1.Current Situation and Methodological Reflections on Blinding Assessment in Randomised Controlled Trials of Acupuncture
Hang ZHOU ; Liqiong WANG ; Jianfeng TU ; Guangxia SHI ; Jingwen YANG ; Shiyan YAN ; Cunzhi LIU
Journal of Traditional Chinese Medicine 2024;65(19):1978-1982
Blinding is an important means to control and reduce measurement bias in clinical research, and blinding assessment is the main method to measure the success of the blinding method. By summarizing the current situation of blinding assessment in randomized controlled trials (RCT) of acupuncture, it was found that the report rate of blinding assessment by acupuncture RCT was relatively low, and the studies reporting blinding assessment had several problems, such as incomplete assessment individuals, unreasonable assessment questionnaires, and unscientific analysis methods, and the setting of the assessment time point is controversial. Given the above problems, this paper discussed the key elements of blinding assessment individuals, assessment questionnaires, assessment time points, and analysis methods. It is suggested that blinding assessment should be carried out on all blinded participants and personnel in the study; the assessment questionnaire should be designed by direct inquiry, with responses designed using three or more categorical options that include an "unclear" option; the early stage of the trial should be taken as the mandatory time point for assessment, integrating the evaluation index of the James blinding index and the Bang blinding index, in order to standardize the application of blinding assessment in acupuncture RCT and improve the quality of acupuncture clinical research.
2.Value of transvaginal ultrasound combined with 3.0T magnetic resonance imaging for the diagnosis of ectopic pregnancy
Jianguo LI ; Rong LI ; Daibin JIANG ; Lamei YANG ; Yan TAN ; Yuan TU
Chinese Journal of Radiological Health 2024;33(2):195-199
Objective To compare the value of transvaginal ultrasound, 3.0T magnetic resonance imaging (MRI) scanning alone and in combination for diagnosis of ectopic pregnancy, so as to provide insights into early screening of ectopic pregnancy. Methods This study enrolled a total of 130 patients with suspected ectopic pregnancy admitted to Dachuan People’s Hospital in Dazhou City, Sichuan Province, China between February 2019 and December 2022. All patients underwent transvaginal ultrasound examination and 3.0T MRI scanning. The consistency of transvaginal ultrasound and 3.0T MRI with clinical diagnostic results was evaluated with surgical pathology or clinical follow-up results as the golden standards. The sensitivity, specificity, and accuracy of transvaginal ultrasound and 3.0T MRI, alone and in combination, were compared for diagnosis of ectopic pregnancy. Results Of the 130 patients with suspected ectopic pregnancy, 108 cases were confirmed with ectopic pregnancy by surgical pathology, and 22 cases were confirmed without ectopic pregnancy by clinical follow-up. The sensitivity, specificity, and accuracy of transvaginal ultrasound were 85.19% (92/108), 54.55% (12/22), and 80.00% (104/130), respectively, with 0.358 consistency with clinical diagnostic results. The sensitivity, specificity, and accuracy of 3.0T MRI were 92.59% (100/108), 81.81% (18/22), and 90.77% (118/130), respectively, with 0.694 consistency with clinical diagnostic results. The sensitivity, specificity, and accuracy of transvaginal ultrasound combined with 3.0T MRI were 98.15% (106/108), 72.73% (16/22), and 93.85% (122/130), respectively, with 0.764 consistency with clinical diagnostic results. In addition, the sensitivity and accuracy of transvaginal ultrasound combined with 3.0T MRI were significantly higher than transvaginal ultrasound alone for diagnosis of ectopic pregnancy (χ2 = 11.88 and 10.96, both P < 0.01). Conclusion Transvaginal ultrasound combined with 3.0T MRI may provide more diagnostic information for ectopic pregnancy, and is highly consistent with the clinical diagnostic results. In addition, transvaginal ultrasound combined with 3.0T MRI improves the diagnostic sensitivity and accuracy for ectopic pregnancy than transvaginal ultrasound alone.
