Background: Laryngopharyngeal reflux disease (LPRD) is an extraesophageal syndromic manifestation of gastroesophageal reflux disease (GERD). Despite the increasing incidence of and concern about LPRD, treatment with proton pump inhibitors (PPIs) is unsatisfactory. Here, LPRD was treated with Tonghua Liyan (THLY) granules in combination with PPIs to evaluate treatment efficacy and possible adverse reactions. Methods: Seventy-six LPRD patients with stagnation of phlegm and qi syndrome (SPQS) were randomly divided into an experimental group and a control group. The experimental group received THLY granules combined with rabeprazole capsules. The control group received THLY granule placebo combined with rabeprazole capsules. A parallel, randomized, double-blind, placebo-controlled clinical trial was conducted with these two groups. The treatment cycle was 8 weeks. The reflux symptom index (RSI), clinical symptom score, salivary pepsin content, reflux finding score (RFS) and gastroesophageal reflux disease questionnaire (GerdQ) were used to evaluate clinical efficacy. The final efficacy rate was evaluated according to the RSI and clinical symptom score. Results: Compared with those at baseline, all the indicators in the experimental group and control group significantly improved (p < 0.01). In terms of the RSI, clinical symptom score, and RFS, the experimental group had a higher degree of improvement (p < 0.05), and the overall efficacy rate was higher (p < 0.05). In terms of the salivary pepsin concentration and GerdQ, there was no significant difference between the test group and the control group (p > 0.05). Both groups of safety indicators showed no abnormalities and did not cause any allergic reactions in the body. Conclusion: Compared with PPIs alone, THLY granules combined with PPIs are more effective in the treatment of LPRD patients with SPQS in terms of symptoms and signs. This combination treatment, because of its higher clinical efficacy and lack of obvious adverse reactions, is worthy of clinical promotion and further in-depth study. Clinical Trial Registration: www.chictr.org.cn, identifier ChiCTR2100046614.

OBJECTIVE: To observe the effect of auricular acupressure combined with Tongtian Oral Liquid for immediate pain relief in patients with acute migraine without aura, and to analyze the risk factors that affect the number of acute attacks of migraine without aura.
METHODS: This retrospective study analyzed data of 180 patients diagnosed with acute migraine without aura who were admitted to Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine). The patients were divided into an intervention group 1 (n=60), an intervention group 2 (n=60), and a control group (n=60) according to different treatment methods. The intervention group 1 received auricular acupressure + Tongtian oral liquid, the intervention group 2 received Jing point bloodletting + Tongtian oral liquid, and the control group received ibuprofen + flunarizine. Before treatment, 60 minutes and 120 minutes after treatment, the visual analogue scale (VAS) and the short-form McGill pain questionnaire (SF-MPQ) were used to score the pain in the three groups to evaluate the efficacy of immediate analgesia. Symptoms including fatigue, drowsiness, nausea, and vomiting after 2 hours of treatment were observed. The amount of ibuprofen used within 24 hours was calculated. The drug treatment was continued for one month. The frequency of migraine attacks was compared among the three groups. The relevant factors affecting the number of migraine attacks were analyzed.
RESULTS: The VAS and SF-MPQ scores of the three groups were all decreased 120 minutes after treatment as compared with those before treatment (P<0.01). The decline rate in the intervention group 1 > that in intervention group 2 > that in control group (P<0.01). The immediate analgesic efficiency at 60 minutes, intervention group 1 > intervention group 2 > control group (100% vs. 76.67% vs. 56.67%, P<0.001). After 2 hours of treatment, more cases of fatigue and lethargy occurred in the control group (P<0.05). There was no significant difference in nausea and vomiting among the three groups (P>0.05). The 24-hour ibuprofen dosage and headache recurrence ratio, control group > intervention group 2 > intervention group 1 (P<0.05). The number of headache attacks within 30 days was significantly higher in the control group than in the intervention groups (P=0.012). There was no significant statistical difference between the two intervention groups (P=0.568). Regression analysis found that age (OR=1.036, 1.006-1.068), body mass index (OR=1.101, 1.008-1.201), hypertension (OR=2.879, 1.187-6.986), chronic gastritis (OR=2.839, 1.213-6.647), children with educational problems (OR=0.333, 0.164-0.676), and residual fatigue symptoms (OR=4.539, 1.828-11.271) affected the number of headache attacks within the one month of treatment.
CONCLUSIONS: Auricular acupressure combined with Tongtian Oral Liquid can relieve the acute pain of migraine without aura and reduce the number of pain episodes. The curative effect of this combination is better than that of western medicine alone.

