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[Treatment and prognosis of stage III-IV laryngeal squamous cell carcinoma].

BACKGROUND & OBJECTIVE: Laryngeal squamous cell carcinoma (LSCC) is a common malignancy of the head and neck. Stage I-II LSCC patients have a favorable prognosis after operation or radiotherapy, but the curative effect and prognosis of stage III-IV LSCC are not satisfying, and its treatment is also controversial. This study was to summarize our experience in treating stage III-IV LSCC patients, evaluate the treatment results, and seek more reasonable therapeutic modality. METHODS: Records of 202 stage III-IV LSCC patients, treated in Cancer Center of Sun Yat-sen University from Jan. 1, 1991 to Jan. 1, 2000, were retrospectively analyzed. Of the 202 patients, 64 received surgery alone, 83 received surgery and preoperative or postoperative radiotherapy, 41 received radiotherapy, and 14 received chemotherapy. The overall survival rate was estimated using life table method by SPSS10.0 software. Survival curves were compared with Wilcoxon method; relapse statuses were compared with Chi(2) test. RESULTS: The 5- and 10-year overall survival rates of the 202 patients was (42.12+/-3.62)% and (33.20+/-4.32)%, and the median survival time was 48.5 months. The 5-year survival rates were 61.07% in glottic carcinoma group and 26.07% in supraglottic carcinoma group, and were 53.41% in surgery alone group, 51.04% in surgery plus radiotherapy group, 18.33% in radiotherapy group and 7.14% in chemotherapy group. There was no significant difference between surgery alone group and surgery plus radiotherapy group (P>0.05). Of the 147 patients received surgery, the 5-year survival rates were 56.15% for the 31 patients received partial laryngectomy and 52.08% for the 116 patients received total laryngectomy. Eleven patients had tumor relapsed after total laryngectomy within 5 years. CONCLUSIONS: Surgery, especially total laryngectomy, is the major treatment modality for stage III-IV LSCC. Partial laryngectomy may be performed with strict selection. Postoperative radiotherapy may be preformed on the patients with suspect of tumor residue or positive margin.

Adult↗

[Surgical treatment of carcinoma of low rectum].

1230 cases of low rectal cancer were treated surgically from 1954 through 1990 with a resectability rate of 79.92% and a curative resectability rate of 63.98%. Among curative resections, abdomino-perineal excision accounted for 71.16% and sphincter-saving resection for 28.84%. Before 1980, 19.19% cases were treated with SSR and since 1980 it was raisen to 41.04%. In comparison of the results of group before 1980 with those since 1980, the mortality rate of curative resection was 1.56% and 0.99% respectively. The 5-year survival rate of curative resection (life table method) was 58.96% +/- 2.87% in APR and 80.39% +/- 5.06% in SSR before 1980, and 71.65% +/- 3.28% in APR and 83.82% +/- 3.46% since 1980. The local recurrence after curative resection was 13.57% in APR and 12.33% in SSR. The data showed that in properly selected cases, the outcome was better in SSR than in APR either in survival or in quality of life. The feasibility and reasonality of the SSR and the rules for selecting the operative procedures in low rectal cancer were discussed in detail.

Female↗

Cisplatin-fluorouracil exclusive chemotherapy for T1-T3N0 glottic squamous cell carcinoma complete clinical responders: five-year results.

