Volume 93  ·   Issue 43  ·  2013

To evaluate the current status and trend of acute stroke randomized controlled trials (RCTs) in Mainland China.

Acute stroke RCTs were retrieved from 8 databases published in Chinese or English language from January 1996 to May 2013.Those with transient ischemic attack (TIA) or traumatic hemorrhage were excluded.Methodological items were referred to the Cochrane Collaboration′s tool for assessing risk of bias.The definitions of Wade were used to assess the outcome measures.The data were processed by SPSS 16.0.Data were summarized as frequency (and%) or median and interquartile range.Difference in proportions was assessed withχ2 test.

A total of 13 493 RCTs were identified.The number of acute stroke RCTs increased by years, but only 52 multi-center RCTs were published.There were 13 multi-center placebo controlled drug trials.Among them, only 3 had a sample size of over 500 cases.In multi-center nondrug trials, only 3 used allocation concealment.The studied types of stroke included ischemic stroke (63.9%, 8623/13 493), intracerebral hemorrhage (30.8%, 4157/13 493) and subarachnoid hemorrhage (5.3%, 713/13 495).There were 61.5% (32/52) multi-center drug trials, including 65.6% (21/32) in Western drug treatment and 34.4% (11/32) in traditional Chinese medicine.There were 38.5% (20/52) non-drug trials including 8 physical therapy, 7 surgery and 5 acupuncture treatment.There were 2 multi-center placebo controlled drug trials and 2 multi-center non-drug trials used mortality/disability for assessing outcome measures over a follow-up period of 90 days or more.

In the past 17 years in mainland China, the number of acute stroke RCTs has increased dramatically, but the high-quality trials are scarce.The future acute stroke trials should pay more attention to true randomization, blinding and better patient outcome measures.

To explore the prognostic value of posterior cerebral artery (PCA) laterality in patients with symptomatic middle cerebral artery (MCA) occlusion on standard medical therapy.

Forty consecutive patients with first onset isolated atherosclerotic occlusion in M1 segment of MCA received medication from June 2009 to March 2013.All patients underwent magnetic resonance angiography (MRA) for assessment of PCA laterality.Clinical data and modified Rankin Scale (mRS) at 3 months were compared between PCA positive and negative patients.Retrospective analysis was performed on their clinical and imaging data.

Among them,20 patients (50%) showed PCA laterality on MRA and 32 patients (80%) completed a 3-month follow-up.No significant difference existed between PCA laterality positive and negative groups in a favorable outcome of mRS=0-1 at 3 months (P=0.433).

The presence of PCA laterality showed no prognostic effect on patients with symptomatic MCA occlusion on standard medical therapy.

To explore the evaluation of ABCD³score in the prediction of stroke risk after transient ischemic attack and the influencing factors of early stroke risks.

From October 2010 to September 2012, the data were prospectively collected from patients with transient ischemic attack according to the World Health Organization time-based criteria.ABCD²and ABCD³scores were available within 7 days of index transient ischemic attack.The predictive outcome was stroke occurrence at 90 days.Risks of stroke stratified according to the score were analysed by Logistic regression.And ABCD²and ABCD³model were compared by AUROCC.

Among 321 eligible patients, 4 cases were lost to follow-up.There were 38 (11.8%) patients with ischemic stroke during a 90-day follow-up, including 22 (57.9%) males, 16 (42.1%) females.There were no occurrence of death, no hemorrhagic stroke.Multivariate analysis revealed that dual TIA (OR=4.116, 95% CI 1.284-3.195), history of stroke (OR=4.022, 95% CI 1.472-10.944) and unilateral weakness (OR=3.117, 95% CI 1.222-7.948) were the risk factors of early stroke.The ABCD³score (0.733, 95% CI,0.0.681-0.780) was statistically higher than that of ABCD²score (0.674, 95% CI, 0.619-0.725) (P<0.05).

ABCD³may effectively predict early risk of stroke after TIA.

To explore the efficacy and safety of intravenous thrombolysis (IVT) directed by whole-brain computed tomographic perfusion (CTP).

