1.Reliability and correlation of in vivo heptic shimming of liver and water suppression with 3.0T proton MRS
Li XU ; Changhong LIANG ; Zaiyi LIU ; Zhenjun ZHAO ; Biao HUANG ; Qiongxin ZENG ; Yuanqiu XIAO
Chinese Journal of Medical Imaging Technology 2009;25(7):1208-1210
Objective To assess the reliability of auto-shimming line width (LW) and water suppression rate (WS), and the correlation between them. Methods GE Signa Excite HD 3.0T system and eight-channel torso phased-array coils with PRESS sequence were performed in 38 volunteers. Liver spectra were collected with TR of 1500 ms, TE of 30 ms, VOI of 2 cm×2 cm×2 cm, NSA of 64 times. Spectroscopy routine auto-shimming pre-scanning program was executed and the values of LW and WS were recorded. Then another spectroscopy routine auto-shimming pre-scanning program was performed repeatedly and 38 groups of data were obtained totally. Intra-class correlation coefficients (ICC), coefficient of variation (CV) and significance test were conduced on 38 groups of LW and WS data. Spearman rank correlation analysis was used to assess the correlation of LW and WS. Results ①The ICC of LW and WS was 0.862 and 0.961 (both P<0.0001), respectively, while the value of CV was 0.20, 0.18, 0.09 and 0.08, respectively. Significant difference was not observed; ②The value of correlation coefficient was -0.659, -0.485 (both P<0.0001), respectively. Conclusion ①The reliability is excellent for in vivo liver 3.0T 1H-MRS and WS appears relatively stable; ②Indexes of LW correlate with WS moderately, and it seems the smaller the value of LW is, the easier to achieve higher WS.
2.Effects of traditional Chinese medicine syndrome differentiation quadruple therapy on serum vascular active substance in patients with acute pancreatitis
Guohong YANG ; Dongling ZHANG ; Xiao WANG ; Zhenjun ZENG ; Chunying LI
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2017;24(5):502-507
Objective To observe the effects of traditional Chinese medicine (TCM) syndrome differentiation quadruple therapy on serum thromboxane A2 (TXA2), prostacyclin (PGI2) and platelet activating factor (PAF) levels in patients with acute pancreatitis (AP). Methods Ninety patients with AP admitted to the First Affiliated Hospital of Henan University of TCM from January 2016 to March 2017, and they were divided into an observation group and a control group according to the random numbers generated by computer inpatients, 45 cases in each group. The control group was given routine treatment of western medicine, and the observation group was given TCM syndrome differentiation quadruple therapy according to the patient's disease individual situation and on the basis of western medicine treatment. The TCM syndrome differentiation quadruple therapy included the following methods: intragastric administration of TCM decoction [gastrointestinal excess heat syndrome (rhubarb, sodium sulfate, aurantii fructus immaturus, magnolia bark, etc.), damp heat syndrome of liver and gallbladder (radix bupleuri, aurantii fructus immaturus, baical skullcap root, rhubarb, etc.), each group of above agents immersed in water and decocted to make juice 400 mL, once 100 mL taken orally, every 4 hours]; retention enema with TCM decoction [rhubarb, magnolia bark, aurantii fructus immaturus, sodium sulfate (dissolved) etc, each dose of agents forming decoction 400 mL, 200 mL taken for proctoclysis, once every 6 hours]; Chinese medicine package (boswellin, myrrha, dandelion, coptidis rhizoma and so on crushed and mixed with honey, then applied to the body surface of the pancreas and its periphery, 1 dose each time for 4 hours, once a day ); intravenous drip of blood-activating and stasis-resolving TCM (Dengzhanhuasu injection 100 mg added to 5% glucose solution 250 mL for intravenous drip). The times of disappearance of abdominal distension, abdominal pain, and the recovery times of bowel sound, blood amylase, lipase, C-reactive protein (CRP), white blood cell count (WBC) levels to normal were compared between the two groups; the modified CT severity index (MCTSI) score and the changes of serum TXA2, PAF and PGI2 levels were observed before and after treatment in the two groups. Results The abdominal pain and abdominal distension disappearance times in observation group were shorter than those in control group [abdominal pain (days): 5.07±1.88 vs. 6.02±1.89, abdominal distension (days): 3.50±1.49 vs. 4.40±1.53, both P < 0.05]; the recovery times of bowel sounds, WBC, CRP, amylase and lipase to normal were shorter than those of the control group [bowel sounds (days): 4.05±1.79 vs. 5.00±1.55, WBC (days): 3.93±1.49 vs. 5.98±2.90, CRP (days): 6.17±2.46 vs. 7.92±2.84, blood amylase (days): 3.5 (3.0, 5.0) vs. 5.0 (3.0, 5.5), lipase (days): 5.0 (3.0, 7.0) vs. 6.5 (5.0, 9.0), all P <0.05]; the scores of MCTSI in the two groups were lower than those before treatment and the degree of decrease in the observation group was more significant than that in the control group [2 (0, 