1.Keyhole Approach Endoscopic Surgery versus Stereotactic Aspiration plus Urokinase in Treating Basal Ganglia Hypertensive Intracerebral Hemorrhage.
Jin-Long MAO ; Yong-Ge XU ; Yong-Chun LUO ; Guo-Zhen ZHANG ; Ming LIANG ; Ye-Feng HU ; Chun-Sen SHEN
Acta Academiae Medicinae Sinicae 2020;42(4):513-520
To compare the short-and long-term effect of two minimal invasive surgical therapies including keyhole approach endoscopic surgery(KAES)and stereotactic aspiration plus urokinase(SAU)in treating basal ganglia hypertensive intracerebral hemorrhage(hICH). The clinical data of 117 hICH patients(63 received KAES and 54 received SAU)were retrospectively analyzed.The operation time,blood loss during surgery,and drainage time were compared between two groups.The residual hematoma volume,hematoma clearance rate(HCR),Glasgow coma scale(GCS)score,and National Institute of Health Stroke Scale(NIHSS)score were recorded at baseline and in the ultra-early stage,early stage,and sub-early stage after surgery.The 30-day mortality and serious adverse events were assessed and the 6-month modified Rankin scale(mRS)score was rated. Baseline data showed no significant difference between these two groups.Compared with the SAU group,the KAES group had significantly longer operation time,more intraoperative blood loss,and shorter drainage time(all <0.001).In the ultra-early stage after surgery,HCR was significantly higher in the KAES group(<0.001),whereas in the early and sub-early stage,HCR showed no significant differences(all >0.05).In the ultra-early and early stage,the GCS and NIHSS scores showed no significant differences between two groups(all >0.05),whereas in the sub-early stage,the NIHSS score was better in the SAU group(=0.034).The 30-day mortality and incidences of serious adverse events showed no significant difference(all >0.05).The good recovery(mRS≤3)at 6-months follow-up showed no significant difference between the two groups(=0.413). Both KAES and SAU are safe and effective in treating basal ganglia hICH.In the ultra-early stage after surgery,KAES achieves better residual hematoma volume and HCR,and patients undergoing SAU quickly catch up.The short-and long-term effectiveness of SAU is comparable or even superior to KAES.
Basal Ganglia
;
Humans
;
Intracranial Hemorrhage, Hypertensive
;
Retrospective Studies
;
Treatment Outcome
;
Urokinase-Type Plasminogen Activator
2.Effects of neuraxial block and general anesthesia on tumor metastasis in rats.
Wei ZHENG ; Yan-ping LI ; Ren-chun LAI ; Ya-li LU ; Zhi-wen SHEN ; Xu-dong WANG
Journal of Southern Medical University 2008;28(12):2218-2220
OBJECTIVETo investigate the effects of different anesthesia methods on immune surveillance and tumor metastasis in tumor-bearing rats.
METHODSSeventy-two Fischer 344 rats were randomly assigned into 3 equal groups and anesthetized for 1 h with ketamine (group K), propofol (group P), or neuraxial block (group B). All the rats were subjected to laparotomy followed by intravenous injection of MADB106 tumor cells, and 24 h after the injection, the number and activity of circulating CD3(+), CD4(+), CD8(+), and D4(+)/CD8(+) lymphocyte subsets and NK cellèCD161a(+)éwere assessed. Three weeks later, the lung metastases were counted.
RESULTSCompared with those in group B, the numbers of CD3(+), CD4(+), CD8(+), and CD161a(+) lymphocytes and the activity of circulating NK cells were significantly reduced, and the lung metastases of MADB106 increased significantly in groups K and P (P<0.05 or 0.01 ). The activity of immune surveillance in group K was significantly lower than that in group P except for CD8(+) cells, and the tumor metastases in group K increased significantly in comparison with those in group P (P<0.05 or 0.01).
CONCLUSIONNeuraxial block provides protection of the activity of immune surveillance and reduces tumor metastases in tumor-bearing rats compared with general anesthesia.
