金鸡化瘀颗粒联合阿奇霉素治疗慢性盆腔炎的临床研究

Clinical study on Jinji Huayu Granules combined with azithromycin in treatment of chronic pelvic inflammation

目的探讨金鸡化瘀颗粒联合阿奇霉素治疗慢性盆腔炎的临床效果。方法选取2016年6月-2018年8月唐山市丰润区中医医院收治的94例慢性盆腔炎患者,随机分成对照组(n=47)和治疗组(n=47)。其中对照组口服阿奇霉素片,0.5 g/次,1次/d。治疗组在此基础上口服金鸡化瘀颗粒,10 g/次,3次/d。所有患者均治疗14 d。比较两组临床疗效及治疗前后主症积分变化;并于治疗前后,行常规妇科B超检查测量患者输卵管直径和盆腔包块直径,使用魏氏法测定红细胞沉降率(ESR),由血常规检查测定血小板计数(PLT)值,同时利用酶联免疫法检测两组患者血清肿瘤坏死因子(TNF)-α、白介素(IL)-4水平,分别采用免疫比浊法和化学发光法分析血清C反应蛋白(CRP)、糖蛋白抗原125(CA125)水平;汇总两组不良反应及随访6个月的复发情况。结果治疗后,对照组和治疗组的总有效率分别是83.0%、95.7%,两组比较差异有统计学意义(P<0.05)。与治疗前相比,两组治疗后各项主症(下腹胀痛或刺痛、腰骶胀痛、带下量多、带下色黄质稠或气臭)积分均显著降低(P<0.05);但治疗组下降更显著(P<0.05)。两组治疗后输卵管直径、盆腔包块直径较治疗前均显著缩短(P<0.05),且治疗组减小更显著(P<0.05)。与治疗前对比,两组治疗后ESR、PLT值及血清TNF-α、CRP、CA125浓度均显著降低(P<0.05),而血清IL-4水平均显著升高(P<0.05);且治疗后,治疗组上述指标(ESR、PLT、TNF-α、IL-4、CRP、CA125)的改善效果均显著优于对照组同期(P<0.05)。随访6个月,对照组和治疗组的复发率分别是25.5%、8.5%,两组比较差异有统计学意义(P<0.05)。结论金鸡化瘀颗粒联合阿奇霉素治疗慢性盆腔炎的整体疗效显著,可有效缓解患者症状,改善输卵管形态,缩小盆腔包块,纠正血瘀状态,正性调控体内促炎/抗炎因子表达,降低复发风险,具有一定的临床推广应用价值。

Objective To investigate the clinical effect of jinji Huayu Granules combined with azithromycin in treatment of chronic pelvic inflammation. Methods 94 Patients with chronic pelvic inflammatory admitted to Tangshan Fengrun distDrict Hospital of Traditional Chinese Medicine from June 2016 to August 2018 were randomly divided into control group(n=47) and treatment group(n=47). The control group was po administered with Azithromycin Tablets, 0.5 g/time, 1 time daily. The treatment group was po administered with Jinji Huayu Granules on the basis of control group, 10 g/time, three times daily. All patients were treated for 14 days. The clinical efficacy and the changes of main symptom scores before and after treatment were compared between the two groups. Before and after treatment, routine gynecological B-ultrasound examination was performed to measure the diameter of fallopian tube and pelvic mass of the subjects, the erythrocyte sedimentation rate(ESR) was determined by Wechsler method, the platelet count(PLT) was determined by routine blood examination, and the serum levels of tumor necrosis factor(TNF)-α and interleukin(IL)-4 were detected by enzyme-linked immunosorbent assay. The serum levels of C-reactive protein(CRP) and glycoprotein antigen 125(CA125) were analyzed by immunoturbidimetry and chemiluminescence respectively. Adverse reactions and recurrence after 6 months follow-up of the two groups were summarized. Results The total effective rate of the treatment group was 95.7%, significantly higher than that of the control group(83.0%)(P < 0.05). Compared with before treatment, the scores of main symptoms(lower abdominal distending pain or stabbing pain, lumbosacral distending pain, leukorrhagia, leukorrhagia yellow and thick or smelly) after treatment in both groups were significantly reduced(P < 0.05). However, the decrease was more significant in the treatment group(P < 0.05). After treatment, the diameter of fallopian tube and pelvic mass in the two groups were significantly shorter than before treatment(P < 0.05), and the reduction in the treatment group was more significant(P < 0.05). Compared with before treatment, ESR, PLT values and serum TNF-α, CRP, CA125 concentrations in the two groups were significantly decreased after treatment(P < 0.05), while serum IL-4 levels were significantly increased(P < 0.05). After treatment, the improvement effect of the above indexes(ESR, PLT, TNF-α, IL-4, CRP, CA125) in the treatment group is significantly better than that in the control group at the same time(P < 0.05). The recurrence rate of the treatment group after 6 months of follow-up was 8.5%, significantly lower than that of the control group(25.5%, P < 0.05). Conclusion Jinji Huayu Granules combined with azithromycin has a significant overall effect in the treatment of chronic pelvic inflammatory, and can effectively relieve the symptoms of patients, improve the shape of fallopian tubes, and can reduce pelvic mass, correct blood stasis state, positively regulate the expression of pro-inflammatory and anti-inflammatory factors, reduce the risk of recurrence, which has a certain clinical application value.