宁心安神法联合按需盐酸达帕西汀片治疗原发性早泄的临床研究
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1.河南省濮阳市中医医院男科;2.北京中医药大学厦门医院男科;3.河南省中医药研究院附属医院

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国家中医药管理局全国名老中医卢太坤传承工作室项目[(2011)41];河南省中医药拔尖人才培养项目[(2021)15]


Clinical study on the treatment of primary premature ejaculation with Ningxinanshen method combined with Dapoxetine Hydrochloride Tablets on demand
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    摘要:

    目的:观察宁心安神法联合按需盐酸达帕西汀片(必利劲)治疗原发性早泄(PE)的临床疗效。 方法:将2020.1~2021.1我院男科门诊就诊的原发性PE患者120例,随机分成对照组和试验组,其中对照组60例给予盐酸达帕西汀片治疗,性生活前1~3h口服30mg;试验组60例在对照组基础上加服宁心止泄汤,每日1剂,早晚温服。治疗周期为2个月。评估2组阴道内射精潜伏时间(IELT)、早泄评估量表(PEP)、不良反应发生率和安全性等。结果:治疗后2组患者IELT均较治疗前明显延长(P<0.01),其差值试验组明显高于对照组(P<0.01);2组PEP评分指标明显改善(P<0.01),其差值试验组明显高于对照组(P<0.01);2组患者所有不良反应均较轻,无患者因不良反应而停药,不良反应发生率有显著性差异(P<0.05)。结论:宁心安神法联合按需盐酸达帕西汀片治疗原发性PE的临床疗效明显优于盐酸达帕西汀片单独治疗,能显著提高IELT和PEP,安全性高,具有较大的临床应用价值。

    Abstract:

    Objective To observe the clinical effect of Ningxinanshen method combined with Dapoxetine Hydrochloride Tablets (bilijin) on demand in the treatment of primary premature ejaculation (PE). Methods 120 patients with Primary PE from January 2020 to January 2021 were randomly divided into the control group and the experimental group. 60 patients were treated with Dapoxetine Hydrochloride Tablets, 30 mg, 1-3 hours before sex in the control group; 60 patients were given one dose of Ningxinzhixie decoction daily and taken warm in the morning and evening, additionally were given Dapoxetine Hydrochloride Tablets, 30 mg, 1-3 hours before sex in the experimental group.The treatment cycle is 2 months. Two groups were evaluated for intravaginal ejaculatory latency time,(IELT), premature ejaculation profile (PEP) , incidence of adverse events and safety. Results After treatment, the IELT of the two groups was significantly longer than that before treatment(P<0.01), and the difference between the experimental group and the control group was significantly higher(P<0.01); PEP scores were significantly improved in two groups (P<0.01), and the difference between the experimental group and the control group was significantly higher(P<0.01); All adverse reactions of the two groups were mild, and no patients stopped the drug due to adverse reactions. The incidence of adverse events was statistically significant between two groups.(P<0.05).Conclusion The clinical effect of Ningxinanshen method combined with Dapoxetine Hydrochloride Tablets on demand in the treatment of primary PE is significantly better than that of Dapoxetine Hydrochloride Tablets alone, which can significantly improve IELT and PEP, with high safety and great clinical application value.

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  • 收稿日期:2021-09-07
  • 最后修改日期:2021-11-11
  • 录用日期:2021-11-29
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