Prospective Randomized Controlled Clinical Trial Research Articles

Effects of Houpupaiqi mixture on recovery of gastrointestinal function after open gastrointestinal surgery:a multi-center prospective study

Objective To investigate the effects of Houpupaiqi mixture on the recovery of gastrointestinal function after open gastrointestinal surgery,and evaluate the efficacy and safety of Houpupaiqi mixture.Methods A total of 144 selected patients who underwent open gastrointestinal surgery were enrolled into the multi-center prospective randomized double-blind controlled clinical trial from October 2010 to September 2011.Of the 144 patients,66 were from People's Hospital of Peking University,72 were from Beijing Friendship Hospital of Capital University of Medical Sciences,and 6 were from People's Hospital of Guangdong Province.All the patients were randomly divided into 2 groups (test group:96 patients,control group:48 patients) at the ratio of 2∶1 according to the random number table.Five patients who did not meet the criteria were excluded from the study,and then there were 92 patients in the test group and 47 patients in the control group.The study was assessed by the ethics committees,and all the patients signed the informed consent form.Houpupaiqi mixture (50 ml) or placebo (50 ml) were administered in the test group and control group at postoperative 16 and 20 hours,respectively.Parenteral and enteral nutritional support were given after pulling out of gastric tube.A standard intravenous analgesia was applied in the 2 groups,and agents which stimulate or suppress gastrointestinal motility were prohibited.The time for the recovery of regular bowel sounds,the first exhaust and first defecation time,and the time of first solid food intake of the 2 groups were recorded.Vital signs were recored before operation and after drug administration.Blood and urinary routine test,hepatic and renal function test,electrocardiogram examination,record of adverse drug event were carried out at postoperative day 6.The time for the indexes above and relevant frequencies were calculated,and the survival curve were drawn by Kaplan-Meier method.All the time points were analyzed using the Log-rank test.The measurement data were analyzed using the t test or rank-sum test,and the enumeration data were analyzed using the chi-square test or Fisher exact probability.Results The median time for the recovery of regular bowel sounds,median time for first exhaust and defecation were 21.4 (20.0,23.7)hours,45.0 (40.0,54.0) hours and 65.5 (54.7,74.0) hours in the test group,and 47.5 (44.0,56.5) hours,91.0 (87.0,93.8)hours,98.0 (94.0,113.5)hours in the control group,there were significant differences between the 2 groups (Log-rank values =21.67,53.15,11.81,P＜0.05).The median time of first solid food intake were 72.5 (66.2,110.5) hours of the test group and 116.3 (114.8,117.3) hours of the control group,with no significant difference between the 2 groups (Log-rank value =13.70,P ＞ 0.05).There were no significant differences in the body temperature,respiration,heart rate,systolic blood pressure and diastolic blood pressure before and after medication between the 2 groups (Z =0.03,0.68,0.97,0.22,0.72,P ＞ 0.05).There were no significant differences in the number of patients with abnormal results of blood test,hepatic function,renal function and electrocardiogram between the 2 groups (P ＞ 0.05).No severe adverse event was observed in the clinical trial.Conclusion Houpupaiqi mixture significantly promotes the recovery of gastrointestinal function of the patients who underwent open gastrointestinal surgery with relatively low adverse events. Key words: Digestive diseases ; Gastrointestinal surgery ; Houpupaiqi mixture; Gastrointestinal function ; Postoperative ileus

A prospective randomized control clinical trial about clopidogrel combined with warfarin versus clopidogrel alone in the prevention of restenosis after femoral-popliteal artery angioplasty

