Clinical Observation of Qingre Tiaoxue Decoction Combined with Wuwei Xiaodu Drink in Enema Treatment of Sequelae of Pelvic Inflammatory Disease / 中国实验方剂学杂志

ABSTRACT

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 follow-up, 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 for 3 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 (WHOQOL-BREF) 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-α and 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.