Application of Circulating Tumor DNA in Precision Diagnosis and Treatment of Colorectal Cancer / 肿瘤防治研究

Colorectal cancer (CRC) is one of the most common malignant tumors recorded worldwide. This condition has high morbidity and mortality and seriously endangers people's health. Traditional diagnostic models fail to meet people's current needs for real-time monitoring of tumors. Compared with traditional detection methods, ctDNA detection is not only noninvasive but can also attain real-time detection of comprehensive genomic information of tumors. The advancement of detection technology has gradually highlighted the potential of ctDNA detection in the clinical treatment of CRC. This article reviews the advancements on the clinical application of ctDNA in early screening, minimal residual disease detection, and guidance on individualized treatment of CRC patients.

Pathologic assessment of esophageal cancer following neoadjuvant therapy / 中国胸心血管外科临床杂志

@#China is a country with a high incidence of esophageal cancer. Most patients are already in the locally advanced stage when first diagnosed. Preoperative neoadjuvant therapy followed by surgery has become the standard treatment mode for them. Closely related to prognosis, the evaluation of tumor response is essential. Response evaluation criteria in solid tumors is the gold standard to evaluate tumor response, but the lesions must meet the measurement standards. Tumor regression grading (TRG) systems are designed to classify regressive changes after neoadjuvant treatment based on histopathological results to reveal prognostic information. Concentrating on pathologic assessment of esophageal cancer following neoadjuvant therapy, this article reviews histopathological changes, commonly used TRG systems and current debate.

Medication Analysis of Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Allergic Rhinitis Based on Clinical Efficacy Evaluation / 中国实验方剂学杂志

ObjectiveTo explore the role of efficacy evaluation methods in providing evidence for traditional Chinese medicine （TCM） clinical practice guidelines based on a demonstration study of clinical efficacy evaluation of TCM for allergic rhinitis （AR），aiming to enrich the sources of evidence for guideline development. MethodReal-world data of TCM medication for AR were collected and efficacy evaluation was carried out. SPSS 16.0 software was used to calculate the conformity of clinical syndromes，main prescriptions， and medications to the guidelines. Correlation analysis of efficacy and medications was performed according to guideline conformity to compare the differences in medications between real-world clinical applications and current guidelines. ResultA total of 198 cases were collected and the clinical medications were compared with the relevant guidelines for AR. It was found that the clinical syndrome conformity was above 70%，and in addition to the guideline syndrome，there were also syndromes in six meridians and other mixed syndromes in clinical practice. The guideline conformity of the main prescriptions used in clinical practice showed a positive correlation trend with efficacy. There were some differences between the commonly used drugs in clinical practice and those recommended by the guidelines. For example，for lung Qi deficiency and cold syndrome，drugs such as Angelicae Dahuricae Radix， Magnoliae Flos， and Schisandrae Chinensis Fructus were often used. For kidney Yang deficiency syndrome，drugs such as Atractylodis Macrocephalae Rhizoma and Ostreae Concha were often used. For spleen Qi deficiency and weakness syndrome，drugs such as Poria， Cinnamomi Ramulus， and Magnoliae Flos were used. For lung Qi deficiency and cold syndrome in children，drugs such as Chebulae Fructus， Cicadae Periostracum， Zingiberis Rhizoma， and Ginseng Radix et Rhizoma were used. For lung and spleen Qi deficiency syndrome，drugs such as Dioscoreae Rhizoma， Menthae Haplocalycis Herba， Amomi Fructus， and Zingiberis Rhizoma were used. There were also some differences in the commonly used drugs for adults and children. For example，for lung Qi deficiency and cold syndrome，adults often used Angelicae Dahuricae Radix， Magnoliae Flos， and Tribuli Fructus，while children often used Ginseng Radix et Rhizoma， Paeoniae Radix Alba， and Poria. For lung meridian hidden heat syndrome， adults often used Bupleuri Radix， Asari Radix et Rhizoma， Pinelliae Rhizoma， and Xanthii Fructus， while children often used Houttuyniae Herba， Menthae Haplocalycis Herba， Citri Reticulatae Pericarpium， and Massa Medicata Fermentata. ConclusionEffective medication regimens can be screened out based on efficacy evaluation methods，which can help supplement immediate， objective， and clinically relevant evidence of medication for the development of clinical practice guidelines in TCM from the perspective of clinical effectiveness.