Using two antithrombotic treatment (clopidogrel vs. clopidogrel combined warfarin) strategies after femoral-popliteal artery angioplasty prospectively, to evaluate which strategy is more effective for the restenosis prevention. Totally 50 patients referred for endovascular treatment (including the percutaneous transluminal angioplasty (PTA) and stent implantation) of the superficial femoral artery and popliteal artery from January 2008 to May 2009 were randomly divided into clopidogrel group (group A, 25 cases, 30 limbs) and clopidogrel plus warfarin group (group B, 25 cases, 33 limbs) before operation. Clinical outcomes and restenosis rate of the target lesions were evaluated at 3, 6 and 12 months after operation. Totally 88 patients were screened for participation in the study, 56 patients were included after the follow-up of 12 months. At 3 months, the rates of restenosis were 16.7% in group A and 18.2% in group B (χ² = 0.025, P = 0.874). At 6 months, the accumulated restenosis rates were 36.7% in group A and 36.4% in group B (χ² = 0.001, P = 0.98). At 12 months, the accumulated restenosis rates were 53.3% in group A and 42.4% in group B (χ² = 0.75, P = 0.387). Analysis for the critical limb ischemia sub-group showed that follow-up of 12 months, the accumulated restenosis rate was 8/10 in group A and 6/12 in group B (χ² = 1.023, P = 0.312). The clopidogrel alone treatment for PTA or PTA plus stent implantation of femoral popliteal artery has no statistically significant difference in comparison with the clopidogrel combined warfarin treatment in terms of the cumulative vascular restenosis rate at 3, 6, 12 months postoperatively.

Bevacizumab and risk of hand-foot syndrome associated with chemotherapy.

e13591 Background: Hand-foot syndrome (HFS) is a dose-limiting cutaneous side effect of many chemotherapeutic agents. Its pathogenesis and risk factors have not been well understood. In this study, we propose that the inhibition of angiogenesis may contribute to the development of HFS. We investigated the risk of chemotherapy-induced HFS in patients treated with bevacizumab, an angiogenesis inhibitor that is widely used for the treatment of various cancers with a systematic review and a meta-analysis of published randomized-controlled clinical trials (RCTs). Methods: Databases from PUBMED, Cochrane Database, and abstracts presented at the American Society of Clinical Oncology until December, 2011 were searched for the identification of relevant studies. Eligible studies included prospective RCTs in which the addition of bevacizumab to chemotherapy was compared directly to chemotherapy alone in cancer patients. Relative risk (RR), and 95% confidence interval (CI) were calculated using a fixed-or random-effects model based on the heterogeneity of the included studies. Results: A total of six RCTs including 5,043 patients (bevacizumab 2665, control 2378) with a variety of tumors were analyzed. The addition of bevacizumab to chemotherapy significantly increased the risk of developing HFS with an RR of 1.68 (95% CI: 1.17-2.40, p=0.005) in comparison to chemotherapy alone. The risk of HFS significantly increased in patients receiving bevacizumab at 2.5 mg/kg/week (RR of 1.88, 95% CI: 1.39-2.54, p<0.001) and at 5 mg/kg/week (RR of 1.19, 95% CI: 1.03-1.36, p=0.016); however, the increased risk of HFS did not vary significantly with bevacizumab dosage (p=0.72) and with tumor types (p=0.92). The increased risk of HFS varied with concurrent chemotherapeutic agents with a significant difference (p=0.034) between docetaxel (RR 6.94, 95% CI: 1.67-28.81) and 5-FU based agents, including capecitabine (RR 1.25, 95% CI: 1.10-1.42). Conclusions: The risk of HFS associated with chemotherapeutic agents significantly increased with the use of bevacizumab, suggesting an important role of angiogenesis in the development of HFS. Moreover, combination with docetaxel appears to confer a higher risk than 5-FU based agents.

Does a Pulsed Mode Offer Advantages Over a Continuous Wave Mode for Excisional Biopsies Performed Using a Carbon Dioxide Laser?