A total of 65 patients with acute ischemic stroke at our hospital during the period of April 2011 to April 2013, selected in accordance with the established CTP or TTW standard (0 to 3.0 h and 3.0 to 4.5 h) for IVT were included for analysis.The primary endpoint events were Barthel index (BI) and the rate of serious adverse events at 14 days post-onset.The latter included mortality and symptomatic intracerebral hemorrhage (ICH).And secondary indicators included the incidence of reperfusion, recanalization, ICH and neurological improvement at Day 14, as well as time indicators, such as onset-to-door time (ODT), door-to-treatment time (DTT) and onset-to-treatment time (OTT).Statistical calculations for continuous variables were compared with t or Mann-Whitney U test.And other comparisons were made with Pearson Chi-square or Fisher′s exact test.

Twenty-five and 40 cases with acute ischemic stroke were enrolled according to CTP or TTW standard for IVT respectively.Baseline characteristics, including age, gender, risk factors, blood pressure, blood sugar, National Institute of Health stroke scale (NIHSS) and drug dose showed no significant difference among groups.DTT and OTT in CTP group were significantly longer than those of the 0 to 3.0 h subgroup, while similar with those of the 3.0 to 4.5 h subgroup.Interestingly, consistent with a significant higher rate of transferring for consultation in the CTP group comparing with the TTW group (52.0% vs 25.0%, P=0.03), the rate was also significantly higher than the 0 to 3.0 h subgroup (52.0% vs 7.7%, P=0.02), but not significantly higher than the 3.0 to 4.5 subgroup.Both primary endpoint events and secondary outcome measures among three groups showed no significant differences.As for secondary outcome measures, CTP group had a higher recanalization than the 3.0 to 4.5 h subgroup (52.0% vs 37.0%, P=0.28) and there was a trend toward significance.CTP excluded 58 cases, including 20 proved cases of malignant infarction on magnetic resonance imaging.

CTPis able to select reasonable candidates for IVT in an extended time window with effectiveness and safety comparable to TTW standard.Furthermore, it is quicker and more sensitive than TTW standard in detecting malignant infarction.

To compare the efficacy of laryngeal mask airway-Supreme ^TMversus common laryngeal mask airway in children with general anesthesia.

With local research ethics committee′s approval and written informed parental consent, 100 children were randomly divided into groups L (size 2.0 common laryngeal mask airway) and S (size 2.0 laryngeal mask airway-Supreme^TM) according to random number (n=50 each).After anesthesia induction, a common laryngeal mask airway or laryngeal mask airway-Supreme ^TMwas inserted and mechanically ventilated.Time and ease for insertion, insertion success rate, airway leak pressure, success rate and ease of disposal sputum collecting tube insertion in group S, quality of airway during anesthetic maintenance, abdominal circumference changes and complications within 24 h post-operation were measured.

Compared with group L,abdominal circumference increased less in group S (0.90±0.35 vs 0.43±0.18 cm, n=46, P<0.01).No significant inter-group differences existed for other measurements.Disposal sputum collecting tube was successfully placed in group S (100%).

In children with mechanical ventilation, laryngeal mask airway-Supreme^TMcan be effectively applied to maintain a good airway.And the incidence of gastric insufflation is lower.It is particularly useful for those requiring evacuation of gastric contents during general anesthesia.

To evaluate the outcomes of primary total knee arthroplasty (TKA) in the treatment of knee with severe lateral instability and summarize the essential points of operation and rehabilitation.

From February 2005 to August 2010, primary TKA was performed in 27 severe lateral unstable knees (25 cases), including 3 males (3 knees) and 22 females (24 knees).Their mean age was 57.8 (37-71) years.And their primary diseases included rheumatoid arthritis (22 knees in 21 cases) and osteoarthritis (5 knees in 4 cases).Thirteen lateral unstable knees were accompanied with 18.08°±5.96° (15-35°) varus deformity; in the rest 14 knees, there was medial instability with 20.71°±7.03° (15-35°) valgus deformity.Blood loss volume, operative duration and complications were recorded.During the follow-up period, HSSscore, knee stability and varus/valgus status were recorded preoperatively, 1,3, 6,12 months and then annually postoperatively.

AORI typeⅠ bone defect was found at the proximal tibia in 18 knees and distal lateral femoral condyle in 10 knees.All defects were reconstructed with cement or autograft. AORI typeⅡ bone defects at proximal tibia in 3 knees were reconstructed with metal augmentation.Blood loss during the first 24 hours were (438.9±109.5)(400-700) ml and operative duration (91.1±11.6)(70-110) min.The mean follow-up period was (41.6±10.9)(27-60) months.At the final follow-up, the HSS score increased from (45.8±5.4) to (85.4±4.5)(t=30.15, P<0.01).Five knees in 5 cases had mild postoperative instability.All cases were allowed to walk with knee orthosis for 4-6 weeks.At the end of follow-up, mild lateral instability of 2 knees persisted.One augmented knee had osteolysis beneath metal block.

