Objective:To investigate the clinical features, imaging characteristics, surgical strategies, and therapeutic outcomes of otitis media complicated with inflammatory response of local meninges.Methods:A retrospective analysis was conducted on the clinical data of 8 patients with chronic suppurative otitis media complicated with inflammatory response of local meninges, treated by the Department of Otolaryngology, Head and Neck Surgery, PLA General Hospital from 2019 to 2023. Appropriate surgical strategies were selected based on the patient′s clinical manifestations, imaging characteristics, extent of lesions, and facial nerve function. Follow-up was performed postoperatively to assess the therapeutic outcomes.Results:Among the eight patients, there were six males and two females, with an average age of (55.9±12.6) years old. The primary clinical manifestations included otorrhea, hearing loss, facial paralysis, earache, headache, and fever. All patients had a history of chronic suppurative otitis media and tympanic membrane perforation, with varying degrees and types of hearing loss. Seven patients presented with peripheral facial palsy preoperatively, with the House-Brackmann (H-B) grading scale as follows: 4 cases (4/7) in grade Ⅳ, 1 case (1/7) in grade Ⅴ, and 2 cases (2/7) in grade Ⅵ. The mean duration of otorrhea and/or hearing loss was (24.68±12.18) years, while, the average duration of severe headache, aggravated otorrhea and facial paralysis was (2.73±3.92) months. Preoperative high-resolution CT scan of the temporal bone revealed soft tissue shadow in the middle ear and mastoid process, with partial defects in the mastoid cortex. Cranial MRI T1WI showed high signal in the meninges on the affected side, with contrast-enhanced MRI indicating localized meningeal thickening. Four patients (4/8) had diabetes mellitus, and 2 patients (2/8) had a history of middle ear/mastoid surgery. All patients underwent surgical treatment, including thorough removal of lesions, adequate drainage, and facial nerve decompression. Tympanoplasty and hearing reconstruction were performed when conditions permitted. Specifically, 5 patients underwent intact canal wall radical mastoidectomy with facial nerve decompression and tympanoplasty, 2 patients underwent canal wall down mastoidectomy with facial nerve exploration decompression, and 1 patient underwent modified radical mastoidectomy. Postoperatively, patients experienced significant relief and gradual disappearance of ear and head pain. The postoperative H-B grading scale of facial nerve function was as follows: 4 cases in grade Ⅰ (4/8, including 1 case without preoperatively facial palsy), 2 cases (2/8) in grade Ⅱ, and 2 cases (2/8) in grade Ⅲ. Postoperative cranial MRI showed a significant reduction in localized meningeal thickening on the affected side.Conclusions:Patients with long-term chronic suppurative otitis media and/or cholesteatoma who suddenly presented with headache, fever, aggravated otorrhea, and facial paralysis should be suspected of having inflammatory response of local meninges. High-resolution CT of temporal bone and cranial MRI provide crucial diagnostic information. Early surgical exploration and thorough lesion removal are effective treatment methods.

Objective:To investigate the clinical features, imaging characteristics, surgical strategies, and therapeutic outcomes of otitis media complicated with inflammatory response of local meninges.Methods:A retrospective analysis was conducted on the clinical data of 8 patients with chronic suppurative otitis media complicated with inflammatory response of local meninges, treated by the Department of Otolaryngology, Head and Neck Surgery, PLA General Hospital from 2019 to 2023. Appropriate surgical strategies were selected based on the patient′s clinical manifestations, imaging characteristics, extent of lesions, and facial nerve function. Follow-up was performed postoperatively to assess the therapeutic outcomes.Results:Among the eight patients, there were six males and two females, with an average age of (55.9±12.6) years old. The primary clinical manifestations included otorrhea, hearing loss, facial paralysis, earache, headache, and fever. All patients had a history of chronic suppurative otitis media and tympanic membrane perforation, with varying degrees and types of hearing loss. Seven patients presented with peripheral facial palsy preoperatively, with the House-Brackmann (H-B) grading scale as follows: 4 cases (4/7) in grade Ⅳ, 1 case (1/7) in grade Ⅴ, and 2 cases (2/7) in grade Ⅵ. The mean duration of otorrhea and/or hearing loss was (24.68±12.18) years, while, the average duration of severe headache, aggravated otorrhea and facial paralysis was (2.73±3.92) months. Preoperative high-resolution CT scan of the temporal bone revealed soft tissue shadow in the middle ear and mastoid process, with partial defects in the mastoid cortex. Cranial MRI T1WI showed high signal in the meninges on the affected side, with contrast-enhanced MRI indicating localized meningeal thickening. Four patients (4/8) had diabetes mellitus, and 2 patients (2/8) had a history of middle ear/mastoid surgery. All patients underwent surgical treatment, including thorough removal of lesions, adequate drainage, and facial nerve decompression. Tympanoplasty and hearing reconstruction were performed when conditions permitted. Specifically, 5 patients underwent intact canal wall radical mastoidectomy with facial nerve decompression and tympanoplasty, 2 patients underwent canal wall down mastoidectomy with facial nerve exploration decompression, and 1 patient underwent modified radical mastoidectomy. Postoperatively, patients experienced significant relief and gradual disappearance of ear and head pain. The postoperative H-B grading scale of facial nerve function was as follows: 4 cases in grade Ⅰ (4/8, including 1 case without preoperatively facial palsy), 2 cases (2/8) in grade Ⅱ, and 2 cases (2/8) in grade Ⅲ. Postoperative cranial MRI showed a significant reduction in localized meningeal thickening on the affected side.Conclusions:Patients with long-term chronic suppurative otitis media and/or cholesteatoma who suddenly presented with headache, fever, aggravated otorrhea, and facial paralysis should be suspected of having inflammatory response of local meninges. High-resolution CT of temporal bone and cranial MRI provide crucial diagnostic information. Early surgical exploration and thorough lesion removal are effective treatment methods.