PURPOSE: To evaluate cisplatin-fluorouracil exclusive chemotherapy (EC) for T1-T3N0 glottic squamous cell carcinoma complete clinical responders (CCR) after cisplatin-fluorouracil induction chemotherapy (IC). PATIENTS AND METHODS: A retrospective analysis was performed of 58 patients with T1-T3N0 glottic squamous cell carcinoma CCR after IC consecutively managed at our department between 1985 and 1992. Twenty-one CCR were managed with EC. Thirty-seven CCR were managed with IC and a conventional laryngeal-preservation modality. Analyses of survival, local control, nodal recurrence, distant metastasis, and metachronous second primary tumor were performed using the Kaplan-Meier actuarial life-table method. In CCR managed with EC, the independent factors of age, tumor classification, exact tumor location, true vocal cord motion, arytenoid cartilage motion, total dosage of drugs delivered, and number of courses received were tested for potential correlation with survival, local recurrence, nodal recurence, and distant metastasis. RESULTS: The 5-year survival, local control, nodal recurrence, distant metastasis, and metachronous second primary tumor rates in CCR managed with EC were 95.2%, 70.7%, 0%, 0%, and 14.3%, respectively. The 5-year rates of survival, local control, nodal recurrence, distant metastasis, and metachronous second primary tumor in CCR managed with IC and a conventional laryngeal-preservation modality were 86.1%, 97%, 2.7%, 6%, and 14.5%, respectively. Local recurrence was statistically more likely in CCR managed with EC (P = .002). Local recurrence in CCR managed with EC was always salvaged with partial laryngectomy or radiation therapy, which resulted in an overall 100% local control and laryngeal-preservation rate within this group. In CCR managed with EC, none of the variables analyzed was statistically related to survival, local recurrence, nodal recurrence, or distant metastasis. CONCLUSION: The present retrospective studies demonstrated that within T1-T3N0 glottic squamous cell carcinoma CCR, there is clearly a significant subset of patients with chemocurable tumors who achieved both perfect preservation of structure-supporting voice and long-term survival after EC. Careful monthly follow-up evaluation allowed for timely successful salvage of local recurrence after EC without the need for total laryngectomy. Such management did not appear to increase the risk for subsequent nodal failure, subsequent distant metastasis, or reduced survival.

Adult↗

The prophylactic efficacy of tricyclic antidepressants--a five year followup.

1. In order to evaluate the efficacy of antidepressants in the prevention of recurrent depression, a longitudinal life-table analysis was carried out involving 217 unipolar patients whose depressive symptoms had remitted following treatment with one of five standard tricyclics (imipramine, amitriptyline, desipramine, nortriptyline, and doxepin). 2. Following six months continued euthymic mood these patients were maintained on the medication to which they initially responded to in a clinical setting over a 5 year period. These patients were compared against a group of 28 individuals who were treated acutely for their depression and responded to one of the above the 5 standard antidepressants, but following 5-6 months continuation treatment were taken off the antidepressant at their own request. 3. Though there was a lower rate of relapse in patients receiving active medication vs the no treatment group, the frequency of relapse was high for the group on active drug. 4. Using the longitudinal life-table method of Fleiss there was a pessimistic-optimistic average relapse rate of 30%, 50%, and 60%, at 1, 2, and 3 years respectively while on active drug vs a 51%, 74%, and 83% relapse rate on no treatment. Overall 87 of 217 patients on active drug (40.1%) were observed to have suffered a depressive relapse over the 5 year course.

Adult↗

Role of bypass, endarterectomy, extra-anatomic bypass and endovascular surgery in unilateral iliac occlusive disease: a review of 1257 cases.

Some 1257 patients who had undergone revascularization procedures for unilateral iliac occlusions were reviewed retrospectively. A total of 824 patients were operated upon using conventional operations, 165 patients had femorofemoral bypass and 268 were treated using endovascular surgery techniques. Revascularization was performed through an extraperitoneal approach by means of iliac thromboendarterectomy (560) or iliac femoral bypass (264) if there was a total occlusion of either the common or external iliac artery (group 1). A femorofemoral crossover bypass was inserted when the operative risk was considered to be high (group 2). Endovascular procedures (percutaneous transluminal angioplasty 234, laser percutaneous transluminal angioplasty 11, stenting 22, atherectomy one) were used in recent years to treat stenoses or occlusions of 3 cm or less (group 3). The indications for operation were severe claudication in 79.7% in group 1 and 92.6% in group 3, whereas in group 2 66.7% of patients presented with symptoms of more advanced ischaemia. The immediate patency rate was 97.0% after extraperitoneal reconstructive surgery, 96.9% in the femorofemoral group and 92.1% in patients having an endovascular procedure. The operative mortality rate was 0.7, 4.2, and 0.3% for groups 1-3, respectively. The 5-year patency rate, analysed by the life-table method, was 77.9% in group 1, 75.3% in group 2 and 73.7% in group 3 (P = n.s., log rank test). The different revascularization techniques were chosen on the basis of the type of disease present and the patient's general condition. All procedures appeared to be effective when correctly selected.

Adult↗

Anastomotic aneurysms after surgical treatment of Takayasu's arteritis: a 40-year experience.