Animal studies of excisional biopsies have shown less thermal damage when a carbon dioxide (CO(2)) laser (10.6 μm) is used in a char-free (CF) mode than in a continuous-wave (CW) mode. The authors' aim was to evaluate and compare clinical and histopathologic findings of excisional biopsies performed with CW and CF CO(2) laser (10.6 μm) modes. This prospective randomized controlled clinical trial included 60 patients with similar fibrous hyperplasias of the buccal plane willing to undergo excisional CO(2) laser biopsy. Patients were randomly allocated to the CW (5 W) or CF (140 Hz, 400 μs, 33 mJ) group. Duration of surgery, intra- and postoperative complications, and the width (micrometers) of the histopathologic collateral thermal damage zone were registered as primary outcome variables. Secondary outcome variables were pain (patients filled in a visual analog scale [VAS]) and analgesic intake (recorded by patients). The study group consisted of 36 women and 24 men with a median age of 50.5 years. Median durations of surgery were 74.5 seconds in the CW group and 83.5 seconds in the CF group. Intraoperative venous bleeding occurred in 16.7% of patients in the CW group and in 13.3% of patients in the CF group. Median areas of histopathologic collateral damage zones were similar in the CW group (166.5 μm) and the CF group (162.5 μm). There was no statistically significant difference between the VAS values of the 2 groups. Analgesic intake was recorded by 16.7% of patients in the CW group and by 6.7% of patients in the CF group (P = .23, not significant). No statistically significant correlation was found between areas of thermal damage zones and postoperative VAS scores. In contrast to previous animal studies, no significant difference was found in the widths of thermal damage zones between the CW and CF groups. The VAS values and analgesic intake were low in the 2 groups. The 2 CO(2) laser modes are appropriate for the excision of intraoral mucosal lesions. A safety border of at least 1 mm is recommended regardless of the laser mode used.

Effect of Xuebijing injection treatment on acute respiratory distress syndrome: a multicenter prospective randomized control clinical trial

To assess the therapeutic effect of Xuebijing injection on adult patients with acute respiratory distress syndrome (ARDS). A multicenter prospective randomized control study was conducted at 10 intensive care units in Jiangsu province. A total of 172 early ARDS patients were randomly divided into Xuebijing treatment and control groups. All patients received routine therapy of ARDS while additional Xuebijing injection 100 ml was administered in the treatment group intravenously for 7 days. Lung injury score, acute physiology and chronic health evaluation II (APACHE II) score, multiple organ dysfunction score (MODS) and PaO2/FiO2 of the patients was recorded before and after treatment. Mortality at 28 days and the duration of mechanical ventilation were compared between two groups. Ninety-one patients were assigned to receive Xuebijing injection and 81 patients as control; Mortality at Days 28 and 90, the duration of mechanical ventilation and ventilation free days showed no difference between two groups (P > 0.05). PaO2/FiO2 improved after randomization versus pre-treatment in all patients. There was no significant difference between two groups. Murray scores were not significantly different between two groups. In a subgroup analysis of patients with pulmonary infection, pulmonary contusion and extra-pulmonary cause, two groups had no difference in mortality at Day 28, mortality at Day 90, the duration of mechanical ventilation, ventilation free days and days of ICU stay (P > 0.05). The treatment of Xuebijing injection early in course of ARDS does not improve the mortality of ARDS patients. But it may improve lung function and oxygenation. Further studies are warranted.

Medical Exercise Therapy is Effective After Arthroscopic Surgery of Degenerative Meniscus of the Knee: A Randomized Controlled Trial

BackgroundThere is no consensus in postoperative rehabilitation regimen for people who had undergone surgery for degenerative medial meniscus damage. The aim of this study was to examine whether it is beneficial to undergo postoperative physiotherapy after surgery for these patients.MethodsA prospective randomized controlled clinical trial. Over a 4 month period, 70 participants were randomly assigned into a high repetitive, high dosage medical exercise therapy group (EG) (n = 36) or into a control group (CG) (n = 34). Pain was a composite score of visual analogue scale (VAS). Function was measured with a functional assessment questionnaire (KOOS). Muscle strength was measured with a five repetition maximum test of quadriceps femoris.ResultsPrognostic variables were similar between the groups at baseline. Five (7%) people dropped out during the treatment period. The EG achieved significantly better outcome effects than the CG at pain (VAS reduced 1.9 in EG and 0.6 in CG) and function (KOOS decreased 18 in EG and only 6 in CG).ConclusionsFor people who have undergone surgery for degenerative meniscus damage, postoperative high repetitive, high dosage medical exercise therapy is an efficient treatment alternative compared to no rehabilitation.

