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Biomedical subjects

R P Perng

Publications and source records attributed to R P Perng.

At least 19 recordsLinked to original sources

Restoration of cytotoxic T lymphocyte function in malignant pleural effusion: interleukin-15 vs. interleukin-2.

The present study attempts to define the role of interleukin-15 (IL-15), as compared with IL-2, in generating cytotoxic T lymphocytes (CTL) from the malignant effusions of cancer patients. Effusion-associated lymphocytes (EAL) from malignant effusion were incubated with IL-15 or IL-2 with or without alphaCD3. Proliferation and cytotoxicity assays were performed. IL-15 was found to have at least an equivalent, if not higher, activity to IL-2 in terms of lymphocyte proliferation and generation of CTL from EAL. The proliferative response of EAL, cocultured with IL-15, with or without alphaCD3, was partly inhibited by pretreatment with an anti-IL2 receptor beta chain monoclonal antibody (mAb). The proliferative response of EAL, cocultured with alphaCD3, IL-2, or both, was partly inhibited by pretreatment with an anti-IL-2 receptor alpha chain mAb. Overnight [5lCr] release assays against K562, Daudi, and the patients' autologous tumor cells were done to evaluate EAL's cytolytic activity. MHC class I Ab blocked the stimulated cytolytic activity of EAL against autologous tumors. An mAb depletion assay showed that the phenotype of the restored EAL was CD16-CD4-CD8+; thus, the restored activity of EAL was CTL activity. The results suggest that both IL-15 and IL-2 can restore CTL activity from EAL in the presence of T cell receptor (TCR)-CD3 engagement, but the effect of IL-15 was superior.

Adenocarcinoma↗

A phase II trial of tamoxifen, ifosfamide, epirubicin, and cisplatin combination chemotherapy for inoperable non-small-cell lung cancer.

A phase II trial of tamoxifen, ifosfamide, epirubicin, and cisplatin (TIEP) chemotherapy was conducted in patients with chemonaive inoperable non-small-cell lung cancer (NSCLC) to assess response and toxicity. From October 1997 to August 1998, 19 patients were treated. The treatment schema included tamoxifen 60 mg twice daily by mouth on days 1 to 3, ifosfamide 3 g/m2 intravenous infusion (IV) 60 minutes with mesna on day 2, epirubicin 50 mg/m2 IV bolus on day 2, and cisplatin 60 mg/m2 IV 60 minutes on day 2 every 4 weeks for up to six cycles. All patients were evaluable for response and toxicity. The major toxicity was myelosuppression; grade 3 or 4 leukopenia or neutropenia occurred in 14 of 19 (73.7%) patients during treatment, and 6 patients (31.6%) experienced fever in association with the neutropenia; no toxic deaths occurred. Grade 3 anemia occurred in six patients (31.6%) during the treatment. Grade 3 or 4 nausea/vomiting occurred in only one patient. Toxicities other than neutropenia and anemia were minimal. After two cycles of treatment, 9 of 19 patients attained a partial response (47.4%, 95% confidence interval 24.9%-69.9%) in this study. The median time to disease progression was 6 months and median survival time was 12 months. We conclude that TIEP is an active combination regimen with an acceptable toxicity profile in Chinese patients with inoperable NSCLC.

Aged↗

A phase II trial of vinorelbine and cisplatin in previously untreated inoperable non--small-cell lung cancer.

Weekly vinorelbine injection with cisplatin had been used in treatment of non-small-cell lung cancer. We performed a phase II trial to evaluate the efficacy and toxicity of a new schedule of vinorelbine and cisplatin in patients with previously untreated, inoperable (stage IIIB or stage IV) non-small-cell lung cancer. From April 1996 to May 1997, 52 patients were enrolled for study, and 50 patients were eligible and evaluable for both response and toxicity assessment. Therapy consisted of vinorelbine, 30 mg/m2, intravenously on days 1 and 5 of a 21-day cycle, and cisplatin 100 mg/m2 (reduced to 80 mg/m2 after the first seven patients) given on day 1. A total of 211 treatment courses were administered; the median number of cycles administered per patient was 4.5 (range: 1-6), the median dose intensity for vinorelbine was 16.9 mg/m2/week (84.4%), whereas that of cisplatin was 22.8 mg/m2/week (84.7%). Twenty-five patients responded to therapy for an overall response rate of 50%; one patient attained a complete response (2%). The main toxicities were vomiting, myelosuppression, and diarrhea, which included World Health Organization grade 3 or 4 nausea/vomiting (58% patients), anemia (41% patients), neutropenia (12% patients), and diarrhea (14%). The median duration of responses was 9 months. The median time to disease progression was 6.8 months (range 0.4-18.1 months). Median survival was 13 months, and 54% of patients were alive at 1 year. We conclude that this new schedule of vinorelbine and cisplatin achieves a high response with acceptable toxicity profile in patients with advanced non-small-cell lung cancer.

