chemoresistance of tumors. We also found that the formation of intrinsic multidrug resistance is related to environmental factors that are common with tumor growth of hepatocellular carcinoma. The aim of this study was to explore the molecular mechanisms by which multidrug resistance of hepatocellular carcinoma is induced by the microenvironment. In particular, the regulation of nuclear transcription factor (hypoxia-inducible factor-1α, HIF-1α) activation in the process of multidrug resistance formation was investigated.</p><p><b>METHODS</b>HepG2 cells were exposed to different microenvironmental conditions respectively, such as hypoxia, stimulation of glucose deprivation and transfection of plasmid PcDNA3/HBx. In the HepG2 cells, the expression of the related MDR proteins, HIF-1α protein expression and localization, activity of extracellular signal-regulated kinase/mitogen-activated protein kinase (ERK/MAPK) were detected. Specific inhibitor U0126 was used to block ERK/MAPK signal pathway, the alteration of HIF-1α and the related MDR proteins were investigated. Multivariate analysis of variance (MANOVA) repeated measures and one-way analysis of variance (ANOVA) followed by Tukey test or t-test were used to determine differences over time and effects of the treatments.</p><p><b>RESULTS</b>The above three microenvironment factors increase the expression of the related MDR proteins (including P-gp, LRP, and MRP1) and induce MDR of HepG2 cells. HIF-1α was induced at the protein and mRNA levels and the nuclear translocation was also increased. The activity of ERK/MAPK was also increased in HepG2 cells. But when ERK/MAPK pathway was inhibited, the mRNA and protein expression of MDR1, MRP1, and LRP was to some extent decreased. Inhibition of ERK/MAPK significantly reduced activated HIF-1α protein and the nuclear translocation of HIF-1α, whereas HIF-1α mRNA levels were not affected.</p><p><b>CONCLUSIONS</b>The microenvironmental factors could induce MDR of HepG2 cells by the activity of HIF-1α. The activity of HIF-1α is regulated by the ERK/MAPK pathway at the phosphorylation level. As an important nuclear transcription factor, HIF-1α controls the transcription of MDR-related genes and the synthesis of their corresponding proteins by ERK/MAPK signal pathway in HepG2 cells.</p>