Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Tic Disorders/drug therapy* ; Treatment Outcome

Objective:To explore the value of using computed tomography(CT)values to distinguish fresh and old fractures vertebral bodies in osteoporotic vertebral compression fractures(OVCF).Methods:Retrospective analysis of clinical data of 101 OVCF patients in our hospital from September 2022 to September 2023.Kappa test for consistency between magnetic resonance imaging(MRI)and vertebral CT values in distinguished fresh or old OVCF.The difference of CT values between fresh,old fractures and adjacent normal vertebral bodies were compared.The diagnostic efficiency was analyed by receiver operating characteristic(ROC)curve.Results:There was a high consistency between vertebral CT values and MRI in the diagnosis of OVCF in fresh and old fractures(Kappa value=0.934).There was a difference in difference of CT values between adjacent normal vertebral bodies and fresh fractures vertebral bodies(P＜0.05).There was a difference in difference of CT values of fresh fractures vertebral bodies and old fractures vertebral bodies(P＜0.05).The ROC curve analysis results showed that,the combined measurement of CT values of fresh and old fractured vertebral bodies has an area under the curve(AUC)of 0.723,which was higher than alone measurement of the CT values of fresh fractured vertebral bodies and old fractured vertebral bodies of 0.536 and 0.610(Z=2.548,2.605,2.841,P＜0.05).Conclusion:CT values of vertebral bodies show high consistency in distinguish fresh and old fractures of OVCF compared to MRI findings,and the diagnostic efficiency of combine detection is relatively high.

Objective:To explore the diagnostic value of conventional computed tomography(CT)combined with enhanced CT scan in bone metastases.Methods:This study was a retrospective observational study,84 suspected bone metastases patients admitted to our hospital from January 2022 to August 2024 were selected,All patients underwent conventional CT and enhanced CT scan and pathological examination,Using pathological examination results as the"gold standard"for diagnosis.The imaging manifestations of bone metastases using conventional CT combined with enhanced CT scan examination were observed;The detection rate and bone metastases types of conventional CT and enhanced CT scan were analyzed;The bone metastases location in different types of malignant tumors were analyzed;The detection results of bone metastases between conventional CT and enhanced CT scan were compared;the diagnostic efficacy of conventional CT and enhanced CT scan alone and in combination for bone metastases were analyzed by Receiver operating characteristic(ROC)curve.Results:The detection rate of osteogenic,osteolytic,cystic and mixed bone metastases by conventional CT combined with enhanced CT scan was supered to that of conventional CT and enhanced CT scan alone(P＜0.05).Bone metastases from lung cancer,breast cancer and other tumors mainly occur in the spine,limbs and ribs,while esophageal cancer,gastric cancer,liver cancer,prostate cancer,thyroid cancer,renal cancer,and nasopharyngeal cancer had relatively fewer bone metastases.The positive detection cases of bone metastases used conventional CT combined with enhanced CT scan were supered to those used conventional CT and enhanced CT scan alone.The sensitivity,specificity and accuracy of conventional CT combined with enhanced CT scan for the diagnosis of bone metastases were 94.00％,94.11％and 94.04％,respectively,and the positive/negative predictive values were 95.91％and 91.42％,respectively.The sensitivity,specificity and accuracy of conventional CT scan were 84.00％,78.78％and 80.95％,respectively,and the positive/negative predictive values were 85.71％and 74.28％,respectively.The sensitivity,specificity and accuracy of enhanced CT were 89.79％,85.71％and 88.09％,respectively.and the positive and negative predictive values were 89.79％and 85.71％,respectively.The diagnostic efficacy of conventional CT combined with enhanced CT scan for bone metastases was significantly better than that of conventional CT and enhanced CT scan alone.Conclusions:Conventional CT combined with enhanced CT scan can significantly improve the diagnostic efficiency of bone metastases,and provide an important basis for clinical treatment.