Adult↗

Interrelationships between cellular nucleotide excision repair, cisplatin cytotoxicity, HER-2/neu gene expression, and epidermal growth factor receptor level in non-small cell lung cancer cells.

Nucleotide excision repair (NER) is a major repair mechanism for DNA lesions induced by cisplatin. Overexpressions of epidermal growth factor receptor (EGFR) and HER-2/neu have been reported to affect the sensitivity of certain human cancer cells to cisplatin, presumably by modification of DNA repair activity through interference with NER. Using an in vitro repair assay, we investigated NER activity of cisplatin-induced DNA lesions in a panel of 16 non-small cell lung cancer (NSCLC) cell lines. The interrelationships between NER activity, cisplatin sensitivity, HER-2/neu expression and EGFR level, were also analyzed. The results showed that high NER activity was closely correlated with cisplatin resistance and high levels of HER-2/neu expression (P<0.05). Analysis of the relationships between EGFR level and each of the other three parameters revealed no statistically significant correlations (all P values were >0.05 by Spearman rank correlation), but a trend of association (all the values of proportion of accordance were > or =62.5% by using a 2x2 contingency table). These results suggest that NER activity may play an important role in the cisplatin resistance of NSCLC cells and there may be an association between enhanced NER activity and high levels of p185neu and probably EGFR in NSCLC cells. The finding that high levels of EGFR showed very little influence on the relationship between p185neu and cisplatin resistance suggests that EGFR may be a less crucial factor in modulating the chemoresistance of NSCLC cells when compared with HER-2/neu.

Antineoplastic Agents↗

Non-small cell lung cancer in very young and very old patients.

STUDY OBJECTIVE: A cancer registry was analyzed to determine if the clinicopathologic characteristics, treatment modalities, and prognosis of non-small cell lung cancer (NSCLC) patients < 40 years of age at diagnosis differed from patients > 80 years of age at diagnosis. DESIGN: Retrospective review of patients with NSCLC diagnosed between 1987 and 1996. SETTING: General teaching hospital in Taiwan. PATIENTS: There were 6,048 cases of NSCLC diagnosed during this period. Among them, 127 patients were < 40 years old and 184 patients were > 80 years old. These patients were selected for our study. MEASUREMENTS: Data regarding demographics, presentation symptoms, histology, tumor staging, treatment modality, and survival were obtained from all patients. Pearson's chi(2) test and the Kaplan-Meier method with a log-rank test were used for statistical analysis. RESULTS: We found significantly more female patients (p < 0.001) and adenocarcinoma (p < 0.001) in the younger group, when compared with the older patients. Cough was the most frequent presenting symptom in both age groups, followed by dyspnea, chest pain, and hemoptysis. There was no statistical difference in the severity of the disease in terms of staging between the two age groups. Young patients received surgical intervention more frequently than the aged (p = 0.025). The older patients received only supportive care more frequently (p = 0.011) than the younger patients. Survival was better in young patients, when compared with other patients or aged patients (p < 0.001). CONCLUSIONS: The female sex and adenocarcinoma were predominant in young NSCLC patients, when compared with the older patients. Young NSCLC patients tended to receive more aggressive treatment and had better survival.

Adenocarcinoma↗

A multicenter phase II trial of vinorelbine plus gemcitabine in previously untreated inoperable (Stage IIIB/IV) non-small cell lung cancer.

