Background Pelvic inflammatory disease (PID), often triggered by pathogens like Chlamydia, is a major cause of female infertility. This study investigated molecular mechanisms in PID and the therapeutic potential of DanZhiYin (DZY) and its components. Methods Bioinformatic analysis of dataset GSE110106 identified differentially expressed genes in PID, validated clinically. A Chlamydia infection model in OE-E6/E7 cells was used. siRNA knockdown and overexpression revealed GADD45A's role. Anti-inflammatory effects of DZY, Salvia miltiorrhiza, and Poriferast-5-en-3β-ol were tested via quantitative reverse transcription polymerase Chain Reaction (qRT-PCR) and enzyme-linked immunosorbent assay (ELISA). Molecular dynamics and rescue experiments clarified the mechanism, and a PID mouse model assessed efficacy. Results MAPK signaling was upregulated in PID. GADD45A was identified as a key diagnostic marker, with an area under the curve (AUC) of 0.747. Chlamydia infection increased GADD45A and cytokines; its silencing reduced inflammation, while overexpression exacerbated it. DZY, Salvia miltiorrhiza, and Poriferast-5-en-3β-ol inhibited inflammation dose-dependently. Poriferast-5-en-3β-ol directly binds to GADD45A, thereby suppressing the production of IL-1β and TNF-α by inhibiting p38 MAPK and its phosphorylated form (p-p38). In vivo, all treatments reduced bacterial load and inflammation, with DZY being most effective. Conclusion GADD45A is a central inflammatory regulator in PID. DZY and Poriferast-5-en-3β-ol attenuate inflammation by targeting GADD45A, providing new mechanistic and therapeutic insights for PID.

目的 分析康妇消炎栓给药途径相关安全风险,为其安全合理使用提供参考.方法 总结康妇消炎栓不良反应监测数据、国内文献报道及药品监管机构采取的风险管理等资料,分析康妇消炎栓经阴道给药的不良反应情况,分析其存在的风险.结果 2004年1月1日至2022年1月31日,国家药品不良反应监测系统共收到康妇消炎栓不良反应报告1916例.康妇消炎栓为直肠栓,但有215例报告给药途径为阴道给药.对比分析显示,与直肠给药相比,阴道给药报告相关的用药部位疼痛,外阴阴道瘙痒、不适、灼烧感,过敏反应等占比更高.文献分析结果显示,经阴道给药可能影响其制剂疗效,并可能引起阴道刺激等不良反应.结论 根据药品不良反应评估结果,国家药品监督管理局已对康妇消炎栓药品说明书进行统一修订,药品上市许可持有人也应开展与医务人员和患者的沟通和教育,进一步控制康妇消炎栓阴道给药相关安全风险.

目的：观察中药坐浴联合保妇康栓纳阴治疗宫颈高危型人乳头瘤病毒(HPV)持续感染的临床疗效。方法：63例宫颈高危型HPV持续感染者，随机分为两组，观察组31例采用中药煎汤坐浴联合保妇康栓纳阴治疗，对照组32例单独使用保妇康栓治疗。结果：连续治疗3个疗程，停药后1个月复查HPV转阴率，观察组83.87%，对照组59.37%，观察组的宫颈外观改善也优于对照组；针对转阴者于停药后7个月再次复查HPV，观察组复阳率7.69%，对照组复阳率36.84%，观察组的宫颈外观改善仍优于对照组。差异均有统计学意义(P＜0.05)。结论：中药坐浴联合保妇康栓纳阴治疗宫颈高危型HPV持续感染疗效显著，且宫颈外观改善明显，HPV复阳率较低。

异病同治是指不同疾病在其发展过程中出现相同病机和证候时,可采用大致相同的治法和方药进行治疗[1].丹枝饮是北京中医药大学东方医院金哲教授的经验方,既往基础试验研究证明其可有效改善盆腔血流动力学,缓解盆腔"血瘀微环境"状态,具有化瘀通络之效[2～4],单盲法随机对照临床试验也证实该方对以"血瘀"为病机的盆腔炎性疾病后遗症、慢性盆腔痛等具有良好的临床疗效[5].本文通过总结该方异病同治实践经验,以推广名老中医的诊疗思路.