The effect of black tea on risk factors of cardiovascular disease in a normal population

ObjectivesA prospective randomized controlled clinical trial determined the effect of Mauritian black tea consumption on fasting blood plasma levels of glucose, lipid profiles and antioxidant status in a normal population. MethodsThe study group (71%) consumed 3 x 200ml of black tea infusate/day for 12weeks without additives followed by a 3week wash-out. The control group (29%) consumed equivalent volume of hot water for same intervention period. ResultsThe tea used had high levels of gallic acid derivatives (50±0.4mg/L), flavan-3-ols (42±2mg/L), flavonols (32±1mg/L) and theaflavins (90±1mg/L). Daily 9g supplementation of black tea infusate induced, in a normal population, a highly significant decrease of fasting serum glucose (18.4%; p<0.001) and triglyceride levels (35.8%; p<0.01), a significant decrease in LDL/HDL plasma cholesterol ratio (16.6%; p<0.05) and a non significant increase in HDL plasma cholesterol levels (20.3%), while a highly significant rise in plasma antioxidant propensity (FRAP: 418%; p<0.001) was noted . ConclusionBlack tea consumed within a normal diet contributes to a decrease of independent cardiovascular risk factors and improves the overall antioxidant status in humans.

An unusual solitary endobronchial pulmonary arteriovenous malformation in a 10 year-old child

Pulmonary arteriovenous malformations (PAVMs) are relatively rare in children. They may occur both as single isolated anomalies and, much more commonly, as one of many widely distributed arteriovenous malformations (AVMs) in other organs and anatomic locations such as the liver, brain, nose and spine. The latter phenotypically defines the condition known as Hemorrhagic Hereditary Telengiectasia (HHT). We report a case of a 10 year-old female with an isolated endobronchial right lower lobe PAVM. The patient's chest radiograph and fine-cut contrast-enhanced CT (CECT) of the neck and thorax were both uncharacteristically normal and, hence, non-diagnostic. Surgical lobectomy was the only means by which to both diagnose and treat this life-threatening condition. This unique case points out the dilemma facing the physician in such a case with only two management options neither of which is ideal: to either obtain a diagnosis with biopsy which is minimally invasive yet life-threatening due to the potential for fatal hemorrhage, or to perform a pulmonary lobectomy which entails removal of an entire lobe of the lung without a pre-operatively confirmed indication to justify the procedure. To our knowledge, this is the first reported case of a child with an endobronchial PAVM who did not carry the diagnosis of HHT, had normal chest radiography, and had a normal fine-cut CECT of the neck and thorax where such a management dilemma arose. This case points out that a high index of suspicion for PAVMs must be maintained despite normal chest radiography and CECT of the chest. In such cases, empiric lobectomy becomes the sole therapeutic and definitive diagnostic intervention. We hope that such a case published in the literature serves as a guide to physicians confronting similar circumstances as the rarity of such a constellation of variables precludes higher levels of evidence reporting such as a retrospective case series or prospective randomized controlled clinical trials.

The role of hysteroscopy before intracytoplasmic sperm injection (ICSI): a randomized controlled trial

The role of hysteroscopy before intracytoplasmic sperm injection (ICSI): a randomized controlled trial

The effect of bevacizumab on primary progressive cancers.

