1.Cost-effectiveness Analysis of Three Chemotherapy Regimens for Metastatic Colorectal Cancer
Yan CHEN ; Guoming CHEN ; Ying ZHAN ; Hua SHAO
China Pharmacy 2015;(32):4465-4467
OBJECTIVE:To investigate clinical efficacy of oxaliplatin+calcium folinate+5-fluorouracil(mFOLFOX6),oxalipl-atin+capecitabine(CapeOX),irinotecan+calcium folinate+5-fluorouracil(FOLFIRI)for metastatic colorectal cancer,and to conduct cost-effectiveness analysis. METHODS:48 patients with colorectal cancer were divided into mFOLFOX6 group(30 cases),Cape-OX group(8 cases)and FOLFIRI group(10 cases). Clinical efficacy and ADR of 3 groups were analyzed,and cost-effectiveness analysis was also conducted. RESULTS:Clinical effective rates of mFOLFOX6 group,CapeOX group and FOLFIRI group were 96.67%,87.50% and 80.00%,respectively,the mFOLFX6 group was significantly higher than the other 2 groups,with statistical significance(P<0.05). mFOLFOX6 group had high incidence of gastrointestinal side effects (70.00%). FOLFIRI group had high incidence of myelosuppression (70.00%). CapeOX and mFOLFOX6 group suffered from liver injury possibly,without statistical significance (P>0.05). The C/E of mFOLFOX6 group,CapeOX group and FOLFIRI group were 11 950,15 674 and 18 397 re-spectively,to which results of sensitivity analysis were same. CONCLUSIONS:The cost-effectiveness of mFOLFOX6 regimen is superior to CapeOX and FOLFIRI regimen in the treatment of metastatic colorectal cancer,but it has the high incidence of gastroin-testinal side effects.
2.Troubleshooting of bioinequivalence of compound valsartan tablets.
Da SHAO ; Yifan ZHANG ; Yan ZHAN ; Xiaoyan CHEN ; Dafang ZHONG
Acta Pharmaceutica Sinica 2014;49(4):524-9
The study aims to evaluate the bioequivalence of valsartan hydrochlorothiazide tablets, and to investigate the potential cause of bioinequivalence. This was a single-center study with an open, randomized double-way crossover design. Test and reference preparations containing 160 mg of valsartan and 25 mg of hydrochlorothiazide were given to 36 healthy male volunteers. Plasma concentrations of valsartan and hydrochlorothiazide were determined simultaneously by LC-MS/MS. The pharmacokinetic parameters and relative bioavailability were calculated, while the bioequivalence between test and reference preparations were evaluated. The dissolution profiles of test and reference preparations in four different mediums were determined via dissolution test and HPLC. The similarity was investigated according to the similarity factors (f2). The F(o-t) and F(0-infinity) were (139.4 +/- 65.2)% and (137.5 +/- 61.2)% for valsartan of test preparations. It led to get the conclusion that test and reference preparations were not bioequivalent for valsartan. A significant difference was observed between test and reference tablets in the valsartan dissolution test of pH 1.2 hydrochloric acid solution. The key factor of the bioinequivalence might be that dissolution of valsartan in acid medium has marked difference between two preparations.
3.Clinical study of laparoscopic renal cyst decortication in polycystic kidney
Xinmin NIU ; Chen SHAO ; Zhong YUE ; Xiaoxiong ZHAN
Chinese Journal of Primary Medicine and Pharmacy 2015;(z1):7-10,11
ObjectiveToevaluatetheclinicalvalueoflaparoscopicrenalcystdecorticationandopencyst decortication surgery in the treatment of polycystic kidney disease.Methods Various clinical parameters were retro-spectively analyzed in 108 patients with polycystic kidney,include laparoscopic 60cases and open surgery 48cases.The observation indexes include operative time,operative bleeding,restoration time of bowel functions,postoperative drain-age volume,hospital time,postoperative complications,kidney function,blood pressure,and the clinical effects were estimated.Results In the laparoscopic group,the average operation time was (57.7 ±13.2) min,the average blood was (35.9 ±17.3)mL,the average time of exsufflation was (1.6 ±0.7)d,the average postoperative drainage volume was (23.2 ±4.3)mL,the average hospital time was (5.1 ±0.8)d.As compared with the open surgery group,the op-eration time,hospital stay,operative bleeding,postoperative drainage and hospital time of the laparoscopic group short-ened significantly(all P<0.05).The complication rate of the laparoscopic group and open surgery group were 5.0%and 16.7%separately.The complication incidence was significantly lower in the laparoscopic group than that in the open surgery group(P<0.05).At 3 months postoperative,the levels of serum creatinine(Cr),urea nitrogen(UN)and systolic blood pressure were obviously decreased compared with preoperative.There were no significant difference be-tween the two groups(P>0.05).The follow-up data showed that the cure rate and effective rate of the open surgery group were 81.2%and 18.8%,and the cure rate and effective rate of the laparoscopic group were 85.0% and15. 0%respectively.There were no significant difference of the clinical effects between the two groups (P >0.05). Conclusion The laparoscopic was superior to the open surgery in the operation time,hospital time,operative bleed-ing,postoperative drainage and hospital time.Laparoscopic renal cyst decortication in polycystic kidney is open surgery safer,little injury,quick recovery.Laparoscopic renal cyst decortication is safe and effective therapy,which can be used as primary surgical treatment for patients with polycystic kidney.
