摘要
目的探讨金英胶囊治疗盆腔炎性疾病(PID)(湿热蕴结证)的有效性及安全性。方法研究入选2016年1月至2017年9月共9家医院招募的PID(湿热蕴结证)患者,随机分为试验组和对照组。其中对照组给予左氧氟沙星片、甲硝唑片和金英胶囊模拟剂,疗程2周(14 d);试验组给予金英胶囊、左氧氟沙星片模拟剂和甲硝唑片模拟剂,疗程为4周(28 d),均随访2个月经周期。比较两组McCormack评分、中医证候评分、实验室检查指标、阴道分泌物涂片检查的变化以及随访疾病复发和后遗盆腔痛发生的情况并进行安全性评估。结果最终纳入统计分析155例,试验组77例,对照组78例。金英胶囊应用14、28 d与抗生素应用14 d均能有效改善McCormack量表评分,组间差异无统计学意义(P>0.05)。在28 d疗程结束4周后随访试验组与对照组受试者McCormack评分临床改善及以上分别达到了96.10%和96.16%;试验组治疗后7、14、28 d的中医证候愈显率高于对照组,但各项组两组间差异无统计学意义(P>0.05);比较试验组和对照组受试者的28 d疗程结束后4周随访的中医证候疗效愈显率,试验组为81.82%,明显高于对照组67.95%,且差异有统计学意义(P<0.05)。比较试验组和对照组受试者的总有效率,两组中医证候总有效率均显著提高,所有组间差异无统计学意义。随访复发率与后遗盆腔痛发生率,组间差异无统计学意义。试验组未发生不良事件及不良反应,两组不良反应及不良事件的发生率差异无统计学意义。结论金英胶囊单独用药治疗PID(湿热蕴结证)28 d疗程结束后4周随访中医证候愈显率明显高于左氧氟沙星片联合甲硝唑片治疗组,其治疗盆腔炎性疾病(湿热蕴结证)有一定临床疗效,未发现严重不良反应。
ObjectiveTo evaluate the the clinical efficacy and safety of Jinying capsules in treating pelvic inflammatorydisease(PID)(Accumulated Damp-heat Syndrome).MethodsFrom January 2016 to September 2017,patients withPID(accumulated damp-heat syndrome)were recruited from 9 hospitals and they were randomly divided into experimen-tal group and control group.The control group was treated with levofloxacin tablet,metronidazole tablet and Jinying cap-sules simulator for 2 weeks(14 days),while the experimental group was given Jinying capsule,levofloxacin tablet simula-tor and metronidazole tablet simulator for 4 weeks(28 days).Patients in both groups were followed up for 2 menstrual cy-cles.The following indexes were compared,including the scores of Mc Cormack and TCM syndrome,laboratory examina-tion indexs,examination of vaginal secretion smear,during the disease recurrence follow-up and subsequent pelvic pain,and the patient received a safety evaluation.ResultsA total of 155 patients were enrolled,77 in the experimental group,and 78 in the control group.Jinying capsule application for 14 and 28 days and antibiotic application for 14 days could ef-fectively improve the McCormack scale score,there beingno significant difference between the two groups(P>0.05).The clinical improvement of Mc Cormack score inthe experimental group and the control group reached96.10% and 96.16% respectively 4 weeks after the 28 dtreatment.The recovery rate of TCM syndrome in the ex-perimental group was higher than that in the control group on the 7 th,14 th and 28 th day after treatment,but there was no significant difference between the two groups(P>0.05).At the end of 4-week follow-up after the 28 d treatment,the recovery rate of TCM syndrome in the experimentalgroup was significantly higher than that in the control group(81.82% and 67.95%,respectively),and the difference be-tween the two groups was statistically significant(P<0.05).Comparing the total effective rate of the subjects in the exper-imental group and the control group,the total effective rate of TCM syndromes in the two groups were significantly im-proved,there being no significant difference between the two groups in the follow-up recurrence rate or the incidence ofsubsequent pelvic pain.There was no significant difference between the follow-up recurrence rate and the incidence ofpelvic pain.There were no adverse events or adverse reactions in the experimental group,and there was no significant dif-ference in the incidence of adverse events or adverse reactions between the two groups.ConclusionJinying capsulealone in the treatment of PID(accumulated damp-heat syndrome)4 weeks after the 28 d treatment has significantly high-er effevtive rate in the treatment of TCM syndrome than levofloxacin combined with metronidazole.Jinying capsule in thetreatment of pelvic inflammatory disease(accumulated damp-heat syndrome)has a certain clinical effect and no seriousadverse reactions are found.
作者
刘艳霞
刘朝晖
周德平
裴凤兰
李勤
陈淑琼
王秋凤
王延婷
金哲
LIU Yan-xia;LIU Zhao-hui;ZHOU De-ping;PEI Feng-lan;LI Qin;CHEN Shu-qiong;WANG Qiu-feng;WANG Yanting;JIN Zhe(Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078,China)
出处
《中国实用妇科与产科杂志》
CAS
CSCD
北大核心
2020年第2期163-167,共5页
Chinese Journal of Practical Gynecology and Obstetrics