Exploration and consideration on establishing a core outcome set of Traditional Chinese Medicine clinical trials in distal radius fracture / 中国骨伤

There are inconsistencies in treatment outcomes, measurement instruments, and criteria for assessing clinical effectiveness in studies related to distal radius fractures (DRF), resulting in potential biases and failing to provide high-quality clinical evidence. To address these challenges, international researchers have reached a consensus on developing the core outcome indicator set for distal radius fractures(COS-DRF). However, it's important to note that the existing COS-DRF framework could not reflect the unique characteristics of Traditional Chinese Medicine (TCM) treatment. Currently, there are no established standards for treatment outcomes and measurement instruments specific to TCM clinical research, nor has a COS-DRF been established for TCM clinical studies in China. In light of these gaps, our research team aims to construct a core set of treatment outcomes for TCM clinical research on distal radius fractures. This involves compiling a comprehensive list of treatment outcomes and measurement instruments, initially derived from a thorough literature review and expert consensus, which will then undergo further refinement and updates based on real-world clinical experiences, incorporating feedback from 2 to 3 rounds of expert consensus or Delphi questionnaire surveys. Our goal is to establish a COS-DRF or CMS-DRF that aligns with the principles and practices of TCM, and provide high-quality evidence for clinical practice.

Screening of Clinical Efficacy Evaluation Indicators for Traditional Chinese Medicine Injections based on Mixed Method Research / 中医杂志

Currently， evidence on the efficacy and risk of traditional Chinese medicine （TCM） injections is seriously insufficient， and it is difficult to evaluate TCM injections comprehensively， truly and objectively using available efficacy evaluation indicators. Therefore， establishing a clinical efficacy evaluation system that can effectively reflect TCM injections is imperative. Core outcome set （COS） has played an important role in screening TCM efficacy evaluation indicators， however， there are still certain problems， such as large differences in efficacy indicators， non-standardization， and lack of featured and specific TCM indicators. Mixed method research （MMR） has the advantages of looking at problems from both quantitative and qualitative perspectives. It is thereby proposed to use COS and MMR integrated model to establish a clinical efficacy evaluation indicator system that not only fully considers the cha-racteristics of TCM injections， but also highlights the efficacy and advantages of TCM injections from the perspective of TCM intervention. Simultaneously， an indicator screening method using MMR to optimize COS research model is formulated， which can provide ideas for the research on efficacy evaluation indicators of TCM injections.

Clinical Effect of Shugan Hewei Prescription Combined with Vonoprazan on Refractory Gastroesophageal Reflux Disease Due to Qi Depression and Phlegm Obstruction / 中国实验方剂学杂志

ObjectiveTo evaluate the clinical efficacy and adverse effects of Shugan Hewei prescription combined with vonoprazan in the treatment of refractory gastroesophageal reflux disease （RGERD） due to qi depression and phlegm obstruction. MethodEighty RGERD patients who met the inclusion criteria underwent 24-hour pH impedance and high-resolution esophageal manometry and electronic gastroscopy. The 80 patients were randomly assigned to an observation group （Shugan Hewei prescription， one bag each time， twice a day + vonoprazan， 20 mg each time， once a day） and a control group （vonoprazan， 20 mg each time， once a day） by the random number table method. The treatment in both groups lasted for 4 weeks. The clinical efficacy was examined. The scores of TCM symptoms （pharyngeal discomforts such as phlegm obstruction， retrosternal discomfort， and belching）， somatic symptoms， quality of life， and improvement of esophageal mucosa under gastroscopy were observed in both groups before treatment and after treatment for 2 and 4 weeks. ResultSeventy-five patients completed the trial were included in this study， including 38 patients in the observation group and 37 patients in the control group. The total response rate in the observation group was 89.47%（34/38）， which was higher than that （62.16%，23/37） in the control group （χ2=13.014， P<0.01）. After treatment， the scores of esophageal mucous membrane， reflux disease symptoms， TCM symptoms， gastroesophageal reflux disease health-related quality of life scale （GERD-HRQL）， and somatic self-rating scale （SSS） decreased in both groups（P<0.05）. Moreover， the observation group outperformed the control group in alleviating heartburn， acid reflux， throat discomforts， midnight coughing， nausea and dry vomiting， mucousy mouth， and insomnia in the patients with GERD （P<0.05，P<0.01）. However， the two groups showed no statistically significant differences in the improvement of esophageal mucosa after treatment. ConclusionThe combination of Shugan Hewei prescription with vonoprazan was superior to vonoprazan alone in treating RGERD regarding clinical symptoms， physical signs， quality of life， and somatic symptoms， without causing obvious adverse effects.