PURPOSE: To evaluate the clinical characteristics of anastomotic aneurysms that develop in surgically treated patients with Takayasu's arteritis. METHODS: Among 103 patients with Takayasu's arteritis treated surgically over 40 years, 91 patients with 259 anastomoses (allowing for exclusion of 12 operative deaths) participated in follow-up study from 1 month to 37.3 years with a mean value +/- SEM of 17.3 +/- 1.1 years with a follow-up completion rate of 93% at 30 years. The clinical characteristics of anastomotic aneurysms were clarified, and the influences of several factors (sites of anastomoses, occlusive or aneurysmal disease, suture material, preoperative systemic inflammation, and administration of corticosteroids) on formation of anastomotic aneurysms were analyzed by means of life-table method and Cox regression analysis. RESULTS: Twenty-two uninfected anastomotic aneurysms were found among 14 patients (22 of 259 anastomoses, 8.5%). The interval between the previous operation and diagnosis varied from 1.6 to 30 years with a mean value +/- SEM of 9.8 +/- 1.8 years. The cumulative incidence of anastomotic aneurysm at 20 years was 12.0%. Systemic inflammation or steroid administration had little influence on formation of anastomotic aneurysm. Instead, anastomotic aneurysm tended to occur after operations for aneurysmal lesions. CONCLUSIONS: Anastomotic aneurysm can occur anytime after operations for Takayasu's arteritis. The development of anastomotic aneurysm is not influenced by any factor specific to this disease except the presence of an aneurysmal lesion.

Adolescent↗

[Assessment of risk for tin mine dust in Guangxi].

OBJECTIVE: To explore the minimum observed adverse effect level(LOAEL) and intensity of pathogenesis of tin mine dust. METHODS: A cohort study design with retrospective assessment of exposure was used. Selected 4,471 male tin miners who were exposed to tin at least one year during 1960 to 1974 and were compared with 4,797 pottery dust exposed workers in the same way designed. Statistical analysis system SAS, PROC LIFETEST were used to perform the non-parameter calculation by Life Table method. RESULTS: Tin mine cohort subjects were followed up to December 31, 1994. The percentage of miners who developed silicosis was 21.7% (971/4,471). 81% of the patients had been exposed to dust before 1958. The cumulative total dust exposure(CTD) was significantly correlated with silicosis risk. The risk of silicosis was 0.012 when CTD was less than 50 mg/m-3.year-1. The risk of silicosis was increased to 0.971 when CTD was beyond 400 mg.m-3.year-1. However, the risk of silicosis was only 0.369 for dust exposed workers in pottery factories when CTD was beyond 400 mg.m-3.year-1. CONCLUSION: There was significant relationship between cumulative dust exposure and the incidence of silicosis in tin exposed workers. And silicosis induced by tin mine dust is more serious than the pottery dust.

Cohort Studies↗

Phase III long-term study and comparative clinical study of nipradilol ophthalmic solution in patients with primary open-angle glaucoma and ocular hypertension.

Nipradilol (CAS 81486-22-8) is a non-selective beta-blocker with alpha-1 blocking and nitroglycerin-like vasodilating activities. In the present communication, the long-term efficacy and safety of nipradilol were investigated and the efficacy, safety and utility of topical nipradilol and timolol (CAS 91524-16-2) were compared in patients with primary open-angle glaucoma or ocular hypertension. In the long-term study, nipradilol for 1 year (52 weeks) was performed by registration method. 67 out of 68 patients were subjected to analysis and 57 patients (83.8 %) completed 52-week instillation. 0.25 % nipradilol was applied twice daily to patients. As a result, intraocular pressure (IOP) decreased significantly by 4.0 mmHg to 4.8 mmHg compared with the baseline without tachyphylaxis. The incidence of adverse events was 12.5 % at 52 weeks by analysis with Kaplan-Meier life-table method. It showed no significant trend of increase after 3 months. In the multi-centered double-masked comparative randomized study, 0.25 % nipradilol was assigned to 96 patients and 0.5 % timolol to 100 patients. Each patient was instilled nipradilol or timolol twice daily for 8 weeks. IOP significantly decreased by 4.2 mmHg and by 4.7 mmHg at 8 weeks and the incidence of adverse events was 10.5 % and 12.1 % in the nipradilol and timolol group, respectively. No significant between-group difference in IOP reduction or incidence of adverse events was seen. Topical nipradilol showed long-term ocular hypotensive effects and clinical safety in a 52-week study, and its efficacy and safety equivalent to timolol was confirmed in a 8-week comparative study.

