ObjectiveTo construct an outcome set for clinical evaluation of traditional Chinese medicine （TCM） for chronic pulmonary heart disease， and to provide consensus outcomes for the evaluation of the clinical effectiveness of TCM for chronic pulmonary heart disease. MethodsWe searched randomised controlled trials of TCM for chronic pulmonary heart disease on China National Knowledge Infrastructure （CNKI）， Wanfang Data Knowledge Service Platform （WF）， VIP Chinese Science Journals Database （VIP）， Chinese Biomedical Literature Service Database （SinoMed）， PubMed， Cochrane Library， and Embase. We also searched Chinese Clinical Trial Registry Platform and the U.S. Clinical Trial Registry database to obtain the outcome indicators reported in the clinical research protocols of TCM for chronic pulmonary heart disease. The outcome indicators were also collected through semi-structured interviews of clinicians and patients. Then integrated the outcome indicators collected by the above methods to construct the indicator pool. Through two rounds of Delphi surveys and a consensus conference， the core outcome set for clinical evaluation of TCM for chronic pulmonary heart disease was determined. ResultsAfter screening， there were 1313 literature meeting the criteria， and 595 outcome indicators were extracted， then combined with the outcomes from semi-structured interviews which clinicians and patients concerned， finally an indicator item pool containing 369 outcome indicators were formed. After the initial screening of indicators in the pool by the steering committee， 58 indicators were established into the initial list of indicator entries. In the first round of Delphi survey， the expert coordination coefficient for the results was 0.401， and the Cronbach coefficient was 0.989. A total of 35 indicators that did not meet the criteria ［＜70% of the participants rated the outcome as 7~9 （critical） and the mean of the expert ratings ＜7］ were deleted， and 23 were retained， with 7 new indicators added that were open to supplementation by the experts， resulting in a total of 30 indicators that were included in the second round of Delphi survey. In the second round of Delphi survey， the expert coordination coefficient was 0.303， and the Cronbach coefficient was 0.974， with a total of 7 indicators that did not meet the criteria being deleted， and 21 indicators being retained for the consensus conference. After the consensus meeting， the core outcome set for clinical evaluation of chronic pulmonary heart disease in two major categories， acute exacerbation stage and stable stage， was finally determined， in which there were four indicators in acute exacerbation stage： N-terminal B-type natriuretic peptide precursor （NT-proBNP）， blood qi analysis， all-cause mortality rate， and complication rate； and there were eight indicators in the stable stage： pulmonary function index， six-minute walk test distance， New York cardiac function classification， all-cause mortality rate， re-hospitalisation rate， Chronic Obstructive Pulmonary Disease Assessment Test （CAT） score， Short Form 36 Health Survey （SF-36）， and TCM syndrome score. ConclusionThe core outcome sets of TCM clinical evaluation in the acute exacerbation stage and stable stage are constructed， which is helpful to improve the practicability， comparability and transparency of TCM clinical research results in pulmonary heart disease.