TKA for knees with severe lateral instability requires a deep understanding of causes and a rational treatment.Proper handling of bone defects and careful release of lateral soft tissue are two critical points for postoperative knee stability.Wearing knee orthosis during the early postoperative stage may be helpful or residual mild instability.

To explore the clinical characteristics of primary biliary cirrhosis (PBC) with Sjögren syndrome (SS) so as to seek diagnostic rationales.

Sixty-four PBC patients, 57 SS patients and 93 PBC with SS patients were recruited from Peking Union College Hospital between 2006 and 2009.And their clinical, laboratory and pathological data were analyzed.

The patients of PBC with SS (53±10) years were older than those of PBC (50±11) years (P<0.05) or SS (48±14) years (P<0.05); Comparing PBC with SS and SS, fever was more in SS (P<0.05); compare with PBC, the positive rates of anti-centromere antibody (ACA)(P<0.05) and anti-SSA antibody (P<0.05) increased obviously in PBC with SS.Comparing with SS,the positive rate of anti-SSA antibody (P<0.05) and anti-SSB antibody (P<0.05) were apparently increased obviously in PBC with SS.

PBC with SSis a special subgroup with the characteristic both PBC and SS.But it can not differentiate from PBC or SS, Anti-SSA antibody and ACA are helpful for diagnosis of PBC with SS.

To explore the correlation of XRCC1 Arg194Trp Arg399Gln SNPs with the risks and clinicopathological factors of cervical cancer.

Polymorphisms Arg194Trp, Arg399Gln of XRCC1 gene in 253 cervical cancer patients and 350 healthy controls were analyzed by mismatch amplification polymerase chain reaction (MAMA-PCR).

Compared with the Arg/Arg genotypes, the Trp/Trp genotypes could increase the risk of cervical cancer (P=0.000).Arg/Arg was a protection factor with an odds ratio of 0.116 (95% CI=0.043- 0.316).The frequency of Arg and Gln allele among cervical cancer and healthy controls were 56.81%, 43.19% and 64.86%, 35.14%.Compared with the Arg genotypes, the Gln genotypes could increase the risk of cervical cancer (P<0.05).Compared with the Arg/Arg genotypes, the Gln/Gln genotypes could increase the risk of cervical cancer (P<0.01).Arg/Arg was a protection factor with an odds ratio of 0.188 (95% CI=0.089-0.398).Using haplotypes 194Trp-399Gln as a reference, women carrying 194Arg-399Gln and 194 Arg-399Arg halpotypes had a significantly decreased risk for cervical carcinoma.The adjusted OR and 95% CI were 0.613[0.446, 0.842] and 0.635[0.449, 0.899].The frequencies of Arg/Arg, Arg/Gln, Gln/Gln genotype had significant relationship with clinical stage and histological grade.Tumor diameter, patient age and neoplastic form had no relationship.

Compared with the Arg/Arg genotypes, the Trp/Trp and Gln/Gln genotypes could increase the risk of cervical cancer.The Trp or Gln genotypes risk increases.Arg may be a protection factor.The frequencies of Arg399Gln SNP have a correlation with stage and histological grade.

To explore the effects of nutritional liquid supplement designed for diabetes mellitus on postprandial glucose state and pregnancy outcomes in patients with gestational diabetes mellitus (GDM).

A total of 69 cases of pregnant GDM women at Department of Obstetrics& Gynecology, First Affiliated Hospital, Chongqing Medical University from October 2011 to January 2012 were randomized into the intervention and control groups.But only 31 cases in intervention group finished the study versus 29 cases in control group.The inter-group differences were analyzed for general clinical profiles before intervention, 2-hour postprandial blood glucose levels and pregnancy outcomes, etc.The General Linear Model Repeated Measures process was used to analyze the variance of 2-hour postprandial blood glucose data.And the Mauchy′s test of sphericity was employed to determine the correlation.