Administration, Topical↗

Carotid-subclavian bypass grafting with polytetrafluoroethylene grafts for symptomatic subclavian artery stenosis or occlusion: a 20-year experience.

BACKGROUND AND PURPOSE: Since the advent of subclavian artery percutaneous transluminal angioplasty/stenting, several authorities advocate it as the treatment of choice for patients with subclavian artery disease, claiming results equal to or better than those of reconstructive vascular surgery. However, most of their quoted surgical series included patients who may have other brachiocephalic disease who were treated nonuniformly by means of various bypass grafts with different grafts in the same series (eg, Dacron, polytetrafluoroethylene [PTFE], or vein). In this study, we analyze the long-term results of a large series of carotid-subclavian bypass grafts for subclavian artery disease in which PTFE was uniformly used; the study can be used as a future reference to compare the results of subclavian artery percutaneous transluminal angioplasty/stenting. PATIENT POPULATION AND METHODS: Fifty-one patients with symptomatic subclavian artery disease (40 occlusions and 11 stenoses) who were treated with carotid-subclavian bypass grafts (PTFE [Goretex]) during a 20-year period were analyzed. Graft patency was determined clinically and confirmed with Doppler scanning pressures and duplex ultrasound scanning. The cumulative patency, overall survival, and symptom-free survival rates were calculated with the life table method. RESULTS: Indications for surgery were arm ischemia in 34 patients (67%), vertebrobasilar insufficiency (VBI) in 27 (53%), and symptomatic subclavian steal in 7 (14%). A combination of arm ischemia and VBI occurred in 17 (33%) of these patients. The mean follow-up was 7.7 years with a median of 7.0 years (range, 1-19 years). The 30-day morbidity rate was 6%, with no perioperative stroke or mortality. Immediate relief of symptoms was achieved in 100% of patients; however, four patients (8%) had late recurrent symptoms (three with VBI). The primary patency and secondary patency rates at 1, 3, 5, and 10 years were 100%, 98%, 96%, and 92% and 100%, 98%, 98%, and 95%, respectively. The symptom-free survival rates at 1, 3, 5, and 10 years were 100%, 96%, 82%, and 47%, respectively. The overall survival rates at 1, 3, 5, and 10 years were 100%, 98%, 86%, and 57%. The mean hospital stay was 3.5 days in the late 70s and 80s and 2.1 days in the 90s (P <. 001). CONCLUSIONS: Carotid-subclavian bypass grafts with PTFE grafts for subclavian artery disease are safe, effective, and durable and should remain the procedure of choice, particularly in good-risk patients.

Aged↗

Does female gender or hormone replacement therapy affect early or late outcome after carotid endarterectomy?

OBJECTIVE: Subgroup analyses of the Asymptomatic Carotid Atherosclerosis Study and the North American Symptomatic Carotid Endarterectomy Trial trials have questioned the ability of carotid endarterectomy (CEA) to reduce the risk of stroke in women. The purpose of this study was to test the effect of female gender and estrogen-based hormone replacement therapy on perioperative (30-day) and long-term (5-year) outcomes after CEA. METHODS: From 1988 to 1998, 361 CEAs were performed in 326 patients (246 male, 115 female) by a single surgeon. Retrospective data were collected with chart review, and follow-up data were obtained with clinical examination or telephone interview. Follow-up was possible in 95% of patients. Reoperative CEAs and combined aortic or cardiac procedures were excluded. Statistical analysis used life-table methods, Student t test, and Pearson chi(2) tests when appropriate. RESULTS: Age and preoperative risk factors were similar between women and men. CEA was performed for symptomatic (50% female, 42% male) and asymptomatic carotid stenosis (50% female, 58% male; P =.19). Perioperative (30-day) stroke rate was similar for women and men (3.6% female, 1.2% male; P =.13). No perioperative strokes occurred in asymptomatic patients. With previous stroke or transient ischemic attack, a trend was seen towards an increased perioperative stroke rate in women (7.0% female, 2.8% male; P =.25). Long-term follow-up showed a similar trend in the 5-year stroke rate in symptomatic patients (7.0% female, 2.8 male; P =.23). The stroke-free survival rate was not significantly different between genders (87% female, 75% male; P =.58). Reoperation was performed for asymptomatic recurrent carotid stenosis in five men (2.3%) and two women (1.9%; P =.84). Interestingly, the use of estrogen-based hormone replacement therapy in women showed a trend toward increasing stroke rate at 30 days (1.2% versus 8.7%; P =.08) and at 5 years (2.3% versus 8.7%; P =.16). CONCLUSION: This retrospective study confirms that CEA provides long-term reduction in stroke risk and improved stroke-free survival rates in both men and women. However, women with previous neurologic symptoms and those using hormone replacement therapy appear to be at higher stroke risk at the time of surgery.