STUDY OBJECTIVE: Vinorelbine and gemcitabine are two active single agents used in the treatment of non-small cell lung cancer (NSCLC). A clinical trial was conducted to evaluate the efficacy and toxicity of vinorelbine plus gemcitabine in patients with inoperable (stage IIIB or IV) NSCLC. DESIGN: A multicenter phase II study. Vinorelbine, 20 mg/m(2), was given as a 10-min IV infusion, followed by a 30-min IV infusion of gemcitabine, 800 mg/m(2), on days 1, 8, and 15 of each 28-day cycle. PATIENTS AND MEASUREMENTS: From March 1998 to August 1998, 40 patients were enrolled in the study. The efficacy and toxicity of the treatment were recorded. RESULTS: All patients are evaluable for treatment response and toxicity profile. Two patients achieved a complete response, and 27 patients achieved a partial response, with an overall response rate of 72.5% (95% confidence interval, 58.7 to 86.3%). Median survival time was 11 months. The significant (World Health Organization grade, 3/4) toxicities were myelosuppression, including leukopenia (47.5% of patients), anemia (17.5% of patients), and thrombocytopenia (12.5% of patients). However, febrile neutropenia occurred in three patients and accounted for one treatment-related death. Fatigue, or flu-like syndrome, occurred in 17 patients, and the symptoms were reversed spontaneously 1 to 2 days after injection in 10 patients. Another seven patients needed dose reduction to ameliorate symptoms. Interstitial pneumonitis occurred in six patients who recovered after steroid treatment. No patient suffered from grade 3 or 4 nausea/vomiting. CONCLUSION: The combination of vinorelbine and gemcitabine in patients with advanced NSCLC is a highly active non-cisplatin-containing regimen with an acceptable toxicity profile.

Adult↗

Disconnection of a venous Port-A-Cath followed by embolization after saline flush: rare case report.

A 77-year-old man presented with painful swelling of his Port-A-Cath insertion site soon after flushing with normal saline. No discomfort or abnormality was found during the saline flush. A chest roentgenogram showed that the disconnected catheter had separated from the disc and was absent from its original location. The disconnected catheter was found embolized, by chest roentgenogram and CT scan, to the right atrium and hepatic vein. The patient was treated successfully with an X-ray guided extraction of the catheter. The possibility of catheter disconnection with embolization should be considered and a chest roentgenogram performed immediately in cases of rapid swelling of subcutaneous tissue around the port chamber after fluid infusion.

Aged↗

Argyrophilic nucleolar organizer regions in cells of thymoma and thymic carcinoma: correlation with DNA ploidy and clinicopathologic characteristics.

STUDY OBJECTIVES: To evaluate the usefulness of argyrophilic nucleolar organizer region (AgNOR) counting and flow cytometric DNA analysis in the differential diagnosis of thymoma and thymic carcinoma, as well as in the differences among various stages and histologic subtypes of these tumors. DESIGN AND INTERVENTIONS: Paraffin-embedded blocks of 64 thymic epithelial tumors (20 noninvasive thymomas, 34 invasive thymomas, and 10 thymic carcinomas) were studied by AgNOR counting and flow cytometric DNA analysis. The thymomas were histologically classified as medullary, cortical, or mixed subtype. MEASUREMENTS AND RESULTS: Invasive thymomas had more AgNORs (-/+ SD) than noninvasive thymomas (7.93+/-2.90 vs 5.97+/-1.77; p < 0.01). The number of AgNORs of thymoma increased progressively with advances in stage (p < 0.01). Cortical thymomas had the highest number of AgNORs among the three subtypes (p < 0.05). Patients with thymoma who presented with myasthenia gravis also had a higher number of AgNORs (8.30+/-3.12 vs 6.50+/-2.03; p < 0.01). The AgNOR number did not correlate with the DNA ploidy of all specimens. CONCLUSIONS: AgNOR counting is useful in differentiating between invasive and noninvasive thymomas, and in predicting the stage of thymomas. A greater number of AgNORs was observed in patients with cortical thymoma and in those who presented with myasthenia gravis.

Adult↗

Tracheal bronchus associated with lung cancer: a case report.

Tracheal bronchus is a rarely found congenital bronchial anomaly. It usually originates from the right lateral wall of the trachea at the level < 2 cm above the tracheal bifurcation. The patients usually are asymptomatic, but some may experience recurrent pneumonia, chronic bronchitis, or bronchiectasis. It is very rare for a malignant tumor to grow from this aberrant bronchus. There are only four cases of lung cancer developing from the tracheal bronchus reported in the world literature, and we present a fifth case.

Aged↗

Differential effects of different cytokines on the tumorigenicity and immunogenicity of murine tumors.