4.CT-guided localization with combination of methylene blue and a Hookwire system for small pulmonary nodules before video-assisted thoracoscopic resection:the clinic application
Tongfu YU ; Hai XU ; Xisheng LIU ; Min ZONG ; Liang CHEN ; Quan ZHU ; Yongfeng SHAO ; Bicheng ZHAN
Chinese Journal of Thoracic and Cardiovascular Surgery 2012;28(7):401-404
Objective To evaluate the clinical application of CT-guided localization with combination of methylene blue and a Hookwire system for small pulmonary nodules (SPNs) before video-assisted thoracoscopic resection.Methods CTguided localization the SPNs before resection in 56 patients and 60 nodules,then underwent video-assisted thoracic surgery (VATS) resection.Among 56 patients,19 males and 37 females,aged from 35 to 81 years,mean age was (61.1 ±8.9)years.Results SPNs diameter (6.80 ±4.12) mm,distance from the parietal pleura (15.38 ±4.63) mm.CT-guided localization success rate was 100%,positioning time (10.76 ± 8.17) min,8.9% (5/56) had micro pneumothorax aftet positioning,7.1% (4/56) occurrence of needle tract bleeding,no conservative treatment.VATS resection rate was 100%.The pathology of 60 lesions were shown:Bronchiolo-alveolar carcinoma(BAC) were 33 lesions(55.0%),BAC and adenocarcinoma were 11 lesions(18.3%),Atypicaladenomatous hyperplasia (AAH) were 7 lesions (11.8%),Inflammation were 4 lesions (6.7%),Harmatoma were 3 lesions(5.0%),Tuberculoses were 2 lesions(3.3%).Conclusion CT-guided localization with combination of methylene blue and a Hookwire system before video-assisted thoracoscopic resection is a promising technique for small solitary pulmonary nodules.It could play an important role in accurate localization of small pulmonary nodules,and it is a safe technique with clinical application.
5.Comparison of detection rate of osteoporosis in different sex,age and skeleton location
Zhiwei ZHAN ; Yu PEI ; Ruiqin DU ; Guochang CHEN ; Weiqing SHAO ; Zhihui CUI
Chinese Journal of Tissue Engineering Research 2005;9(3):242-244
BACKGROUND:Bone mineral density(BMD) is still regarded as the standard of early diagnosis and treatment of osteoporosis(OP) at present.But it is found in detection that different sex,age and skeleton location have different OP detection rate,so it is necessary to analyze the difference. OBJECTIVE:To compare the difference of OP detection rate at different skeleton location between males and females with the increase of age. DESIGN:A cross-sectional study taking patients as the subjects. SETTING:Endocrine department of an artillery general hospital of Chinese PLA. PARTICIPANTS:A total of 147 patients,including 54 males and 93 females, aged from 50 to 78 years old,who were hospitalized in our outpatient clinic from September 2000 to January 2002,were selected and divided into 3 groups according to age,50 to 59 years old group (n=46,13 males and 33 females),60 to 69 years old group (n=66,26 males and 40 females) and 70 to 79 years old group (n=35,15 accordance with the OP diagnostic criteria recommended by WHO[1]. Exclusive criterion: secondary OP patients caused by chronic disease of liver,kidney, heart, and gastrointestinal tract and some endocrine disease such as diabetes,hyperthyroidism and so on. INTERVENTIONS:Every subject filled in the history questionnaire in detail.Height and body mass were measured accurately and body mass index(BMI) was calculated (kg/m2).A new type of Norland Excell plus dual-energy X-ray absorptiometry(DEXA) was used to detect BMD(g/cm2) of L2- 4 and proximate femur(neck of femur, Ward's triangle,greater trochanter).The detected values were compared with the normal data of young adults of the same sex and the T value(SD) was obtained. RESULTS:OP in lumber vertebra was predominant in female climacteric(χ 2=10.14,P< 0.01),and the detection rate of OP in lumber vertebra and neck of femur increased with age(χ 2=7.41, P< 0.05).OP in simple neck of femur increased significantly in males after 60 yeas old(χ 2=9.11,P< 0.05). Females were more liable to suffer from OP in simple lumber vertebra and in both lumber vertebra and neck of femur(χ 2=8.04,P< 0.05;χ 2=14.26,P< 0.01).Age had significant negative correlation with BMD in neck of femur,Ward's triangle and great trochanter of females(r=- 0.364,- 0.389, P< 0.01;r=- 0.504,P< 0.001),while BMI was positively correlated with L2- 4,neck of femur and great trochanter significantly(r=0.306,0.329,0.338,P< 0.05). CONCLUSION:Detection rate of OP changes with skeleton detecting location and age.It is very significant to recognize and evaluate these objective phenomena correctly for the diagnosis and treatment of OP.
