Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
With the widespread promotion and application of the Enhanced Recovery After Surgery (ERAS) concept in the surgical fields, the implementation of the ERAS concept in the treatment of lower extremity deep venous thrombosis (DVT) was explored in the vascular surgery. The “Six-Step” comprehensive treatment protocol and the establishment of the ERAS system for lower extremity DVT developed by the Department of Vascular Surgery at the First Affiliated Hospital of Chongqing Medical University were elaborated. The protocol includes steps such as filter placement, thrombus clearance, relief of venous outflow obstruction, dissolution of residual thrombus, filter retrieval, and standardized post-discharge anticoagulation management, along with their respective advantages. Additionally, the training and dissemination efforts undertaken to promote the “Six-Step” comprehensive treatment protocol were described. A comparison was made between ERAS and traditional recovery surgery, highlighting the comprehensive clinical benefits of the former. The aim is to promote the standardized implementation of the ERAS system in lower extremity DVT treatment and to bring greater benefits to patients.
The master protocol platform trial is a trial in which multiple treatments or different combinations of treatments are consistently evaluated in the context of a single disease, possibly within several sub-studies for different disease subtypes, allowing multiple treatments to enter or exit the trial platform based on a certain decision algorithm. Compared with the traditional clinical trial design, the master protocol platform trial as a scientific innovative model of clinical trial can accelerate drug evaluation to deal with the contradiction between the awaited evaluation of numerous drugs and lack of effective therapy for diseases. By using the large-scale randomized controlled clinical trial for COVID-19 inpatients (RECOVERY) led by the University of Oxford in the UK in 2020 as an illustration, this paper introduced the concept, design principle, and basic trial process of the master protocol platform trial to provide methodological references for clinical research of drugs.
目的 比较草酸铂联合氟尿嘧啶/亚叶酸钙 （FOLFOX4）与草酸铂联合卡培他滨（XELOX）治疗晚期结直肠癌的临床疗效。 方法 将2007年1月－2011年12月收治的58例转移或复发晚期结直肠癌患者按照化学疗法（化疗）方案的不同分为两组，其中FOLFOX4组28例（男性患者占57.1%，平均年龄56.3岁），XELOX组30例（男性患者占63.3%，平均年龄57.8岁）。所有患者疗程不少于2个化疗周期，评价指标为病情缓解率和化疗药物的毒副作用。 结果 FOLFOX4组完全缓解率（CR）和部分缓解率（PR）分别为10.7%（3/28）和32.1%（9/28），总有效率为42.8%（12/28）；XELOX组CR和PR率分别为13.3%（4/30）和30.0%（9/30），总有效率为43.3%（13/30），两组总有效率差异无统计学意义（P=0.971）。XELOX组有10.0%（3/30）和16.7%（5/30）的患者分别出现中性粒细胞降低和神经毒性，但均显著低于FOLFOX4组[39.3%（11/28）、43.3%（13/30）]（P=0.009，0.014）。XELOX组手足综合症发生率明显高于FOLFOX4组[40.0%（12/30）、14.5（4/28），P=0.029），但程度较轻, 主要为Ⅰ～Ⅱ度。 结论 XELOX与FOLFOX4化疗方案治疗晚期结直肠癌患者的疗效相似，但XELOX化疗方案毒副反应相对较小。
ObjectiveTo investigate effects of vitamin K2 in combination with 5-fluorouracil (5-FU) on proliferation, migration, and invasiveness of hepatocellular carcinoma cells in vitro. MethodsHuman hepatocellular carcinoma PLC/RAF/5 cells were cultured in vitro and exposed to vitamin K2 (10 μmol/L) and 5-FU (10 μg/mL) alone or in combination for 24 h. The cell proliferation, migration, and invasiveness were measured by CCK-8 assay, wound-scratch assay, and Matrigel invasion chamber assay, respectively. ResultsThe abilities of proliferation, migration, and invasion of PLC/RAF/5 cells were significantly decreased after either alone vitamin K2 or 5-FU treatment (all P<0.05) as compared with the control cells, and above effects were further enhanced by the vitamin K2 in combination with 5-FU treatment as compared with either alone drug treatment (all P<0.05). ConclusionCombination use of vitamin K2 and 5-FU might be an effective method for inhibiting growth, migration, and invasiveness of hepatocellular carcinoma cells.
ObjectiveTo evaluate the efficacy and toxicity of TEC and CEF regimen in preoperative chemotherapy for patients with breast cancer. MethodsA total of one hundred breast cancer patients undergoing preoperative chemotherapy were divided into TEC group (n=50) and CEF group (n=50) by the pairgroup method and received surgical therapy after three courses of chemotherapy. The efficacy and toxicity of preoperative chemotherapy of patients in two groups were analyzed. ResultsFour patients with stage ⅢB breast cancer quit from CEF group after two courses of treatment because of the worse satisfaction. Clinical complete remission (cCR) was 7 cases, clinic partial remission (cPR) was 34 cases, stable disease (SD) was 9 cases, therefore, the remission rate (RR) was 82.0% (41/50), and reduction rate of tumor was 64.0% (32/50) in TEC group. cCR was 2 cases, cPR was 32 cases, SD was 12 cases, thus the RR was 680% (34/50), and reduction rate of tumor was 40.0% (20/50) in CEF group. The clinical efficacy and reduction rate of tumor of patients in TEC group were significantly superior than those in CEF group (Plt;0.05). The negative conversion ratio of lymph nodes were 54.1% (20/37) and 57.1% (20/35) in TEC group and CEF group, which was not statistically different (Plt;0.05). The occurrence of hair loss and leukopenia of patients in TEC group were significantly higher than those in CEF group (Plt;0.05), while the differences in thrombocytopenia, low concentration of hemoglobin, nausea, vomiting, diarrhea, cardiac toxicity, and neurotoxicity were not significant (Pgt;0.05). ConclusionTEC regimen is better than CEF regimen in the efficacy and safety of neo-adjuant therapy for patients with breast cancer, and well tolerated.
Objective To construct an intervention program for postoperative fear of falling in elderly patients with hip fracture based on cognitive behavioral theory. Methods Based on cognitive behavioral theory and literature review, an initial draft of intervention plan for postoperative fear of falling in elderly patients with hip fracture was constructed. From January to March 2025, after two rounds of expert consultations and revisions, the final plan was formed. Results A total of 16 experts across the country were invited to participate in two rounds of Delphi expert consultations, covering areas such as orthopedic clinical nursing, orthopedic clinical medicine, nursing education, nursing management, rehabilitation therapy, and psychological therapy. The active participation rates for the two rounds of consultations were 94.12% and 100.00%, respectively. The expert authority coefficients were 0.860 and 0.907, respectively, and the Kendall harmony coefficients were 0.369 and 0.524, respectively. Ultimately, a program composed of 5 primary indicators (fall fear management team, fall fear management goals, fall fear assessment, fall fear intervention measures, and post-intervention effect evaluation), 17 secondary indicators, and 31 tertiary indicators was constructed. Conclusion The intervention program for postoperative fear of falling in elderly patients with hip fracture based on cognitive behavior theory constructed in this study is scientific and operable, which can provide reference and guidance for clinical nursing staff.