Advances in novel drugs, therapies, and genetic techniques have revolutionized the diagnosis and treatment of cancers, substantially improving cancer patients' prognosis. Although rare tumors account for a non-negligible number, the practice of precision medicine and development of novel therapies are largely hampered by many obstacles. Their low incidence and drastic regional disparities result in the difficulty of informative evidence-based diagnosis and subtyping. Sample exhaustion due to difficulty in diagnosis also leads to a lack of recommended therapeutic strategies in clinical guidelines, insufficient biomarkers for prognosis/efficacy, and inability to identify potential novel therapies in clinical trials. Herein, by reviewing the epidemiological data of Chinese solid tumors and publications defining rare tumors in other areas, we proposed a definition of rare tumor in China, including 515 tumor types with incidences of less than 2.5/100 000 per year. We also summarized the current diagnosis process, treatment recommendations, and global developmental progress of targeted drugs and immunotherapy agents on the status quo. Lastly, we pinpointed the current recommendation chance for patients with rare tumors to be involved in a clinical trial by NCCN. With this informative report, we aimed to raise awareness on the importance of rare tumor investigations and guarantee a bright future for rare tumor patients.
Humans ; Neoplasms/pathology* ; Biomarkers ; Prognosis ; Oceans and Seas ; China/epidemiology*

Objective: To investigate the clinical features of Hashimoto′s thyroiditis(HT) with elevated serum IgG4 levels and to guide the clinical practice. Methods: Serum IgG4 concentrations were detected in patients with HT by nephelometric immunoassay. These patients were classified into two groups according to the IgG4 levels: positive group(IgG4≥1.35 g/L), and negative group(IgG4<1.35 g/L). The clinical characteristics of these two groups, including age, gender, medical history, serological features, and ultrasound were compared. Results: Nine out of 111 patients with HT were positive with IgG4(8.11%), all of them were women. There was no significant difference in gender, age, BMI, dose of levothyroxine administration, FT₃, FT₄, and TSH levels between the two groups. The volume of thyroid in positive group was larger than that in negative group [57.81(38.36, 74.93) ml vs 25.07(18.48, 42.14) ml, P=0.015], and the level of thyroglobulin antibodies(TgAb; P=0.011) and thyroid peroxidase antibodies(TPOAb; P=0.025) in positive group were also significantly higher than those in negative group. Moreover, the positive group had a slightly higher risk of PTC than that of negative group(11.1% vs 2.94%, P=0.290), though the difference was not significant. Correlation analysis showed that IgG4 was positively associated with TgAb, TPOAb, and thyroid volume. Conclusions The levels of TgAb and TPOAb are higher, the volume of thyroid gland is greater, and the risk of PTC with lymph node metastasis is more frequent in HT patients with elevated serum IgG4. For HT patient with elevated serum IgG4, their thyroid function and morphology should be more closely monitored.

Objective: To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019. Methods: The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies, while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug. Characteristics on stage, scope, indication of those trials, classification and mechanism of involved products, as well as listed anticancer drugs were summarized and depicted. Results: There were 474 cancer drug trials registered in China in 2019, accounting for 21.8% of the total, and 397 (83.8%) were initiated by domestic pharmaceutical enterprises. Overall, international multicenter trials accounted for 13.1%, and phase I trials accounted for 47.3%. Compared with global enterprises, the proportion of international multi-center trials initiated by domestic companies is lower (4.8% vs. 55.8%, P<0.001), and the proportion of phase I clinical trials and bioequivalence trials is higher (51.9% vs. 23.4%, 19.4% vs. 1.3%, P<0.001). An accumulative of 27 cancer types were involved for all the cancer drug trials, and lung cancer, solid tumor, and breast cancer were the most common cancer types, with 103, 95 and 49 trials, respectively. For the three cancer types unique to Chinese population, gastric, liver and esophageal cancer, the total number of initiated trials was 47. For all those trials, there were 335 cancer drug varieties, with 86.0% developed by domestic pharmaceutical enterprises, including 300 therapeutic drugs, 30 adjunctive drugs and 5 preventive drugs. In terms of mechanism, targeted drugs and immune drugs were the most popular, accounting for 74.6% and 20.3%, respectively. In addition, 17 anticancer drugs targeting on 11 cancer types were approved in China in 2019. Conclusions Clinical trials on cancer drugs in China have ushered a booming era, with large number of innovative agents represented by targeted drugs and immune drugs under clinical development or putting into clinical practice. Those local enterprises are playing more and more critical roles. Strengthening clinical research and development on Chinese unique cancer types is the key direction of future work.

