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[Hierarchies according to the level of evidence of source data, before their integration in the synthesis, in the matter of therapeutic efficacy].

The discipline therapeutic information uses the concept of the level of evidence for source data concerning therapeutic efficacy, and its ordering before integration in syntheses. In this paper we will start by considering the problems raised by the definition of the level of evidence in terms of the dimensions it covers. We have differentiated three components: clinical pertinance of the question asked, the methods used to reply and the quality of the data collected. Second, we will examine the different criteria important for each of these three dimensions. There are many criteria possible which do not all have the same weight, and thus for any non-arbitrary tool developed to enable the level of evidence to be ordered, it is necessary to know the weight of the different criteria. Thirdly, we will present the techniques used for working with multicriteria situations in econometrics which represent a methodology we propose using to apply in our context. To do so we need to build a 'reference' base for the level of evidence using 'experts' opinions which will help us to examine the weights of the different criteria. This approach, in conjunction with some epistemological and sociological considerations, may contribute to a better understanding of the different dimensions of this concept.

Clinical Trials as Topic↗

Nimesulide. An update of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy.

Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) administered orally or rectally twice daily for a variety of inflammatory and pain states. In mostly short term studies (up to 4 weeks), it was effective in reducing pain associated with osteoarthritis, cancer, thrombophlebitis, oral surgery and dysmenorrhoea in adults, reducing pain associated with general surgery in adults and children, and pain, fever and inflammation accompanying respiratory tract infections, otorhinolaryngological diseases and traumatic injury in adults and children. Nimesulide appeared to be at least as effective as other NSAIDs in all of these indications. Nimesulide has been well tolerated by adult, elderly and paediatric patients in clinical trials and large postmarketing surveillance studies. In general qualitative terms nimesulide exhibits the usual adverse events associated with NSAIDs (gastrointestinal, dermatological and neurological). However, it has a pharmacodynamic profile suggestive of a possibly reduced propensity to cause adverse gastrointestinal effects, although this has not been conclusively demonstrated in comparative clinical trials, many of which showed a similar incidence of such effects for nimesulide and the comparator agent. Additionally, nimesulide has been well tolerated by most aspirin (acetylsalicylic acid)- and/or NSAID-intolerant patients and in patients with asthma. Thus, available evidence indicates that nimesulide is an effective and well tolerated alternative to other NSAIDs in the short term treatment of pain and inflammation of osteoarthritis and various other causes.

Animals↗

Effect and efficacy - on the function of models for the assessment of therapeutic efficacy.

Whilst the "effect" of a drug can be observed or deduced from observational data, the concept of "therapeutic efficacy" represents mainly a theoretical construction of a high degree of abstraction which is inconceivable without reciprocal combination with other theoretical constructs. The "therapeutic efficacy" of drugs can be investigated only via clinical-pharmacological or clinical models. Several examples are given. The strength of evidence of models is discussed as well as the necessity to continually test them empirically.

Animals↗

[Influential factors to therapeutic efficacy of uterine artery embolization in the treatment of uterine fibroids].

OBJECTIVE: To investigate the therapeutic efficacy of uterine artery embolization in the treatment of uterine fibroids and to analyse the influential factors to the therapeutic efficacy. METHODS: Thirty-two patients with symptomatic uterine myomas were treated by superselective catheterization and embolization of bilateral uterine arteries using PVA particles. Patients were followed for 6 months after uterine artery embolization. Baseline symptoms and the volume of the fibroids were used as parameters to evaluate the therapeutic efficacy. Influential factors to therapeutic efficacy were analyzed. RESULTS: The clinical symptoms, especially heavy menstrual bleeding, were improved markedly. An average of 55.6% volume reduction of the fibroids was achieved during the 6 month follow-up. The submucosal and intramural location of the myomas reduced more in the volume compared with that of the subserosal location. CONCLUSION: Selective uterine artery embolization is effective for uterine myoma. Influential factors to the therapeutic efficacy may include: postprocedural vascular reconstruction in the fibroid, location of the fibroid, hemodynamic status of the fibroid, and the mode of embolization (unilateral or bilateral).

Adult↗

[The therapeutic efficacy of a gonococcal vaccine].

The therapeutic efficacies of 2 gonococcal vaccines are compared. One of them is made from gonococcal strains selected for their antigenic characteristics, the other is a commercial vaccine prepared from a random sample of gonococcal strains. The studies have demonstrated a higher therapeutic efficacy of the former vaccine. This fact calls for the creation at production centers of permanent collections of antigenically full-value gonococcal cultures; such collections will help improve the gonococcal vaccine, standardize it, and enhance its biological activity.