e13075 Background: Effective treatment has not been identified for primary progressive cancers, which are characterized by rapid progression within 3 months. We hypothesized that angiogenesis may play an important role in the development of primary progression. Therefore, we conducted a systematic review and meta-analysis of published randomized controlled clinical trials (RCTs) to assess the effect of the angiogenesis inhibitor bevacizumab on primary progressive tumors. Methods: Databases from PUBMED, the Web of Science, and abstracts presented at the American Society of Clinical Oncology (ASCO) conferences until December 1st, 2010 were searched to identify relevant studies. Primary progressive cancer was defined as progressive disease to systematic anti-neoplastic therapy as the best response by RECIST criteria. Eligible studies included prospective RCTs in which the combination of bevacizumab and chemotherapy or biological therapy was compared to chemotherapy or biological therapy alone in cancer patients. Summary incidence of primary progressive cancer, relative risk (RR), and 95% confidence interval (CI) were calculated based on the heterogeneity of included studies. Results: A total of 2,981 patients with a variety of advanced tumors from 6 studies were included for analysis. The overall incidence of primary progressive cancer with chemotherapy or biological therapy was 33.2% (95% CI: 20.7-48.6%). When compared to the systematic therapy alone, the addition of bevacizumab significantly reduced the overall risk of primary progression (27.8% versus 33.2%; RR 0.86, 95% CI: 0.78-0.96, p<0.006). However, the effect varied significantly with tumor types (p=0.001), with the highest reduction seen in patients with renal cell cancer (RR 0.61; 95% CI: 0.46-0.80) and the lowest in malignant mesothelioma (RR 1.34, 95% CI: 1.03-1.74). The risk reduction did not vary significantly with bevacizumab doses (p=0.91) and chemotherapy regimens (p=0.13). The risk reduction was significantly correlated with an increase in response rate (p=0.003). Conclusions: The addition of bevacizumab to chemotherapy or biological therapy may be effective in the treatment of primary progressive cancers.

Feasibility and preliminary effectiveness of ice therapy in patients with an acute tear in the gastrocnemius muscle: a pilot randomized controlled trial

Objective: To investigate the feasibility of a randomized controlled trial and the preliminary effectiveness of ice therapy in the acute phase of a gastrocnemius tear for the quality of functional recovery. Design: A pilot version of an intended prospective randomized controlled clinical trial was conducted. Participants: A total of 19 patients with an acute tear in the gastrocnemius muscle were randomly allocated to either active or control treatment. Intervention: The intervention consisted of the repeated application of crushed ice. Main measures: Primary outcome measures were functional capacity and reconvalescence time. Secondary outcome measures were pain and work absenteeism. The number of patients we could include within the 6-hour time window and dropping out from the pilot study were regarded as indicators of the feasibility of ice therapy. Results: A total of 16 patients were excluded from the study because diagnosis was not made within 6 hours after onset of the complaint. The 19 patients included completed the treatment. For functional capacity, reconvalescence time, work absenteeism and pain relief, no significant differences between the intervention and control group were found. Conclusions: The execution of a randomized controlled trial on ice therapy for acute gastrocnemius tear is feasible though quite an enterprise. First, it is recommended to improve the recruitment processes. Second, power analysis demands inclusion of 396 participants. Preliminary effectiveness in our limited-sized trial indicates that the use of ice is not beneficial for people who receive ice therapy.

Increased Risk of High-Grade Hypertension With Bevacizumab in Cancer Patients: A Meta-Analysis