BACKGROUND: The clinical trials of new anti-tumor drugs are prospering in China. The acceptance of clinical trials in patients is an important factor affecting the speed and quality of clinical trials. Previous studies have investigated the acceptance of clinical trials in those cancer patients, who have never participated in a trial. This study is designed to investigate and compare the acceptance and related causes of clinical trials in cancer patients who have once participated in a clinical trial or not. METHODS: From June 2018 to April 2019, a standardized questionnaire-based survey was conducted among two groups of cancer patients classified by history of clinical trial participation in Cancer hospital, Chinese Academy of Medical Science, mainly focusing on their overall acceptance of clinical trials and related considerations, including the role of attending doctors, as well as group differences between the two participants. RESULTS: A total of 538 patients were enrolled with an average age of 53.5 years old, 51.1% of whom were males, and 43.3% of whom have never participated in a clinical trial. Overall, 502 patients (93.3%) were willing to or recommend their relatives or friends to participate in clinical trials, and patients with history of clinical trial participation had higher willingness (96.6% vs 90.8%, P=0.008). Patients were most likely to be motivated by expectation of optimal treatment (100.0% vs 99.3%) for both those who had once participated in a clinical trial or those not, respectively followed by financial burden reduction (56.0%) and recommendation by attending doctor (43.7%). The main reasons for unwillingness-to-participate for those who had once participated in a clinical trial were abandoning other treatment options, divided into control group or additional visits, while for those who had never participated in a clinical trial, ineffective treatment or serious adverse reactions were their main concerns. In the decision-making of clinical trial participation, 88% patients highly valued the role of recommendation by attending doctors. Among patients without trial participation history, 60.9% of those had no unwillingness-to-participate expressed that recommendation by attending doctors would change their decisions. The study also reported patients' preferences for information and access to clinical trials. CONCLUSIONS The acceptance of clinical trials in cancer patients in our hospital is generally high, especially in patients who had a history of trial participation. It's of substantial significance to give full play to the role of doctors in improving the acceptance of clinical trials of cancer patients in China.

BACKGROUND: Early investigation suggested patients' level of awareness regarding clinical trials was related with willingness to participation. This study was intended to evaluate the level of awareness of cancer patients regarding clinical trials and related influencing factors, and to compare the differences of awareness between patients who attended clinical trials before and not. METHODS: From Jun, 2018 to April, 2019, standardized question-naires were gathered from cancer patients (attended clinical trials vs not attended clinical trials) in our hospital regarding basic information and 10 other questions about awareness. The level of awareness was evaluated and patients were classified into "low cognition" and "high cognition" groups. Logistic regression analysis was performed to determine whether certain characteristics would predict for awareness. RESULTS: Of the 617 participants, 38.6% have attended clinical trials before. 338 (54.6%) patients had a correct overall understanding of clinical trials, while 44 (7.1%) patients still thought participants were the victim of scientific research. Except for the compensation of medical expenses (51.5% vs 48.7%) and related laws of clinical trials (52.3% vs 45.5%), other parts of understanding were elevated in patients attended clinical trials before comparing with patients who didn't, including significance (86.2% vs 77.6%), risk disclosure (91.2% vs 71.6%), confidentiality (73.2% vs 59.7%), voluntariness (95.8% vs 76.3%), withdrawal (86.6% vs 68.2%) and expenses (62.8% vs 39.2%). The proportion of participants who understand these components did not increase even in 239 patients who had attended clinical trials before. Participants who attended clinical trials before (OR=1.83, 95%CI: 1.11-3.00), unmarried/divorced (OR=5.04, 95%CI: 1.73-14.66), retired (OR=2.53, 95%CI: 1.16-5.50) had a higher level of awareness, while patients who had bad impression with doctors (OR=0.43, 95%CI: 0.26-0.72) had lower awareness. CONCLUSIONS The current level of awareness for clinical trials of cancer patients in our hospital was relatively low, even in patients who had attended clinical trials before. It's necessary to improve patients' awareness of clinical trial by promoting harmony relationship between patients and doctors, as well as by enhancing related propagation. Strengthening the adequacy and efficacy of informed consent in clinical trials also needs to be achieved in the future.