Anti-Bacterial Agents↗

Therapeutic efficacy of decreased nitrite production by bezafibrate in patients with primary biliary cirrhosis.

BACKGROUND: The therapeutic efficacy of bezafibrate, a hypolipidemic drug, has been shown in patients with primary biliary cirrhosis (PBC) in some pilot studies; however, little is known regarding the mechanism of action of bezafibrate in PBC. This study was conducted to evaluate the therapeutic efficacy, as well as to gain insight about the possible mechanism of action, of bezafibrate in PBC. METHODS: Sixteen patients with PBC were administered with bezafibrate (400 mg/day) either with (n = 10) or without ursodeoxycholic acid (UDCA; n = 6). The peripheral blood of these patients was collected before and at different times after therapy commencement, and antigen-presenting dendritic cells (DCs) were then cultured. The DCs were enriched and cultured with Staphylococcus aureus Cowan strain-1 for 48 h to evaluate their capacity to produce nitrite. RESULTS: One month after the start of bezafibrate therapy, the serum levels of alkaline phosphatase (P = 0.0005), gamma-glutamyl transpeptidase (P = 0.0006), total cholesterol (P = 0.0072), and immunoglobulin M (P = 0.0281) were decreased significantly compared to those before patients started bezafibrate therapy. The levels of nitrite produced by DCs decreased in all patients with PBC within 1 month of commencement of bezafibrate therapy. Moreover, decreased nitrite production by DCs was also seen when nitrite production was evaluated 1 year after the start of bezafibrate therapy. CONCLUSIONS: This study reconfirms the therapeutic efficacy of bezafibrate in patients with PBC, including those with UDCA-resistant PBC. Downregulation of nitrite production by DCs may have some relationship with the therapeutic efficacy of bezafibrate; however, further study will be needed to clarify whether or not the antiinflammatory activity of bezafibrate is mediated through nitrite production.

Adult↗

[Studies on the production rate of estradiol in the testis in male infertility--studies of the predictive values on therapeutic efficacy in patients with oligozoospermia].

It is surmised that studies on the relationship between the endocrinological milieu and therapeutic efficacy in male infertile patients are essential in elucidating the etiology of this disease and devising effective therapeutic methods. The relation between serum gonadotropin level and therapeutic efficacy has already been reported. In the present study, we investigated the basal levels of two sex steroids, i.e., testosterone and estradiol, and the estradiol:testosterone (E2/T) ratio, and also the increases in these parameters after the administration of hCG to human subjects presenting various degrees of testicular dysfunction, e.g., male infertile patients, aged males, Klinefelter's syndrome and hypogonadotropic hypogonadism. Special attention was given to the characteristics of the reserve capacity for secretion of estradiol in male infertile patients. The hCG test was performed on a total 527 subjects, including 65 normal adult males. The reserve capacity for the secretion of estradiol was investigated on the basis of the increasing rate in the serum E2/T ratio. The increasing rate in the serum E2/T ratio was statistically larger in subfertile males, oligozoospermia and azoospermia in comparison with the normal adult males. On the other hand, the aged males did not show any difference from the normal adult males, whereas the results were significantly lower in the male subjects with Klinefelter's syndrome and hypogonadotropic hypogonadism. It was considered that the increase in the serum E2/T ratio is one characteristic of the gonads of male infertile patients. The results of multiple regression analysis showed that the LH level, the pretreatment sperm concentration and the increasing rate in the serum E2/T ratio were important factors determining the increase in the sperm concentration after treatment. Accordingly, for cases of oligozoospermia characterized by an LH level of 13.7mIU/ml or less and a sperm concentration of 5 x 10(6)/ml or more, the relationship between the increasing rate in the serum E2/T ratio and therapeutic efficacy was investigated. It was found that the increasing rate in the serum E2/T ratio was significantly greater in the therapeutically ineffective cases compared with the therapeutically effective cases. On the basis of this finding, it was surmised that the percentage increase in the serum E2/T ratio is one index reflecting testicular function. In addition, for cases of oligozoospermia characterized by an LH level of 13.7mIU/ml or less, a sperm concentration of 5 x 10(6)/ml or more and the increasing rate in the serum E2/T ratio of 4.01 or less, the relationship between the degree of spermatogenesis and therapeutic efficacy was investigated.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

[Plasma substitutes: strategies for use in intensive therapy to maintain a correct ratio between therapeutic efficacy and costs].