UNASSIGNED: Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer. Immune checkpoint inhibitors (ICIs) have been widely used to treat various tumors and have changed the landscape of tumor management, but the data from real-world studies of ICIs for TNBC treatment remain limited. The aim of this study was to evaluate the efficacy of ICIs in the treatment of patients with advanced TNBC in a real-world setting and to explore possible correlates.
UNASSIGNED: The clinical data of advanced TNBC patients who received ICI treatment in the Chinese People\'s Liberation Army (PLA) General Hospital were collected. Treatment responses, outcomes and adverse events (AEs) were assessed.
UNASSIGNED: Eighty-one patients were included in the study. The confirmed objective response rate (ORR) was 32.1%, and the disease control rate (DCR) was 64.2%. The median progression-free survival (PFS) was 4.2 months, and the median overall survival (OS) was 11.0 months. PFS and OS were longer in patients who achieved clinical benefit from ICIs and shorter in patients who received later-line ICIs and higher levels of inflammation; specifically, patients with higher TILs had longer PFS. Overall AEs were tolerable.
UNASSIGNED: ICIs are effective in the treatment of advanced TNBC, and the adverse reactions are tolerable. A panel of biomarkers including LDH, ALP, and bNLR were identified to predict the efficacies of ICIs in TNBC treatment.

OBJECTIVE: To evaluate and compare the diagnostic value of diffusion-related texture analysis parameters obtained from various magnetic resonance diffusion models as early predictors of the clinical response to chemotherapy in patients with colorectal liver metastases (CRLM).
METHODS: Patients (n = 145) with CRLM were prospectively and consecutively enrolled and scanned using diffusion-weighted imaging (DWI)-magnetic resonance imaging (MRI)/intravoxel incoherent motion (IVIM)/diffusion kurtosis imaging (DKI) before (baseline) and two-three weeks after (follow-up) commencing chemotherapy. Therapy response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). The histogram and texture parameters of each diffusion-related parametric map were analysed between the responding and non-responding groups, screened using LASSO, and fitted with binary logistic regression models. The diagnostic efficacy of each model in the early prediction of CRLM was analysed, and the corresponding receiver operating characteristic (ROC) curve was drawn. The area under the curve (AUC) and 95% confidence intervals (CI) were calculated.
RESULTS: Of the 145 analysed patients, 69 were in the responding group and 76 were in the non-responding group. Among all models, the difference value based on the histogram and texture features of the DKI-derived parameters performed best for the early prediction of CRLM treatment efficacy. The AUC of the DKI model in the validation set reached 0.795 (95% CI 0.652-0.938). Among the IVIM-derived parameters, the difference model based on D and D* performed best, and the AUC in the validation set reached 0.737 (95% CI 0.586-0.889). Finally, in the DWI sequence, the model comprising baseline features performed the best, with an AUC of 0.699 (95% CI 0.537-0.86) in the validation set.
CONCLUSIONS: Baseline DWI parameters and follow-up changes in IVIM and DKI parameters predicted the chemotherapeutic response in patients with CRLM. In addition, as very early predictors, DKI-derived parameters were more effective than DWI- and IVIM-related parameters, in which changes in D-parameters performed best.

BACKGROUND: Optimal treatment strategy for severe fever with thrombocytopenia syndrome (SFTS) remained unknown. We aimed to evaluate the efficacy of intravenous immunoglobulin (IVIG) on SFTS.
METHODS: A retrospective cohort study was conducted based on medical records of the laboratory-confirmed SFTS patients hospitalized during 2010-2020 in the 154th hospital, China. A 1:1 propensity score matching with age, sex, the interval from symptom onset to admission, presence of chronic viral hepatitis, diabetes and disease severity was performed between Non-IVIG group (supportive therapy) and IVIG group (IVIG plus supportive therapy). The matching variables were adjusted to compare the case fatality rates (CFRs), viral load and laboratory parameters between the two groups. Risk ratio (RR) and 95% confidence interval (CI) were reported.
RESULTS: Totally 2219 SFTS patients were recruited. CFRs were significantly higher in 1051 patients in IVIG group than 1168 patients in Non-IVIG group (19.0% vs. 4.6%, RR = 4.30, 95% CI 3.12-5.93). The difference remained significant after matching (17.2% vs. 5.1%, RR = 4.02, 95% CI 2.71-5.97). The CFR of IVIG group was significantly higher in all age groups, two IVIG therapy delay groups and two therapy duration groups compared to that of Non-IVIG group (all P < 0.05). IVIG therapy was related to higher viral loads and reduced counts of lymphocytes, T cells, CD4+ T cells and natural killer cells in the blood (all P < 0.05).
CONCLUSIONS: No obvious efficacy of IVIG in saving life or improving outcome of SFTS was observed. Caution is needed for clinical physicians to continue prescribing IVIG for SFTS patients.
BACKGROUND: Natural Science Foundation of China.