Objective:To explore the value of using computed tomography(CT)values to distinguish fresh and old fractures vertebral bodies in osteoporotic vertebral compression fractures(OVCF).Methods:Retrospective analysis of clinical data of 101 OVCF patients in our hospital from September 2022 to September 2023.Kappa test for consistency between magnetic resonance imaging(MRI)and vertebral CT values in distinguished fresh or old OVCF.The difference of CT values between fresh,old fractures and adjacent normal vertebral bodies were compared.The diagnostic efficiency was analyed by receiver operating characteristic(ROC)curve.Results:There was a high consistency between vertebral CT values and MRI in the diagnosis of OVCF in fresh and old fractures(Kappa value=0.934).There was a difference in difference of CT values between adjacent normal vertebral bodies and fresh fractures vertebral bodies(P＜0.05).There was a difference in difference of CT values of fresh fractures vertebral bodies and old fractures vertebral bodies(P＜0.05).The ROC curve analysis results showed that,the combined measurement of CT values of fresh and old fractured vertebral bodies has an area under the curve(AUC)of 0.723,which was higher than alone measurement of the CT values of fresh fractured vertebral bodies and old fractured vertebral bodies of 0.536 and 0.610(Z=2.548,2.605,2.841,P＜0.05).Conclusion:CT values of vertebral bodies show high consistency in distinguish fresh and old fractures of OVCF compared to MRI findings,and the diagnostic efficiency of combine detection is relatively high.

Objective:To explore the diagnostic value of conventional computed tomography(CT)combined with enhanced CT scan in bone metastases.Methods:This study was a retrospective observational study,84 suspected bone metastases patients admitted to our hospital from January 2022 to August 2024 were selected,All patients underwent conventional CT and enhanced CT scan and pathological examination,Using pathological examination results as the"gold standard"for diagnosis.The imaging manifestations of bone metastases using conventional CT combined with enhanced CT scan examination were observed;The detection rate and bone metastases types of conventional CT and enhanced CT scan were analyzed;The bone metastases location in different types of malignant tumors were analyzed;The detection results of bone metastases between conventional CT and enhanced CT scan were compared;the diagnostic efficacy of conventional CT and enhanced CT scan alone and in combination for bone metastases were analyzed by Receiver operating characteristic(ROC)curve.Results:The detection rate of osteogenic,osteolytic,cystic and mixed bone metastases by conventional CT combined with enhanced CT scan was supered to that of conventional CT and enhanced CT scan alone(P＜0.05).Bone metastases from lung cancer,breast cancer and other tumors mainly occur in the spine,limbs and ribs,while esophageal cancer,gastric cancer,liver cancer,prostate cancer,thyroid cancer,renal cancer,and nasopharyngeal cancer had relatively fewer bone metastases.The positive detection cases of bone metastases used conventional CT combined with enhanced CT scan were supered to those used conventional CT and enhanced CT scan alone.The sensitivity,specificity and accuracy of conventional CT combined with enhanced CT scan for the diagnosis of bone metastases were 94.00％,94.11％and 94.04％,respectively,and the positive/negative predictive values were 95.91％and 91.42％,respectively.The sensitivity,specificity and accuracy of conventional CT scan were 84.00％,78.78％and 80.95％,respectively,and the positive/negative predictive values were 85.71％and 74.28％,respectively.The sensitivity,specificity and accuracy of enhanced CT were 89.79％,85.71％and 88.09％,respectively.and the positive and negative predictive values were 89.79％and 85.71％,respectively.The diagnostic efficacy of conventional CT combined with enhanced CT scan for bone metastases was significantly better than that of conventional CT and enhanced CT scan alone.Conclusions:Conventional CT combined with enhanced CT scan can significantly improve the diagnostic efficiency of bone metastases,and provide an important basis for clinical treatment.

