Treatment of Diabetic Retinopathy with Blood Stasis， Collateral Obstruction， and Qi and Yin Deficiency Syndrome with Tongluo Mingmu Capsules： A Randomized， Double-blind， and Multi-center Phase Ⅲ Clinical Trial / 中国实验方剂学杂志

ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome. MethodA randomized， double-blind， positive-control， and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome in four test centers were included （the ratio of the treatment group to the control group was 3∶1）. On the basis of standardized hypoglycemic treatment， the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day， while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy， traditional Chinese medicine（TCM） syndrome score， corrected visual acuity， fundus changes， fundus fluorescence angiography， and other curative effect indexes before and after treatment in the two groups. At the same time， general examination， laboratory examination， and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable， with the difference not statistically significant. After 12 weeks of treatment， the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group （61.0%， 189/310） was better than that in the control group （44.1%， 45/102）， and the difference was statistically significant （χ2=8.880， P<0.01）. The total effective rate of TCM syndromes in the treatment group （88.4%， 259/293） was better than that in the control group （69.9%， 65/93）， and the difference was statistically significant （χ2=17.927， P<0.01）. The disappearance rate of dry eyes （χ2=8.305）， dull complexion （χ2=4.053）， lassitude （χ2=10.267）， shortness of breath （χ2=8.494）， and dry stool （χ2=8.657） in the treatment group was higher than that in the control group， and the difference between the groups was statistically significant （P<0.05， P<0.01）. In terms of improving corrected visual acuity （χ2=8.382）， fundus changes （χ2=6.026） ， the treatment group was significantly better than the control group （P<0.05）. During the trial， the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%， respectively. There was no significant difference between the two groups. In addition， there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes， visual acuity， fundus changes， and fundus fluorescein angiography， with great safety. Therefore， it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.

Reverse partial pulmonary resection: a new surgical approach for pediatric pulmonary cysts / 南方医科大学学报

OBJECTIVE@#To evaluate the safety and efficacy of reverse partial lung resection for treatment of pediatric pulmonary cysts combined with lung abscesses or thoracic abscess.@*METHODS@#We retrospectively analyzed the clinical data of children undergoing reverse partial lung resection for complex pulmonary cysts in our hospital between June, 2020 and June, 2021.During the surgery, the patients lay in a lateral position, and a 3-5 cm intercostal incision was made at the center of the lesion, through which the pleura was incised and the fluid or necrotic tissues were removed.The anesthesiologist was instructed to aspirate the sputum in the trachea to prevent entry of the necrotic tissues in the trachea.The cystic lung tissue was separated till reaching normal lung tissue on the hilar side.The proximal end of the striated tissue in the lesion was first double ligated with No.4 silk thread, the distal end was disconnected, and the proximal end was reinforced with continuous sutures with 4-0 Prolene thread.The compromised lung tissues were separated, and the thoracic cavity was thoroughly flushed followed by pulmonary inflation, air leakage management and incision suture.@*RESULTS@#Sixteen children aged from 3 day to 2 years underwent the surgery, including 3 with simple pulmonary cysts, 11 with pulmonary cysts combined with pulmonary or thoracic abscess, 1 with pulmonary cysts combined with tension pneumothorax and left upper lung bronchial defect, and 1 with pulmonary herpes combined with brain tissue heterotaxy.All the operations were completed smoothly, with a mean operation time of 129 min, an mean hospital stay of 11 days, and a mean drainage removal time of 7 days.All the children recovered well after the operation, and 11 of them had mild air leakage.None of the children had serious complications or residual lesions or experienced recurrence of infection after the operation.@*CONCLUSION@#Reverse partial lung resection is safe and less invasive for treatment of complex pediatric pulmonary cysts complicated by infections.

Ki-67 expression and its effect on response to neo-adjuvant chemotherapy in invasive breast cancer / 中华病理学杂志

Objective@#To investigate the response to neoadjuvant chemotherapy (NAC) among different molecular subtypes of breast cancers using molecular classification with Ki-67 (ER+ PR+ HER2+ Ki-67) or without Ki-67 (ER+ PR+ HER2).@*Methods@#One hundred and twenty-seven cases of invasive breast cancer confirmed by core needle biopsy before NAC were collected from January 2007 to December 2009 and diagnosed at West China Hospital, Sichuan University. The cases were classified into different molecular subtypes using molecular classifications with or without Ki-67. Their clinical and pathological response to NAC was evaluated and compared.@*Results@#The different subtypes using both molecular classifications showed significant difference in clinical response(with Ki-67: χ2=22.40, P<0.01; without Ki-67: χ2=9.202, P=0.027)but not pathological(P>0.05) response to NAC. By multivariate analysis, Ki-67 was predictive for a clinical complete response (P=0.041) and clinical overall response (P<0.01); also Ki-67 was the only clinicopathological factor predictive of pathological response(P=0.041).@*Conclusion@#The molecular classification with Ki-67 is better to predict breast cancers responsiveness to NAC than the molecular classification without Ki-67.