6.Troubleshooting of bioinequivalence of compound valsartan tablets.
Da SHAO ; Yi-Fan ZHANG ; Yan ZHAN ; Xiao-Yan CHEN ; Da-Fang ZHONG
Acta Pharmaceutica Sinica 2014;49(4):524-529
The study aims to evaluate the bioequivalence of valsartan hydrochlorothiazide tablets, and to investigate the potential cause of bioinequivalence. This was a single-center study with an open, randomized double-way crossover design. Test and reference preparations containing 160 mg of valsartan and 25 mg of hydrochlorothiazide were given to 36 healthy male volunteers. Plasma concentrations of valsartan and hydrochlorothiazide were determined simultaneously by LC-MS/MS. The pharmacokinetic parameters and relative bioavailability were calculated, while the bioequivalence between test and reference preparations were evaluated. The dissolution profiles of test and reference preparations in four different mediums were determined via dissolution test and HPLC. The similarity was investigated according to the similarity factors (f2). The F(o-t) and F(0-infinity) were (139.4 +/- 65.2)% and (137.5 +/- 61.2)% for valsartan of test preparations. It led to get the conclusion that test and reference preparations were not bioequivalent for valsartan. A significant difference was observed between test and reference tablets in the valsartan dissolution test of pH 1.2 hydrochloric acid solution. The key factor of the bioinequivalence might be that dissolution of valsartan in acid medium has marked difference between two preparations.
Administration, Oral
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Adolescent
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Adult
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Angiotensin II Type 1 Receptor Blockers
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administration & dosage
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adverse effects
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blood
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pharmacokinetics
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Antihypertensive Agents
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administration & dosage
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adverse effects
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blood
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pharmacokinetics
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Area Under Curve
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Chromatography, Liquid
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Cross-Over Studies
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Drug Liberation
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Humans
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Hydrochlorothiazide
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administration & dosage
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adverse effects
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blood
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pharmacokinetics
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Male
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Tablets
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Tandem Mass Spectrometry
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Therapeutic Equivalency
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Valsartan
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administration & dosage
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adverse effects
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blood
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pharmacokinetics
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Young Adult
7.Analysis of CT findings of benign and malignant pancreatic neuroendocrine tumors
Tiegong WANG ; Qian ZHAN ; Fang LIU ; Luguang CHEN ; Chengwei SHAO ; Jianping LU
Chinese Journal of Pancreatology 2015;15(4):242-246