Objective To observe the improvement of motor dysfunction and serum levels of C-reactive protein(CRP),blood glucose and blood lipid in post-stroke patients treated with scalp acupuncture at different needle retention time.Methods A total of 120 patients with motor dysfunction after stroke were randomly divided into control group,observation group 1 and observation group 2,with 40 cases in each group.The patients in the 3 groups were treated with scalp acupuncture,body acupuncture and routine rehabilitation exercise,once a day and 6 times a week,lasting for 2 weeks.The control group was given scalp acupuncture with retaining of needles for 30 minutes,the observation group 1 was given scalp acupuncture with retaining of needles for one hour,and the observation group 2 was given scalp acupuncture with retaining of needles for 2 hours.Before and after treatment,the 3 groups were observed in the changes of the scale scores of National Institutes of Health Stroke Scale(NIHSS),Fugl-Meyer Assessment(FM A),Berg Balance Scale(BBS)and modified Barthel Index(MBI),and the levels of laboratory indicators of peripheral blood CRP,fasting plasma glucose(FPG),total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C)and low-density lipoprotein cholesterol(LDL-C).After treatment,the clinical safety of the three groups was evaluated.Results(1)After treatment,the scale scores of NIHSS in the three groups were lower(P＜0.01)and the scale scores FMA,BBS and MBI were higher than those before treatment(P＜0.05 or P＜0.01).The comparison of post-treatment scale scores showed that the differences among the three groups were statistically significant(P＜0.01).The intergroup comparison showed that the decrease of NIHSS score and the increase of FMA,BBS and MBI scores in the observation group 2 were significantly superior to those in the control group and the observation group 1(P＜0.01);the improvement of FMA score in the observation group 1 was significantly superior to that in the control group(P＜0.01),while the improvement of NIHSS,BBS and MBI scores tended to be superior to that in the control group without statistically significant differences(P＞0.05).The results indicated that the curative effect of scalp acupuncture plus exercise regimen was positively correlated with the duration of needle retention for scalp acupuncture.(2)After treatment,the laboratory indicator levels of CRP and FPG in the peripheral blood of the three groups,the levels of TG and LDL-C in the two observation groups and the level of HDL-C in the observation group 2 were improved compared with those before treatment(P＜0.05 or P＜0.01).Statistically significant differences were presented in the post-treatment levels of CRP and TG in peripheral blood among the three groups(P＜0.05 or P＜0.01).The intergroup comparison showed that the improvement of CRP and TG levels in the observation group 2 was significantly superior to that in the control group,and the improvement of CRP level in the observation group 2 was significantly superior to that in the observation group 1,the differences being statistically significant(P＜0.05 or P＜0.01).The TC level in the three groups after treatment did not differ from that before treatment,and there was no significant difference in TC level after treatment among the three groups either(P＞0.05).(3)During the treatment,no adverse reactions such as fainting,needle breaking and hematoma occurred in the three groups,the vital signs of the patients were stable,and there were no obvious abnormal changes in pulse,blood pressure and respiratory rate.Conclusion Scalp acupuncture can effectively improve the motor function of post-stroke patients in a pasitive time-effect relationship with the needle retention,and better the curative effect can be achieved by retaining of the needle for 2 h.

Objective: To analyze and compare therapy responses, outcomes, and incidence of severe hematologic adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia (CML) . Methods: Data of patients with chronic phase CML diagnosed between January 2006 and November 2022 from 76 centers, aged ≥18 years, and received initial flumatinib or imatinib therapy within 6 months after diagnosis in China were retrospectively interrogated. Propensity score matching (PSM) analysis was performed to reduce the bias of the initial TKI selection, and the therapy responses and outcomes of patients receiving initial flumatinib or imatinib therapy were compared. Results: A total of 4 833 adult patients with CML receiving initial imatinib (n=4 380) or flumatinib (n=453) therapy were included in the study. In the imatinib cohort, the median follow-up time was 54 [interquartile range (IQR), 31-85] months, and the 7-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.2%, 88.4%, 78.3%, and 63.0%, respectively. The 7-year FFS, PFS, and OS rates were 71.8%, 93.0%, and 96.9%, respectively. With the median follow-up of 18 (IQR, 13-25) months in the flumatinib cohort, the 2-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.4%, 86.5%, 58.4%, and 46.6%, respectively. The 2-year FFS, PFS, and OS rates were 80.1%, 95.0%, and 99.5%, respectively. The PSM analysis indicated that patients receiving initial flumatinib therapy had significantly higher cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) and higher probabilities of FFS than those receiving the initial imatinib therapy (all P<0.001), whereas the PFS (P=0.230) and OS (P=0.268) were comparable between the two cohorts. The incidence of severe hematologic adverse events (grade≥Ⅲ) was comparable in the two cohorts. Conclusion: Patients receiving initial flumatinib therapy had higher cumulative incidences of therapy responses and higher probability of FFS than those receiving initial imatinib therapy, whereas the incidence of severe hematologic adverse events was comparable between the two cohorts.
Adult ; Humans ; Adolescent ; Imatinib Mesylate/adverse effects* ; Incidence ; Antineoplastic Agents/adverse effects* ; Retrospective Studies ; Pyrimidines/adverse effects* ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy* ; Treatment Outcome ; Benzamides/adverse effects* ; Leukemia, Myeloid, Chronic-Phase/drug therapy* ; Aminopyridines/therapeutic use* ; Protein Kinase Inhibitors/therapeutic use*

