Measuring the willingness to pay for drinking water quality improvements: results of a contingent valuation survey in Songzi, China.

The aim of this study is to elicit local residents' willingness to pay (WTP), by applying the contingent valuation method as a surcharge on their water bill, for a given improvement in the drinking water quality and the supply reliability. The mean WTP for the drinking water quality improvement program was estimated to be 16.71 yuan (0.3% of total household income). The results note that more educated respondents and households with higher income and with fewer household members are, on average, willing to pay more. This study also demonstrates that respondents' concerns regarding drinking water quality and perceptions of the health risk of drinking water quality can have significant positive impacts on people's WTP. The research results can help decision-makers understand the local population's demand for improved drinking water quality and undertake an environmental cost-benefit analysis.

Intracranial tuberculomas diagnosed with Xpert MTB/RIF Ultra assay of formalin-fixed paraffin-embedded brain tissues and treated with an optimized antituberculosis regimen: A case report.

Diagnosis of intracranial tuberculoma remains a challenge due to its rarity, non-specific clinical presentation, and radiological findings. Herein, we describe a case of intracranial tuberculomas in a male diabetic patient who presented headache and vomiting on admission. Neuroimaging findings indicated multiple ring contrast-enhanced lesions with extensive perilesional edema. However, a cerebrospinal fluid (CSF) examination was normal. When a biopsy of brain lesions was performed, pathological characteristics of tuberculosis were absent and acid-fast staining was negative. A tuberculosis diagnosis was subsequently obtained from an Xpert MTB/RIF Ultra assay of formalin-fixed paraffin-embedded brain tissue. The patient was treated with an optimized anti-tuberculosis regimen which included high-dose intravenous administration of rifampicin and isoniazid, and oral administration of linezolid. The patient recovered well and exhibited marked clinical improvement. This case report demonstrates that when CSF analysis does not indicate the presence of intracranial tuberculomas, analysis of formalin-fixed paraffin-embedded brain tissue specimens with the Xpert MTB/RIF Ultra assay may be able to confirm a diagnosis. Furthermore, a high dose of rifampicin and isoniazid plus linezolid may improve patient outcome.

Acupuncture and moxibustion for malignant tumor patients with psychological symptoms of insomnia, anxiety and depression: a systematic review and Meta-analysis.

OBJECTIVE: To evaluate the efficacy and safety of acupuncture and moxibustion therapy (AMT) for cancer-related psychological symptoms (CRPS) of insomnia, depression and anxiety. METHODS: Seven databases were searched for randomized controlled trials (RCT) comparing AMT to routine care or conventional drug for alleviating CRPS of insomnia, depression, and anxiety before April 2020. Two independent reviewers performed the data extraction and assessed the risk of bias. RESULTS: A total of 30 RCTs involving 2483 cancer patients were enrolled. The pooled analysis indicated that the treatment group was significantly better than the control group in improving the depression effective rate [= 1.29, 95% (1.12, 1.49), 0.0004], the quality of life (QOL) [1.11, 95% (0.80, 1.42), 0.000 01], and reducing Self-rating Anxiety Scale (SAS) [ï¹£7.75, 95% (ï¹£10.44, ï¹£5.05), 0.000 01]. But there was no statistically significant difference between two groups in improving the insomnia effective rate [= 1.18, 95% (0.93, 1.51), 0.18]. The subgroup analysis showed the effectiveness of different intervention on CRPS. Compared with routine care, AMT helps relieve CRPS better evaluated by Pittsburgh Sleep Quality Index (PSQI), Hamilton Depression Scale (HAMD), and Self-rating Depression Scale (SDS), and depression effective rate. Compared with conventional drug, AMT performs better evaluated by SDS, depression effective rate and QOL. Moreover, the conventional drug showed higher treatment efficacy on improving insomnia effective rate compared with AMT. Compared to conventional drug, AMT plus conventional drug resulted in a significant reduction on CRPS such as PSQI, HAMD, SDS, and SAS, and also had a meaningful improvement on insomnia effective rate, depression effective rate and QOL. Fewer published reports were found on the adverse events of AMT than the conventional drug. CONCLUSION: The results suggested that AMT might be effective in improving CPRI; however, a definite conclusion could not be drawn because the quality of trials are low. Further large-scale and high-quality RCTs to verify the efficacy and safety of AMT on CRPS are still warranted.