Hypertension is associated with the use of bevacizumab, an angiogenesis inhibitor widely used in cancer therapy. Currently, the risk of severe hypertension associated with bevacizumab is unclear. We performed a systematic review and meta-analysis of published randomized-controlled clinical trials (RCTs) to assess the risk of high-grade hypertension in cancer patients treated with bevacizumab. Databases from PUBMED, the Web of Science, and abstracts presented at the American Society of Clinical Oncology conferences until May 2009 were searched to identify relevant studies. Eligible studies included prospective RCTs in which bevacizumab was directly compared with controls in cancer patients receiving concurrent antineoplastic therapy. Summary incidence, relative risk (RR), and 95% confidence interval (CI) were calculated employing a fixed- or random-effects model based upon the heterogeneity of the included studies. A total of 12,656 patients with a variety of tumors from 20 studies were included for the analysis. The incidence of all-grade hypertension in patients receiving bevacizumab was 23.6% (95% CI: 20.5-27.1) with 7.9% (95% CI: 6.1-10.2) being high-grade (grade 3 or 4). Patients treated with bevacizumab had a significantly increased risk of developing high-grade hypertension with an RR of 5.28 (95% CI: 4.15-6.71, P < 0.001) in comparison with controls. Even though not statistically significant, there was a trend suggesting that bevacizumab may increase the risk of hypertensive crisis (grade 4) with an RR of 3.16 (95% CI: 0.91-10.90). The increased risk of high-grade hypertension was observed in patients receiving bevacizumab at 2.5 mg/kg/week (RR = 4.78, 95% CI: 3.59-6.36) as well as 5 mg/kg/week (RR = 5.39, 95% CI: 3.68-7.90). The risk of high-grade hypertension may vary with tumor types, with RRs ranging from 2.49 (95% CI: 0.94-6.59) in patients with mesothelioma to 14.80 (95% CI: 0.92-238.51) in patients with breast cancer. Bevacizumab may significantly increase the risk of high-grade hypertension in cancer patients. Close monitoring and adequate management are highly recommended to decrease cardiovascular complications.

Discrete cerebral hypothermia in the management of traumatic brain injury: a randomized controlled trial

Hypothermia has been extensively evaluated in the management of traumatic brain injury (TBI), but no consensus as to its effectiveness has yet been reached. Explanatory hypotheses include a possible confounding effect of the neuroprotective benefits by adverse systemic effects. To minimize the systemic effects, the authors evaluated a selective cerebral cooling system, the CoolSystem Discrete Cerebral Hypothermia System (a "cooling cap"), in the management of TBI. A prospective randomized controlled clinical trial was conducted at Grady Memorial Hospital, a Level I trauma center. Adults admitted with severe TBI (Glasgow Coma Scale [GCS] score < or = 8) were eligible. Patients assigned to the treatment group received the cooling cap, while those in the control group did not. Patients in the treatment group were treated with selective cerebral hypothermia for 24 hours, then rewarmed over 24 hours. Their intracranial and bladder temperatures, cranial-bladder temperature gradient, Glasgow Outcome Scale (GOS) and Functional Independence Measure (FIM) scores, and mortality rates were evaluated. The primary outcome was to establish a cranial-bladder temperature gradient in those patients with the cooling cap. The secondary outcomes were mortality and morbidity per GOS and FIM scores. The cohort comprised 25 patients (12 in the treatment group, 13 controls). There was no significant intergroup difference in demographic data or median GCS score at enrollment (treatment group 3.0, controls 3.0; p = 0.7). After the third hour of the study, the mean intracranial temperature of the treatment group was significantly lower than that of the controls at all time points except Hours 4 (p = 0.08) and 6 (p = 0.08). However, the target intracranial temperature of 33 degrees C was achieved in only 2 patients in the treatment group. The mean intracranial-bladder temperature gradient was not significant for the treatment group (p = 0.07) or the controls (p = 0.67). Six (50.0%) of 12 patients in the treatment group and 4 (30.8%) of 13 in the control group died (p = 0.43). The medians of the maximum change in GOS and FIM scores during the study period (28 days) for both groups were 0. There was no significant difference in complications between the groups (p value range 0.20-1.0). The cooling cap was not effective in establishing a statistically significant cranial-bladder temperature gradient or in reaching the target intracranial temperature in the majority of patients. No significant difference was achieved in mortality or morbidity between the 2 groups. As the technology currently stands, the Discrete Cerebral Hypothermia System cooling cap is not beneficial for the management of TBI. Further refinement of the equipment available for the delivery of selective cranial cooling will be needed before any definite conclusions regarding the efficacy of discrete cerebral hypothermia can be reached.

