CN116637160A - 健脾益肾祛湿丸及其在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用 - Google Patents
健脾益肾祛湿丸及其在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用 Download PDFInfo
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Abstract
本申请涉及健脾益肾祛湿丸及其在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用,临床疗效显著,盆腔炎性疾病后遗症脾虚湿盛证患者口服健脾益肾祛湿丸的临床疗效较好,可有效改善患者下腹疼痛、腰骶胀痛、带下异常、身倦乏力的症状,且安全性较高,值得临床上广泛推广使用。
Description
技术领域
本申请涉及生物医药技术领域,尤其涉及健脾益肾祛湿丸及其在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用。
背景技术
盆腔炎性疾病后遗症(SequelaeofPelvic Inflammatory Disease,SPID),是指女性的内生殖器及其周围结构如结缔组织、盆腔腹膜等产生的炎性疾病,未得到及时治疗而遗留的以慢性盆腔痛为主的后遗症,是妇科常见病之一。其临床症状主要有小腹和/或腰骶区域长期、反复的疼痛,劳累后、性交后、排便时及月经前后加重,伴有白带异常或月经紊乱。本病以往称之为慢性盆腔炎,具有病程时间长、容易反复发作、缠绵难愈的特点。相关流行病学显示,对于育龄期妇女而言,尤其是慢性盆腔炎导致的不孕患者占不孕患者总数的41.2%。SPID不仅增加了女性患不孕症、异位妊娠、慢性盆腔疼痛的风险,同时还可能带来其他一系列的健康问题,如抑郁,焦虑等心理精神疾病。
因此,积极有效的治疗盆腔炎对改善妇女的生活质量有着重要意义。西医治疗SPID大多采用抗生素对症治疗,起效快,但易导致病情迁延难愈,反复发作,并且长期或联合多种抗生素使用易产生耐药性,存在药物不良反应等问题。目前西医治疗SPID,尚无有效的治疗方法。SPID的治疗已成为现代医学亟待解决的临床关键科学问题。因此,开展针对SPID为核心的女性生殖系统疾病的中医防治研究已成为疾病治疗关键。
发明内容
鉴于上述问题,本申请的核心是提供一种健脾益肾祛湿丸及其在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用,可以解决西医治疗SPID易导致病情迁延难愈,反复发作,并且长期或联合多种抗生素使用易产生耐药性,存在药物不良反应的问题。
为解决上述技术问题,本申请提供了一种健脾益肾祛湿丸,包括:
黄芪13g、桑寄生13g、薏苡仁13g、党参片13g、续断片13g麸炒苍术13g、山药13g、蒲公英13g、白花蛇舌草13g、茯苓12g、败酱草12g、甘草片12g、赤芍12g。
为解决上述技术问题,本申请还提供了一种健脾益肾祛湿丸在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用。
优选地,所述健脾益肾祛湿丸的用法用量为每日3次,1次6g,饭后服用。
优选地,用药后观察使用者的下腹疼痛、腰骶胀痛、带下异常、身倦乏力指标。
本申请取得的有益效果是:
本申请发现并证明了健脾益肾祛湿丸在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用,临床疗效显著,盆腔炎性疾病后遗症脾虚湿盛证患者口服健脾益肾祛湿丸的临床疗效较好,可有效改善患者下腹疼痛、腰骶胀痛、带下异常、身倦乏力的症状,且安全性较高,值得临床上广泛推广使用。
具体实施方式
下面将结合实施例对本申请技术方案进行详细的描述。以下实施例仅用于更加清楚地说明本申请的技术方案,因此只作为示例,而不能以此来限制本申请的保护范围。除非另有定义,本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同;本文中所使用的术语只是为了描述具体的实施例的目的,不是旨在于限制本申请;本申请的说明书和权利要求书中的术语“包括”和“具有”以及它们的任何变形,意图在于覆盖不排他的包含。
本申请的核心是提供了一种健脾益肾祛湿丸及其在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用,解决了西医治疗SPID易导致病情迁延难愈,反复发作,并且长期或联合多种抗生素使用易产生耐药性,存在药物不良反应的问题。
本治疗适用的人群为:(1)年龄为20-50岁,有性生活的患者;(2)符合背景技术中SPID的西医诊断标准者;(3)符合背景技术中SPID的中医诊断标准者;(4)尿妊娠试验阴性者;
本治疗不适用的人群为:(1)年龄≤20周岁或≥50周岁,或无性生活史者;(2)不符合本病中医及西医诊断标准者;(3)急性盆腔炎、慢性盆腔炎急性发作者;(4)合并其他疾病如妇科肿瘤、急性阴道炎等;(5)合并心脑血管,肝肾及血液系统等全身性疾病患者。
一般资料:本实施例中的60例SPID患者均按照病症的诊断、纳入及排除不适用人群选取,按照随机数字表法,分为治疗组和对照组,各30例。观察组年龄31-47岁,平均(38.73±7.952)岁;对照组年龄32-48岁,平均(40.10±7.889)岁。两组患者的一般资料比较无显著差异(P>0.05),具有可比性。
治疗方法
对照组给予康妇炎胶囊治疗,主要成分:蒲公英、败酱草、薏苡仁、赤芍、苍术、当归、川芎、香附、延胡索、泽泻、白花蛇舌草,规格:0.4g×24粒×2板/盒,山东步长神州制药有限公司生产,国药准字:Z20055634。每日3次,1次3粒,饭后服用,14天为一个疗程。
治疗组给予健脾益肾祛湿丸治疗,组分:黄芪13g、桑寄生13g、薏苡仁13g、党参片13g、续断片13g麸炒苍术13g、山药13g、蒲公英13g、白花蛇舌草13g、茯苓12g、败酱草12g、甘草片12g、赤芍12g。使用时,将以上组分制成水丸,每瓶装60g。每日3次,1次6g,饭后服用,14天为一个疗程。
比较两组患者治疗前后中医证候分级量化积分:主症:①下腹疼痛;②腰骶胀痛;0~6分,(无~重)为评分标准,评分越高说明患者病情越重。次症:①带下异常;②经行腹痛加重;③月经不调;④经血有无血块;⑤身倦乏力;⑥低热起伏;0~3分,(无~重)为评分标准,评分越高说明患者病情越重。
(2)比较两组患者治疗前后局部体征量化积分:①子宫活动受限、压痛;②左侧附件增厚、包块、压痛;③右侧附件增厚、包块、压痛;④宫骶韧带增粗、压痛;0~3分,(无~重)为评分标准,评分越高说明患者病情越重。
参照《中药新药临床研究指导原则》、《妇产科学》、《中医妇科学》进行判定:①痊愈:治疗后下腹疼痛和腰骶胀痛等症状消失,妇科检查正常;证候及体征积分之和减少≥95%;②显效:治疗后下腹疼痛腰骶胀痛等症状明显减轻,妇科检查明显改善;证候及体征积分之和减少≥70%,<95%;③有效:治疗后下腹疼痛和腰骶胀痛等症减轻,妇科检查相对改善;证候及体征积分之和减少≥30%,<70%;④无效:治疗后下腹疼痛、腰骶胀痛等症无减轻或有加重,妇科检查较治疗前无改善或有所加重;证候及体征积分之和减少<30%。
数据分析采用SPSS 25.0软件对数据进行统计分析。计量资料以描述,计数资料以频数或百分率描述表示。符合方差齐性且呈正态分布的计量资料两组组间比较使用独立样本t检验、两组治疗前后组内比较使用配对样本t检验;计数资料两组组间比较采用χ2检验。检验水准α=0.05。