Objective: To investigate the association of plasma vitamin B₁₂ level with plasma uric acid level among the elderly over 65 in 9 longevity areas of China. Methods: The elderly over 65 years old with complete information on plasma vitamin B₁₂ and plasma uric acid from Healthy Aging and Biomarkers Cohort Study (2017 to 2018) were recruited in this study. Information on socio-demographic characteristics, life styles, diet intake, and health status were collected by questionnaire and physical examination; and fasting venous blood was collected to detect the levels of plasma vitamin B₁₂, uric acid and other indicators. Multiple linear regression models were used to analyze the association of plasma vitamin B₁₂ level per interquartile range increase with plasma uric acid level. The association trend of plasma vitamin B₁₂ level with plasma uric acid level was described by restrictive cubic splines fitting multiple linear regression model. Multiple logistic regression models were used to analyze the association of plasma vitamin B₁₂ level stratified by quartiles with hyperuricemia. Results: A total of 2 471 participants were finally included in the study, the age was (84.88±19.76) years old, of which 1 291 (52.25%) were female. The M (Q₁, Q₃) level of plasma vitamin B₁₂ was 294 (203, 440) pg/ml and the plasma uric acid level was (341.01±90.46) μmol/L. A total of 422 participants (17.08%) were defined with hyperuricemia. The results of multiple linear regression model showed that there was a positive association of plasma vitamin B₁₂ level with plasma uric acid level after adjustment for covariates (P<0.05). An IQR increase in plasma vitamin B₁₂ (237 pg/ml) was associated with a 6.36 (95%CI: 2.00-10.72) μmol/L increase in the plasma uric acid level. The restrictive cubic splines curve showed a positive linear association of log-transformed plasma vitamin B₁₂ with uric acid level (P<0.001). Conclusion: There is a positive association of plasma vitamin B₁₂ level with plasma uric acid level among the elderly over 65 years old in 9 longevity areas of China.
Humans ; Female ; Aged ; Aged, 80 and over ; Male ; Vitamin B 12 ; Uric Acid ; Cohort Studies ; Hyperuricemia ; Vitamins ; Folic Acid

Objective: To investigate the association of mixed exposure to greenness and nitrogen dioxide(NO₂) and hypertension among the older adults aged 65 years and over in China. Methods: The study subjects were from the Chinese Longitudinal Healthy Longevity Survey from 2017 to 2018. A total of 15 423 older adults aged 65 years and over meeting the criteria were finally included in the study. A questionnaire survey was used to collect information on demographic characteristics, lifestyle habits and self-reported prevalence of hypertension. Blood pressure values were obtained through physical examination. The level of normalized difference vegetation index(NDVI) was measured by the Medium-resolution Imaging Spectral Radiator(MODIS) of the National Aeronautics and Space Administration(NASA). The concentration of NO₂ was from China's surface air pollutant data set. Meteorological data was from NASA MERRA-2. The exposure to NDVI and NO₂ for each study subject was calculated based on the area within a 1 km radius around their residence. The association between mixed exposure of NDVI and NO₂ as well as their interaction and hypertension in older adults was analyzed by using the multivariate logistic regression model. The restrictive cubic spline(RCS) function was used to explore the exposure-response relationship between greenness and NO₂ and the risk of hypertension in study subjects. Results: The mean age of 15 423 older adults were (85.6±11.6). Women accounted for 56.3%(8 685/15 423) and 55.6%(8 578/15 423) lived in urban areas. The mean time of residence was (60.9±28.5) years. 59.8% of participants were with hypertension. The mean NDVI level was 0.41±0.13, and the mean NO₂ concentration was (32.18±10.36) μg/cm³. The results of multivariate logistic regression analysis showed that NDVI was inversely and linearly associated with the hypertension in older adults, with the OR(95%CI) value of 0.959(0.928-0.992). Compared with the T₁ group of NDVI, the risk of hypertension was lower in the T₃ group, with the OR(95%CI) value of 0.852(0.769-0.944), and the trend test was statistically significant(P<0.05). Compared with the T₁ group of NO₂, the risk of hypertension was higher in the T₂ and T₃ groups, with OR(95%CI) values of 1.160(1.055-1.275) and 1.244(1.111-1.393), and the trend test was statistically significant (P<0.05). The result of the RCS showed that NDVI was inversely and linearly associated with hypertension in older adults. NO₂ was nonlinearly associated with hypertension in older adults. The interaction analysis showed that NDVI and NO₂ had a negative multiplicative interaction on the risk of hypertension, with OR(95%CI) value of 0.995(0.992-0.997). Conclusion: Exposure to greenness and NO₂ are associated with hypertension in older adults.
Aged ; Humans ; Female ; Nitrogen Dioxide ; Air Pollution ; Prevalence ; Hypertension/epidemiology* ; China/epidemiology* ; Particulate Matter/analysis*