Anesthesia, Epidural ; adverse effects ; Anesthesia, General ; adverse effects ; Animals ; Breast Neoplasms ; immunology ; surgery ; Female ; Immunologic Surveillance ; immunology ; Ketamine ; pharmacology ; Lung Neoplasms ; immunology ; secondary ; Male ; Neoplasm Metastasis ; Neoplasm Transplantation ; Nerve Block ; Propofol ; pharmacology ; Random Allocation ; Rats ; Rats, Inbred F344
3.Microsurgical treatment of multiple intracranial aneurysms
Chun-Yang LIANG ; Ru-Xiang XU ; Chun-Sen SHEN ; Yi-Wu DAI ; Jiang-Hong HE ; Yun-Jun LI ; Yong-Chun LUO
Chinese Journal of Neuromedicine 2010;9(1):57-60
Objective To explore the problems of microsurgical treatment of multiple intracranial aneurysms with regard to the indications,surgical timing,operative approaches and the prevention of complications, and improve their diagnoses and treatments. Methods We retrospectively reviewed the data of 33 patients with multiple intracranial aneurysms admitted to our hospital from Jan.2000 to Dec.2008 and their clinical manifestations,imaging features and microsurgical treatments were summarized. Results In the 33 cases of multiple intracranial aneurysms,the male-to-female sex ratio was 1:1.75 and the average age at onset of symptoms was 56.52.Twenty-four patients showed good postoperative prognosis(Glasgow Outcome Scale IV-V) with 2 deaths.Conclusion Individual treatment should be adopted in the treatment of differently localized multiple intracranial aneurysms with different sizes and clinical classifications,and the utilization of temporary blockade and ultrasound during the operation can improve the therapeutic effects and reduce the postoperative complication rates.
4.Stereotactic surgery in treating intracranial cystic lesions
Jiang-Hong HE ; Ru-Xiang XU ; Qun WEI ; Chun-Sen SHEN ; Yi-Wu DAI ; Chun-Yang LIANG ; Yun-Jun LI
Chinese Journal of Neuromedicine 2010;09(8):809-811,815
Objective To explore the methods, efficacy and advantages ofstereotactic surgery.Methods A retrospective analysis of 29 consecutive patients with 37 lesions (mean age, 34.6 years),received surgery between Dec 2002 and Nov 2009, was performed. Histological findings showed 11 craniopharyngiomas, 5 cystic gliomas, 3 metastases and 10 cerebral abscesses. Eighteen patients underwent cyst aspiration by the Ommaya reservoir system combined with 32P endocavitary irradiation;median irradiation doses were 800 μCi. One was treated with aspiration and then radiotherapy only. Ten patients with cerebral abscesses received cystic drainage (8 cases) and aspiration (2 cases). Results No operative bleeding and death were found in this experiment. Follow up was performed for a median of 10.6 months (range, 1-60 months) and 4 were out of contact. All patients with craniopharyngiomas remained stable without recurrence after treatment; complete resolution was achieved in all patients with cerebral abscess; in the other 8 patients with tumors(12 lesions), 5 were under control of the symptoms for an average of 14 months and 3 (2 with metastases and 1 with glioblastoma) did not get improvement after the treatment. Two patients with craniopharyngioma experienced a transient slightly worsening of hypothalamic functions, including transient diabetes insipidus, low fever and vomit. Conclusion Stereotactic technique has its advantages in treating patients with cerebral abscess, craniopharyngiomas,metastatic tumors and gliomas that were small size, while it does not that effective in the cystic metastases that are in large size and difficult to control in a short term.
5.Effects of linggui zhugan decoction combined calorie restriction on the insulin resistance of model rats and mechanisms research.
