1.Evaluation of the efficacy,safety and cost-effectiveness of different formulations of short-acting rhGH in the treatment of patients with short stature
Zhuoting ZHENG ; Yilong LIU ; Xiaomao QIN ; Zhen ZENG ; Run YAN ; Enwu LONG
China Pharmacy 2025;36(9):1111-1116
OBJECTIVE To compare the efficacy, safety, and cost-effectiveness of two different formulations of short-acting recombinant human growth hormone (rhGH) in the treatment of patients with short stature. METHODS Data from patients with short stature treated with short-acting rhGH at the Leshan People’s Hospital from August 2016 to June 2023 were collected. Patients were divided into powder formulation group and aqueous formulation group based on the rhGH formulation used. The changes in growth-related efficacy indicators and the occurrence of adverse drug reactions were compared between two groups after 12 months of treatment; cost-effectiveness analysis and sensitivity analysis were used to compare the cost per unit of effect achieved; subgroup analysis was performed by dividing the patients into growth hormone deficiency (GHD) subgroup and idiopathic short stature (ISS) subgroup based on clinical diagnosis. RESULTS After 12 months of treatment, the height and the levels of insulin-like growth factor-1 and insulin-like growth factor binding protein-3 in serum in aqueous formulation group and powder formulation group were significantly increased compared to before treatment (P<0.001), but there was no statistically significant difference in the changes of the above indicators between the two groups(P>0.05). The analysis results of GHD and ISS subgroups were consistent with the overall population. In the overall population, the cost-effectiveness ratio of powder formulation group (2 582 yuan/cm) was significantly better than that of aqueous formulation group (6 729 yuan/cm), with a statistically significant difference (P<0.001), and the result was consistent in the GHD and ISS subgroups as well as in the sensitivity analysis. No serious adverse drug reactions occurred in either powder formulation or aqueous formulation group, and there was no statistically significant difference in the incidence of various adverse reactions between two groups (P>0.05). CONCLUSIONS Short-acting rhGH powder and aqueous formulations have equivalent efficacy and safety, but the powder formulation has greater economic advantages.
2.Development of the Chinese Premature Ovarian Insufficiency Quality of Life Scale
Yunling ZHENG ; Yuxin ZOU ; Yucheng LI ; Zhuoting CHEN ; Liuqian HUANG ; Xinyi PAN ; Ling ZHU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(5):1287-1296
Objective To develop a quality of life(QoL)scale for Premature Ovarian Insufficiency(POI)with high reliability and validity in accordance with China's national conditions.Methods The theoretical framework of the scale was constructed under the guidance of traditional Chinese medicine theory with reference to the development method of the QoL scale.Literature analysis method,medical record review method,patient interview method,Delphi expert consultation method and clinical investigation were used to establish,improve and screen the scale items to form the final scale,and the characteristics and differentiation in terms of reliability and validity and feasibility of the final scale were evaluated.Results After screening the entries by the Delphi method and clinical surveys,the Chinese Premature Ovarian Insufficiency Quality of Life Scale was formed,which included three domains of physiology,psychology,and society,and eleven aspects such as menstruation,fertility,and physical symptoms,with 30 entries and two overall evaluations.The Cronbach's coefficient of this scale was 0.910,the fold-half coefficient was 0.956,and the re-test correlation coefficient was 0.868,which showed good internal consistency,fold-half and re-test reliabilities;the scale extracted 9 factors with characteristic root>1,and the cumulative variance contribution rate was 71.063%,the comparative fit index was 0.959,and the goodness-of-fit index was 0.919,and the degree of correlation was tested has showed that the content validity,structural validity and calibration correlation validity were good;the difference in the total scores of the scale between patients with POI and the healthy population was statistically significant,and the scale had a good degree of differentiation.Conclusion As confirmed by this study,the Chinese Premature Ovarian Insufficiency Quality of Life Scale has good reliability,validity,differentiation and feasibility,and can be used as a tool for evaluating the quality of life of POI patients in China as well as enriching the efficacy evaluation system of TCM in treating POI,and it is suitable for clinical popularization and application.
3.Development of the Chinese Premature Ovarian Insufficiency Quality of Life Scale
Yunling ZHENG ; Yuxin ZOU ; Yucheng LI ; Zhuoting CHEN ; Liuqian HUANG ; Xinyi PAN ; Ling ZHU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(5):1287-1296
Objective To develop a quality of life(QoL)scale for Premature Ovarian Insufficiency(POI)with high reliability and validity in accordance with China's national conditions.Methods The theoretical framework of the scale was constructed under the guidance of traditional Chinese medicine theory with reference to the development method of the QoL scale.Literature analysis method,medical record review method,patient interview method,Delphi expert consultation method and clinical investigation were used to establish,improve and screen the scale items to form the final scale,and the characteristics and differentiation in terms of reliability and validity and feasibility of the final scale were evaluated.Results After screening the entries by the Delphi method and clinical surveys,the Chinese Premature Ovarian Insufficiency Quality of Life Scale was formed,which included three domains of physiology,psychology,and society,and eleven aspects such as menstruation,fertility,and physical symptoms,with 30 entries and two overall evaluations.The Cronbach's coefficient of this scale was 0.910,the fold-half coefficient was 0.956,and the re-test correlation coefficient was 0.868,which showed good internal consistency,fold-half and re-test reliabilities;the scale extracted 9 factors with characteristic root>1,and the cumulative variance contribution rate was 71.063%,the comparative fit index was 0.959,and the goodness-of-fit index was 0.919,and the degree of correlation was tested has showed that the content validity,structural validity and calibration correlation validity were good;the difference in the total scores of the scale between patients with POI and the healthy population was statistically significant,and the scale had a good degree of differentiation.Conclusion As confirmed by this study,the Chinese Premature Ovarian Insufficiency Quality of Life Scale has good reliability,validity,differentiation and feasibility,and can be used as a tool for evaluating the quality of life of POI patients in China as well as enriching the efficacy evaluation system of TCM in treating POI,and it is suitable for clinical popularization and application.

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