Discussion on Development Status of Traditional Chinese Medicine Dispensing Granules and Survival Strategy of Enterprises / 中国实验方剂学杂志

As an important complementary form of decoction pieces of traditional Chinese medicine（TCM）， TCM dispensing granules has the advantages of being free of decoction， easy to take， easy to carry and easy to be dispensed， which greatly improves the capacity of emergency services of TCM and is more in line with the needs of modern society. With the end of the pilot project of TCM dispensing granules， the market has been fully liberalized， the competition has been intensified， and it is in the transition period of switching between the new standard and the old one， and there are some problems such as the shortage of varieties， the change of specifications and the difference of quality， and the production enterprises are facing new opportunities and challenges. Based on this， the authors intend to systematically sort out the policies and regulations， enterprise layout and standard formulation since the pilot of TCM dispensing granules. In view of the problems in the post-pilot stage and from the perspective of survival and development of enterprises， it is suggested that enterprises should establish a quality control system for the whole industry chain of TCM dispensing granules to reduce process costs and increase enterprise competitiveness， further increase the investment in scientific research， overcome the key technical problems of difficult varieties， actively and orderly promote the research of national standards， in order to ensure the integrity of clinical formula varieties， and establish and improve the efficacy evaluation mechanism of TCM dispensing granules， build a consistency evaluation system between TCM dispensing granules and decoction pieces. Government departments should strengthen the guidance， fully mobilize the enthusiasm of scientific research institutions， enterprises and hospitals， and explore the establishment of "government-industry-study-research-application" mode to promote the development of TCM dispensing granule industry.

Observation on the efficacy of conbercept combined with subthreshold micropulsed laser photocoagulation in the treatment of diabetic macular edema / 中华眼底病杂志

Objective:To observe the efficacy of intravitreal injection of conbercept (IVC) combined with subthreshold micropulse laser photocoagulation (SMLP) in the treatment of diabetic macular edema (DME).Methods:A randomized controlled trial. From December 2020 to January 2022, 100 patients (100 eyes) with DME diagnosed by examination in Shanxi Aier Eye Hospital were included in the study. The patients were randomly divided into IVC group (50 eyes) and IVC+SMLP group (50 eyes). All the eyes were treated with IVC once a month for 3 times, and the eyes in IVC+SMLP group were treated with SMLP within 2 weeks after IVC. All affected eyes were examined by best corrected visual acuity (BCVA), which was statistically converted to logarithm of the minimum angle of resolution (logMAR) visual acuity. The central macular thickness (CMT) was measured by optical coherence tomography. Before the treatment, the logMAR BCVA of patients in IVC group and IVC+SMLP group were 0.56±0.04 and 0.55±0.03, respectively. The CMT were (437.36±11.35) μm and (434.58±10.88) μm, respectively. There was no significant difference in logMAR BCVA and CMT between the two groups ( t= 0.476, 1.027; P>0.05). The patients were followed up for 12 months after treatment. The times of IVC and the changes of BCVA and CMT were compared between the two groups. Independent sample t-test was used to compare the logMAR BCVA, CMT and times of IVC between groups. Results:After 12 months treatment, the logMAR BCVA of IVC group and IVC+SMLP group were (241.63±29.79) μm and (240.47±30.46) μm, respectively. Compared with those before treatment, 12 months after treatment, the BCVA of the two groups increased significantly ( t=7.014, 5.608; P<0.001), while CMT decreased significantly ( t=8.126, 6.013; P<0.001). There was no significant difference in BCVA and CMT between the two groups ( t=0.835, 0.764; P>0.05). The number of IVC in IVC group and IVC+SMLP group were (8.15±2.04) times and (5.91±1.80) times, respectively, and the difference was statistically significant ( t=5.210, P<0.001). Conclusions:Both IVC+SMLP and IVC alone can effectively reduce CMT and increase BCVA in patients with DME. Combination therapy can reduce the number of IVC.

