Risk Prediction of Major Adverse Cardiovascular Events Occurrence Within 6 Months After Coronary Revascularization: Machine Learning Study.

BACKGROUND: As a major health hazard, the incidence of coronary heart disease has been increasing year by year. Although coronary revascularization, mainly percutaneous coronary intervention, has played an important role in the treatment of coronary heart disease, major adverse cardiovascular events (MACE) such as recurrent or persistent angina pectoris after coronary revascularization remain a very difficult problem in clinical practice. OBJECTIVE: Given the high probability of MACE after coronary revascularization, the aim of this study was to develop and validate a predictive model for MACE occurrence within 6 months based on machine learning algorithms. METHODS: A retrospective study was performed including 1004 patients who had undergone coronary revascularization at The People's Hospital of Liaoning Province and Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from June 2019 to December 2020. According to the characteristics of available data, an oversampling strategy was adopted for initial preprocessing. We then employed six machine learning algorithms, including decision tree, random forest, logistic regression, naïve Bayes, support vector machine, and extreme gradient boosting (XGBoost), to develop prediction models for MACE depending on clinical information and 6-month follow-up information. Among all samples, 70% were randomly selected for training and the remaining 30% were used for model validation. Model performance was assessed based on accuracy, precision, recall, F1-score, confusion matrix, area under the receiver operating characteristic (ROC) curve (AUC), and visualization of the ROC curve. RESULTS: Univariate analysis showed that 21 patient characteristic variables were statistically significant (P<.05) between the groups without and with MACE. Coupled with these significant factors, among the six machine learning algorithms, XGBoost stood out with an accuracy of 0.7788, precision of 0.8058, recall of 0.7345, F1-score of 0.7685, and AUC of 0.8599. Further exploration of the models to identify factors affecting the occurrence of MACE revealed that use of anticoagulant drugs and course of the disease consistently ranked in the top two predictive factors in three developed models. CONCLUSIONS: The machine learning risk models constructed in this study can achieve acceptable performance of MACE prediction, with XGBoost performing the best, providing a valuable reference for pointed intervention and clinical decision-making in MACE prevention.

Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial.

BACKGROUND: Fire needle therapy is a characteristic treatment in traditional Chinese medicine (TCM). An increasing number of studies have indicated that fire needle treatment for psoriasis provides satisfactory results with few side effects and a low recurrence rate. We herein describe the protocol for a multicenter, randomized, single-blind, placebo-controlled trial that will provide high-quality evidence on the efficacy and safety of fire needle therapy for plaque psoriasis. METHODS: Ninety-two patients with blood stasis syndrome (BSS) of plaque psoriasis will be enrolled and randomly assigned to receive fire needle therapy (intervention group) or fire needle control therapy (control group) once a week for 4 weeks. The Psoriasis Area and Severity Index (PASI) score will serve as the major efficacy index, while the body surface area (BSA), Physician Global Assessment (PGA) score, Dermatology Life Quality Index (DLQI) score, patient-reported quality of life (PRQoL), visual analog scale (VAS) score for itching, TCM symptom score, and relapse rate will be assessed as secondary outcomes. The PASI score, BSA, PGA score, and VAS score for itching will be evaluated at baseline and during the 4-week treatment and follow-up periods. DLQI score, PRQoL, and TCM symptom score will be assessed at baseline and during the treatment period. Recurrence will be evaluated during the follow-up period. Safety assessments include vital sign monitoring, routine blood tests, blood biochemistry, routine urine tests, pregnancy tests, physical examinations, and adverse-event recording. SAS software will be used for data analysis. The data network platform will be designed by the data management center of Nanjing Ningqi Medical Technology Co., Ltd. DISCUSSION: It is believed that fire needle therapy can activate the meridians, promote blood circulation, and regulate skin immunity. BSS of plaque psoriasis is related to not only immune dysfunction but also poor or stagnant blood flow. We anticipate that the results of the trial described in this protocol will provide strong evidence for the safety and efficacy of fire needle therapy for BSS of plaque psoriasis. TRIAL REGISTRATION: Clinicaltrials.gov NCT03953885 . Registered on May 15, 2019. Name: Fire Needle Therapy on Plaque Psoriasis with Blood Stasis Syndrome.

