Objective To evaluate the effects of different types of extracorporeal circuits (ECCs) on the concentrations of sufentanil in the priming solution.Methods The experiment was performed in three groups (n =6 each).Two types of ECCs were used:Xi-jing type 90 oxygenator (group Ⅰ) and Termo Capiox SX18 membrane oxygenator (group Ⅱ),while in control group (group Ⅲ) a glass container was used.The ECC and glass container were filled with the priming solution (succinylated gelatin 1000 ml + lactated Ringer' s solution 1000 ml).Sufentanil 15 μg (concentration 7.5 ng/ml) was then added to the priming solution.The priming solution was circulated in the closed ECC or stirred in the glass container.The concentration of sufentanil in the priming solution was determined by gas chromatography-mass spectrometry at 3,5,10,20,30,40,50,60,70,80 and 90 min after addition of sufentanil.Results The concentration of sufentanil in the priming solution was significantly decreased at the different time points in groups Ⅰ and Ⅱ as compared with group Ⅲ (P ＜ 0.05).The concentration of sufentanil in the priming solution was significantly lower at each time point in group Ⅰ than in group Ⅱ (P ＜0.05).Conclusion Both the two types of ECCs can absorb sufentanil and the adsorption of Xi-jing type 90 oxygenator is stronger than that of Termo Capiox SX18 membrane oxygenator.

Objective To compare the pharmacokinetics of remifentanil during general anesthesia in children and adults.Methods Eight children(4 male,4 female)and 8 adults(4 male,4 female),undergoing elective operation under general anesthesia,were randomly divided into 2 groups(n=8 each):group adults(aged 19-60 yr,weighing 45-81 kg)and group children(aged 10 months-7 yr,weighins 7.2-21.0 kg).Remifentanil 5μg/kg was injected intravenously during induction of anesthesia.Arterial blood samples 1.0 ml were taken at 1,2,3,5,7,10,15,20,25,30,45 and 60 min after injection for determination of the plasma concentrations of remifentanil.The pharmacokinetic parameters were calculated using software 3P97.Results Elimination half-life was significantly shorter and apparent volume of distribution and clearance were significantly greater in children than in adults(P<0.05),while no significant change was found in the other pharmacokinetic parameters between the two groups(P>0.05).Conclusion There is difference in the pharmacokineties of remifentanil during general anesthesia between children and adults.The plasma concentration of remifentanil is lower in children than in adults after using the same dose,and the dose should be increased appropriately.

Objective To study the age difference of remifentanil in pharmacokinetics. Methods ASA class Ⅰ or Ⅱ patient,s undergoing selective operation under general anestesia were assigned into group A (65 to 82 years old) and group B(18 to 64 years old) with 60 cases each. Remifentanil 4 μg/kg was infused during induction. Arterial blood samples 1 ml were taken at 1,2,3,5,7,10,15,20,25,30,45,60 min after injection and the concentrations of remifentanil were detected using liquid-liquid extraction and capillary GC-MS-SIM. Results The values of elimination half-tirne(t_(1/2β)), volume distribution(Vd) and clearance(CL) were significantly higher in group A than those in group B[t_(1/2β), (18. 1±9. 2) min vs. (9. 4±4. 6) min, Vd, (60.7±18.2) L vs. (45.3±10.6)L, CL, (2.1±0.3) L/min vs. (3.8±0.4) L/min](P<0.05). Conclusion The t_(1/2β),Vd and CL are significantly higher in the elderly than those in the younger.

0. 5mV or change in color of myocardium in the ischemic area. Blood samples were taken from right atrium for determination of plasma levels of TXB2 and 6-keto-PGFla before epidural block (T0), 40 min after occlusion of coronary artery(T1 ) and 1, 3 and 5 h after reperfusion was started(T2-4 ) . Results There was no significant changes in MAP, HR and CVP in group Ⅱ while in group Ⅰ MAP decreased by 22%, HR 25% and CVP 28% after epidural block as compared with the baseline at T0 . TXB2 levels and TXB2/6-keto-PGF1a ratio increased gradually and significantly from T2-4 as compared with the baseline (T0) and those at T1 in both groups. TXB2 levels and TXB2/6-keto-PGF1a ratio were higher in group Ⅱ those in group 1111111 at T1-4 (P