Objective To explore the CT findings of benign and malignant pancreatic neuroendocrine tumors and improve its diagnostic accuracy.Methods The clinical information and enhanced CT findings of 96 cases with pathologically-proved pancreatic neuroendocrine tumors were retrospectively reviewed.The CT findings were evaluated by several factors,which included tumor size,morphology,location,internal composition,calcification,separation,bile duct and pancreatic duct dilation and CT value.Results All cases were divided into benign or malignant according to pathological grades,and benign group involved 40 cases with 41 lesions,while malignant group involved 56 cases with 59 lesions.The size of malignant lesions was significantly larger than that of benign lesions (median size 6.0 cm vs 2.2 cm),the shape of the lesions was irregular,and was mainly cystic solid,and mottling,curve shape,clumps calcification was present,then the bile duct and pancreatic duct was mild to moderately dilated,and the difference between the two groups was statistically significant (P <0.05).But the difference of tumor location,separation was not significant.45.76% (27/59) of the malignant lesions reached the peak value in arterial phase,and 44.07% (26/59) reached the peak value in venous phase;while 68.29% (28/41) of the benign lesions reached the peak value in arterial phase,and 31.71% (13/41) reached the peak value in venous phase.The CT values of malignant lesions in plain CT scanning,arterial phase,venous phase,balance phase were (39.02 ±7.53),(121.20 ± 54.73),(125.25 ± 40.77),(101.41 ± 28.68) Hu,while they were (41.49 ± 8.59),(144.73 ± 53.95),(157.05 ±44.72),(121.02 ±29.80) Hu in benign group.In plain CT scanning,the difference of CT value between malignant and benign lesions was not significant;but in the enhanced phase,the CT value of malignant lesions was significantly lower than that of benign lesions,and the difference was statistically significant (P < 0.05).Conclusions The lesion with its size ≥ 3.0 cm,irregnlar morphology,cystic necrosis,calcification,pancreatic and bile duct dilatation is suggestive of malignancy tumor.The average CT values of malignant group are lower than those of the benign group in arterial,venous and balance phases.
8.TOXICITY AND TISSUE SCHIZONTOCIDAL ACTIVITY OF PRIMAQUINE COMBINED WITH PYRONARIDINE IN LABORATORY ANIMALS
Baoruo SHAO ; Chongqin ZHAN ; Keyong CHEN ; Xiuyu YC ; Baoying LIN ; Shuhua HA ; Yunzheng SHANG
Chinese Journal of Parasitology and Parasitic Diseases 1987;0(01):-
Groups of mice were administered intragastrically either with primaquine alone or in combination with pyronaridine. The number of mice died in groups treated by pyronaridine 293-507 mg/kg combined with primaquine 50 mg/kg were not more than those in group by primaquine alone, but significantly less than those in groups by combination of chloroquine 102-253 mg/kg and primaquine. The tests of primary tissue schizontocidal activity in rhesus monkeys inoculated, with Pladmodium cynomolgi sporozoitcs showed that all monkeys were cured either by treatment of ig primaquine alone, 3 mg/kg/d ? 3, or by a single im dose of pyronaridine 10 mg/kg combined with primaquine starting on the day of infection. No influence of pyronaridine on primaquine was observed in P. yoelii sporozoites-infected mice.
9.Hand-assisted laparoscopic hepatectomy for left hepatoma
Shao-Geng ZHANG ; Yong-Biao CHEN ; Xiao-Jing ZHAN ; Yuan GAO ; Wei-Ming WEI ;
Chinese Journal of General Surgery 2000;0(12):-
Objective To study the feasibility and safety of hand-assisted laparoscopic hepatectomy for huge left hepatoma.Methods Nine patients with huge left hepatoma underwent hand- assisted laparoscopic hepatectomy including hepatocellular carcinoma(4 cases),intrahepatic cholangioearcinoma(1 case),hepatic metastatic squamous carcinoma(1 case),hepatic cavernous hemangioma(2 cases),and hepatic spindle cell tumor(1 case).The mean age was 45.3 years.AFP was positive in 3 cases and CEA was positive in 1 case.The preoperative liver function was Child-Pugh A in all patients.The procedure included dissection of left hepatic ligaments and portal triad clamping with Pringle's maneuver and hepatectomy.Results The laparoscopic procedures were completed safely in all patients including 6 left lateral segmentectomies and 3 left hemihepatectomies.There was no conversion to laparotomy.Mean surgical time was 111.7 minutes.Mean blood loss was 97.8 ml.Portal triad clamping was used in 8 cases and mean clamping time was 13.4 minutes.Neither formidable bleeding nor gas embolism occurred.There were no serious postoperative complications such as postoperative bleeding or bile leak or liver failure.Liver function recovered within 7 to 10 days.Preoperatively positive AFP and CEA turned negative after operation.The mean postoperative hospital stay was 8.4 days.Four patients with HCC underwent postoperative prophylactic hepatic arterial chemoembolization within the first postoperative month. All patients were tumor-free as evaluated by postoperative follow-up of 4~11 months.Conclusions Hand-assisted laparoscopic hepatectomy for huge left hepatoma is feasible and safe in appropriately selected patients.