Identification of a 5-gene-based signature to predict prognosis and correlate immunomodulators for rectal cancer.

BACKGROUND: Specific tumor markers have yet to be identified in rectal cancer. This study aims to identify a novel genetic signature in rectal cancer to provide clues for survival and immunotherapy. METHODS: DEGs were obtained from two GEO datasets of rectal cancer. By using data from TCGA and GSE133057, two cohorts of rectal cancer were applied to establish and evaluate the signature. A nomogram was constructed for training and validation. We integrated the risk-score with clinicopathological features and assessed its interplay with immune cells and molecules. Finally, our study performed functional annotations, gene-targeted miRNAs, and single-cell analysis. RESULTS: A total of 468 DEGs were identified, and a signature consisting of 5 genes (CLIC5, ENTPD8, PACSIN3, HGD, and GNG7) was selected to calculate the risk-score. The model exhibited high performance in time-dependent ROC and a nomogram. Further results showed that overall survival was significantly worse in the high-risk group. As an independent prognostic factor, the risk-score was associated with vascular invasion. There was a dramatic difference in nonregulatory CD4+ and CD8+ T cells between the high and low-risk groups, and the 5 genes were correlated with immune inhibitors. There was a considerable difference in autophagy, immune, cell cycle, infection, and apoptosis-associated terms and pathways in GO and KEGG. The functional states of differentiation, apoptosis, and quiescence were closely related to the 5-gene signature in single-cell analysis. CONCLUSION: Our results suggest that the signature could serve as a novel prognostic biomarker in rectal cancer, which might benefit decision-making regarding immunotherapy.

Case Report: Refractory Hypotension of GABA B Receptor Autoimmune Encephalitis.

Introduction: With the development of antibody detection technology, Gamma-Aminobutyric Acid (GABA) B receptor encephalitis is a known autoimmune disease. This paper describes a patient with refractory hypotension who suffered GABA B receptor autoimmune encephalitis. Case Report: We describe a 63-year-old man with GABA B receptor autoimmune encephalitis who had hypotension on day 17 of the disease onset. Despite two rounds of immunoglobulin administration, high-dose intravenous steroid injections and immunosuppressive therapy on day 35 of hospitalization, psychiatric symptoms and seizures were significantly improved; however, the patient's blood pressure remained low. Conclusion: This case study and literature review investigated the impairment of autonomic nerve function and its subsequent management in patients with GABA B receptor autoimmune encephalitis.

Differentiation and Treatment of Malignant Tumors based on the Theory of Ministerial Fire / 中医杂志

The occurrence of malignant tumors is closely related to the ministerial fire. The variant ministerial fire is the fundamental factor of the formation of cancer toxin， and ministerial fire dislocation and hyperactivity are the basis for the generation of variant ministerial fire. When the ministerial fire cannot keep its position or moves without restraint， burning and exuberant， the variant ministerial fire comes out. Under the guidance of the theory of ministerial fire， the basic treatment methods to differentiate and treat malignant tumors are the direct repulsion of variant ministerial fire， and the regulation of dislocated and hyperactive ministerial fire. The method of clearing heat and resolving toxins is often used， taking a large amounts of bitter and cold herbs to reduce variant ministerial fire. For ministerial fire dislocation， ministerial fire depletion， true yang insufficiency， and the ministerial fire failing to rely on， it is common to have symptoms of upper heat and lower cold， for which the treatment method is to benefit the source of the fire， and Modified Yinhuo Decoction （引火汤加减） is commonly used. For insufficient true yin and lack of support for ministerial fire， it is suggested to nourish kidney essence， and the medicinals of enriching yin and boosting kidney are commonly used. In terms of ministerial fire hyperactivity， the treatment method should be nourishing the heart and calming the mind， and Jiaotai Pills （交泰丸） is often used to clear heart and clam the mind， and return fire to its origin. At the same time， methods such as regulating qi， resolving phlegm， clearing fire， and dispelling stasis are used to clear away tangible pathogens， so that the ministerial fire acts in a controlled manner and keeps its position and destiny.

