Background::Statins are the first line of treatment for dyslipidemia, but their side effects often reduce medication compliance. Natto and red yeast rice are natural ingredients with lipid-lowering effects. However, the efficacy of Natto Red Yeast Rice (NRYR) supplement in combination with statins in regulating blood lipid levels has not been fully evaluated.Methods::A multicenter, double-blinded, randomized-controlled trial was conducted among individuals with low-density lipoprotein cholesterol (LDL-C) of 3.4 to 5.0 mmol/L at six sites in China, of those at moderate risk of cardiovascular disease (CVD) are prioritized. Participants are enrolled and randomly assigned into four groups by a combination of NRYR (or its placebo) and Simvastatin (or its placebo) in a ratio of 1:1:1:1. After examination at baseline, all participants underwent intervention for 3 months and two follow-up visits at 1 month and 3 months after the intervention. The primary outcome is the change in LDL-C level at 3 months, and secondary outcomes include changes in levels of other lipid profiles and biomarkers, as well as calculated 10-year CVD risk. A total of 1136 participants were randomly assigned, of whom 1110 received the intervention.Discussion::This study may provide new evidence for the efficacy of NRYR supplement in combination with statins to regulate lipid levels and optimize lipid management.Trial Registration::Chinese Clinical Trial Registry database: registration nos. ChiCTR2200064214, ChiCTR2200064215.

Background::Statins are the first line of treatment for dyslipidemia, but their side effects often reduce medication compliance. Natto and red yeast rice are natural ingredients with lipid-lowering effects. However, the efficacy of Natto Red Yeast Rice (NRYR) supplement in combination with statins in regulating blood lipid levels has not been fully evaluated.Methods::A multicenter, double-blinded, randomized-controlled trial was conducted among individuals with low-density lipoprotein cholesterol (LDL-C) of 3.4 to 5.0 mmol/L at six sites in China, of those at moderate risk of cardiovascular disease (CVD) are prioritized. Participants are enrolled and randomly assigned into four groups by a combination of NRYR (or its placebo) and Simvastatin (or its placebo) in a ratio of 1:1:1:1. After examination at baseline, all participants underwent intervention for 3 months and two follow-up visits at 1 month and 3 months after the intervention. The primary outcome is the change in LDL-C level at 3 months, and secondary outcomes include changes in levels of other lipid profiles and biomarkers, as well as calculated 10-year CVD risk. A total of 1136 participants were randomly assigned, of whom 1110 received the intervention.Discussion::This study may provide new evidence for the efficacy of NRYR supplement in combination with statins to regulate lipid levels and optimize lipid management.Trial Registration::Chinese Clinical Trial Registry database: registration nos. ChiCTR2200064214, ChiCTR2200064215.

Background::Despite the adverse effects of ambient fine particulate matter (PM 2.5) on type 2 diabetes and the beneficial role of physical activity (PA), the influence of PM 2.5 on the relationship between PA and type 2 diabetes remains unclear. Methods::In this prospective study with 71,689 participants, PA was assessed by a questionnaire and was categorized into quartiles for volume and three groups for intensity. Long-term PM 2.5 exposure was calculated using 1-km resolution satellite-based PM 2.5 estimates. PM 2.5 exposure and PA's effect on type 2 diabetes were assessed by cohort-stratified Cox proportional hazards models, individually and in combination. Results::In 488,166 person-years of follow-up, 5487 incident type 2 diabetes cases were observed. The association between PA and type 2 diabetes was modified by PM 2.5. Compared with the lowest quartile of PA volume, the highest quartile was associated with reduced type 2 diabetes risk in low PM 2.5 stratification (≤65.02 μg/m 3) other than in high PM 2.5 stratification (>65.02 μg/m 3), with the hazard ratio (HR) of 0.75 (95% confidence interval [CI]: 0.66-0.85) and 1.10 (95% CI: 0.99-1.22), respectively. Similar results were observed for PA intensity. High PM 2.5 exposure combined with the highest PA levels increased the risk of type 2 diabetes the most (HR= 1.79, 95% CI: 1.59-2.01 for PA volume; HR = 1.82, 95% CI: 1.64-2.02 for PA intensity). Conclusion::PA could reduce type 2 diabetes risk in low-pollution areas, but high PM 2.5 exposure may weaken or even reverse the protective effects of PA. Safety and health benefits of PA should be thoroughly assessed for long-term polluted residents.