Quantitative characterization of cell physiological state based on dynamical cell mechanics for drug efficacy indication / 药物分析学报

Cell mechanics is essential to cell development and function,and its dynamics evolution reflects the physiological state of cells.Here,we investigate the dynamical mechanical properties of single cells under various drug conditions,and present two mathematical approaches to quantitatively character-izing the cell physiological state.It is demonstrated that the cellular mechanical properties upon the drug action increase over time and tend to saturate,and can be mathematically characterized by a linear time-invariant dynamical model.It is shown that the transition matrices of dynamical cell systems signifi-cantly improve the classification accuracies of the cells under different drug actions.Furthermore,it is revealed that there exists a positive linear correlation between the cytoskeleton density and the cellular mechanical properties,and the physiological state of a cell in terms of its cytoskeleton density can be predicted from its mechanical properties by a linear regression model.This study builds a relationship between the cellular mechanical properties and the cellular physiological state,adding information for evaluating drug efficacy.

Study on the efficacy evaluation criteria of randomized controlled trials of TCM in the treatment for edema / 国际中医中药杂志

Objective:To analyze the efficacy evaluation criteria of the existing TCM treatment for edema RCT research, and to provide reference for the construction of unified standards.Methods:The batabases CNKI, WanFang Data, VIP, CBM, Pubmed and Web of Science were retrieved. The randomized controlled trials for the treatment of edema of TCM research, from September 1, 1993 to July 31, 2022, were screened and included. The content of efficacy evaluation, performed statistics on evaluation standard, the curative effect evaluation indexes, as well as standard composition, usage were extracted. We analyzed the characteristics, application and problems of the existing efficacy evaluation criterion.Results:A total of 123 Chinese articles were included. The included literature involved nephrogenic edema, cardiogenic edema, idiopathic edema, apoplexy limb edema and other edema. In recent years, randomized controlled trials on the treatment of edema by TCM have mainly used four efficacy evaluation criteria. Of which the Guidelines for Clinical Research on New Chinese Medicines (Trial) in 2002 had the highest utilization rate of 29.27%. Secondly, the utilization rate of Standard for Diagnosis and Curative Effect of TCM Diseases and Syndromes was 21.14%. The rest of the criteria were used by less than 6%. While 39.02% of the literature did not use the standards or used self-designed standards. Among the composition of efficacy evaluation indices, the application rate of TCM syndrome or symptom efficacy index was the highest (91.87%), the utilization rate of the Minnesota Living with Heart Failure Questionnaire Indicators was only 4.88%; biochemical tests accounted for a large proportion of Western medical indicators, while the measurement of edema severity was rarely applied. Conclusions:At present, the evaluation criteria of edema curative effect are diversified and insufficiently popularized, which need to be further screened and improved. It is suggested to construct a TCM edema efficacy evaluation model based on the characteristics of edema syndrome, comprehensively evaluate the efficacy from multiple dimensions such as TCM syndromes, western medicine indicators, and quality of life, and improve the scientific indicators.

Ideas and Methods of Establishing an Efficacy Evaluation System for Heart Failure：Combining Syndrome in Traditional Chinese and Disease Western Medicine，based on Doctors-patients Shared Reported Outcomes and Using 1+N Model / 中医杂志

Establishing an efficacy evaluation system that conforms to the laws of traditional Chinese medicine （TCM） is one of the keys in the development of TCM. With certain progress in recent years， however， the clinical efficacy evaluation systems or consensus that has been formed are not widely adopted. The main reason is the lack of objectification and standardization of efficacy evaluation， and additionally fixed efficacy evaluation system cannot meet the needs of different clinical research purposes. This paper initially analyzed the development status of clinical efficacy evaluation of heart failure （HF）， and then discussed the specific methods， advantages and difficulties in constructing a TCM clinical efficacy evaluation system for HF using the 1+N model， guided by the idea of combining traditional Chinese and western medicine， disease and syndrome， and based on the shared reported clinical outcomes by doctors and patients. Establishing an efficacy evaluation system that combines disease and syndrome can build a bridge to connect TCM with western medicine； the shared reported clinical outcomes by doctors and patients can reflect the people-centered concept and holism concept in TCM； the 1+N efficacy evaluation model can meet the general clinical research need by constructing one core outcome set （“1”）， and can match different research purposes by adding numbers of other outcomes （“N”）. One difficulty in constructing the TCM efficacy evaluation system for HF is to unify the differentiation standard for TCM syndromes of HF and the standardization to diagnose HF firstly， and then distinguish between syndrome efficacy standards and syndrome diagnostic standards. By constructing a 1+N model-based efficacy evaluation system for HF that not only conforms to the characteristics of TCM itself but also embodies the evidence-based medicine concept in western medicine， it is expected to provide ideas for evaluating clinical efficacy of TCM.