BACKGROUND: The coice of one product rather than another in clinical practice is based on two main criteria: therapeutic efficacy and the cost of the product in question. However, if therapeutic efficacy is equal, the choice of a less expensive product is not necessarily the right option. We compared the costs and therapeutic efficacy of two products used in plasma replacement therapy in order to identify which would be the most advantageous. METHODS: A total of 126 patients due to undergo major abdominal surgery were recruited and, having been duly informed, they were divided into two random groups. One group was treated with a solution of hydroxyethylamide 6% with an intermediate molecular weight (MW 200 kDa SD 0.5), and the other was treated with a solution of modified fluid gelatine (MFG) at 4% (MW 30 kDa). The solutions were administered to patients at the start of surgery until the morning of the first postoperative day in order to maintain mean arterial pressure (MAP) greater than 60 mmHg and central venous pressure (CVP) between 10 and 14 mmHg. Moreover, the costs of the two products and their additional charges were taken into consideration, taken from the supply lists provided by the pharmacy in the hospital where the study was carried out. RESULTS: No significant differences were found between the two groups in terms of therapeutic efficacy. In economic terms, the cost of the entire infusion treatment was comparable between the two groups in spite of the higher cost of hydroxyethylamide. CONCLUSIONS: The higher cost of hydroxyethylamide was compensated by the fact that a smaller amount of the solution is required to obtain the same hemodynamic parameters guaranteed by gelatine. Moreover, no adverse reactions were reported in this study to either compound. In the international literature, gelatine is associated with adverse reactions in a greater number of cases than hydroxyethylamide. This study shows that when proposing strategies of use, a simple cost analysis of the products used is not sufficient for a correct decision.

Adult↗

[Therapeutic efficacy of pralidoxime chloride on acute dichlorvos poisoning].

OBJECTIVE: To study the therapeutic efficacy and mechanism of oxime drug, pralidoxime chloride (PAM-Cl), on acute dichlorvos (DDV) poisoning. METHODS: The toxic signs and survival rate were recorded and ChE activity in blood was determined in treatment group with PAM-Cl and non-treatment group after DDV was given to rats and mice by gastrogavage; the therapeutic efficacy and reactivation of DDV-inhibited ChE by PAM-Cl were observed on the patients with acute DDV poisoning. RESULTS: (1) The alleviated and delayed toxic signs as well as higher survival rate were found in PAM-Cl treatment group compared with non-treatment group. (2) After the rats were exposed to DDV, the ChE activities of whole blood in different time within 24 h were statistically significantly higher in PAM-Cl treatment group than in non-treatment group (P < 0.05). (3) After PAM-Cl treatment, muscular fasciculation and other nicotinic signs in poisoned patients were disappeared and the inhibited blood ChE activities were gradually reactivated to normal level. CONCLUSION: PAM-Cl has therapeutic efficacy against acute toxicity of DDV through its reactivation of inhibited ChE.

Acute Disease↗

Insulin-like growth factor (IGF)-I/IGF-binding protein-3 complex: therapeutic efficacy and mechanism of protection against type 1 diabetes.

IGF-I regulates islet beta-cell growth, survival, and metabolism and protects against type 1 diabetes (T1D). However, the therapeutic efficacy of free IGF-I may be limited by its biological half-life in vivo. We investigated whether prolongation of its half-life as an IGF-I/IGF binding protein (IGFBP)-3 complex affords increased protection against T1D and whether this occurs by influencing T cell function and/or islet beta-cell growth and survival. Administration of IGF-I either alone or as an IGF-I/IGFBP-3 complex reduced the severity of insulitis and delayed the onset of T1D in nonobese diabetic mice, but IGF-I/IGFBP-3 was significantly more effective. Protection from T1D elicited by IGF-I/IGFBP-3 was mediated by up-regulated CCL4 and down-regulated CCL3 gene expression in pancreatic draining lymph nodes, activation of the phosphatidylinositol 3-kinase and Akt/protein kinase B signaling pathway of beta-cells, reduced beta-cell apoptosis, and stimulation of beta-cell replication. Reduced beta-cell apoptosis resulted from elevated Bcl-2 and Bcl-X(L) activity and diminished caspase-9 activity, indicating a novel role for a mitochondrial-dependent pathway of beta-cell death. Thus, IGF-I/IGFBP-3 affords more efficient protection from insulitis, beta-cell destruction, and T1D than IGF-I, and this complex may represent an efficacious therapeutic treatment for the prevention of T1D.