BACKGROUND: Granulocyte-macrophage colony stimulating factor (GM-CSF) or other cytokine gene transfer into tumor cells makes an effective tumor vaccine. However, this technique is time consuming and it is not possible for routine use in every patient. METHODS: The present study was designed to combine use of the irradiated B-16 cell line, a C57BL6 mice melanoma cell line, and cytokine (GM-CSF, interleukin-4 [IL-4], IL-10, or IL-12) manipulation, to enhance effectiveness of the tumor vaccine in prevention or reduction of subcutaneous tumor formation or pulmonary metastases. RESULTS: The results of in vitro studies show that the cytolytic activity of the splenocyte was highest when IL-2 or IL-4 was added to the culture medium. Immune splenocytes demonstrated the same level of cytolytic activity regardless of whether the mice were immunized once, twice or thrice. The proliferation assay was higher in immune splenocytes compared with normal splenocytes. The results of both the subcutaneous and pulmonary tumor growth models showed that immunization alone retarded tumor growth and prolonged survival, and this effect was essentially the same regardless of the frequency of immunization. However, the effect was much stronger when IL-4 was used during immunization in the subcutaneous tumor model, whereas IL-12 was the most optimal cytokine in the pulmonary metastases model. CONCLUSIONS: Different cytokines have different effects on immunization in different animal models even with the same tumor and animal. Careful selection of the appropriate cytokine for tumor vaccine immunization must be considered when different patterns of tumor recurrence are noted in clinical practice.

Animals↗

Pulmonary alveolar-septal amyloidosis presenting as heart failure with unilateral pleural effusion: a case report.

We report a case of pulmonary alveolar-septal amyloidosis associated with chylothorax and paraproteinemia initially presenting as congestive heart failure with unilateral pleural effusion. A 72-year-old man was initially diagnosed with congestive heart failure based on the correlation of clinical manifestation and chest radiography. Concentric left ventricular hypertrophy with mild hypokinesis of the left ventricle was found on cardiac echography. Thoracocentesis was performed for right-sided pleural effusion, which persisted despite medical treatment; chylous exudate was aspirated. Because the etiology of the exudative pleural effusion was undetermined, the patient underwent a thoracotomy that showed pulmonary alveolar-septal amyloidosis. Immunoglobulin M paraproteinemia was identified by serum immunoelectrophoresis. We conclude that it is imperative to search for the cause of an undetermined exudative pleural effusion, with particular attention to chylothorax and amyloidosis as the differential diagnoses.

Aged↗

Depressed cytolytic activity of peripheral blood mononuclear cells in unusually high paclitaxel concentrations: reversal by IL-2 and IL-12.

BACKGROUND: Human lymphocyte function was inhibited by high concentrations of paclitaxel and the effect was reversed by interleukin (IL)-2. However, there was no parallel study determining the relationship between paclitaxel concentrations in the lymphocyte cultures and pharmacokinetic analysis in human patients, nor was there any study on the reversal by cytokines, other than IL-2, of the paclitaxel-induced suppression of lymphocyte cytotoxicity. METHODS: We tested the effect of different doses of paclitaxel with various incubation times on the cytolytic activity of peripheral blood mononuclear cells (PBMNCs) against K-562 target cells. RESULTS: Our results showed that using a schedule similar to that for treating patients with tolerable doses of paclitaxel, no inhibition of cytolytic activity of PBMNCs was seen. When the paclitaxel concentration was increased 10-fold, the cytolytic activity of PBMNCs was significantly reduced. This suppression was reversed by the simultaneous addition of a low dose (10 U/ml) of IL-2 or IL-12. Addition of granulocyte macrophage-colony stimulating factor (10 U/ml) did not affect the cytolytic activity of PBMNCs, whereas addition of IL-4 reduced it. Time kinetic studies revealed that, with the addition of IL-2 or IL-12, most of the mononuclear cellular cytolytic activity recovered within 48 to 72 hours. CONCLUSIONS: These findings suggested that, to reduce the toxicity on mononuclear cellular function when high-dose paclitaxel treatment is elected in clinical practice, paclitaxel should be infused over a longer duration of time, or the treatment should be combined with the administration of a low dose of IL-2 or IL-12.

Antineoplastic Agents, Phytogenic↗

Acute respiratory distress syndrome following cutaneous exposure to Lysol: a case report.

Lysol (mixed cresols) is a brand of popular detergent commonly used to disinfect toilets and floors in Taiwan. We report a patient with acute respiratory failure immediately following chemical burns caused by skin contact with Lysol solution. On admission, chest radiography showed bilateral diffuse pulmonary infiltrates and an arterial blood gas analysis disclosed hypoxemia refractory to a high concentration of oxygen by inhalation. Under the impression of acute respiratory distress syndrome, our patient was admitted to the intensive care unit for respiratory care. Poor clinical improvement was noted, despite aggressive respiratory therapy. High-dose steroid therapy (hydrocortisone 30 mg/kg/day) was administered from the seventh day after mechanical ventilation began and the ratio of arterial partial pressure of oxygen to fractional concentration of oxygen in inspired gas improved thereafter. The amount of steroid was gradually tapered to the maintenance dose and the patient was successfully weaned from the ventilator after a 93-day course of mechanical ventilation.