Yuan-yuan WANG ; Ming-hua JIN ; Bin KE ; Su-hua LI ; Yong-zhi SHEN ; Jia-yu ZHAI ; Chun-yu CHEN ; Jian QIN
Chinese Journal of Integrated Traditional and Western Medicine 2013;33(3):356-360
OBJECTIVETo explore the effects of Linggui Zhugan Decoction (LZD) combined calorie restriction on fasting plasma glucose (FPG), the insulin resistance (IR), and the peroxisome proliferator-activated receptor gamma (PPAR-gamma) of IR model rats.
METHODSTotally 48 male Wistar rats were randomly divided into the control group, the model group, the calorie restriction group, and the TCM + calorie restriction group, 12 in each group. Ordinary forage was given to those in the control group, and high fat diet was fed to those in the rest 3 groups for 12 weeks to establish the IR model. After successful modeling, rats in the control group and the model group were continually fed with the original farage for 4 days. The normal saline at the daily dose of 20 mL/kg was given to them by gastrogavage. The normal saline at the daily dose of 20 mL/kg was given to rats in the calorie restriction group by gastrogavage after 4-day calorie restriction. LZD at the daily dose of 20 mL/kg was given to rats in the TCM +calorie restriction group by gastrogavage after 4-day calorie restriction. The body weight, FPG, serum fasting insulin (FINS), insulin resistance index (IRI), and the protein expression of PPAR-y in the omental adipose tissue were compared.
RESULTSAfter 4-day calorie restriction, the body weight obviously decreased in the calorie restriction group and the TCM +calorie restriction group, when compared with the model group (P <0.01). There was no statistical difference between the former two groups (P >0.05). The FINS and IRI obviously decreased in the calorie restriction group (P <0.01, P <0.05). The FPG, FINS, and IRI significantly decreased in the TCM + calorie restriction group (P <0. 05, P <0.01). The protein expression of PPAR-gamma obviously decreased in the calorie restriction group and the TCM + calorie restriction group (P <0.01).The phlegm dampness state was alleviated, with more significant effects shown in the TCM + calorie restriction group.
CONCLUSIONSLZD combined calorie restriction could reduce the body weight, FPG, and IRI of IR rats. Besides, it showed better effects than calorie restriction alone. Its effects in improving IR might be correlated with inhibiting the activities of PPAR-gamma. Meanwhile, it might play a role in inhibiting the differentiation of fat cells.
Animals ; Blood Glucose ; analysis ; Caloric Restriction ; Drugs, Chinese Herbal ; pharmacology ; Insulin ; metabolism ; Insulin Resistance ; Male ; PPAR gamma ; metabolism ; Rats ; Rats, Wistar
6.Application of damage control surgery idea in the treatment of severe pancreatic duodenal injury.
Ren-wu ZHU ; Ye-chun GU ; Yang-gui JIANG ; Mao-sen ZHAO ; Xian SHEN
Chinese Journal of Gastrointestinal Surgery 2013;16(12):1187-1190
OBJECTIVETo explore the significance of damage control surgery (DCS) in the treatments of severe pancreaticoduodenal injuries.
METHODSClinical data of 19 patients with severe pancreaticoduodenal injuries managed with DCS approach in Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine and the First Affiliated Hospital of Wenzhou Medical College from March 2005 to January 2013 were analyzed retrospectively.
RESULTSThree cases were cured after damage control operation and postoperative ICU resuscitation treatment. Twelve cases underwent definite operations (distal pancreaticojejunal Roux-en-Y anastomosis, proximal duodenojejunal Roux-en-Y anastomosis or pancreaticoduodenectomy) after damage control operation and postoperative ICU resuscitation treatment and cured. Four cases died after damage control operation due to multiple organ failure and the mortality was 21.1%.
CONCLUSIONApplication of DCS approach can improve the prognosis of patients with severe pancreaticoduodenal injuries.
Adult ; Duodenum ; injuries ; surgery ; Female ; Humans ; Male ; Middle Aged ; Pancreas ; injuries ; surgery ; Pancreaticoduodenectomy ; Retrospective Studies ; Young Adult
7.Study on the response of specific antibodies against SARS-CoV in patients infected with SARS.