4) vs. 4 (0, 6), P < 0.05]. The TXA2 and PAF levels of the two groups were significantly lower than those before treatment and the level of PGI2 was significantly higher than that before treatment; after treatment for 3 days, the differences between the two groups showed statistical significance and on the 7th day after treatment, the degrees of improvement in observation group were more obvious than those of the control group [TXA2 (ng/L): 276.81±31.48 vs. 345.42±47.27, PAF (ng/L): 72.65±17.61 vs. 89.77±15.59, PGI2 (ng/L): 104.43±18.67 vs. 94.37±17.91, all P < 0.05]; on the 14th day after treatment, the values of the two groups were very close and there were no statistically significant differences (all P >0.05). Conclusions The TCM differentiation syndrome quadruple therapy for treatment of AP is beneficial to the disappearance of clinical symptoms of patients with different syndromes, recovery of abnormal signs and improvement of laboratory indexes, and its early use can significantly reduce the serum levels of TXA2, PAF and increase the level of PGI2 in patients with AP.
3.Preparation and Formula Optimization of Diphenidol Hydrochloride Push-pull Osmotic Pump Tablets
Yuan ZENG ; Lanqiong ZHU ; Zhenjun GUO ; Hui LIU ; Fen WU ; Shiqin LIAO ; Ting DUAN
China Pharmacist 2018;21(10):1750-1755
Objective: To prepare diphenidol hydrochloride push-pull osmotic pump tablets and in-vestigate the influence of differ-ent factors on in-vitro drug release. Methods: The cumulative release of different formulas was detected. Using the cumulative release and similarity factor f2as the evaluation criterion, single factor experiment was applied to screen the core formula and coating process. Results: The drug release behavior was affected by the content of PEO in the drug containing layer, the content of NaCl and the weight gain of the coating layer. After the formula was optimized, the NaCl content in the drug containing layer was 10mg, the PEO-N10 con-tent was 15mg. In the push layer, the content of PEO-WSR303 was 60 mg, that of NaCl was 20 mg. The optimized coating liquid for-mula contained 1. 25 g·L-1PEG4000 and the coating weight gain was 7% of the core. The optimized formula fitted a zero-order equa-tion within 2-12h with the drug release equation of Q=6. 308t-2. 5037(r=0. 995 8). Conclusion: The preparation technology of di-phenidol hydrochloride push-pull osmotic pump tablets is stable, and the in-vitro drug release fits zero-order model.
4.Stent-assisted coil embolization for acutely ruptured wide-necked intracranial aneurysms
Wenxian ZENG ; Zhenjun LI ; Jianbo ZHANG ; Hongliang MENG ; Chuanzhi DUAN ; Xifeng LI ; Xin ZHANG ; Xuying HE
Chinese Journal of Neuromedicine 2019;18(3):243-249
Objective To explore the efficacy and safety of stent-assisted coil embolization of acutely ruptured wide-necked intracranial aneurysms. Methods One hundred and sixty patients with acutely ruptured wide-necked intracranial aneurysms (160 ruptured aneurysms), admitted to and underwent stent-assisted coil embolization in our hospital from January 201l to May 2018, were chosen. The clinical data, outcomes and complications of these patients were retrospectively analyzed. The differences of clinical data between patients with and without complications were compared. Modified Rankin scale (mRS) was used to evaluate the prognoses of these patients. Univariate and multivariate Logistic regression analyses were conducted to analyze the risk factors of prognoses. Results All 160 stents were successfully released. Complete occlusion after endovascular procedures was achieved in 127 patients (79.4%); 17 aneurysms (10.6%) had neck residual and 16 aneurysms (10.0%) had aneurysm residual. Surgery-related complications occurred in 17 patients (10.6%), of which, 6 (3.8%) showed hemorrhagic events and 11 (6.9%) had ischemic events. The distributions of aneurysm sites between patients with ischemia related complications and those without ischemia related complications were statistically different (P<0.05). Poor prognosis was noted in 24 patients (15%) and good prognosis was noted in 136 (85%). The mRS scores, preoperative Hunt-Hess grades and distributions of stent types between patients with good prognosis and patients with poor prognosis were statistically different (P<0.05). Logistic regression analysis indicated that baseline mRS scores ≥4 (OR=39.000, 95% CI:10.861-140.038, P=0.000), preoperative Hunt-Hess grading IV-V (OR=13.000, 95%CI: 4.063-41.596, P=0.015), and Solitaire stents placement (OR=3.333, 95%CI: 1.332-8.339, P=0.028) were the independent risk factors for poor clinical outcomes in patients with acutely ruptured wide-necked intracranial aneurysms. Conclusion Stent-assisted coil embolization is suggested to be a safe and efficacious way to treat acutely ruptured wide-necked intracranial aneurysms, and patients with baseline mRS scores≥4, preoperative Hunt-Hess grading IV-V and Solitaire stents placement are more prone to having poor clinical outcomes.