产后盆底功能障碍是以压力性尿失禁、粪失禁、盆腔器官脱垂和女性性功能障碍为主要临床表现的一种妇科疾病,严重影响患者产后的生活质量和心理健康.为有效预防和控制盆底功能障碍的发生、发展,本研究分别从"未病先防、既病防变、愈后防复"三个方面,结合偏颇体质类型,通过调摄精神、饮食调养、运动养生、起居有常等方法,以滋补肝肾、益气健脾、清热利湿、活血化瘀为治则,探讨体质调理在中医防治产后盆底功能障碍性疾病中的应用.

卵巢储备功能低下指卵巢内卵母细胞的数量减少和(或)质量下降,影响月经和排卵.西医多采用激素替代治疗或促排卵治疗,不易被患者接受,激素替代一旦停止,病情多复发.金哲教授从中医辨证求因、审因论治,认为临床上本病以肾气亏虚、肝郁脾虚证多见,治疗以补肾疏肝健脾为主,兼调冲任气血,以平为期,养卵、促卵相结合,注意作息、情志调摄,临床效果显著.

目的:评价灵莲花颗粒对不同睡眠质量更年期综合征(menopausal syndrome,MPS)(心肾不交证)患者的疗效.方法:选取2014年11月—2016年2月就诊于北京中医药大学东方医院、北京大学第一医院等11家医院门诊且符合MPS诊断属心肾不交证患者238例,其中睡眠质量良好者141例,质量较差者97例,根据不同治疗方法分为试验组及对照组,对照组给予坤泰胶囊,试验组给予灵莲花颗粒,比较两组疾病疗效、睡眠质量及激素水平[促卵泡生成激素(FSH)、雌二醇(E2)].结果:睡眠质量良好及较差者中试验组治疗后改良Kupperman评分、PSQI评分低于对照组,差异有统计学意义(P<0.05);试验组治疗后E2高于对照组,FSH低于对照组,且睡眠质量较差者疗效更佳,差异有统计学意义(P<0.05).结论:灵莲花颗粒可提高MPS心肾不交证患者的睡眠质量,改善其临床症状及激素水平,其整体疗效优于坤泰胶囊.

目的 基于中医传承辅助平台分析金哲教授对体外受精-胚胎移植(In vitro fertilization and embryo transfer,IVF-ET)失败后调理的用药规律,旨在为继承其学术经验提供相关量化数据支持.方法 收集整理2018年10月—2019年10月期间金哲教授门诊不孕症患者行IVF-ET失败后调理的处方150首,共涉及中药136味,运用中医传承辅助系统建立相应数据库,以挖掘高频药物、核心用药集群、新方分析等来总结金哲教授对IVF-ET失败后调理用药的配伍规律.结果 频次≥44次的中药有20味,高频药物组合中前5位分别是川芎、桑寄生,续断、桑寄生,菟丝子、枸杞子,月季花、川芎,丹参、桑寄生.结论 经数据挖掘统计分析得出金哲教授对IVF-ET失败后调理在补益肝肾的基础上,使用健脾养血通络的药物,能够改善子宫内膜环境和卵巢功能,从而提高IVF-ET的成功率,为临床IVF-ET失败调理提供思路.

目的评价妇炎舒胶囊联合应用抗菌药物治疗盆腔炎性疾病（PID）湿热瘀结证的有效性和安全性。方法采用前瞻性、多中心、随机、双盲设计,2017年6月至2018年9月在5家医院入组20～50岁288例PID患者,按区组随机1:1比例分配至研究组（采用妇炎舒胶囊治疗）及对照组（采用安慰剂治疗）,两组各144例均从入组第1～14 d加服左氧氟沙星片+甲硝唑片。比较两组治疗8周后（2个月经周期后）McCormack量表评分,中医证候等,并在停药后1个月后随访。结果研究组McCormack量表评分较治疗前下降[（7.65±2.21）分】,并高于对照组下降[（4.01±2.46）分]（P ＜0.0001）;研究组中医证候有效率[93.75%（135/144）]高于对照组[41.67%（60/144）]（P ＜0.0001）;研究组停药后1个月内复发率为3.50%（5/144）、盆腔痛发生率为10.49%（15/144）,均低于对照组（P ＜0.0001）。结论抗生素联合应用妇炎舒胶囊在改善PID患者McCormack量表评分、中医证候疗效、疾病及盆腔痛后遗症均优于单纯使用抗生素组。

卵巢储备功能指卵巢内储备的卵母细胞数量及质量,代表着女性的生殖潜能.卵巢储备功能下降(diminished ovarian reserve,DOR)是指卵巢产生卵子能力减弱,卵泡质量下降,导致女性生育能力下降及性激素缺乏的病症,进一步则可发展为早发性卵巢功能不全、卵巢早衰,影响女性的生殖能力[1].DOR目前已成为不孕症夫妇选择辅助生殖技术的第二大因素[2],其主要原因,无外乎"种、子"二字."种"为卵子的在官腔中的种植,"子"为卵子在卵巢中的发育.如何使DOR患者能够顺利"种子",一直是目前研究热点之一.现将DOR的中医助孕方略简述如下,与君共飨.

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(14d);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(28d),均随访2个月经周期.比较两组McCorrnack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14d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、28d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.

目的 探讨红核妇洁洗液治疗细菌性阴道病(BV)的有效性和安全性.方法 采用前瞻性、阳性药物平行对照、多中心临床研究方法,共纳入来源于2017年10月至2020年5月北京中医药大学东方医院等10家医院226例BV患者,试验组112例,给予红核妇洁洗液(10 mL/袋),每次1袋,稀释至100 mL阴道冲洗,2次/d,连用7d;对照组114例,给予甲硝唑栓(0.5 g/枚),睡前阴道给药,1次/d,连用7d.停药后3d比较两组阴道分泌物革兰染色积分法评分(Nugent评分)＜7分的患者所占百分率、Nugent评分变化值,阴道微生态恢复情况、中医证候疗效,并于停药28 d后比较两组疾病复发率.结果 停药后3d,两组Nugent评分均降低,试验组75.89％(85/112)的受试者Nugent评分＜7分,非劣于对照组78.95％(90/114),95％CI-0.1395 ～ 0.0784;在阴道微生态恢复方面两组疗效相当,试验组在改善阴道pH值方面有优势,差异无统计学意义(P=0.6679);两组中医证候评分均降低,试验组中医证候有效率65.45％(72/110),高于对照组60.53％(69/114),组间比较差异无统计学意义;其中气味臭秽消失率高于对照组17％,组间差异有统计学意义(P=0.0281).停药后28 d内,试验组复发率15.71％(11/70),低于对照组18.82％(16/85)3个百分点,差异无统计学意义(P=0.6115),提示红核妇洁洗液有更好预防BV复发的趋势.试验期间两组均未发生不良反应.结论 红核妇洁洗液治疗BV疗效非劣于甲硝唑栓,在改善阴道pH值方面有一定的优势,且疾病复发率更低,安全有效.

OBJECTIVE:To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease (PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine (TCM). METHODS:We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group (n = 78) and control group (n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d. They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge, and pelvic ultrasound. RESULTS:Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant (P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1 (P = 0.0131), and 73.33% of the experimental group and 56.94% of the control group at week 4 (P = 0.0369). No significant differences were found between the two groups on the Physicochemical indexes (all P > 0.05). No adverse events or reactions occurred in the experimental groups. CONCLUSION:Jinying capsule can reduce the dosage of antibiotics needed for PID treatment, and improve the symptoms in PID patients.

目的:基于中医传承辅助平台软件(v2.5),总结金哲教授辨证治疗DOR(卵巢储备功能下降)的用药规律.方法:纳入2016年7月—2018年6月金哲教授生殖内分泌门诊诊治的DOR患者62例、426诊次,采集患者临床信息,建立临床方剂基础数据库,对分别对月经前半期方215首、月经后半期方211首的用药频次、药物性味归经进行分析.结果:62例患者426诊次,月经前半期方215首共用药144种,累计用药频次3855,其中用药频次最高者为菟丝子,其后依次为白术、杜仲、枸杞子、红芪、生麦芽;月经后半期方211首共用药148种,累计用药频次3594,其中用药频次最高者为菟丝子,其后依次为白术、覆盆子、枸杞子、茯苓、红芪;药性使用频次最高者均为温性;药味使用频次最高者为甘味;归经频次最高者均为肝经、其次均为肾经、脾经.结论:金哲教授治疗DOR常肝脾肾同调,临证用药善于甘、温、苦、平配伍,以平为期,通过该研究,有助于把握金哲教授治疗本病的用药规律.