(1) No significant difference in general clinical profiles before intervention between intervention and control groups (P>0.05). (2) The mean values of 2-hour postprandial blood glucose were as follows:intervention group (mmol/L): 6.2±0.7 (1w), 5.9±0.5 (2w),5.7±0.5 (3w), 5.8±0.6 (4w), 5.7±0.5 (5w), 5.7±0.4 (6w), 5.9±0.3 (7w), 6.0±0.4 (8w),6.0±0.5 (9w); control group:6.7±0.3 (1w),6.2±0.4 (2w),6.2±0.5 (3w),6.2±0.4 (4w),6.1±0.4 (5w), 6.0±0.3 (6w),5.8±0.4 (7w),6.1±0.4 (8w),6.1±0.4 (9w).The results of Mauchy′s test of sphericity indicated that the blood glucose level of the intervention group was significantly lower than that of the control group (P<0.01). (3) The incidence of premature rupture of membranes and polyhydramnios, rate of neonatal pneumonia, weight of newborn and pregnancy women and level of glycosylated hemoglobin in intervention group were significantly lower than those in control group (P<0.05).

Compared with common diet, after using nutritional supplement, the postprandial blood glucose level is significantly reduced and the pregnancy outcomes also improved in GDM patients.

To evaluate the efficacy and safety of Kuntai Capsule and Estrogen for Menopausal Syndrome.

Related randomized controlled trials about Kuntai capsule and estrogen in recent 10 years were collected by various kinds of database according to strict inclusion and exclusion criteria.Valid data were extracted to conduct meta-analysis by Rev Man5.0.

A total of 196 articles were retrieved, but only 6 were finally included.Meta-analysis showed that no significant differences were observed in Kupperman score between Kuntai group and estrogen[WMD=0.22,95% CI (-1.14,1.58),P>0.05].While E₂ level was significantly higher in estrogen group than that in Kuntai[WMD=-59.59,95% CI (-87.35,-31.83),P<0.01].The incidence of adverse effects was significantly lower in Kuntai group compared to the estrogen group[RR=0.61, 95% CI (0.45,0.83),P<0.01].

Kuntai can improve symptoms of menopausal syndrome effectively as the same as estrogen and tends to have lower incidence of adverse effects.

To evaluate the correlation between the length of first metatarsal, hallux valgus angle (HVA), intermetatarsal 1-2 angle (IMA1-2), plantar appearance, sesamoid position and postoperative 2-5 transfer metatarsalgia.

Retrospective analysis was performed for the clinical data of 375 cases (626 feet) undergoing osteotomy of first metatarsal with mini-incision.All cases were examined radiographically via weight-bearing and lateral views.H VA, IMA1-2 and the length of first metatarsal were measured preoperatively and postoperatively.Forefoot plantar pressure was measured during walking by Footscan system preoperatively and postoperatively.

After a mean follow-up period of 12-30 (18.5±6.8) months, all patients had satisfactory bone healing without late healing or disunion.There were superficial wound infection (n=1, 1 foot) and suture reaction (n=1, 1 foot).HVA was 7.18°±4.55°postoperatively and corrected by 30.54°; IMA1-2 5.07°±1.70°and corrected by 12.33°.The number of shorting of first metatarsal during 0-2 mm was 424 feet, there was 1 case of transfer metatarsalgia at rays 4; the number during 2-4 mm was 186 feet, there were 5 cases of transfer metatarsalgia at rays 2.The center of pressure shifted laterally; the number during 2-4 mm was 16 feet, there were 4 cases of transfer metatarsalgia at rays 2 and 3.The center of pressure shifted evidently medially; the shorting of first metatarsal was 4.8±0.46 mm.A negative correlation was found between length of metatarsal and transfer metatarsalgia at rays 2 and 3.No correlation existed between transfer metatarsalgia at rays 2 and 5, HVA and IMA1-2.A positive correlation existed between HVA decrease and patient satisfaction with their postoperative foot alignment.There was no correlation between lengthening of metatarsal and IMA1-2 decrease.

Length preservation of first metatarsal seems to prevent the postoperative transfer metatarsalgia on second and third rays.The shorting of first metatarsal should be no more than 2 mm.

To evaluate the efficacy and safety of foam sclerotherapy for lower extremity varicosis in C4 to C6 patients.

A total of 32 patients (32 limbs) with serious lower extremity varicosis classified as C4 to C6 were enrolled.Ultrasonic monitoring of foam sclerotherapy was performed after subfascial endoscopic perforator suture and saphenous vein ligation.They were followed up monthly at outpatient department.Duplex Doppler scan was performed during each interview.