5.Application value of biological mesh in the pelvic floor reconstruction of extralevator abdominoperineal excision for advanced low rectal cancer
Jiagang HAN ; Zhenjun WANG ; Guanghui WEI ; Zhigang GAO ; Baocheng ZHAO ; Zhiwei ZHAI ; Bingqiang YI ; Yong YANG ; Huachong MA ; Zhulin LI ; Jianliang WANG ; Sanshui YU ; Liangang MA ; Weigen ZENG
Chinese Journal of Digestive Surgery 2018;17(2):161-167
Objective To investigate the application value of biological mesh in the pelvic floor reconstruction of extralevator abdominoperineal excision (ELAPE) for advanced low rectal cancer (RC).Methods The retrospective cohort study was conducted.The clinicopathological data of 228 patients with advanced low RC who underwent ELAPE in the Beijing Chaoyang Hospital of Capital Medical University between August 2008 and December 2016 were collected.Of 228 patients,174 using biological mesh closure and 54 using primary closure were respectively allocated into the biological mesh group and primary closure group.Observation indicators:(1)intra-and post-operative situations;(2) postoperative complications (including short-term and long-term complications);(3) follow-up and survival situations.Follow-up using outpatient examination and telephone interview was performed to detect postoperative long-term complications,tumor recurrence or metastasis and overall survival up to December,2017.Measurement data with normal distribution were represented as( x) ±s,and comparison between groups was analyzed using the independent-sample t test.Measurement data with skewed distribution were described as M (range),and comparison between groups was analyzed using the nonparametric test.Comparisons of count data were evaluated by the chi-square test or Fisher exact probability.Results (1)Intra-and post-operative situations:all the patients underwent successful ELAPE.The perineal operation time,time of indwelling perineal drainage-tube and hospital expenses were respectively (60 ± 50)minutes,(11.6 ± 2.4) days,(57 781± 11 337) yuan in the biological mesh group and (50±21) minutes,(8.9± 1.7) days,(53 714± 13 395)yuan in the primary closure group,with statistically significant differences between groups (t =3.327,7.691,-2.203,P<0.05).The total operation time and duration of postoperative hospital stay were respectively (242±53) minutes,(13.0±5.0) days in the biological mesh group and (228±51) minutes,(12.0±5.0) days in the primary closure group,with no statistically significant difference between groups (t =1.701,1.309,P>0.05).(2) Postoperative complications:26 and 19 patients in the biological mesh group and primary closure group had respectively perineal wound complications (1 patient combined with multiple complications),showing a statistically significant difference between groups (x2 =10.660,P<0.05).The perineal wound infection,perineal hernia and disruption of perineal wound were respectively detected in 20,6,1 patients in the biological mesh group and 12,7,3 patients in the primary closure group,showing statistically significant differences between groups (x2 =3.931,5.282,P<0.05).(3) Follow-up and survival situations:174 patients in the biological mesh group were followed up for 64 months (range,13-112 months),and 54 patients in the primary closure group were followed up for 51 months (range,23-76 months).The local recurrence rate,distal metastasis rate and overall survival rate were respectively 5.17% (9/174),20.11% (35/174),77.59% (135/174) in the biological mesh group and 7.41%(4/54),24.07%(13/54),79.63%(43/54) in the primary closure group,with no statistically significant difference between groups (x2 =0.080,0.389,0.101,P>0.05).Conclusions The biological mesh in the pelvic floor reconstruction of ELAPE for advanced low RC is safe and feasible.Compared with primary closure,biological mesh closure will extend perineal operation time and time of indwelling perineal drainage-tube,and increase hospital expenses,but doesn't affect total operation time and duration of postoperative hospital stay,meanwhile,it can also reduce the overall perineal wound complications,especially in perineal wound infection,perineal hernia and disruption of perineal wound.