Objective In recent decades,China has implemented a series of policies to address air pollution.We aimed to assess the health effects of these policies on stroke burden attributable to ambient fine particulate matter(PM2.5). Methods Joinpoint regression was applied to explore the temporal tendency of stroke burden based on data from the Global Burden of Disease 2019 study. Results The age-standardized rates of disability-adjusted life year(DALY)for stroke attributable to ambient PM2.5 in China,increased dramatically during 1990-2012,subsequently decreased at an annual percentage change(APC)of-1.98[95%confidence interval(CI):-2.26,-1.71]during 2012-2019.For ischemic stroke(IS),the age-standardized DALY rates doubled from 1990 to 2014,and decreased at an APC of-0.83(95%CI:-1.33,-0.33)during 2014-2019.Intracerebral hemorrhage(ICH)showed a substantial increase in age-standardized DALY rates from 1990 to 2003,followed by declining trends,with APCs of-1.46(95%CI:-2.74,-0.16)during 2003-2007 and-3.33(95%CI:-3.61,-3.06)during 2011-2019,respectively.Conversely,the age-standardized DALY rates for subarachnoid hemorrhage(SAH)generally declined during 1990-2019. Conclusion Our results clarified the dynamic changes of the ambient PM2.5-attributable stroke burden in China during 1990-2019,highlighting the health effects of air quality improvement policies.

Background::Despite the adverse effects of ambient fine particulate matter (PM 2.5) on type 2 diabetes and the beneficial role of physical activity (PA), the influence of PM 2.5 on the relationship between PA and type 2 diabetes remains unclear. Methods::In this prospective study with 71,689 participants, PA was assessed by a questionnaire and was categorized into quartiles for volume and three groups for intensity. Long-term PM 2.5 exposure was calculated using 1-km resolution satellite-based PM 2.5 estimates. PM 2.5 exposure and PA's effect on type 2 diabetes were assessed by cohort-stratified Cox proportional hazards models, individually and in combination. Results::In 488,166 person-years of follow-up, 5487 incident type 2 diabetes cases were observed. The association between PA and type 2 diabetes was modified by PM 2.5. Compared with the lowest quartile of PA volume, the highest quartile was associated with reduced type 2 diabetes risk in low PM 2.5 stratification (≤65.02 μg/m 3) other than in high PM 2.5 stratification (>65.02 μg/m 3), with the hazard ratio (HR) of 0.75 (95% confidence interval [CI]: 0.66-0.85) and 1.10 (95% CI: 0.99-1.22), respectively. Similar results were observed for PA intensity. High PM 2.5 exposure combined with the highest PA levels increased the risk of type 2 diabetes the most (HR= 1.79, 95% CI: 1.59-2.01 for PA volume; HR = 1.82, 95% CI: 1.64-2.02 for PA intensity). Conclusion::PA could reduce type 2 diabetes risk in low-pollution areas, but high PM 2.5 exposure may weaken or even reverse the protective effects of PA. Safety and health benefits of PA should be thoroughly assessed for long-term polluted residents.

Objective:To study the degree of recognition about the protection of traditional knowledge of Chi-nese medicine and its influencing factors among Shaanxi University of Chinese Medicine students and provide scien-tific evidence for improving relevant policies.Methods: 1,162 college students were chosen by stratified cluster sampling from Shaanxi University of Chinese Medicine and questionnaires were surveyed among them.Rank sum test and multiple linear regression model were used to explore the related factors on degree of recognition about the protection of traditional knowledge of Chinese medicine.Results: The overall cognition-scoring rate was 36.55％,and subscales in descending order by scoring rate were loss of traditional knowledge of Chinese medicine,international and domestic related protection systems.There were significant differences in scores between age groups,majors,grades,place of origin,family monthly income per capita,parents'educational background,moti-vation of applying for medical school,and whether they had taken the protection of traditional knowledge of Chinese medicine courses(P<0.05).Conclusion:The overall cognition-scoring rate among Shaanxi University of Chi-nese Medicine students was generally low.In order to motivate students to protect traditional knowledge of Chinese medicine and promote a healthy development of Chinese medicine,measures from national institution and school education should be conducted.