Study on efficacy and safety of Huangqi Guizhi Wuwu decoction treatment for oxaliplatin induced peripheral neurotoxicity: A protocol for a randomized, controlled, double-blind, multicenter trial.

BACKGROUND: Oxaliplatin can cause severe peripheral neurotoxicity, which is an important reason for clinical oxaliplatin reduction and cessation of treatment. Oxaliplatin induced peripheral neurotoxicity (OIPN) can cause paresthesia and dysesthesia, even affect the quality life of patients. So far, there are no recognized and effective measures to prevent OIPN. Huangqi Guizhi Wuwu decoction is a classical prescription of ancient Chinese medicine recorded in "the synopsis of the Golden Chamber," which can be used in the treatment of various neurotoxicity. However, there is a lack of large-scale and high-quality clinical studies on the prevention of OIPN by Huangqi Guizhi Wuwu decoction. The purpose of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction on preventing OIPN. METHODS/DESIGN: This study is a randomized, controlled, double-blind, and multicenter clinical trial. Three hundred sixty patients will be randomly assigned into Huangqi Guizhi Wuwu decoction group and Huangqi Guizhi Wuwu decoction mimetic agent group. Patients will receive chemotherapy with FOLFOX of 8 cycles of 3 weeks with Traditional Chinese Medicine (TCM) for 6 months and 1-year follow-up. The primary outcome measure is the differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment. The secondary outcome measure is the improvement in other symptoms associated with chemotherapy. Four methods will be used to evaluate the efficacy of neurotoxicity, including oxaliplatin specific toxicity grading standard (Levi classification); CTCAE4.02 version; EORTC QLQ-CIPN20 scale, EORTC QLQ C30 scale, and EORTC QLQ-CR29 scale are used at the same time; Electromyography. DISCUSSION: This study will provide objective evidences to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction on preventing OIPN. TRIAL REGISTRATION: Clinical Trials.gov (Identifier: NCT04261920).

Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial.

Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with NCT03961230.

Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine.

BACKGROUND: Plaque psoriasis is a refractory inflammatory skin disease. The common therapies used to treat plaque psoriasis in traditional Chinese medicine (TCM) and western medicine (WM) have distinct characteristics and advantages. Although a combination of TCM and WM therapies, adjusted to the clinical situation, is widely used, there are no systematic studies on the hierarchical selection of this treatment combination based on the severity of skin lesions. We therefore designed a randomized clinical trial to focus on the sequence of internal and external treatments of TCM in patients with mild-to-moderate plaque psoriasis and to optimize the integration of Chinese and western medicine for the treatment of patients with severe plaque psoriasis, thereby achieving high-level clinical evidence and establish treatment norms for the integrated use of Chinese and western medicines. METHODS: In this proposed multicenter, single-blinded, randomized controlled trial, 108 patients with mild-to-moderate plaque psoriasis will be randomly assigned to two groups in a 1:1 ratio to receive either internal or external TCM treatment, and 270 patients with severe plaque psoriasis will be randomly assigned to three groups in a 1:1:1 ratio to receive treatment with TCM or WM, or TCM + WM. All enrolled patients will receive 8 weeks of treatment. Follow-up assessments will be done 8 weeks after the treatment. The primary outcome of this study is the evaluation of efficacy and relapse rate, based on the Psoriasis Area and Severity Index, and the secondary outcome measures include determination of the affected body surface area, physician's global assessment, pruritus scores (determined using a visual analog scale), TCM symptom score, Dermatology Life Quality Index, patient-reported quality of life score and incidence of serious adverse events. DISCUSSION: This study will provide high-level clinical evidence for internal and external TCM treatment optimization and will contribute to establishing norms for the integration of Chinese and western Medicines. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03941431. Registered on 8 May 2019.

