1.Blinding Designs and Critical Issues in Acupuncture Clinical Trials
Tinglan LIU ; Haoran ZHANG ; Xiaoyu LIU ; Zhiyi XIONG ; Chengyi SUN ; Shiyan YAN
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(7):1765-1770
Blinding is an important method to control the measure bias in clinical trials.As a complex and invasive intervention,acupuncture has more difficulty in blinding implementation compared to drugs and has a higher risk of unblinding breakage.This article provides an overview of the blinding in acupuncture clinical study and summarized the key aspects,including:there is no standard for the application and reporting of sham acupuncture design and blinding measures,appropriate sham acupuncture devices still need to be developed,currently there are no effective methods of operator blinding,blinding assessment has not been given due attention,sham acupuncture design should be standardized and reported.Researchers should conduct further studies to address critical questions and challenges to provide methodological support to improve and promote the quality of acupuncture clinical research.
2.Ovarian-adnexal reporting and data system ultrasound 2022 version(O-RADS US v2022)and it combined with risk of malignancy index 4 for differential diagnosis of benign and malignant adnexal tumors
Jian LI ; Fangxin LIU ; Jianguo QI ; Tinglan XU ; Yongfeng REN ; Zhou WANG ; Fei CHEN ; Zizhuo LI
Chinese Journal of Medical Imaging Technology 2024;40(6):893-897
Objective To observe the value of ovarian-adnexal reporting and data system ultrasound 2022 version(O-RADS US v2022)and it combined with risk of malignancy index 4(RMI4)for differential diagnosis of benign and malignant adnexal tumors.Methods Data of 126 patients with adnexal tumors confirmed by surgical pathology were retrospectively analyzed.O-RADS US v2022 was used to classify:1-3 as benign lesion and 4-5 as malignant lesion.RMI4 classification took 450 as the critical value.And classification was performed based on the two combination.Taking pathological results as gold standard,receiver operating characteristic(ROC)curve was drawn to evaluate the efficacy of O-RADS US v2022 and RMI4 alone or combination for the differential diagnosis of benign and malignant adnexal tumors.Results Among 126 cases,94 were benign and 32 were malignant tumors.The sensitivity,specificity,accuracy and area under the curve(AUC)of O-RADS US v2022 were 78.13%,80.85%,80.16%and 0.795,respectively.The diagnostic results of RMI4 were 71.88%,84.04%,80.95%and 0.780,respectively.The specificity and accuracy of the combination of the two(93.62%,92.06%)were higher than those of O-RADS US v2022(x2=7.322,5.967,P=0.007,0.015)or RMI4(x2=4.625,5.331,P=0.032,0.021),while no significant difference in sensitivity and AUC(87.50%,0.906)was found with O-RADS US v2022 or RMI4(all P>0.05).Conclusion O-RADS US v2022 could effectively differentiate benign and malignant adnexal tumors,and combined with RMI4 could improve the diagnostic specificity and accuracy.
3.Investigation of Mechanism of Aurantii Fructus Immaturus and Naringin in Preventing Postoperative Intestinal Adhesion
Yuqing FAN ; Tinglan ZHANG ; Yan LIU ; Chang CHEN ; Sha CHEN ; Jinzhu JIANG ; Jintang CHENG ; An LIU ; Cong GUO ; Zhiyong YAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(24):50-57
ObjectiveTo investigate the preventive effect and mechanism of Aurantii Fructus Immaturus and naringin on postoperative intestinal adhesion in rats. MethodThe preventive effect of Aurantii Fructus Immaturus and naringin on intestinal adhesion was studied by cecal scraping model of rats, the model rats were randomly divided into model group, dexamethasone sodium phosphate group and Aurantii Fructus Immaturus low, medium and high dose groups (1.58, 3.15, 6.30 g·kg-1·d-1), tsham-operated group was treated with an incision in the abdomen. Adhesion was assessed by Nair method after 7 d of administration. Hematoxylin-eosin (HE) staining was used to observe the pathological morphology and inflammatory cell infiltration of cecum, the expression of matrix metalloproteinase-9 (MMP-9) in cecal adhesion was detected by immunohistochemistry. Meanwhile, intestinal adhesion model rats were randomly divided into model group, dexamethasone sodium phosphate group, naringin low, medium, high dose groups (50, 100, 200 mg·kg-1·d-1), and the sham-operated group was treated with an incision in the abdomen. Adhesion was assessed after 7 d of administration, HE staining was used to observe the pathological morphology and inflammatory cell infiltration in the cecum, and the expression of MMP-9 in the cecal adhesion tissue was detected by immunohistochemistry. Expressions of transforming growth factor-β1 (TGF-β1) and α-smooth muscle actin (α-SMA) in cecum were analyzed by western blot. ResultAurantii Fructus Immaturus could inhibit the formation of postoperative intestinal adhesions in rats, reduce the inflammatory response of damaged cecum tissue, and up-regulate the expression of MMP-9 in the adherent tissue in a dose-dependent manner. All dose groups of naringin could significantly inhibit the formation of postoperative intestinal adhesions in rats, reduce inflammatory cell infiltration and fibrous proliferation in tissue, up-regulate the expression of MMP-9 in the adherent tissue in a dose-dependent manner, and inhibit the expression of TGF-β1 and α-SMA in cecal tissue. ConclusionAurantii Fructus Immaturus and naringin can reduce postoperative intestinal adhesion formation in rat model, and their effects may be related to reducing tissue fibrosis and accelerating extracellular matrix degradation.