Animals↗

Tumor-specific granulocyte/macrophage colony-stimulating factor and interferon gamma secretion is associated with in vivo therapeutic efficacy of activated tumor-draining lymph node cells.

In this study, cytokine release by tumor-draining lymph node cells sensitized in vitro (IVS-TDLN) was examined and correlated with therapeutic efficacy in adoptive immunotherapy. Mice bearing immunologically distinct MCA 207 and MCA 205 sarcoma tumors were utilized in criss-cross experiments. IVS-TDLN obtained from mice bearing 10-day subcutaneous (s.c.) tumors mediated immunologically specific regression of established 3-day pulmonary metastases, but demonstrated non-specific cytolytic reactivity against both tumors in a 4-h 51Cr-release assay. By contrast, these IVS-TDLN cells were found specifically to secrete granulocyte/macrophage colony-stimulating factor (GM-CSF) and interferon gamma (IFN gamma) when restimulated in vitro with irradiated tumor cells. To determine the predictive value of tumor-specific cytokine release with in vivo therapeutic efficacy, a kinetic analysis of antitumor activities of TDLN obtained from animals bearing MCA 207 tumors for increasing lengths of time was performed. IVS-TDLN cells from mice bearing day-7, -10 and -14 s.c. tumors manifested tumor-specific release of GM-CSF and IFN gamma, and mediated significant antitumor reactivity in vivo. In contrast IVS-LN cells from day-0 and day-21 tumor-bearing animals did not release significant amounts of GM-CSF and IFN gamma, and were not therapeutically efficacious in vivo. Day-4 IVS-TDLN released high levels of GM-CSF and IFN gamma non-specifically, and were not therapeutic in adoptive immunotherapy at doses effective for day-7 and day-14 IVS-TDLN cells. In other experiments, IVS cells generated from different lymph node groups in animals bearing 10-day established s.c. tumors were examined and found to have unique profiles of cytokine release. In these studies, the ability of IVS cells to release specifically both cytokines as opposed to one was associated with greater therapeutic efficacy on a per cell basis. Our findings suggest that the tumor-specific releases of GM-CSF and IFN gamma are useful parameters to assess the in vivo therapeutic efficacy of immune lymphocytes.

Animals↗

[Effect of polymorphism of human intestinal fatty acid binding protein gene on the therapeutic efficacy of fenofibrate].

OBJECTIVE: To explore the effect of polymorphism in codon Ala54Thr of human intestinal fatty acid-binding protein gene (IFABP) on the therapeutic efficacy of fenofibrate. METHODS: Totally 147 patients with hyperlipidemia [72 men mean age: (56.2 +/- 8.63) years; 75 women mean age: (58.4 +/- 9.12) years] were enrolled. IFABP genotypes were detected by polymerase chain reaction, Hha I digestion, and sequencing. Four weeks before and after treatment, the levels of fasting serum total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), apolipoprotein A I (apoA I) and apolipoprotein B (apoB) were detected with biochemical techniques. RESULTS: The frequency of IFABP genotype was 0.47 for A/A, 0.37 for A/T, and 0.16 for T/T, and the allelic frequency was 0.65 for A and 0.35 for T. No significant different was found in lipid levels in every genotype before treatment (P > 0.05). After 4 weeks of treatment, the levels of TC, TG, LDL-C, and apoB significantly decreased (P < 00.01), and the levels of HDH-C and apoA I significantly increased (P < 0.01). The total therapeutic efficacy on A54A and A54T were 97% and 95%, respectively. In the patients with T54T genotype after treatment, no significant difference in lipids levels was found except TG (P < 0.05), and the total efficacy was only 38%. The total therapeutic efficacies of fenofibrate on A54A and A54T were higher than those of T54T, and there was significant different between A54A and T54T (P < 0.01). CONCLUSION: The polymorphism of human IFABP gene in hyperlipidemia is related with the therapeutic efficacy of fenofibrate, and the T54T IFABP genotype may have strong negative effect on such efficacy.

Aged↗

Liposome longevity and stability in circulation: effects on the in vivo delivery to tumors and therapeutic efficacy of encapsulated anthracyclines.