Objective To explore the efficacy of unrelated cord blood transplantation treatment of mucopolysaccharidosis Ⅰ (MPS Ⅰ).Methods A 4-year-and-2-month-old boy with MPS Ⅰ who received treatment of human leucocyte antigen-mismatched unrelated cord blood stem cell transplantation after diagnosis was identified.The pre-treatment regimen was Busulfan + Cyclophosphamide + Fludarabine (Bu/Cy4 + Flud).Bu with the dosage of 1.2 mg/kg,once every 6 hours,4 days;Cy with the dosage of 50 mg/(kg · d) for 4 days and Flud with the dosage of 30 mg/(m2 · d) lasted for 4 days,respectively.The day that the graft was transplanted was defined as 0 day,days betore transplantation as negative days,days after transplantation as positive days.After pre-treatment,4.60 × 107/kg of cord blood nucleated cells and 3.05 × 105/kg CD34 positive cells were transplanted into the child.The combination of Antihuman thymocyte globulin,Cyclosporin A and Mycophenolate mofetil was administrated for prophylaxis of graft versus host disease(GVHD).After transplantation,the patient was given granulocyte colony stimulating factor to promote reconstitution of hematopoiesis.Results The myeloid and platelet engraftment time was respectively 15 days and 24 days after transplantation.Short tandem repeat (STR) DNA fingerprinting showed a full donor chimerism on day 21 after transplantation,and the full donor chimerism was stable afterwards.The peripheral-blood α-L-iduronidase (IDUA) activity returned to the normal value,and the IDUA gene sequencing did not demonstrate any mutation in 83 days after transplantation.On day 12 after transplantation,pulmonary infection with pulmonary hypertension occurred.Grade-Ⅱ acute intestinal GVHD occurred on day 15,Grade-Ⅱ acute cutaneous GVHD on day 51,and chronic GVHD (cutaneous,localized) on day 180.Otherwise,the patient complicated with hemorrhagic cystitis on day 35.These complications was cured favourably.In an 18-month-follow-up,the height of the boy increased by 3 cm,and his body weight had increased by 2.4 kg.His corneas regained clear,and his hepatosplenomegaly disappeared.The glycosaminoglycan of urine was negative.The neurocognitive performance of the boy had a little improvement.The abnormalities of fingers and other skeletons had no marked change.Conclusions Unrelated cord blood transplantation for MPS Ⅰ have definited effect.It is the first case report in China on treatment of MPS Ⅰ by unrelated cord blood transplantation.The researchers have accumulated some preliminary experience for future treatment of MPS Ⅰ by unrelated cord blood transplantation.

With the development of bio-technological drugs, drug immunogenicity evaluation has become key factor of clarifying safety and efficacy of these drugs. It has become the focus to establish a stable and reliable evaluation system. Due to the advantages such as continuous real-time monitoring, surface plasmon resonance (SPR) technology has been widely used in bio-technological drugs immunogenicity assessments. Our study applied this technology to detect anti-drug antibody (ADA) of a recombinant human anti-rabies monoclonal antibody NM57 in the sera of 48 volunteers admitted in phase I clinical trials. This method could satisfy the basic requirements of detection of ADA.

Objective To examine the causes of high frequency sensorineural hearing loss caused by piston technique of stapes surgery.Methods The retrospective analysis involved in thirty cases(49 ears)with stapedectomy from February 2004 to 2009 at our hospital.Pure tone audiometry was performed for each patient who underwent stapedectomy both during the two days preoperation and 1,3,6 months postoperation.Results One month after operation at 8000 Hz,the air conduction hearing threshold was 8 dB less than that before,4 000 Hz average bone conduction hearing threshold was 10 dB less than that before(P < 0.01).The average high-frequency hearingthreshold of ≥40 years old group was noticeably declined than that of 40 years old group(P < 0.01).There was no association between the tinnitus and high frequency hearing loss.(P >0.05).Conclusion Transient high-frequency sensorineural hearing losses occurred to most patients under going stapedectomy,but showed significant improvement,3 months after the surgery.The average high-frequency hearing threshold of ≥40 years old group was seriously declined than that of 40 years old group.

OBJECTIVE: To compare the effect of tinnitus masking and tinnitus retraining therapy (TRT) in patients with subjective tinnitus, and to analyze the effect of TRT within the positive or negative group of tinnitus masking test. METHOD: The 217 patients from January, 2006 to April, 2008 in our hospital, were performed with the determination of tinnitus including pitch matching, intensity matching, Feldmann masking curve and residual inhibition test with Tinni Test. Of which 143 cases were positive and 74 were negative in tinnitus masking. The follow-up was 6 months and 10 cases were lost. 207 patients were divided into two groups for prospective study: 69 cases in tinnitus masking group and 138 cases in TRT group, The curative effect was evaluated according to tinnitus handicap inventory (THI) and Subjective Visual Tinnitus Scale (SVTS). RESULT: Both masking treatment and TRT were effective for cases with tinnitus, there was significant difference of the score of THI and SVTS of tinnitus between pretherapy and posttherapy (P < 0.01). TRT therapy was more effective than masking therapy, there was significant difference of the THI score between TRT and masking group,but there was no significant difference of of the SVTS between them. TRT therapy was suitable for the patients with both positive effect and negative effect of masking test, and there was no significant difference between them. CONCLUSION Both TRT and masking therapy are the most important therapy for tinnitus patients, but TRT is much more effective than masking therapy in some aspects.
Acclimatization ; Acoustic Stimulation ; Adolescent ; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Tinnitus ; psychology ; therapy ; Treatment Outcome ; Young Adult