ABSTRACT
As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.
Subject(s)
Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional/methods , Outcome Assessment, Health Care , Reference Standards , Reproducibility of Results , Research Design , Clinical Trials as TopicABSTRACT
The diagnosis of mediastinal space-occupying lesions largely relies on X-ray and computed tomography. However, thanks to technological progress, transthoracic echocardiography can clearly display the mediastinal structures surrounding the heart and great vessels, thereby improving the detection rate of mediastinal space-occupying lesions. Primary mediastinal teratoma is relatively rare, and removal of giant mediastinal teratoma by thoracoscopic surgery has rarely been reported. Here, we report a case of giant mediastinal teratoma diagnosed by transthoracic echocardiography, which was treated by complete thoracoscopic resection and confirmed by histology.
Subject(s)
Echocardiography/methods , Mediastinal Neoplasms/diagnostic imaging , Teratoma/diagnostic imaging , Adult , Diagnosis, Differential , Female , Humans , Mediastinal Neoplasms/surgery , Mediastinum/diagnostic imaging , Mediastinum/surgery , Teratoma/surgery , ThoracoscopyABSTRACT
Subaortic stenosis (SAS) is a congenital heart disease, and its association with hypertrophic cardiomyopathy is very rare and clinically underappreciated. We report here a case of a 45-year-old female who was admitted to our hospital with chest tightness and shortness of breath. Both transthoracic and transesophageal echocardiography revealed asymmetric left ventricular hypertrophy and a membrane-like echo below the level of the aortic valve. This patient was diagnosed with membranous SAS with hypertrophic cardiomyopathy. Screening of her immediate family members revealed that her son also had hypertrophic cardiomyopathy. The patient chose conservative treatments and has been closely followed-up after discharge.
Subject(s)
Cardiomyopathy, Hypertrophic/complications , Cardiomyopathy, Hypertrophic/diagnostic imaging , Discrete Subaortic Stenosis/complications , Discrete Subaortic Stenosis/diagnostic imaging , Heart Defects, Congenital/complications , Heart Defects, Congenital/diagnostic imaging , Echocardiography/methods , Female , Heart/diagnostic imaging , Humans , Middle AgedABSTRACT
The purpose of this research was to construct a lentiviral vector containing pir-b gene, and to detect the expression of pir-b gene in 293T cells. The open reading frame (ORF) of pir-b gene from the mRNA of mouse was cloned, then inserted into a sequencing vector. The pir-b gene was subcloned into the transfer plasmid of the lentivirus system, which was transfected together with the packaging plasmids into 293T cells by Lipofectin 2000, thereafter, the supernatant was collected and concentrated to transfect 293T cells. Western blot was used to detect the expression of the exogenous PIR-B after 293T cells were infected by the virus, while the lentivirus harboring egfp gene was packaged as the control group. The result indicated that the ORF of the pir-b gene was successfully cloned, the sequence of which was consistent to that was expected and the PIR-B protein could be expressed in 293T cells normally. It is concluded that the lentiviral vector containing pir-b gene was constructed successfully, which would contribute to illustrating the important role of pir-b gene in the immunological regulation.