早期先兆流产是临床表现常为停经后有早孕反应,以后出现阴道少量流血,或时下时止,或淋漓不断,色红,持续数日或数周,无腹痛或有轻微下腹胀痛,腰痛及下腹坠胀感.金哲教授采用中药治疗早期先兆流产有丰富的临床经验,以补肾健脾安胎为主,兼益气养血、滋阴清热,常联合使用,疗效显著.

Objective: To determine the clinical features and outcomes of pneumocystic pneumonia (PCP) in patients treated with rituximab for autoimmune diseases. Methods: PCP patients with autoimmune diseases as underlying diseases from January 2009 to April 2019 in Peking University First Hospital (male 67 cases, female 35 cases, age 17-79) were retrospectively reviewed. Patients were grouped as rituximab group and non-rituximab group based on the fact if they were treated with rituximab before the onset of PCP. Demographic data, clinical features, and outcomes of the two groups were analyzed. Results: There were 102 cases altogether, and 7 patients were treated with rituximab before the onset of PCP. Patients in rituximab group were relatively younger than that in non-rituximab group [(32.0±18.7) vs (52.4±14.9) years, P=0.010]. Patients in rituximab group had more CD3(+), CD4(+), CD8(+)T lymphocytes in peripheral blood samples than that in non-rituximab group [(1 306±596) vs (546±439)/μl, (674±401) vs (243±232)/μl, (616±249) vs (282±256)/μl, respectively, all P<0.01]. However, the B lymphocyte count and plasma level of IgG and IgM were significantly lower in rituximab group than that in non-rituximab group [0 (0, 0.2) vs 72 (50.0, 124.4)/μl, 4.0 (2.6, 5.8) vs 9.4 (5.3, 12.0) g/L, 0.3 (0.2, 1.0) vs 1.1 (0.6, 1.8) g/L, respectively, all P<0.05]. The incidence of Cytomegalovirus (CMV) pneumonia was significantly lower in rituximab group (0/7 and 57/95, P=0.007). Other demographic data, the use of corticosteroids, the incidence of severe PCP, mechanical ventilation, intubation, pneumothorax and mediastinal emphysema complications, as well as hospital mortality and length of stay in hospital in the two groups were comparable. Conclusions: In patients treated with rituximab for autoimmune diseases, the number of B lymphocytes in peripheral blood and the plasma level of immunoglobulins but not CD3(+), CD4(+), and CD8(+)T lymphocyte counts may play an important role in the pathogenesis of PCP. These patients are not vulnerable to be complicated with CMV pneumonia.

Honghuaruyi (HHRY) pill is considered as an effective treatment for Chronic pelvic pain (CPP) with the efficacy of promoting qi and blood circulation but lack of high-quality clinical evidence. This study is to evaluate the efficacy and safeties of HHRY pill.280 patients were randomly divided into two groups to receive HHRY pill or placebo. Pain relief rate, curative effect of disease as well as qi stagnation and blood stasis symptom in TCM, clinical signs of CPP, adnexal masses size and amount of fluid and EQ-5D instruments were evaluated. After treatment, pain relief rate was significantly higher (P<0.05). There was also significant difference (P<0.0001) of curative effect in both disease and symptom. The score of low abdominal pain, etc. were significantly lower (P<0.05). The score of tenderness caused by limited uterine activity and thickening or with adnexal masses of attachments were significantly different (P<0.05). The increased size of adnexal mass in HHRY pill group was 0.53 ± 8.19 and was 0.80 ± 4.28 in placebo group. The decreasing amount of fluid in HHRY pill group was 0.53 ± 2.63 and was 1.10 ± 3.40 in placebo group. Pain, anxiety and EQ-VAS score were significantly improved (P<0.05). No serious adverse reactions occurred. This study indicated HHRY pill would reduce patients’ chronic pelvic pain, improve corresponding clinical signs, symptoms in TCM and enhance the quality of life. However, more biochemical indicators are needed to assess the effect.