All patients were treated successfully.An average of 3.2 perforators were ligated per leg (1-5 perforators).The average volume of foam sclerosing agent was 27.5 ml per leg.Mild chest tightness was observed in one patient but computed tomography (CT) scan excluded pulmonary embolism.Obvious local inflammatory reaction was observed in 4 patients.Residual vein mass without blood signal was seen in 3 patients.No such serious complication as cerebral ischemia was observed.The average follow-up period was 4.8 (1-10) months.Obvious varicose veins and clinical symptoms disappeared at 1 month.And venous ulcers in patients classified as C5 healed within 3 months.

Ultrasonic monitoring of foam sclerotherapy, incorporation with saphenous vein ligation and subfascial endoscopic perforator suture,is both safe and effective in the treatment of serious lower extremity varicosis classified as C4 to C6.

To explore the effects of endogenous dopamine (DA) on striatum medium spiny neurons (MSNs) in acute brain slices by the means of electrophysiology and elucidate the impact of nigrostriatal circuit loop on the functional status of MSNs.

Various structural combinations of striatum and cortex or/and substantia nigra were used to explore the conditions with appearance of spontaneous two-state voltage oscillations.And the blockage of dopaminergic or glutamic acid receptor was employed to examine how aminoglutaminic acid from cortex and dopamine from substantia nigra influenced two-state voltage oscillations.

It was found that 65.2% (30/46) MSNs recorded in corticostriatonigral slices displayed spontaneous and two-state voltage oscillations.92.3% (24/26) of MSNs in dorsal striatum close to cortex.And the percentage was only 30% (6/20) in ventral striatum.The amplitude of depolarized plateau potential (up state) decreased through a blockage of dopamine receptor (P<0.05).The potential level of up state decreased through a blockage of D1 receptor (P<0.05) and action potentials were stopped.The results of blocking D2 receptors were the increased potentials level of two states (P<0.05).The membrane potential of MSNs showed a stable resting level in corticostriatonigral (-67±3 mV,n=10), corticostriatal (-70±3 mV, n=10), striatal (-73±3 mV, n=10) and nigrostriatal (-71±3 mV, n=10) slices.There was no significant difference (P>0.05).

Endogenous dopamine from substantia nigra may regulate the instantaneous integration and coding of information from cortex by tonic effect on short-term plasticity of paired and short pulses in corticostriatal synapses.

To explore the regulative effects of hydrogen-rich medium on lipopolysaccharide (LPS) -induced monocytes adhesion to human umbilical vein endothelial cells (HUVEC) and vascular endothelial permeability in vitro.

Endothelial cells were seeded in 6-well plates and randomly divided into 4 groups (n=42 each) :control (A), hydrogen-rich medium (B), LPS (C) and LPS+ hydrogen-rich medium (D).Cells were cultured in plain culture medium in groups A and C or in hydrogen-saturated culture medium in groups B and D.LPS 1μg/ml was added into groups C and D.When forming a monolayer, monocytes were added into each group after 6, 12 and 24 h respectively.After a 90-minute co-culturing,adhesion status was detected by Wright-Giemsa stain.Supernatants were collected to detect the concentrations of vascular cell adhesion molecule-1 (VCAM-1) and E-selectin by enzyme-linked immunosorbent assay (ELISA).The expression of VEcadherin was measured by Western blot.Cells were stained with immunofluorescence to show the distribution of VE-cadherin after a 24-hour incubation.

Compared with group A, the adhesion of monocytes to endothelial cells increased (P<0.05) in group C, the levels of E-selectin and VCAM-1 became elevated (P<0.05) while the expression of VE-cadherin decreased significantly (P<0.05).Compared with group C, adhesion decreased in group D (P<0.05), the levels of E-selectin and VCAM-1 decreased (P<0.05) while there was an increased expression of VE-cadherin (P<0.05).Three timepoints showed the same tendency.The results of 24 h fluorescence indicated that, compared with group A, VE-cadherin was incomplete in cell-cell connections in group C.However it was complete and well-distributed in group D versus group C.

Hydrogen-rich medium may reduce the LPS-induced release of adhesion molecules, lessen monocytic adhesion to HUVEC and regulate the expression of VE-cadherin to protect vascular permeability.