0.5 mV and change in color of myocardium. Blood samples were taken from right atrium for determination of plasma SOD activity and plasma MDA level and from coronary sinus and artery for determination of blood lactate level before occlusion of LAD ( T0 ) , before reperfusion (T1),1,2,3,4,5,6 h after reperfusion (T2-7 ) . Myocardial lactate production was calculated from the difference between coronary sinus and arterial blood lactate concentrations. Results ( 1) In HTEA group HR, MAP and CVP decreased by 22% , 25% and 28% after epidural blockade, while in control group there was no significant change after epidural saline. (2) In HTEA group plasma SOD activity started increasing at T6 and blood MDA level decreased at T4 and T5, whereas in control group blood SOD activity started decreasing and blood MDA level started increasing at T3 . (3) Myocardium released no lactate before ischemia. Myocardial lactate release greatly increased during ischemia and started decreasing after reperfusion in both groups. But myocardial lactate production was significantly less in HTEA group than that in control group. (4) One animal died from ventricular fibrillation at the beginning of reperfusion in HTEA group while in control group four animals died. Conclusion HTEA can alleviate the myocardial ischemia-reperfusion injyry by blocking sympathetic nervous activity.

Objective To modify gas chromatography-mass spectrometry (GC-MS) for determination of plasma sufentanil concentrations.Methods Fentanyl was used as the internal standard.The plasma samples were extracted with ethyl acetate and petroleum ether.An HP-5MS capillary column was used.The initial temperature of the column was set at 130 ℃,and the final temperature was 320 ℃.The injector port temperature was set at 290 ℃,and the interface temperature was 300 ℃.The carrier gas was high purity helium (purity 99.999％) with a constant flow rate of 1 ml/min.The injection volume was 1 μl with splitless injection.The MS conditions were as follows:EI source,ion source temperature 230 ℃,four-pole temperature 150 ℃,electron bombardment energy 70 eV,multiply voltage 2112 V,selective ion monitoring mode,solvent delay 7 min.The characteristic ions of sufentanil and fentanyl were obtained in 8.20-8.40 min and 7.60-7.80 min,respectively,according to the characteristic ion curve of sufentanil and fentanyl.Results The standard curve of sufentanil had good linear relationship in the range of 0.02-10.00 ng/ml and the equation was Y =0.1625X + 0.0316,R2 =0.9987.The extraction recovery was more than 80％,intra-day and inter-day determinations were less than 8％,and the limit of detection was 0.02 ng/ml.Conclusion When modified GC-MS is applied to determine the concentrations of sufentanil in plasma,not only the determination is sensitive and accurate,but also the procedures are simplified,and it is more suitable for the pharmacological research of sufentanil.

According to Standard Protocol Items: Recommendations for Interventional Trials, Consolidated Standard of Reporting Trials 2010 Statement (CONSORT), CONSORT Extension for Non-Pharmacologic Treatment Interventions (CONSORT for NPT) and Good Clinical Practice, the detailed requirements for protocol writing, reporting, and practicing of clinical trial were classified and summarized in this article. By combining the practical situation of clinical trial of external treatment of TCM such as tuina, the requirernents for clinical trial protocol writing of external treatment of TCM were analyzed and acquired which could improve the quality of clinical trial protocol of external treatment of TCM, thus to provide references for standardized execution of TMC clinical trial and reports of research results.
Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Humans ; Massage ; standards ; Quality Control ; Reference Standards

