Imipenem/cilastatin sodium (IMP/CS) was administered to patients with severe infections complicated by hematological disorders and solid tumors to assess its efficacy and safety. Primary diseases in this series of 76 cases included 37 cases of hematological disorders (acute leukemia in 25 cases, malignant lymphoma in 7 cases, aplastic anemia in 3 cases and 2 other diseases) and 38 cases of solid tumors (lung cancer in 7 cases, gastric cancer in 11 cases, esophageal cancer in 6 cases, pancreatic cancer in 3 cases, bile duct cancer in 4 cases, hepatocellular cancer in 3 cases, and 4 other diseases). Following results were obtained. 1. Types of infection in hematological diseases were sepsis in 5 cases, suspected sepsis in 24 cases, pneumonia in 5 cases and 3 others. The efficacy rates were 100% in sepsis, 62.5% in suspected sepsis, 80% in pneumonia and 73% in all cases. 2. Types of infection in solid tumors were sepsis in 2 cases, suspected sepsis in 13 cases, pneumonia in 10 cases, cholecystitis in 2 cases, cholangitis in 5 cases, liver abscess in 2 cases, and 4 others. The efficacy rates were 50% in sepsis, 69.2% in suspected sepsis, 80% in pneumonia, and 71.1% in all cases. 3. IPM/CS was administered in single use in 66 cases and in combination with other antibiotics in 9 cases. The efficacy rate in the single use was 72.7% and that in the combination use was 66.7%. 4. The efficacy rate in 35 cases of first use was 71.4% and that in 40 cases of second use was 72.5%.(ABSTRACT TRUNCATED AT 250 WORDS)
We developed a protocol to initiate surgical source control immediately after admission (early source control) and perform initial resuscitation using early goal-directed therapy (EGDT) for gastrointestinal (GI) perforation with associated septic shock. This study evaluated the relationship between the time from admission to initiation of surgery and the outcome of the protocol.This examination is a prospective observational study and involved 154 patients of GI perforation with associated septic shock. We statistically analyzed the relationship between time to initiation of surgery and 60-day outcome, examined the change in 60-day outcome associated with each 2 hour delay in surgery initiation and determined a target time for 60-day survival.Logistic regression analysis demonstrated that time to initiation of surgery (hours) was significantly associated with 60-day outcome (Odds ratio (OR), 0.31; 95% Confidence intervals (CI)), 0.19-0.45; P <0.0001). Time to initiation of surgery (hours) was selected as an independent factor for 60-day outcome in multiple logistic regression analysis (OR), 0.29; 95% CI, 0.16-0.47; P <0.0001). The survival rate fell as surgery initiation was delayed and was 0% for times greater than 6 hours.For patients of GI perforation with associated septic shock, time from admission to initiation of surgery for source control is a critical determinant, under the condition of being supported by hemodynamic stabilization. The target time for a favorable outcome may be within 6 hours from admission. We should not delay in initiating EGDT-assisted surgery if patients are complicated with septic shock.
In human clinical trials, ethical considerations for study subjects override the scientific requirements of trial design. Noncompliance with an intervention or study procedure for ethical reasons is thus inevitable in practice (Piantadosi, 1997). The Coronary Drug Project (CDP) trial (CDP Research Group, 1980) was a typical example of trials with noncompliance. The CDP trial was a large, double-blinded, randomized trial testing the effect of the cholesterol-lowering drug, clofibrate, on mortality. Patients were randomly assigned to the clofibrate or placebo groups and were followed for at least 5 years, documenting clinic visits and examinations. During each 4-month follow-up visit, the physician assessed compliance by counting or estimating the number of capsules returned by the patients. In the protocol, good compliers were defined as patients taking more than 80% of the prescribed treatment. Table 1 summarizes the incidence of death during the 5-year follow-up period, based on the treatment assigned and compliance status. Patients who left the trial before the end of the 5-year follow-up period were excluded.
Supplementary Figure from HER3 Augmentation via Blockade of EGFR/AKT Signaling Enhances Anticancer Activity of HER3-Targeting Patritumab Deruxtecan in EGFR-Mutated Non–Small Cell Lung Cancer
