Biomaterial Database

Randomized clinical trial of non-specific immunotherapy with cell-wall skeleton of Nocardia rubra. 1984

K Yasumoto, and Y Yamamura

A randomized clinical trial of intrapleural Nocardia rubra cell-wall skeleton (N-CWS) followed by intradermal N-CWS was performed against lung cancer patients from November, 1977 to June, 1981. Totally, 190 patients were entered into this trial. The N-CWS treatment was effective in terms of prolongation of remission duration against not only operable but also inoperable patients. However, significant improvement of survival rate was observed only in operable patients, especially curative operation group (p less than 0.05). The mode of recurrence was classified as local recurrence and distant metastasis in the curative operation group. The rates of distant metastasis were 34.1 and 17.6% respectively, in the control and the N-CWS groups. The rate of local recurrence was 13.6% in the control group, although no local recurrence was observed in the N-CWS group. These results indicate the clinical effectiveness of the N-CWS treatment especially in curatively resectable lung cancer. Major and frequent side-effects of the N-CWS treatment were fever up to 40 degrees C with an average duration of 2 days following intrapleural instillation and skin reaction at the site of intradermal injections. No serious side effect was experienced during this trial.

UI	MeSH Term	Description	Entries
D007167	Immunotherapy	Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection.	Immunotherapies
D008175	Lung Neoplasms	Tumors or cancer of the LUNG.	Cancer of Lung,Lung Cancer,Pulmonary Cancer,Pulmonary Neoplasms,Cancer of the Lung,Neoplasms, Lung,Neoplasms, Pulmonary,Cancer, Lung,Cancer, Pulmonary,Cancers, Lung,Cancers, Pulmonary,Lung Cancers,Lung Neoplasm,Neoplasm, Lung,Neoplasm, Pulmonary,Pulmonary Cancers,Pulmonary Neoplasm
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009615	Nocardia	A genus of gram-positive, aerobic bacteria whose species are widely distributed and are abundant in soil. Some strains are pathogenic opportunists for humans and animals.	Micropolyspora
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D002473	Cell Wall	The outermost layer of a cell in most PLANTS; BACTERIA; FUNGI; and ALGAE. The cell wall is usually a rigid structure that lies external to the CELL MEMBRANE, and provides a protective barrier against physical or chemical agents.	Cell Walls,Wall, Cell,Walls, Cell
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man