Kangfu Xiaoyan Suppository is widely used in the treatment of gynecological inflammatory diseases. Long-term clinical application and a certain amount of research evidences show that Kangfu Xiaoyan Suppository can alleviate the clinical symptoms of pelvic inflammatory diseases,reduce the recurrence rate,and relieve sequelae,with a better safety and economic characteristics. As a type of nationally protected traditional Chinese medicine and type B medicine included in medical insurance,it has been selected as a Chinese patent medicine for rectal administration. It was included in the Guidelines for diagnosis and treatment of common gynecological diseases of traditional Chinese medicine published by the Chinese Academy of Traditional Chinese Medicine in 2012,the Pelvic inflammatory diseases diagnosis and treatment guidelines issued by the Infectious Diseases Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2014,and the group standard of Single use of traditional Chinese medicine/combined antibiot guidelines for clinical practice-pelvic inflammatory diseases of the Chinese Academy of Traditional Chinese Medicine in 2017. To further enhance clinicians' understanding of the drug and better guide its rational clinical use,experts from the field of gynecology of traditional Chinese and Western medicine were invited to develop and compile this expert consensus. This consensus takes full account of clinical evidences and expert clinical experience,and form recommendations for clinical problems based on evidences and consensus recommendations for clinical problems without evidence by nominal grouping method. The expert consensus is mainly formed in the consideration of six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on clinical research evidences and expert experience,this consensus provides a preliminary reference for the clinical use of the drug in a concise and clear format. However,evidence-based support is still required in a large number of high-quality studies,and this consensus will be revised in the future according to new clinical problems and the update of evidence-based evidence in practical application.

Objective To investigate the clinical characteristics and risk factors of cytomegalovirus (CMV) reactivation in immunocompetent patients in respiratory intensive care unit (RICU). Methods Clinical data of immunocompetent patients whose serum CMV-DNA was monitored during hospitalization in the RICU of Peking University First Hospital from July 2014 to July 2018 were collected and reviewed in this retrospective study. Patients were divided into the CMV reactivation group and non reactivation group. Demographics, clinical features, and outcomes of patients in the two groups were analyzed. The multivariable logistic regression analysis was used to analyze the independent risk factors for CMV reactivation. Results Of the 81 patients, 11 (13.6％) were in the reactivation group and 70 (86.4％) were in the non reactivation group. Length of RICU stay were longer in the group with CMV reactivation compared to patients without CMV reactivation [54(50, 68) vs 32(17, 43) d, P=0.012]. Baseline demographic and disease characteristics, rate of ventilator-associated pneumonia, duration of mechanical ventilation and mortality were similar in the two groups. Multivariable logistic regression analysis showed that blood transfusion (OR=11.481, 95％CI: 1.154-114.201; P=0.037) and corticosteroids use (OR=13.952, 95％CI:2.301-84.609; P=0.004) were independent risk factors for CMV reactivation. Conclusions CMV reactivation is associated with a longer stay in the RICU in immunocompetent patients, blood transfusion and corticosteroids use constitute risk factors.

卵巢储备功能降低(DOR)导致的不孕症业已成为生殖健康领域的难题,引起了国内外学者的广泛关注,其根本病机为肾精亏虚.中医药治疗不孕症历史悠久、经验丰富,针对DOR不孕症,从肾论治.将中西医治疗思想相结合,辨病论治与辨证论治结合,采纳中医专病通治方的理念,确定补肾养血、疏肝健脾的治法治则,组方遣药,通过中药补肾方加减可多系统、多靶点、多环节调节生殖功能,充分发挥中医药优势.同时,提出“长(卵)排(卵)并调,数量质量并举”假说,临床上采用中西医结合的两阶段疗法,达到增加卵泡数量,改善卵泡质量,促进卵泡发育和排出的效果,有效规范治疗DOR不孕症.