Comparison of gingival blood flow during healing of simplified papilla preservation and modified Widman flap surgery: a clinical trial using laser Doppler flowmetry

This prospective randomized-controlled clinical trial compared the gingival blood flow responses following simplified papilla preservation (test) versus modified Widman flap (control). Twenty contra-lateral upper sites with pocket depth > or = 5 mm after initial treatment in 10 chronic periodontitis patients were randomly assigned to either test or control treatment, using a split-mouth design. Laser Doppler flowmetry recordings were performed pre-operatively, following anaesthesia, immediately post-operatively and on days 1, 2, 3, 4, 7, 15, 30 and 60, at nine selected sites per flap. Significant ischaemia was observed at all sites following anaesthesia and immediately post-operatively. At the mucosal flap basis, a peak hyperaemic response was observed on day 1, which tended to resolve by day 4 at the test sites, but persisted until day 7 at the control sites. The buccal and palatal papillae blood perfusion presented the maximum increase on day 7 in both groups and returned to baseline by day 15. Both surgical modalities yielded significant pocket depth reduction, recession increase and clinical attachment gain. Periodontal access flaps represent an ischaemia-reperfusion flap model. The simplified papilla preservation flap may be associated with faster recovery of the gingival blood flow post-operatively compared with the modified Widman flap.

Early hospital discharge versus continued hospitalization in febrile pediatric cancer patients with prolonged neutropenia: A randomized, prospective study

Hospitalization with single or multi-agent antibiotic therapy has been the standard of care for treatment of febrile neutropenia in cancer patients. We hypothesized that an empiric antibiotic regimen that is effective and that can be administered once-daily will allow for improved hospital utilization by early transition to outpatient care. Febrile pediatric cancer patients with anticipated prolonged neutropenia were randomized between a regimen of once-daily ceftriaxone plus amikacin (C + A) and imipenem monotherapy (control). Afebrile patients on C + A satisfying "Early Discharge Criteria" at 72 hr continued treatment as outpatients. We compared the outcome, adverse events, duration of hospitalization, and cost between both groups. A prospective randomized controlled clinical trial was conducted on 129 febrile episodes in pediatric cancer patients with prolonged neutropenia. No adverse events were seen in 32 children (84% of study arm) treated on an outpatient basis. We found a statistically significant difference between the duration of hospitalization of the C + A group [median 5 days] and control [median 9 days](P < 0.001), per episode antibiotic cost (P < 0.001) and total episode cost (P < 0.001). There was no statistically significant difference in the response to treatment at 72 hr or after necessary antimicrobial modifications. We conclude that pediatric febrile cancer patients initially considered at risk for sepsis due to prolonged neutropenia can be re-evaluated at 72 hr for outpatient therapy. The convenience, low incidence of adverse effects, and cost benefit of the once-daily regimen of C + A may be particularly useful to reduce the overall treatment costs and duration of hospitalization.

Distal Splenorenal Shunt Versus Transjugular Intrahepatic Portal Systematic Shunt for Variceal Bleeding: A Randomized Trial

Variceal bleeding refractory to medical treatment with beta-blockers and endoscopic therapy can be managed by variceal decompression with either surgical shunts or transjugular intrahepatic portal systemic shunts (TIPS). This prospective randomized trial tested the hypothesis that patients receiving distal splenorenal shunts (DSRS) would have significantly lower rebleeding and encephalopathy rates than TIPS in management of refractory variceal bleeding. A prospective randomized controlled clinical trial at 5 centers was conducted. One hundred forty patients with Child-Pugh class A and B cirrhosis and refractory variceal bleeding were randomized to DSRS or TIPS. Protocol and event follow-up for 2-8 years (mean, 46 +/- 26 months) for primary end points of variceal bleeding and encephalopathy and secondary end points of death, ascites, thrombosis and stenosis, liver function, need for transplant, quality of life, and cost were evaluated. There was no significant difference in rebleeding (DSRS, 5.5%; TIPS, 10.5%; P = .29) or first encephalopathy event (DSRS, 50%; TIPS, 50%). Survival at 2 and 5 years (DSRS, 81% and 62%; TIPS, 88% and 61%, respectively) were not significantly different (P = .87). Thrombosis, stenosis, and reintervention rates (DSRS, 11%; TIPS, 82%) were significantly (P < .001) higher in the TIPS group. Ascites, need for transplant, quality of life, and costs were not significantly different. DSRS and TIPS are similarly efficacious in the control of refractory variceal bleeding in Child-Pugh class A and B patients. Reintervention is significantly greater for TIPS compared with DSRS. Because both procedures have equivalent outcomes, the choice is dependent on available expertise and ability to monitor the shunt and reintervene when needed.