3.Efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children:meta-analysis of single-group rate
Caixia TU ; Danyang REN ; Jianling SHEN ; Yunwei LI ; Yanming YANG ; Aihua YAN ; Lin LI ; Huiying LI
China Pharmacy 2024;35(15):1893-1898
OBJECTIVE To investigate the efficacy and safety of clobazam in the additional treatment of refractory epilepsy in children, and provide reference for clinically safe and rational drug use. METHODS The literatures about additional clobazam treatment for refractory epilepsy in children were searched from PubMed, The Cochrane Library, Embase, CNKI, VIP and Wanfang database during the inception to November 2023. After literature screening and data extraction, the quality of included literature was evaluated according to quality evaluation tool for methodological evaluation indicators of non-randomized controlled trial, and then meta-analysis of single-group rate and sensitivity analysis were performed by using RevMan 5.3 software. RESULTS Finally, 18 one-arm studies were included, with a total of 1 424 children. The results showed that compared with before additional treatment, the proportion of patients with seizures-free (proportion of patients with seizure reduction of 100%) was 24%[95%CI (0.18,0.32), P<0.000 01] after conversion; the proportion of patients with seizure reduction ≥75% was 32%[95%CI(0.25,0.40), P<0.000 1] after conversion; the proportion of patients with seizure reduction ≥50% was 53%[95%CI(0.44,0.61),P<0.000 01]; the proportion of patients with seizure reduction <50% or no change was 35%[95%CI(0.24,0.49),P=0.04] after conversion; the proportion of patients with seizure increase was 9%[95%CI(0.05,0.18),P<0.000 01] after conversion. The proportion of patients with adverse reactions was 31%[95%CI(0.23,0.40),P<0.000 1] after conversion; the proportion of patients with discontinuation due to adverse reactions was 10%[95%CI(0.07, 0.15), P<0.000 01] after conversion. The common adverse drug reactions were drowsiness, fatigue and behavior change, etc. The results of the sensitivity analysis showed that the study was robust. CONCLUSIONS Clobazam is an effective additional therapy for refractory epilepsy in children, but its adverse effects should be vigilant.
4.A multicenter study of neonatal stroke in Shenzhen,China
Li-Xiu SHI ; Jin-Xing FENG ; Yan-Fang WEI ; Xin-Ru LU ; Yu-Xi ZHANG ; Lin-Ying YANG ; Sheng-Nan HE ; Pei-Juan CHEN ; Jing HAN ; Cheng CHEN ; Hui-Ying TU ; Zhang-Bin YU ; Jin-Jie HUANG ; Shu-Juan ZENG ; Wan-Ling CHEN ; Ying LIU ; Yan-Ping GUO ; Jiao-Yu MAO ; Xiao-Dong LI ; Qian-Shen ZHANG ; Zhi-Li XIE ; Mei-Ying HUANG ; Kun-Shan YAN ; Er-Ya YING ; Jun CHEN ; Yan-Rong WANG ; Ya-Ping LIU ; Bo SONG ; Hua-Yan LIU ; Xiao-Dong XIAO ; Hong TANG ; Yu-Na WANG ; Yin-Sha CAI ; Qi LONG ; Han-Qiang XU ; Hui-Zhan WANG ; Qian SUN ; Fang HAN ; Rui-Biao ZHANG ; Chuan-Zhong YANG ; Lei DOU ; Hui-Ju SHI ; Rui WANG ; Ping JIANG ; Shenzhen Neonatal Data Network
Chinese Journal of Contemporary Pediatrics 2024;26(5):450-455
Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75%(27/36);boys accounted for 64%(23/36).Among the 36 neonates,31(86%)had disease onset within 3 days after birth,and 19(53%)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61%)had left cerebral infarction and 13(36%)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75%)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72%)and seizures in 10 neonates(34%).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33%,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44%(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.