CD49f Can Act as a Biomarker for Local or Distant Recurrence in Breast Cancer / 한국유방암학회지

PURPOSE: Metastasis and local recurrence are the primary causes of treatment failure and patient death in breast cancer. The aim of this study was to validate a metastasis- and local recurrenceassociated biomarker for prognostic evaluation and planning treatment strategies. METHODS: Formalin-fixed, paraffin-embedded tissues from a cohort of 312 patients (all stage II and III) were used. The prevalence of CD49f⁺ cells in the patients' tumors was analyzed and correlated with clinical characteristics to determine its prognostic and clinical implications. RESULTS: CD49f⁺ tumor cells were found in a minority of tumors, with 62.8% of the samples showing not a single cell of this subtype. In the clinical characteristics analysis, which were performed with t-tests, CD49f⁺ tumors were not associated with age, tumor size, World Health Organization grade, nodal status, human epidermal growth factor receptor 2 status, progesterone receptor status, or estrogen receptor status, although they were significantly associated with disease recurrence (distant metastasis or/and local recurrence). Univariate survival analysis using the Kaplan-Meier method showed that CD49f⁺ tumors were associated with markedly decreased disease-free survival (DFS); the same result was found using multivariate Cox analysis, even when only chemotherapy-treated patients were analyzed. CONCLUSION: Our results indicated that breast tumors with CD49f⁺ cancer cells are associated with an increased risk for disease recurrence after initial surgery with poor clinical outcomes (decreased DFS). Therefore, as it requires testing for only one additional protein, adding CD49f testing to conventional surgical pathology is a strategy that has great potential for prognostic and treatment-guidance purposes.

Roles of microRNAs in the anti-tumor effects of metformin / 国际肿瘤学杂志

Recent epidemiologic data indicate that metfomin has an anti-tumor effect.However,the underlying anti-tumor mechanisms remain unclear.MicroRNAs (miRNAs)can exhibit pro-oncogenic or anti-oncogenic effects by regulating the differentiation and proliferation of cells.In vitro studies show that metformin can regulate the expressions of multiple miRNAs which are closely associated with tumor development,a process possibly relating to the anti-cancer roles of metformin.

Randomized Double-blind and Multi-center Clinical Trial ofLianhua Jizhi Tablets in Treatment of Acute Trachitis and Bronchitis with Syndrome of Phlegm-Heat Obstructing Lung / 中国中医药信息杂志

Objective To evaluated the effectiveness and safety ofLianhua Jizhi Tablets for acute trachitis and bronchitis with syndrome of phlegm-heat obstructing.Methods A randomized double-blind, placebo-controlled and multi-center clinical trial design was selected. Totally 240 cases were randomly divided into experimental group and control group, 120 cases in each group, of which 237 cases were included in the analysis of FAS. Experimental group was givenLianhua Jizhi Tablets, while control group was given placebo, 12 tablets/day, 7 days for a course. Curative effect of acute trachitis and bronchitis, TCM syndrome and disappearance of cough, cough and sputum symptom scores and area under the curve (AUC) were observed. The safety was evaluated. Results The cure rates of disease in experimental group and control group were 66.67% (78/117) and 29.17% (35/120), respectively;cure rates of TCM syndrome in experimental group and the control group were 68.38% (80/117) and 27.50% (33/120), respectively;there was statistically significant difference in area under the curve of cough and sputum symptom score between the two groups (P<0.01). Disappearance rates (cure) of daytime cough in experimental group and control group were 52.99% (62/117) and 13.33% (16/120), respectively;disappearance rates (cure) of nocturnal cough in experimental group and control group were 76.52% (88/115) and 31.90% (37/116), respectively;there were no side effects in experimental group.ConclusionLianhua Jizhi Tablets can significantly relieve clinic symptoms in the treatment of acute trachitis and bronchitis, and have good clinical efficacy and safety.