Effect and Mechanism of Cyclocarya paliurus(Batal.)lljinskaja Polysaccharides on Type 2 Diabetic Rats by Regulating GLUT4 Translocation in Islet and Liver / 医药导报

Objective To investigate the effect of Cyclocarya paliurus(Batal.)lljinskaja polysaccharides on insulin resistance in type 2 diabetic rats by regulating glucose transporter 4(GLUT4)translocation in islet and liver.Methods High-fat diet combined with low-dose streptozotocin(35 mg·kg-1)to induce type 2 diabetes model,all the rats were randomly divided into model control group,Cyclocarya paliurus polysaccharides groups(5,10 g·kg-1)and metformin group(0.25 g·kg-1),and treated for eight weeks(n=9 in each group).Fasting glucose and lipid were determined.Histopathology of rat islet and liver were observed by hematoxylin and eosin staining.Protein expressions of phosphorylated phosphoinositide-3-kinase(p-PI3K),phosphorylated serine-threonine kinase 1(p-Akt1),and GLUT4 in islet were measured by immunohistochemistry staining.GLUT4 translocation in the islet and liver was detected by immunofluorescence.Results Compared with the model control group,the Cyclocarya paliurus polysaccharides group and metformin group had declined fasting glucose levels and increased high-density lipoprotein(P＜0.05).The structure of the islets and liver was relatively complete.The content of p-PI3K,p-Akt1 and GLUT4 in the islet increased(P＜0.05).GLUT4 translocation in the liver and islet enhanced(P＜0.05).Conclusions Cyclocarya paliurus polysaccharides alleviate glucose and lipid metabolism disorders.The mechanism may lay in it activating protein expressions of p-PI3K,p-Akt1,and GLUT4 in islet cells.GLUT4 translocation to the islet and liver cell membrane are increased to regulate peripheral islet resistance.

Research progress of traditional Chinese medicine regulating related signaling pathways to promote tendon-bone healing / 中国药房

Tendon-bone healing is a complex biological process. Multiple signaling pathways are involved in tendon-bone healing， including transforming growth factor-β signaling pathway， bone morphogenetic protein signaling pathway， Wnt signaling pathway， fibroblast growth factor signaling pathway and nuclear transcription factor-κB signaling pathway. This paper summarizes the research status of traditional Chinese medicine regulating related signaling pathways to promote tendon-bone healing. It is found that a variety of traditional Chinese medicine monomers or herbal extracts （such as baicalein， icariin， total flavonoids of Drynaria fortunei， parthenolide， total saponins of Panax notoginseng， etc.） and traditional Chinese medicine compounds （such as Taohong siwu decoction， Liuwei dihuang pill， Xujin jiegu liquid， etc.） can promote bone formation， anti-inflammatory， anti-oxidation， by regulating the above signaling pathways， thereby effectively promoting tendon-bone healing.

Challenges and Suggestions for Improvement of the Electronic Informed Consent System in Clinical Application / 中国医学伦理学

The electronic informed consent (eIC) system is a product of modernization development of electronic and intelligent technology. In the context of COVID-19, the eIC system can adapt to the epidemic prevention and control requirements, showing its time-space advantages. By introducing the concept, form and the use of eIC system, this paper analyzed the challenges of acceptance, understanding, consent and information security faced by the eIC system. Based on this, some suggestions were put forward, including strengthening the training of the relevant personnel involved in the eIC system, enhancing and improving the functions of the eIC system, and perfecting the relevant laws and regulations of the eIC system, so as to provide reference for the future research and application of eIC.

Supervision of Electronic Informed Consent in International Clinical Research and Its Implications for China / 中国医学伦理学

At present, China is still in the exploratory stage in the field of electronic informed consent (eIC), and relevant policies, regulations and application guidelines have not yet been established and improved. While the traditional informed consent supervision system is difficult to meet the needs of the innovative development of eIC, such as subject privacy and data security. Through sorting out and analyzing the legal norms and construction system of eIC supervision in Europe and the United States, combined with the current development status, problems, and challenges of eIC in China, this paper targeted proposed the path to construct the supervision of eIC in clinical research in China from the aspects of restricting the signing form and process of eIC, adjusting the ethical review paradigm of eIC, enhancing the strength of eIC ethical review, improving the construction of eIC legal system, and strengthening the training of relevant researchers.