5.Establishment of UPLC-DAD fingerprint of raw and vinegar Bupleurum bupleurum and study on spectral effect relationship of anti-hepatic fibrosis
Ni-Ping CHEN ; Yan WANG ; Yan DONG ; Yang-Xin XIAO ; Ji-Yuan TU ; Yan-Ju LIU ; Zhong-Shi ZHOU
Chinese Pharmacological Bulletin 2024;40(6):1145-1152
Aim To establish the fingerprint of raw bupleurum and vinegar bupleurum,investigate the difference in their anti-liver fibrosis effects,and ex-plore the relationship between the chemical composition of raw bupleurum and vinegar bupleurum and their an-ti-liver fibrosis efficacy.Methods The fingerprints of 10 batches of raw bupleuri and 10 batches of bupleuri were established by UPLC method.The liver fibrosis cell model in vitro was established by TGF-β induced LX-2 hepatic stellate cells.The liver fibrosis cell mod-el was analyzed with collagen type Ⅰ(col1a1)and α-smoothmuscleactin.The expression of α-SMA protein was used as the pharmacodynamic index.MetaboAna-lyst5.0 was used to screen the difference markers af-fecting the quality of raw bupledges and vinegar bu-pledges with VIP value>1 as the criterion.Orthogo-nal partial least squares discriminant analysis(OPLS-DA)was used to screen the main components of raw bupleurum and vinegar bupleurum against liver fibro-sis.Results There were 18 peaks in the UPLC fin-gerprints of raw bupleurum and vinegar bupleurum,and the analysis results showed that there were nine main differences between raw bupleurum and vinegar bupleurum,among which peaks 9,7 and 6 could be considered as bupleurin d,bupleurin a and bupleurin f.The results of spectral effect relationship showed that the main components of bupleurum anti-liver fibrosis were peaks 11,12,14,15 and 18.Conclusions The established fingerprint method of raw bupleurum and vinegar bupleurum is simple and feasible,and the important components of anti-liver fibrosis activity are screened through the spectrum effect relationship,which provides a basis for clarifying the material basis of anti-liver fibrosis effect of raw bupleurum and vine-gar bupleurum.
6.Comparison of immediate germline sequencing and multi-step screening for Lynch syndrome detection in high-risk endometrial and colorectal cancer patients
An-Shine CHAO ; Angel CHAO ; Chyong-Huey LAI ; Chiao-Yun LIN ; Lan-Yan YANG ; Shih-Cheng CHANG ; Ren-Chin WU
Journal of Gynecologic Oncology 2024;35(1):e5-
Objective:
Lynch syndrome (LS) is a hereditary cancer predisposition syndrome with a significantly increased risk of colorectal and endometrial cancers. Current standard practice involves universal screening for LS in patients with newly diagnosed colorectal or endometrial cancer using a multi-step screening protocol (MSP). However, MSP may not always accurately identify LS cases. To address this limitation, we compared the diagnostic performance of immediate germline sequencing (IGS) with MSP in a high-risk group.
Methods:
A total of 31 Taiwanese women with synchronous or metachronous endometrial and colorectal malignancies underwent MSP which included immunohistochemical staining of DNA mismatch repair (MMR) proteins, MLH1 promoter hypermethylation analysis, and germline sequencing to identify pathogenic variants. All patients who were excluded during MSP received germline sequencing for MMR genes to simulate IGS for the detection of LS.
Results:
Our findings indicate that IGS surpassed MSP in terms of diagnostic yield (29.0% vs.19.4%, respectively) and sensitivity (90% vs. 60%, respectively). Specifically, IGS successfully identified nine LS cases, which is 50% more than the number detected through MSP.Additionally, germline methylation analysis revealed one more LS case with constitutional MLH1 promoter hypermethylation, bringing the total LS cases to ten (32.3%). Intriguingly, we observed no significant differences in clinical characteristics or overall survival between patients with and without LS in our cohort.
Conclusion
Our study suggests that IGS may potentially offer a more effective approach compared to MSP in identifying LS among high-risk patients. This advantage is evident when patients have been pre-selected utilizing specific clinical criteria.
7.Comparison of immediate germline sequencing and multi-step screening for Lynch syndrome detection in high-risk endometrial and colorectal cancer patients
An-Shine CHAO ; Angel CHAO ; Chyong-Huey LAI ; Chiao-Yun LIN ; Lan-Yan YANG ; Shih-Cheng CHANG ; Ren-Chin WU
Journal of Gynecologic Oncology 2024;35(1):e5-
Objective:
Lynch syndrome (LS) is a hereditary cancer predisposition syndrome with a significantly increased risk of colorectal and endometrial cancers. Current standard practice involves universal screening for LS in patients with newly diagnosed colorectal or endometrial cancer using a multi-step screening protocol (MSP). However, MSP may not always accurately identify LS cases. To address this limitation, we compared the diagnostic performance of immediate germline sequencing (IGS) with MSP in a high-risk group.
Methods:
A total of 31 Taiwanese women with synchronous or metachronous endometrial and colorectal malignancies underwent MSP which included immunohistochemical staining of DNA mismatch repair (MMR) proteins, MLH1 promoter hypermethylation analysis, and germline sequencing to identify pathogenic variants. All patients who were excluded during MSP received germline sequencing for MMR genes to simulate IGS for the detection of LS.
