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.
Virtual clinical trials are clinical trials conducted through computer simulation technology, which breaks through the limitations of traditional clinical trials and has the advantages of saving time, reducing costs, and reducing the risk of human trials. With the application of new computer technologies such as population pharmacokinetics, physiologically-based pharmacokinetics, quantitative systems pharmacology, and artificial intelligence, the field of virtual clinical trials in healthcare has become an important development direction. This article will give a preliminary review of the connotation, methods and future development trends of virtual clinical trials, aiming to provide reference for the application of new technologies and methods in clinical trials.
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 assess the safety and effect of different intravenous chemotherapic regimens in patients with gastric carcinomas who had received gastrectomy. Method A systematic review of all the relevant randomized controlled trials (RCTs) was performed. RCTs were identified from Medline and Embase (1980-2001.4), Chinese Bio-medicine Database (1990-2001.1). Literature references were checked at the same time. We included randomized andquasi-randomized trials in patients with confirmed gastric carcinomas who had received gastrectomy comparing the effect of intravenous chemotherapy after gastrectomy with that of gastrectomy alone.Results Twenty trials involving 4 171 patients were included. Meta-analysis was done with fixed effects model. Heterogeneity analyses was performed also. The effects of intravenous chemotherapy with 5FU + MCCNU, 5FU + MMC, 5FU + BCNU or FAM after gastrectomy were failed to show have better effects than that of surgery alone. There were eleven trials which detailed the side effects according to the toxicity grade by WHO standard. The side effects halting treatment were haematologic and biochemical toxicity, debilitating nausea and vomiting. There were twenty-two patients died of chemotherapic toxicity. Conclusions Based on the review, there is no enough evidence to show that intravenous chemotherapy after gastrectomy have positive treatment effect on gastric cancer.
目的 為避免選擇和發表偏倚,系統評價者應采用多種查詢技術,并盡力獲得未發表的研究.本文試圖探討,英特網檢索對鑒定未發表和正在進行的臨床試驗是否有用.研究設計 利用七個Cochrane系統評價的查詢策略回顧性地在英特網上檢索未納入的隨機對照試驗.方法 檢索策略 以普通檢索式"研究方法學 NEAR干預措施NERA 條件"、用AltaVista在英特網上搜索.測量指標包括搜索時間、英特網搜索已發表研究的回溯率、精確度(已發表和未發表的隨機臨床試驗鏈接的網頁比例)、英特網檢索到的未納入的未發表和正在進行的研究數.結果 用21小時查詢了429個網頁,找到14個鏈接到未發表的、正在進行的或最近完成的試驗,至少有9個與4篇系統評價相關.英特網檢索已發表研究文獻的回溯率在0～43.6%,其鏈接已發表和未發表研究的精確度在0～20.2%.結論 未發表尤其是正在進行的試驗的信息可在英特網上找到.潛在的問題是如何評價未經同行評審的電子出版物的質量.急需更強的搜索工具.建議用"Open Trial Initiative"定義英特網發表試驗的語法,以加強試驗登記的共同操作性.因此,專門的搜索引擎可找到更多有關正在進行和已完成的臨床試驗信息.
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 assess the efficacy and safety of Chinese medicinal herbs for asymptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. Data Selection Randomized clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatment, or interferon treatment for asymptomatic HBV carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Results Three randomized clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40 (95 % CI 1.01 to 5.72) for clearance of serum HBsAg, and 2.54 (1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomized clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. No serious adverse event was observed. Conclusions There is insufficient evidence for treatment of asymptomatic HBVcarriers using Chinese medicinal herbs due to the low quality of the trials. Further randomized, double blind, placebo-controlled trials are needed.
Since the outbreak of the coronavirus disease (COVID-19), more than 200 interventional clinical trials have been registered in Chinese Clinical Trial Registry (www.chictr.org.cn) and the US Clinical Trials Registry (www.clinicaltrials.gov), testing or going to test treatments of COVID-19 in China from January 23rd, 2020 to March 5th, 2020. This situation has drawn attentions from various sectors of society. This article summarizes the basic design features of 249 registered COVID-19 clinical trials in China, compares them with National Clinical Trials Network practices in the USA, and describes a concept of national clinical trials network as a strategy to enhance quality and efficiency of clinical research in cases like COVID-19 outbreak as well as other disease fields.
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.
Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials.