Routine Supportive Therapy Research Articles

Umbilical cord blood stem cells transplantation as an adjunctive treatment strategy for liver cirrhosis in Chinese population: a meta-analysis of effectiveness and safety.

ObjectiveThe aim of the study was to evaluate the efficacy and safety of umbilical cord blood stem cells (USCs) transplantation combined with routine supportive therapy (RST) for liver cirrhosis (LC).Materials and methodsClinical trials involved in this research were searched from Web of Science, PubMed, EMBASE, Cochrane Library, Wanfang and CNKI database. Treatment effects, quality of life (QoL), adverse events and other outcome measures were extracted and evaluated.ResultsA total of 10 trials including 616 LC patients were involved in this study. Based on our analysis, the liver function of LC patients was significantly improved after USCs transplantation and RST combined therapy, indicated by decreased total bilirubin, alanine aminotransferase, aspartate aminotransferase levels and prothrombin time and increased serum albumin level and prothrombin activity. Compared to those treated by RST alone, patients treated by combined therapy showed more satisfied treatment effects, improved QoL reflected by improved appetite (odds ratio [OR]=5.43, 95% CI=2.84 to 10.38, P<0.00001) and relieved fatigue (OR=4.33, 95% CI=0.87 to 21.60, P=0.07), ascetic fluid (OR=4.56, 95% CI=2.69 to 7.74, P<0.00001), abdominal distension (OR=4.01, 95% CI=1.34 to 12.02, P=0.01) and edema (OR=2.69, 95% CI=0.23 to 31.72, P=0.43). No serious adverse events occurred during USCs therapy.ConclusionUSCs transplantation is a safe and effective adjuvant therapy for RST-treated LC, possibly through improving patients’ liver function.

Lung protective effects of budesonide nebulization during perioperative period of thoracolumbar fusion.

To determine the pulmonary protective effect of budesonide nebulization in patients undergoing spinal fusion for thoracolumbar degenerative disorders. Forty patients who underwent spinal fusion at our hospital from January 2013 to December 2013 for the treatment of thoracolumbar degenerative disorders were randomly allocated into a budesonide intervention group (budesonide group) and a control group. The control group received routine supportive therapy including rehydration, analgesia, and neurotrophic drug treatment; in addition to these, the budesonide group was administered with budesonide nebulization (1-mg budesonide/2-mL saline, twice daily) from 1 day preoperatively through 3 days postoperatively. Respiratory symptoms, arterial blood gas, and pulmonary complication before and after the operations were observed and compared between the two groups. The patients ranged in age from 46 to 81 years old (mean, 62.4±9.4 years), and comprised 20 men and 20 women. There were no significant differences in postoperative body temperature, heart rate, and respiratory rate between the groups (P>0.05). The change in arterial partial pressure of oxygen (PaO2) from baseline was significantly lower in the budesonide group than in the control group (at 2.4±12.4 vs. 16.0±11.3 mmHg) (P=0.002), so was the findings for oxygen saturation (SpO2) (0.2%±2.3% vs. 2.6%±3.3%), respectively (P=0.047). The incidence of postoperative pulmonary symptoms and complications, such as coughing, shortness of breath, and dyspnea, was 0% in the budesonide group and 15% in the control group; overall, the budesonide group performed better than control group in all pulmonary parameters. None of the patients in the budesonide group experienced severe events associated with glucocorticoid therapy. Perioperative budesonide nebulization may reduce the postoperative pulmonary complications in middle-aged and elderly patients undergoing thoracolumbar fusion to treat thoracolumbar degeneration, with favorable efficacy and safety.

The efficacy and safety of entecavir in patients with advanced schistosomiasis co-infected with hepatitis B virus

To evaluate the efficacy and safety of entecavir (ETV) in patients with advanced schistosomiasis and hepatitis B virus (HBV) co-infection. Sixty-seven patients with advanced schistosomiasis and HBV co-infection were enrolled in this study. The patients were randomly divided into the ETV treatment group (n=35) and the control group (n=32). The patients in the control group adopted routine supportive therapy for 52 weeks, and those in the ETV treatment group received ETV at a dose of 0.5mg once daily on the basis of routine supportive therapy for 52 weeks. Hepatic fibrosis markers (hyaluronic acid, type III procollagen, type IV collagen, laminin, and fibronectin), Ishak fibrosis score, alanine transaminase (ALT), HBV DNA, and Child-Pugh score were compared between the two groups. The intention to treat (ITT) population was used for the analysis. The measurement data and count data were analyzed by t-test and Chi-square test, respectively. After 52 weeks of treatment, the hepatic fibrosis markers (hyaluronic acid, type III procollagen, type IV collagen, laminin, and fibronectin) were significantly improved in the ETV treatment group compared to the control group (all p<0.05). A ≥1-point improvement in the Ishak fibrosis score was found in 25.7% (9/35) of the ETV group, and the mean change from the baseline in the Ishak fibrosis score was a 0.3-point reduction. The control group showed disease progression in the Ishak fibrosis score. More patients in the ETV group than in the control group had undetectable serum HBV DNA levels (82.9% vs. 3.1%, p<0.05) and ALT normalization (68.6% vs. 18.3%, p<0.05). The ETV treatment group demonstrated an improvement in Child-Pugh score at week 52 (-3.7 vs. 0.3, p<0.05). In addition, no obvious adverse reactions were observed during ETV treatment. ETV is safe and effective in patients with advanced schistosomiasis and HBV co-infection.

Efficacy of antiviral treatment on patients with acute-on-chronic hepatitis B liver failure with low viral load.

To investigate the efficacy of antiviral treatment on patients with acute-on-chronic hepatitis B liver failure with low viral load. 352 patients with acute-on-chronic hepatitis B liver failure including 175 cases of low HBV viral load and 177 cases of high HBV viral load were enrolled into this study. The patients were divided into the antiviral group which received antiviral therapy (Lamivudine, Entecavir or Telbivudine) plus routine supportive therapy and the control group which received supportive therapy only. The clinical features and the 24-week short-term efficacy of antiviral therapy were assessed. At week 24,total survival rate in antiviral group was higher than that in control group (P = 0.010). The survival rate of patients with low viral load in the antiviral group was higher than that in the control group (P = 0.001). But there was no significant difference between the antiviral group and the control group with high viral load (P = 0.856). But in the antiviral group, there was no significant difference in survival rate between the patients with high HBV viral load and those with low viral load (P = 0.755). Antiviral therapy can significantly improve survival rate of patients of acute-on-chronic hepatitis B liver failure with low viral load. Liver failure;

Challenging issues associated with organ transplantation for Jehovah’s Witness individuals

Organ transplantation is one of modern medicine’s stunning but incomplete successes. Since renal transplantation was first practiced in the 1950s, advances in surgical technique, organ preservation, immunosuppression, and ongoing meticulous treatment of medical complications after transplantation have led to a 5-year survival after transplantation of 50% to 90% for all solid organs. Because of the great expense involved ($100,000 to 300,000 easily for solid organ transplantation in the United States) and the limited supply of organs, organ transplantation remains an elective and selective choice in modern health care. Considering the present state of the art and science of medicine, it cannot and should not be performed on every candidate. Every transplant program operates with a list of indications and contraindications for transplantation. Candidates must have organ failure (usually single organ) with a reasonable chance to survive the waiting period, the transplant procedure, and the initiation of immunosuppression so that a return to physiologic function is probable. As a general rule, gender, ethnicity, and religious belief are considered to be irrelevant to candidacy for organ transplantation. On the other hand, almost all programs require that the recipient have some resources prior to and after transplantation—financial to offset the considerable costs of transplantation and after-care and personal or psychosocial to handle the responsibilities and the inevitable stresses of transplantation. The paper “Lung Transplantation in a Jehovah’s Witness” by Conte and Orens1 in this issue raises a number of fundamental issues in the candidacy for lung transplantation. Although there is some variation in practice among individuals of the Jehovah’s Witness (JW) faith on medical matters, most adults willfully decline transfusion of blood products based on the particular and idiosyncratic JW interpretation of certain biblical texts.1 A review of the literature indicates that individuals who subscribe to the JW faith have undergone successful transplantation of kidneys,2 hearts,3 and livers.4 Success can be attributed to boldness and respect for patient preference from individual transplant surgeons, careful attention to techniques to minimize hemorrhage during surgery, and improvements in transfusion medicine. The introduction of erythropoietin therapy5,6 and antifibrinolytic agents such as aprotinin7,8 have reduced the likelihood and risks of excess hemorrhage to the patient. Nonetheless, the stipulation of the JW patient imposes a restriction on routine supportive therapy that may impact the potential success of organ transplantation. Conte and Oren1 indicate that the patient in question and the transplant team were “willing to accept a poor outcome.” Herein lies the crux of the difficult calculus of decision-making for any candidate regardless of religious belief. If a potential recipient is wealthy, appealing, and young, is it ethical to utilize scarce resources even if the chances of a good outcome—survival with reasonable physiologic function—are lower than in most other candidates? How objective does our decisionmaking need to be? How much risk of a poor outcome would be acceptable? If the patient had been grossly obese at 200% of her ideal body weight, most transplant programs would be reluctant to accept her as a candidate because of concerns about Associate Professor of Clinical Pediatrics, Washington University School of Medicine, St. Louis, Missouri. Submitted June 19, 1999; accepted July 27, 1999. J Heart Lung Transplant 2000;19:119–120. Copyright © 2000 by the International Society for Heart and Lung Transplantation. 1053-2498/00/$–see front matter PII S1053-2498(99)00073-X

Phase I/II trial of dexverapamil, epirubicin, and granulocyte‐macrophage–colony stimulating factor in patients with advanced pancreatic adenocarcinoma

The purpose of this study was to determine the maximum tolerated dose (MTD) of a cytotoxic regimen consisting of the second-generation chemosensitizer dexverapamil (DVPM), high dose epirubicin, and recombinant human granulocyte-macrophage-colony stimulating factor (GM-CSF) in pancreatic carcinoma. Twenty-eight previously untreated patients with locally advanced or metastatic adenocarcinoma of the pancreas were studied. Treatment consisted of oral DVPM at a dose of 1000-1200 mg/day for 3 days, epirubicin administered as an intravenous bolus injection on Day 2 with an initial dose of 90 mg/m2, and a dose of GM-CSF of 400 micrograms administered subcutaneously from Day 5s through 14. Epirubicin dose escalation levels were 90, 105, 120 and 135 mg/m2. Consecutive cohorts of four to eight patients were planned at each dose level. Treatment cycles were repeated every 3 weeks. Hematologic toxicity, specifically granulocytopenia, constituted the dose-limiting toxicity with an MTD of 120 mg/m2 for epirubicin. Despite routine supportive therapy with GM-CSF, four, two, and five patients experienced Grade 4 granulocytopenia during their first two treatment courses at levels 105, 120, and 135 mg/m2, respectively. Grade 4 granulocytopenia was observed in two, three, and one additional patients during subsequent courses with these levels. Nonhematologic toxicity was uncommon, generally modest, and did not correlate clearly with the anthracycline dose. Dexverapamil-related cardiovascular symptoms occurred frequently, but they never resulted in serious toxicity requiring active medical intervention or permanent discontinuation of therapy. Nine of 28 patients achieved partial responses to this therapy. Stable disease was observed in nine patients, and tumor progress occurred in 10. The MTD of epirubicin for this regimen with DVPM and GM-CSF was 120 mg/m2 every 3 weeks. Though it remains uncertain whether the encouraging response activity observed in this disease-oriented Phase I study was, in fact, due to successful modulation of multidrug resistance, these results suggest that this regimen is likely to be an effective and tolerable treatment strategy for patients with pancreatic cancer, which should be evaluated further.

Identification of drugs taken in overdose cases.

Over one year ago, it became very clear to us that the management of patients suffering from overdoses of drugs could be conducted with an increased amount of confidence once the identity of the drug or drugs involved had been established, With this in mind, we embarked upon a collaborative research project involving the Suburban Hospital and the Laboratory of Chemistry of the National Heart and Lung Institute of the National Institutes of Health, both of Bethesda, Md Various techniques for securing the above information were studied and a satisfactory method involving mass spectrometry has been developed [ 11. This has been in routine use for fourteen months and the purpose of this paper is to report some of the results obtained during this period. In a middle class, suburban community such as Bethesda, overdoses of the more notorious drugs such as the opiates represent less of a problem on a day-to-day basis than do overdoses of prescribed drugs such as sedatives and tranquillizers. In cases where massive quantities of such compounds have been consumed by the patient, routine supportive therapy may often be deemed inadequate and recourse may be made to more aggressive detoldfication methods such as hemo- and peritoneal dialysis. Before such measures can be initiated however, reliable identification of the drug or drugs involved is necessary. It is well known that gas-liquid chromatography is an excellent 17