6.Effect of bone marrow mesenchymal stem cells transplantation on recovery of neurological functions and Nogo-A expression in cerebral ishchemia rats at recovery stage
Zhenjun LI ; Wenchao LIU ; Chuanzhi DUAN ; Xin ZHANG ; Xifeng LI ; Wenxian ZENG ; Jianbo ZHANG ; Xuying HE
Chinese Journal of Neuromedicine 2018;17(2):117-123
Objective To investigate the effect of bone marrow mesenchymal stem cells (BMSCs) transplantation on recovery of neurological functions and Nogo-A expression in cerebral ischemia rats at recovery stage.Methods BMSCs were isolated and cultured by whole bone marrow adherence method.Thirty-six SD rats were randomized into sham-operated group,ischemia group and BMSCs transplantation group (n=12).The middle cerebral artery occlusion (MCAO) models in the ischemia group and BMSCs transplantation group were established with Zea Longa line embolism.After 21 d of MCAO,one mL ofBMSCs (3×106) were transplanted into rats of the BMSCs transplantation group,and same amount of phosphate buffer was given to the rats of the sham-operated group and ischemia group.After 14 and 28 d of treatment,neurological functions of the rats were evaluated by modified neurological severity scale (mNSS);the brain infarct sizes were tested by TTC staining;the pathological alterations were tested by HE staining,and the Nogo-A expression was determined by immunofluorescence.Results After 14 and 28 d of treatment,as compared with the ischemia group,BMSCs group had significantly lower mNSS scores (14 d∶ 7.50±0.55 vs.6.17±0.75;28 d∶ 7.33±0.52 vs.5.67±0.82),statistically smaller brain infarct sizes (14 d∶ 31.38%±1.02% vs.26.32%±1.19%;28 d∶27.71%±0.55% vs.21.68%±1.09%),and significantly lower Nogo-A expression (14 d∶ 39.33%±2.08% vs.33.67%±2.52%;28 d∶ 30.33%±0.58% vs.25.67%±4.39%,P<0.05).What's more,rats in the BMSCs group had milder cell damage and decreased scar tissues as compared with those in the ischemia group.Conclusion BMSCs transplantation can improve the neurological function of cerebral ischemia rats at recovery stage,and it may work via regulation of Nogo-A expression.
7.Safety and effectiveness of stent-assisted coil embolization in treatment of acute intracranial rupture wide-necked aneurysms
Hongliang MENG ; Zhenjun LI ; Heng ZENG ; Chuanzhi DUAN ; Xifeng LI ; Xin ZHANG ; Xuying HE
Chinese Journal of Neuromedicine 2021;20(6):584-589
Objective:To evaluate the safety and effectiveness of stent-assisted coil embolization in treatment of acute intracranial rupture wide-necked aneurysms.Methods:A total of 249 patients with acute intracranial wide-necked aneurysms (301 aneurysms) treated with stent-assisted coil embolization in our hospital from January 2014 to December 2018 were chosen in our study; these patients were divided into ruptured group ( n=114) and non-ruptured group ( n=135). The differences in the prognoses (modified Rankin scale [mRS] scores) and perioperative complications, mortality, and aneurysm recurrence rate were retrospectively analyzed. Univariate analysis and multivariate Logistic regression analysis were used to screen the risk factors for perioperative complications and recurrence of aneurysms in patients from the ruptured group. Results:The incidence of perioperative complications in the ruptured group (10.5%) was slightly higher than that in the un-ruptured group (6.6%), and the recurrence rate of aneurysms in the un-ruptured group (12.8%) was slightly higher than that in the ruptured group (9.6%), but the differences were not statistically significant ( P>0.05); except for 2 patients in the ruptured group who died of postoperative recurrent hemorrhage, the prognosis of the rest patients in the 2 groups was good (mRS scores≤3). Univariate analysis showed that there was significant difference in the age distribution between the complication group and the non-complication group in the ruptured patients ( P<0.05), and the sizes and degrees of embolization between the ruptured group and un-ruptured group showed significant differences ( P<0.05). Multivariate Logistic regression analysis showed that ages at 40-60 years was independent risk factor for perioperative complication ( OR=17.819, 95%CI: 2.356-137.719, P=0.005), and aneurysm diameter>10 mm and aneurysm Raymond grading 3 embolization were independent risk factors for aneurysm recurrence ( OR=36.823, 95%CI: 0.862-768.308, P=0.000; OR=52.813, 95%CI: 2.967-938.152, P=0.007). Conclusion:Stent-assisted coil embolization in the treatment of acute intracranial rupture wide-necked aneurysms is safe and effective, but patients aged 40-60 years should be wary of high incidence of perioperative complications, and patients with large aneurysms and incomplete embolization should be wary of their high risk of aneurysm recurrence.