Objective To evaluate the cerebral protection of dexmedetomidine during craniotomy under general anesthesia in the patients with craniocerebral injury.Methods Sixty patients with craniocerebral injury,aged 30-50 yr,with body mass index of 18-25 kg/m2,of ASA physical status Ⅱ or Ⅲ,with Glasgow Coma Scale score of 6-12,scheduled for elective craniotomy under general anesthesia,were randomized into 2 groups (n =30 each) using a random number table:control group (group C) and dexmedetomidine group (group Dex).Anesthesia was induced with iv midazolam,propofol,cisatracurium and sufentanil.The patients were endotracheally intubated and mechanically ventilated.In group Dex,dexmedetomidine 1 μg/kg was infused intravenously over 10 min before induction of anesthesia,followed by infusion at a rate of 0.5 μg · kg-1 · h-1 until the end of operation.The equal volume of normal saline was given in group C.Immediately before beginning of surgery (T0),at the moment when the duramater was opened (T1),at 2 h after beginning of surgery (T2),at the duramater closing (T3) and at the end of surgery (T4),blood samples were obtained from the radial artery and jugular venous bulb for blood gas analysis,arteriovenous blood O2 difference and cerebral O2 extraction rate were calculated.The serum concentrations of S-100β were measured by ELISA.Results The serum concentrations of S-100β were significantly increased at T2-4 than at T0 in both groups.The serum concentrations of S-100β were significantly decreased at T2-4 in group Dex than in group C.The parameters of cerebral oxygen metabolism were all within the normal range in both groups.Conclusion Dexmedetomidine (1 μg/kg infused intravenously before induction of anesthesia,followed by infusion at a rate of 0.5 μg · kg-1 · h-1 until the end of operation) provides cerebral protection to some extent during craniotomy under general anesthesia in the patients with craniocerebral injury.

Objective To develop a reliable and reproducible modei of hyperalgesia arising from chronic compression of dorsal root ganglion (DRG) and investigate the contribution of spinal cord dorsal horn calcitonin gene-related peptide (CGRP) to the clinical manifestation of sciatica.Methods Sixty healthy Wistar rats of either sex weighing 200-300 g were randomly divided into three groups: group A control ( n = 12) ; group B sham operation (n = 24) and group C chronic compression of DRG ( n = 24) . In group B and C the animals were anesthetized with intraperitoneal 1.25% thiopental sodium (50mg?kg-1) . The animals were then placed in prone position and the left L4 and L5 intervertebral foramina were exposed. In group C a 4 mm long 1-0 chromic catgut was inserted into the intervertebral foramen. Motor function of the hind limbs was assessed by gait disturbance scores (GDS) , and paw-withdrawal threshold (PWT) was measured with modified Randall algometer 3, 5, 7, 10, 14, 17, 21 and 28 days after operation. In group B and C 12 animals were decapitated on the 5th and 28th days after operation respectively and lumbar section of spinal cord was removed for determination of dorsal horn CGRP content (by radio-immunoassay) and microscopic examination of DRG. Results In chronic compression group (C) significant hyperalgesia occurred after operation and reached a peak one week after operation then gradually decreased but didn't return to normai on the 28th day, while in sham operation group (B) postoperative hyperalgesia quickly decreased and returned to normai on the 7th day. In group C dorsal horn CGRP content on the compressed side significantly increased on the 5th and 28th day after operation as compared with that on the contralateral side in the sham operation and control group. Microscopic examination of DRG showed significant edema of endoneurium and neurons which persisted on the 28th day but significantly attenuated. Conclusion This animal model reliably produces a disorder resembling low back pain. It is easy to perform less traumatic and produces significant hyperalgesia. The dorsal horn CGRP content on the compressed side significantly increases, which is consistent with chronic pain.

Objective To integrative the effect of ulinastatin on postoperative cognitive function in elderly gastric cancer surger-y.Methods Two hundred elderly patients with gastric cancer surgery were randomly divided into observed group (100 cases)and control group (100 cases).Patients in observed group received the intravenous drip of ulinastatin before and after the surgery,while others only received the intravenous drip of physiological saline before and after the surgery.Results The urine output of observed group was (441.7±78.5)mL,which was significantly lower than that in control group as the result was (613.2±81.2)mL(P <0.05).After the treatment,the score of MMSE,visual regeneration and association learning in both observed group and control group were significantly lower than that before the treatment(P <0.05).The scores of MMSE,visual regeneration and association learning in observed group were 24.4±1.5,9.7±1.7 and 12.4±1.8,which were significantly higher than that in control group as the scores were 21.1±1.0,8.7±1.5 and 11.3±1.7 (P <0.05).The level of S100βin serum of observed group at the end of sur-gery,1 day and 3 day after the surgery were (0.099±0.024)μg/L,(0.074±0.026)μg/L and (0.061±0.022)μg/L,which were significantly lower than that in control group as the results were (0.138±0.042)μg/L,(0.110±0.034)μg/L and (0.075±0.031)μg/L (P < 0.05).Conclusion Ulinastatin can not only improve the postoperative cognitive dysfunction in elderly patients with postoperative,but can also reduce the level of S100βin serum.It provides brain protection for patients.