对两组患者治疗前的年龄、病程、中医证候评分及局部体征总分进行了分析比较,结果显示P>0.05,表明差异无统计学意义,故两组患者的一般资料及病情表现程度具有可比性。详见表1。
表1观察组与对照组的一般资料比较
治疗12周后临床疗效评价
由表2可知,60例盆腔炎患者经治疗12周后,观察组30例患者中有0例痊愈,28例显效,2例有效,0例无效,总有效率100.0%;对照组30例患者中有0例痊愈,12例显效,18例有效,0例无效,总有效率100.0%。经卡方检验P<0.05,认为治疗12周后两组间疗效比较有统计学意义,且观察组疗效优于对照组。
表2两组治疗12周临床疗效
治疗前后两组患者中医证候积分比较
由表3可知,观察组和对照组治疗后各中医证候积分及总分较治疗前均显著改善(P<0.05),且健脾益肾祛湿丸组治疗盆腔炎中医证候疗效更佳。进一步分析可知,与对照组同期比较,观察组治疗后对下腹疼痛、腰骶胀痛、带下异常、身倦乏力的疗效更佳(P<0.05)。
表3两组治疗前后各中医证候积分及总分比较
注:与对照组同期比较,*P<0.05,**P<0.01;与本组治疗前比较,△P<0.05,△△P<0.01。
治疗前后两组患者局部体征积分比较
由表4可知,观察组和对照组治疗后局部体征积分较治疗前均显著改善(P<0.05),且健脾益肾祛湿丸组治疗盆腔炎局部体征疗效更佳。
表4两组治疗前后局部体征积分比较
组别 | 0周 | 12周 | P值 |
观察组 | 7.30±1.968 | 1.23±1.006**△△ | P<0.05 |
对照组 | 8.03±1.732 | 3.00±1.203**△△ | P<0.05 |
注:与本组治疗前比较,*P<0.05,**P<0.01;与对照组同期比较,△P<0.05,△△P<0.01。
采用随即对照的临床研究方法,将符合纳入排除标准的60例患者,分为观察组(健脾益肾祛湿丸)、对照组(康妇炎胶囊)两组,观察两组治疗前后的临床疗效、中医证候积分、局部体征评分等指标的变化进行比较分析。得出的结果为:2组在中医症候积分、局部体征评分上比较,差异具有统计学意义;2组治疗后有效率评价比较,差异具有统计学意义。结论为:健脾益肾祛湿丸治疗盆腔炎性疾病后遗症脾虚湿盛证患者中,在改善下腹疼痛、腰骶胀痛、带下异常、身倦乏力方面的疗效优于对照组,彰显了健脾益肾祛湿丸治疗SPID的临床优势,为SPID患者的中医治疗提供了新的思路。同时通过实验数据表明健脾益肾祛湿丸在治疗盆腔炎性疾病后遗症脾虚湿盛证患者的临床疗效更显著,并可以有效改善其下腹疼痛、腰骶胀痛、带下异常、身倦乏力的症状。且安全性较高,值得临床上广泛推广使用。
最后应说明的是:以上各实施例仅用以说明本申请的技术方案,而非对其限制;尽管参阅前述各实施例对本申请进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本申请各实施例技术方案的范围,其均应涵盖在本申请的权利要求和说明书的范围当中。尤其是,只要不存在结构冲突,各个实施例中所提到的各项技术特征均可以任意方式组合起来。本申请并不局限于文中公开的特定实施例,而是包括落入权利要求的范围内的所有技术方案。
Claims (4)
1.一种健脾益肾祛湿丸,其特征在于,包括:
黄芪13g、桑寄生13g、薏苡仁13g、党参片13g、续断片13g麸炒苍术13g、山药13g、蒲公英13g、白花蛇舌草13g、茯苓12g、败酱草12g、甘草片12g、赤芍12g。
2.根据权利要求1所述的健脾益肾祛湿丸在治疗盆腔炎性疾病后遗症脾虚湿盛证中的应用。
3.根据权利要求2所述的应用,其特征在于,所述健脾益肾祛湿丸的用法用量为每日3次,1次6g,饭后服用。
4.根据权利要求1所述的应用,其特征在于,用药后观察使用者的下腹疼痛、腰骶胀痛、带下异常、身倦乏力指标。
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