Tratamiento tópico con nanopartículas de plata y <i>Stryphnodendron Adstringens</i> (Mart.) <i>Coville</i> en lesiones cervicales: ensayo clínico aleatorizado

Nascimento, Cristiane Araújo; Santos, Ana Caroline Melo dos; Silva, Denise Macedo da; Barbosa, Nirliane Ribeiro; Moura, Edilson Leite de; Silva, Veracilda Bezerra da; Balliano, Tatiane Luciano; Figueiredo, Elaine Virginia Martins de Souza; Farias, Karol Fireman de; Pitta, Guilherme Benjamin Brandão

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Original Article • Rev. esc. enferm. USP 57 • 2023 • https://doi.org/10.1590/1980-220X-REEUSP-2022-0338en copiar

Tratamiento tópico con nanopartículas de plata y Stryphnodendron Adstringens (Mart.) Coville en lesiones cervicales: ensayo clínico aleatorizado

Autoría SCIMAGO INSTITUTIONS RANKINGS

RESUMEN

Objetivo:

evaluar la viabilidad de la incorporación de la tecnología como una nueva alternativa para el tratamiento de temas sobre lesiones cervicales.

Método:

Se trata de un ensayo clínico aleatorizado, doble ciego, controlado y con un diseño prospectivo. Durante la realización de este estudio se incluyeron 43 mujeres divididas entre los grupos A (pomada sin nanopartículas de plata n = 23) y B (pomada con nanopartículas de plata n = 20) clínicamente sanas y usuarias del sistema unificado de salud.

Resultados:

No hubo diferencias significativas al comparar antes y después del uso de la pomada para la prueba de IVA (p = 0,15), la prueba de Schiller (p = 0,15), los cambios celulares (p = 0,47) y el análisis microbiológico (p = 0,89) mediante citología. Tras el uso, no se observó ninguna reacción adversa en la muestra estudiada.

Conclusiones:

Con base en los resultados identificados en este estudio, se identificó que el producto es seguro y no promueve eventos adversos. Con relación a la eficacia del producto en lesiones cervicales uterinas, es necesario continuar el estudio en fase II. Registro de Estudios Clínicos Brasileños: UTN: U1111-1218-2820.

DESCRIPTORES
Lesiones Intraepiteliales Escamosas de Cuello Uterino; Neoplasias del Cuello Uterino; Stryphnodendron barbatimam; Fitoterapia

Pap smear	Before		After
Pap smear	N	%	N	%
Sample evaluation
Satisfactory	38	88.4	39	90.7
Poor	5	11.6	4	9.3
Epithelium represented in the sample
Scaly glandular metaplastic	29	67.4	37	86
Scaly metaplastic	6	14	0	0
Scaly	3	7	2	4.7
Unsatisfactory	5	11.6	4	9.3
Representativeness of the transformation zone
Yes	33	76.8	36	83.7
Not	5	11.6	3	7
Poor	5	11.6	4	9.3
Benign reactive or repairing cellular changes
Inflammation. immature squamous metaplasia	10	23.3	7	16.3
Inflammation. atrophy with inflammation	4	9.3	32	74.4
Inflammation	22	51.2	0	0
Inflammation. nuclear activation	2	4.6	0	0
Poor	5	11.6	4	9.3
Microbiology
Lactobacillus sp.	26	60.5	26	60.5
Lactobacillus sp. Coconuts and other bacilli.	4	9.3	7	16.2
Lactobacillus sp. Coconuts. Candida sp.	4	9.3	0	0
Supracytoplasmic bacilli (suggestive of Gardnerella/ Mobiluncus)	1	2.3	6	14
Poor	8	18.6	4	9.3
Conclusion of the analysis
Negative for malignancy	32	74.4	35	81.4
Atypical cells of undetermined significance. Scaly: Possibly non-neoplastic (ASC-US)	6	14	4	9.3
Poor	5	11.6	4	9.3