Adult↗

Phase II trial of intrapleural paclitaxel injection for non-small-cell lung cancer patients with malignant pleural effusions.

A phase II clinical trial of intrapleural paclitaxel injection for malignant effusions of non-small-cell lung cancer (NSCLC) was conducted in order to evaluate the efficacy and toxicity profile of paclitaxel pleurodesis in patients with malignant effusions. From February to May of 1996, 15 NSCLC patients with malignant pleural effusions were enrolled on study. After adequate drainage and assurance of lung re-expansion, paclitaxel 125 mg m-2 diluted in normal saline was infused through a preinserted pig-tail catheter which was removed 2 h later. Chest radiography and sonography were scheduled 4 days later; depending on whether there remained a significant amount of pleural effusion, further drainage by needle thoracentesis or by a pig-tail catheter was performed. All patients were assessable for toxicity. Ipsilateral chest and/or shoulder pain, fever, facial flushing and nausea were the most frequent side-effects. Grade 4 neutropenia, grade 3 anaemia, and grade 3 renal impairment occurred in one patient each. Fourteen patients were evaluable for response at the end of the fourth week. Overall response rate of pleural effusion in evaluable patients was 92.9%, with a complete response rate of 28.6%. There was one out of 14 evaluable patients whose measurable tumour lesion decreased by more than 50% (partial response). No disease progression was noted among evaluable patients at the end of the fourth week. It is concluded that paclitaxel is a useful agent for the treatment of malignant pleural effusions. Because of its relatively low systemic toxicity, intrapleural paclitaxel injection in combination with systemic chemotherapy or radiotherapy can be considered in treating NSCLC patients with malignant pleural effusions.

Aged↗

Sialyl stage-specific embryonic antigen-1: a useful marker for differentiating the etiology of pleural effusion.

OBJECTIVES: To assess the usefulness of sialyl stage-specific embryonic antigen-1 (SSEA-1) levels in differentiating the etiology of pleural effusion (PE). DESIGN: A solid-phase immunoradiometric sandwich assay with an FH6 monoclonal antibody was used to measure sialyl SSEA-1 levels in PEs of 132 patients with various diseases. Paired serum sialyl SSEA-1 levels were measured simultaneously in 47 patients with various subtypes of lung cancer RESULTS: The pleural sialyl SSEA-1 levels were significantly higher in patients who had adenocarcinoma of the lung with positive cytology than in all the other patients, including those having malignancies other than adenocarcinoma of the lung, adenocarcinoma of the lung with cytology-negative PE, and benign diseases. There were no significant differences among sialyl SSEA-1 levels in the pleural fluid containing no adenocarcinoma cells. Using the cutoff value of 265 U/mL, the sensitivity was 64% (25/39) and the specificity was 95% (88/93) for the pleural sialyl SSEA-1 level to differentiate adenocarcinoma from other effusions. CONCLUSIONS: With high specificity and modest sensitivity, the pleural sialyl SSEA-1 level is a useful biochemical marker for differentiating the etiology of PEs caused by adenocarcinoma from other diseases.

Adenocarcinoma↗

Impact of nutritional status on the survival of lung cancer patients.

BACKGROUND: Weight loss, disease extent, performance status and sex have emerged as prognostic factors for lung cancer. The assessment of performance status is rather subjective and crude. Parameters of nutritional status were used in this study to represent the performance status of patients. The prevalence of protein-calorie malnutrition in lung cancer patients and the impact of this on patient survival were also investigated. METHODS: Nutritional status was assessed in 150 newly diagnosed lung cancer patients. Anthropometric and biochemical parameters measured were: weight/height ratio, percent of standard triceps skin-fold thickness, percent of standard arm muscle circumference, serum albumin, transferrin, creatinine height index and total lymphocyte count. Performance status and survival time were estimated for all patients. RESULTS: The prevalence of abnormality in each nutritional parameter ranged from 15 to 31%. Most of the patients (59%) had at least one abnormal nutritional parameter. A low profile of performance status was associated with lower nutritional parameters such as triceps skin-fold thickness, percent of standard arm muscle circumference, serum albumin and creatinine height index. Patients who died within six months after diagnosis had significantly lower values of all nutritional parameters than those who survived more than six months. Patients with more abnormal parameters tended to have poorer survival rates. CONCLUSIONS: Both anthropometric and biochemical nutritional parameters might be reliable indicators for the assessment of performance status and survival for patients with lung cancer.