Aged↗

A multimodal strategy for the treatment of patients with T2 invasive squamous cell carcinoma of the glottis.

BACKGROUND: The current conservative standard of care for T2 squamous cell carcinoma of the glottis is either partial laryngectomy or radiation therapy. METHODS: Based on an inception cohort of 100 patients with T2 squamous cell carcinoma of the glottis and a minimum of 3 years of follow-up, the present study documented the results achieved with a multimodal strategy using platinum-based induction chemotherapy and partial laryngeal surgery. Statistical analysis of survival and local control was based on the Kaplan-Meier actuarial life table method. Univariate analysis was performed to determine whether there was a correlation among various factors and toxicity, clinical response, histologic regression, local control, and survival. RESULTS: A complete clinical response and a partial response after induction chemotherapy was achieved in 24% and 58% of patients, respectively. Complete histologic regression was noted in 31%. A significant statistical relation (P < 0.0001) was noted between a complete clinical response after induction chemotherapy and a complete histologic regression. The 5-year actuarial survival estimate was 85.8%. The 5-year actuarial local control estimate was 95.7% (97.7% if the vocal cord was mobile and 93.8% if the motion of the vocal cord was impaired). Salvage treatment resulted in an overall 99% rate of local control and a 95% rate of laryngeal preservation. CONCLUSIONS: Because this represents a nonrandomized retrospective study, no definitive conclusions can be derived. However, when compared with the data reported in a large series using radiation therapy or partial laryngectomy alone, this 10-year experience suggests that, in patients with "early" invasive squamous cell carcinoma of the glottis, the use of platinum-based induction chemotherapy prior to a conventional conservative treatment modality should be investigated further.

Adult↗

Clinical and physiological outcomes of a university-hospital pulmonary rehabilitation program.

Pulmonary rehabilitation programs have resulted in improvements in quality of life, capacity for carrying out daily activities, and physical conditioning, as well as reduced hospitalization and cost of care. In our retrospective study, we reviewed the data of 75 patients who had participated in Loma Linda University Medical Center's pulmonary rehabilitation program--in order to determine its effect on survival, progression of disease, and quality of life for a selected group of patients with chronic obstructive pulmonary disease (COPD). A multidisciplinary rehabilitation team evaluated each patient and developed for him a plan of care that included a 2-week inpatient education program. The cumulative survival rate of our group computed by the life table methods was 86.5% at 5 years of rehabilitation, and 64% at 10 years. The mean FEV1 at the beginning of the program was 1.53 1 and the mean FVC was 2.87 1; the mean change in FEV1 was - 45 ml/yr, and in FVC, - 70 ml/yr. By use of a questionnaire, we also found that most of our responding patients felt that their quality of life had improved. Our findings compare favorably with other published data and suggest that it is possible to improve the survival of patients with COPD by early diagnosis, comprehensive treatment, continuing medical care, and home visitation.

California↗

Survival of Mexican-American males with seminoma.

OBJECTIVE: The objective was to determine if ethnicity was a prognostic variable in survival outcomes for testicular seminoma. MATERIALS: Eighty-seven consecutive patients with a histologic diagnosis of seminoma treated at University of illinois Hospitals were evaluated. RESULTS: There were 52 (57%) white, 22 (24%) African-American, 16 (18%) Mexican-American and 1% Asian patients. Adjusted survivals for the life-table method were 84% and 80% for the whites and Africa-American patients and 69% for the Hispanic patients. The poorer outcome appeared to be related to stage at diagnosis. CONCLUSION: In this population with testicular seminoma Mexican-American patients appear to have a worse prognosis than other ethnic groups. These differences were associated to a delayed diagnosis probably due to cultural influences.