Pap smear	Before								After
	Barbatimão ointment					X²	GL	p¹	Barbatimão ointment					X²	GL	p^1a
	No silver nanoparticles		With silver nanoparticles						No silver nanoparticles		With silver nanoparticles
	N^b	%	N^b	%	Total				N^b	%	N^b	%	Total
Epithelia represented in the sample					34	3.848	1	0.05					41	0.024	1	0.87
Scaly. glandular. metaplastic	17	50.0	11	32.4	28				20	48.8	17	41.5	37
Scaly. metaplastic	1	2.9	5	14.7	6				–	–	–	–
Scaly	–	–	–	–	0				2	4.9	2	4.9	4
Benign reactive or repairing cellular changes					37	3.446	6	0.75					42	1.389	2	0.49
Inflammation. metaplasia. scaly immature	5	13.5	2	5.4	7				2	4.8	4	9.5	6
Inflammation. atrophy with inflammation	3	8.1	2	5.4	5				19	45.2	14	33.3	33
Inflammation	11	29.7	12	32.4	22				2	4.8	1	2.4	3
Inflammation. nuclear activation	1	2.7	1	2.7	2				–	–	–	–	0
Microbiology					34	8.133	6	0.22					39	2.414	4	0.66
Lactobacillus sp.	11	32.4	10	29.4	21				11	28.2	13	33.3	24
Lactobacillus sp. Coconuts and other bacilli.	3	8.8	5	14.6	8				5	11.9	3	7.7	8
Lactobacillus sp. Coconuts. Candida sp.	3	8.8	1	2.9	4				–	–	–	–	0
Supracytoplasmic bacilli (suggestive of Gardnerella/Mobiluncus)	1	2.9	0	0	1				5	12.8	2	5.1	7
Conclusion of the analysis					37	0.047	1	0.82					39	0.27	1	0.87
Negative for malignancy	17	45.9	14	37.8	31				19	48.7	16	41.0	35
Atypical cells of undetermined significance. Scaly: Possibly non-neoplastic (ASC-US)	3	8.1	3	8.1	6				2	5.1	2	5.1	4
Sample observation					30	0.213	3	0.97					43	4.686	4	0.32
Nonspecific chronic cervicitis with squamous metaplasia	9	30.0	6	20.0	15				6	14.0	10	23.3	16
Chronic bacterial cervicitis with squamous metaplasia and nuclear activation	4	13.3	3	10.0	7				6	14.0	4	9.3	10
Chronic mycotic cervicitis with squamous metaplasia	1	3.3	1	3.3	2				3	7.0	2	4.7	5
Suggested colposcopy with directed biopsy.	3	10.0	3	10.0	6				8	18.6	3	7.0	11
Poor	–	–	–	–	0				0	0.0	1	2.3	1

Culture of vaginal secretion	Before								After
	Barbatimão ointment					X ²	GL	p ¹	Barbatimão ointment					X ²	GL	p ¹	p ^a
	No silver nanoparticles		With silver nanoparticles						No silver nanoparticles		With silver nanoparticles
	N	%	N	%	Total N				N	%	N	%	Total N
Presence of Microorganism					43	0.414	1	0.52					43	0.022	1	0.883	1.00^c
Absent	2	4.65	3	6.97	5				2	4.65	2	4.65	4
Present	21	48.8	17	39.5	38				21	48.8	18	41.8	39
Pathogenicity					43	1.082	1	0.29					43	0.393	1	0.531	0.02^b
Normal Microbiota	18	41.8	18	41.8	36				14	32.5	14	32.5	28
Pathogenic	5	11.6	2	4.65	7				9	20.9	6	13.9	15
Aerobic/Anaerobic					43	0	0	0					43	0.890	1	0.345	1.00^b
Optional anaerobic	23	53.4	20	46.5	43				22	51.1	20	46.5	42
Anaerobic	0	0.0	0	0.0	0				1	2.33	0	0.0	1
Antibiotic resistance					43	0.890	1	0.34					43	0.527	1	0.468	0.62^b
No	22	51.1	20	46.5	42				22	51.1	18	41.8	40
Yes	1	2.33	0	0.0	1				1	2.33	2	4.65	3
Gram positive/Gram negative					43	0.820	1	0.36					43	0.890	1	0.345	0.37^b
Positive	20	46.5	19	44.1	39				22	51.1	20	46.5	42
Variable	3	6.71	1	2.33	4				1	2.33	0	0.0	1
Search for Trichomonas vaginallis					43	0	0	0					43	0	0	0
Absent	23	53.4	20	46.5	43				23	53.4	20	46.5	43
Present	0	0.0	0	0.0	0				0	0.0	0	0.0	0
Search for Gardnerella vaginallis					43	0.225	1	0.63					43	1.082	1	0.298	0.12^b
Absent	21	48.8	19	44.1	40				18	41.8	18	41.8	36
Present	2	4.65	1	2.33	3				5	11.6	2	4.65	7
Search for Monilia					43	0.096	1	0.75					43	0.045	1	0.832	0.68^b
Absent	20	46.8	18	41.8	38				19	44.1	17	39.8	36
Present	3	6.70	2	4.65	5				4	9.30	3	6.70	7

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[1] Corresponding author: Guilherme Benjamin Brandão Pitta Rua Doutor Jorge de Lima, 113, Trapiche da Barra 57010-382 – Maceió, AL, Brazil guilhermebbpitta@gmail.com