Improvement of high-quality evaluation criteria of Chinese patent medicines based on whole process control / 中国中药杂志

Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.

Multiomics and Multidimensional Testing for Efficacy Monitoring of Patients with Lymphoma / 中国实验血液学杂志

OBJECTIVE@#To explore the role of a new blood-based, multiomics and multidimensional method for evaluating the efficacy of patients with lymphoma.@*METHODS@#10 ml peripheral blood was extracted from each patient, and the genomic copy number aberrations (CNA) and fragment size (FS) were evaluated by low-depth whole genome sequencing of cfDNA, and the level of a group of plasma tumor marker (PTM) were detected at the same time. The cancer efficacy score (CES) was obtained by standardized transformation of the value of above three numerical indexes, and the changes of CES before and after treatment were compared to evaluate the patient's response to the treatment regimen.@*RESULTS@#A total of 35 patients' baseline data were collected, of which 23 cases (65.7%) had elevated CES values. 18 patients underwent the first time test. The results showed that the CES value of 9 patients with positive baseline CES decreased significantly at the first test, and the efficacy evaluation was PR, which was highly consistent with the imaging evaluation results of the same period. At the same time, the CNA variation spectrum of all patients were evaluated and it was found that 23 patients had partial amplification or deletion of chromosome fragments. The most common amplification site was 8q24.21, which contains important oncogenes such as MYC. The most common deletion sites were 1p36.32, 4q21.23, 6q21, 6q27, 14q32.33, and tumor suppressor-related genes such as PRDM1, ATG5, AIM1, FOXO3 and HACE1 were expressed in the above regions, so these deletions may be related to the occurrence and development of lymphoma.@*CONCLUSION@#With the advantages of more convenience, sensitivity and non-invasive, this multiomics and multidimensional efficacy detection method can evaluate the tumor load of patients with lymphoma at the molecular level, and make more accurate efficacy evaluation, which is expected to serve the clinic better.

Application of metabonomics in breast cancer / 药学实践杂志

Breast cancer is a kind of malignant tumor discovered lately, with a high incidence and a poor prognosis. The shortage of relevant biological biomarkers lead to the unsatisfactory treatment efficacy and the early diagnosis in breast cancer. Metabolomics is a new discipline that uses high-throughput analysis techniques to study the dynamic changes of endogenous metabolites under the influence of different pathological physiological stimulation or gene mutations, which has provided a novel way for biomarker screening and disease diagnosis and treatment. The overview of metabolomics and its applications in breast cancer early diagnosis, drug efficacy evaluation, and disease prognosis were summarized in this review.

Distribution and transfusion efficacy of unexpected antibody / 中国输血杂志

【Objective】 To investigate the clinical characteristics and antibody distribution as well as evaluate the transfusion efficacy in unexpected antibody positive patients. 【Methods】 A total of 12 235 patients from January 1, 2022 to March 31, 2023 who hospitalized in our hospital and applied for blood transfusion were selected, and those with unexpected antibody were included. The clinical data, including gender, age, diagnosis, blood type, history of transfusion and pregnancy were collected for antibody distribution analysis. Patients who received transfusion were grouped according to the DAT results and the components of red blood cells transfused, and the Hb values of each group before and after transfusion were compared. 【Results】 Among12 235 patients, 118 were positive for antibody screening, with a prevalence of 0.96%. The antibodies from Rh system were the most common (27.43%, 48/175), followed by MNS system (8.57%, 15/175) and Lewis system (6.29%, 11/175), mainly anti-E (18.29%, 32/175), anti-M (8.00%, 14/175) and anti-Lea (5.71%, 10/175). In addition, 62 transfused patients were divided into group A with suspended red blood cell transfusion and group B with washed red blood cell transfusion for positive DAT, and group C for negative DAT. Hb values (g/L) pre- and post-transfusion were 59.19±15.67 vs 77.52±15.09 in group A, 56.35±14.08 vs 74.44±15.63 in group B, 56.00±12.06 vs 75.00±4.73 in group C, respectively. The Hb values of post-transfusion for three groups were all higher than those of pre-transfusion (P<0.05). 【Conclusion】 Anti-E from Rh system is the most common antibody in patients with unexpected antibody. Appropriate red blood cells transfusion with Hb increases by an average of 6-7 g/L per 1 U of red blood cells indicating good transfusion efficacy. For positive DAT patients, transfusion of suspended red blood cell is feasible.