Objective To systematically evaluate and compare the efficacy and safety of different oral Chinese patent medicine combined with hormone replacement therapy(HRT)in the treatment of ovarian hypofunction related diseases.Methods Relevant randomized controlled studies on Chinese patent medicine combined with HRT for the treatment of premature ovarian insufficiency,diminished ovarian reserve,premature ovarian failure were systematically searched in CNKI,WanFang,VIP,SinoMed,PubMed,and WOS databases,and the network Meta-analysis was performed using R 4.1.0 software.Results Eighty-three randomized controlled studies were included,with 3819 cases in the control group and 3844 cases in the experimental group,involving a total of 14 Chinese patent medicine(Kuntai capsule,Peikun pill,Zuogui pill,Heche Dazao capsule,Zishen Yutai pill,Fuke Yangrong capsule,Liuwei Dihuang pill,Rentaipan tablet,Guishen pill,Huanshao capsule,Qilin pill,Tiaojing Cuyun pill,Fufang Ejiao plasma,and Zuogui pill+Ruogui pill).The results of network Meta-analysis showed that:①Lowering of follicle stimulating hormone:the top 3 in the ranking were Zishen Yutai pill,Liuwei Dihuang pill,Fuke Yangrong capsule combined with HRT.② Increasing antral follicle counting:the top 3 in the ranking were Zuogui pill,Fuke Yangrong capsule,Zuogui pill+Ruogui pill combined with HRT.③Elevating of anti-Müllerian tube hormones:the top 3 in the ranking were Rentaipan tablet,Liuwei Dihuang pill,Kuntai capsule combined with HRT.④ Lowering Kupperman's score:the top 1 in the ranking was Kuntai capsule+HRT.⑤ Increasing in overall efficiency:the top 3 in the ranking were Fufang Ejiao plasma+HRT,Guishen pill+HRT,Zishen Yutai pill+HRT.The adverse events of combined HRT with oral Chinese patent medicine were mainly gastrointestinal discomfort,dizziness and headache,breast distension and pain.Conclusion The combination of oral Chinese patent medicine with HRT can better improve ovarian function and alleviate perimenopausal symptoms.For patients with fertility requirements,priority should be given to Fuke Yangrong capsule or Liuwei Dihuang pill combined with HRT to improve FSH levels and increase follicular reserve.For patients with obvious perimenopausal symptoms,priority should be given to Kuntai capsule combined with HRT to alleviate the symptoms.And Fufang Ejiao plasma,Guishen pill,Zishen Yutai pill combined with HRT should be given to increase the overall effective rate of the treatment.

Objective To systematically evaluate and compare the efficacy and safety of different oral Chinese patent medicine combined with hormone replacement therapy(HRT)in the treatment of ovarian hypofunction related diseases.Methods Relevant randomized controlled studies on Chinese patent medicine combined with HRT for the treatment of premature ovarian insufficiency,diminished ovarian reserve,premature ovarian failure were systematically searched in CNKI,WanFang,VIP,SinoMed,PubMed,and WOS databases,and the network Meta-analysis was performed using R 4.1.0 software.Results Eighty-three randomized controlled studies were included,with 3819 cases in the control group and 3844 cases in the experimental group,involving a total of 14 Chinese patent medicine(Kuntai capsule,Peikun pill,Zuogui pill,Heche Dazao capsule,Zishen Yutai pill,Fuke Yangrong capsule,Liuwei Dihuang pill,Rentaipan tablet,Guishen pill,Huanshao capsule,Qilin pill,Tiaojing Cuyun pill,Fufang Ejiao plasma,and Zuogui pill+Ruogui pill).The results of network Meta-analysis showed that:①Lowering of follicle stimulating hormone:the top 3 in the ranking were Zishen Yutai pill,Liuwei Dihuang pill,Fuke Yangrong capsule combined with HRT.② Increasing antral follicle counting:the top 3 in the ranking were Zuogui pill,Fuke Yangrong capsule,Zuogui pill+Ruogui pill combined with HRT.③Elevating of anti-Müllerian tube hormones:the top 3 in the ranking were Rentaipan tablet,Liuwei Dihuang pill,Kuntai capsule combined with HRT.④ Lowering Kupperman's score:the top 1 in the ranking was Kuntai capsule+HRT.⑤ Increasing in overall efficiency:the top 3 in the ranking were Fufang Ejiao plasma+HRT,Guishen pill+HRT,Zishen Yutai pill+HRT.The adverse events of combined HRT with oral Chinese patent medicine were mainly gastrointestinal discomfort,dizziness and headache,breast distension and pain.Conclusion The combination of oral Chinese patent medicine with HRT can better improve ovarian function and alleviate perimenopausal symptoms.For patients with fertility requirements,priority should be given to Fuke Yangrong capsule or Liuwei Dihuang pill combined with HRT to improve FSH levels and increase follicular reserve.For patients with obvious perimenopausal symptoms,priority should be given to Kuntai capsule combined with HRT to alleviate the symptoms.And Fufang Ejiao plasma,Guishen pill,Zishen Yutai pill combined with HRT should be given to increase the overall effective rate of the treatment.