Pan-yong MAO ; Lei ZHU ; You-chun WANG ; Jun HOU ; Yan HU ; Hong-hui SHEN ; Shao-jie XIN ; Bao-sen LI ; Yuan-li MAO ; Hui ZHUANG
Chinese Journal of Epidemiology 2004;25(10):856-858
OBJECTIVETo study the response of specific antibodies against severe acute respiratory syndrome (SARS)-CoV in patients infected with SARS.
METHODSIgM-capture, indirect and antigen-sandwiched enzyme linked immunosorbent assay (ELISA) were used to detect the SARS-CoV specific IgM, IgG and total antibodies in sera of clinical SARS patients or non-SARS individuals.
RESULTSThe positive rates of IgM, IgG and total antibodies to SARS-CoV in 146 sera of SARS patients collected in different phases of the disease were 61.64%, 53.43% and 69.86%, respectively. The earliest detectable days after onset of the disease for IgM and IgG to SRAS-CoV were 7 and 12 days, respectively. The specific IgM disappeared as early as 42 days after the onset of SARS. Of 70 sera from hepatitis A patients, 2 showed false positive results, while 127 sera from other patients were all negative, detected by the 3 methods. Serum from one medical worker who had been close contact to SARS patients was positive for anti-SARS-CoV IgG and total antibodies. These 3 methods used for detection were all not influenced by rheumatoid factor (RF).
CONCLUSIONAll of the three methods were specific and sensitive for the detection of specific antibodies to SARS-CoV, and useful for epidemiological research and clinical diagnosis, but not for early diagnosis of SARS.
Antibodies, Viral ; blood ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Immunoglobulin G ; blood ; Immunoglobulin M ; blood ; Male ; SARS Virus ; immunology ; Sensitivity and Specificity ; Severe Acute Respiratory Syndrome ; immunology ; virology
8.Relationship of sphenoid intersinus septa with transsphenoidal resection of sellar area tumor
Qun WEI ; Yun-Jun LI ; Chun-Sen SHEN ; Jiang-Hong HE ; Jia-Zhen QIN ; Yong-Chun LUO ; Chun-Yang LIANG ; Ru-Xiang XU
Chinese Journal of Neuromedicine 2011;10(7):697-699
Objective To study the relationship of sphenoidal intersinus septa with transsphenoidal resection of sellar area tumor. Methods The pre-operative MRI and CT images of the sphenoid intersinus septa and its importance in transsphenoidal resection of sellar area tumor were studied in 107 patients, admitted to our hospital from January 2008 to December 2010. The amounts, locations, anatomic specialties of the septa and its relationships with the floor of selle, the internal carotid artery canals and the tumors were analyzed to guide the operative procedures during the operation. Results Total removal of the tumors in seller region was obtained in 67 patients, subtotal removal in 21 and partial removal in 19. According to the MRI and CT images of the sphenoid intersinus septa, the location of the tumor and the carotid artery in 47 patients were quickly determined; complex sphenoid intersinus septa was noted in 11 patients, and the relation of sellar floor with the septa was quickly determined and the scope and direction of removal were determined too. Rupture of the internal carotid artery occurred in 1 patient, and damages of the cavernous sinuses occurred in 4. Conclusion Careful study of the pre-operative MRI or CT images of the sphenoidal intersinus septa and its relationship with the floor of seller, the internal carotid artery and the tumor will assure the transspenoidal surgery more precisely and safely, and the complication can be efficiently prevented and decreased.
9.Atezolizumab therapy in Chinese patients with locally advanced or metastatic solid tumors: An open-label, phase Ⅰ study.
