清热调血汤内服联合五味消毒饮灌肠治疗湿热瘀滞证盆腔炎性疾病后遗症的临床观察

Clinical Observation of Qingre Tiaoxue Decoction Combined with Wuwei Xiaodu Drink in Enema Treatment of Sequelae of Pelvic Inflammatory Disease

目的:清热调血汤内服联合五味消毒饮灌肠评价中医综合疗法治疗盆腔炎性疾病后遗症(湿热瘀滞证)的临床疗效及对免疫炎症因子的调节作用。方法:将160例患者按随机数字表法以1∶1分为观察组和对照组各80例。对照组脱落、失访4例,剔除3例,完成73例;观察组脱落、失访4例,剔除2例,完成74例。对照组口服妇科千金胶囊,2粒/次,3次/d;采用五味消毒饮加减灌肠,1剂/d,煎制剂成150 mL,保留灌肠,1次/晚,保留2~4 h,于月经后3 d开始灌肠,每个周期连续灌肠14 d。观察组灌肠治疗同对照组,并给予清热调血汤加减内服,1剂/d。连续治疗3个月经周期,经期停服。盆腔疼痛程度采用疼痛视觉模拟评分(VAS)法,分别评价痛经程度和非经期下腹、腰骶的疼痛程度;进行治疗前后湿热瘀滞证,Mc Cormack量表,世界卫生组织生存质量测定简表(WHOQOL-BREF)评分;进行治疗前后阴道彩超检查、宫颈分泌物培养和白带常规检查;检测治疗前后CD4+,CD8+,CD4+/CD8+等T淋巴细胞亚群和肿瘤坏死因子(TNF)-α,白细胞介素-2(IL-2),IL-6水平;并进行安全性评价。结果:经重复测量的方差分析,两组患者治疗后痛经VAS评分和非经期VAS评分均逐渐下降(P<0.05),观察组在3个月经周期期间和治疗后的痛经VAS评分和非经期VAS评分均低于对照组(P<0.01);观察组体征评分、湿热瘀滞证评分均低于对照组(P<0.01),WHOQOL-BREF评分高于对照组(P<0.01);观察组患者盆腔积液深度和盆腔炎性包块的体积均小于对照组(P<0.01);观察组CD4+和CD4+/CD8+高于对照组(P<0.01),CD8+低于对照组(P<0.01);观察组TNF-α和IL-6水平均低于对照组(P<0.01),IL-2水平高于对照组(P<0.01);观察组综合疗效优于对照组(Z=2.028,P<0.05);观察组中医证候疗效优于对照组(Z=2.064,P<0.05);研究过程患者均没有发生严重不良事件,未发现中药相关不良反应。结论:清热调血汤加减内服联合五味消毒饮加减灌肠的综合疗法干预SPID湿热瘀滞证患者,可明显改善临床症状和体征,提高患者生活质量,并能调节细胞免疫功能和炎症因子,有着较好的综合疗效和中医证候疗效,临床使用安全。

Objective:To discuss clinical effect of comprehensive Qingre Tiaoxue decoction combined with Wuwei Xiaodu drink and enema to sequelae of pelvic inflammatory disease(syndrome of dampness heat stasis)and to study the moderating effect to immune inflammatory factor. Method: One hundred and sixty patients were randomly divided into control group(80 cases)and observation group(80 cases)by random number table. The 73 patients in control group completed the therapy(4 patients were exfoliated or lost to followup,3 patients were eliminate),74 patients in observation group completed the therapy(4 patients were exfoliated or lost to follow-up,2 patients were eliminate). Patients in control group got Fuke Qianjin capsules,2 grains/time,3 times/day,and at the third day after menstruation,addition and subtraction therapy of Wuwei Xiaodu drink with enema for 14 days at every night,1 dose/day,and enema continued for 2-4 h/day. Based on the treatment of enema in control group,patients in observation group added Qingre Tiaoxue decoction for3 menstrual cycles,1 dose/day,and stopping during menstrual cycle. Degree of pelvic pain,dysmenorrhea and the degree of pain in the lower abdomen and lumbosacral in the non menstrual period were evaluated by pain visual simulation score(VAS). Before and after treatment,scores of syndrome of dampness heat stasis,Mc Cormack scale,and Summary of the World Health Organization Quality of Life Measurement Scale(WHOQOLBREF)scale were graded,and vaginal ultrasonography,culture of cervical secretion and routine examination of leucorrhea were detected. And levels of CD4+,CD8+,CD4+/CD8+,T lymphocyte subsets,tumor necrosis factor-α(TNF-α),interleukin-2(IL-2)and IL-6 were detected and safety was evaluated. Result: By ANOVA of repeated measurement,after treatment,scores of VAS during dysmenorrheal and VAS during non menstrual period in two groups decreased(P<0.05),and during 3 menstrual cycles,scores of VAS during dysmenorrheal and VAS during non menstrual period in observation group were lower than those in control group(P<0.01).Scores of physical sign and syndrome of damp heat and stasis were lower than those in control group(P<0.01),score of WHOQOL-BREF was higher than that in control group(P<0.01). The depth of pelvic effusion and the volume of pelvic inflammatory mass in observation group were less than those in control group(P<0.01). Levels of CD4+,CD4+/CD8+and IL-2 were higher than those in control group(P<0.01),and levels of CD8+,TNF-αand IL-6 were lower than those in control group(P<0.01). Comprehensive curative effect in observation group was better than that in control group(Z=2.028,P<0.05). And curative effect of traditional Chinese medicine(TCM)Syndrome in observation group was better than that in in control group(Z=2.064,P<0.05). And there were no serious adverse events and adverse reaction caused by Chinese medicine. Conclusion: Comprehensive therapy of Chinese medicine and enema to sequelae of pelvic inflammatory disease can improve the clinical symptoms and signs,improve the quality of life of patients,and regulate the cellular immune function and inflammatory factors. It has better comprehensive curative effect and TCM syndrome curative effect,and is safe for clinical use.