Objective To summarize the research progress of stem cell transplantation in treating spinal cord injury (SCI) at different stages based on the pathophysiological mechanism of SCI. Methods The relevant research literature at home and abroad was extensively reviewed to explore the impact of transplantation timing on the effectiveness of stem cell transplantation in treating SCI. Results Researchers performed different types of stem cell transplantation for subjects at different stages of SCI through different transplantation approaches. Clinical trials have proved the safety and feasibility of stem cell transplantation at acute, subacute, and chronic stages, which can alleviate inflammation at the injured site and restore the function of the damaged nerve cells. But the reliable clinical trials comparing the effectiveness of stem cell transplantation at different stages of SCI are still lacking. Conclusion Stem cell transplantation has a good prospect in treating SCI. In the future, the multi-center, large sample randomized controlled clinical trials are needed, with a focus on the long-term effectiveness of stem cell transplantation.
Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.
Heart failure affects quality of life and life expectancy of tens of millions of individuals. There are no available economic and effective treatments for end-stage heart failure. Hydrogels are novel tissue engineering materials, which have the potential to ameliorate myocardium remodeling, increase cardiac output, improve quality of life and prolong life span by implantation into myocardium. The preclinical experiments and clinical trials have greatly explored the function of hydrogels in heart failure. In this review, we summarized the approaches of implantation, mechanism and clinical outcomes of the hydrogels.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Objective To explore the feasibility of breast cancer patients in China with 1–2 positive sentinel lymph nodes (SLN) to avoid axillary lymph node dissection (ALND). Methods A total of 328 patients who received sentinel lymph node biopsy (SLNB) in our hospital from 2010 to 2016 were collected retrospectively, and patients met the criteria of Z0011 clinical trials (which required no acceptance of neoadjuvant therapy, clinical tumor size was in T1/T2 stage, two or less positive SLNs were detected, received breast-conservation surgery, acceptance of whole breast radiotherapy after surgery and neoadjuvant systemic treatment) were enrolled to breast-conservation group. Patients met the criteria of Z0011 clinical trials, excepting the surgery (received non-breast-conservation surgery), were enrolled to non- breast-conservation group. Comparison of clinicopathological features between the breast-conservation group/non-breast-conservation group and the Z0011 ALND group was performed. Results Among the 328 patients, only 29 patients (8.8%) completely correspond with the results of Z0011 clinical trials. There was no statistical significance between the breast-conservation group and the Z0011 ALND group in the age, clinical T stage, expression of estrogen (ER), expression of progesterone (PR), pathological type, histological grade, number of positive lymph nodes, and incidence of non-sentinel node metastasis (P>0.05). A total of 81 patients were included in the non-breast-conservation group. It showed no statistical significance between the non-breast-conservation group and the Z0011 ALND group in expressions of ER and PR, and histological grade (P>0.05), while there was statistically significant difference in age, clinical T stage, pathological type,number of positive lymph nodes, and incidence of non-sentinel node metastasis (P<0.05). Patients in the non-breast-conservation group showed a lower age, higher percentage of lobular carcinoma and T2 stage, more positive lymph nodes, and high incidence of non-sentinel node metastasis. Conclusion It’s feasible for Z0011 clinical trials results to be used in the clinical practice of our country, but the actual situation of breast conservation in our country may lead to low adaptive population.
Objective To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A randomized, single-blind, controlled clinical trial was performed. The positive control was imported cefepime. The dosages of cefepime were 1g for moderate infection and 2g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days. Results Thirty-one patients were enrolled in the trial, of whom 30 were evaluable (15 in the triagroup and 15 in the control group). No significant differences were observed between the trial group and the control group with respect to the cure rate (40% vs. 27%), the effective rate (80% vs. 87%), the bacterial clearance rate (92% vs. 100%), and the incidence of adverse drug reactions (12.5% vs. 13%) (Pgt;0.05). Conclusion Domestic cefepime injection is effective and safe in the treatment of acute bacterial lower respiratory tract infection.
Objective To review the current progress of clinical and experimental research of vascularized lymph node transfer for lymphedema. Methods The domestic and abroad literature about vascularized lymph node transfer in treatment of lymphedema was reviewed and analyzed. Results Experimental studies in animal model indicate that vascularized lymph node transfer can improve lymph node survival and show a promising effectiveness in reducing lymphedema. " Lymphatic wick” and " lymph pump” were the two main hypotheses proposed to explain the potential functional mechanism of vascularized lymph node transfer in treatment of lymphedema. Improvement in lymphedema symptoms are reported in most of the clinical trials, but the level of evidence to advocate this procedure in the treatment of lymphedema remains low because of the small number of the cases and problems in their methodologies. Conclusion Based on current evidence, vascularized lymph node transfer seems to be a promising treatment for lymphedema, but long-term well-designed studies are required to further explore the effectiveness of this procedure.
Objective To determine the effects recombinant human growth hormone (GH) and hypocaloric nutrition on postoperative convalescence, we performed a placebo-controlled randomized double-blind trial in 18 patients after elective gastrectomy or colectomy. Methods The subjects received parenteral nutrition containing 20 calories/kg per day and 1 g protein/kg per day. Daily injections of drug or placebo were given during the first postoperative week. Result The nine control subjects lost 3.3 kg (5.9% of preoperative weight) and had a cumulative nitrogen loss of 32.6 ± 4.2 g nitrogen at eight days. The patients receiving GH lost significantly less weight (1.3 kg) and nitrogen loss was 7.3 ± 3.1 g at eight days (Plt;0.001). Kinetic studies demonstrated that anabolic effects of GH were associated with increased protein synthesis, and amino acid flus studies across the forearm revealed increased uptake of amino acid nitrogen in the GH-treated patients. Body composition analysis revealed that the patients receiving GH maintained their lean body mass despite the major surgical procedure. Conclusion We conclude that the postoperative catabolic response can be modified with GH and hypocaloric nutrition. The metabolic and physiologic effects should now be studied in a larger number of patients to determine if this approach can reduce morbidity, mortality, and length of hospital stay for surgical patients.
Artificial intelligence (AI) for science (AI4S) technology, the AI technology for scientific research, has shown tremendous potential and influence in the field of healthcare, redefining the research paradigm of medical science under the guidance of computational medicine. We reviewed the main technological trends of AI4S in reshaping healthcare paradigm: knowledge-driven AI, leveraging extensive literature mining and data integration, emerges an important tool for understanding disease mechanisms and facilitating novel drug development; data-driven AI, delving into clinical and human-related omics data, unveils individual variances and disease mechanisms, and further establishes patient-centric digital twins to guide drug development and personalized medicine. Meanwhile, based on authentic patient digital twin models, adaptable strategies are employed to further propel the development of "e-drugs" that mimic the authentic mechanisms. These digital twins of drugs are evaluated for drug efficacy and safety through large-scale cloud-based virtual clinical trials, and followed by rationally designed real-world clinical trials, thus notably reducing drug development costs and enhancing success rates. Despite encountering challenges such as data scale, quality control, model interpretability, the transition from science insights to engineering solutions, and regulatory hurdles, we anticipate the integration of AI4S technology to revolutionize drug development and clinical practices. This transformation brings revolutionary changes to the medical field, offering novel opportunities and challenges for the development of medical science, and more importantly, providing necessary but personalized healthcare solutions for humankind.
Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.