The effect of liposome composition on drug delivery to tumors and therapeutic efficacy of liposome-encapsulated anthracyclines was investigated in two murine tumor models: an ascitic tumor (J6456 lymphoma) and a solid carcinoma (M-109). Longevity in circulation correlated positively with high drug levels in the extracellular (ascitic) tumor fluid and with delayed peak tumor levels. Using polyethylene-glycol(PEG)-coated liposomes, liposome stability (drug retention) was found to be an important determinant of therapeutic efficacy, as indicated by the superior survival conferred by high Tm phosphatidylcholines (hydrogenated, dipalmitoyl) over low Tm (egg phosphatidyl-choline). Replacing PEG with another negatively-charged surface headgroup (phosphatidyl-glycerol, phosphatidyl-inositol) resulted in relatively shorter longevity in circulation of the liposome-associated drug, but no detectable differences in anti-tumor efficacy. When neither the surface charged headgroup nor the PEG coating are present, the resulting drug formulation was significantly less effective than PEG and phosphatidylinositol-based formulations in both tumor models. In conclusion, longevity in circulation, as obtained with PEG coating, tends to improve the therapeutic efficacy of liposome-encapsulated anthracyclines. The current therapeutic models were however unable to detect differences between the therapeutic activity of PEG and other liposome formulations with relatively small differences in circulation longevity.

Animals↗

[Transition zone index in predicting therapeutic efficacy of benign prostatic hyperplasia].

PURPOSE: We studied how transition zone index (TZ index) influenced the therapeutic efficacy of benign prostatic hyperplasia (BPH). In addition, we retrospectively investigated the availability of TZ index in selection of the more effective therapeutic method for BPH. METHOD: One hundred twenty-five patients with symptomatic BPH whose prostate volume (PV) was more than 15 ml by transrectal ultrasonography were investigated. Sixty-nine men underwent transurethral resection of the prostate (TURP) whereas 56 were treated with alpha 1-blocker. Tamsulosin hydrochloride. These patients were evaluated based on TZ index as well as ordinary parameters of BPH; international prostatic symptom score, QOL score, peak flow rate and PV. RESULTS: The patients with TZ index > or = 0.5 showed good therapeutic results in the TURP group. On the other hand, the patients with TZ index < 0.5 showed favorable response in alpha 1-blocker group. Multivariate analysis revealed that TZ index affected the therapeutic efficacy more strongly than the other parameters. CONCLUSION: TZ index had strong influence on therapeutic efficacy of TURP or alpha 1-blocker and seemed to be a useful tool for the selection of BPH therapy.

Adrenergic alpha-Antagonists↗

Influence of corticosteroid hormones on the therapeutic efficacy of cyclophosphamide.

The purpose of this investigation was to clarify the relation between the therapeutic efficacy of cyclophosphamide and the activity of the endogenous and exogenous corticosteroid hormones using ICR female mice with ascitic Ehrlich tumor. A single ip injection of the drug, 3 mg/mouse, was given to each mouse 36 hr after tumor inoculation (1 X 10(6) tumor cells, ip), and the drug effect was assessed in terms of the number of 1-month survivors with and without tumor. The clock time of drug administration which produced minimal therapeutic efficacy chronologically coincided with the dark period (8 PM approximately 8 AM) and/or with a stage of increased plasma corticosterone in mice. In support of this, concomitant administration of corticosterone (hydrocortisone or corticosterone) significantly depressed the anti-tumor effect of the drug. Evidence is presented to indicate that the adverse effect of corticosteroids is related to an accelerated metabolism of cyclophosphamide within the host. The drug effect for a given total dose was improved by the use of hourly partitioned injections in place of a single injection. It was concluded that the therapeutic efficacy of cyclophosphamide is dependent on the time of exposure to drug action on the scale of hours, but not days, and that the anti-tumor effect of the drug can be suppressed by increased activity of endogenous and exogenous corticosteroid hormones through acceleration of the drug metabolism.

Adrenal Cortex Hormones↗

Comparison of the therapeutic efficacy of continuous and intermittent injection of isosorbide dinitrate: a randomized study on unstable angina.