UNASSIGNED: To investigate texture parameters of contrast-enhanced computed tomography (CT) images before and after transarterial chemoembolization (TACE) as a tool for assessing the therapeutic response and survival predication in hepatocellular carcinoma (HCC).
UNASSIGNED: Data of 77 HCC patients who underwent three-phase dynamic contrast-enhanced CT examination within 4 weeks before and 4-8 weeks after TACE were collected and efficacy evaluation was performed according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) standard. The remission group consisted of 31 patients (12 with complete remission+19 with partial remission), while the non-remission group consisted of 46 patients (27 with stable disease+19 with progressive disease). Full-volume manual delineation of the region of interest (ROI) and texture analysis of the ROI were performed on the CT images using FireVoxel software. Changes in the 48 texture parameters from three-phase CT images before and after TACE were calculated and compared between the two groups. The receiver operating characteristic (ROC) curve and the areas under the curve (AUC) were used to analyze the diagnostic performance of texture parameters. A multifactorial Cox model was used for predicting survival. The C-indices of texture parameter difference values with predictive value, texture features model, and texture features combined with mRECIST in predicting OS were compared with those of mRECIST.
UNASSIGNED: A total of 41 changes in texture parameters were statistically significant between the remission and non-remission groups. The receiver operating characteristic (ROC) curve showed that the AUC of changes in the 90th percentile in the arterial phase was the largest at 0.842. When the cut-off value was 70.50, the Youden index was the largest (0.621), and the sensitivity and specificity were 0.710 and 0.911, respectively. Three changes in texture parameters were independent factors associated with patient survival, with a hazard of 0.173, 2.068, and 1.940, respectively. The C-index of the OS predicted by the texture features model was not statistically different from that of the mRECIST (0.695 vs. 0.668, p=0.493). While the C-indices of skewness in the portal venous phase combined with mRECIST (0.729, p=0.015), skewness in the delayed phase combined with mRECIST (0.715, p=0.044), and skewness in both two phases combined with mRECIST (0.728, p=0.017) were statistically different.
UNASSIGNED: Changes in the texture parameters of CT images before and after TACE treatment can be used to obtain relevant grayscale histogram parameters for evaluating the early efficacy of TACE in HCC treatment. And the texture analysis combined with mRECIST may be superior to the mRECIST alone in predicting survival in HCC after TACE treatment.