Results:
Our findings indicate that IGS surpassed MSP in terms of diagnostic yield (29.0% vs.19.4%, respectively) and sensitivity (90% vs. 60%, respectively). Specifically, IGS successfully identified nine LS cases, which is 50% more than the number detected through MSP.Additionally, germline methylation analysis revealed one more LS case with constitutional MLH1 promoter hypermethylation, bringing the total LS cases to ten (32.3%). Intriguingly, we observed no significant differences in clinical characteristics or overall survival between patients with and without LS in our cohort.
Conclusion
Our study suggests that IGS may potentially offer a more effective approach compared to MSP in identifying LS among high-risk patients. This advantage is evident when patients have been pre-selected utilizing specific clinical criteria.
8.Comparison of immediate germline sequencing and multi-step screening for Lynch syndrome detection in high-risk endometrial and colorectal cancer patients
An-Shine CHAO ; Angel CHAO ; Chyong-Huey LAI ; Chiao-Yun LIN ; Lan-Yan YANG ; Shih-Cheng CHANG ; Ren-Chin WU
Journal of Gynecologic Oncology 2024;35(1):e5-
Objective:
Lynch syndrome (LS) is a hereditary cancer predisposition syndrome with a significantly increased risk of colorectal and endometrial cancers. Current standard practice involves universal screening for LS in patients with newly diagnosed colorectal or endometrial cancer using a multi-step screening protocol (MSP). However, MSP may not always accurately identify LS cases. To address this limitation, we compared the diagnostic performance of immediate germline sequencing (IGS) with MSP in a high-risk group.
Methods:
A total of 31 Taiwanese women with synchronous or metachronous endometrial and colorectal malignancies underwent MSP which included immunohistochemical staining of DNA mismatch repair (MMR) proteins, MLH1 promoter hypermethylation analysis, and germline sequencing to identify pathogenic variants. All patients who were excluded during MSP received germline sequencing for MMR genes to simulate IGS for the detection of LS.
Results:
Our findings indicate that IGS surpassed MSP in terms of diagnostic yield (29.0% vs.19.4%, respectively) and sensitivity (90% vs. 60%, respectively). Specifically, IGS successfully identified nine LS cases, which is 50% more than the number detected through MSP.Additionally, germline methylation analysis revealed one more LS case with constitutional MLH1 promoter hypermethylation, bringing the total LS cases to ten (32.3%). Intriguingly, we observed no significant differences in clinical characteristics or overall survival between patients with and without LS in our cohort.
Conclusion
Our study suggests that IGS may potentially offer a more effective approach compared to MSP in identifying LS among high-risk patients. This advantage is evident when patients have been pre-selected utilizing specific clinical criteria.
9.Effect and mechanism of Dahuang Zhechong Pills in improving liver aging in rats by regulating ROS-mediated PI3K/Akt/FoxO4 signaling pathway.
Yan FU ; Wei WU ; Yi-Gang WAN ; Hai-Ming YANG ; Yue TU ; Si-Yi LIU ; Qi-Jun FANG ; Ying-Lu LIU ; Mei-Zi WANG ; Huang HUANG
China Journal of Chinese Materia Medica 2023;48(11):3014-3021
Recent studies have shown that the occurrence and development of common liver diseases, including non-alcoholic fatty liver disease, cirrhosis, and liver cancer, are related to liver aging(LA). Therefore, to explore the effect and mechanism of Dahuang Zhechong Pills(DHZCP), a traditional classic prescription in improving LA with multiple targets, the present study randomly divided 24 rats into a normal group, a model group, a DHZCP group, and a vitamin E(VE) group, with six rats in each group. The LA model was induced by continuous intraperitoneal injection of D-galactose(D-gal) in rats. For the LA model rats, the general situation was evaluated by aging phenotype and body weight(BW). LA was assessed by the pathological characteristics of hepatocyte senescence, hepatic function indexes, the staining characteristics of phosphorylated histone family 2A variant(γ-H2AX), and the expression levels of cell cycle arrest proteins(P21, P53, P16) and senescence-associated secretory phenotype(SASP) in the liver. The activation of the reactive oxygen species(ROS)-mediated phosphatidylinositol-3 kinase(PI3K)/protein kinase B(Akt)/forkhead box protein O4(FoxO4) signaling pathway was estimated by hepatic ROS expression feature and the protein expression levels of the key signaling molecules in the PI3K/Akt/FoxO4 signaling pathway. The results showed that after the treatment with DHZCP or VE for 12 weeks, for the DHZCP and VE groups, the characterized aging phenotype, BW, pathological characteristics of hepatocyte senescence, hepatic function indexes, relative expression of ROS in the liver, protein expression levels of key signaling molecules including p-PI3K, p-Akt, and FoxO4 in the liver, staining characteristics of γ-H2AX, and the protein expression levels of P16, P21, P53, interleukin-6(IL-6), and tumor necrosis factor-α(TNF-α) in the liver were improved, and the effects of DHZCP and VE were similar. Based on the D-gal-induced LA model in rats, this study demonstrates that DHZCP can ameliorate LA with multiple targets in vivo, and its effects and mechanism are related to regulating the activation of the ROS-mediated PI3K/Akt/FoxO4 signaling pathway in the liver. These findings are expected to provide new pharmacological evidence for the treatment of DHZCP in aging-related liver diseases.