Effects of moving cupping therapy for plaque psoriasis: study protocol for a randomized multicenter clinical trial.

BACKGROUND: It is difficult to achieve a balance among safety, efficacy, and cost for the clinical treatment of plaque psoriasis. The current treatment of psoriasis often involves comprehensive therapy such as topical plasters, internal medicine, and phototherapy, which are expensive, and some of the drugs have serious side effects. Moving cupping is a type of cupping that has been used clinically for thousands of years in China. It has the advantage of being inexpensive and easy to perform. Therefore, it is widely used in public hospitals in China for psoriasis treatment. However, a comprehensive evaluation of the current clinical evidence of its efficacy is lacking. In this study, we aimed to evaluate the efficacy and safety of moving cupping to treat plaque psoriasis. METHODS: A multicenter, two-arm parallel group, single-blind, randomized, controlled trial will be conducted at six hospitals in China between August 1, 2019 and December 31, 2021. A total of 122 adult patients (aged 18-65 years) who meet the inclusion criteria are being recruited. Participants will receive either basic treatment combined with moving cupping therapy or basic treatment combined with moving cupping placebo. The treatment cycle will be 4 weeks, and the efficacy of treatment will be assessed weekly by the Psoriasis Area and Severity Index during the treatment period and follow-up visits at weeks 6 and 8. The body surface area, physician's global assessment, Dermatology Life Quality Index, patient-reported quality of life, visual analog scale, Traditional Chinese Medication syndrome scoring scale, combined medication, and adverse events will also be recorded and compared to the relative baseline values. DISCUSSION: The findings of this trial may lead to better decisions regarding the treatment of plaque psoriasis. If the trial outcomes are considered favorable, this ancient Chinese medical therapy may be worthy of widespread use because of its convenience and low cost. TRIAL REGISTRATION: This study was registered on May 15,2019 at ClinicalTrials.gov with the identifier number NCT03952676.

Oral Taodan granules for mild-to-moderate psoriasis vulgaris: protocol for a randomized, double-blind, multicenter clinical trial.

BACKGROUND: Psoriasis is a common chronic inflammatory skin disease with high recurrence rates and increasing incidence. Patients require long-term medication to reduce symptoms and prevent disease progression. Therefore, the development of treatments with high efficiency and low rate of adverse events is of utmost importance. Traditional Chinese medicine (TCM) plays an outstanding role in reducing disease symptoms and improving quality of life. The aim of this trial is to clarify the treatment efficacy, safety, and control of disease recurrence in patients with psoriasis with blood-stasis syndrome treated with Taodan granules (TDKL). METHODS: This trial is a five-center, randomized, double-blind, placebo-controlled study planned to transpire between September 1, 2019, and December 31, 2021. A sample size of 216 participants (108 per group) with mild-to-moderate psoriasis will be randomly assigned to receive TDKL or placebo twice per day, 7 days per week, for 8 weeks. The study duration will be 17 weeks, including a 1-week screening period, 8 weeks of intervention, and another 8 weeks of follow-up. The primary outcomes are improvement in the Psoriasis Area and Severity Index score and recurrence rate after 8 weeks of treatment. Secondary outcomes include body surface area affected and the scores for the Physician Global Assessment, Dermatology Life Quality Index, pain-related quality of life, pain on the visual analogue scale, and TCM syndromes. The number, nature, and severity of adverse events will be carefully recorded. DISCUSSION: The study results will help clarify the safety and efficacy of TDKL as treatment for psoriasis with respect to both disease regression and recurrence rate. We expect that this study will provide high-quality evidence with important public health implications that may alter the approach to psoriasis management in China. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov (ID: NCT03942198).