OBJECTIVE: To observe the effects of point-pricking method with fire needle on the symptoms of knee joint and physio-psychological health in the patients with knee osteoarthritis (KOA).
METHODS: Sixty six patients with KOA were randomly divided into a fire needling group (33 cases) and a filiform needling group (33 cases). The patients received the point-pricking method with fire needle in the fire needle group while the conventional acupuncture with filiform needle was provided in the filiform needling group. The basic health management was performed in both groups. The acupoints included bilateral Liangqiu (ST34), Xuehai (SP10), Dubi (ST35), Neixiyan (EX-LE4), Yanglingquan (GB34) and Zusanli (ST36) as well as Ashi points. The treatment was conducted twice a week for 6 weeks consecutively. Before and after treatment, the scores of Western Ontario and McMaster University Osteoarthritis Index (WOMAC), traditional Chinese medicine (TCM) symptoms and visual analogue score (VAS), the numbers of affected areas of knee joint pain and the scores of 12-item short-form health survey (SF-12) were assessed and the incidence of adverse effects was recorded.
RESULTS: The score for pain, stiffness and function, as well as the total score of WOMAC were all reduced (P<0.05), the score of TCM symptoms, VAS score and the numbers of the affected areas of knee joint pain were lower (P<0.05) after treatment when compared with those before treatment within group. After treatment, the score of each domain of SF-12 (i.e. general health, physical function, role-physical, vitality, role-emotional, physical component summary and mental component summary) was higher in comparison to those before treatment in both groups (P<0.05), while the scores of bodily pain, mental health and social functioning in SF-12 were increased in the fire needling group (P<0.05). Compared with the filiform needling group, the score of joint function and the total score in WOMAC and VAS score were reduced remarkably (P<0.05), and general health score in SF-12 was more obviously increased (P<0.05) in the fire needling group after treatment. None adverse effects were found in either group.
CONCLUSIONS: The point-pricking method with fire needle is safe and effective when compared with conventional acupuncture with filiform needle. In the aspects of improving knee joint function, relieving joint pain and advancing the quality of life, the point-pricking method with fire needle is superior to the conventional acupuncture with filiform needle.
目的:观察火针点刺对膝关节骨关节炎(KOA)患者膝关节症状及生理、心理健康等方面的影响。方法:将66例KOA患者随机分为火针组和毫针组, 每组33例。两组均进行基础健康管理, 取穴为双侧梁丘、血海、犊鼻、内膝眼、阳陵泉、足三里及阿是穴, 火针组接受火针点刺治疗, 毫针组采用普通毫针治疗, 每周治疗2次, 连续治疗6周。治疗前、后比较两组患者西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分、中医症状评分、疼痛视觉模拟量尺(VAS)评分、膝关节疼痛地图个数、生活质量量表SF-12评分, 记录不良反应发生情况。结果:与治疗前比较, 火针组与毫针组治疗后WOMAC疼痛、僵硬、关节功能和总分均降低(P<0.05), 中医症状评分、VAS评分、膝关节疼痛受累区域个数均降低(P<0.05), SF-12量表中总体健康、生理功能、生理职能、活力、情感职能、生理健康状况、心理健康状况评分均升高(P<0.05), 火针组躯体疼痛、心理健康、社会功能评分升高(P<0.05);治疗后, 与毫针组比较, 火针组WOMAC关节功能评分和总分、VAS评分降低(P<0.05), SF-12量表中总体健康评分升高(P<0.05)。两组均未出现不良反应。结论:火针点刺与毫针治疗KOA均安全有效, 其中火针点刺在改善患者膝关节功能、缓解膝关节疼痛、提高生活质量方面作用优于毫针。.

UNASSIGNED: This study aimed to evaluate the clinical efficacy of recombinant human growth hormone (rhGH) in the treatment of children with idiopathic short stature (ISS) and growth hormone deficiency (GHD) and to explore the related factors affecting treatment efficacy.
UNASSIGNED: The current research reflects a real-world study. A total of 79 patients with ISS and 95 patients with GHD (both groups pre-puberty) who had been treated with rhGH for more than one year from January 2010 to September 2019 were included in this study. The patients were divided into two groups, ie, an ISS and a GHD group, respectively. The growth indexes, such as chronological age (CA), bone age (BA), height standard deviation score (HtSDS), insulin-like growth factor-1 (IGF-1) SDS, and body mass index were recorded and compared between the two groups before and after treatment. The treatment efficacy was evaluated according to changes in HtSDS before and after treatment, and the influencing factors of clinical efficacy were analyzed using a multivariate regression model.
UNASSIGNED: At the start of treatment, the differences in CA, BA, height, weight, sexual development stage, HtSDS, mid-parental height SDS, and IGF-1 SDS between the two groups were not statistically significant (P > 0.05). However, the initial dose of rhGH in the GHD group was significantly lower than in the ISS group (P < 0.001). Following rhGH treatment, the differences in CA, BA, BA/CA ratio, and IGF-1 SDS measured at 6, 12, 18, and 24 months between the ISS and GHD groups were not statistically significant, while the difference in HtSDS measured at 6 months was statistically significant. With the extension of rhGH treatment time, the annual growth rate (GV) gradually decreased, and the difference between HtSDS and the baseline gradually increased; however, the differences between the ISS and GHD groups were not statistically significant. The most important factor affecting the treatment efficacy for patients with ISS was age at the start of treatment; the most important factors affecting the treatment efficacy for patients with GHD were age and IGF-1 SDS.
UNASSIGNED: Recombinant human growth hormone treatment can significantly improve the height of patients with ISS and GHD. There was no significant difference in growth rate between patients with ISS and those with GHD at relatively high doses. The common factor affecting the treatment efficacy of the two groups was the age at the start of treatment. During treatment, monitored data indicated that rhGH treatment of GHD and ISS thyroid function showed a clinical phenomenon in the form of increased free triiodothyronine, rather than hypothyroidism, which was rarely reported in existing studies.