One-stage operation surgical efficacy observation of congenital preauricular fistula infection and static period of inflammation in children / 临床耳鼻咽喉头颈外科杂志

Objective:To compare the clinical effect of surgical treatment of congenital preauricular fistulas in children during the local infection period and static inflammatory period. Methods:Forty children with congenital preauricular fistula infection treated in our hospital from January 2020 to December 2022 were selected as the experimental group, and 39 children with congenital preauricular fistula inflammation at static period were selected as the control group. The fistula of the two groups of children aged between 1-14 years old was located in front of the foot of the ear wheel or the foot of the ear wheel, and all were unilateral fistulas. The postoperative follow-up was 6 months to 2 years, and the efficacy of the two groups was compared. Results:There was no significant difference in the healing rate of stage Ⅰ and stage Ⅱ between the two groups（P>0.05）. There was no significant difference in fistula recurrence rate and satisfaction with the preauricular scar between the two groups after treatment（P>0.05）. There was no significant difference in postoperative hospital stay between the experimental group and the control group（P>0.05）. Conclusion:The effect of surgical treatment of congenital preauricular fistula in the infected period is similar to that of surgical treatment in the static period of inflammation, and it can reduce the pain of dressing change under local anesthesia in children, avoid the second operation in children, and reduce the economic cost. This treatment method is worthy of clinical promotion. Appropriate incision and resection method were designed according to the fistula and infection sites.

Implementation and effectiveness evaluation of clinical nutrition pharmacist-involved consultation in nutrition support therapy / 中华临床营养杂志

Objective:To explore the necessity and feasibility of clinical nutrition pharmacist-involved consultation, and evaluate the impact on clinical outcome.Methods:Patients who received the nutritional consultation involving pharmacists at Shanxi Bethune Hospital between 2019 and 2021 were retrospectively enrolled. Patient clinical characteristics, distribution, consultation purpose and nutrition management regimen, and clinical outcomes were collected and analyzed.Results:There was increasing utilization of nutrition pharmacist-involved consultations and referrals to pharmacy clinic over the three years. An average of 95.3% of consultation advices were accepted. Over 90% of patients who were scored 3-6 points with Nutritional Risk Screening 2002 benefited from such consultations. Patients with tumors, elderly patients, and patients with digestive system disorders showed the most benefit from nutritional consultations. The purpose of consultation was focused on the development of individualized nutritional management plans, which brought about improvement in patient's nutritional indicators.Conclusion:There is a strong demand for nutritional pharmacy consultation in large-scale comprehensive hospitals, and the standardized consultation workflow paves the way for comprehensive and individualized nutrition therapy.

Clinical Effect of Fangfeng Tongshengsan on Post-chemoembolization Syndrome with Primary Liver Cancer or Postoperative Liver Metastases of Colorectal Cancer / 中国实验方剂学杂志

ObjectiveTo observe the effect of the Fangfeng Tongshengsan on post-chemoembolization syndrome with primary liver cancer or postoperative liver metastases of colorectal cancer. MethodSeventy-two patients suffered from post-chemoembolization syndrome after transcatheter hepatic arterial chemoembolization were randomly divided into 2 groups， including a Fangfeng Tongshengsan group and a control group， with 36 patients in each group. The patients in Fangfeng Tongshengsan group orally took the decoction for consecutive 7 d. The patients in the control group were physically cooled down with alcohol rub bath and ice pack for consecutive 7 d. Furthermore， the difference of fever， Karnofsky performance status （KPS）， pain in the liver region， nausea vomiting， constipation， and liver function between these two groups were observed. ResultCompared with the control group， Fangfeng Tongshengsan significantly relieved fever， reduced the body temperature （P<0.05）， and shortened the duration of fever （P<0.05）， indicating that Fangfeng Tongshengsan remarkably improved the KPS （P<0.05）. Meanwhile， Fangfeng Tongshengsan obviously alleviated nausea， vomiting， and constipation status and shortened the duration time compared with the control group （P<0.05）. In addition， the parameters of liver function including alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， γ-glutamyl transpeptidase （GGT）， and total bilirubin （TBIL） were significantly decreased in the Fangfeng Tongshengsan group （P<0.05）， which indicated that Fangfeng Tongshengsan alleviated liver dysfunction of patients with post-chemoembolization syndrome. ConclusionFangfeng Tongshengsan can be used to treat post-chemoembolization syndrome with primary liver cancer and postoperative liver metastases of colorectal cancer.