Asian People↗

Longterm followup (12-15 years) of a randomized controlled trial comparing Bassini-Stetten, Shouldice, and high ligation with narrowing of the internal ring for primary inguinal hernia repair.

BACKGROUND: Shouldice repair for primary inguinal hernia is reported to have better results than classic Bassini-type repairs. The indirect inguinal hernia with a firm posterior wall is often assumed to be adequately treated by high ligation and ring narrowing. STUDY DESIGN: This double randomized controlled trial compared high ligation and ring narrowing with Bassini-Stetten repair for the indirect inguinal hernia with a firm posterior wall, and Shouldice with Bassini-Stetten repair for the inguinal hernia with a weakened posterior wall, direct or indirect. This report focuses on longterm (12-15 years) recurrence rates. RESULTS: From July 1980 to May 1983, 102 indirect primary inguinal hernias with a firm posterior wall (group I) and 263 primary inguinal hernias with a weakened posterior wall (group II) were included. By 1995, 89 patients with 100 hernia repairs had died, and for 30 repairs the patients could not be located. In 41 hernia repairs, a recurrence had been established previously. Of the remaining 194 hernia repairs, followup was updated by physical examination in 179 (92%) and by telephone interview in 15 (8%). A total of 83 recurrences were recorded, 42% of which were asymptomatic at the time of diagnosis. Seventy-three percent of the recurrences happened > 2 years after the operation. The life-table method showed the following longterm (12-15 years) recurrence rates: group I, Bassini-Stetten 33% versus ring narrowing 34%; group II, Bassini-Stetten 32% versus Shouldice 15% (p = 0.033). CONCLUSIONS: The Shouldice is the best type of hernia repair, although the 15% recurrence rate is high. Bassini-Stetten and high ligation with ring narrowing are inadequate repairs, regardless of the type of hernia.

Aged↗

Long-term experience with Multiload intrauterine devices.

This paper reports the joint experience of three investigators who used three types of the Multiload (ML) IUD (MLCu250 Short, MLCu250 Standard, and MLCu375) in 1987 consecutive insertions during which an experience of 56,005 woman-months of use was accumulated. The material was analyzed using the life-table method and complemented with a case by case investigation, the main purpose of the study being the specific analysis of IUD-related complications. The authors also evaluated return of fertility whenever a device was removed because of wish of pregnancy. Results indicate that serious IUD-related complications were rare, continuation rate high, and reversibility of fertility unaffected by the device.

Computer Simulation↗

Follow-up study after percutaneous transluminal cerebral angioplasty.

The purpose of this study was to assess the safety and efficacy of percutaneous transluminal cerebral balloon angioplasty (PTCBA) of extra- and intra-cranial arteries by investigating procedural outcome. Eighty haemodynamically significant extra- and intra-cranial lesions (% diameter stenosis > 70) in 74 clinically symptomatic patients were treated by elective and initial PTCBA between March 1991 and February 1996 and thereafter followed. Death, stroke, surgery, or repeated angioplasty of restenosis or new lesions were regarded as cerebral events after the initial PTCBA. The procedural and clinical success rates were 81 % (65 of 80) and 81 % (60 of 74), respectively. Progressively ischaemic symptoms disappeared completely after clinically successful dilatation. Angiographic restenosis rate at 3 months was 22 %(14 of 65). By life-table method, the death/stroke risk was 16 %, and any cerebral event risk was 49 % at 2 years following PTCBA, respectively. The most common of first cerebral events presented was repeated angioplasty of restenosis. In conclusion, PTCBA has great efficacy in decreasing recurrent neurological symptoms and produces a favourable short-term outcome, whereas restenosis limits long-term benefit.

Adolescent↗

Chemotherapy alone with curative intent in patients with invasive squamous cell carcinoma of the pharyngolarynx classified as T1-T4N0M0 complete clinical responders.