Clinical efficacy and optimal dose of apatinib combined with chemotherapy in patients with advanced non-small cell lung cancer / 国际肿瘤学杂志

Objective:To explore the clinical efficacy of different doses of apatinib combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) and the adverse reactions.Methods:A total of 69 patients with NSCLC diagnosed in the No. 901 Hospital of the Chinese People′s Liberation Army Joint Logistics Support Force were selected from January 2018 to June 2020, and were divided into chemotherapy alone group (docetaxel+ cisplatin was used), apatinib group A [apatinib (0.25 g)+ docetaxel+ cisplatin was used] and apatinib group B [apatinib (0.50 g)+ docetaxel+ cisplatin was used] according to random number table method, with 23 cases in each group. The objective response rate (ORR), disease control rate (DCR), median overall survival (OS), median progression-free survival (PFS), and incidences of adverse reactions were compared between the three groups of patients.Results:One patients in the apatinib group B withdrew from the study due to acute myocardial infarction. After 4 cycless of treatment, the ORR of the patients in the chemotherapy alone group, apatinib group A and apatinib group B were 17.39% (4/23), 47.83% (11/23) and 54.55% (12/22) respectively, with a statistically significant difference ( χ2=7.41, P=0.024). The ORR of the apatinib group B was higher than that of the chemotherapy alone group, with a statistically significant difference ( χ2=6.77, P=0.009). There were no statistically significant differences in ORR between the apatinib group A and chemotherapy alone group, the apatinib group A and apatinib group B ( χ2=4.85, P=0.028; χ2=0.20, P=0.652). The DCR of the patients in the three groups were 47.83% (11/23), 78.26% (18/23) and 86.36% (19/22) respectively, with a statistically significant difference ( χ2=9.03, P=0.011). The DCR of the apatinib group B was higher than that of the chemotherapy alone group, with a statistically significant difference ( χ2=7.52, P=0.006). There were no statistically significant differences in DCR between the apatinib group A and the chemotherapy alone group, the apatinib group A and apatinib group B ( χ2=4.57, P=0.033; χ2=0.51, P=0.477). The median OS of the patients in the three groups were 6.8, 9.2 and 9.9 months respectively, with a statistically significant different ( χ2=8.91, P=0.022). Compared with the chemotherapy alone group, the median OS of the apatinib group A and apatinib group B were significantly prolonged, with statistically significant differences ( χ2=7.25, P=0.036; χ2=8.60, P=0.029). Compared with the apatinib group A, the median OS of the apatinib group B was prolonged, but there was no statistically significant different ( χ2=1.54, P=0.201). The median PFS of the patients in the three groups were 5.2, 7.7 and 8.2 months respectively, with a statistically significant different ( χ2=8.79, P=0.026). Compared with the chemotherapy alone group, the median PFS of the apatinib group A and apatinib group B were significantly prolonged, with statistically significant differences ( χ2=7.01, P=0.039; χ2=8.36, P=0.031). Compared with the apatinib A group, the median PFS of the apatinib group B was prolonged, but there was no statistically significant different ( χ2=1.68, P=0.186). There were statistically significant differences in the incidences of fatigue [34.78% (8/23) vs. 65.22% (15/23) vs. 72.73% (16/22), χ2=7.50, P=0.024], hypertension [4.35% (1/23) vs. 34.78% (8/23) vs. 68.18% (15/22), χ2=20.07, P<0.001], hand-foot syndrome [4.35% (1/23) vs. 43.48% (10/23) vs. 72.73% (16/22), χ2=22.28, P<0.001] and oral mucositis [8.70% (2/23) vs. 39.13% (9/23) vs. 72.73% (16/22), χ2=19.26, P<0.001] among the three groups. Compared with the chemotherapy alone group, the incidences of hypertension and hand-foot syndrome in the apatinib group A and the incidences of fatigue, hypertension, hand-foot syndrome and oral mucositis in the apatinib group B were increased, with statistically significant differences ( χ2=6.77, P=0.009; χ2=9.68, P=0.002; χ2=6.51, P=0.011; χ2=20.00, P<0.001; χ2=22.37, P<0.001; χ2=19.21, P<0.001). Conclusion:Apatinib (0.50 g) combined with chemotherapy has better short-term efficacy than chemotherapy alone in advanced NSCLC. Apatinib (0.25 g) and apatinib (0.50 g) can prolong the survival of patients, but increasing the treatment dose can not achieve longer survival benefit.