Hedgehog pathway orchestrates the interplay of histone modifications and tailors combination epigenetic therapies in breast cancer

Epigenetic therapies that cause genome-wide epigenetic alterations, could trigger local interplay between different histone marks, leading to a switch of transcriptional outcome and therapeutic responses of epigenetic treatment. However, in human cancers with diverse oncogenic activation, how oncogenic pathways cooperate with epigenetic modifiers to regulate the histone mark interplay is poorly understood. We herein discover that the hedgehog (Hh) pathway reprograms the histone methylation landscape in breast cancer, especially in triple-negative breast cancer (TNBC). This facilitates the histone acetylation caused by histone deacetylase (HDAC) inhibitors and gives rise to new therapeutic vulnerability of combination therapies. Specifically, overexpression of zinc finger protein of the cerebellum 1 (ZIC1) in breast cancer promotes Hh activation, facilitating the switch of H3K27 methylation (H3K27me) to acetylation (H3K27ac). The mutually exclusive relationship of H3K27me and H3K27ac allows their functional interplay at oncogenic gene locus and switches therapeutic outcomes. Using multiple in vivo breast cancer models including patient-derived TNBC xenograft, we show that Hh signaling-orchestrated H3K27me and H3K27ac interplay tailors combination epigenetic drugs in treating breast cancer. Together, this study reveals the new role of Hh signaling-regulated histone modifications interplay in responding to HDAC inhibitors and suggests new epigenetically-targeted therapeutic solutions for treating TNBC.

Discussion on Quality Assurance and Improvement Mode of Ethics Committee / 中国医学伦理学

With the continuous improvement of the ethics committee status and the rapid growth of ethical review projects, the ethics committee urgently needs to establish an evaluation mechanism for continuous improvement. In view of a series of problems faced by the ethics committee in its daily management and operation, this paper discussed the concept and measures of introducing quality assurance and quality improvement into the ethics committee. Through comparing the advantages and disadvantages of the three models of quality assurance and quality improvement, this paper summarized the practical experience, further determined the internal evaluation, improvement model and evaluation elements of ethics committee, constantly improve the internal evaluation system of the ethics committee, strengthen the education and training of the ethics committee, and implement the whole chain electronic review, so as to improve the operation efficiency and review ability of the ethics committee, and provide sufficient ethical protection for the protection of the rights and interests of subjects.

Research progress on the mechanism of iron overload in the occurrence and development of osteoarthritis / 中国临床药理学与治疗学

Osteoarthritis (OA) is a common chronic degenerative disease, and its condition tends to worsen with age. The pathogenesis of OA is complex, and many risk factors can lead to the occurrence of OA. Iron is one of the essential trace elements in the body, and its metabolic balance is extremely important to human health. Iron overload is closely related to the occurrence and development of OA. Excessive iron deposition in joint tissue can easily lead to lesions of articular cartilage and synovium, as well as affect subchondral bone reconstruction and lead to the occurrence of OA. The author reviewed the relevant research literature in recent years, and reviewed the mechanism of iron overload in the occurrence and development of OA, in order to provide new ideas and directions for the research and diagnosis and treatment of OA.

Ethical analysis and countermeasures of artificial intelligence application in clinical trials / 中国临床药理学与治疗学

The development of artificial intelligence is becoming more and more mature, and has penetrated into every field of clinical trials. Artificial intelligence has brought new development opportunities for clinical trials. However, the application of artificial intelligence in clinical trials is still in the exploratory stage, facing many ethical issues, including trial risk caused by data quality, privacy protection caused by data regulation, and contradiction between data authorization and informed consent. We should precisely position the realizable application of artificial intelligence in clinical trials, understand its practical ethical issues, and formulate corresponding coping strategies to ensure the maximum improvement of the whole process performance of clinical trials, including strengthening data quality management and reducing clinical trial risks; optimizing data monitoring mechanisms to ensure data security and privacy; building a data authorization platform and improving judicial protection of informed consent, etc.

Dendrimers as potential drug carriers. Part II. Prolonged delivery of ketoprofen by in vitro and in vivo studies.

Ketoprofen, a non-steroidal anti-inflammatory drug with well-known anti-inflammatory, antipyretic and analgesic properties, has low solubility in water and causes local or systemic disturbance in the gastrointestinal tract. In the present study we investigated the potential of polyamidoamine (PAMAM) dendrimers as drug carriers of ketoprofen by in vitro and in vivo studies. The in vitro release of ketoprofen from the drug-dendrimer complex is significantly slower compared to pure ketoprofen. Anti-nociceptive studies using the acetic acid-induced writhing model in mice showed a prolonged pharmacodynamic behavior for the ketoprofen-PAMAM dendrimer complex. Also, the blood level studies were investigated. We concluded that PAMAM dendrimers might be considered as a potential drug carrier of ketoprofen with a sustained release behavior under suitable conditions.