Adult↗

Ifosfamide-based chemotherapy for previously treated lung cancer patients.

BACKGROUND: Ifosfamide-based chemotherapy has already been the basis of three separate clinical trials. In this study, ifosfamide was administered to lung cancer patients who had failed to respond to previous chemotherapy, to assess its response rate and toxicity. METHODS: From January 1993 to December 1996, 21 patients were treated, including eight patients with small cell lung cancer (SCLC) and 13 with non-small cell lung cancer (NSCLC). Patients who had histocytologically confirmed lung cancer, were previously treated with chemotherapy, had a measurable lesion(s), were younger than 75 years of age, had an Eastern Cooperative Oncology Group performance status of 0-3 and adequate marrow, renal and liver function were eligible for inclusion in this study. For SCLC patients, ifosfamide 2.4 g/m2 intravenous (i.v.) infusion was given over 30 minutes on days 1-3 every four weeks. For NSCLC two regimens were used: IFL (ifosfamide 2 g/m2, 5-fluorouracil (FU) 600 mg/m2 and leucovorin 50 mg/m2 i.v. infusion on days 1-3 every four weeks) and LIFE (leucovorin 50 mg/m2, ifosfamide 1 g/m2, 5-FU 400 mg/m2 and epirubicin 12 mg/m2 i.v. infusion on days 1-3 every four weeks). For NSCLC patients, IFL was used for the first two years of treatment and LIFE was used in the last two treatment years. All patients were evaluated for treatment response and toxicity. RESULTS: The major toxic effect, myelosuppression (grade 3 or 4 leukopenia), occurred in 62.5% of SCLC patients and 23.1% of NSCLC patients during treatment, and in 62.5% and 10% of SCLC and NSCLC patients, respectively, throughout the course. Only one SCLC and one NSCLC patient experienced febrile neutropenia. One toxic death, attributed to febrile neutropenia, was documented in a patient with SCLC. Alopecia was ubiquitous. Other toxicities were uncommon and mild. The overall response rate was 50% in SCLC and 7.7% in NSCLC. The median time to disease progression was 61 days in SCLC and 47 days in NSCLC. Median survival was 172 days in SCLC and 173 days in NSCLC. CONCLUSIONS: The study results suggest that ifosfamide chemotherapy is active with an acceptable toxicity profile in previously treated SCLC patients. However, it lacks efficacy in NSCLC patients who have been previously treated.

Adult↗

Randomized, double-blind, placebo-controlled study of transdermal nicotine patch for smoking cessation.

Smoking cessation is an arduous process because nicotine withdrawal syndrome, which occurs following sudden interruption of nicotine use in long-term smokers, frequently prevents them from giving up the habit. Nicotine supplement systems may relieve smokers' nicotine withdrawal symptoms and, thus, help in the process of abstinence from smoking. The purpose of the present study was to investigate the effectiveness and safety of a 30-mg transdermal nicotine patch in a smoking cessation program for Chinese smokers. In this randomized, double-blind, placebo-controlled study, 30 heavy smokers, who had smoked more than 20 cigarettes per day for more than a year, were treated with 30-mg transdermal nicotine patches, and 32 heavy smokers were given placebo patches during a 6-week smoking cessation program. The clinical characteristics of the two groups were similar. After 6 weeks, the use of the transdermal nicotine patch was associated with markedly reduced nicotine dependence and severity of withdrawal symptoms. Nineteen (63%, 95% confidence interval, CI, 46%-80%) of the smokers treated with the transdermal nicotine patch had successfully quit smoking at the end of the program (6 weeks) and nine (30%, 95% CI 14%-46%) remained abstinent 1 year later. In contrast, only 11 (34%, 95% CI 18%-50%) of the smokers in the placebo group had successfully stopped smoking after 6 weeks, and three remained abstinent 1 year later (9%, 95% CI 0%-19%). However, there was no statistically significant difference between the two groups of smokers after 1 year of follow-up (p = 0.08). Side-effects were minimal and did not affect the efficacy of the skin patch. The results indicate that the transdermal nicotine patch is an effective aid in smoking cessation programs.

Administration, Cutaneous↗