Efficacy analysis of anlotinib combined with chemotherapy for advanced non-small cell lung cancer after failure of second-line chemotherapy / 国际肿瘤学杂志

Objective:To observe the efficacy and safety of anlotinib combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who failed second-line chemotherapy.Methods:A retrospective analysis was performed on 80 patients with advanced NSCLC who had failed second-line chemotherapy admitted in the Department of Oncology of Chaohu Hospital of Anhui Medical University from January 2017 to October 2019, and the patients were divided into control group ( n=36) and observation group ( n=44) according to the different treatment regimens. The control group was given pemetrexed + cisplatin, and the observation group adopted pemetrexed + cisplatin + anlotinib. The objective response rate (ORR), disease control rate (DCR), median progression-free survival (PFS), overall survival (OS), changes in levels of serum vascular endothelial growth factor (VEGF), carcinoembryonic antigen (CEA) and carbohydrate antigen 199 (CA199) and treatment-related adverse reactions were compared between the two groups. Results:After 2 cycles of treatment, the ORR in the control group and observation group were 5.56% (2/36) and 18.18% (8/44), with no statistically significant difference ( χ2=1.85, P=0.174). The DCR in the two groups were 58.33% (21/36) and 81.82% (36/44), and the DCR in the observation group was significantly higher than that in the control group, with a statistically significant difference ( χ2=5.33, P=0.021). The median PFS in the two groups were 4.0 months and 6.0 months, and the median PFS in the observation group was longer than that in the control group, with a statistically significant difference ( χ2=28.47, P<0.001). The median OS in the two groups were 13.0 months and 14.8 months, with no statistically significant difference ( χ2=1.56, P=0.212). The levels of serum VEGF [(21.72±5.42) ng/L vs. (36.97±7.53) ng/L, t=14.13, P<0.001; (16.61±4.14) ng/L vs. (38.85±8.61) ng/L, t=23.09, P<0.001], CEA [(4.91±1.58) ng/ml vs. (6.62±2.84) ng/ml, t=4.64, P<0.001; (3.07±1.32) ng/ml vs. (7.08±3.31) ng/ml, t=11.50, P<0.001] and CA199 [(16.83±5.23) U/ml vs. (20.95±7.94) U/ml, t=3.75, P<0.001; (13.37±5.85) U/ml vs. (21.66±8.72) U/ml, t=7.55, P<0.001] in the control group and observation group after 2 cycles of treatment were significantly decreased compared with those before treatment, and the levels of serum VEGF, CEA and CA199 in the observation group were significantly lower than those in the control group ( t=4.78, P<0.001; t=5.68, P<0.001; t=2.76, P=0.007). The incidence of elevated blood pressure in the observation group was significantly higher than that in the control group [25.00% (11/44) vs. 2.78% (1/36), χ2=7.67, P=0.006]. Conclusion:Pemetrexed + cisplatin + anlotinib regimen for patients with advanced NSCLC who failed second-line chemotherapy can improve DCR, prolong PFS and improve the levels of serum tumor-related markers, with controllable adverse reactions.