BACKGROUND: Curcuma longa L., Azadirachta indica A Juss. Cassia tora L. has been used in Unani medicine for various skin ailments. Several researches have been conducted on these plants which have shown anti-microbial, anti-bacterial, anti-fungal, antiviral, anti-oxidant, wound healing, anti-inflammatory, and immune modulation activities. Skin diseases and the use of these drugs are mentioned in classical Unani literature like The Canon of medicine, Continens Liber, Hippocratic treatments, The Complete Book of the Medical Art etc. AIM: The aim of the study was to formulate anti-microbial soap and to evaluate its clinical efficacy of in the management of Tinea corporis.
METHODS: The anti-microbial soap was prepared by hydroalcholic extracts of Curcuma longa L., Azadirachta indica A Juss. and Cassia tora L. The prepared soap was evaluated for various physicochemical parameters, microbiological evaluation, stability study, skin irritation, In-vitro anti-microbial activity, GCMS analysis, and a clinical trial was carried out to evaluate its efficacy. A Single Blind Randomized Placebo Controlled trail on 30 patients aged between 18 and 60 years of either gender was carried out. The participants were randomly allocated to receive either anti-microbial soap or Placebo soap for 4 weeks. Subjective parameters including erythema, pruritis and desquamation were assessed weekly while as objective parameter including Photograph of lesion, Total Symptom Score (TSS) and KOH mount was assessed at baseline and at the end of the trial.
RESULTS: The improvement in subjective parameters was found significant in test group. Erythema, scaling, and desquamation was completely relieved by 70%, 80% and 25% patients respectively in test group while as none of the patients got complete relief in control group. There was statistically significant reduction in average TSS 8.65 ± 0.6708 to 3.05 ± 1.35 p < 0.001. KOH mount turned negative in 80% patients in test group while as only 20% turned negative in control group.
CONCLUSIONS: It is concluded that Unani drugs can be utilized in better way by modifying into a convenient dosage form. Anti-microbial soap was formulated by adding minimal additives to achieve effectiveness, with cost effective benefits and less or no side effects. Anti-microbial soap was effective in management of management of Tinea corporis. Moreover further studies on large sample size are required to fine-tune these observations.

Objective: Thymosin alpha 1 (Thymosin-α1) is a potential treatment for patients with COVID-19. We aimed to determine the effect of Thymosin-α1 in non-severe patients with COVID-19. Methods: We retrospectively enrolled 1,388 non-severe patients with COVID-19. The primary and secondary clinical outcomes were evaluated with comparisons between patients treated with or without Thymosin-α1 therapy. Results: Among 1,388 enrolled patients, 232 patients (16.7%) received both Thymosin-α1 therapy and standard therapy (Thymosin-α1 group), and 1,156 patients (83.3%) received standard therapy (control group). After propensity score matching (1:1 ratio), baseline characteristics were well-balanced between the Thymosin-α1 group and control group. The proportion of patients that progressed to severe COVID-19 is 2.17% for the Thymosin-α1 group and 2.71% for the control group (p = 0.736). The COVID-19-related mortality is 0.54% for the Thymosin-α1 group and 0 for the control group (p = 0.317). Compared with the control group, the Thymosin-α1 group had significantly shorter SARS-CoV-2 RNA shedding duration (13 vs. 16 days, p = 0.025) and hospital stay (14 vs. 18 days, p < 0.001). No statistically significant difference was found between the Thymosin-α1 group and control group in duration of symptoms (median, 4 vs. 3 days, p = 0.843) and antibiotic utilization rate (14.1% vs. 15.2%, p = 0.768). Conclusion: For non-severe patients with COVID-19, Thymosin-α1 can shorten viral RNA shedding duration and hospital stay but did not prevent COVID-19 progression and reduce COVID-19-related mortality rate.