Objective To explore the characteristics of traditional Chinese medicine(TCM)syndrome,syndrome elements and their combination,and the distribution of TCM syndrome types in advanced non-small cell lung cancer(NSCLC)patients suffering from hypothyroidism after treatment with immune checkpoint inhibitors(ICIs).Methods The analysis was conducted on 168 patients with NSCLC at stage ⅢB-ⅣB confirmed by pathological findings,whose epidermal growth factor receptor/anaplastic lymphoma kinase(EGFR/ALK)was negative,and then suffering from hypothyroidism after treatment with ICIs from January 2020 to June 2023,who admitted to Zhongshan Hospital of Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine.The patients'information collected by four diagnostic methods of TCM was analyzed,and then cluster analysis was used to explore the characteristics of TCM syndrome and the distribution of TCM syndrome types of immunotherapy-induced hypothyroidism in advanced NSCLC.Moreover,the distribution of TCM syndrome types in the patients with different genders,age groups,and hypothyroidism grades was analyzed.Results(1)The TCM syndrome of hypothyroidism appearing in 168 patients with advanced NSCLC after immunotherapy was characterized by deficiency type,which manifested as follows:cough,fatigue and weakness,amnesia,lusterless complexion,spontaneous sweating,dry skin,white sputum,unwilling to talk,dizziness,nocturnal polyuria,blurred vision,emaciation,poor skin elasticity,poor appetite or even anorexia,somnolence,long-term poor appetite,edema,insomnia,low voice,dull pain,light white color of fingernails,spitting,frequently intolerance of cold,thirst,bright pale complexion,preference of warmth and aversion to cold,thirst with preference of hot drink,dyspnea,frequent constipation,dry stools,puffiness of face and eyelid,dreaminess,abdominal fullness,lumbar pain,and weakness in defecation.The tongue manifestation and pulse condition were characterized by white and thin coating,pale-red tongue,tongue with tooth-marks,pale and enlarged tongue,pale tongue,deep pulse,slippery pulse,feeble pulse,weak cubital pulse,and thready pulse.(2)The disease-location syndrome elements usually involved in the lung,spleen,and kidney,and the disease-nature syndrome elements usually involved in qi deficiency,yang deficiency,blood deficiency,and water retention.(3)The cluster analysis yielded three syndrome types,and they were lung and spleen qi deficiency syndrome,kidney yang deficiency syndrome,and qi deficiency and water retention syndrome in decreasing sequence of occurrence frequency.(4)Statistically significant difference of the distribution of TCM syndrome types was presented in the patients with various age groups(P<0.01).Lung and spleen qi deficiency syndrome was the main syndrome type in the patients aged 60-69 years old,kidney yang deficiency syndrome was frequently seen in the patients being or over 70 years old,and qi deficiency and water retention syndrome was frequently seen in the patients less than 50 years old.No statistically significant difference of the distribution of TCM syndrome types was presented in the patients with various genders and in the patients with various grades of hypothyroidism(P>0.05).Conclusion The immunotherapy-induced hypothyroidism in patients with advanced NSCLC is usually differentiated as the TCM syndrome types of lung-qi and spleen-qi deficiency,kidney yang deficiency,and qi deficiency and water retention.Deficiency of healthy qi contributes to the fundamental pathogenesis of the development and progression of the disease.Clinicians should pay attention to the changes of symptoms in time and monitor the thyroid function indicators of the patients,thus to avoid serious immunotherapy-related adverse events(irAEs).

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

BACKGROUND: Osteoporosis is a serious threat to the health and quality of life in the elderly. It is important to establish an ideal experimental animal model to study the etiology and treatment of osteoporosis.OBJECTIVE: To establish a rat model of osteoporosis induced by different dosages of retinoic acid, thus selecting the optimal dosage.METHODS: Eighty female Sprague-Dawley rats were randomly divided into control, low-, middle- and high-dosage groups based on body mass (n=20 per group), The rats in the latter three groups were induced with 80, 100, and 120 mg/(kg?d) retinoic acid via gastric lavage for 14 days.RESULTS AND CONCLUSION: Compared with the control group, the bone mineral density, number of osteoblasts and osteoclasts, and bone microarchitecture in the low-dosage group showed no significant changes, while there were significant decrease in the serum level of calcium and bone mineral density of femur, significant increase in the number of osteoclasts at the femur and significant changes in the femoral microarchitecture in the middle- and high-dosage groups, especially in the middle-dose group. To conclude, 120 mg/(kg?d) retinoic acid via gastric lavage for 14 days can induce a stable osteoporosis model in rats.