BACKGROUND: The current studies documented the results achieved with chemotherapy alone with curative intent in a series of 67 patients with invasive squamous cell carcinoma of the pharyngolarynx classified as T1-T4N0M0 complete clinical responders after a platin-based induction chemotherapy regimen. METHODS: Group I consisted of 36 patients with tumors originating from the glottis. Group II consisted of 31 patients with tumors originating from sites within the pharyngolarynx other than the glottis. A minimum of 3 years of follow-up was achieved. Statistical analyses of survival, local control, lymph node control, distant metastasis, and second primary tumor rates were based on the Kaplan-Meier life-table method. Laryngeal preservation rates and local control rates are presented. RESULTS: The 5-year actuarial survival estimate was 85.1% in Group I patients and 54.8% in Group II patients. Survival was statistically more likely to be reduced in Group II patients compared with Group I patients (P = 0.01). The 5-year actuarial local control estimate was 65.7% in Group I patients and 37.5% in Group II patients. Local failure was statistically more likely to occur in Group II patients compared with Group I patients (P = 0.02). Local control rates after salvage treatment were 100% in Group I patients and 83% in Group II patients. Laryngeal preservation rates after salvage treatment were 100% in Group I patients and 64% in Group II patients. The 5-year actuarial lymph node control estimate was 90% in Group I patients and 73.7% in Group II patients. Lymph node failure was statistically more likely to occur in Group II patients compared with Group I patients (P = 0.04). The 5-year actuarial estimate for patients without distant metastasis was 100% in Group I patients and 90% in Group II patients. Distant metastasis was statistically more likely to occur in Group II patients compared with Group I patients (P = 0.03). The 10-year actuarial estimate for patients without metachronous second primary tumors was 56.4% in Group I and 46.1% in Group II. CONCLUSIONS: The current report 1) contradicts the old dogma of nonchemocurability for invasive squamous cell carcinoma of the upper aerodigestive tract and 2) suggests that the use of a platin-based chemotherapy-alone regimen with curative intent in patients with invasive squamous cell carcinoma of the pharyngolarynx who are classified as T1-T4N0M0 complete clinical responders after receiving an induction chemotherapy regimen is best indicated when the tumor originates from the glottis.

Adult↗

Anti-infectives-induced adverse drug reactions in hospitalized patients.

OBJECTIVES: To assess the rate and seriousness of adverse drug reactions (ADRs) attributable to anti-infective agents in hospitalized patients; to estimate the likelihood of experiencing anti-infectives-induced ADRs at different length of drug usage in the hospital; to compare different classes of anti-infectives in inducing ADRs; to determine the impact of age and sex on anti-infectives-induced ADRs. DESIGN: Prospective cohort study. PARTICIPANTS: Patients admitted to the infectious diseases department at a university teaching hospital, on Sunday to Wednesday, over a 9 months period, who received at least one anti-infective agent were eligible to enter the study. MAIN OUTCOME MEASURES: Any suspected noxious and untoward medical events, including laboratory tests abnormalities following anti-infective therapy. METHODS: All patients admitted have received at least one anti-infective drug. Anti-infective agents induced ADRs were detected by interviewing patients and daily chart review. The seriousness, causality, and type of reactions were classified based on World Health Organization (WHO) definitions. Chi-square analysis was performed to assess the influence of sex and age on occurring ADRs. Both Kaplan-Meier and life table method were used to estimate the time to occur the ADR in anti-infective users. To compare the estimated risk of ADRs induced by different classes of anti-infectives, odds ratios were estimated. In all classes of anti-infectives, the odds ratio of each class was estimated with regard to anti-tuberculosis agents, which had the highest prevalence of ADRs. RESULTS: During the study period, 460 patients were entered the study. During the same period, 38 ADRs were recognized of which 20 (42%) were serious. The most recognized ADRs were suspected to be induced by anti-tuberculosis agents (29.8%). However in comparing with anti-tuberculosis agents, anti-fungal agents were associated with the highest ADR rate (odds ratio [OR], 4.21; 95% confidence interval [CI], 1.41-1.256) whereas cephalosporines were associated with the lowest rate, (OR, 0.1; 95%CI, 0.04-0.26). The survival analysis shows that the likelihood of experiencing an ADR was increased at first 14 days of drug therapy. Also Chi-square analysis shows that greater risk of anti-infectives-induced ADRs was observed in women. CONCLUSION: The rate of ADRs induced by anti-infective agents in this study was 8.2%. This is higher than a standard (5%) which has been reported in other studies. This study also shows that some of the classes of anti-infective agents like anti-fungals need more attention.

Anti-Infective Agents↗