Animals
;
Rats
;
Proto-Oncogene Proteins c-akt/genetics*
;
Phosphatidylinositol 3-Kinases/genetics*
;
Reactive Oxygen Species
;
Tumor Suppressor Protein p53/genetics*
;
Signal Transduction
;
Liver
;
Aging
;
Cell Cycle Proteins
;
Interleukin-6
10.Efficacy and safety of different doses of zinc in the treatment of diarrhea in children:a systematic review
Caixia TU ; Danyang REN ; Yunwei LI ; Yanming YANG ; Jianling SHEN ; Yan LIU ; Ting LIU ; Huiying LI
China Pharmacy 2023;34(17):2154-2161
OBJECTIVE To investigate the efficacy and safety of different doses of zinc in the treatment of diarrhea in children, and to provide a reference for clinical safe and rational drug use. METHODS Retrieved from PubMed, Cochrane Library, Embase database, randomized controlled trials about zinc (zinc group) versus placebo or conventional treatment (control group) in the treatment of diarrhea in children were collected from the inception to October 2022. Then, the quality of the included literature was evaluated by the Cochrane Handbook 6.0, and meta-analysis and sensitivity analysis were performed by RevMan 5.3 software. RESULTS Finally, 25 RCTs were included, with a total of 8 618 children. The results of meta-analysis showed that in terms of duration of diarrhea, in zinc <20 mg group, the zinc group was significantly shorter than the control group [SMD= -0.39, 95%CI(-0.71, -0.08), P=0.01], but in subgroups of <6 months old, there was no significant difference between the two groups [SMD=0.01, 95%CI(-0.10, 0.11), P=0.88]. In zinc 20 mg group, the zinc group was significantly shorter than the control group [SMD=-0.52, 95%CI(-0.80, -0.23), P=0.000 3]. In zinc >20 mg group, the zinc group was significantly shorter than the control group [SMD=-0.83, 95%CI(-1.39, -0.27), P=0.004]. In zinc >10 mg (age ≤12 months) or zinc > 20 mg (age >12 months) group (short for “constant dose group”), the zinc group was significantly shorter than the control group [SMD=-0.16, 95%CI(-0.27, -0.06), P= 0.003]. In the aspect of diarrhea rate after 7 days of treatment,there was no significant difference in the diarrhea rate after 7 E-mail:lihuiying@etyy.cn days of treatment between the zinc group and the control group: in zinc <20 mg group[OR=1.28,95%CI (0.96,1.70),P=0.09], in zinc 20 mg group [OR=0.40, 95%CI (0.15,1.01),P= 0.05], in constant dose group [OR=0.64, 95%CI (0.28, 1.44), P=0.28]. In terms of vomiting rate, in zinc <20 mg group, the vomiting rate of zinc group was significantly higher than that of the control group [OR=2.13, 95%CI (1.68, 2.70), P<0.001]; in constant dose group, vomiting rate of zinc group was significantly higher than that of the control group [OR=1.84, 95%CI (1.44, 2.34), P<0.001]. CONCLUSIONS Zinc can significantly shorten the duration of diarrhea in children(6 months and above), but low doses can increase the risk of vomiting, which should be taken attention in clinical.

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