Li ZHANG ; Ji Fang GONG ; Hong Ming PAN ; Yu Xian BAI ; Tian Shu LIU ; Ying CHENG ; Ya Chi CHEN ; Jia Ying HUANG ; Ting Ting XU ; Fei Jiao GE ; Wan Ling HSU ; Jia SHI ; Xi Chun HU ; Lin SHEN
Journal of Peking University(Health Sciences) 2022;54(5):971-980
OBJECTIVE:
To evaluate pharmacokinetics (PK), efficacy, and safety of atezolizumab (anti-PD-L1) in high interest cancers in China, including esophageal cancer (EC), gastric cancer (GC), hepatocellular carcinoma (HCC), nasopharyngeal cancer (NPC), and non-small cell lung can-cer (NSCLC).
METHODS:
This phase I, open-label study was conducted at 6 Chinese sites from August 4, 2016 to April 15, 2019. The patients were ≥18 years old with a histologically documented incurable or metastatic solid tumor that was advanced or recurrent and had progressed since the last anti-tumor the-rapy. The PK phase characterized PK and safety of atezolizumab following multiple-dose administration when atezolizumab was administered as a single agent. The extension phase studied safety and efficacy of atezolizumab, as monotherapy (EC, GC, HCC, NPC) and with chemotherapy (NSCLC).
RESULTS:
This study enrolled 120 patients (PK phase: n=20; extension phase: n=20/cohort). Fourty-two patients (42.0%) were PD-L1 positive in atezolizumab monotherapy group (100 patients), of the 9 patients (9.0%) with microsatellite instability-high (MSI-H) tumors. Atezolizumab clearance was 0.219 L/d, and steady state was reached after 6 to 9 weeks (2-3 cycles) of repeated dosing. Objective response rates (ORRs) in EC, GC, HCC, NPC, and NSCLC were 10.0%, 15.0%, 10.0%, 5.0%, and 40.0%, respectively. In the patients with PD-L1 positive tumors, ORR was 11.9% with atezolizumab and 46.2% with atezolizumab plus gemcitabine and cisplatin. Two GC patients achieved durable response after pseudo-progression. The most common treatment-related adverse events in the atezolizumab monotherapy group were fatigue, anemia, fever, and decreased white blood cell count. The most common treatment-related adverse events in the combination group were anemia, decreased white blood cell count, and decreased appetite. No new safety signals were identified.
CONCLUSION
Atezolizumab's PK, efficacy, and safety were similar in Chinese patients vs. global patients in previous studies.
Adolescent
;
Antibodies, Monoclonal, Humanized
;
Antineoplastic Agents/therapeutic use*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Carcinoma, Hepatocellular/drug therapy*
;
Cisplatin/therapeutic use*
;
Humans
;
Liver Neoplasms/drug therapy*
;
Lung Neoplasms/pathology*
;
Nasopharyngeal Neoplasms/drug therapy*
10.Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study.
Yuan-Kai SHI ; Xiao-Nan HONG ; Jian-Liang YANG ; Wei XU ; Hui-Qiang HUANG ; Xiu-Bin XIAO ; Jun ZHU ; Dao-Bin ZHOU ; Xiao-Hong HAN ; Jian-Qiu WU ; Ming-Zhi ZHANG ; Jie JIN ; Xiao-Yan KE ; Wei LI ; De-Pei WU ; Shen-Miao YANG ; Xin DU ; Yong-Qian JIA ; Ai-Chun LIU ; Dai-Hong LIU ; Zhi-Xiang SHEN ; Lian-Sheng ZHANG ; Leonard JAMES ; Edward HELLRIEGEL
Chinese Medical Journal 2021;134(11):1299-1309
BACKGROUND:
Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.
METHODS:
This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR.
RESULTS:
A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities.
CONCLUSION:
Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Adult
;
Antineoplastic Combined Chemotherapy Protocols
;
Bendamustine Hydrochloride/therapeutic use*
;
China
;
Humans
;
Lymphoma, Non-Hodgkin/drug therapy*
;
Neoplasm Recurrence, Local/drug therapy*
;
Prospective Studies
;
Rituximab/therapeutic use*