A Case Report of AFP-producing Primary Lung Squamous Cell Carcinoma with Significant Therapeutic Effect / 中国肺癌杂志

BACKGROUND@#Primary lung squamous carcinoma that produces alpha-fetoprotein (AFP) is rare and only four related cases have been reported so far. The specific reasons for elevated serum level of AFP and effective treatment regimens for AFP-producing lung squamous carcinoma are not clear. This paper reports the diagnosis and treatment of AFP-producing lung squamous carcinoma so as to provide some references for similar cases in clinical practice.@*METHODS@#The diagnosis and treatment of an AFP-producing lung squamous carcinoma patient admitted to the Shandong Cancer Hospital on October 23, 2020 was retrospectively analyzed, and literatures were reviewed.@*RESULTS@#A 52-year-old male patient was diagnosed as T4N3M0 stage, IIIc right upper lobe lung squamous cell carcinoma with mediastinal lymph node metastasis and multiple metastases in the lung. The main tumor marker was abnormally increased serum AFP. After the rapid progression of two lines chemotherapy, the patient was given anlotinib combined with carrizumab as third-line treatment. The efficacy evaluation reached to partial response (PR) and stable disease (SD) after 2 and 4 cycles of treatment, respectively. The treatment regimen was replaced with albumin paclitaxel plus carrizumab due to gastrointestinal bleeding after the fifth cycle. The patient's condition was under continuous control.@*CONCLUSIONS@#The AFP-producing lung squamous carcinoma patient had a good response to anlotinib and immunotherapy in the case report, which may provide some guidances for the clinical practice and the research on AFP-producing lung squamous carcinoma.

Research Progress of PD-L1 Expression in Circulating Tumor Cells in Malignant Tumors / 肿瘤防治研究

In recent years, with the in-depth study of PD-1 and PD-L1 and the development of immunotherapy, the first problem is how to screen the beneficiaries. Recent clinical studies have shown that the expression level of PD-L1 in circulating tumor cells (CTC) can be used as a potential biomarker to play a guiding role in immunotherapy of malignant tumors. This article reviews the latest clinical research progress on the expression of PD-L1 in circulating tumor cells in various solid tumors.

Clinical problems and outcome indicators in the expert consensus determined by the Delphi method of 5-aminolevulinic acid photodynamic therapy for the treatment of oral potential malignant diseases / 口腔疾病防治

Objective@#To determine the clinical problems and outcome indicators that need to be included in the expert consensus of 5-aminolevulinic acid (ALA) photodynamic therapy in the treatment of oral potential malignant diseases. @*Methods@# Based on the relevant literature, the clinical problems and outcome indicators were drafted during the meeting. The Delphi method was used for expert consultation and expert opinion collection. The average and standard deviation of the voting results were calculated to determine the importance of the indicators, and the positive coefficient, variation coefficient and coordination coefficient were calculated for quality control. @* Results@#In the first round of the Delphi method, 12 outcome indicators (the main reference elements include photon integral flux, power density, illumination time, and spot diameter were identified; the specific parameters are photon integral flux of 100 J/cm2 and power density of 100-600 mW/cm2. A diode laser of (630 ± 5) nm wavelength should be chosen. The analgesic regimen is local anesthesia supplemented by hypothermia and intermittent laser irradiation before treatment. Lesions with hyperkeratotic require pretreatment. The concentration of ALA administered was set at 20%. Eight clinical problems (main reference elements of photodynamic irradiation dose, specific parameters, choice of light source, evaluation criteria of efficacy, prevention of adverse effects, dosing concentration, whether oral potentially malignant diseases with hyperkeratosis should be pretreated, administration of photosensitizers) were included according to the literature and expert discussion. In the second round, 89 experts completed the questionnaire and gave very important evaluations of 9 outcome indicators (the main reference elements included photon integral flux, power density and illumination time; the specific parameters were a photon integral flux of 100 J/cm 2 and a power density of 100-600 mW/cm2). A diode laser of (630 ± 5)nm wavelength should be chosen. The concentration of ALA administered was set at 20%. Six clinical problems (main reference elements of photodynamic irradiation dose, specific parameters, choice of light source, evaluation criteria of efficacy, dosing concentration, administration of photosensitizers), and the remaining 3 were given important evaluations, with good consistency.@*Conclusion@# In this study, the irradiation dose, mode of administration and concentration, evaluation criteria of efficacy, prevention of adverse effects and pretreatment regimen of ALA photodynamic therapy for oral potentially malignant diseases determined by the Delphi method had good agreement among experts.