Therapeutic efficacy of intermittent and continuous injection of isosorbide dinitrate (ISDN) was compared in 22 patients (mean age 64 +/- 10, 18 males and 4 females) with unstable angina at rest. They were randomized into 2 groups that received either continuous (10 mg/h, group A) or intermittent (10 mg/10 min every 2 hours, group B) injection of ISDN for 3 days (phase 1). Each injection protocol was switched (phase 2) and subsequently switched back to the initial protocol (phase 3) in a cross-over fashion. The serum concentrations of ISDN, 2-isosorbide mononitrate (2-ISMN) and 5-ISMN were measured serially during both intermittent and continuous injection protocols. In addition, the incidence and duration of angina and changes in systolic blood pressure were analyzed. There were 3 treatment-failure cases during the intermittent injection period and 1 during the continuous injection period. Three of these treatment-failure cases developed small acute myocardial infarcts despite emergent coronary arteriography followed by intra-coronary thrombolysis and percutaneous balloon angioplasty. There was no difference in therapeutic efficacy between continuous and intermittent ISDN in terms of the incidence, duration of angina attacks and the number of patients whose angina was suppressed. After bolus injection of ISDN (10 mg/10 min), the serum concentration of ISDN increased rapidly and returned to the control level at 60 minutes after the injection. The serum 5-ISMN and 2-ISMN concentrations also increased immediately after injection and then decreased gradually reaching statistically insignificant level to the control values at 60 minutes after injection. With continuous injection, ISDN and its metabolites increased gradually and reached similar but slightly lower serum concentrations to the peak levels during intermittent injection. We conclude that the therapeutic efficacy of intermittent and continuous injection of ISDN is similar in patients with unstable angina.

Adult↗

Therapeutic efficacy of granulocyte colony-stimulating factor alone and in combination with antibiotics against Pseudomonas aeruginosa infections in mice.

The therapeutic efficacy of granulocyte colony-stimulating factor (G-CSF) against an experimental intramuscular infection induced by Pseudomonas aeruginosa in mice was confirmed. Bacterial growth in the infected thigh muscle was suppressed by G-CSF treatment. The change in the number of peripheral blood polymorphonuclear leukocytes (PMN) after bacterial challenge was investigated. The results showed that G-CSF could stimulate stronger defense mechanisms after stimulation by bacterial challenge. In the G-CSF-treated group, more clusters of matured PMN were observed in the infected thigh muscle 6 h after bacterial challenge. Next, the correlation between the number of PMN in the blood at the time of infection and the therapeutic efficacy of antibiotics was investigated. The therapeutic efficacy of ceftazidime, a beta-lactam antibiotic, was affected by the number of blood PMN at the time of infection. In particular, a decrease of peripheral blood PMN at the time of infection resulted in a dramatic decrease in the efficacy of ceftazidime. The reduction in leukopenia by G-CSF remarkably strengthened the therapeutic effect of antibiotics in mice.

Animals↗

Radiofrequency ablation of hepatocellular carcinoma in patients with decompensated cirrhosis: evaluation of therapeutic efficacy and safety.

OBJECTIVE: Our objective was to determine the therapeutic efficacy and safety of radiofrequency ablation in the treatment of hepatocellular carcinoma (HCC) in patients with decompensated cirrhosis. SUBJECTS AND METHODS: Nineteen patients with 26 HCC nodules (range, 0.8-5 cm; mean, 1.96 cm) and decompensated liver cirrhosis (mean Child score, 10.7) were treated with radiofrequency ablation using cooled-tip electrodes and a 200-W generator. Radiofrequency ablation was performed under the guidance of sonography or CT. Procedure-related complications, therapeutic efficacy, each patient's survival, changes in blood test results--that is, serum aminotransferase and bilirubin--and changes in the Child score before and after ablation therapy were analyzed. To assess the therapeutic response of the tumor to radiofrequency ablation, we performed contrast-enhanced CT after the procedure and during follow-up. RESULTS: Complete necrosis without marginal recurrence at the 6-month follow-up was attained in 23 lesions (88.5%). During follow-up (mean, 13.3 months), one patient experienced a remote tumor recurrence in the liver. The median survival time was 12.0 +/- 1.7 months. Two patients died of liver failure--one at 2 months and one at 4 months after treatment. The other patients were followed for at least 6 months (range, 6-28 months; mean, 12 months). The first and second weeks after therapy, the serum aminotransferase and bilirubin levels were significantly higher than were pretreatment levels (p < 0.05). However, 3 weeks after therapy, those figures were nearly restored to the pretreatment levels. The mean Child scores 3 weeks after radiofrequency ablation (10.8) were similar to those before treatment (10.7). CONCLUSION: Radiofrequency ablation can be used selectively for treatment of HCC in patients with decompensated cirrhosis but has the potential to aggravate the preexisting hepatic dysfunction.

Adult↗