The Presence of EpCAM-/CD49f+ Cells in Breast Cancer Is Associated with a Poor Clinical Outcome / 한국유방암학회지

PURPOSE: It is well established that breast cancer stem cells (BCSCs) play an essential role in tumor invasion for both local and distant metastasis. The aim of this study was to establish whether BCSCs could act as a prognostic and clinical marker. METHODS: We analyzed tumor tissues from 161 breast cancer patients. Dual immunohistochemistry and immunofluorescence were performed on all the slides, and we analyzed the relationship between EpCAM-/CD49f+ tumor cells and key clinical and prognostic factors. RESULTS: Univariate survival analysis using the Kaplan-Meier method showed that the presence of EpCAM-/CD49f+ tumor cells in breast cancer was significantly associated with shorter disease-free survival (DFS) and overall survival (OS). Multivariate analysis showed that the presence of EpCAM-/CD49f+ cells was associated with shorter DFS (p=0.010; hazard ratio [HR], 2.070) and OS (p=0.002; HR, 3.235). Tumors containing EpCAM-/CD49f+ cells were also more likely to metastasize after initial surgery (p=0.048). CONCLUSION: Our study suggests that breast tumors containing EpCAM-/CD49f+ cells are more likely to undergo distant metastasis after initial surgery and are associated with a shorter DFS and OS.

Effect of shensong yangxin capsule on ventricular premature beat and cardiovascular autonomic nervous function in patients with coronary heart disease / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the clinical efficacy of shensong yangxin capsule (SYC) on ventricular premature beat (VPB) differentiated in TCM as palpitation of Qi-yin deficiency syndrome or Xin collateral stagnation syndrome, and cardiovascular autonomic nervous function in patients with coronary heart disease (CHD).</p><p><b>METHODS</b>The randomized, double-blind, parallel contrast method was adopted, patients were randomly assigned by 3:1 ratio into two groups. One hundred and sixty-five patients in SYC treated group and 56 in the control group (treated with Xinlvning tablet), and the therapeutic course for both groups was 4 weeks.</p><p><b>RESULTS</b>The clinical efficacy on VPB and in improving TCM syndromes was better in SYC group than that in the control group (P < 0.01). After treatment, the heart rate variability (HRV) and QT dispersion in the two groups were improved in a certain degree. The changes of SDNN, SDANN, SDNN Index and PNN50 in the two groups were significantly different (P < 0.05, P < 0.01), the efficacy in the treated group was superior to that in the control group.</p><p><b>CONCLUSION</b>SYC has definite effect on VPB and TCM Syndromes, it can obviously meliorate the activity of cardiovascular autonomic nervous system in the patients with CHD.</p>

SPSS programs for blind review in drug clinical trials / 中国临床药理学与治疗学

This article discusses SYNTAX EDITOR'S actual application of SPSS (11.5) FOR WINDOWS for blind review in drug clinical trials with examples. The results show that applying SPSS software can deal with blind review easily, and produce corresponding report, get fast and exact result.

Phase Ⅱ Clinical Study of Lianhua Qingwen Capsule for Influenza / 中药新药与临床药理

Objective To evaluate the therapeutic effect and safety of Lianhua Qingwen Capsules (LHQC) in the treatment of influenza. Methods A multi- center, randomized, double- blind, positive- controlled, parallel group trial was designed. A total of 240 cases, which were diagnosed with influenza and classified as the syndrome of toxic heat invading lung, aged from 18 to 50 years old, with body temperature over 38.0 ℃ and disease course with 48 hours, was recruited. The intent- to- treat infected (ITTI) population was 152 cases , among which 76 were treated with LHQC (4 capsules thrice daily for 3 days) and other 76 with Lingyang Ganmao Capsules (2 capsules thrice daily for 3 days). Results In the ITTI population, the effective rate for subsiding fever was 71.1 % and 53.9 % (P=0.029), and that for relieving TCM symptoms was 73.7 % and 55.3 % (P=0.018) in LHQC group and Lingyang Ganmao Capsules group, respectively. A safety analysis was conducted in 233 cases. No adverse action was found in LHQC group while two adverse events (allergic dermatitis and diarrhea) in Lingyang Ganmao Capsules group. Conclusion Early application of LHQC is effective and safe in treating infuenza.