8.Effects of Codonopsis pilosula polysaccharide on gastric mucosal injury in rats with chronic atrophic gastritis
Ran ZHANG ; Kun YANG ; Zhenjun ZENG ; Sujuan LI ; Jie LIU
China Pharmacy 2024;35(16):1985-1990
OBJECTIVE To investigate the effects of Codonopsis pilosula polysaccharide (CPP) regulating the nuclear factor- erythroid 2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling pathway on gastric mucosal injury in rats with chronic atrophic gastritis (CAG). METHODS Rats were randomly divided into control group, model group, CPP low-dose, medium-dose and high-dose groups (CPP 10, 20, 40 mg/kg), and ML385 group (Nrf2 inhibitor ML385 30 mg/kg+CPP 40 mg/kg), 10 rats per group. CAG rat model was established using N-methyl-N′- nitro-N-nitrosoguanidine combined with irregular diet, then they were given drugs for consecutive 6 weeks. HE staining was used to observe the pathological changes in gastric tissue morphology; the levels of serum gastrin (GAS), motilin (MTL), pepsin (PP), as well as tumor necrosis factor-α (TNF-α), interleukin-8 (IL-8) malondialdehyde (MDA) and superoxide dismutase (SOD) in gastric mucosal tissue were detected; TUNEL assay was used to observe gastric mucosal tissue cell apoptosis; immunohistochemical assay was adopted to observe the expressions of Nrf2 and recombinant Bcl2 associated X protein (Bax) in gastric mucosal tissue; Western blot was used to detect the expressions of Nrf2, HO-1, Bax and Bcl-2 proteins in gastric mucosal tissue. RESULTS Compared with the control group, the gastric mucosal tissue was damaged; the levels of GAS, MTL, PP and SOD, and the protein expressions of Nrf2, HO-1 and Bcl-2 were significantly reduced in model group (P<0.05), while the levels of MDA, TNF-α and IL-8, the cell apoptosis index, and the protein expression of Bax were significantly increased (P<0.05). Compared with model group, CPP low-dose, medium-dose and high- dose groups showed varying degrees of improvement in gastric mucosal histopathology; the levels of the quantitative indicators were significantly reversed (P<0.05). Nrf2 inhibitor ML385 significantly attenuated the improvement effect of high-dose CPP on the above indicators in CAG rats (P<0.05). CONCLUSIONS CPP can improve gastric mucosal injury in CAG rats, and inhibit oxidative stress, inflammatory response, and cell apoptosis. The mechanism of action may be related to the activation of Nrf2/HO-1 signaling pathway.
