Devasahayam J Christopher, Narmada Ashok, Aruna Ravivarma, Deepa Shankar, Erik Peterson, Phuong T Dinh, P K Vedanthan
{"title":"与fda批准的提取物相比,印度尘螨过敏原皮肤点刺试验提取物的低效力:一项双盲随机对照试验。","authors":"Devasahayam J Christopher, Narmada Ashok, Aruna Ravivarma, Deepa Shankar, Erik Peterson, Phuong T Dinh, P K Vedanthan","doi":"10.1177/2152656718796746","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration (USFDA)-approved extracts.</p><p><strong>Methods: </strong>A randomized comparison trial of Indian manufactured and USFDA-approved extracts of <i>Dermatophagoides pteronyssinus</i> (DP) and Dermatophagoides <i>farinae</i> (DF) was done at Christian Medical College & Hospital, Vellore, India from April 2014 to June 2015, to compare the skin test reactivity of indigenous allergen extracts of dust mites against validated allergen. Study enrollment included 197 patients with allergic disorders that showed sensitivity to dust mite during routine allergy skin testing. Study participants were tested with varying dilutions of DP and DF indigenous extracts along with USFDA-approved allergens in a blinded fashion. Results were recorded, and statistical significance was calculated using the Friedman rank sum test.</p><p><strong>Results: </strong>Using the Friedman rank sum test with a Tukey adjustment for multiple comparisons, we found that the extracts in each dilution were significantly different (<i>P</i> < .0001). The full strength indigenous extracts, B-DF (DF allergen standard extract from Bioproducts and Diagnostics, India) and C-DF (DF allergen extract from Creative Diagnostics, India) extracts, had mean wheal sizes of 7.69 (standard deviation [SD] 9.91) and 31.01(SD 51.04), respectively. The full strength S-DF (DF allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) had a mean wheal size of 109.97 (SD 162.73), which was significantly higher (<i>P</i> < .0001) than both the indigenous extracts. For each of the dilutions, the S-DF mean wheal size was significantly greater than that of the corresponding B-DF and C-DF wheal sizes. The full strength indigenous C-DP (DP allergen extract from Creative Diagnostics, India) had mean wheal size of 39.37 (SD 51.74). The full strength standard S-DP (DP allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) extract had a mean wheal size of 167.66 (SD 270.80), which was significantly higher (<i>P</i> < .0001) than the indigenous C-DP extract. Similar differences were seen across all dilutions.</p><p><strong>Conclusion: </strong>The indigenous extracts have significantly lower potency compared to USFDA-approved extracts; hence, there is an urgent need for policy makers to institute stringent criteria for standardization of antigens in India.</p>","PeriodicalId":45192,"journal":{"name":"Allergy & Rhinology","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2018-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/2152656718796746","citationCount":"6","resultStr":"{\"title\":\"Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial.\",\"authors\":\"Devasahayam J Christopher, Narmada Ashok, Aruna Ravivarma, Deepa Shankar, Erik Peterson, Phuong T Dinh, P K Vedanthan\",\"doi\":\"10.1177/2152656718796746\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration (USFDA)-approved extracts.</p><p><strong>Methods: </strong>A randomized comparison trial of Indian manufactured and USFDA-approved extracts of <i>Dermatophagoides pteronyssinus</i> (DP) and Dermatophagoides <i>farinae</i> (DF) was done at Christian Medical College & Hospital, Vellore, India from April 2014 to June 2015, to compare the skin test reactivity of indigenous allergen extracts of dust mites against validated allergen. Study enrollment included 197 patients with allergic disorders that showed sensitivity to dust mite during routine allergy skin testing. Study participants were tested with varying dilutions of DP and DF indigenous extracts along with USFDA-approved allergens in a blinded fashion. Results were recorded, and statistical significance was calculated using the Friedman rank sum test.</p><p><strong>Results: </strong>Using the Friedman rank sum test with a Tukey adjustment for multiple comparisons, we found that the extracts in each dilution were significantly different (<i>P</i> < .0001). The full strength indigenous extracts, B-DF (DF allergen standard extract from Bioproducts and Diagnostics, India) and C-DF (DF allergen extract from Creative Diagnostics, India) extracts, had mean wheal sizes of 7.69 (standard deviation [SD] 9.91) and 31.01(SD 51.04), respectively. The full strength S-DF (DF allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) had a mean wheal size of 109.97 (SD 162.73), which was significantly higher (<i>P</i> < .0001) than both the indigenous extracts. For each of the dilutions, the S-DF mean wheal size was significantly greater than that of the corresponding B-DF and C-DF wheal sizes. The full strength indigenous C-DP (DP allergen extract from Creative Diagnostics, India) had mean wheal size of 39.37 (SD 51.74). The full strength standard S-DP (DP allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) extract had a mean wheal size of 167.66 (SD 270.80), which was significantly higher (<i>P</i> < .0001) than the indigenous C-DP extract. Similar differences were seen across all dilutions.