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 analyze the effectiveness of single three-dimensional (3D)-printed microporous titanium prostheses and flap combined prostheses implantation in the treatment of large segmental infectious bone defects in limbs. METHODS: A retrospective analysis was conducted on the clinical data of 76 patients with large segmental infectious bone defects in limbs who were treated between January 2019 and February 2024 and met the selection criteria. Among them, 51 were male and 25 were female, with an age of (47.7±9.4) years. Of the 76 patients, 51 had no soft tissue defects (single prostheses group), while 25 had associated soft tissue defects (flap combined group). The single prostheses group included 28 cases of tibial bone defects, 11 cases of femoral defects, 5 cases of humeral defects, 4 cases of radial bone defects, and 3 cases of metacarpal, or carpal bone defects, with bone defect length ranging from 3.5 to 28.0 cm. The flap combined group included 3 cases of extensive dorsum of foot soft tissue defects combined with large segmental metatarsal bone defects, 19 cases of lower leg soft tissue defects combined with large segmental tibial bone defects, and 3 cases of hand and forearm soft tissue defects combined with metacarpal, carpal, or radial bone defects, with bone defect length ranging from 3.8 to 32.0 cm and soft tissue defect areas ranging from 8 cm×5 cm to 33 cm×10 cm. In the first stage, vancomycin-loaded bone cement was used to control infection, and flap repair was performed in the flap combined group. In the second stage, 3D-printed microporous titanium prostheses were implanted. Postoperative assessments were performed to evaluate infection control and bone integration, and pain release was evaluated using the visual analogue scale (VAS) score. RESULTS: All patients were followed up postoperatively, with an average follow-up time of (35.2±13.4) months. In the 61 lower limb injury patients, the time of standing, walk with crutches, and fully bear weight were (2.2±0.6), (3.9±1.1), and (5.4±1.1) months, respectively. The VAS score at 1 year postoperatively was significantly lower than preoperative one ( t=-10.678, P<0.001). At 1 year postoperatively, 69 patients (90.8%) showed no complication such as infection, fracture, prosthesis displacement, or breakage, and X-ray films indicated good integration at the prosthesis-bone interface. According to the Paley scoring system for the healing of infectious bone defects, the results were excellent in 37 cases, good in 29 cases, fair in 3 cases, and poor in 7 cases. In the single prostheses group, during the follow-up, there was 1 case each of femoral prostheses fracture, femoral infection, and tibial infection, with a treatment success rate of 94.1% (48/51). In lower limb injury patients, the time of fully bear weight was (5.0±1.0) months. In the flap combined group, during the follow-up, 1 case of tibial fixation prostheses screw fracture occurred, along with 2 cases of recurrent foot infection in diabetic patients and 1 case of tibial infection. The treatment success rate was 84.0% (21/25). The time of fully bear weight in lower limb injury patients was (5.8±1.2) months. The overall infection eradication rate for all patients was 93.4% (71/76). CONCLUSION The use of 3D-printed microporous titanium prostheses, either alone or in combination with flaps, for the treatment of large segmental infectious bone defects in the limbs results in good effectiveness with a low incidence of complications. It is a feasible strategy for the reconstruction of infectious bone defects.
Humans ; Male ; Female ; Middle Aged ; Printing, Three-Dimensional ; Titanium ; Retrospective Studies ; Surgical Flaps ; Adult ; Prosthesis Implantation/methods* ; Plastic Surgery Procedures/methods* ; Treatment Outcome ; Prostheses and Implants ; Bone Diseases, Infectious/surgery* ; Extremities/surgery* ; Prosthesis Design