9.Stent-assisted coil embolization in acute intracranial ruptured wide-necked aneurysms: a multicenter clinical analysis
Heng ZENG ; Ming ZHONG ; Nan YANG ; Zhenjun LI ; Xifeng LI ; Chuanzhi DUAN ; Ming ZHONG ; Jianping DENG ; Peng HU ; Xuying HE
Chinese Journal of Neuromedicine 2023;22(7):657-665
Objective:To investigate the safety and efficacy of stent-assisted coil embolization in acute intracranial ruptured wide-necked aneurysms, and explore the safety of different antiplatelet drug regimens during perioperative period and the risk factors for prognoses.Methods:A perspective multicenter study was performed. A total of 417 patients with intracranial ruptured wide-necked aneurysms treated by stent-assisted coil embolization in Neurosurgery Departments of 4 hospitals (First Affiliated Hospital of Wenzhou Medical University [ n=41], Zhujiang Hospital of Southern Medical University [ n=111], Tangdu Hospital of Air Force Military Medical University [ n=100], and Xuanwu Hospital of Capital Medical University [ n=165]) from June 2017 to January 2020 were included. According to the different antiplatelet drugs regimens used in perioperative period, these patients were divided into loaded clopidogrel group ( n=87), loaded clopidogrel combined with aspirin group ( n=212), and tirofiban group ( n=118). Clinical data and perioperative complications of 3 groups were compared. Modified Rankin scale (mRS) was used to evaluate the prognoses of patients at discharge; differences of clinical data between the poor prognosis group and good prognosis group were compared. Independent risk factors for prognoses of patients with intracranial ruptured wide-necked aneurysms were analyzed by multivariate Logistic regression analysis. Receiver operating characteristic (ROC) curve was used to analyze the predictive values of risk factors in poor prognosis. Results:Degrees of aneurysm embolization immediately after surgery: Raymond grading I was noted in 351 patients (84.2%), grading II in 44 patients (10.6%), and grading III in 22 patients (5.2%). Perioperative complications were noted in 44 patients (10.6%), and death was noted in 4 (1%). Intraoperative thrombosis incidence of the loaded clopidogrel group, loaded clopidogrel combined with aspirin group and tirofiban group was 5.7% (5/87), 5.7% (12/212) and 0.8% (1/118); that in tirofiban group was significantly lower than that in the loaded clopidogrel group and loaded clopidogrel combined with aspirin group ( P<0.05). At discharge, 360 patients (86.3%) had good prognosis and 57 patients (13.7%) had poor prognosis. Multivariate Logistic regression analysis showed age≥60 years ( OR=3.407, 95% CI: 1.620-7.166, P=0.001), preoperative Hunt-Hess grading 3 ( OR=11.445, 95% CI: 3.584-36.547, P<0.001), preoperative Hunt-Hess grading 4 ( OR=88.951, 95% CI: 14.519-544.948, P<0.001), preoperative Hunt-Hess grading 5 ( OR=64.949, 95% CI: 12.809-329.325, P<0.001), and multiple stenting ( OR=4.709, 95% CI: 1.215-18.248, P=0.025) were independent risk factors for poor prognosis of these patients. ROC curves showed that area under the curve of combination of age, number of implanted stents, and preoperative Hunt-Hess grading in predicting poor prognosis of these patients was 0.821, with optimal diagnostic threshold of 0.500, sensitivity of 0.667, and specificity of 0.833. Conclusion:Stent-assisted coil embolization is safe and effective in acute intracranial ruptured wide-necked aneurysms; tirofiban is safe as perioperative antiplatelet drug; patients with old age, preoperative Hunt-Hess grading≥3, and multiple stents are prone to have poor prognosis.
10.Preliminary report on prospective, multicenter, open research of selective surgery after expandable stent combined with neoadjuvant chemotherapy in the treatment of obstructive left hemicolon cancer.
Jiagang HAN ; Zhenjun WANG ; Yong DAI ; Xiaorong LI ; Qun QIAN ; Guiying WANG ; Guanghui WEI ; Weigen ZENG ; Liangang MA ; Baocheng ZHAO ; Yanlei WANG ; Kaiyan YANG ; Zhao DING ; Xuhua HU
Chinese Journal of Gastrointestinal Surgery 2018;21(11):1233-1239
OBJECTIVE:
To evaluate the safety and feasibility of neoadjuvant chemotherapy prior elective surgery following self-expanding metallic stents (SEMS) for complete obstructive left hemicolon cancer.
METHODS:
This prospective, multicenter, open-labelled trial was approved by the Ethics Committee of Beijing Chaoyang Hospital, Capital Medical University(2016-ke-161-1) and registered in Clinicaltrials.gov (NCT02972541).