Prediction of adverse cardiovascular events in patients with acute ST-elevation myocardial infarction after percutaneous coronary intervention / 中国基层医药

Objective:To investigate the application value of combined detection of hypoxia-inducible factor-1α (HIF-1α), N-terminal proBNP (NT-proBNP) and thromboxane B 2 (TXB 2) in the prediction of major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction. Methods:The clinical data of 136 patients with acute ST-elevation myocardial infarction who received treatment in Jinhua Municipal Central Hospital, China between February 2018 and September 2019 were retrospectively analyzed. These patients were assigned to MACE group ( n = 33) and no MACE group ( n = 103) according to whether MACE occurred. The basic data was compared between the two groups. Serum levels of HIF-1α, NT-proBNP and TXB 2 prior to PCI were analyzed. The receiver operating characteristic (ROC) curve was plotted to investigate the application value of combined detection of serum HIF-1α, NT-proBNP and TXB 2 levels in the prediction of acute ST-elevation myocardial infarction after PCI. Results:At 6 months after PCI, MACE occurred in 33 out of 136 patients with acute ST-elevation myocardial infarction, with the incidence of 24.26%. There were no significant differences in age, sex and accompanied diseases between MACE and no MACE groups (all P > 0.05). Serum HIF-1α level in the MACE group was significantly lower than that in the no MACE group [(31.54 ± 5.26) ng/L vs. (37.18 ± 6.94) ng/L, t = 4.286, P < 0.05]. Serum levels of NT-proBNP and TXB 2 in the MACE group were (1 246.83 ± 243.71) μg/L and (125.13 ± 20.16) ng/L, respectively, which were significantly higher than those in the no MACE group [(876.92 ± 173.04) μg/L, (95.73 ± 18.24) ng/L, t = 9.617, 7.835, both P < 0.05]. ROC curve analysis showed that the optimal cutoff values of serum HIF-1α, NT-proBNP and TXB 2 levels in the prediction of MACE occurrence in patients with acute ST-elevation myocardial infarction after PCI were 32.67 ng/L, 1 018.27 μg/L and 112.19 ng/L, respectively. The sensitivity and specificity of combined detection of serum HIF-1α, NT-proBNP and TXB 2 levels in the prediction of MACE occurrence in patients with acute ST-elevation myocardial infarction after PCI were 69.70% (23/33) and 98.06% (101/103), respectively. The specificity of the combined detection of serum HIF-1α, NT-proBNP and TXB 2 levels was higher than that of detection of serum HIF-1α, NT-proBNP or TXB 2 level alone. The area under the curve (AUC) plotted regarding the prediction of MACE occurrence in patients with acute ST-elevation myocardial infarction after PCI by combined detection of serum HIF-1α, NT-proBNP and TXB 2 levels was 0.901, which was significantly higher than the AUC obtained for detection of serum HIF-1α, NT-proBNP or TXB2 level alone ( Z = 2.007, 1.991 and 2.217, all P < 0.05). Conclusion:Combined detection of serum HIF-1α, NT-proBNP and TXB 2 levels exhibits a higher value in the prediction of MACE occurrence in patients with acute ST-elevation myocardial infarction after PCI than detection of serum HIF-1α, NT-proBNP or TXB 2 level alone.

Ethical issues and countermeasures of early phase trials / 中国临床药理学与治疗学

Early phase trials refer to the early exploratory stage of transferring drug development into clinical trials. With China's strong encouragement for innovative drug research and development and enterprises vigorous investment, a large number of innovative drugs have entered early clinical trials. Early phase trials are generally based on innovative diagnosis and treatment mechanisms, pharmaceutical technology and drug delivery methods. Their research design are complex and diverse, and the new technology such as computer simulation are also widely used in the early phase trial process. These aspects are major challenges for the scientific and ethical review of early phase trials. Based on the characteristics of early phase trials, this article analyzes the ethical issues in early clinical trials such as risk uncertainty, therapeutic misunderstanding, subject compensation, breakthrough treatment, etc., and puts forward ethical countermeasures and suggestions.