Individuals with congenital absence of the vas deferens (CAVD) may transmit cystic fibrosis (CF)-causing variants of the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene to their offspring through assisted reproductive technology (ART). We aimed to delineate the spectrum and estimate the prevalence of CF-causing variants in Chinese individuals with CAVD through a cohort analysis and meta-analysis. CFTR was sequenced in 145 Chinese individuals with CAVD. CFTR variants were classified as CF-causing or non-CF-causing variants regarding clinical significance. A comprehensive genotype analysis was performed in Chinese individuals with CAVD, incorporating previous studies and our study cohort. The prevalence of CF-causing variants was estimated through meta-analysis. In our cohort, 56 different CFTR variants were identified in 108 (74.5%) patients. Twenty variants were categorized as CF-causing and were detected in 28 (19.3%) patients. A comprehensive genotype analysis of 867 patients identified 174 different CFTR variants. Sixty-four were classified as CF-causing variants, 56.3% of which had not been previously reported in Chinese patients with CF. Meta-analysis showed that 14.8% (95% confidence interval [CI]: 11.0%-18.9%) CAVD cases harbored one CF-causing variant, and 68.6% (95% CI: 65.1%-72.0%) CAVD cases carried at least one CFTR variant. Our study underscores the urgent need for extensive CFTR screening, including sequencing of whole exons and flanking regions and detection of large rearrangements and deep intronic CF-causing variants, in Chinese individuals with CAVD before undergoing ART. The established CF-causing variants spectrum may aid in the development of genetic counseling strategies and preimplantation diagnosis to prevent the birth of a child with CF.
Adult ; Humans ; Male ; China ; Cohort Studies ; Cystic Fibrosis/genetics* ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics* ; Genotype ; Male Urogenital Diseases/genetics* ; Mutation ; Vas Deferens/abnormalities* ; East Asian People/genetics*

The bioactivity-guided isolation of potentially active natural products has been widely utilized in pharmaceutical discovery. In this study, by screening fungal extracts against coxsackievirus B3 (CVB3), three new aspochalasins, templichalasins A‒C (1‒3), along with six known aspochalasins (4‒9) were isolated from an active extract derived from the endophytic fungus Aspergillus templicola LHWf045. Compound 1 features a unique 5/6/5/7/5 pentacyclic ring system, while compounds 2 and 3 possess unusual 5/6/6/7 tetracyclic skeletons. Their structures were characterized through extensive spectroscopic analyses, electronic circular dichroism (ECD) calculations, and single-crystal X-ray diffraction analysis. Additionally, we demonstrated that compound 4 can be readily converted into compounds 1‒3 under mild acidic conditions and proposed a plausible mechanism for this conversion. Bioactivity evaluation of compounds 1‒9 against CVB3 revealed the inhibitory effects of all compounds against the virus. Notably, compound 9 exhibited superior antiviral activity, surpassing the commercial drug ribavirin in selectivity index (SI) value.
Antiviral Agents/isolation & purification* ; Aspergillus/chemistry* ; Molecular Structure ; Enterovirus B, Human/drug effects* ; Endophytes/chemistry* ; Cytochalasins/isolation & purification* ; Drug Discovery ; Humans

Objective To explore the effect of urine mixing degree on 24-hour urinary total protein(24 h UTP)in patients with chronic kidney disease(CKD).Methods From October 1,2023 to December 31,2023,30 hospitalized patients who needed to complete 24 h UTP testing in Zhongshan Hospital,Fudan University were selected.A 5 L unified container was used to collect urine for 24 hours.After collection and one hour's standing,the urine sample was divided into upper,middle,and lower equal parts according to volume,which was defined as direct-sampling group.Then,the urine samples were fully mixed with a magnetic stirrer and sampled again according to the above-mentioned three-equal sampling method,which was defined as mixed-sampling group.The generalized estimating equation was used to compare the urinary protein concentration before and after mixing and at different sampling location.Results The results of generalized estimating equation showed that after controlling the variable"sampling position",there was no significant difference in urinary protein concentration between the direct-sampling group and the mixed-sampling group.After controlling the variable"mixing method",there was still no significant difference in urinary protein concentration at different sampling positions.After adjusting the covariates such as age,gender,and estimated glomerular filtration rate(eGFR),the results were consistent.Conclusions With standard protocol,the entire 24-hour urine sample is a relatively even-distributed solution.After the total urine collection is completed,the temporary sample can be directly extracted from any level of the original urine within 1 hour,and the urine protein concentration of the sample multiplied by the urine volume can reflect the 24 h UTR.

Background/Aims: This study aimed to assess the impact of INTERCEPT Foam Spray (IFS) application on delayed endoscope reprocessing through microbiological surveillance culture (MSC). Methods: A quasi-experimental, matched-comparison pilot study was conducted using gastrointestinal endoscopy. IFS was applied to the endoscopes after precleaning and before reprocessing the next day. An equal number of endoscopes, matched by endoscope type, were subjected to routine reprocessing. The MSC were subjected to high-level disinfection to detect any contamination. Data were analyzed using the chi-square test or Fisher exact test (categorical data) and Student t-test (continuous data). Results: In total, 150 MSCs were collected from 42 endoscopes. Positive MSCs were observed in 4.0% (4/75) of the sprayed group and 1.3% (1/75) of the control group (95% confidence interval, 30.34–0.31; p>0.05), all of which were contributed by colonoscopes. Colonoscope were more prone to positive MSC (mean difference in percentage, p<0.05). Mean spraying hours were not associated with detected growth (11.7% vs. 13.6%; 95% confidence interval, 1.43 to –5.27; p>0.05), with environmental and skin flora being the primary contaminants. Conclusions IFS may be applied when delayed endoscope processing is necessary, but with caution when applied to colonoscopes. However, further research is warranted to verify the result.