INCLUSION CRITERIA:
(1)age between 18 and 75 years old;(2) adenocarcinoma confirmed by pathology;(3) left hemicolon cancer confirmed by clinical manifestations and imaging examinations with the distance to anal verge > 15 cm; (4) resectable cancer evaluated by imaging examination without distant metastasis; (5) Eastern Cooperative Oncology Group (ECOG) score ≤ 1 or Karnofsky Performance Scale (KPS) > 70, indicating tolerance of neoadjuvant chemotherapy and operation; (6) absence of chemotherapy or radiotherapy within past six months; (7) bone marrow system and hepatorenal function: hemoglobin ≥ 90 g/L, neutrophil ≥ 1.5×10/L, platelet ≥ 80×10/L, total bilirubin ≤ 1.5×ULN(upper limits of normal), serum transaminase ≤ 2.5×ULN, serum creatinine ≤ 1.0×ULN, endogenous creatinine clearance rate > 50 ml/min; (8) sign for informed consent.
EXCLUSION CRITERIA:
(1) multiple primary colorectal cancer; (2) rejection of operation;(3) presenting peritonitis or bowel perforation before SEMS; (4) unqualified conditions proved by inspector from registration data. According to inclusion criteria, 62 consecutive patients receiving neoadjuvant chemotherapy prior to elective surgery following SEMS for complete obstructive left hemicolon cancer from Beijing Chaoyang Hospital of Capital Medical University (n=31), Qilu Hospital of Shandong University (n=14), the Third Xiangya Hospital of Central South University (n=13), Zhongnan Hospital of Wuhan University (n=2), the Fourth Hospital of Hebei Medical University (n=2) between December 2015 and December 2017 were prospectively enrolled in this study. Patients were divided into neoadjuvant chemotherapy group and elective surgery group according to the investigator's clinical experience and patient's preference. Patients in the elective surgery group received surgery within one to two weeks after SEMS placement without neoadjuvant chemotherapy. Those in the neoadjuvant chemotherapy group received 2 cycles of CapeOX or 3 cycles of mFOLFOX6 neoadjuvant chemotherapy within one to two weeks after SEMS placement, and then underwent surgery within 3 weeks after finishing neoadjuvant chemotherapy. Data between groups were compared using Student t-test, chi-square analysis or Fisher exact test analysis, including basic clinical informations, operational conditions and postoperative complications. The adverse reactions during the neoadjuvant chemotherapy were recorded. Surgical difficulty was assessed using visual analog scales ranging from 1 to 10, where 1 represented the lowest and 10 the highest degree of surgical difficulty, as judged by the surgeon.
RESULTS:
The study included 38 males and 24 females with mean age of (64.8±8.8) years. The clinical baseline data between 2 groups were not significantly different (all P>0.05) except the average time interval between SEMS and surgery was significantly longer in neoadjuvant chemotherapy group [(61.6±13.5) days vs. (10.4±5.2) days, t=16.679, P<0.001]. There was no stent migration in either group. Three patients had perforation in the elective surgery group; one patient had perforation and one had obstruction in the neoadjuvant chemotherapy group; and all these patients received emergent surgery. Adverse reactions of neodajuvant chemotherapy were mainly degree 1 and 2 except one patient with degree 3 diarrhea. Patients in neoadjuvant chemotherapy group had significantly lower rate of stoma [4.8%(1/21) vs. 34.1%(14/41), χ²=6.538, P=0.011], higher rate of laparoscopic surgery [71.4%(15/21) vs. 36.6%(15/41), χ²=6.751, P=0.009], shorter mean operative time (147 minutes vs. 178 minutes, t=-3.255, P=0.002), less mean intraoperative blood loss (47 ml vs. 127 ml, t=-4.129, P<0.001), lower degree of surgical difficulty(3.3 vs. 5.6, t=-5.091, P<0.001), shorter mean postoperative exhausting time (56.2 hours vs. 69.0 hours, t=-2.891, P=0.006), and shorter mean postoperative hospital stay (8.5 days vs. 13.5 days, t=-2.246, P=0.028) as compared with patients in the elective surgery group. Surgical site infection rate and anastomotic leakage rate did not differ significantly between two groups(all P>0.05).
CONCLUSION
Neoadjuvant chemotherapy prior elective surgery following SEMS is a relatively safe and feasible approach in the treatment for obstructive left hemicolon cancer, and is associated with less stoma, more laparoscopic surgery, shorter operative time, less blood loss, lower surgical difficulty, and faster postoperative recovery as compared with conventional elective surgery.
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Colorectal Neoplasms
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surgery
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therapy
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Female
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Humans
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Intestinal Obstruction
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Male
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Middle Aged
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Neoadjuvant Therapy
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Prospective Studies
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Stents
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Treatment Outcome