</p><p><strong>Conclusion: </strong>The indigenous extracts have significantly lower potency compared to USFDA-approved extracts; hence, there is an urgent need for policy makers to institute stringent criteria for standardization of antigens in India.</p>\",\"PeriodicalId\":45192,\"journal\":{\"name\":\"Allergy & Rhinology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2018-09-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1177/2152656718796746\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergy & Rhinology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/2152656718796746\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2018/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"OTORHINOLARYNGOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergy & Rhinology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/2152656718796746","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2018/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"OTORHINOLARYNGOLOGY","Score":null,"Total":0}
引用次数: 6
摘要
背景:皮肤点刺试验是检测免疫球蛋白e介导的变应性疾病最重要的诊断工具。随着在印度进行的过敏测试数量的增加,有必要了解本土提取物与美国食品和药物管理局(USFDA)批准的提取物的效力。方法:2014年4月至2015年6月,在印度Vellore基督教医学院和医院,对印度生产的和美国fda批准的Dermatophagoides pteronyssinus (DP)和Dermatophagoides farinae (DF)提取物进行随机比较试验,比较土产尘螨过敏原提取物与验证过敏原的皮肤试验反应性。研究纳入了197例在常规过敏皮肤试验中对尘螨敏感的过敏性疾病患者。研究参与者用不同稀释度的DP和DF本土提取物以及美国食品和药物管理局批准的过敏原进行盲法测试。记录结果,采用Friedman秩和检验计算统计显著性。结果:采用多重比较的弗里德曼秩和检验和Tukey调整,我们发现不同稀释度的提取物具有显著差异(P P P P结论:本土提取物的效价明显低于美国fda批准的提取物;因此,决策者迫切需要在印度制定严格的抗原标准化标准。
Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial.
Background: Skin prick testing is the most important diagnostic tool to detect immunoglobulin E-mediated allergic diseases. With increase in the number of allergy tests performed in India, it is imperative to know the potency of indigenous extracts in comparison with U.S. Food and Drug Administration (USFDA)-approved extracts.
Methods: A randomized comparison trial of Indian manufactured and USFDA-approved extracts of Dermatophagoides pteronyssinus (DP) and Dermatophagoides farinae (DF) was done at Christian Medical College & Hospital, Vellore, India from April 2014 to June 2015, to compare the skin test reactivity of indigenous allergen extracts of dust mites against validated allergen. Study enrollment included 197 patients with allergic disorders that showed sensitivity to dust mite during routine allergy skin testing. Study participants were tested with varying dilutions of DP and DF indigenous extracts along with USFDA-approved allergens in a blinded fashion. Results were recorded, and statistical significance was calculated using the Friedman rank sum test.
Results: Using the Friedman rank sum test with a Tukey adjustment for multiple comparisons, we found that the extracts in each dilution were significantly different (P < .0001). The full strength indigenous extracts, B-DF (DF allergen standard extract from Bioproducts and Diagnostics, India) and C-DF (DF allergen extract from Creative Diagnostics, India) extracts, had mean wheal sizes of 7.69 (standard deviation [SD] 9.91) and 31.01(SD 51.04), respectively. The full strength S-DF (DF allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) had a mean wheal size of 109.97 (SD 162.73), which was significantly higher (P < .0001) than both the indigenous extracts. For each of the dilutions, the S-DF mean wheal size was significantly greater than that of the corresponding B-DF and C-DF wheal sizes. The full strength indigenous C-DP (DP allergen extract from Creative Diagnostics, India) had mean wheal size of 39.37 (SD 51.74). The full strength standard S-DP (DP allergen extract from Jubilant Hollister Stier, Spokane, WA, USA) extract had a mean wheal size of 167.66 (SD 270.80), which was significantly higher (P < .0001) than the indigenous C-DP extract. Similar differences were seen across all dilutions.
Conclusion: The indigenous extracts have significantly lower potency compared to USFDA-approved extracts; hence, there is an urgent need for policy makers to institute stringent criteria for standardization of antigens in India.