Background/Aims: This study aimed to assess the impact of INTERCEPT Foam Spray (IFS) application on delayed endoscope reprocessing through microbiological surveillance culture (MSC). Methods: A quasi-experimental, matched-comparison pilot study was conducted using gastrointestinal endoscopy. IFS was applied to the endoscopes after precleaning and before reprocessing the next day. An equal number of endoscopes, matched by endoscope type, were subjected to routine reprocessing. The MSC were subjected to high-level disinfection to detect any contamination. Data were analyzed using the chi-square test or Fisher exact test (categorical data) and Student t-test (continuous data). Results: In total, 150 MSCs were collected from 42 endoscopes. Positive MSCs were observed in 4.0% (4/75) of the sprayed group and 1.3% (1/75) of the control group (95% confidence interval, 30.34–0.31; p>0.05), all of which were contributed by colonoscopes. Colonoscope were more prone to positive MSC (mean difference in percentage, p<0.05). Mean spraying hours were not associated with detected growth (11.7% vs. 13.6%; 95% confidence interval, 1.43 to –5.27; p>0.05), with environmental and skin flora being the primary contaminants. Conclusions IFS may be applied when delayed endoscope processing is necessary, but with caution when applied to colonoscopes. However, further research is warranted to verify the result.

Background/Aims: This study aimed to assess the impact of INTERCEPT Foam Spray (IFS) application on delayed endoscope reprocessing through microbiological surveillance culture (MSC). Methods: A quasi-experimental, matched-comparison pilot study was conducted using gastrointestinal endoscopy. IFS was applied to the endoscopes after precleaning and before reprocessing the next day. An equal number of endoscopes, matched by endoscope type, were subjected to routine reprocessing. The MSC were subjected to high-level disinfection to detect any contamination. Data were analyzed using the chi-square test or Fisher exact test (categorical data) and Student t-test (continuous data). Results: In total, 150 MSCs were collected from 42 endoscopes. Positive MSCs were observed in 4.0% (4/75) of the sprayed group and 1.3% (1/75) of the control group (95% confidence interval, 30.34–0.31; p>0.05), all of which were contributed by colonoscopes. Colonoscope were more prone to positive MSC (mean difference in percentage, p<0.05). Mean spraying hours were not associated with detected growth (11.7% vs. 13.6%; 95% confidence interval, 1.43 to –5.27; p>0.05), with environmental and skin flora being the primary contaminants. Conclusions IFS may be applied when delayed endoscope processing is necessary, but with caution when applied to colonoscopes. However, further research is warranted to verify the result.

Objective:To investigate the change of D-Dimer (D-D), cardiac troponin I (cTnI) and vasoactive-inotropic score (VIS) after Stanford type A aortic dissection (TAAD) and thier predictive effect on death outcome.Methods:120 patients with TAAD who were treated in the Affiliated Hospital of Jining Medical College from January 2019 to January 2022 were retrospectively selected and divided into death group ( n=17) and survival group ( n=103) according to the 28-day survival after operation. The difference of clinical data between the two groups was compared, and the influencing factors of postoperative death in TAAD patients were analyzed by logistic regression method. Results:The age, deep hypothermic circulatory arrest time, D-D and cTnI of the patients in the death group were (60.50±5.42)years old, (30.40±9.92)min, (15.65±5.52)g/L and (3.32±0.82)mg/L, respectively, which were significantly higher than those in the survival group (all P<0.05). The VIS score and change of VIS score in the death group at 24 hours after operation were (9.66±1.10)points and (4.50±0.91)points respectively, which were significantly higher than those in the survival group (all P<0.05). Logistic regression analysis showed that age, D-D, cTnI and change of VIS score were the influencing factors of death after TAAD (all P<0.05). The area under the receiver operating characteristic (ROC) curve predicted by the D-D, cTnI and change of VIS score for death in TAAD patients was 0.718, 0.691 and 0.789 respectively (all P<0.05). Conclusions:Postoperative death of TAAD patients is affected by their age, D-D, cTnI and change of VIS score. The D-D, cTnI and change of VIS score have certain application value in predicting postoperative death of patients.