Spinal Anesthesia with an Indwelling Catheter Reduces the Stress Response in Pediatric Open Heart Surgery

Extreme stress and inflammatory responses to open heart surgery are associated with increased morbidity and mortality. Based on both animal and adult human data, it was hypothesized that spinal anesthesia would be more effective at attenuating these responses than conventional high dose intravenous opioid techniques in infants and young children undergoing open heart surgery. A prospective randomized controlled clinical trial was performed in 60 children aged up to 24 months undergoing open heart surgery. Patients were randomly assigned to receive either high-dose intravenous opioid or high-dose intravenous opioid plus spinal anesthesia. Spinal anesthesia was administered via an indwelling intrathecal catheter. Spinal anesthesia significantly reduced the stress responses as measured by plasma norepinephrine and epinephrine concentrations (both P < 0.05). Spinal anesthesia reduced plasma lactate concentrations (P < 0.05), but increased fluid requirements during the first postoperative day (P < 0.05). There were no differences in other cardiovascular parameters. Continuous spinal anesthesia reduces stress responses in infants and young children undergoing cardiac surgery with cardiopulmonary bypass more effectively than high-dose intravenous opioids alone.

Oral misoprostol vs. vaginal misoprostol for termination of pregnancy with intrauterine fetal demise in the second-trimester

Misoprostol a synthetic prostaglandin E/1 analog widely prescribed for the prevention and treatment of peptic ulcer has become an important drug in obstetrics and gynecology. We have recently reported its ability to bring about cervical changes uterine contractions and successful induction of labor at term. Misoprostol has also been found to be effective in inducing abortion and therefore offers an effective alternative to the available medical and surgical options in second-trimester abortion. Because of the different pharmacokinetics when given orally or vaginally the optimum dosage and route of administration have not been definitively determined w4x. We performed a prospective randomized-controlled clinical trial at Wad Medeni Teaching Hospital to compare the efficacy of oral misoprostol with that of vaginal misoprostol for pregnancy termination in cases of intrauterine fetal demise in the second trimester. (excerpt)

CLINICAL TRIAL OF PROPHYLAXIS OF WOUND SEPSIS IN ELECTIVE COLORECTAL SURGERY COMPARING TICARCILLIN WITH INIDAZOLE

A prospective randomized single blind controlled clinical trial was undertaken to compare prophylactic therapy using a systemic antibiotic active against both aerobic and anaerobic bacteria with an oral antibiotic agent active only against anaerobic bacteria in elective colorectal surgery. One hundred and thirty-one patients received ticarcillin and 130 received tinidazole. The wound infection rate was 8% in those patients receiving ticarcillin prophylaxis and 20% in those receiving tinidazole (P < 0.05). Multivariate analysis of the factors affecting wound infection rate showed that there were three independent factors that reached statistical significance: the prophylactic antibiotic used; the type of hospital (public or private) in which the operation was performed, and the presence of a stoma at operation. The wound infection rate in those patients receiving tinidazole prophylaxis was more than twice that reported previously by the authors. The mortality in patients receiving ticarcillin prophylaxis was 1.5% compared to 9.2% in those receiving tinidazole prophylaxis (P < 0.05). The clinical anastomotic leakage rate was similar in each antibiotic prophylactic group, 8.6% in those receiving ticarcillin and 7.3% in those receiving tinidazole.