Clinical Comprehensive Evaluation of Jintiange Capsules in Treatment of Osteoporosis / 中国实验方剂学杂志

ABSTRACT

ObjectiveTo comprehensively evaluate the clinical value of Jintiange Capsules （JCs） in the treatment of osteoporosis （OP） and clarify the intrinsic advantages and clinical treatment characteristics of JCs， providing references for relevant departments of national health and medicine decision-making and the basis and clues for clinical and basic in-depth research. MethodBased on evidence-based medical evidence， this study integrated quantitative and qualitative methods and combined with questionnaires， official website data， human experience， pharmacoeconomic evaluation， and other research methods. From the effectiveness， safety， economy， innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics of the '6+1' dimension， the clinical evidence and value of JCs in the treatment of OP were comprehensively evaluated， forming the 'clinical evidence and value evaluation index'. The comprehensive evaluation of clinical value was based on the multi-criteria decision analysis framework. The expert meeting method was used to empower each dimension and value index. The clinical evidence and value evaluation software of Chinese patent medicine （CSC v2.0） was used to calculate the total value score， and the clinical advantages of JCs were comprehensively evaluated. ResultBased on randomized controlled clinical studies and systematic review， data analysis of spontaneous reporting system （SRS）， case reports， non-clinical safety studies， etc.， serious adverse drug reactions （ADRs） were reported after the launch of this product monitored by SRS， mainly involving abnormal liver function and adverse reactions of cardiovascular system. Therefore， the safety evidence adequacy of this product should be further improved， and the safety evaluation was Grade B. Meta-analysis showed that JCs were superior to the control group in improving the total clinical effective rate， improving bone mineral density， reducing visual analogue scale （VAS） score， and shortening fracture healing time. Combined with Grading of Recommendations Assessment， Development and Evaluation （GRADE） evidence evaluation， the comprehensive evaluation of effectiveness was Grade A. Pharmacoeconomic evaluation showed that JCs combined with calcium carbonate D3 tablets were more cost-effective than calcium carbonate D3 tablets alone in patients with OP. Compared with Gushukang capsules， JCs had more cost-effectiveness advantages， but the sample size included in the study was small， and the results needed to be verified by further studies. Combined with the results of the Comparative Assessment of Structure Prediction （CASP） evaluation list， the comprehensive economic evaluation was Grade B. JCs were the only bionic medicine of tiger bone in China with all intellectual property rights， with 3 national invention patents. Its process preparation and fingerprint detection had obvious technical advantages. It had innovative advantages in the supply base equipment， medicine resource management， production technology， and other aspects. Thus， its innovative comprehensive evaluation was Grade A. JCs were in capsule dosage form， which was relatively convenient for storage and transportation. The dosage form was suitable for indications， and the usage was easy for patients to grasp and accept. The statutory information and non-statutory information met the national standards. The comprehensive evaluation of suitability was Grade A. JCs did not contain toxic ingredients， had no restrictions on origin and prescription， and had abundant resources of original medicinal materials. The affordability of JCs in the treatment of OP was good in urban areas （14.97%） but not in rural areas （39.76%）. The price was higher than that of similar Chinese patent medicines， and the comprehensive evaluation of availability was Grade B. JCs had a reasonable proportion of natural animal bones， and their composition was basically the same as that of natural tiger bones. After marketing， more than 2 000 cases of real-world clinical research evidence was accumulated， and the comprehensive evaluation of TCM characteristics was Grade B. CSC v2.0 software was used for quantitative synthesis of the '6+1' dimension， and the comprehensive clinical value of JCs in the treatment of OP was Grade A. ConclusionJCs have good clinical value in the treatment of OP， and the TCM characteristics are prominent. It is suggested that JCs can be directly transformed into the related policy results of basic clinical drug management according to procedures.