Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland: A meta-analysis and trial sequential analysis
Objective: To evaluate the efficacy and safety of Rupi Sanjie (RPSJ) capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland. Methods: A meta-analysis was conducted on randomized controlled trials (RCT) related to RPSJ capsule plus surgical operation...
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| Autores principales: | , |
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| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Editorial Board of Journal of Hainan Medical University
2021
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| Materias: | |
| Acceso en línea: | https://doaj.org/article/292465cc1b7d4aff914cb791b3bdc774 |
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| Sumario: | Objective: To evaluate the efficacy and safety of Rupi Sanjie (RPSJ) capsule plus the
conventional surgical operation for treatment of hyperplasia nodule of mammary gland.
Methods: A meta-analysis was conducted on randomized controlled trials (RCT) related to
RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary
gland. The methodological quality of eligible RCTs was assessed according to the criteria from
the Cochrane Handbook for Systematic Reviews of Interventions. RevMan5.3 and Stata14.0
were used for data analyses. Trial sequential analysis was performed to estimate the sample
size of systematic review base on TSA software v0.9. Results: Twenty-two RCTs were totally
included in this study, involving 2135 patients. The result showed the clinical recurrence rate
of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment
alone group (RR: 0.25, 95%CI [0.17, 0.37], P＜0.01). The clinical cure rate and total effective
rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical
treatment group (RR: 1.63, 95%CI [1.46, 1.82], P＜0.01); (RR: 1.29, 95%CI [1.22, 1.37], P
＜0.01). Application of RPSJ capsule decreased the occurrence of adverse events including
nausea, vomiting, irregular menstruation, constipation, dizziness, and headache etc. (RR: 0.90,
95%CI [0.54, 1.49], P=0.68). The results of trial sequential analysis demonstrated that the
current available data did not reach the expected value. Conclusion: RPSJ capsule plus the
conventional surgical treatment was more effective in reducing the clinical recurrence rate,
and improving the total clinical effective rate and clinical cure rate, with a decrease in the
occurrence of adverse events. |
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