Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmace...Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmaceutical quality of the original product and the generics including pH,content and related substance,and calcipotriol stability in the matrix.Intradermal retention of calcipotriol ointments in vitro was investigated using skin of Bama miniature pig.The pharmacodynamics study was performed in psoriasis guinea pig models.Results The matrix of original product is better than the generics,and influenced the drug diffusion,stability and in vitro retention,thus resulted in the difference in pharmacodynamics.The retention amount of calcipotriol in the original product was significantly higher than that of generic B,and approximately 4 folds higher than that of generic A.All of the three ointments improved pathological indexed in psoriasis guinea pigs,and there was a significant difference between the preparation group and the model group (P =0.001).Guinea pigs in the original group had the lowest interleukin-17 level (35.7 ± 1.13 μg/ml) and Baker Score (2.70 ± 0.97) compared with generic A (37.9 ±3.3 μg/ml,3.10 ± 0.22,respectively) and generic B (39 ± 4.6μg/ml,3.80 ± 0.57,respectively),but no statistical difference was found among the three groups (all P ＞ 0.05).Conclusions Difference occurs in the internal quality between the original product and the generics.The original preparation owns suitable balance between matrix stability and transdermal ability so that showes superiority in pharmaceutical properties,intradermal retention and therapeutic effect in vitro and in vivo,which suggests that more attention should be paid to the formulation and process during the research and development of the generics.The original product is recommended with priority for treatment especially at emergency.展开更多
目的:观察卤米松乳膏联合卡泊三醇软膏治疗稳定期斑块状银屑病患者的效果。方法:回顾性分析2020年7月至2021年7月该院收治的108例稳定期斑块状银屑病患者的临床资料,按照治疗方法不同将其分为观察组和对照组各54例。对照组予以卡泊三醇...目的:观察卤米松乳膏联合卡泊三醇软膏治疗稳定期斑块状银屑病患者的效果。方法:回顾性分析2020年7月至2021年7月该院收治的108例稳定期斑块状银屑病患者的临床资料,按照治疗方法不同将其分为观察组和对照组各54例。对照组予以卡泊三醇软膏治疗,观察组予以卤米松乳膏联合卡泊三醇软膏治疗,两组均治疗6周。比较两组治疗前后银屑病面积和严重程度指数(Psoriasis Area and severity Index,PASI)评分、临床疗效、治疗前后炎性因子[白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)]水平和不良反应发生率。结果:治疗后,两组PASI评分均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05);观察组治疗总有效率为94.44%(51/54),高于对照组的75.93%(41/54),差异有统计学意义(P<0.05);治疗后,两组IL-6、TNF-α水平均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:卤米松乳膏联合卡泊三醇软膏治疗稳定期斑块状银屑病患者可提高治疗总有效率,降低PASI评分和炎性因子水平,效果优于单纯卡泊三醇软膏治疗。展开更多
目的观察白芍总苷(total glucosides of paeony,TGP)联合窄谱中波紫外线(narrow band ultraviolet B light,NB-UVB)、卡泊三醇治疗中度寻常性银屑病的临床疗效和安全性。方法 154例中度寻常性银屑病患者随机分为治疗组78例和对照组76例...目的观察白芍总苷(total glucosides of paeony,TGP)联合窄谱中波紫外线(narrow band ultraviolet B light,NB-UVB)、卡泊三醇治疗中度寻常性银屑病的临床疗效和安全性。方法 154例中度寻常性银屑病患者随机分为治疗组78例和对照组76例。两组给予NB-UVB每周3次照射和卡泊三醇乳膏每日2次外用治疗,此外,治疗组给与白芍总苷胶囊600mg口服,3次/d。两组疗程均为8周。以银屑病皮损面积和严重程度(PASI)评分评价疗效并记录不良反应。结果治疗8周后,治疗组PASI评分(2.1±0.8)低于对照组(5.3±1.4),差异有统计学意义(P<0.05);治疗组有效率(88.46%)高于对照组(73.68%),差异有统计学意义(P<0.05)。两组未见明显不良反应。结论 TGP联合NB-UVB、卡泊三醇治疗中度寻常性银屑病疗效好,安全性高。展开更多
文摘Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmaceutical quality of the original product and the generics including pH,content and related substance,and calcipotriol stability in the matrix.Intradermal retention of calcipotriol ointments in vitro was investigated using skin of Bama miniature pig.The pharmacodynamics study was performed in psoriasis guinea pig models.Results The matrix of original product is better than the generics,and influenced the drug diffusion,stability and in vitro retention,thus resulted in the difference in pharmacodynamics.The retention amount of calcipotriol in the original product was significantly higher than that of generic B,and approximately 4 folds higher than that of generic A.All of the three ointments improved pathological indexed in psoriasis guinea pigs,and there was a significant difference between the preparation group and the model group (P =0.001).Guinea pigs in the original group had the lowest interleukin-17 level (35.7 ± 1.13 μg/ml) and Baker Score (2.70 ± 0.97) compared with generic A (37.9 ±3.3 μg/ml,3.10 ± 0.22,respectively) and generic B (39 ± 4.6μg/ml,3.80 ± 0.57,respectively),but no statistical difference was found among the three groups (all P ＞ 0.05).Conclusions Difference occurs in the internal quality between the original product and the generics.The original preparation owns suitable balance between matrix stability and transdermal ability so that showes superiority in pharmaceutical properties,intradermal retention and therapeutic effect in vitro and in vivo,which suggests that more attention should be paid to the formulation and process during the research and development of the generics.The original product is recommended with priority for treatment especially at emergency.
文摘目的:观察卤米松乳膏联合卡泊三醇软膏治疗稳定期斑块状银屑病患者的效果。方法:回顾性分析2020年7月至2021年7月该院收治的108例稳定期斑块状银屑病患者的临床资料,按照治疗方法不同将其分为观察组和对照组各54例。对照组予以卡泊三醇软膏治疗,观察组予以卤米松乳膏联合卡泊三醇软膏治疗,两组均治疗6周。比较两组治疗前后银屑病面积和严重程度指数(Psoriasis Area and severity Index,PASI)评分、临床疗效、治疗前后炎性因子[白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)]水平和不良反应发生率。结果:治疗后,两组PASI评分均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05);观察组治疗总有效率为94.44%(51/54),高于对照组的75.93%(41/54),差异有统计学意义(P<0.05);治疗后,两组IL-6、TNF-α水平均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:卤米松乳膏联合卡泊三醇软膏治疗稳定期斑块状银屑病患者可提高治疗总有效率,降低PASI评分和炎性因子水平,效果优于单纯卡泊三醇软膏治疗。
文摘目的观察白芍总苷(total glucosides of paeony,TGP)联合窄谱中波紫外线(narrow band ultraviolet B light,NB-UVB)、卡泊三醇治疗中度寻常性银屑病的临床疗效和安全性。方法 154例中度寻常性银屑病患者随机分为治疗组78例和对照组76例。两组给予NB-UVB每周3次照射和卡泊三醇乳膏每日2次外用治疗,此外,治疗组给与白芍总苷胶囊600mg口服,3次/d。两组疗程均为8周。以银屑病皮损面积和严重程度(PASI)评分评价疗效并记录不良反应。结果治疗8周后,治疗组PASI评分(2.1±0.8)低于对照组(5.3±1.4),差异有统计学意义(P<0.05);治疗组有效率(88.46%)高于对照组(73.68%),差异有统计学意义(P<0.05)。两组未见明显不良反应。结论 TGP联合NB-UVB、卡泊三醇治疗中度寻常性银屑病疗效好,安全性高。
